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    <VOL>89</VOL>
    <NO>248</NO>
    <DATE>Friday, December 27, 2024</DATE>
    <UNITNAME>Contents</UNITNAME>
    <CNTNTS>
        <AGCY>
            <EAR>
                Agency Health
                <PRTPAGE P="iii"/>
            </EAR>
            <HD>Agency for Healthcare Research and Quality</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Request for Information:</SJ>
                <SJDENT>
                    <SJDOC>Impact of Ageism in Healthcare, </SJDOC>
                    <PGS>105605-105606</PGS>
                    <FRDOCBP>2024-31074</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Agency</EAR>
            <HD>Agency for International Development</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Anti-Harassment Intake Summary Sheet, </SJDOC>
                    <PGS>105535</PGS>
                    <FRDOCBP>2024-30954</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Agricultural Marketing</EAR>
            <HD>Agricultural Marketing Service</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Fees for Official Inspection and Weighing Services under the United States Grain Standards Act, </DOC>
                    <PGS>105381-105386</PGS>
                    <FRDOCBP>2024-30603</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Agriculture</EAR>
            <HD>Agriculture Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Agricultural Marketing Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Crop Insurance Corporation</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Consumer Financial Protection</EAR>
            <HD>Bureau of Consumer Financial Protection</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Home Mortgage Disclosure Adjustment to Asset-Size Exemption Threshold, </DOC>
                    <PGS>105429-105431</PGS>
                    <FRDOCBP>2024-30652</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Centers Disease</EAR>
            <HD>Centers for Disease Control and Prevention</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Sole Source Cooperative Agreement:</SJ>
                <SJDENT>
                    <SJDOC>World Health Organization, </SJDOC>
                    <PGS>105607</PGS>
                    <FRDOCBP>2024-31197</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Centers Medicare</EAR>
            <HD>Centers for Medicare &amp; Medicaid Services</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>105607-105608</PGS>
                    <FRDOCBP>2024-30853</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Children</EAR>
            <HD>Children and Families Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Prevention Services Data Collection, </SJDOC>
                    <PGS>105608-105609</PGS>
                    <FRDOCBP>2024-31075</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Refugee Assistance Program Estimates: Cash and Medical Assistance, </SJDOC>
                    <PGS>105609-105610</PGS>
                    <FRDOCBP>2024-31044</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Unaccompanied Children Bureau Incident Reporting, </SJDOC>
                    <PGS>105610-105613</PGS>
                    <FRDOCBP>2024-30851</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Coast Guard</EAR>
            <HD>Coast Guard</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Electronic Submission of Mariner Course Completion Data; Correction, </DOC>
                    <PGS>105473</PGS>
                    <FRDOCBP>2024-30599</FRDOCBP>
                </DOCENT>
                <SJ>Safety Zone:</SJ>
                <SJDENT>
                    <SJDOC>Beaufort River, Beaufort, SC, </SJDOC>
                    <PGS>105451-105452</PGS>
                    <FRDOCBP>2024-30980</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Erie Canal, North Tonawanda, NY, </SJDOC>
                    <PGS>105453-105454</PGS>
                    <FRDOCBP>2024-30753</FRDOCBP>
                </SJDENT>
                <SJ>Security Zone:</SJ>
                <SJDENT>
                    <SJDOC>Port of Miami, Florida, </SJDOC>
                    <PGS>105454-105456</PGS>
                    <FRDOCBP>2024-30598</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Commerce</EAR>
            <HD>Commerce Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Industry and Security Bureau</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Institute of Standards and Technology</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Oceanic and Atmospheric Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Telecommunications and Information Administration</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Copyright Royalty Board</EAR>
            <HD>Copyright Royalty Board</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Adjustment of Cable Statutory License Royalty Rates, </DOC>
                    <PGS>105635</PGS>
                    <FRDOCBP>2024-30822</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Defense Department</EAR>
            <HD>Defense Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Navy Department</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>105553</PGS>
                    <FRDOCBP>2024-30889</FRDOCBP>
                      
                    <FRDOCBP>2024-30893</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Education Department</EAR>
            <HD>Education Department</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Assistance to States for the Education of Children with Disabilities; Withdrawal, </DOC>
                    <PGS>105505-105506</PGS>
                    <FRDOCBP>2024-31187</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Student Assistance General Provisions-Readmission for Servicemembers, </SJDOC>
                    <PGS>105554-105555</PGS>
                    <FRDOCBP>2024-30850</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Employment and Training</EAR>
            <HD>Employment and Training Administration</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>National Apprenticeship System Enhancements; Withdrawal, </DOC>
                    <PGS>105504-105505</PGS>
                    <FRDOCBP>2024-31078</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Energy Department</EAR>
            <HD>Energy Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Energy Regulatory Commission</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Western Area Power Administration</P>
            </SEE>
            <CAT>
                <HD>RULES</HD>
                <SJ>Energy Conservation Program:</SJ>
                <SJDENT>
                    <SJDOC>Energy Conservation Standards for Dishwashers, Residential Clothes Washers, and Consumer Clothes Dryers, </SJDOC>
                    <PGS>105408-105429</PGS>
                    <FRDOCBP>2024-30797</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Inflation Adjustment of Civil Monetary Penalties, </DOC>
                    <PGS>105403-105408</PGS>
                    <FRDOCBP>2024-30697</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Environmental Impact Statements; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Remediation of Area IV and the Northern Buffer Zone of the Santa Susana Field Laboratory, </SJDOC>
                    <PGS>105555-105559</PGS>
                    <FRDOCBP>2024-30795</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Environmental Protection</EAR>
            <HD>Environmental Protection Agency</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Air Quality State Implementation Plans; Approvals and Promulgations:</SJ>
                <SJDENT>
                    <SJDOC>Colorado; Common Provisions Regulation, </SJDOC>
                    <PGS>105461-105463</PGS>
                    <FRDOCBP>2024-30695</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Indiana; Update to Code of Federal Regulations References, </SJDOC>
                    <PGS>105459-105461</PGS>
                    <FRDOCBP>2024-30729</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Kentucky; Revisions to Jefferson County Control of Open Burning, </SJDOC>
                    <PGS>105463-105465</PGS>
                    <FRDOCBP>2024-30741</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Spokane Regional Clean Air Agency; Control of Emissions from Existing Large Municipal Waste Combustors, </SJDOC>
                    <PGS>105468-105470</PGS>
                    <FRDOCBP>2024-30535</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Washington; Excess Emissions, Startup, Shutdown, and Malfunction Revisions, Energy Facility Site Evaluation Council, </SJDOC>
                    <PGS>105456-105459</PGS>
                    <FRDOCBP>2024-30536</FRDOCBP>
                </SJDENT>
                <SJ>Outer Continental Shelf Air Regulations:</SJ>
                <SJDENT>
                    <SJDOC>Amendment to State Requirements Incorporated by Reference; Massachusetts, </SJDOC>
                    <PGS>105465-105468</PGS>
                    <FRDOCBP>2024-30800</FRDOCBP>
                </SJDENT>
                <SJ>Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Ethiprole, </SJDOC>
                    <PGS>105470-105472</PGS>
                    <FRDOCBP>2024-30581</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <PRTPAGE P="iv"/>
                    <DOC>Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen, Oxides of Sulfur, and Particulate Matter, </DOC>
                    <PGS>105692-105788</PGS>
                    <FRDOCBP>2024-29463</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Air Quality State Implementation Plans; Approvals and Promulgations:</SJ>
                <SJDENT>
                    <SJDOC>Florida; Second Planning Period Regional Haze Plan, </SJDOC>
                    <PGS>105506-105534</PGS>
                    <FRDOCBP>2024-30751</FRDOCBP>
                </SJDENT>
                <SJ>National Emission Standards for Hazardous Air Pollutants:</SJ>
                <SJDENT>
                    <SJDOC>Polyether Polyols Production Industry, </SJDOC>
                    <PGS>105986-106061</PGS>
                    <FRDOCBP>2024-29466</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Environmental Impact Statements; Availability, etc., </DOC>
                    <PGS>105604</PGS>
                    <FRDOCBP>2024-30976</FRDOCBP>
                </DOCENT>
                <SJ>Pesticides:</SJ>
                <SJDENT>
                    <SJDOC>Comparison of Aquatic Life Protective Values Developed under the Federal Insecticide, Fungicide and Rodenticide Act and the Clean Water Act, </SJDOC>
                    <PGS>105567-105604</PGS>
                    <FRDOCBP>2024-31086</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Executive Office</EAR>
            <HD>Executive Office for Immigration Review</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Clarification Regarding Bars to Eligibility During Credible Fear and Reasonable Fear Review, </DOC>
                    <PGS>105392-105403</PGS>
                    <FRDOCBP>2024-30500</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <DOC>Security Bars and Processing; Delay of Effective Date, </DOC>
                    <PGS>105386-105391</PGS>
                    <FRDOCBP>2024-30774</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Aviation</EAR>
            <HD>Federal Aviation Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Drug and Alcohol Testing of Certificated Repair Station Employees Located Outside of the United States; Correction, </DOC>
                    <PGS>105447</PGS>
                    <FRDOCBP>2024-30848</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <DOC>Regulatory Updates to BasicMed; Correction, </DOC>
                    <PGS>105446-105447</PGS>
                    <FRDOCBP>2024-30940</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <DOC>Removal of Check Pilot Medical Certificate Requirement; Correction, </DOC>
                    <PGS>105447-105448</PGS>
                    <FRDOCBP>2024-30939</FRDOCBP>
                </DOCENT>
                <SJ>Special Conditions:</SJ>
                <SJDENT>
                    <SJDOC>Safran Electric and Power S.A. Model ENGINeUS 100A1 Electric Engines, </SJDOC>
                    <PGS>105432-105446</PGS>
                    <FRDOCBP>2024-30855</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Airworthiness Directives:</SJ>
                <SJDENT>
                    <SJDOC>Deutsche Aircraft GmbH (Type Certificate Previously Held by 328 Support Services GmbH; AvCraft Aerospace GmbH; Fairchild Dornier GmbH; Dornier Luftfahrt GmbH) Airplanes, </SJDOC>
                    <PGS>105487-105490</PGS>
                    <FRDOCBP>2024-30763</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>General Electric Company Engines, </SJDOC>
                    <PGS>105483-105485</PGS>
                    <FRDOCBP>2024-30785</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>The Boeing Company Airplanes, </SJDOC>
                    <PGS>105485-105487</PGS>
                    <FRDOCBP>2024-30918</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Communications</EAR>
            <HD>Federal Communications Commission</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Achieving 100 Percent Wireless Handset Model Hearing Aid Compatibility, </DOC>
                    <PGS>105473</PGS>
                    <FRDOCBP>C1-2024-25088</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <DOC>Connect America Fund, Alaska Connect Fund, Eligible Telecommunication Carrier Annual Reports and Certifications, Telecommunications Carriers Eligible to Receive Universal Service Support, Universal Service Reform—Mobility Fund; Correction, </DOC>
                    <PGS>105473-105474</PGS>
                    <FRDOCBP>2024-30967</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <DOC>Interstate Telecommunications Relay Services Fund Support for Internet Protocol Captioned Telephone Service Compensation; Correction, </DOC>
                    <PGS>105474</PGS>
                    <FRDOCBP>2024-30498</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Charter Amendments, Establishments, Renewals and Terminations:</SJ>
                <SJDENT>
                    <SJDOC>Disability Advisory Committee, </SJDOC>
                    <PGS>105604</PGS>
                    <FRDOCBP>2024-30792</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Crop</EAR>
            <HD>Federal Crop Insurance Corporation</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Flax Revenue and Expanded Unit Options for Crop Insurance; Correction, </DOC>
                    <PGS>105381</PGS>
                    <FRDOCBP>2024-30548</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Energy</EAR>
            <HD>Federal Energy Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Application:</SJ>
                <SJDENT>
                    <SJDOC>Allegheny Hydro Group Lock and Dam 4, Inc., </SJDOC>
                    <PGS>105560</PGS>
                    <FRDOCBP>2024-30867</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>CW Bill Young Hydropower Group, Inc., </SJDOC>
                    <PGS>105563-105564</PGS>
                    <FRDOCBP>2024-30868</FRDOCBP>
                </SJDENT>
                <SJ>Authorization for Continued Project Operation:</SJ>
                <SJDENT>
                    <SJDOC>Briar Hydro Associates, </SJDOC>
                    <PGS>105559-105560</PGS>
                    <FRDOCBP>2024-31045</FRDOCBP>
                      
                    <FRDOCBP>2024-31047</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>City of St. Cloud, Minnesota, </SJDOC>
                    <PGS>105561-105562</PGS>
                    <FRDOCBP>2024-31046</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Combined Filings, </DOC>
                    <PGS>105562-105563</PGS>
                    <FRDOCBP>2024-31069</FRDOCBP>
                </DOCENT>
                <SJ>Environmental Assessments; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Appalachian Power Co., </SJDOC>
                    <PGS>105564</PGS>
                    <FRDOCBP>2024-31048</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Black Bayou Gas Storage, LLC, </SJDOC>
                    <PGS>105562</PGS>
                    <FRDOCBP>2024-30869</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Qualifying Facility Rates and Requirements Implementation Issues under the Public Utility Regulatory Policies Act, </SJDOC>
                    <PGS>105561</PGS>
                    <FRDOCBP>2024-30865</FRDOCBP>
                </SJDENT>
                <SJ>Interregional Transfer Capability Study:</SJ>
                <SJDENT>
                    <SJDOC>Strengthening Reliability through the Energy Transformation, </SJDOC>
                    <PGS>105790-105983</PGS>
                    <FRDOCBP>2024-30493</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Motor</EAR>
            <HD>Federal Motor Carrier Safety Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Exemption Application:</SJ>
                <SJDENT>
                    <SJDOC>Parts and Accessories Necessary for Safe Operation; Waymo, LLC and Aurora Operations, Inc.; Denial, </SJDOC>
                    <PGS>105675-105680</PGS>
                    <FRDOCBP>2024-30860</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Qualification of Drivers; Epilepsy and Seizure Disorders, </SJDOC>
                    <PGS>105680-105682</PGS>
                    <FRDOCBP>2024-30884</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Qualification of Drivers; Hearing, </SJDOC>
                    <PGS>105682-105683</PGS>
                    <FRDOCBP>2024-30896</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Railroad</EAR>
            <HD>Federal Railroad Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Petition for Extension of Waiver of Compliance, </DOC>
                    <PGS>105683-105684</PGS>
                    <FRDOCBP>2024-31054</FRDOCBP>
                      
                    <FRDOCBP>2024-31061</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Reserve</EAR>
            <HD>Federal Reserve System</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Change in Bank Control:</SJ>
                <SJDENT>
                    <SJDOC>Acquisitions of Shares of a Bank or Bank Holding Company, </SJDOC>
                    <PGS>105604-105605</PGS>
                    <FRDOCBP>2024-31073</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Food and Drug</EAR>
            <HD>Food and Drug Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Food Labeling:</SJ>
                <SJDENT>
                    <SJDOC>Nutrient Content Claims; Definition of Term Healthy, </SJDOC>
                    <PGS>106064-106165</PGS>
                    <FRDOCBP>2024-29957</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products, </DOC>
                    <PGS>105490-105504</PGS>
                    <FRDOCBP>2024-30544</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence, </DOC>
                    <PGS>105613-105617</PGS>
                    <FRDOCBP>2024-30776</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Foreign Assets</EAR>
            <HD>Foreign Assets Control Office</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Sanctions Action, </DOC>
                    <PGS>105687</PGS>
                    <FRDOCBP>2024-30821</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>General Services</EAR>
            <HD>General Services Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Acquisition Regulation:</SJ>
                <SJDENT>
                    <SJDOC>Office of Management and Budget Approval Table, </SJDOC>
                    <PGS>105474-105477</PGS>
                    <FRDOCBP>2024-30670</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Health and Human</EAR>
            <HD>Health and Human Services Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Agency for Healthcare Research and Quality</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Centers for Disease Control and Prevention</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Centers for Medicare &amp; Medicaid Services</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Children and Families Administration</P>
            </SEE>
            <SEE>
                <PRTPAGE P="v"/>
                <HD SOURCE="HED">See</HD>
                <P>Food and Drug Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Indian Health Service</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Institutes of Health</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Homeland</EAR>
            <HD>Homeland Security Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Coast Guard</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Transportation Security Administration</P>
            </SEE>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Procedures for Listing Designated Countries and Location of List, </DOC>
                    <PGS>105391-105392</PGS>
                    <FRDOCBP>2024-31210</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <DOC>Security Bars and Processing; Delay of Effective Date, </DOC>
                    <PGS>105386-105391</PGS>
                    <FRDOCBP>2024-30774</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Housing</EAR>
            <HD>Housing and Urban Development Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Application for Roster Personnel Designation and Appraisal Reports, </SJDOC>
                    <PGS>105622-105623</PGS>
                    <FRDOCBP>2024-30796</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Office of the Chief Human Capital Officer Personnel Security Integrated System for Tracking, </SJDOC>
                    <PGS>105621-105622</PGS>
                    <FRDOCBP>2024-31120</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Indian Health</EAR>
            <HD>Indian Health Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Indian Health Service Loan Repayment Program, </SJDOC>
                    <PGS>105617-105619</PGS>
                    <FRDOCBP>2024-31030</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Industry</EAR>
            <HD>Industry and Security Bureau</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Commerce Control List:</SJ>
                <SJDENT>
                    <SJDOC>Implementation of Controls on Advanced Technologies Consistent With Controls Implemented by International Partners; Correction, </SJDOC>
                    <PGS>105448-105450</PGS>
                    <FRDOCBP>2024-30723</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Interior</EAR>
            <HD>Interior Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Land Management Bureau</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Ocean Energy Management Bureau</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Internal Revenue</EAR>
            <HD>Internal Revenue Service</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Guidance:</SJ>
                <SJDENT>
                    <SJDOC>Definition of Domestically Controlled Qualified Investment Entities; Correction, </SJDOC>
                    <PGS>105450-105451</PGS>
                    <FRDOCBP>2024-30928</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>International Trade Com</EAR>
            <HD>International Trade Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Investigations; Determinations, Modifications, and Rulings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Certain Wireless Communication Devices and Components Thereof, </SJDOC>
                    <PGS>105627-105628</PGS>
                    <FRDOCBP>2024-30897</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Raw Flexible Magnets from China and Taiwan, </SJDOC>
                    <PGS>105627</PGS>
                    <FRDOCBP>2024-31085</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Justice Department</EAR>
            <HD>Justice Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Executive Office for Immigration Review</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Privacy Act; Matching Program, </DOC>
                    <PGS>105628-105629</PGS>
                    <FRDOCBP>2024-30466</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Labor Department</EAR>
            <HD>Labor Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Employment and Training Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Mine Safety and Health Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Occupational Safety and Health Administration</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Land</EAR>
            <HD>Land Management Bureau</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Environmental Impact Statements; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Approved Resource Management Plan Amendments and Record of Decision for Utility-Scale Solar Energy Development, </SJDOC>
                    <PGS>105623-105625</PGS>
                    <FRDOCBP>2024-30953</FRDOCBP>
                </SJDENT>
                <SJ>Public Land Order:</SJ>
                <SJDENT>
                    <SJDOC>No. 7956; Withdrawal of Pactola Reservoir—Rapid Creek Watershed; South Dakota, </SJDOC>
                    <PGS>105625-105626</PGS>
                    <FRDOCBP>2024-30790</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Library</EAR>
            <HD>Library of Congress</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Copyright Royalty Board</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Millenium</EAR>
            <HD>Millennium Challenge Corporation</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Report on the Selection of Eligible Countries for Fiscal Year 2025, </DOC>
                    <PGS>105635-105637</PGS>
                    <FRDOCBP>2024-30925</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Mine</EAR>
            <HD>Mine Safety and Health Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Ground Control for Surface Coal Mines and Surface Work Areas of Underground Coal Mines, </SJDOC>
                    <PGS>105633-105634</PGS>
                    <FRDOCBP>2024-30941</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Main Fan Operation and Inspection (I-A, II-A, III, and V-A Mines), </SJDOC>
                    <PGS>105632-105633</PGS>
                    <FRDOCBP>2024-30942</FRDOCBP>
                </SJDENT>
                <SJ>Petition:</SJ>
                <SJDENT>
                    <SJDOC>Modification of Application of Existing Mandatory Safety Standards, </SJDOC>
                    <PGS>105629-105631</PGS>
                    <FRDOCBP>2024-30944</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Credit</EAR>
            <HD>National Credit Union Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>105637-105638</PGS>
                    <FRDOCBP>2024-30989</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Institute</EAR>
            <HD>National Institute of Standards and Technology</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Dietary Supplement Laboratory Quality Assurance Program Consortium, </DOC>
                    <PGS>105535-105536</PGS>
                    <FRDOCBP>2024-30948</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Institute</EAR>
            <HD>National Institutes of Health</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>National Institute of Mental Health, </SJDOC>
                    <PGS>105619</PGS>
                    <FRDOCBP>2024-30957</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute on Aging, </SJDOC>
                    <PGS>105619-105620</PGS>
                    <FRDOCBP>2024-30874</FRDOCBP>
                      
                    <FRDOCBP>2024-30875</FRDOCBP>
                      
                    <FRDOCBP>2024-30876</FRDOCBP>
                      
                    <FRDOCBP>2024-30878</FRDOCBP>
                      
                    <FRDOCBP>2024-30879</FRDOCBP>
                      
                    <FRDOCBP>2024-30881</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Oceanic</EAR>
            <HD>National Oceanic and Atmospheric Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Fisheries of the Exclusive Economic Zone Off Alaska:</SJ>
                <SJDENT>
                    <SJDOC>Inseason Adjustment to the 2025 Bering Sea and Aleutian Islands Pollock, Atka Mackerel, and Pacific cod Total Allowable Catch Amounts, </SJDOC>
                    <PGS>105478-105481</PGS>
                    <FRDOCBP>2024-30714</FRDOCBP>
                </SJDENT>
                <SJ>Fisheries of the Exclusive Economic Zone off Alaska:</SJ>
                <SJDENT>
                    <SJDOC>Reallocation of Pacific Cod in the Central Regulatory Area of the Gulf of Alaska, </SJDOC>
                    <PGS>105481-105482</PGS>
                    <FRDOCBP>2024-30977</FRDOCBP>
                </SJDENT>
                <SJ>Taking or Importing of Marine Mammals:</SJ>
                <SJDENT>
                    <SJDOC>U.S. Navy Repair and Replacement of the Q8 Bulkhead at Naval Station Norfolk; Correction, </SJDOC>
                    <PGS>105477-105478</PGS>
                    <FRDOCBP>2024-30823</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Hearings, Meetings, Proceedings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Gulf of Mexico Fishery Management Council, </SJDOC>
                    <PGS>105540-105541</PGS>
                    <FRDOCBP>2024-31036</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Pacific Fishery Management Council, </SJDOC>
                    <PGS>105539-105542</PGS>
                    <FRDOCBP>2024-30794</FRDOCBP>
                      
                    <FRDOCBP>2024-31039</FRDOCBP>
                      
                    <FRDOCBP>2024-30786</FRDOCBP>
                </SJDENT>
                <SJ>Taking or Importing of Marine Mammals:</SJ>
                <SJDENT>
                    <SJDOC>Geophysical Surveys Related to Oil and Gas Activities in the Gulf of Mexico, </SJDOC>
                    <PGS>105536-105539</PGS>
                    <FRDOCBP>2024-31041</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>
                National Telecommunications
                <PRTPAGE P="vi"/>
            </EAR>
            <HD>National Telecommunications and Information Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Impact of L-Band MSS Direct-to-Device Operations on GPS, </DOC>
                    <PGS>105542-105553</PGS>
                    <FRDOCBP>2024-30760</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Navy</EAR>
            <HD>Navy Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>105553-105554</PGS>
                    <FRDOCBP>2024-30894</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Nuclear Regulatory</EAR>
            <HD>Nuclear Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Voluntary Reporting of Planned New Reactor Applications, </SJDOC>
                    <PGS>105638-105639</PGS>
                    <FRDOCBP>2024-31063</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Occupational Safety Health Adm</EAR>
            <HD>Occupational Safety and Health Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Nationally Recognized Testing Laboratories:</SJ>
                <SJDENT>
                    <SJDOC>UL LLC; Grant of Expansion of Recognition, </SJDOC>
                    <PGS>105634-105635</PGS>
                    <FRDOCBP>2024-31020</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Ocean Energy Management</EAR>
            <HD>Ocean Energy Management Bureau</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Joint Record of Decision:</SJ>
                <SJDENT>
                    <SJDOC>Proposed SouthCoast Wind Project, </SJDOC>
                    <PGS>105626-105627</PGS>
                    <FRDOCBP>2024-31062</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Pipeline</EAR>
            <HD>Pipeline and Hazardous Materials Safety Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>105684-105687</PGS>
                    <FRDOCBP>2024-30990</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Postal Service</EAR>
            <HD>Postal Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Product Change:</SJ>
                <SJDENT>
                    <SJDOC>Priority Mail and USPS Ground Advantage Negotiated Service Agreement, </SJDOC>
                    <PGS>105639-105644</PGS>
                    <FRDOCBP>2024-30801</FRDOCBP>
                      
                    <FRDOCBP>2024-30802</FRDOCBP>
                      
                    <FRDOCBP>2024-30803</FRDOCBP>
                      
                    <FRDOCBP>2024-30804</FRDOCBP>
                      
                    <FRDOCBP>2024-30805</FRDOCBP>
                      
                    <FRDOCBP>2024-30844</FRDOCBP>
                      
                    <FRDOCBP>2024-30847</FRDOCBP>
                      
                    <FRDOCBP>2024-31010</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Priority Mail Express, Priority Mail, and USPS Ground Advantage Negotiated Service Agreement, </SJDOC>
                    <PGS>105639-105645</PGS>
                    <FRDOCBP>2024-30807</FRDOCBP>
                      
                    <FRDOCBP>2024-30808</FRDOCBP>
                      
                    <FRDOCBP>2024-30809</FRDOCBP>
                      
                    <FRDOCBP>2024-30812</FRDOCBP>
                      
                    <FRDOCBP>2024-30813</FRDOCBP>
                      
                    <FRDOCBP>2024-30814</FRDOCBP>
                      
                    <FRDOCBP>2024-30815</FRDOCBP>
                      
                    <FRDOCBP>2024-30816</FRDOCBP>
                      
                    <FRDOCBP>2024-30819</FRDOCBP>
                      
                    <FRDOCBP>2024-30820</FRDOCBP>
                      
                    <FRDOCBP>2024-30829</FRDOCBP>
                      
                    <FRDOCBP>2024-30830</FRDOCBP>
                      
                    <FRDOCBP>2024-30833</FRDOCBP>
                      
                    <FRDOCBP>2024-30836</FRDOCBP>
                      
                    <FRDOCBP>2024-30837</FRDOCBP>
                      
                    <FRDOCBP>2024-30839</FRDOCBP>
                      
                    <FRDOCBP>2024-30840</FRDOCBP>
                      
                    <FRDOCBP>2024-30842</FRDOCBP>
                      
                    <FRDOCBP>2024-30995</FRDOCBP>
                      
                    <FRDOCBP>2024-31000</FRDOCBP>
                      
                    <FRDOCBP>2024-31001</FRDOCBP>
                      
                    <FRDOCBP>2024-31002</FRDOCBP>
                      
                    <FRDOCBP>2024-31004</FRDOCBP>
                      
                    <FRDOCBP>2024-31005</FRDOCBP>
                      
                    <FRDOCBP>2024-31007</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Presidential Documents</EAR>
            <HD>Presidential Documents</HD>
            <CAT>
                <HD>PROCLAMATIONS</HD>
                <SJ>Trade:</SJ>
                <SJDENT>
                    <SJDOC>United States-Israel Agreement on Trade in Agricultural Products and for Other Purposes; Implementation (Proc. 10875), </SJDOC>
                    <PGS>105333-105342</PGS>
                    <FRDOCBP>2024-31353</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>EXECUTIVE ORDERS</HD>
                <DOCENT>
                    <DOC>Executive Orders Relating to Certain Certificates and Badges; Amendments (EO 14131), </DOC>
                    <PGS>105377-105379</PGS>
                    <FRDOCBP>2024-31355</FRDOCBP>
                </DOCENT>
                <DOCENT>
                    <DOC>Manual for Courts Martial, United States; 2024 Amendments (EO 14130), </DOC>
                    <PGS>105343-105376</PGS>
                    <FRDOCBP>2024-31354</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Securities</EAR>
            <HD>Securities and Exchange Commission</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Electronic Data Gathering, Analysis, and Retrieval System Filer Access and Account Management, </DOC>
                    <PGS>106168-106229</PGS>
                    <FRDOCBP>2024-30494</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>105664-105665</PGS>
                    <FRDOCBP>2024-30768</FRDOCBP>
                </DOCENT>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Qualitative Feedback on Agency Service Delivery, </SJDOC>
                    <PGS>105673</PGS>
                    <FRDOCBP>2024-30986</FRDOCBP>
                </SJDENT>
                <SJ>Self-Regulatory Organizations; Proposed Rule Changes:</SJ>
                <SJDENT>
                    <SJDOC>BOX Exchange LLC, </SJDOC>
                    <PGS>105657-105660</PGS>
                    <FRDOCBP>2024-30899</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Cboe BZX Exchange, Inc., </SJDOC>
                    <PGS>105650-105654, 105665-105669</PGS>
                    <FRDOCBP>2024-30905</FRDOCBP>
                      
                    <FRDOCBP>2024-31092</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Cboe EDGX Exchange, Inc., </SJDOC>
                    <PGS>105660-105664</PGS>
                    <FRDOCBP>2024-30901</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>ICE Clear Credit LLC, </SJDOC>
                    <PGS>105654-105657</PGS>
                    <FRDOCBP>2024-30778</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>NYSE American, LLC, </SJDOC>
                    <PGS>105669-105673</PGS>
                    <FRDOCBP>2024-31090</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>NYSE Arca, Inc., </SJDOC>
                    <PGS>105650</PGS>
                    <FRDOCBP>2024-30914</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>The Options Clearing Corp., </SJDOC>
                    <PGS>105645-105650</PGS>
                    <FRDOCBP>2024-31089</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Small Business</EAR>
            <HD>Small Business Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Disaster Declaration:</SJ>
                <SJDENT>
                    <SJDOC>North Carolina; Public Assistance Only, </SJDOC>
                    <PGS>105673-105674</PGS>
                    <FRDOCBP>2024-30922</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Social</EAR>
            <HD>Social Security Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Civil Monetary Penalty Inflation Adjustment, </DOC>
                    <PGS>105674</PGS>
                    <FRDOCBP>2024-30791</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>State Department</EAR>
            <HD>State Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Culturally Significant Objects Imported for Exhibition:</SJ>
                <SJDENT>
                    <SJDOC>Edvard Munch: Technically Speaking, </SJDOC>
                    <PGS>105674-105675</PGS>
                    <FRDOCBP>2024-30946</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Transportation Department</EAR>
            <HD>Transportation Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Aviation Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Motor Carrier Safety Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Railroad Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Pipeline and Hazardous Materials Safety Administration</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Security</EAR>
            <HD>Transportation Security Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Speaker Request Form, </SJDOC>
                    <PGS>105620-105621</PGS>
                    <FRDOCBP>2024-30789</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Treasury</EAR>
            <HD>Treasury Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Foreign Assets Control Office</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Internal Revenue Service</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Reporting, Procedures and Penalties Regulations, </SJDOC>
                    <PGS>105687-105688</PGS>
                    <FRDOCBP>2024-30825</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Insurance Marketplace Aggregate Retention Amount Calculation for Calendar Year 2025 under the Terrorism Risk Insurance Program, </DOC>
                    <PGS>105688-105689</PGS>
                    <FRDOCBP>2024-30885</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Veteran Affairs</EAR>
            <HD>Veterans Affairs Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Veterans Legacy Memorial, </SJDOC>
                    <PGS>105689-105690</PGS>
                    <FRDOCBP>2024-30949</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Western</EAR>
            <HD>Western Area Power Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Rate Order:</SJ>
                <SJDENT>
                    <SJDOC>No. WAPA-219; Loveland Area Projects, </SJDOC>
                    <PGS>105564-105567</PGS>
                    <FRDOCBP>2024-30862</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <PTS>
            <HD SOURCE="HED">Separate Parts In This Issue</HD>
            <HD>Part II</HD>
            <DOCENT>
                <DOC>Environmental Protection Agency, </DOC>
                <PGS>105692-105788</PGS>
                <FRDOCBP>2024-29463</FRDOCBP>
            </DOCENT>
            <HD>Part III</HD>
            <DOCENT>
                <DOC>Energy Department, Federal Energy Regulatory Commission, </DOC>
                <PGS>105790-105983</PGS>
                <FRDOCBP>2024-30493</FRDOCBP>
            </DOCENT>
            <HD>Part IV</HD>
            <DOCENT>
                <DOC>Environmental Protection Agency, </DOC>
                <PGS>105986-106061</PGS>
                <FRDOCBP>2024-29466</FRDOCBP>
                <PRTPAGE P="vii"/>
            </DOCENT>
            <HD>Part V</HD>
            <DOCENT>
                <DOC>Health and Human Services Department, Food and Drug Administration, </DOC>
                <PGS>106064-106165</PGS>
                <FRDOCBP>2024-29957</FRDOCBP>
            </DOCENT>
            <HD>Part VI</HD>
            <DOCENT>
                <DOC>Securities and Exchange Commission, </DOC>
                <PGS>106168-106229</PGS>
                <FRDOCBP>2024-30494</FRDOCBP>
            </DOCENT>
        </PTS>
        <AIDS>
            <HD SOURCE="HED">Reader Aids</HD>
            <P>Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.</P>
            <P>To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.</P>
        </AIDS>
    </CNTNTS>
    <VOL>89</VOL>
    <NO>248</NO>
    <DATE>Friday, December 27, 2024</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <RULES>
        <RULE>
            <PREAMB>
                <PRTPAGE P="105381"/>
                <AGENCY TYPE="F">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBAGY>Federal Crop Insurance Corporation</SUBAGY>
                <CFR>7 CFR Part 457</CFR>
                <DEPDOC>[Docket ID FCIC-24-0005]</DEPDOC>
                <RIN>RIN 0563-AC86</RIN>
                <SUBJECT>Flax Revenue and Expanded Unit Options for Crop Insurance; Correction</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Crop Insurance Corporation, U.S. Department of Agriculture (USDA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Correcting amendment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>On November 27, 2024, the Federal Crop Insurance Corporation revised the Area Risk Protection Insurance Regulations and Common Crop Insurance Policy, Basic Provisions. In reviewing the changes made, FCIC found provisions that were inadvertently omitted and provisions that should have been omitted but were not. This document makes the corrections.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective December 27, 2024.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Chandra Place; telephone (816) 926-3875; email 
                        <E T="03">chandra.place@usda.gov.</E>
                         Persons with disabilities who require alternative means of communication should contact the USDA Target Center at (202) 720-2600 or 844-433-2774.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    The Common Crop Insurance Regulations in 7 CFR part 457 were revised by a final rule with request for comments published in the 
                    <E T="04">Federal Register</E>
                     on November 27, 2024 (89 FR 93463-93470). Changes were made in that rule to regulations to allow revenue coverage for flax under the Small Grain Crop Insurance Provisions (7 CFR 457.101), to combine written agreement deadlines in the Dry Bean Crop Insurance Provisions (7 CFR 457.150) to match other insurance policies, to expand the availability of enterprise and optional units for some specialty and perennial crops, and to make clarifications and corrections to the Area Risk Protection Insurance Policy, Basic Provisions (7 CFR part 407) and Common Crop Insurance Policy, Basic Provisions (7 CFR 457.8). Since the publication of the rule, FCIC has identified provisions that were inadvertently omitted and provisions that should have been omitted but were not that need correction. This document makes the corrections in the following Provisions:
                </P>
                <P>• Small Grains Crop Insurance Provisions (7 CFR 457.101); and</P>
                <P>• Green Pea Crop Insurance Provisions (7 CFR 457.137).</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 7 CFR Part 457</HD>
                    <P>Acreage allotments, Crop insurance, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <P>Accordingly, 7 CFR part 457 is corrected by making the following amendments:</P>
                <PART>
                    <HD SOURCE="HED">PART 457—COMMON CROP INSURANCE REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="7" PART="457">
                    <AMDPAR>1. The authority citation for part 457 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>7 U.S.C. 1506(l), 1506(o).</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="457">
                    <AMDPAR>2. In § 457.101, in the “Small Grains Crop Provisions”, in section 11, add paragraphs (c)(1)(i)(A) through (D) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 457.101</SECTNO>
                        <SUBJECT>Small grain crop insurance provisions.</SUBJECT>
                        <STARS/>
                        <HD SOURCE="HD3">11. Settlement of Claim</HD>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(1) * * *</P>
                        <P>(i) * * *:</P>
                        <P>(A) Which is abandoned;</P>
                        <P>(B) Put to another use without our consent;</P>
                        <P>(C) Damaged solely by uninsured causes; or</P>
                        <P>(D) For which you fail to provide records of production that are acceptable to us;</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="7" PART="457">
                    <AMDPAR>3. In § 457.137, revise the introductory text to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 457.137</SECTNO>
                        <SUBJECT>Green pea crop insurance provisions.</SUBJECT>
                        <P>The Green Pea Crop Insurance Provisions for the 2025 and succeeding crop years are as follows:</P>
                        <FP SOURCE="FP-1">United States Department of Agriculture</FP>
                        <FP SOURCE="FP-1">Federal Crop Insurance Corporation</FP>
                        <FP SOURCE="FP-1">Green Pea Crop Provisions</FP>
                        <P>In return for your payment of premium and administrative fee for the coverage, these Green Pea Crop Provisions will be attached to and made part of the Common Crop Insurance Policy, Basic Provisions (Basic Provisions) subject to the terms and conditions in your policy.</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <NAME>Marcia Bunger,</NAME>
                    <TITLE>Manager, Federal Crop Insurance Corporation.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30548 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3410-08-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBAGY>Agricultural Marketing Service</SUBAGY>
                <CFR>7 CFR Part 800</CFR>
                <DEPDOC>[Doc. No. AMS-FGIS-24-0010]</DEPDOC>
                <RIN>RIN 0581-AE28</RIN>
                <SUBJECT>Fees for Official Inspection and Weighing Services Under the United States Grain Standards Act</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Agricultural Marketing Service, Department of Agriculture (USDA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Agricultural Marketing Service (AMS), Federal Grain Inspection Service (FGIS or Service) published an interim rule in the 
                        <E T="04">Federal Register</E>
                         on June 6, 2024, establishing revised fees for official services performed by FGIS and requesting comments. The revised fees announced in the interim rule became effective on July 8, 2024, and will remain in effect until new fees are established. This final rule adopts the fees established by the interim rule without change and responds to public comments submitted in response to the interim rule.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective January 27, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Denise Ruggles, Executive Program Analyst, USDA, AMS, FGIS, Telephone: 816-702-3897, Email: 
                        <PRTPAGE P="105382"/>
                        <E T="03">Denise.M.Ruggles@usda.gov;</E>
                         or Anthony Goodeman, Senior Policy Advisor, USDA, AMS, FGIS, Telephone: 202-720-2091, Email: 
                        <E T="03">Anthony.T.Goodeman@usda.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This final rule adopts, without change, revised fees for official services performed by FGIS, as well as the regulatory changes needed to implement those fees, as described in an interim rule (“Fees for Official Inspection and Weighing Services under the United States Grain Standards Act”) published in the 
                    <E T="04">Federal Register</E>
                     on June 6, 2024 (89 FR 48257). The revised fees became effective on July 8, 2024, and will remain in effect until new fees are established.
                </P>
                <P>
                    The revised fees were calculated using standardized formulas modeled after those used in other AMS user-fee funded grading programs. A forthcoming final rule (“Formulas for Calculating Hourly and Unit Fees for FGIS Services”) to be published separately in the 
                    <E T="04">Federal Register</E>
                     will amend FGIS's user fee regulations. Prospective customers can find FGIS's fee schedules posted on AMS's public website at: 
                    <E T="03">https://www.ams.usda.gov/about-ams/fgis-program-directives.</E>
                </P>
                <P>The United States Grain Standards Act (USGSA) authorizes and requires the Secretary of Agriculture to charge and collect reasonable fees to cover the estimated costs for performing official grain inspection and weighing services (which are mandatory under the Act for U.S. grain exports). In 2015, Congress amended the USGSA to provide that “[i]n order to maintain an operating reserve of not less than 3 and not more than 6 months, the Secretary shall adjust the fees . . . not less frequently than annually.” (7 U.S.C. 79(j)(4) and 79a(l)(3)). To comply with these provisions, FGIS, then the Grain Inspection, Packers, and Stockyards Administration (GIPSA), issued regulations requiring the agency to review and adjust fees annually in order to maintain a 3- to 6-month reserve of operating expenses. (81 FR 49855). AMS published the 2024 interim rule to address FGIS's immediate financial needs, ensure the agency's continued provision of mandatory official services, and prevent disruption to the grain industry.</P>
                <HD SOURCE="HD1">Comment Review</HD>
                <P>
                    AMS published the interim rule in the 
                    <E T="04">Federal Register</E>
                     on June 6, 2024 (89 FR 48257). The interim rule became effective on July 8, 2024. Copies of the interim rule were sent via email to FGIS stakeholders. The interim rule was also made available through the internet by AMS via 
                    <E T="03">https://www.regulations.gov.</E>
                     AMS provided a 30-day comment period, ending July 8, 2024, to give interested persons an opportunity to comment on the interim rule.
                </P>
                <P>FGIS received two comments to the interim rule. One of the comments was irrelevant to the subject of the rule and was not considered with respect to this rulemaking action. The other comment was jointly submitted by two trade organizations. One of the trade organizations represents grain, feed, processing, exporting, and other grain handling companies who collectively operate over 8,000 facilities. The other trade association represents private and publicly owned companies and farmer-owned cooperatives that are involved in, and provide services to, the agri-bulk products international trading industry.</P>
                <P>The trade associations' comment generally supported the interim rule; however, the comment expressed concern with the fee changes “and the potential impact of promoting the marketing of high-quality grain to both domestic and foreign buyers based on the agency's current financial status.” The comment also expressed concern about the shifting marketplace, with potentially reduced exports, noting the likelihood of reduced exports in the upcoming 12- to 18-months, and the importance of FGIS taking all measures to control costs. The comment noted that significant fee increases are unsustainable, but also articulated the importance of FGIS, and the accurate, timely, cost-effective delivery of official grain inspection and weighing services. As a strategy to improve the current method for calculating fees, the comment suggested that FGIS de-couple the other Schedule A user fees from the five-year rolling average for tonnage fees to make the fees more in line with the market rates.</P>
                <P>FGIS agrees with the commenters. FGIS took steps to mitigate a larger increase in the fees through stakeholder interactions prior to publishing the interim rule, and published a more moderate fee increase that would spread the rebuild of the three- to six-month operating reserve over the duration of three years. This step allowed 2024 fees to be substantially lower than they would have been if FGIS attempted to rebuild the reserve more quickly. FGIS is actively taking steps to reduce costs and respond to the evolving export market. FGIS detailed over 10 percent of its staff, froze hiring and awards, reduced overtime, and stopped travel unless mission critical. These steps, coupled with the revised fees, have set FGIS on a path for continued, uninterrupted operations. FGIS is partnering with industry stakeholders to review ways to continue to reduce costs through the use of inspection automation technology.</P>
                <P>
                    Based on the comments received, the critical requirement for mandatory FGIS inspection and weighing services, and the immediate need for the revised fees published in the interim rule, FGIS has determined that finalizing the interim rule, as published in the 
                    <E T="04">Federal Register</E>
                     on June 6, 2024 (89 FR 48257) is consistent with and will tend to effectuate the purposes of the Act. Accordingly, FGIS has made no changes to the fees published in the interim rule and concludes the action through this final rule.
                </P>
                <HD SOURCE="HD1">Revised Fees</HD>
                <P>
                    Tables 2 through 4, below, set forth the revised fees for FGIS inspection and weighing services effective July 8, 2024, as described in the interim rule published on June 6, 2024 (89 FR 48257). The revised fees will remain in effect until new fees are established. The revised fees were calculated using standardized formulas modeled after those used in other AMS user-fee funded grading programs. A forthcoming final rule to be published separately in the 
                    <E T="04">Federal Register</E>
                     will amend FGIS's user fee regulations to incorporate the formulas.
                </P>
                <GPOTABLE COLS="5" OPTS="L2,nj,i1" CDEF="s50,13,13,11,9">
                    <TTITLE>
                        Table 1—Fees for Official Services Performed at an Applicant's Facility in an Onsite FGIS Laboratory 
                        <SU>1</SU>
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1">Service</CHED>
                        <CHED H="1">
                            Regular
                            <LI>rate</LI>
                            <LI>Monday-Friday</LI>
                            <LI>(6 a.m.-6 p.m.)</LI>
                        </CHED>
                        <CHED H="1">
                            Night
                            <LI>differential</LI>
                            <LI>Monday-Friday</LI>
                            <LI>(6 p.m.-6 a.m.)</LI>
                        </CHED>
                        <CHED H="1">
                            Overtime rate
                            <LI>Sunday and</LI>
                            <LI>Saturday</LI>
                        </CHED>
                        <CHED H="1">Holiday rate</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="22">Inspection and Weighing Services Hourly Fees (per service representative):</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">One-Year Contract (per hour per Service representative)</ENT>
                        <ENT>$65.00</ENT>
                        <ENT>$71.50</ENT>
                        <ENT>$81.30</ENT>
                        <ENT>$97.50</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <PRTPAGE P="105383"/>
                        <ENT I="03">Noncontract (per hour per Service representative)</ENT>
                        <ENT>93.30</ENT>
                        <ENT/>
                        <ENT>116.60</ENT>
                        <ENT>140.00</ENT>
                    </ROW>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="25">Service</ENT>
                        <ENT>2024 Rate</ENT>
                    </ROW>
                    <ROW EXPSTB="03">
                        <ENT I="22">
                            Additional Tests (cost per test, assessed in addition to the hourly rate): 
                            <SU>2</SU>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="03">
                        <ENT I="03">Aflatoxin (rapid test kit method)</ENT>
                        <ENT>17.90</ENT>
                    </ROW>
                    <ROW EXPSTB="03">
                        <ENT I="03">All other Mycotoxins (rapid test kit method)</ENT>
                        <ENT>32.60</ENT>
                    </ROW>
                    <ROW EXPSTB="03">
                        <ENT I="03">NIR or NMR Analysis (protein, oil, starch, etc.)</ENT>
                        <ENT>4.30</ENT>
                    </ROW>
                    <ROW EXPSTB="03">
                        <ENT I="03">Waxy corn (per test)</ENT>
                        <ENT>4.30</ENT>
                    </ROW>
                    <ROW EXPSTB="03">
                        <ENT I="03">Class Y Weighing—online (per carrier)</ENT>
                        <ENT>2.80</ENT>
                    </ROW>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="03">Fees for other tests not listed above will be based on the noncontract hourly rate from Fee Table 1 (per hour/per representative)</ENT>
                    </ROW>
                    <ROW EXPSTB="04" RUL="s">
                        <ENT I="21">Tonnage Fee (assessed in addition to all other applicable fees, only one tonnage fee will be assessed when inspection and weighing services are performed on the same carrier).</ENT>
                    </ROW>
                    <ROW EXPSTB="03" RUL="s">
                        <ENT I="25">Service</ENT>
                        <ENT>2024 Rate</ENT>
                    </ROW>
                    <ROW EXPSTB="03">
                        <ENT I="22">
                            All outbound carriers serviced by the specific field office (per-metric ton): 
                            <SU>3</SU>
                        </ENT>
                    </ROW>
                    <ROW EXPSTB="03">
                        <ENT I="03">
                            Delegated States/Designated Agencies (national $0.057) 
                            <SU>4</SU>
                        </ENT>
                        <ENT>0.057</ENT>
                    </ROW>
                    <ROW EXPSTB="03">
                        <ENT I="03">League City tonnage fee (local $0.080 plus national $0.057)</ENT>
                        <ENT>0.137</ENT>
                    </ROW>
                    <ROW EXPSTB="03">
                        <ENT I="03">New Orleans tonnage fee (local $0.012 plus national $0.057)</ENT>
                        <ENT>0.069</ENT>
                    </ROW>
                    <ROW EXPSTB="03">
                        <ENT I="03">Pacific Northwest tonnage fee (local $0.135 plus national $0.057)</ENT>
                        <ENT>0.192</ENT>
                    </ROW>
                    <ROW EXPSTB="03">
                        <ENT I="03">Toledo tonnage fee (local $0.154 plus national $0.057)</ENT>
                        <ENT>0.211</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         Fees apply to original inspection and weighing, re-inspection, and appeal inspection service and include, but are not limited to, sampling, grading, weighing, prior to loading stowage examinations, and certifying results performed within 25 miles of an employee's assigned duty station. Travel and related expenses will be charged for service outside 25 miles as found in § 800.72(a).
                    </TNOTE>
                    <TNOTE>
                        <SU>2</SU>
                         Appeal and re-inspection services will be assessed the same fee as the original inspection service.
                    </TNOTE>
                    <TNOTE>
                        <SU>3</SU>
                         Standard carrier capacity for trucks/submitted samples—52,800 lbs. (approx. 23.95 metric tons (mt)), container—54,000 lbs. (approx. 24.49 mt), rail—220,000 lbs. (approx. 99.79 mt), barge—3,648,000 lbs. (approx. 1,654.70 mt), Pacific Northwest (PN) barge—6,707,000 lbs. (approx. 3,042.24 mt).
                    </TNOTE>
                    <TNOTE>
                        <SU>4</SU>
                         Tonnage fee is assessed on export grain inspected and/or weighed, excluding land carrier shipments to Canada and Mexico.
                    </TNOTE>
                </GPOTABLE>
                <GPOTABLE COLS="2" OPTS="L2,nj,p1,8/9,i1" CDEF="s200,12">
                    <TTITLE>
                        Table 2—Services Performed at Other Than an Applicant's Facility in an FGIS Laboratory 
                        <E T="0731">1 2</E>
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1"> </CHED>
                        <CHED H="1"> </CHED>
                    </BOXHD>
                    <ROW RUL="s">
                        <ENT I="25">Service</ENT>
                        <ENT>2024 Rate</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">Original Inspection and Weighing (Class X) Services:</ENT>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="03">Sampling only (use hourly rates from Fee Table 1)</ENT>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="22">Stationary Lots (sampling, grade/factor, and checkloading):</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Truck/trailer/container (per carrier)</ENT>
                        <ENT>$35.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Railcar (per carrier)</ENT>
                        <ENT>51.90</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Sacked grain (per hour per service representative plus an administrative fee per hundred weight)</ENT>
                        <ENT>0.125/CWT</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">Lots sampled online during loading (sampling use hourly rates from Fee Table 1, plus):</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Truck/trailer/container (per carrier)</ENT>
                        <ENT>21.30</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Railcar (per carrier)</ENT>
                        <ENT>43.90</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Sacked grain (per hour per service representative plus an administrative fee per hundred weight)</ENT>
                        <ENT>0.125/CWT</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">Other services:</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Submitted sample (per sample—grade and factor)</ENT>
                        <ENT>21.30</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Factor only (per factor—maximum 2 factors)</ENT>
                        <ENT>10.40</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Class X Weighing will be based on the noncontract hourly rate from Fee Table 1 (per hour/per service representative)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">Additional tests (excludes sampling):</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Aflatoxin (rapid test kit method)</ENT>
                        <ENT>52.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">All other Mycotoxins (rapid test kit method)</ENT>
                        <ENT>67.60</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Fecal Matter Assay—Detection of Fecal Matter (Qualitative)</ENT>
                        <ENT>326.55</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">NIR or NMR Analysis (protein, oil, starch, etc.)</ENT>
                        <ENT>17.90</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Test Kit Evaluation (Monday-Friday)</ENT>
                        <ENT>111.70</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Tilletia controversa Kühn (TCK) spores testing (per sample)</ENT>
                        <ENT>326.55</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Waxy Corn (per test)</ENT>
                        <ENT>17.90</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Fees for other tests not listed above will be based on the noncontract hourly rate from Fee Table 1</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">Pesticide Residue Testing:</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Routine Compounds (per hour per service representative)</ENT>
                        <ENT>376.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Non-routine Compounds (Subject to availability) (per hour per service representative)</ENT>
                        <ENT>200.90</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">Original Inspection and Weighing (Class X) Services:</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">
                            Appeal inspection and review of weighing service 
                            <SU>3</SU>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">Sampling service for Appeals additional (hourly rates from Fee Table 1)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Board appeal and Appeals (grade and factor)</ENT>
                        <ENT>142.70</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="105384"/>
                        <ENT I="03">
                            Factor only (per factor—max 2 factors) 
                            <SU>4</SU>
                        </ENT>
                        <ENT>75.10</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">Additional tests (assessed in addition to all other applicable tests):</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Aflatoxin (rapid test kit method)</ENT>
                        <ENT>52.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">All other Mycotoxins (rapid test kit method)</ENT>
                        <ENT>82.20</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Mycotoxin (per test—HPLC)</ENT>
                        <ENT>245.60</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">NIR or NMR Analysis (protein, oil, starch, etc.)</ENT>
                        <ENT>31.10</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Sunflower oil (per test)</ENT>
                        <ENT>31.10</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Fees for other tests not listed above will be based on the noncontract hourly rate from Fee Table 1</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">Stowage examination (service on request):</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Ship (per stowage space) (minimum 5 spaces per ship)</ENT>
                        <ENT>89.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Subsequent ship examinations (same as original) (minimum 3 spaces per ship)</ENT>
                        <ENT>89.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Barge (per examination)</ENT>
                        <ENT>71.30</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">All other carriers (per examination)</ENT>
                        <ENT>28.20</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         Fees apply to original inspection and weighing, re-inspection, and appeal inspection service and include, but are not limited to, sampling, grading, weighing, prior to loading stowage examinations, and certifying results performed within 25 miles of an employee's assigned duty station. Travel and related expenses will be charged for service outside 25 miles as found in § 800.72(a).
                    </TNOTE>
                    <TNOTE>
                        <SU>2</SU>
                         In addition to a 2-hour minimum charge on Saturday, Sunday, and holidays, an additional charge will be assessed when the revenue from the services in Fee Table 2, does not equal or exceed what would have been collected at the applicable hourly rate.
                    </TNOTE>
                    <TNOTE>
                        <SU>3</SU>
                         If, at the request of the Service, a file sample is located and forwarded by the Agency, the Agency may, upon request, be reimbursed at the rate of $3.50 per sample by the Service. (Invoice processed through appropriate payment method.)
                    </TNOTE>
                    <TNOTE>
                        <SU>4</SU>
                         Factor only appeal—In accordance with 800.135(b) Kind and Scope, an appeal inspection is limited to the kind and scope of the original or re-inspection service; in the case of factor-only inspections, the service is limited to a maximum of two factors with no grade assignment.
                    </TNOTE>
                </GPOTABLE>
                <GPOTABLE COLS="2" OPTS="L2,nj,i1" CDEF="s200,12">
                    <TTITLE>Table 3—Miscellaneous Services</TTITLE>
                    <BOXHD>
                        <CHED H="1">Service</CHED>
                        <CHED H="1">2024 Rate</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">
                            Grain grading seminars (per hour per service representative) 
                            <SU>1</SU>
                        </ENT>
                        <ENT>$111.70</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Samples provided to interested parties (per sample)</ENT>
                        <ENT>5.20</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Extra copies of certificates and divided lots (per certificate)</ENT>
                        <ENT>3.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Special mailing (actual cost)</ENT>
                        <ENT>Actual cost</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Travel (mileage, airfare, per diem, etc.)</ENT>
                        <ENT>Actual cost</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Preparing certificates onsite or during other than normal business hours (use hourly rates from Table 2.)</ENT>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="22">
                            Special Weighing Services (per hour per service representative): 
                            <SU>10</SU>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Scale testing and certification</ENT>
                        <ENT>145.20</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Evaluation of weighing and material handling systems</ENT>
                        <ENT>145.20</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">NTEP prototype evaluation (other than Railroad Track Scales)</ENT>
                        <ENT>145.20</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">NTEP prototype evaluation of Railroad Track Scales</ENT>
                        <ENT>145.20</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Use of FGIS railroad track scale test equipment per facility for each requested service</ENT>
                        <ENT>870.70</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Mass standards calibration and re-verification</ENT>
                        <ENT>145.20</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Special [weighing] projects</ENT>
                        <ENT>145.20</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         Regular business hours—Monday through Friday—service provided at other than regular business hours will be charged at 1
                        <FR>1/2</FR>
                         times the applicable hourly rate (see § 800.0(b)(14) for definition of “business day.”)
                    </TNOTE>
                </GPOTABLE>
                <HD SOURCE="HD1">Regulatory Changes</HD>
                <P>The interim rule added a new section (§ 800.74) to the regulations to implement the revised fees set forth above. In addition, because the current user fee regulation at 7 CFR 800.71 does not permit fee increases greater than 5 percent, the interim rule imposed a temporary stay on § 800.71. The interim rule also placed a temporary stay on § 800.72(b), as the additional charge provided therein was incorporated into Fee Table 2, footnote 2, above. To accommodate the stay imposed on §§ 800.71 and 800.72(b), and the addition of § 800.74, the interim rule also made conforming changes where § 800.71 or § 800.72 were otherwise referenced in 7 CFR part 800, including in the following sections: §§ 800.34, 800.36, 800.73, 800.156(d)(5), and 800.197(b).</P>
                <HD SOURCE="HD1">Required Regulatory Analyses</HD>
                <HD SOURCE="HD2">Executive Orders 12866, 13563, and 14094</HD>
                <P>This rule is being issued in conformance with Executive Order 12866, “Regulatory Planning and Review,” Executive Order 13563, “Improving Regulation and Regulatory Review,” and Executive Order 14094, “Modernizing Regulatory Review.” Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 14094 reaffirms, supplements, and updates Executive Order 12866 and further directs agencies to solicit and consider input from a wide range of affected and interested parties through a variety of means.</P>
                <P>
                    OMB has designated this rule as not significant under Executive Orders 12866, 13563, and 14094. Accordingly, OMB has not reviewed this rule under those orders. Since grain export volume can vary significantly from year to year, estimating the impact of future fee changes can be difficult. FGIS recognizes the need to provide predictability to the industry for inspection and weighing fees. The statutory requirement to maintain an operating reserve between 3 to 6 months of operating expenses ensures that FGIS can adequately cover its costs without 
                    <PRTPAGE P="105385"/>
                    imposing an undue burden on its customers.
                </P>
                <P>
                    FGIS regularly reviews its user-fee financed programs to determine whether the fees charged for performing official inspection and weighing services adequately cover the costs of providing those services. Due to limitations in the current regulations (7 CFR 800.71(b)(3)), which permit fee increases of no more than 5 percent per year, combined with four years of rate decreases, and noneconomic factors that led to the 2020-2023 period having highest inflation in more than 40 years,
                    <SU>1</SU>
                    <FTREF/>
                     FGIS faced an operating deficit that was forecasted to grow without corrective action.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         For example, the Consumer Price Index (CPI) Calculator (
                        <E T="03">https://data.bls.gov/cgi-bin/cpicalc.pl</E>
                        ) shows prices up 20 percent between January 2020 and February 2024, and up 31 percent between January 2016 and February 2024.
                    </P>
                </FTNT>
                <P>This rule revises the fees for official grain inspection and weighing services provided by FGIS to ensure the stability of the program. In conjunction with AMS's forthcoming final rule (“Formulas for Calculating Hourly and Unit Fees for FGIS Services”) amending FGIS's user fee regulations, this rule will also ensure that FGIS complies with the USGSA, which requires the agency to charge fees sufficient to cover its costs and maintain a 3- to 6-month operating reserve. FGIS will continue to seek out cost-saving measures and implement appropriate changes to reduce its costs to provide alternatives to fee increases.</P>
                <P>This rule is unlikely to have an annual effect of $200 million or more or adversely affect the economy. FGIS has operated at a net loss for five consecutive years, and even with the maximum fee increases permitted under the current regulations, the agency has been unable to reduce the deficits and rebuild the operating reserve. While this rule addresses the agency's current deficit, the forthcoming final rule seeks to prevent additional deficits in future years by revising FGIS's user fee regulations to enable more accurate calculation of the agency's costs and greater flexibility in future rate changes. </P>
                <HD SOURCE="HD2">Regulatory Flexibility Analysis</HD>
                <P>Under the requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-12), FGIS has considered the economic impact of this final rule on small entities. Accordingly, FGIS has prepared this regulatory flexibility analysis. The purpose of the Regulatory Flexibility Act is to fit regulatory actions to the scale of businesses subject to such actions. This ensures that small businesses will not be unduly or disproportionately burdened.</P>
                <P>The Small Business Administration (SBA) defines small businesses by their North American Industry Classification System Codes (NAICS). This final rule will affect customers of FGIS's official inspection and weighing services in the domestic and export grain markets (NAICS code 115114). Current guidance from the SBA provides a revenue cutoff at $34 million to differentiate large and small firms in this industry. Fees for the program which apply to this industry are provided on the FGIS website.</P>
                <P>Under the USGSA, all grain exported from the United States must be officially inspected and weighed, with few exceptions. FGIS provides mandatory inspection and weighing services at 29 export facilities in the United States. Five delegated State agencies provide mandatory inspection and weighing services at 20 facilities. All of these facilities are owned by multinational corporations, large cooperatives, or public entities that do not meet the requirements for small entities established by the SBA.</P>
                <P>The USGSA requires the registration of all persons engaged in the business of buying grain for sale in foreign commerce. In addition, those persons who handle, weigh, or transport grain for sale in foreign commerce must also register. The regulations found at 7 CFR 800.30 and 800.31 define a foreign commerce grain business as the business of regularly buying, handling, weighing, or transporting grain for sale in foreign commerce totaling 15,000 metric tons or more during the preceding or current calendar year. Currently, there are 174 businesses registered to export grain, most of which are not small businesses.</P>
                <P>Although most exporters are not small businesses, most users of FGIS's official inspection and weighing services (which include domestic grain businesses as well as exporters) meet the SBA requirements for small entities. Data on user fee receipts from FGIS for the past 5 years, plus 2024 through February, show a total of 2,123 different accounts over this time, though many firms are represented by multiple accounts. For the purpose of this regulatory flexibility analysis, FGIS will consider accounts as representing establishments, with multiple establishments associated with larger firms.</P>
                <P>FGIS identified a total of 31 large firms, as defined by the SBA firm size classification of receipts in excess of $34 million. FGIS also identified the total number of establishments affiliated with the 31 large firms to be 133. With a total number of establishments of 2,123, this means 1,990, or 94 percent, of the establishments that paid fees to FGIS over the 2019-2024 period are small businesses according to the SBA definition.</P>
                <P>Table 4 shows that, while only 6 percent of the firms are considered large, in total they have contributed the vast majority of the fees paid to the program. In each of the five previous years, and for the year 2024 to date, the 31 large firms paid between 86 and 90 percent of all FGIS fees, with an average of 89 percent. The remaining 1,990 establishments paid on average 11 percent of total fees.</P>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,12,12,12,12,12">
                    <TTITLE>Table 4—FGIS Billed Accounts Summary Table for Regulatory Flexibility Analysis by Small Business Administration Size Classification</TTITLE>
                    <BOXHD>
                        <CHED H="1">Fiscal year</CHED>
                        <CHED H="1">All firms</CHED>
                        <CHED H="2">
                            Total fees
                            <LI>paid</LI>
                        </CHED>
                        <CHED H="1">Large firms</CHED>
                        <CHED H="2">
                            Total fees
                            <LI>paid</LI>
                        </CHED>
                        <CHED H="2">
                            Share paid
                            <LI>(%)</LI>
                        </CHED>
                        <CHED H="1">Small firms</CHED>
                        <CHED H="2">
                            Total fees
                            <LI>paid</LI>
                        </CHED>
                        <CHED H="2">
                            Share paid
                            <LI>(%)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">2019</ENT>
                        <ENT>$32,314,848</ENT>
                        <ENT>$27,694,899</ENT>
                        <ENT>86</ENT>
                        <ENT>$4,619,949</ENT>
                        <ENT>14</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">2020</ENT>
                        <ENT>30,746,015</ENT>
                        <ENT>27,386,467</ENT>
                        <ENT>89</ENT>
                        <ENT>3,359,547</ENT>
                        <ENT>11</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">2021</ENT>
                        <ENT>34,320,110</ENT>
                        <ENT>30,693,195</ENT>
                        <ENT>89</ENT>
                        <ENT>3,626,915</ENT>
                        <ENT>11</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">2022</ENT>
                        <ENT>31,663,547</ENT>
                        <ENT>28,183,027</ENT>
                        <ENT>89</ENT>
                        <ENT>3,480,520</ENT>
                        <ENT>11</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">2023</ENT>
                        <ENT>27,734,760</ENT>
                        <ENT>25,069,234</ENT>
                        <ENT>90</ENT>
                        <ENT>2,665,526</ENT>
                        <ENT>10</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">Oct 2023-Feb 2024</ENT>
                        <ENT>10,702,712</ENT>
                        <ENT>9,679,943</ENT>
                        <ENT>90</ENT>
                        <ENT>1,022,769</ENT>
                        <ENT>10</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="105386"/>
                        <ENT I="03">Grand Total</ENT>
                        <ENT>167,481,991</ENT>
                        <ENT>148,706,765</ENT>
                        <ENT>89</ENT>
                        <ENT>18,775,226</ENT>
                        <ENT>11</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The revised fees implemented by the interim rule and adopted herein do not change the relative burden of fees on small businesses. The provisions of this final rule will apply equally to all entities. The revised fees will benefit all inspection applicants, regardless of size, as the fees more closely reflect the current costs of inspections. Finally, this final rule will not impose additional reporting, record keeping, or other compliance requirements on small entities. FGIS has not identified any other Federal rules which may duplicate, overlap, or conflict with this final rule.</P>
                <HD SOURCE="HD2">Executive Order 12988</HD>
                <P>This final rule has been reviewed under Executive Order 12988—Civil Justice Reform. It is not intended to have retroactive effect. Section 18 of the USGSA (7 U.S.C. 87g) provides that no State or subdivision thereof may require or impose any requirements or restrictions concerning the inspection, weighing, or description of grain under the USGSA. Otherwise, this final rule will not preempt any State or local laws, regulations, or policies unless they present an irreconcilable conflict with this final rule. There are no administrative procedures that must be exhausted prior to any judicial challenge to the provisions of this final rule.</P>
                <HD SOURCE="HD2">Executive Order 13175</HD>
                <P>This final rule has been reviewed under Executive Order 13175—Consultation and Coordination with Indian Tribal governments, which requires agencies to consider whether their rulemaking actions would have Tribal implications. FGIS has determined that this final rule is unlikely to have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.</P>
                <HD SOURCE="HD2">Congressional Review Act</HD>
                <P>Pursuant to the Congressional Review Act (5 U.S.C. 801-808), the Office of Information and Regulatory Affairs designated this final rule as not a major rule, as defined by 5 U.S.C. 804(2).</P>
                <HD SOURCE="HD2">E-Government Act</HD>
                <P>USDA is committed to complying with the provisions of the E-Government Act (44 U.S.C. 3601-3616) by promoting the use of the internet and other information technologies to provide increased opportunities for citizen access to government information and services, and for other purposes.</P>
                <HD SOURCE="HD2">Paperwork Reduction Act</HD>
                <P>This final rule will not impose any additional reporting or recordkeeping requirements on either small or large FGIS customers. In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), FGIS reports and forms are periodically reviewed to reduce information collection requirements and duplication.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 7 CFR Part 800</HD>
                    <P>Administrative practice and procedure, Conflict of interests, Exports, Freedom of information, Grains, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <REGTEXT TITLE="7" PART="800">
                    <AMDPAR>For the reasons set forth in the preamble, the Agricultural Marketing Service adopts the interim rule amending 7 CFR part 800 published June 6, 2024, at 89 FR 48257, as final without change.</AMDPAR>
                </REGTEXT>
                <SIG>
                    <NAME>Melissa Bailey,</NAME>
                    <TITLE>Associate Administrator, Agricultural Marketing Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30603 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <CFR>8 CFR Part 208</CFR>
                <DEPDOC>[CIS No. 2791-25; DHS Docket No. USCIS-2020-0013]</DEPDOC>
                <RIN>RIN 1615-AC57</RIN>
                <AGENCY TYPE="O">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Executive Office for Immigration Review</SUBAGY>
                <CFR>8 CFR Part 1208</CFR>
                <DEPDOC>[A.G. Order No. 6106-2024]</DEPDOC>
                <RIN>RIN 1125-AB08</RIN>
                <SUBJECT>Security Bars and Processing; Delay of Effective Date</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Citizenship and Immigration Services (“USCIS”), Department of Homeland Security (“DHS”); Executive Office for Immigration Review (“EOIR”), Department of Justice (“DOJ”).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Interim final rule with request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>On December 23, 2020, during the COVID-19 pandemic, the Department of Homeland Security (“DHS”) and the Department of Justice (“DOJ”) (collectively, “the Departments”) published a final rule entitled Security Bars and Processing (“Security Bars final rule”) to define “danger to the security of the United States” to include certain emergency public health concerns. The Departments have delayed the final rule's effective date such that it has never gone into effect. This rulemaking further delays the Security Bars final rule's effective date until December 31, 2025.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P/>
                    <P>
                        <E T="03">Effective date:</E>
                         As of December 27, 2024, the effective date of the final rule published December 23, 2020, at 85 FR 84160, which was delayed by the rules published at 86 FR 6847 (Jan. 25, 2021), 86 FR 15069 (Mar. 22, 2021), 86 FR 73615 (Dec. 28, 2021), and 87 FR 79789 (Dec. 28, 2022), is further delayed until December 31, 2025.
                        <PRTPAGE P="105387"/>
                    </P>
                    <P>
                        <E T="03">Submission of public comments:</E>
                         Comments must be submitted on or before January 27, 2025.
                    </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit comments on this rulemaking, identified by DHS Docket No. USCIS-2020-0013, through the Federal eRulemaking Portal at 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the website instructions for submitting comments. The electronic Federal Docket Management System will accept comments prior to midnight eastern time at the end of the day listed in the 
                        <E T="02">DATES</E>
                         section.
                    </P>
                    <P>
                        Comments submitted in a manner other than the one listed above, including emails or letters sent to the Departments' officials, will not be considered comments on the rule and may not receive a response from the Departments. Please note that the Departments cannot accept any comments that are hand-delivered or couriered. In addition, the Departments cannot accept comments contained on any form of digital media storage devices, such as CDs, DVDs, or USB drives. The Departments are not accepting mailed comments at this time. If you cannot submit your comment by using 
                        <E T="03">https://www.regulations.gov,</E>
                         please contact Samantha Deshommes, Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security, by telephone at (240) 721-3000 for alternate instructions.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P/>
                    <P>
                        <E T="03">For USCIS:</E>
                         Rená Cutlip-Mason, Chief, Division of Humanitarian Affairs, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security, 5900 Capital Gateway Drive, Camp Springs, MD 20588-0009; telephone (240) 721-3000 (not a toll-free call).
                    </P>
                    <P>
                        <E T="03">For EOIR:</E>
                         Sarah Flinn, Acting Assistant Director for Policy, Office of Policy, Executive Office for Immigration Review, Department of Justice, 5107 Leesburg Pike, Falls Church, VA 22041; telephone (703) 305-0289 (not a toll-free call).
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Public Participation</HD>
                <P>Interested parties are invited to comment on this action to further delay the effective date of the Security Bars final rule by submitting relevant written data, views, or arguments. To provide the most assistance to the Departments, comments should reference specific portions of the rule; explain the reason for any recommendation; and include data, information, or authority that supports the recommended course of action. Comments must be submitted in English, or an English translation must be provided. Comments submitted in a manner other than those listed above, including emails or letters sent to the Departments' officials, will not be considered comments on the rule and may not receive a response from the Departments.</P>
                <P>
                    <E T="03">Instructions:</E>
                     If you submit a comment, you must include the agency name and the DHS Docket No. USCIS-2020-0013 for this rulemaking. All submissions will be posted, without change, to the Federal eRulemaking Portal at 
                    <E T="03">https://www.regulations.gov</E>
                     and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any public comment submission you make to the Departments. The Departments may withhold information provided in comments from public viewing that they determine may impact the privacy of an individual or is offensive. For additional information, please read the Privacy and Security Notice available at 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>
                    <E T="03">Docket:</E>
                     For access to the docket and to read background documents or comments received, go to 
                    <E T="03">https://www.regulations.gov,</E>
                     referencing DHS Docket No. USCIS-2020-0013. You may also sign up for email alerts on the online docket to be notified when comments are posted or when the final rule is published.
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>
                    On December 23, 2020, during the COVID-19 pandemic, the Departments published the Security Bars final rule to amend existing regulations to provide that certain emergency public health concerns generated by a communicable disease constitute circumstances for which there are “reasonable grounds for regarding [a noncitizen 
                    <SU>1</SU>
                    <FTREF/>
                    ] as a danger to the security of the United States” or “reasonable grounds to believe that [a noncitizen] is a danger to the security of the United States,” making the noncitizen ineligible to be granted (1) asylum in the United States under section 208 of the Immigration and Nationality Act (“INA” or “the Act”), 8 U.S.C. 1158; (2) withholding of removal under section 241(b)(3) of the INA, 8 U.S.C. 1231(b)(3); and (3) withholding of removal under regulations implementing U.S. obligations under Article 3 of the Convention Against Torture and Other Cruel, Inhumane or Degrading Treatment or Punishment (“CAT”),
                    <SU>2</SU>
                    <FTREF/>
                     8 CFR 208.16(c), 1208.16(c). 
                    <E T="03">See</E>
                     Security Bars and Processing, 85 FR 84160 (Dec. 23, 2020).
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         The Departments use the term “noncitizen” to be synonymous with the term “alien” as it is used in the Immigration and Nationality Act. 
                        <E T="03">See</E>
                         INA 101(a)(3), 8 U.S.C. 1101(a)(3); 8 CFR 1001.1(gg).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, art. 3, Dec. 10, 1984, 1465 U.N.T.S. 85, 114.
                    </P>
                </FTNT>
                <P>
                    Although the Security Bars final rule was scheduled to take effect January 22, 2021, intervening events and circumstances have prompted the Departments to delay its effective date, most recently until December 31, 2024. 
                    <E T="03">See</E>
                     Security Bars and Processing; Delay of Effective Date, 86 FR 6847 (Jan. 25, 2021); Security Bars and Processing; Delay of Effective Date, 86 FR 15069 (Mar. 22, 2021); Security Bars and Processing; Delay of Effective Date, 86 FR 73615 (Dec. 28, 2021); Security Bars and Processing; Delay of Effective Date, 87 FR 79789 (Dec. 28, 2022) (“December 2022 Delay IFR” 
                    <SU>3</SU>
                    <FTREF/>
                    ).
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         “IFR” means “interim final rule.”
                    </P>
                </FTNT>
                <P>
                    In the December 2022 Delay IFR, the Departments explained that they were delaying the Security Bars final rule's effective date because its implementation would be infeasible due to a preliminary injunction 
                    <SU>4</SU>
                    <FTREF/>
                     against another asylum-related rule, Procedures for Asylum and Withholding of Removal; Credible Fear and Reasonable Fear Review, 85 FR 80274 (Dec. 11, 2020) (“Global Asylum final rule”). 87 FR 79790-91. Further, the Departments determined that, as a result of a subsequent, intervening rulemaking, Procedures for Credible Fear Screening and Consideration of Asylum, Withholding of Removal, and CAT Protection Claims by Asylum Officers, 87 FR 18078 (Mar. 29, 2022) (“Asylum Processing IFR”), implementation of the Security Bars final rule would result in conflicting and confusing regulatory text. 
                    <E T="03">Id.</E>
                     at 79791-92. Finally, the Departments stated that delaying the effective date would permit the Departments time to engage in notice-and-comment rulemaking regarding whether to modify or rescind the Security Bars final rule. 
                    <E T="03">Id.</E>
                     at 79792-93.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See Pangea Legal Servs.</E>
                         v. 
                        <E T="03">U.S. Dep't of Homeland Sec.,</E>
                         512 F. Supp. 3d 966, 977 (N.D. Cal. 2021).
                    </P>
                </FTNT>
                <P>
                    The Departments requested public comment on the second, third, and fourth delays and received comments addressing both the delay of the effective date and a potential proposal to modify or rescind the Security Bars final rule. In the December 2022 Delay IFR, the Departments addressed previously received comments related to the Security Bars final rule's delayed 
                    <PRTPAGE P="105388"/>
                    effective date. 
                    <E T="03">See id.</E>
                     at 79792-93 (discussing and responding to comments related to the delayed effective date).
                </P>
                <P>The Departments received comments in response to the December 2022 Delay IFR. Relevant to the delayed effective date, most commenters urged the Departments to rescind the Security Bars final rule in its entirety, rather than issuing another delay. Specifically, commenters stated that repeated delays are an inefficient use of time and resources and that the Departments have had sufficient time to study the Security Bars final rule's legality and impact on asylum seekers. Commenters also expressed concern that further delay without rescission could allow the Security Bars final rule to go into effect if a future administration's priorities were to shift. Another commenter stated that rescission of the rule would not cause the Federal Government to incur any costs because the rule has never been implemented. Some commenters suggested that, if the Departments did not rescind the Security Bars final rule, they should delay the Security Bars final rule's effective date indefinitely or for a significant, extended period of time and suggested that other legal means should be used to manage concerns related to infectious diseases. In contrast, one comment, while not explicitly addressing the December 2022 Delay IFR, appeared to be generally supportive of the Security Bars final rule.</P>
                <P>
                    The Departments have considered the concerns raised by commenters. With respect to commenters' statements that the Departments should have had sufficient time to issue a rule during the most recent delay period, the Departments acknowledge that in the December 2022 Delay IFR, the Departments stated that they were working towards publication of a notice of proposed rulemaking (“NPRM”) to modify or rescind the Security Bars final rule. 
                    <E T="03">See</E>
                     87 FR 79792 (“The Departments are working to publish a separate NPRM in the near future to solicit public comments on whether to modify or rescind the Security Bars rule. . . .”). At that time, the Departments also anticipated that delaying the effective date until December 31, 2024, would provide “sufficient time to complete notice-and-comment rulemaking to modify or rescind the Security Bars final rule, even in the event that circumstances require shifting departmental priorities and resources.” 
                    <E T="03">Id.</E>
                </P>
                <P>
                    However, superseding regulatory priorities prevented completion of this anticipated rulemaking prior to December 31, 2024. 
                    <E T="03">See, e.g., Massachusetts</E>
                     v. 
                    <E T="03">E.P.A.,</E>
                     549 U.S. 497, 527 (2007) (“[A]n agency has broad discretion to choose how best to marshal its limited resources and personnel to carry out its delegated responsibilities.”). For example, since the publication of the December 2022 Delay IFR, the Departments issued the Circumvention of Lawful Pathways and Securing the Border rules. 
                    <E T="03">See, e.g.,</E>
                     Securing the Border, 89 FR 81156 (Oct. 7, 2024); Circumvention of Lawful Pathways, 88 FR 31314 (May 16, 2023).
                </P>
                <P>Accordingly, although the Departments have considered the comments on the December 2022 Delay IFR, the Departments have now determined—in light of the Departments' limited resources and intervening regulatory priorities as just discussed, and for the additional reasons described in Section III of this preamble—that a 1-year further delay of the effective date of the Security Bars final rule is appropriate. The Departments continue to welcome data, views, and information regarding the effective date of the Security Bars rule, including whether the rule should be delayed beyond December 31, 2025. The Departments are not seeking comments on whether the rule should be modified or rescinded or otherwise addressing the substance of the Security Bars final rule.</P>
                <HD SOURCE="HD1">III. Additional Bases for Delay of Effective Date</HD>
                <P>Because of the resource constraints described in section II of this preamble, and for the following additional reasons, the Departments are further delaying the effective date of the Security Bars final rule until December 31, 2025.</P>
                <HD SOURCE="HD2">A. The Security Bars Final Rule's Amendments Would Create Inconsistency</HD>
                <P>
                    Since the December 2020 publication of the Security Bars final rule, the Departments have further issued additional rules involving the credible fear screening process and asylum eligibility to address important policy objectives. 
                    <E T="03">See, e.g.,</E>
                     Asylum Processing IFR, 87 FR 18078; Circumvention of Lawful Pathways, 88 FR 31314; Application of Certain Mandatory Bars in Fear Screenings, 89 FR 41347 (May 13, 2024) 
                    <SU>5</SU>
                    <FTREF/>
                     (“Mandatory Bars rule”); Securing the Border, 89 FR 81156. These rules have made significant changes to the credible fear screening process and to asylum eligibility more generally.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         DHS published a final rule on this same topic. 
                        <E T="03">See</E>
                         Application of Certain Mandatory Bars in Fear Screenings, 89 FR 103370 (December 18, 2024).
                    </P>
                </FTNT>
                <P>
                    Specifically, the Circumvention of Lawful Pathways rule, with certain exceptions, applies a rebuttable presumption of asylum ineligibility to noncitizens who arrive at the southwest land border and adjacent coastal borders within a prescribed period of time. 
                    <E T="03">See</E>
                     88 FR 31314. Similarly, the Securing the Border rule, with an exception for exceptionally compelling circumstances, applies a limitation on asylum eligibility to certain noncitizens who arrive irregularly at the United States southern border during emergency border circumstances. 
                    <E T="03">See</E>
                     89 FR 81156. Additionally, the Asylum Processing IFR allows USCIS asylum officers to adjudicate the asylum applications of noncitizens subject to expedited removal who are found to have a credible fear of persecution or torture. 
                    <E T="03">See</E>
                     87 FR 18078. And the recently published Mandatory Bars rule, as finalized, allows asylum officers to consider the potential applicability of specified mandatory bars to asylum and statutory withholding of removal during fear screening processes. 
                    <E T="03">See</E>
                     89 FR 41347 (NPRM).
                </P>
                <P>These intervening rules and their impacts on the credible fear screening process necessitated further evaluation of their potential interplay with the Security Bars final rule. If the Security Bars final rule were allowed to go into effect, and if a public health situation triggered the bars outlined in the rule, many noncitizens entering the United States would likely be subject to the provisions of several of these rulemakings. This possibility requires further time for the Departments to consider the potential operational impacts of any procedural inconsistencies between the rules (such as those discussed below) and assess whether allowing the Security Bars final rule to go into effect is necessary or practicable.</P>
                <P>
                    Procedurally, the Security Bars final rule—if it were to take effect—would conflict with regulatory changes implemented by the intervening rulemakings, resulting in conflicting and confusing changes to the Departments' regulations. For example, in the December 2022 Delay IFR, the Departments explained that the subsequent publication of the Asylum Processing IFR would create conflicting and confusing regulatory text if the Security Bars final rule were to go into effect. 
                    <E T="03">See</E>
                     87 FR 79791-92. Specifically, the Asylum Processing IFR amended certain regulations related to the credible fear screening process to return to the regulatory framework in place 
                    <PRTPAGE P="105389"/>
                    before the Global Asylum final rule was promulgated and to establish procedures for the newly created Asylum Merits interview process. 
                    <E T="03">Id.</E>
                     at 79792. Because the Security Bars final rule is founded upon the processes set forth in the Global Asylum final rule, allowing the Security Bars final rule to go into effect would add to the Code of Federal Regulations language from the Global Asylum final rule that the Departments have been enjoined from implementing and would result in conflicting regulatory provisions.
                </P>
                <P>
                    Similarly, the Circumvention of Lawful Pathways rule rescinded a separate final rule regarding transit through a third country entitled Asylum Eligibility and Procedural Modifications, 85 FR 82260 (Dec. 17, 2020) (“TCT Bar final rule”). This rescission required, among other changes, removing and reserving 8 CFR 208.30(e)(5)(iii), 208.13(c)(4), and 1208.13(c)(4). 
                    <E T="03">See</E>
                     88 FR 31319. If the Security Bars final rule were to go into effect, its publication of 8 CFR 208.30(e)(5)(iii)—which included provisions implementing the Security Bars final rule and the now-enjoined Global Asylum final rule—would create conflicting and confusing regulatory text, as the remainder of the TCT Bar final rule was rescinded in the Circumvention of Lawful Pathways rule. Additionally, if the Security Bars final rule were to go into effect, its publication of cross-references to the now nonexistent 8 CFR 208.13(c)(4) and 1208.13(c)(4) would introduce inconsistencies in the regulations and create confusion as to the Departments' intended procedures for credible fear determinations.
                </P>
                <P>
                    Likewise, the Security Bars final rule would create procedural confusion because of its inconsistency with the Mandatory Bars rule as finalized. For example, under the Mandatory Bars rule, as finalized, if a noncitizen can establish a credible fear of torture, but appears subject to one or more specified mandatory bars to asylum or withholding of removal, then DHS must issue a Notice to Appear to initiate removal proceedings before an immigration judge or retain jurisdiction over the case for further consideration of the noncitizen's claim for deferral of removal under the CAT (“CAT deferral”). 
                    <E T="03">See</E>
                     8 CFR 208.30(e)(5)(i) (as amended by the Mandatory Bars final rule). In contrast, the Security Bars final rule would publish § 208.30(e)(5)(iv), which contains an additional “more likely than not” CAT deferral screening standard for these same noncitizens. 
                    <E T="03">See</E>
                     85 FR 84177-78, 84195. Thus, these differing provisions would create confusion over the proper procedures for these noncitizens, as one rule requires placement in removal proceedings or further consideration before DHS, while the other rule requires the noncitizen to first meet a higher CAT deferral screening standard.
                </P>
                <P>
                    The Security Bars final rule would also, if it were to take effect, elevate consideration of the now nonexistent regulatory bar created by the TCT Bar final rule above other potential bars that may be considered. 
                    <E T="03">See</E>
                     85 FR 84198 (amending 8 CFR 1208.30 to state in paragraph (g)(1)(ii), another paragraph removed and reserved by the Circumvention of Lawful Pathways rule that would be reprinted if the Security Bars final rule were to go into effect, that an immigration judge “shall first review” any asylum officer determination that a noncitizen is ineligible for asylum under the TCT Bar final rule).
                </P>
                <P>Therefore, the Departments are delaying the effective date of the Security Bars final rule to prevent these confusing and inconsistent changes from taking effect and to avoid the addition to the Code of Federal Regulations of any enjoined language from the Global Asylum final rule while the Departments consider further action on the rule.</P>
                <HD SOURCE="HD2">B. There Would Be No Direct, Immediate Impact on Eligibility for Relief or Protection if the Security Bars Final Rule Takes Effect on December 31, 2024</HD>
                <P>The Departments have also concluded that there would be no direct, immediate impact on eligibility for asylum or other protection if the Security Bars final rule were to go into effect on December 31, 2024, because there is no existing public health situation that would trigger the bars outlined in the rule. This lack of any immediate impact supports further delay of the effective date of the Security Bars final rule while the Departments consider further action on the rule.</P>
                <P>Specifically, the bars outlined in the Security Bars final rule could be triggered in two ways. The first way is “if a communicable disease has triggered an ongoing declaration of a public health emergency.” 85 FR 84193-94, 84197. No such emergency currently exists.</P>
                <P>
                    Second, the bars could be triggered if, “regarding a communicable disease of public health significance as defined at 42 CFR 34.2(b), the Secretary [of Homeland Security] and the Attorney General, in consultation with the Secretary of Health and Human Services, have jointly . . . [d]etermined” that the physical presence in the United States of individuals from affected regions “would cause a danger to the public health,” such that the situation warrants designating noncitizens within the incubation and contagion period of the disease “a danger to the security of the United States.” 85 FR 84193-94, 84196-97. Although a number of “communicable disease[s] of public health significance” within the meaning of 42 CFR 34.2(b) exist in the world today, the Centers for Disease Control and Prevention (“CDC”) has not determined that current health conditions warrant issuance of its most severe type of Travel Health Notice for any geographic area.
                    <SU>6</SU>
                    <FTREF/>
                     In the absence of such conditions, the Departments do not have a current basis for making the determinations required to trigger the bars outlined in the Security Bars final rule—which in effect create an asylum bar based on a general geographic designation. In addition, the Federal Government has measures to address potential public health risks, such as routing international flights from areas with known outbreaks to specific airports and conducting public health screenings of passengers at those airports.
                    <SU>7</SU>
                    <FTREF/>
                     Hence, because the bars would not currently be triggered if the Security Bars final rule went into effect, the Departments believe that the rule is unnecessary in the short term.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See, e.g.,</E>
                         CDC, 
                        <E T="03">Addendum to the Technical Instructions for Medical Examination of Aliens: Communicable Diseases of Public Health Significance</E>
                         (May 15, 2024), 
                        <E T="03">https://www.cdc.gov/immigrant-refugee-health/hcp/panel-physicians/communicable-diseases-addendum.html;</E>
                         CDC, 
                        <E T="03">Travelers' Health: Travel Health Notices</E>
                         (last reviewed Nov. 22, 2024), 
                        <E T="03">https://wwwnc.cdc.gov/travel/notices.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See, e.g.,</E>
                         U.S. Dep't of Health &amp; Human Servs., 
                        <E T="03">Fact Sheet: HHS Actions to Support Response to Marburg Outbreak in Rwanda</E>
                         (Oct. 7, 2024), 
                        <E T="03">https://www.hhs.gov/about/news/2024/10/07/fact-sheet-hhs-actions-to-support-response-marburg-outbreak-in-rwanda.html.</E>
                    </P>
                </FTNT>
                <P>
                    The Departments acknowledge that some commenters suggested that an indefinite delay or a very long delay would be appropriate if the Security Bars final rule were not rescinded. But the Departments believe that a delay of only 1 year is appropriate. The rule has already been delayed for a substantial period, and the Departments project that a 1-year delay will suffice to determine what further regulatory steps best balance the relevant interests. And, as noted above, the Departments welcome comments on whether a delay beyond December 31, 2025, would be appropriate.
                    <PRTPAGE P="105390"/>
                </P>
                <HD SOURCE="HD1">IV. Statutory and Regulatory Requirements</HD>
                <HD SOURCE="HD2">A. Administrative Procedure Act</HD>
                <P>
                    Under the Administrative Procedure Act (“APA”), agencies must generally provide “notice of proposed rule making” in the 
                    <E T="04">Federal Register</E>
                     and, after such notice, “give interested persons an opportunity to participate in the rule making through submission of written data, views, or arguments.” 5 U.S.C. 553(b) and (c). The Departments satisfied this notice requirement through the December 2022 Delay IFR, which indicated the possibility of a future delay of the effective date of the Security Bars final rule and requested comments on such a potential future delay. 87 FR 79793. In the December 2022 Delay IFR, the Departments explicitly stated that they “continue to welcome data, views, and information regarding the effective date of the Security Bars [final] rule” and specifically “solicit[ed] comments on whether the effective date should be delayed beyond December 31, 2024.” 
                    <E T="03">Id.</E>
                </P>
                <P>
                    In addition, the Departments have considered the comments received in response to the December 2022 Delay IFR and have concluded—for the reasons explained in Sections II and III of this preamble—that, notwithstanding certain comments to the contrary, a 1-year delay is appropriate. The agencies have accordingly satisfied any obligation under the APA to consider and respond to the comments received. 
                    <E T="03">See Perez</E>
                     v. 
                    <E T="03">Mortg. Bankers Ass'n,</E>
                     575 U.S. 92, 96 (2015) (“An agency must consider and respond to significant comments received during the period for public comment.”).
                </P>
                <P>
                    The Departments have also determined that good cause exists to forego the APA's procedures that generally require a delay between a final rule's publication and its effective date. 
                    <E T="03">See</E>
                     5 U.S.C. 553(d)(3) (providing that “[t]he required publication or service of a substantive rule shall be made not less than 30 days before its effective date . . . except as otherwise provided by the agency for good cause found and published with the rule”). The purpose of this delay is “to give affected parties time to adjust their behavior before the final rule takes effect.” 
                    <E T="03">Riverbend Farms, Inc.</E>
                     v. 
                    <E T="03">Madigan,</E>
                     958 F.2d 1479, 1485 (9th Cir. 1992); 
                    <E T="03">see also</E>
                     H.R. Rep. No. 79-1980, at 25 (1946) (similar). Here, however, that purpose would not be served by a delay before effectuating this IFR, given that this IFR merely preserves the status quo by further delaying the effective date of the Security Bars final rule. Accordingly, this IFR does not require any parties to change their conduct or take any particular steps in advance of the IFR's effective date. 
                    <E T="03">See United States</E>
                     v. 
                    <E T="03">Gavrilovic,</E>
                     551 F.2d 1099, 1104 &amp; n.9 (8th Cir. 1977) (noting that the legislative history of the APA indicates that the waiting period “was not intended to unduly hamper agencies from making a rule effective immediately,” but intended “to `afford persons affected a reasonable time to prepare for the effective date of a rule . . . or to take any other action which the issuance of rules may prompt' ” (quoting S. Rep. No. 79-752, at 15 (1946))).
                </P>
                <HD SOURCE="HD2">B. Executive Order 12866 (Regulatory Planning and Review), Executive Order 13563 (Improving Regulation and Regulatory Review), and Executive Order 14094 (Modernizing Regulatory Review)</HD>
                <P>Executive Order 12866 (“Regulatory Planning and Review”), as amended by Executive Order 14094 (“Modernizing Regulatory Review”), and Executive Order 13563 (“Improving Regulation and Regulatory Review”), directs agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs of the Office of Management and Budget has determined that this rule is “significant” under Executive Order 12866 and has reviewed this regulation.</P>
                <HD SOURCE="HD2">C. Regulatory Flexibility Act</HD>
                <P>
                    The Departments have reviewed this rule in accordance with the Regulatory Flexibility Act, Public Law 96-354, 94 Stat. 1164 (1980), as amended (codified at 5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ) and have determined that this rule will not have a significant economic impact on a substantial number of small entities. The rule does not regulate “small entit[ies]” as that term is defined in 5 U.S.C. 601(6). Only individuals, rather than entities, may seek asylum or withholding or deferral of removal, and only individual noncitizens are otherwise placed in immigration proceedings.
                </P>
                <HD SOURCE="HD2">D. Unfunded Mandates Reform Act of 1995</HD>
                <P>
                    This rule will not result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, adjusted for inflation, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995, Public Law 104-4, 109 Stat. 48; 
                    <E T="03">see also</E>
                     2 U.S.C. 1532(a).
                </P>
                <HD SOURCE="HD2">E. Congressional Review Act</HD>
                <P>This rule does not meet the criteria set forth in 5 U.S.C. 804(2).</P>
                <HD SOURCE="HD2">F. Executive Order 13132 (Federalism)</HD>
                <P>This rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, the Departments have determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.</P>
                <HD SOURCE="HD2">G. Executive Order 12988 (Civil Justice Reform)</HD>
                <P>This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.</P>
                <HD SOURCE="HD2">H. Family Assessment</HD>
                <P>The Departments have assessed this rule in accordance with section 654 of the Treasury General Appropriations Act, 1999, Public Law 105-277, div. A, 112 Stat. 2681, 2681-528, and have determined that, because the Security Bars final rule is not in effect, further delaying the rule would not affect family well-being. Further, even as compared to a world in which the Security Bars final rule is allowed to go into effect on December 31, 2024, the Departments believe further delay of the rule will not affect family well-being because, as described in section III.B of this preamble, there are no current public health conditions that would trigger the bars outlined in the rule.</P>
                <HD SOURCE="HD2">I. Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments)</HD>
                <P>
                    This rule does not have Tribal implications under Executive Order 13175 because it would not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.
                    <PRTPAGE P="105391"/>
                </P>
                <HD SOURCE="HD2">J. Executive Order 13045 (Protection of Children From Environmental Health Risks and Safety Risks)</HD>
                <P>Executive Order 13045 requires agencies to consider the impacts of environmental health risks or safety risks that may disproportionately affect children. The Departments have reviewed this rule and have determined that this rule is not a covered regulatory action under Executive Order 13045. The rule is not considered economically significant and does not create an environmental risk to health or a risk to safety that might disproportionately affect children.</P>
                <HD SOURCE="HD2">K. Paperwork Reduction Act</HD>
                <P>This rule does not promulgate new, or revise existing, “collection[s] of information” as that term is defined under the Paperwork Reduction Act of 1995, Public Law 104-13, 109 Stat. 163, 44 U.S.C. chapter 35, and its implementing regulations, 5 CFR part 1320.</P>
                <SIG>
                    <NAME>Alejandro N. Mayorkas,</NAME>
                    <TITLE>Secretary, U.S. Department of Homeland Security.</TITLE>
                    <DATED>Dated: December 17, 2024.</DATED>
                    <NAME>Merrick B. Garland,</NAME>
                    <TITLE>Attorney General, U.S. Department of Justice.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30774 Filed 12-20-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9111-97-P; 4410-30-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <CFR>8 CFR Part 217</CFR>
                <SUBJECT>Update to Procedures for Listing Designated Countries and Location of List</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Secretary, Department of Homeland Security (DHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; technical amendment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This rule updates the DHS practice for notifying the public of countries designated for participation in the Visa Waiver Program (VWP). It amends the definition of “designated country” by referring to countries that the Secretary of Homeland Security (Secretary) has designated for VWP participation and noting that a list of such countries is available on the public-facing DHS VWP website. This rule does not alter which countries have been designated for the VWP or the criteria for initial and continued designation as a program country. This update refers the public to the applicable website 
                        <E T="03">www.dhs.gov/visa-waiver-program</E>
                         and will allow DHS to update designations more efficiently and expeditiously.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective on December 23, 2024.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Anjum Agarwala, U.S. Department of Homeland Security; Office of Strategy, Policy, and Plans; VWP Office (202) 790-5207.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    Pursuant to section 217 of the Immigration and Nationality Act (INA), 8 U.S.C. 1187, the Secretary, in consultation with the Secretary of State, may designate certain countries as VWP countries if certain requirements are met.
                    <SU>1</SU>
                    <FTREF/>
                     Once a country has met the requirements and been designated by the Secretary as a program country, eligible citizens and nationals of a program country may apply for admission to the United States at U.S. ports of entry as nonimmigrant visitors for a period of ninety days or less for business or pleasure without first obtaining a nonimmigrant visa, provided that they are otherwise eligible for admission under applicable statutory and regulatory requirements.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         All references to “country” or “countries” in the laws authorizing the VWP are read to include Taiwan. 
                        <E T="03">See</E>
                         Taiwan Relations Act of 1979, Public Law 96-8, section 4(b)(1) (codified at 22 U.S.C. 3303(b)(1)) (providing that “[w]henever the laws of the United States refer or relate to foreign countries, nations, states, governments, or similar entities, such terms shall include and such laws shall apply with respect to Taiwan”). This is consistent with the United States' one-China policy, under which the United States has maintained unofficial relations with Taiwan since 1979.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. List of Designated Countries</HD>
                <P>As noted above, the Secretary, in consultation with the Secretary of State, may designate a country for participation in the VWP, or suspend or terminate such participation, consistent with section 217 of the INA. The regulations currently define “designated country” as a country listed explicitly in 8 CFR 217.2(a).</P>
                <P>
                    Historically, DHS, and before DHS the legacy Immigration and Naturalization Service (INS), have maintained a list in the 
                    <E T="03">Code of Federal Regulations</E>
                     (CFR) of currently designated countries participating in the VWP. This practice started with the designation of the United Kingdom as the first VWP country. 
                    <E T="03">See</E>
                     53 FR 24898 (June 30, 1988). Subsequent designations or terminations have been the subject of a rule in the 
                    <E T="04">Federal Register</E>
                    . Such rules update the list of countries in the CFR. 
                    <E T="03">See, e.g.,</E>
                     73 FR 79597 (Dec. 30, 2008) (Malta); 75 FR 15992 (Mar. 31, 2010) (Greece); 77 FR 64411 (Oct. 22, 2012) (Taiwan); 79 FR 17854 (Mar. 31, 2014) (Chile); 84 FR 60318 (Nov. 8, 2019) (Poland); 86 FR 54031 (Sept. 30, 2021) (Croatia); 88 FR 67065 (Sept. 29, 2023) (Israel); and 89 FR 78785 (Sept. 26, 2024) (Qatar).
                </P>
                <P>
                    Through this final rule, DHS is amending 8 CFR 217.2(a) to remove references to specific countries in the regulations. Instead, DHS will define “designated country” as “any country currently designated by the Secretary for participation in the Visa Waiver Program.” The updated definition will also point readers to the list of currently designated countries on the DHS VWP website, 
                    <E T="03">https://www.dhs.gov/visa-waiver-program.</E>
                </P>
                <P>With this change, DHS will continue to update the list of designated countries on the DHS VWP website. In addition, DHS will continue its outreach to stakeholders and the public, such as through press releases, directly notifying air carriers, and updating the Electronic System for Travel Authorization (ESTA) to account for future changes to the list of designated countries participating in the VWP.</P>
                <P>
                    Following this change, however, DHS will no longer pursue the separate administrative step of publishing a technical amendment in the 
                    <E T="04">Federal Register</E>
                     for each new designation. This change removes an unnecessary administrative burden and allows for more expedient updates to the list of designated countries participating in the VWP. It will also reduce any risk of confusion by the public or international partners due to a time lag between the Secretary's designation and the publication of a technical amendment in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <P>This rule does not change which countries are designated to participate in the VWP.</P>
                <HD SOURCE="HD1">III. Administrative Procedure Act</HD>
                <P>
                    Under the Administrative Procedure Act (5 U.S.C. 553(b)(B)), an agency may waive notice and comment requirements if it finds, for good cause, that the requirements are impracticable, unnecessary, or contrary to the public interest. This rule reflects an administrative change that merely removes the list of designated countries participating in the VWP from the CFR and adds a reference to the DHS VWP website. This rule does not alter which countries have been designated or the criteria for initial and continued designation as a program country. Because the VWP country list is readily available online, the update would not affect the public's rights, interests, or access to information. Therefore, notice 
                    <PRTPAGE P="105392"/>
                    and comment for this rule is unnecessary.
                </P>
                <P>This rule is further excepted from the notice and comment requirement as a procedural rule. For the same reasons previously stated, the rule has no substantive impact or effect on public interest. In removing the list of VWP participating countries from the CFR, while including a reference to another location where a list can be found, the rule is technical in nature and relates only to organization, procedure, and practice. This rule only changes whether a list of designated countries is available in the CFR, making it a procedural rule exempt from notice and comment.</P>
                <P>For the reasons above, DHS also finds that the 30-day delayed effective date requirement for substantive rules does not apply. See 5 U.S.C. 553(d). Good cause exists to make this technical amendment effective immediately under 5 U.S.C. 553(d)(2) and (d)(3).</P>
                <P>Finally, this rule is also excluded from the rulemaking provisions of 5 U.S.C. 553 as a foreign affairs function of the United States. Designating VWP countries advances the President's foreign policy goals and directly involves relationships between the United States and its noncitizen visitors. Accordingly, DHS is not required to provide public notice and an opportunity to comment before implementing this final rule.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 8 CFR Part 217</HD>
                    <P>Air carriers, aliens, maritime carriers, passports, and visas.</P>
                </LSTSUB>
                <HD SOURCE="HD1">Amendments to the Regulations</HD>
                <P>For the reasons set forth in the preamble, DHS amends part 217 of title 8 of the Code of Federal Regulations (8 CFR part 217) as set forth below.</P>
                <PART>
                    <HD SOURCE="HED">PART 217—VISA WAIVER PROGRAM</HD>
                </PART>
                <REGTEXT TITLE="8" PART="217">
                    <AMDPAR>1. The authority citation for part 217 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 8 U.S.C. 1103, 1187; 8 CFR part 2.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="8" PART="217">
                    <AMDPAR>2. In § 217.2(a), revise the definition of “Designated country” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 217.2</SECTNO>
                        <SUBJECT>Eligibility.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>
                            <E T="03">Designated country</E>
                             refers to any country currently designated by the Secretary for participation in the Visa Waiver Program. DHS maintains a list of designated countries at 
                            <E T="03">https://www.dhs.gov/visa-waiver-program.</E>
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <NAME>Alejandro N. Mayorkas</NAME>
                    <TITLE>Secretary of Homeland Security.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31210 Filed 12-23-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-9M-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Executive Office for Immigration Review</SUBAGY>
                <CFR>8 CFR Parts 1003 and 1208</CFR>
                <DEPDOC>[EOIR Docket No. 025-0910; A.G. Order No. 6107-2024]</DEPDOC>
                <RIN>RIN 1125-AB33</RIN>
                <SUBJECT>Clarification Regarding Bars to Eligibility During Credible Fear and Reasonable Fear Review</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Executive Office for Immigration Review, Department of Justice.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Interim final rule; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This interim final rule (“IFR”) makes a technical amendment to Department of Justice (“Department”) regulations to clarify that immigration judges' de novo review of asylum officers' credible fear and reasonable fear determinations shall, where relevant, include review of the asylum officer's application of any bars to asylum or withholding of removal under Department of Homeland Security (“DHS”) regulations, as well as other clarifying technical changes related to credible fear and reasonable fear processes.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P/>
                    <P>
                        <E T="03">Effective date:</E>
                         This interim final rule is effective December 27, 2024.
                    </P>
                    <P>
                        <E T="03">Comments:</E>
                         Electronic comments must be submitted, and written comments must be postmarked or otherwise indicate a shipping date on or before January 27, 2025. The electronic Federal Docket Management System (FDMS) at 
                        <E T="03">https://www.regulations.gov</E>
                         will accept electronic comments until 11:59 p.m. Eastern Time on that date.
                    </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>If you wish to provide comments regarding this rulemaking, you must submit comments, identified by the agency name and reference RIN 1125-AB33 or EOIR Docket No. 025-0910, by one of the two methods below.</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal: www.regulations.gov.</E>
                         Follow the website instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Paper comments that duplicate an electronic submission are unnecessary. If you wish to submit a paper comment in lieu of electronic submission, please direct the mail/shipment to: Sarah Flinn, Acting Assistant Director for Policy, Office of Policy, Executive Office for Immigration Review, Department of Justice, 5107 Leesburg Pike, Suite 1800, Falls Church, VA 22041. To ensure proper handling, please reference the agency name and RIN 1125-AB33 or EOIR Docket No. 025-0910 on your correspondence. Mailed items must be postmarked or otherwise indicate a shipping date on or before the submission deadline.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sarah Flinn, Acting Assistant Director for Policy, Office of Policy, Executive Office for Immigration Review, Department of Justice, 5107 Leesburg Pike, Falls Church, VA 22041; telephone (703) 305-0289 (not a toll-free call).</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">I. Public Participation</HD>
                <P>Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of this IFR via one of the methods and by the deadline stated above. The Department also invites comments that relate to the economic, environmental, or federalism effects that might result from this IFR. Comments that will provide the most assistance to the Department will reference a specific portion of the IFR; explain the reason for any recommended change; and include data, information, or authority that support such recommended change.</P>
                <P>
                    Please note that all comments received are considered part of the public record and made available for public inspection at 
                    <E T="03">www.regulations.gov.</E>
                     Such information includes personally identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.
                </P>
                <P>If you want to submit personally identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online, you must include the phrase “PERSONALLY IDENTIFYING INFORMATION” in the first paragraph of your comment and identify what information you want redacted.</P>
                <P>
                    If you want to submit confidential business information as part of your comment, but do not want it to be posted online, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You also must prominently identify the confidential business information to be redacted 
                    <PRTPAGE P="105393"/>
                    within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted on 
                    <E T="03">www.regulations.gov.</E>
                </P>
                <P>
                    Personally identifiable information located as set forth above will be placed in the agency's public docket file, but not posted online. Confidential business information identified and located as set forth above will not be placed in the public docket file. The Department may withhold from public viewing information provided in comments that it determines may impact the privacy of an individual or is offensive. For additional information, please read the “Privacy &amp; Security Notice” that is available via the link in the footer of 
                    <E T="03">www.regulations.gov.</E>
                     To inspect the agency's public docket file in person, you must make an appointment with the agency. Please see the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     paragraph above for agency contact information.
                </P>
                <HD SOURCE="HD1">II. Legal Authority</HD>
                <P>
                    The Department issues this IFR pursuant to section 103(g) of the Immigration and Nationality Act (“INA”), 8 U.S.C. 1103(g), as amended by the Homeland Security Act of 2002 (“HSA”), Public Law 107-296, 116 Stat. 2135 (as amended). Under the HSA, the Attorney General is charged with “such authorities and functions under [the INA] and all other laws relating to the immigration and naturalization of [noncitizens] 
                    <SU>1</SU>
                    <FTREF/>
                     as were [previously] exercised by the Executive Office for Immigration Review [(“EOIR”)], or by the Attorney General with respect to [EOIR].” INA 103(g)(1), 8 U.S.C. 1103(g)(1); 
                    <E T="03">see also</E>
                     6 U.S.C. 521. The Attorney General also has the authority to “establish such regulations, . . . issue such instructions, review such administrative determinations in immigration proceedings, delegate such authority, and perform such other acts as the Attorney General determines to be necessary for carrying out” the Attorney General's authorities under the INA. INA 103(g)(2), 8 U.S.C. 1103(g)(2). These authorities cover forms of relief or protection from removal, including asylum, statutory withholding of removal under section 241(b)(3) of the INA, 8 U.S.C. 1231(b)(3), and protection under the regulations implementing U.S. obligations under Article 3 of the Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment (“CAT”).
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         For purposes of the discussion in this preamble, the Department uses the term “noncitizen” synonymously with the term “alien” as it is used in the INA. 
                        <E T="03">See</E>
                         INA 101(a)(3), 8 U.S.C. 1101(a)(3); 8 CFR 1001.1(gg).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment art. 3, Dec. 10, 1984, S. Treaty Doc. No. 100-20, 1465 U.N.T.S. 85, 114.
                    </P>
                </FTNT>
                <P>
                    Noncitizens who are physically present or arrive in the United States as provided in section 208 of the INA, 8 U.S.C. 1158, may apply for asylum, subject to certain exceptions in section 208(a)(2) of the INA, 8 U.S.C. 1158(a)(2). By statute, certain noncitizens are ineligible to apply for or to be granted asylum, and Congress has delegated to the Attorney General the authority to establish additional limitations and conditions, consistent with applicable statutes, under which noncitizens shall be ineligible for asylum. 
                    <E T="03">See</E>
                     INA 208(b)(2)(A), 8 U.S.C. 1158(b)(2)(A) (statutory bars to asylum); INA 208(b)(2)(C), 8 U.S.C. 1158(b)(2)(C) (additional limitation authority); INA 208(d)(5)(B), 8 U.S.C. 1158(d)(5)(B) (allowing for additional regulatory conditions or limitations on consideration of asylum applications). The Attorney General is also charged with providing a review procedure for negative credible fear determinations regarding asylum made by an asylum officer during the expedited removal process. 
                    <E T="03">See</E>
                     INA 235(b)(1)(B)(iii)(III), 8 U.S.C. 1225(b)(1)(B)(iii)(III).
                </P>
                <P>
                    Additionally, the United States is a party to the 1967 United Nations Protocol Relating to the Status of Refugees, January 31, 1967, 19 U.S.T. 6223, 606 U.N.T.S. 268 (“Refugee Protocol”), which incorporates Articles 2 through 34 of the 1951 Convention Relating to the Status of Refugees, July 28, 1951, 19 U.S.T. 6259, 189 U.N.T.S. 150 (“Refugee Convention”). Article 33 of the Refugee Convention generally prohibits parties to the Convention from expelling or returning “a refugee in any manner whatsoever to the frontiers of territories where his life or freedom would be threatened on account of his race, religion, nationality, membership of a particular social group or political opinion.” 19 U.S.T. at 6276. Congress codified these obligations in the Refugee Act of 1980, creating the precursor to what is now known as statutory withholding of removal.
                    <SU>3</SU>
                    <FTREF/>
                     The Supreme Court has long recognized that the United States implements its non-refoulement obligations under Article 33 of the Refugee Convention (via the Refugee Protocol) through the statutory withholding of removal provision in section 241(b)(3) of the INA, 8 U.S.C. 1231(b)(3), which provides that a noncitizen may not be removed to a country where their life or freedom would be threatened because of one of the protected grounds listed in Article 33 of the Refugee Convention.
                    <SU>4</SU>
                    <FTREF/>
                      
                    <E T="03">See</E>
                     INA 241(b)(3), 8 U.S.C. 1231(b)(3); 
                    <E T="03">see also</E>
                     8 CFR 208.16, 1208.16. By statute, certain noncitizens are ineligible for statutory withholding of removal. 
                    <E T="03">See</E>
                     INA 241(b)(3)(B), 8 U.S.C. 1231(b)(3)(B) (establishing bars to statutory withholding of removal).
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Public Law 96-212, 94 Stat. 102 (“Refugee Act”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See INS</E>
                         v. 
                        <E T="03">Aguirre-Aguirre,</E>
                         526 U.S. 415, 426-27 (1999); 
                        <E T="03">see also INS</E>
                         v. 
                        <E T="03">Cardoza-Fonseca,</E>
                         480 U.S. 421, 440-41 (1987) (distinguishing between Article 33's non-refoulement prohibition, which aligns with what was then called withholding of deportation, and Article 34's call to “facilitate the assimilation and naturalization of refugees,” which the Court found aligned with the discretionary provisions in section 208 of the INA, 8 U.S.C. 1158). The Refugee Convention and Refugee Protocol are not self-executing. 
                        <E T="03">See, e.g., Al-Fara</E>
                         v. 
                        <E T="03">Gonzales,</E>
                         404 F.3d 733, 743 (3d Cir. 2005) (“The 1967 Protocol is not self-executing, nor does it confer any rights beyond those granted by implementing domestic legislation.”).
                    </P>
                </FTNT>
                <P>
                    Separately, the Department also has authority to implement Article 3 of the United Nations Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, Dec. 10, 1984, S. Treaty Doc. No. 100-20, 1465 U.N.T.S. 85 (entered into force for United States Nov. 20, 1994). The Foreign Affairs Reform and Restructuring Act of 1998 (“FARRA”) provides the Department with the authority to “prescribe regulations to implement the obligations of the United States under Article 3 of the [CAT], subject to any reservations, understandings, declarations, and provisos contained in the United States Senate resolution of ratification of the Convention.” Public Law 105-277, div. G, sec. 2242(b), 112 Stat. 2681, 2681-822 (8 U.S.C. 1231 note). The Department has implemented the United States' obligations under Article 3 of the CAT by regulation, consistent with FARRA. 
                    <E T="03">See, e.g.,</E>
                     8 CFR 1208.16(c)-1208.18; Regulations Concerning the Convention Against Torture, 64 FR 8478 (Feb. 19, 1999), amended by 64 FR 13881 (Mar. 23, 1999).
                </P>
                <HD SOURCE="HD1">III. Background</HD>
                <HD SOURCE="HD2">A. Asylum and Related Protection</HD>
                <P>
                    Asylum is a discretionary form of relief for noncitizens who establish, among other things, that they have experienced past persecution or have a well-founded fear of future persecution on account of race, religion, nationality, membership in a particular social group, or political opinion. INA 208(b)(1), 8 U.S.C. 1158(b)(1) (providing that the Attorney General “may” grant asylum to 
                    <PRTPAGE P="105394"/>
                    refugees); INA 101(a)(42)(A), 8 U.S.C. 1101(a)(42)(A) (defining “refugee”).
                </P>
                <P>
                    Noncitizens who are ineligible, by statute or regulation, to apply for or to be granted asylum, or who are denied asylum as a matter of discretion, nonetheless may qualify for other forms of protection from removal.
                    <SU>5</SU>
                    <FTREF/>
                     Specifically, such an applicant may be eligible for statutory withholding of removal under section 241(b)(3) of the INA, 8 U.S.C. 1231(b)(3). Statutory withholding of removal prevents a noncitizen's removal to any country where the noncitizen's life or freedom would “more likely than not” be threatened because of a protected ground. 
                    <E T="03">See generally</E>
                     8 CFR 1208.16(b)(2) (withholding of removal under the INA); 
                    <E T="03">see also INS</E>
                     v. 
                    <E T="03">Stevic,</E>
                     467 U.S. 407, 413, 424 (1984) (holding that the “clear probability” or “more likely than not” standard applies to withholding of deportation); 
                    <E T="03">INS</E>
                     v. 
                    <E T="03">Cardoza-Fonseca,</E>
                     480 U.S. 421, 449 (1987) (holding that, while withholding of removal requires a showing that it is “more likely than not” that a noncitizen would be subject to persecution, an applicant for asylum must only demonstrate a “well-founded fear” of persecution).
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Applications for asylum are treated as applications for statutory withholding of removal and protection under the CAT, where relevant. 
                        <E T="03">See</E>
                         8 CFR 1208.3(b) (treating an asylum application as an application for statutory withholding of removal), 1208.13(c)(1) (explaining that an asylum applicant shall also be considered for CAT protection “if the applicant requests such consideration or if the evidence presented by the [noncitizen] indicates that the [noncitizen] may be tortured in the country of removal”).
                    </P>
                </FTNT>
                <P>
                    Additionally, noncitizens who express a fear of torture may be eligible for protection under the CAT, which is available in two forms: withholding of removal or deferral of removal. 
                    <E T="03">See</E>
                     8 CFR 1208.16(c) (CAT withholding of removal), 1208.17 (CAT deferral of removal), 1208.18 (CAT implementation). Both withholding of removal and deferral of removal under the CAT prevent a noncitizen's removal to any country where the noncitizen is “more likely than not” to be tortured. 8 CFR 1208.16(c), 1208.17, 1208.18.
                </P>
                <P>
                    The INA includes several statutory bars to asylum, which can affect a noncitizen's ability to apply for, or their eligibility for, such relief. 
                    <E T="03">Compare</E>
                     INA 208(a)(2), 8 U.S.C. 1158(a)(2) (bars to applying for asylum), 
                    <E T="03">with</E>
                     INA 208(b)(2)(A), 8 U.S.C. 1158(b)(2)(A) (bars to eligibility for asylum). For example, the statute contains six mandatory bars to asylum eligibility, covering any noncitizen: (1) who “ordered, incited, assisted, or otherwise participated in the persecution of any person on account of” a protected ground; (2) who, “having been convicted by a final judgment of a particularly serious crime, constitutes a danger to the community of the United States;” (3) for whom “there are serious reasons for believing” that the noncitizen “has committed a serious nonpolitical crime outside the United States” prior to arrival in the United States; (4) for whom “there are reasonable grounds for regarding” as “a danger to the security of the United States;” (5) who is described in the terrorism-related inadmissibility grounds, with limited exception; or (6) who “was firmly resettled in another country prior to arriving in the United States.” 
                    <E T="03">See</E>
                     INA 208(b)(2)(A), 8 U.S.C. 1158(b)(2)(A).
                </P>
                <P>
                    The statute also includes four similar mandatory bars to withholding of removal eligibility for a noncitizen: (1) who “ordered, incited, assisted, or otherwise participated in the persecution of an individual because of the individual's race, religion, nationality, membership in a particular social group, or political opinion”; (2) who, having been convicted by a final judgment of a particularly serious crime, is a danger to the community of the United States; (3) for whom “there are serious reasons to believe” that the noncitizen committed a serious nonpolitical crime outside the United States before their arrival in the United States; or (4) for whom “there are reasonable grounds to believe that” the noncitizen is a danger to the security of the United States, including for engaging in terrorist activities as described in INA 237(a)(4)(B), 8 U.S.C. 1227(a)(4)(B).
                    <SU>6</SU>
                    <FTREF/>
                      
                    <E T="03">See</E>
                     INA 241(b)(3)(B), 8 U.S.C. 1231(b)(3)(B).
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         The statute sets forth another bar to withholding of removal eligibility for those who participated in Nazi persecution, genocide, or the commission of any act of torture or extrajudicial killing. INA 237(a)(4)(D), 8 U.S.C. 1227(a)(4)(D). This bar does not apply to noncitizens in expedited removal, as it only applies to noncitizens who are “deportable” under section 237(a)(4)(D) of the INA, 8 U.S.C. 1227(a)(4)(D), 
                        <E T="03">i.e.,</E>
                         admitted noncitizens. However, this bar could be relevant for purposes of reasonable fear screening, as it could be applied to admitted noncitizens subject to administrative removal under section 238 of the INA, 8 U.S.C. 1228 (expedited removal of noncitizens convicted of committing aggravated felonies).
                    </P>
                </FTNT>
                <P>
                    Regarding protection under the CAT, noncitizens who are subject to a bar to statutory withholding of removal pursuant to section 241(b)(3)(B) of the INA, 8 U.S.C. 1231(b)(3)(B), are likewise ineligible for withholding of removal under the CAT. 
                    <E T="03">See</E>
                     8 CFR 1208.16(d)(2) (explaining that “an application for withholding of removal . . . under the Convention Against Torture shall be denied if the applicant falls within section 241(b)(3)(B) of the Act”). However, there are no bars to deferral of removal under the regulations implementing the CAT. 
                    <E T="03">See</E>
                     8 CFR 1208.17(a); 
                    <E T="03">but see</E>
                     8 CFR 1208.17(d)(4), (e) and (f) (explaining instances where deferral of removal may be terminated). Thus, a noncitizen who is entitled to protection under the CAT but is subject to a mandatory bar to CAT withholding of removal “shall be granted deferral of removal” as a limited form of protection. 8 CFR 1208.17(a). In other words, granting deferral of removal under the CAT is mandatory for noncitizens who establish eligibility for such protection. 
                    <E T="03">Id.</E>
                </P>
                <HD SOURCE="HD2">B. Credible Fear and Reasonable Fear Screening Processes</HD>
                <P>
                    In the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (“IIRIRA”), Public Law 104-208, div. C, 110 Stat. 3009, 3009-546, Congress established the expedited removal process. 
                    <E T="03">See</E>
                     INA 235(b)(1), 8 U.S.C. 1225(b)(1). The process is applicable to noncitizens arriving in the United States (and, in the discretion of the Secretary of Homeland Security, certain other designated classes of noncitizens) who are found to be inadmissible under certain provisions of the INA. 
                    <E T="03">See</E>
                     INA 235(b)(1)(A)(i), 8 U.S.C. 1225(b)(1)(A)(i) (applying the expedited removal process to noncitizens inadmissible under section 212(a)(6)(C) of the INA, 8 U.S.C. 1182(a)(6)(C) (inadmissible based on material misrepresentations), and section 212(a)(7) of the INA, 8 U.S.C. 1182(a)(7) (documentation requirements for admission)).
                </P>
                <P>
                    In the expedited removal process, such noncitizens may be “removed from the United States without further hearing or review unless the [noncitizen] indicates either an intention to apply for asylum under section 1158 of this title or a fear of persecution.” INA 235(b)(1)(A)(i), 8 U.S.C. 1225(b)(1)(A)(i). If a noncitizen indicates an intention to apply for asylum, a fear of persecution or torture, or a fear of return, DHS uses a “credible fear” screening to identify potentially valid claims for asylum, statutory withholding of removal, and CAT protection, so as to prevent noncitizens placed in expedited removal from being removed to a country in which they would face persecution or torture without further consideration of their fear claim. 
                    <E T="03">See</E>
                     INA 235(b)(1)(A)(ii), (B), 8 U.S.C. 1225(b)(1)(A)(ii), (B); 
                    <E T="03">see also</E>
                     8 CFR 235.3(b)(4), 208.30(b).
                </P>
                <P>
                    To implement the credible fear screening process, such noncitizens are referred for an interview by a U.S. Citizenship and Immigration Services 
                    <PRTPAGE P="105395"/>
                    (“USCIS”) asylum officer to determine whether the noncitizen has a credible fear of persecution or torture. INA 235(b)(1)(A)(ii), (B), 8 U.S.C. 1225(b)(1)(A)(ii), (B); 
                    <E T="03">see also</E>
                     8 CFR 235.3(b)(4). The term “credible fear of persecution” means that there is “a significant possibility, taking into account the credibility of the statements made by the [noncitizen] in support of the [noncitizen's] claim and such other facts as are known to the officer, that the [noncitizen] could establish eligibility for asylum under section 1158 of [the INA].” INA 235(b)(1)(B)(v), 8 U.S.C. 1225(b)(1)(B)(v). The credible fear screening by the asylum officer may also include consideration of certain limitations on, or presumptions against, asylum eligibility. 
                    <E T="03">See, e.g.,</E>
                     Circumvention of Lawful Pathways, 88 FR 31314, 31450 (May 16, 2023) (codifying the lawful pathways condition on asylum eligibility at 8 CFR 208.33 and 1208.33); Securing the Border, 89 FR 81156 (Oct 7, 2024) (codifying a limitation on asylum eligibility for certain noncitizens who enter during emergency border circumstances).
                </P>
                <P>
                    During the screening process, such cases may be referred to EOIR for the limited purpose of having an immigration judge review the asylum officer's determination that a noncitizen does not have a credible fear of persecution or torture. INA 235(b)(1)(B)(iii)(III), 8 U.S.C. 1225(b)(1)(B)(iii)(III); 8 CFR 208.30(g)(1). Specifically, if the asylum officer determines that the noncitizen does not have a credible fear of persecution or torture, the noncitizen may request that an immigration judge review that determination. 
                    <E T="03">Id.;</E>
                     8 CFR 208.30(g), 208.33(b), 208.35(b)(2)(v), 1208.30(g), 1208.33(b), 1208.35(b). This process is generally known as a “credible fear review.” 
                    <E T="03">See, e.g.,</E>
                     8 CFR 1003.42 (“Review of credible fear determinations”). Such reviews are intended to be concluded “as expeditiously as possible, to the maximum extent practicable within 24 hours, but in no case later than 7 days” after the asylum officer's determination. INA 235(b)(1)(B)(iii)(III), 8 U.S.C. 1225(b)(1)(B)(iii)(III). No further appeal is available from a credible fear review.
                    <SU>7</SU>
                    <FTREF/>
                      
                    <E T="03">See</E>
                     8 CFR 1003.42(f).
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Although a noncitizen may not appeal an immigration judge's negative credible fear finding, USCIS may, in its discretion, reconsider a negative credible fear determination where such requests are available and initiated within the timeframe set forth by regulation. 
                        <E T="03">See</E>
                         8 CFR 208.30(g)(1)(i); 
                        <E T="03">see also</E>
                         208.33(b)(2)(v)(C) (discretionary USCIS reconsideration under Lawful Pathways rule); 208.35(b)(2)(v)(B) (same for Securing the Border rule).
                    </P>
                </FTNT>
                <P>
                    Separately, reasonable fear proceedings involve noncitizens who have been ordered removed under section 238(b) of the INA, 8 U.S.C. 1228(b), based on an aggravated felony conviction, or whose prior orders of removal have been reinstated under section 241(a)(5) of the INA, 8 U.S.C. 1231(a)(5), but who express a fear of returning to the country of removal. 
                    <E T="03">See</E>
                     8 CFR 208.31(a); 1208.31(a). The reasonable fear screening process was established by regulation to fulfill a statutory mandate to implement, in part, the United States' obligations under Article 3 of the CAT. 
                    <E T="03">See</E>
                     Regulations Concerning the Convention Against Torture, 64 FR at 8478 (“This rule is published pursuant to this mandate to implement United States obligations under Article 3 in the context of the Attorney General's removal of [noncitizens] . . . .”). Specifically, the reasonable fear screening process was established to provide for the fair resolution of claims to withholding of removal under section 241(b)(3) of the INA, 8 U.S.C. 1231(b)(3), and protection under the regulations implementing U.S. obligations under Article 3 of the CAT, without unduly disrupting the streamlined removal processes applicable to these noncitizens. 
                    <E T="03">Id.</E>
                     at 8479.
                </P>
                <P>
                    Similar to credible fear screenings, noncitizens who express fear are referred to an asylum officer for a reasonable fear screening. 
                    <E T="03">See</E>
                     8 CFR 208.31(b)-(c); 
                    <E T="03">see also</E>
                     Regulations Concerning the Convention Against Torture, 64 FR at 8485 (explaining that the reasonable fear process is “modeled on the credible fear screening process”). However, unlike those in the credible fear process, noncitizens subject to the reasonable fear process are categorically ineligible for asylum by virtue of their aggravated felony conviction, INA 208(b)(2)(A)(ii), (B), 8 U.S.C. 1158(b)(2)(A)(ii), (B) (barring from asylum those convicted of an aggravated felony), or being subject to reinstatement, INA 241(b)(5), 8 U.S.C. 1231(b)(5) (rendering those whose removal orders have been reinstated ineligible and unable to apply for any “relief”). Rather, the asylum officer determines whether the noncitizen has a reasonable fear of persecution or torture upon removal and is therefore eligible for consideration of statutory withholding of removal or CAT protection. 
                    <E T="03">See</E>
                     8 CFR 208.31(c). A “reasonable fear of persecution or torture” means that there is a reasonable possibility that the noncitizen would be persecuted because of their race, religion, nationality, membership in a particular social group, or political opinion, or a reasonable possibility that the noncitizen would be tortured if returned to the country of removal. 8 CFR 208.31(c).
                </P>
                <P>
                    Such cases may be referred to EOIR for the limited purpose of having an immigration judge review the asylum officer's determination that a noncitizen does not have a reasonable fear of persecution or torture. 
                    <E T="03">See</E>
                     8 CFR 1208.31(g) (“Review by immigration judge”). If the asylum officer determines that the noncitizen does not have a reasonable fear of persecution or torture, the noncitizen may request that an immigration judge review that determination. 
                    <E T="03">See</E>
                     8 CFR 1208.31(f). This is generally known as a “reasonable fear review.” Such reviews are intended to be conducted within 10 days of filing the referral with the immigration court. 
                    <E T="03">See</E>
                     8 CFR 1208.31(g). No further administrative appeal is available from a negative reasonable fear determination. 
                    <E T="03">See</E>
                     8 CFR 1208.31(g)(1).
                </P>
                <P>
                    During both credible fear and reasonable fear reviews, immigration judges review de novo an asylum officer's determination that a noncitizen does not have a credible fear or reasonable fear, as applicable. 
                    <E T="03">See</E>
                     INA 235(b)(1)(B)(iii)(III), 8 U.S.C. 1225(b)(1)(B)(iii)(III) (providing for prompt review of an asylum officer's determination that a noncitizen does not have a credible fear of persecution); 8 CFR 1003.42(a) (requiring DHS to file the written record of determination with the immigration judge for credible fear review), 1208.31(g) (same for reasonable fear review). The immigration judge's review may include consideration of certain limitations on, or presumptions against, asylum eligibility. 
                    <E T="03">See, e.g.,</E>
                     8 CFR 1208.33(b) (review of the lawful pathways condition on asylum eligibility), 1208.35(b) (review of the limitation on asylum eligibility for certain noncitizens who enter during emergency border circumstances).
                </P>
                <P>
                    However, asylum officers historically have not considered the applicability of mandatory bars to asylum or withholding of removal contained in INA 208(a)(2), (b)(2)(A), 8 U.S.C. 1158(a)(2), (b)(2)(A), or INA 241(b)(3)(B), 8 U.S.C. 1241(b)(3)(B), during credible fear and reasonable fear screenings, and accordingly, immigration judges have not reviewed the application of those bars during review of credible fear and reasonable fear determinations. But in recent years, there have been a number of regulations seeking to permit or mandate the 
                    <PRTPAGE P="105396"/>
                    consideration of some or all of these bars during the credible fear process—followed, in some cases, by regulations reversing that approach.
                </P>
                <P>
                    As one example, in 2020, DHS and DOJ amended the Departments' regulations to instruct asylum officers and immigration judges to apply certain mandatory bars during the credible fear process. 
                    <E T="03">See</E>
                     Procedures for Asylum and Withholding of Removal; Credible Fear and Reasonable Fear Review, 85 FR 80274, 80278 (Dec. 11, 2020) (“Global Asylum Rule”). On January 8, 2021, the Global Asylum Rule was enjoined before its effective date. 
                    <E T="03">Pangea Legal Servs.</E>
                     v. 
                    <E T="03">DHS,</E>
                     512 F. Supp. 3d 966, 977 (N.D. Cal. 2021).
                </P>
                <P>
                    Subsequently, in 2022, the Department and DHS issued a joint rule amending the credible fear regulations at 8 CFR 208.30(e)(5), 8 CFR 1003.42, and 8 CFR 1208.30, as relevant here, returning the regulatory text to the pre-Global Asylum Rule approach where asylum officers do not consider the applicability of mandatory bars for credible fear determinations, and therefore, immigration judges do not consider the applicability of bars in reviewing such determinations. 
                    <E T="03">See</E>
                     Procedures for Credible Fear Screening and Consideration of Asylum, Withholding of Removal, and CAT Protection Claims by Asylum Officers, 87 FR 18078, 18219, 18221-22 (Mar. 29, 2022) (“Asylum Processing IFR”).
                </P>
                <P>
                    Most recently, in December 2024, DHS issued a rule to allow asylum officers to consider the potential applicability of certain bars to asylum and statutory withholding of removal during credible fear and reasonable fear screenings. See 89 FR 103370 (Dec. 18, 2024) (“DHS Mandatory Bars”). Specifically, the rule allows asylum officers to apply the mandatory asylum and withholding of removal bars relating to national security and public safety as set forth in INA 208(b)(2)(A)(i) through (v), 8 U.S.C. 1158(b)(2)(A)(i) through (v) and INA 241(b)(3)(B), 8 U.S.C. 1241(b)(3)(B), during credible fear and reasonable fear screenings in certain instances. 
                    <E T="03">See id.</E>
                </P>
                <HD SOURCE="HD1">IV. Description of the Interim Final Rule</HD>
                <HD SOURCE="HD2">A. Credible Fear and Reasonable Fear Review</HD>
                <P>
                    The Department is issuing this IFR to make a technical amendment to EOIR's regulations in order to clarify the scope of an immigration judge's credible fear or reasonable fear review. Upon a noncitizen's request, immigration judges have always reviewed—and will continue to review—the underlying asylum officer determinations made during credible fear or reasonable fear screenings that a noncitizen could not establish potential eligibility for relief or protection. This rule clarifies that an immigration judge's de novo review of an asylum officer's credible fear or reasonable fear determination includes review of the asylum officer's application of any bars to asylum and withholding of removal considered by the asylum officer pursuant to DHS regulations. 
                    <E T="03">See</E>
                     8 CFR 1003.42(d) (credible fear review), 1208.31(g) (reasonable fear review), 1208.33(b) (credible fear review after application of the lawful pathways rebuttable presumption of asylum ineligibility). This housekeeping measure ensures that immigration judges consider the asylum officers' determinations made regarding credible fear and reasonable fear, including their application of any bars to asylum and withholding of removal, consistent with the statutory scheme. 
                    <E T="03">See</E>
                     INA 235(b)(1)(B)(iii)(III), 8 U.S.C. 1225(b)(1)(B)(iii)(III) (statutory review role); 8 CFR 1003.42(d) (credible fear review), 1208.31(g) (reasonable fear review), 1208.33(b) (credible fear review after application of the lawful pathways rebuttable presumption of asylum ineligibility).
                </P>
                <P>With respect to credible fear screenings, this housekeeping clarification accords with the statutory scheme set forth by the INA. The INA charges asylum officers with making determinations whether a noncitizen has demonstrated a credible fear of persecution, INA 235(b)(1)(B), 8 U.S.C. 1225(b)(1)(B), and immigration judges with reviewing negative credible fear determinations, INA 235(b)(1)(B)(iii)(III), 8 U.S.C. 1225(b)(1)(B)(iii)(III). Consistent with this division of screening and review authority, the DHS regulations governing asylum officers have always addressed whether or not the bars to asylum should be taken into consideration by the asylum officer in credible fear screenings. During the long period when asylum officers did not apply any of those bars, the EOIR regulations governing immigration judges did not expressly address the issue. Instead, the EOIR regulations simply provided for de novo review of the asylum officer's determination that the noncitizen does not have a credible fear of persecution or torture, taking into account any additional evidence or testimony provided during the review.</P>
                <P>Similarly, with respect to reasonable fear screenings, this rule maintains consistency with the existing regulatory scheme, where asylum officers “determine” whether the noncitizen has a reasonable fear of persecution or torture, 8 CFR 208.31(c), and immigration judges may review negative reasonable fear determinations. 8 CFR 1208.31(g). This housekeeping measure clarifies that, going forward, the immigration judge may continue to review the entirety of an asylum officer's negative reasonable fear determination, including application of bars during a reasonable fear screening under DHS regulations. This rule also adds the words “de novo” to state that an “asylum officer's negative decision regarding reasonable fear shall be subject to de novo review by an immigration judge,” 8 CFR 1208.31(g), to explicitly codify the standard by which the immigration judge reviews the asylum officer's determination.</P>
                <P>
                    This rulemaking is intended to prevent future confusion regarding whether an immigration judge's credible fear or reasonable fear review will encompass review of the asylum officer's application of bars to asylum or withholding of removal, consistent with existing review requirements. 
                    <E T="03">See</E>
                     INA 235(b)(1)(B), 8 U.S.C. 1225(b)(1)(B) (charging DHS with making credible fear determinations and the Department with review of those determinations); 8 CFR 1208.31(g) (authorizing immigration judges to conduct reasonable fear reviews). This clarification is particularly important in light of DHS's December 2024 rule to allow asylum officers to consider the potential applicability of certain bars to asylum and withholding of removal during credible fear and reasonable fear screenings. See DHS Mandatory Bars, 89 FR 103370.
                </P>
                <P>
                    Moreover, the Department found recent rulemakings regarding the credible fear screening process instructive on providing clarity regarding immigration judge review during that process. 
                    <E T="03">See, e.g.,</E>
                     Circumvention of Lawful Pathways, 88 FR at 31314; Securing the Border, 89 FR at 81156. In these rulemakings, DHS and DOJ provided specific regulatory provisions regarding immigration judge review of the limitation on asylum eligibility or rebuttable presumption of asylum ineligibility contained in those rules during credible fear reviews. 
                    <E T="03">See, e.g.,</E>
                     8 CFR 1208.33(b) (review of the lawful pathways rebuttable presumption of asylum ineligibility); 1208.35(b) (review of the limitation on asylum eligibility for certain noncitizens who enter during emergency border circumstances). The Department believes that providing clarity in this rule regarding immigration judge review of any bars to asylum or withholding of removal the asylum officer applied 
                    <PRTPAGE P="105397"/>
                    during the credible fear and reasonable fear process would be similarly beneficial.
                </P>
                <P>
                    Specifically, the Department is modifying EOIR's credible fear review regulations to state: “This determination shall, where relevant, include review of the asylum officer's application of any bars to asylum and withholding of removal pursuant to 8 CFR 208.30(e)(5).” 
                    <E T="03">See</E>
                     8 CFR 1003.42(d). The Department is also amending the Circumvention of Lawful Pathways regulatory section to clarify that immigration judges' de novo review under 8 CFR 1208.33(b) includes review of the asylum officer's application of any bars to withholding of removal pursuant to 8 CFR 208.33(b)(2).
                    <SU>8</SU>
                    <FTREF/>
                      
                    <E T="03">See</E>
                     8 CFR 1208.33(b)(1). Similarly, the Department is adding an affirmative sentence stating that, during reasonable fear review before EOIR, “[t]he immigration judge's review shall, where relevant, include review of the asylum officer's application of any bars pursuant to 8 CFR 208.31(c).” 
                    <E T="03">See</E>
                     8 CFR 1208.31(g).
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         In amending these regulatory sections, the Department has determined that it is unnecessary to also amend the Securing the Border regulatory section at 8 CFR 1208.35. First, noncitizens who are not subject to that rule's limitation on asylum eligibility during the credible fear process are instead screened by asylum officers pursuant to the procedures outlined in 8 CFR 208.30 or 208.33, as applicable. Accordingly, in those cases, immigration judges will continue to review negative credible fear determinations under 8 CFR 1003.42 or 1208.33(b), as applicable, and this rule amends both of those sections to clarify immigration judges' authority to review the asylum officer's application of any of the mandatory bars to asylum or withholding of removal during the credible fear process. Second, noncitizens who are subject to the Securing the Border rule's limitation on asylum eligibility during the credible fear process will receive a negative credible fear determination with respect to the noncitizen's asylum claim because of that rule's limitation on asylum, not because of the application of any mandatory bar. These individuals are further screened for potential eligibility for statutory withholding of removal and CAT protection, but the Securing the Border rule does not create a free-standing process for such screenings. Rather, such noncitizens are screened for a reasonable probability of establishing eligibility for statutory withholding of removal or CAT protection under the procedures outlined in the existing Circumvention of Lawful Pathways regulatory section at 8 CFR 208.33(b)(2)(ii), 
                        <E T="03">see</E>
                         8 CFR 208.35(b)(2)(iii), and this rule amends the Circumvention of Lawful Pathways provision at 8 CFR 1208.33(b) to clarify immigration judges' authority to consider the asylum officer's application of any mandatory bars to withholding of removal during credible fear reviews. Accordingly, the Department believes this rule's amendments to 8 CFR 1208.33 and 1003.42 are sufficient to clarify that immigration judges have authority to review an asylum officer's application of any of the mandatory bars even if the noncitizen is subject to the limitation on, or presumption against, asylum eligibility under the Circumvention of Lawful Pathways or the Securing the Border rules.
                    </P>
                </FTNT>
                <P>
                    In making these changes, the Department notes that, while the immigration judge's role is to conduct a de novo review of the asylum officer's credible or reasonable fear determination, both the statute and the regulations contemplate that the immigration judge may make their ultimate de novo determination based on the record the asylum officer provides, as well as evidence or testimony that was not available to the asylum officer. 
                    <E T="03">See, e.g.,</E>
                     INA 235(b)(1)(B)(iii)(III), 8 U.S.C. 1225 (b)(1)(B)(iii)(III) (explaining that a credible fear review “shall include an opportunity for the [noncitizen] to be heard and questioned by the immigration judge. . . .”); 8 CFR 1003.42(d) (noting that, during a credible fear review, the immigration judge will “tak[e] into account the credibility of the statements made by the [noncitizen] in support of the [noncitizen's] claim, and such other facts as are known to the immigration judge”); Immigration Court Practice Manual, Chapter 7.4(e)(4)(E) (October 25, 2023) (stating that, during a reasonable fear review, “[e]ither party may introduce oral or written statements”). This rule, therefore, honors the statutory screening and review scheme, while also preserving the existing statutory and regulatory recognition that additional evidence or testimony may be provided that implicates the noncitizen's credible or reasonable fear.
                </P>
                <P>
                    The Department also notes that there may be instances where review of an asylum officer's application of a bar may be unnecessary to make a determination as to whether a noncitizen has a credible or reasonable fear. For example, if the immigration judge finds that the noncitizen could not establish a credible fear or reasonable fear for a separate reason unrelated to any bars to asylum or withholding of removal, the immigration judge does not need to then conduct further review of the asylum officer's application of any bars. 
                    <E T="03">See INS</E>
                     v. 
                    <E T="03">Bagamasbad,</E>
                     429 U.S. 24, 25 (1976) (“As a general rule courts and agencies are not required to make findings on issues the decision of which is unnecessary to the results they reach.”). This ensures that such reviews are “concluded as expeditiously as possible,” consistent with the statute. INA 235(b)(1)(B)(iii)(III), 8 U.S.C. 1225(b)(1)(B)(iii)(III).
                </P>
                <P>
                    Further, the Department notes that this rulemaking does not itself modify or alter the substantive standards applicable in credible fear or reasonable fear screenings. 
                    <E T="03">See, e.g.,</E>
                     8 CFR 1003.42(d) (credible fear standards), 1208.31(c) (reasonable fear standards), 1208.33(b)(2) (credible fear standards under the Circumvention of Lawful Pathways rule), 1208.35(b)(2)(iii) (credible fear standards under Securing the Border rule). Nor does this rulemaking alter the procedures that immigration judges currently follow during credible fear or reasonable fear reviews. 
                    <E T="03">See generally</E>
                     8 CFR 1003.42, 1208.30(g), 1208.31(g), 1208.33(b), 1208.35(b). In short, during credible fear and reasonable reviews, immigration judges will continue to make a de novo determination as to whether the noncitizen has made a threshold showing under the relevant standard that they could establish eligibility for asylum, statutory withholding of removal, or protection under the CAT, as applicable. This rulemaking simply clarifies that, as part of these existing reviews, immigration judges shall, where relevant, review the asylum officer's application of any bars to asylum or withholding of removal.
                </P>
                <P>
                    Additionally, the changes in this rulemaking do not affect the ability of a noncitizen to pursue or receive deferral of removal under the CAT, 8 CFR 1208.16(c)(4) and 1208.17, or the existing processes for referring noncitizens with a fear of torture for adjudication of their deferral claim, where applicable. 
                    <E T="03">See</E>
                     1208.30(g)(2)(iv)(B) (referrals from positive credible fear review); 1208.31(g)(2)(i) (further consideration from positive reasonable fear review). There are no bars to deferral of removal under the CAT, and noncitizens who demonstrate the requisite credible or reasonable fear of torture will continue to be able to pursue deferral of removal under the CAT, regardless of an asylum officer's application of any bars to asylum or withholding of removal specified in DHS regulations. Noncitizens who are referred for further proceedings after positive credible or reasonable fear determinations, and who then make the requisite showing that they are more likely than not to be tortured, will therefore receive deferral of removal, without any consideration of those bars.
                </P>
                <HD SOURCE="HD2">B. Other Technical Changes</HD>
                <P>
                    This rulemaking is also making minor technical edits for consistency in the EOIR regulations amended by this rule. For example, in 8 CFR 1003.42, the rule decapitalizes the words “Immigration Court” and “Immigration Judge” to read “immigration court” and “immigration judge.” Similarly, the rule replaces outdated references to “the Service” with “DHS” and updates references to form titles in 8 CFR 1003.42 and 1208.31. The rule also makes two non-substantive corrections to inadvertent 
                    <PRTPAGE P="105398"/>
                    errors in cross-references to the definition of “victim of a severe form of trafficking in persons” in 8 CFR 1208.33(a)(3)(i)(C) and 1208.35(a)(2)(i)(C).
                </P>
                <P>
                    This rulemaking also replaces the term “alien” with “noncitizen” in 8 CFR 1003.42, 1208.31, and 1208.33. Similarly, in 8 CFR 1208.33(a)(2)(i), this rulemaking replaces the phrase “unaccompanied alien child as defined in 6 U.S.C. 279(g)(2)” with the phrase “unaccompanied child as defined in 8 CFR 1001.1(hh).” These changes are consistent with recent terminology usage changes at EOIR. 
                    <E T="03">See</E>
                     8 CFR 1001.1(gg) (defining “noncitizen” as equivalent to the statutory term “ `alien,' as defined in section 101(a)(3) of the Act,” 8 U.S.C. 1101(a)(3)), 1001.1(hh) (defining “unaccompanied child” as equivalent to the statutory term “ `unaccompanied alien child' as defined in 6 U.S.C. 279(g)(2)”); 
                    <E T="03">see also</E>
                     Efficient Case and Docket Management in Immigration Proceedings, 89 FR at 46787 (adding new 8 CFR 1001.1(gg)-(hh)).
                </P>
                <P>
                    This rule also removes and reserves 8 CFR 1208.31(b) through (d). These paragraphs were duplicated from 8 CFR 208.31 as part of the reorganization of title 8 following the transfer of functions from the former Immigration and Naturalization Service to DHS due to the HSA. Aliens and Nationality; Homeland Security; Reorganization of Regulations, 68 FR 9824, 9834 (Feb. 28, 2003). Because these paragraphs refer to DHS operations performed by asylum officers, not EOIR immigration judges, they are therefore unnecessary to maintain in EOIR's regulations. The Departments always regarded this duplication as temporary and have periodically taken steps to eliminate unnecessary duplication. 
                    <E T="03">E.g., id.</E>
                     at 9825-26; Background and Security Investigations in Proceedings Before Immigration Judges and the Board of Immigration Appeals, 70 FR 4743, 4749 &amp; n.7 (Jan. 31, 2005); Inflation Adjustment for Civil Monetary Penalties Under Sections 274A, 274B, and 274C of the Immigration and Nationality Act, 73 FR 10130, 10132 (Feb. 26, 2008).
                </P>
                <P>
                    The rule also makes clarifying, technical changes to 8 CFR 1003.42(a) and 8 CFR 1208.31(g) regarding the record forwarded by DHS to the immigration court for credible fear or reasonable fear reviews. These technical edits are designed to emphasize that the immigration judge's review of the asylum officer's determination will consist of the “complete” record, as described by statute in the credible fear context, and as described by regulation in the reasonable fear context, respectively.
                    <SU>9</SU>
                    <FTREF/>
                     In other words, these edits are intended to provide clarity for all parties by emphasizing that it is particularly important for immigration judges to have the complete record to review an asylum officer's application of any bars pursuant to 8 CFR 208.30(e) and 8 CFR 208.31(c). 
                    <E T="03">See</E>
                     8 CFR 1003.42(a), (d), 1208.31(g). These edits to the EOIR regulations do not, however, substantively or procedurally change the content or items that DHS provides to DOJ for the record of a credible fear or reasonable fear determination.
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         In the credible fear context, by statute, the asylum officer “prepare[s] a written record of a determination” that “include[s] a summary of the material facts as stated by the applicant, such additional facts (if any) relied upon by the officer, and the officer's analysis of why, in the light of such facts, the [noncitizen] has not established a credible fear of persecution” and “[a] copy of the officer's interview notes.” INA 235(b)(1)(B)(iii)(II), 8 U.S.C. 1225(b)(1)(B)(iii)(II). Jurisdiction for an immigration judge to review an asylum officer's determination commences when DHS files this written record, as defined by the Act, and a copy of the noncitizen's request for review, if any, with EOIR. 8 CFR 1003.42(a). There is not a corresponding statutory provision regarding the record in the reasonable fear context, but the regulations require the asylum officer to provide EOIR with “[t]he record of determination, including copies of the Notice of Referral to the Immigration Judge, the asylum officer's notes, the summary of the material facts, and other materials upon which the determination was based. . . .” 8 CFR 1208.31(g).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <P>
                    Next, the rule makes two clarifying edits to the EOIR regulations at 8 CFR 1003.42(e). First, the rule amends the regulatory text for specificity to include the form number—Form I-869—for the Record of Negative Credible Fear Finding and Request for Review. 8 CFR 1003.42(e). Second, the rule clarifies that the immigration judge's review of the negative credible fear determination will conclude no later than 7 days after the supervisory asylum officer has “concurred with”—rather than “approved”—the asylum officer's negative credible fear determination for conformity with DHS's terminology regarding its internal processes for supervisory review. 
                    <E T="03">Id.; see, e.g.,</E>
                     8 CFR 208.30(b) (“after supervisory 
                    <E T="03">concurrence”</E>
                    ) (emphasis added), (e)(6)(i) (“[i]f the asylum officer, with 
                    <E T="03">concurrence</E>
                     from a supervisory asylum officer”) (emphasis added), (e)(7)(i)(A) (same).
                </P>
                <P>Additionally, this rule makes technical changes to the EOIR regulations at 8 CFR 1003.42(d) and 1208.33(b)(2)(i) and (ii) to correct two inadvertent omissions and clarify the appropriate countries to consider for screenings related to statutory withholding of removal and CAT protection. First, at 8 CFR 1003.42(d) and 1208.33(b)(2)(i), the Department is adding “withholding” and “deferral” to the list of the forms of relief and protection considered during an immigration judge's credible fear review to ensure that immigration judges are instructed to screen for both forms of CAT protection. This omission was inadvertent in both instances, and amending the provisions in this way is thus a mere technical change.</P>
                <P>
                    Relatedly, the Department is also amending 8 CFR 1003.42(d) and 1208.33(b)(2)(i) and (ii) to make clear that, when screening for statutory withholding of removal and both withholding of removal and deferral of removal under the CAT, the immigration judge considers those forms of protection as to the country or countries of removal identified pursuant to section 241(b) of the Act, 8 U.S.C. 1231(b).
                    <SU>11</SU>
                    <FTREF/>
                     This is a housekeeping measure to add clarity to the regulation and to ensure it is applied consistently with the statute. This is because under section 241(b)(3) of the INA, 8 U.S.C. 1231(b)(3), and the regulations implementing the CAT, both forms of protection prevent removal to a specific country only—the proposed country of removal. 
                    <E T="03">See</E>
                     INA 241(b)(3), 8 U.S.C. 1231(b)(3); 8 CFR 1208.16(c)(2) (providing that it is the noncitizen's burden to establish that they are more likely than not to be tortured in the “proposed country of removal”).
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See also Matter of A-S-M-,</E>
                         28 I&amp;N Dec. 282, n. 4 (BIA 2021) (“DHS has the discretion under section 241(b)(2)(E) of the Act to conceivably remove [a noncitizen] to any country that is willing to accept him or her, if [sic] unable to remove the [noncitizen] to a country designated under sections 241(b)(2)(A) through (D) of the Act. However, where the DHS states that an applicant in withholding-only proceedings may be removed to a country where he or she fears persecution or torture, an Immigration Judge needs to fully consider whether the applicant is eligible to have his or her removal withheld from that country under the Act and the Convention Against Torture.”).
                    </P>
                </FTNT>
                <P>
                    For a noncitizen subject to expedited removal, the identification of the country or countries of removal pursuant to section 241(b) of the Act takes place as part of DHS's removal process and occurs before any potential referral for a credible fear screening or subsequent EOIR credible fear review. 
                    <E T="03">See</E>
                     INA 235(b)(1)(A)(i), 8 U.S.C. 1225(b)(1)(A)(i); 8 CFR 235.3(b)(2)(i) (explaining removability determinations made during expedited removal process). And thus, it is before DHS—not EOIR—that the country or countries of removal will be identified pursuant to section 241(b) of the Act, 8 U.S.C. 1231(b). This country designation is not reviewable during a credible fear review by the immigration judge, who is 
                    <PRTPAGE P="105399"/>
                    authorized to review only “a determination . . . that the [noncitizen] does not have a credible fear of persecution” with respect to identified countries of removal. INA 235(b)(1)(B)(iii)(III), 8 U.S.C. 1225(b)(1)(B)(iii)(III). 
                    <E T="03">See also Matter of A-S-M-,</E>
                     28 I&amp;N Dec. 282, 285 (BIA 2021) (recognizing, in the reasonable fear context, that DHS “`retains discretion' to determine the proper country of removal under section 241(b)(2) of the Act,” 8 U.S.C. 1231(b)(2), and that determination is unreviewable by an immigration judge or the Board of Immigration Appeals). Thus, this change makes clear that the immigration judge reviews the screening eligibility determinations with respect to the country or countries of removal identified pursuant to section 241(b) of the Act, 8 U.S.C. 1231(b).
                </P>
                <HD SOURCE="HD1">V. Statutory and Regulatory Requirements</HD>
                <HD SOURCE="HD2">A. Administrative Procedure Act</HD>
                <P>
                    The Administrative Procedure Act (“APA”) generally requires agencies to publish notice of a proposed rulemaking in the 
                    <E T="04">Federal Register</E>
                     and allow for a period of public comment. 5 U.S.C. 553(b) through (c). The APA's notice-and-comment requirements, however, do not apply to “rules of agency organization, procedure, or practice.” 5 U.S.C. 553(b)(A). Courts “have used the term `procedural exception' as shorthand for that exemption.” 
                    <E T="03">Am. Fed'n of Lab. &amp; Cong. of Indus. Orgs.</E>
                     v. 
                    <E T="03">Nat'l Lab. Rels. Bd.,</E>
                     57 F.4th 1023, 1034 (D.C. Cir. 2023) (citing 
                    <E T="03">Pub. Citizen</E>
                     v. 
                    <E T="03">Dep't of State,</E>
                     276 F.3d 634, 640 (D.C. Cir. 2002) (quoting 
                    <E T="03">JEM Broad. Co., Inc.</E>
                     v. 
                    <E T="03">FCC,</E>
                     22 F.3d 320, 328 (D.C. Cir. 1994))). “[T]he critical feature of a rule that satisfies the . . . procedural exception is that it covers agency actions that do not themselves alter the rights or interests of parties, although it may alter the manner in which the parties present themselves or their viewpoints to the agency.' ” 
                    <E T="03">Id.</E>
                     (citing 
                    <E T="03">James V. Hurson Assocs., Inc.</E>
                     v. 
                    <E T="03">Glickman,</E>
                     229 F.3d 277, 280 (D.C. Cir. 2000) (internal quotations omitted)); 
                    <E T="03">cf. Texas</E>
                     v. 
                    <E T="03">United States,</E>
                     809 F.3d 134, 176 (5th Cir. 2015) (holding that a rule is not procedural when it “modifies substantive rights and interests” (quoting 
                    <E T="03">U.S. Dep't of Lab.</E>
                     v. 
                    <E T="03">Kast Metals Corp.,</E>
                     744 F.2d 1145, 1153 (5th Cir. 1984))).
                </P>
                <P>
                    To determine whether a rule is procedural or substantive, courts “must look at [the rule's] effect on those interests ultimately at stake in the agency proceeding.” 
                    <E T="03">Neighborhood TV Co., Inc.</E>
                     v. 
                    <E T="03">FCC,</E>
                     742 F.2d 629, 637 (D.C. Cir. 1984). That said, “an otherwise-procedural rule does not become a substantive one, for notice-and-comment purposes, simply because it imposes a burden on regulated parties.” 
                    <E T="03">James V. Hurson Assocs., Inc.,</E>
                     229 F.3d at 281. Even “a rule with a `substantial impact' upon the persons subject to it is not necessarily a substantive rule under” the APA. 
                    <E T="03">Elec. Priv. Info. Ctr.</E>
                     v. 
                    <E T="03">U.S. Dep't of Homeland Sec.,</E>
                     653 F.3d 1, 5 (D.C. Cir. 2011) (citing 
                    <E T="03">Pub. Citizen</E>
                     v. 
                    <E T="03">Dep't of State,</E>
                     276 F.3d at 640-41).
                </P>
                <P>
                    The Department has determined that this rule regulates agency procedure and is therefore exempt from notice-and-comment procedures under the APA, 5 U.S.C. 553(b)(A). The amendments adopted through this IFR do not alter individuals' rights or interests nor do they alter any eligibility requirements for relief or protection from removal. 
                    <E T="03">See JEM Broad. Co.,</E>
                     22 F.3d at 326. Instead, these amendments clarify that an immigration judge's review of the determinations made by an asylum officer at the credible fear or reasonable fear screening will include, where relevant, review of the asylum officer's application of any bars to asylum and withholding of removal under DHS regulations. An immigration judge's review of an asylum officer's credible or reasonable fear determination will remain, as it has always been, de novo, and thus the clarifications made in this rule are merely procedural and do not place any new, “substantive burden[s]” on regulated parties. 
                    <E T="03">Elec. Priv. Info. Ctr.,</E>
                     653 F.3d at 6.
                </P>
                <P>
                    EOIR's current regulations provide immigration judges with the broad authority to conduct de novo review of an asylum officer's credible or reasonable fear determination, and do not expressly limit the ability of immigration judges to consider any relevant bars to asylum or withholding of removal, should DHS provide for them by regulation. 
                    <E T="03">See, e.g.,</E>
                     8 CFR 1003.42(d); 1208.31(g). However, rather than risk the potential confusion regarding consideration of the applicability of bars at the immigration judge's review stage, this rule explicitly states that immigration judges shall, where relevant, review the asylum officer's application of such bars. Because this modification is a housekeeping measure, including terminology updates for internal consistency of usage within EOIR's regulations and additions for clarity regarding review of protection claims relating to the designated country of removal, the Department believes that this IFR is an efficient means of making this procedural clarification. 
                    <E T="03">See James V. Hurson Assocs., Inc.,</E>
                     229 F.3d at 282 (“We have, therefore, consistently recognized that `agency housekeeping rules often embody a judgment about what mechanics and processes are most efficient.' This does not convert a procedural rule into a substantive one.”) (citations omitted).
                </P>
                <P>
                    As noted, the Department has previously made conforming changes to its regulations jointly with DHS when DHS modified its own regulations governing whether the asylum officer may consider the mandatory bars to asylum and withholding of removal in credible fear determinations. 
                    <E T="03">See, e.g.,</E>
                     85 FR at 80278 (Global Asylum Rule). However, the Department has determined that, in the interest of administrative efficiency, the Department will simply codify in the EOIR regulations that the immigration judge will review the asylum officer's credible fear or reasonable fear determination, including, as directed by DHS regulations, the asylum officer's application of any bars to eligibility, de novo. This language will ensure that EOIR regulations sufficiently cover any scenario where asylum officers may consider the bars to asylum and withholding of removal in a screening determination, and will not require further EOIR rulemaking action should DHS make future regulatory changes to the applicability of any bars to asylum or withholding of removal during the credible fear or reasonable fear screening processes.
                </P>
                <P>Although prior notice-and-comment is not required, the Department invites public comment on this IFR, and will, before issuing a final rule, consider any such comments submitted in accordance with the requirements herein.</P>
                <P>
                    Additionally, the Department has also determined that, because this is a procedural rule under the APA, the rule is not subject to the APA's requirement of a 30-day delay in the effective date. 
                    <E T="03">See</E>
                     5 U.S.C. 553(d)(3) (providing that “[t]he required publication or service of a 
                    <E T="03">substantive</E>
                     rule shall be made not less than 30 days before its effective date . . . except as otherwise provided by the agency for good cause found and published with the rule”) (emphasis added).
                </P>
                <HD SOURCE="HD2">B. Regulatory Flexibility Act</HD>
                <P>
                    The Regulatory Flexibility Act (“RFA”), as amended by the Small Business Regulatory Enforcement and Fairness Act of 1996, generally requires an agency to prepare and make available to the public a final regulatory flexibility analysis that describes the effect of a rule on small entities (
                    <E T="03">i.e.,</E>
                     small businesses, small organizations, 
                    <PRTPAGE P="105400"/>
                    and small governmental jurisdictions) when the agency is required “to publish a general notice of proposed rulemaking” prior to issuing the final rule. 
                    <E T="03">See</E>
                     5 U.S.C. 603(a), 604(a).
                </P>
                <P>This IFR is not subject to the regulatory flexibility analysis requirement because, as explained above, the Department is not required to publish a proposed rule before publishing this IFR. Such analysis is not required when a rule is exempt from notice-and-comment rulemaking under 5 U.S.C. 553(b) or other law. Because this is a rule of agency procedure and therefore is exempt from notice-and-comment rulemaking, no RFA analysis under 5 U.S.C. 603 or 604 is required. The Department nonetheless welcomes comments regarding potential impacts on small entities, which the Department may consider as appropriate.</P>
                <HD SOURCE="HD2">C. Executive Order 12866 (Regulatory Planning and Review), Executive Order 13563 (Improving Regulation and Regulatory Review), and Executive Order 14094 (Modernizing Regulatory Review)</HD>
                <P>Executive Order 12866, Regulatory Planning and Review, 58 FR 51735 (Sept. 30, 1993), as amended by Executive Order 14094, Modernizing Regulatory Review, 88 FR 21879 (Apr. 6, 2023) and supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, 76 FR 3821 (Jan. 18, 2011), directs agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects, distributive impacts, and equity). Executive Order 13563 further emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility.</P>
                <P>The Office of Management and Budget, Office of Information and Regulatory Affairs (“OIRA”) has designated this IFR a “significant regulatory action” under Executive Order 12866, as amended. Accordingly, OIRA has reviewed this regulation. Further, the Department certifies that this IFR has been drafted in accordance with the principles of Executive Orders 12866, 13563, and 14094.</P>
                <P>Overall, the Department believes that the changes adopted in this IFR will not have a significant impact on adjudicators, the parties, and the broader public. This rule is a housekeeping measure that clarifies existing credible fear and reasonable fear review processes, including the review of the asylum officer's application of the bars to asylum and withholding of removal pursuant to 8 CFR 208.30(e)(5).</P>
                <P>In sum, any changes contemplated by the IFR would not impact the public in a way that would render the IFR in tension with the principles of Executive Orders 12866 or 13563.</P>
                <HD SOURCE="HD2">D. Unfunded Mandates Reform Act of 1995</HD>
                <P>The Unfunded Mandates Reform Act of 1995 (“UMRA”) is intended, among other things, to curb the practice of imposing unfunded Federal mandates on State, local, and Tribal governments, or a private sector mandate, by requiring the preparation of an UMRA analysis for a rule that may directly result in a $100 million or more expenditure (adjusted annually for inflation) in any one year.</P>
                <P>This IFR is not subject to the written statement requirement because no general notice of proposed rulemaking was published prior to issuance of this IFR. 2 U.S.C. 1532(a). In addition, this IFR does not contain such a mandate because it does not impose any enforceable duty upon any other level of government or private sector entity. Any downstream effects on such entities would arise solely due to their voluntary choices, and the voluntary choices of others, and would not be a consequence of an enforceable duty imposed by this IFR. Similarly, any costs or transfer effects on State and local governments would not result from a Federal mandate as that term is defined under UMRA. The requirements of title II of UMRA, therefore, do not apply, and the Department has not prepared a statement under UMRA.</P>
                <HD SOURCE="HD2">E. Executive Order 13132 (Federalism)</HD>
                <P>This IFR will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, the Department has determined that this IFR does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.</P>
                <HD SOURCE="HD2">F. Executive Order 12988 (Civil Justice Reform)</HD>
                <P>This IFR meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, 61 FR 4729 (Feb. 5, 1996).</P>
                <HD SOURCE="HD2">G. Family Assessment</HD>
                <P>
                    The Department has reviewed this IFR in line with the requirements of section 654 of the Treasury and General Government Appropriations Act, 1999, 
                    <E T="03">see</E>
                     5 U.S.C. 601 note, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999. Public Law 105-277, 112 Stat. 2681 (1998). The Department has reviewed the criteria specified in section 654(c)(1), by evaluating whether this regulatory action (1) impacts the stability or safety of the family, particularly in terms of marital commitment; (2) impacts the authority of parents in the education, nurture, and supervision of their children; (3) helps the family perform its functions; (4) affects disposable income or poverty of families and children; (5) only financially impacts families, if at all, to the extent such impacts are justified; (6) may be carried out by State or local government or by the family; or (7) establishes a policy concerning the relationship between the behavior and personal responsibility of youth and the norms of society. If the agency determines a regulation may negatively affect family well-being, then the agency must provide an adequate rationale for its implementation.
                </P>
                <P>The Department has determined that the implementation of this IFR does not impose a negative impact on family well-being or the autonomy or integrity of the family as an institution.</P>
                <HD SOURCE="HD2">H. Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments)</HD>
                <P>This IFR will not have “tribal implications” because it will not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Accordingly, Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) requires no further agency action or analysis for this rulemaking.</P>
                <HD SOURCE="HD2">I. National Environmental Policy Act</HD>
                <P>
                    The Department and its components analyzed this rulemaking action to determine whether the National Environmental Policy Act of 1969, 42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                     (“NEPA”), applies to these actions and, if so, what level of NEPA review is required. 42 U.S.C. 4336.
                </P>
                <P>
                    Federal agencies may establish categorical exclusions for categories of actions they determine normally do not 
                    <PRTPAGE P="105401"/>
                    significantly affect the quality of the human environment, and, therefore, do not require an Environmental Assessment or Environmental Impact Statement. 42 U.S.C. 4336(a)(2), 4336e(1); 40 CFR 1501.4, 1507.3(c)(8). DHS has established its categorical exclusions through Appendix A of the DHS's Directive 023-01, Revision 01,
                    <SU>12</SU>
                    <FTREF/>
                     and Instruction Manual 023-01-001-01, Revision 01 (“Instruction Manual”),
                    <SU>13</SU>
                    <FTREF/>
                     which establishes the procedures that DHS and its components use to comply with NEPA and the Council on Environmental Quality (CEQ) regulations 
                    <SU>14</SU>
                    <FTREF/>
                     for implementing NEPA, 40 CFR parts 1500 through 1508.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         DHS, Implementation of the National Environmental Policy Act, Directive 023-01, Revision 01 (Oct. 31, 2014), 
                        <E T="03">https://www.dhs.gov/sites/default/files/publications/DHS_Directive%20023-01%20Rev%2001_508compliantversion.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         DHS, Implementation of the National Environmental Policy Act (NEPA), Instruction Manual 023-01-001-01, Revision 01 (Nov. 6, 2014), 
                        <E T="03">https://www.dhs.gov/sites/default/files/publications/DHS_Instruction%20Manual%20023-01-001-01%20Rev%2001_508%20Admin%20Rev.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         The Department is aware of the November 12, 2024 decision in 
                        <E T="03">Marin Audubon Society</E>
                         v. 
                        <E T="03">Federal Aviation Administration,</E>
                         No. 23-1067 (D.C. Cir. Nov. 12, 2024). To the extent that a court may conclude that the CEQ regulations implementing NEPA are not judicially enforceable or binding on this agency action, the Department has nonetheless elected to follow those regulations at 40 CFR parts 1500-1508 to meet the agency's obligations under NEPA, 42 U.S.C. 4321 
                        <E T="03">et seq.</E>
                    </P>
                </FTNT>
                <P>
                    Under DHS's NEPA implementing procedures, for an action to be categorically excluded, it must satisfy each of the following three conditions: (1) the entire action clearly fits within one or more of the Categorical Exclusions; (2) the action is not a piece of a larger action; and (3) no extraordinary circumstances exist that create the potential for a significant environmental effect. 
                    <E T="03">See</E>
                     Instruction Manual at V-4 through V-6. The CEQ NEPA regulations allow an agency to adopt another agency's determination that a categorical exclusion applies to a proposed action if the action covered by the original categorical exclusion determination and the adopting agency's proposed action are substantially the same. 40 CFR 1506.3(a), (d).
                </P>
                <P>As discussed in more detail throughout this rule, the Department is modifying EOIR regulations applicable to noncitizens who have been placed into the credible fear and reasonable fear processes to clarify that immigration judges have the authority to review any mandatory bars to asylum or withholding of removal applied by asylum officers during such processes. This clarification in the EOIR regulations is particularly important in light of DHS's December 2024 rule that allows asylum officers to consider the potential applicability of certain bars to asylum and statutory withholding of removal during credible fear and reasonable fear screenings. See DHS Mandatory Bars, 89 FR 103370. DHS has determined that promulgation of the DHS rule, which allows asylum officers to apply the mandatory bars in the first instance during such screenings, qualifies for a categorical exclusion because it fits entirely within DHS categorical exclusion A3, is a standalone rule, and DHS is not aware of any extraordinary circumstances that would cause a significant environmental impact. See DHS Mandatory Bars, 89 FR 103412-413.</P>
                <P>
                    The Department is adopting DHS's categorical exclusion determination. 
                    <E T="03">See</E>
                     42 U.S.C. 4336c; 40 CFR 1506.3(d) (setting forth the ability of an agency to adopt another agency's categorical exclusion determination). The Department has determined that this IFR fits within categorical exclusion A3 for the promulgation of rules that interpret or amend an existing regulation without changing its environmental effect. 
                    <E T="03">See</E>
                     Instruction Manual at A-1 through A-2. This rule does not alter any asylum or withholding of removal eligibility criteria. Instead, this rule clarifies certain procedures, specifically, to make explicit that immigration judges will review de novo any credible or reasonable fear determination, including, where relevant, whether a mandatory bar to asylum or withholding of removal is implicated.
                </P>
                <P>Additionally, this IFR is not a piece of a larger action and serves to clarify the Department's regulations. The Department is not aware of any extraordinary circumstances that would cause an environmental impact. Nothing in the IFR, which clarifies EOIR's existing regulations and authorities, will have a significant effect on the human environment that would necessitate the preparation of an environmental assessment or an environmental impact statement. The Department has also determined that the DHS action, which allows asylum officers to consider certain statutory bars to asylum and statutory withholding of removal during the credible fear and reasonable fear process, and the action covered by this IFR, which clarifies that immigration judges have authority to review asylum officers' application of any such bars during the credible fear and reasonable process, are substantially the same. Therefore, the Department is adopting DHS's categorical exclusion determination. 42 U.S.C. 4336c; 40 CFR 1506.3(d).</P>
                <HD SOURCE="HD2">J. Paperwork Reduction Act</HD>
                <P>This IFR does not propose new or revisions to existing “collection[s] of information” as that term is defined under the Paperwork Reduction Act of 1995, Public Law 104-13, 109 Stat. 163, 44 U.S.C. chapter 35, and its implementing regulations, 5 CFR part 1320.</P>
                <HD SOURCE="HD2">K. Congressional Review Act</HD>
                <P>The Department has determined that this action is a rule relating to agency organization, procedure, or practice that does not substantially affect the rights or obligations of non-agency parties and, accordingly, is not a “rule” as that term is used by the Congressional Review Act (5 U.S.C. 801). Therefore, the reporting requirement of 5 U.S.C. 801 does not apply.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects</HD>
                    <CFR>8 CFR Part 1003</CFR>
                    <P>Administrative practice and procedure, Noncitizens.</P>
                    <CFR>8 CFR Part 1208</CFR>
                    <P>Administrative practice and procedure, Noncitizens, Immigration.</P>
                </LSTSUB>
                <P>Accordingly, for the reasons set forth in the preamble, the Department amends 8 CFR parts 1003 and 1208 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 1003—EXECUTIVE OFFICE FOR IMMIGRATION REVIEW</HD>
                </PART>
                <REGTEXT TITLE="8" PART="1003">
                    <AMDPAR>1. The authority citation for part 1003 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 5 U.S.C. 301; 6 U.S.C. 521; 8 U.S.C. 1101, 1103, 1154, 1155, 1158, 1182, 1226, 1229, 1229a, 1229b, 1229c, 1231, 1254a, 1255, 1324d, 1330, 1361, 1362; 28 U.S.C. 509, 510, 1746; sec. 2 Reorg. Plan No. 2 of 1950; 3 CFR, 1949-1953 Comp., p. 1002; section 203 of Pub. L. 105-100, 111 Stat. 2196-200; sections 1506 and 1510 of Pub. L. 106-386, 114 Stat. 1527-29, 1531-32; section 1505 of Pub. L. 106-554, 114 Stat. 2763A-326 to -328.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="8" PART="1003">
                    <AMDPAR>2. Amend § 1003.42 by:</AMDPAR>
                    <AMDPAR>a. As shown in the following table, removing the words in the left column and adding in their place the words in the right column wherever they appear:</AMDPAR>
                    <GPOTABLE COLS="2" OPTS="L2,tp0,p1,7/8,i1" CDEF="s50,r50">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">an alien</ENT>
                            <ENT>a noncitizen.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">The alien</ENT>
                            <ENT>The noncitizen.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">the alien</ENT>
                            <ENT>the noncitizen.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">the alien's</ENT>
                            <ENT>the noncitizen's.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">an alien's</ENT>
                            <ENT>a noncitizen's.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Aliens</ENT>
                            <ENT>Noncitizens.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">same alien</ENT>
                            <ENT>same noncitizen.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">the Service</ENT>
                            <ENT>DHS.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <AMDPAR>
                        b. Revising paragraphs (a), (d) and (e); and
                        <PRTPAGE P="105402"/>
                    </AMDPAR>
                    <AMDPAR>c. In paragraph (b), (c), and (f) through (i), removing the words “Immigration Court” and “Immigration Judge” and adding in their place “immigration court” and “immigration judge”, respectively.</AMDPAR>
                    <P>The revisions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 1003.42</SECTNO>
                        <SUBJECT>Review of credible fear determinations.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Referral.</E>
                             Jurisdiction for an immigration judge to review a negative credible fear determination by an asylum officer pursuant to section 235(b)(1)(B) of the Act shall commence with the filing by DHS of Form I-863, Notice of Referral to Immigration Judge, and a complete copy of the record of determination as defined in section 235(b)(1)(B)(iii)(II) of the Act with the immigration court.
                        </P>
                        <STARS/>
                        <P>
                            (d) 
                            <E T="03">Standard of review.</E>
                             The immigration judge shall make a de novo determination as to whether there is a significant possibility, taking into account the credibility of the statements made by the noncitizen in support of the noncitizen's claim, and such other facts as are known to the immigration judge, that the noncitizen could establish eligibility for asylum under section 208 of the Act, or could establish eligibility for withholding of removal under section 241(b)(3)(B) of the Act, or withholding or deferral of removal under the Convention Against Torture with respect to the country or countries of removal identified pursuant to section 241(b) of the Act. This determination shall, where relevant, include review of the asylum officer's application of any bars to asylum and withholding of removal pursuant to 8 CFR 208.30(e)(5).
                        </P>
                        <P>
                            (e) 
                            <E T="03">Timing.</E>
                             The immigration judge shall conclude the review to the maximum extent practicable within 24 hours, but in no case later than 7 days after the date the supervisory asylum officer has concurred with the asylum officer's negative credible fear determination issued on the Form I-869, Record of Negative Credible Fear Finding and Request for Review.
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 1208—PROCEDURES FOR ASYLUM AND WITHHOLDING OF REMOVAL</HD>
                </PART>
                <REGTEXT TITLE="8" PART="1208">
                    <AMDPAR>3. The authority citation for part 1208 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 8 U.S.C. 1101, 1103, 1158, 1226, 1252, 1282; Title VII of Pub. L. 110-229; Pub. L. 115-218.</P>
                    </AUTH>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 1208.31 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="8" PART="1208">
                    <AMDPAR>4. Amend § 1208.31 by:</AMDPAR>
                    <AMDPAR>a. Revising the section heading;</AMDPAR>
                    <AMDPAR>b. Removing and reserving paragraphs (b), (c), and (d);</AMDPAR>
                    <AMDPAR>c. Revising paragraph (g) introductory text; and</AMDPAR>
                    <AMDPAR>d. In the additions to the amendments set forth above, as shown in the following table, remove the words in the left column and add in their place the words in the right column wherever they appear:</AMDPAR>
                    <GPOTABLE COLS="2" OPTS="L2,tp0,p1,7/8,i1" CDEF="s50,r50">
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">an alien</ENT>
                            <ENT>a noncitizen.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">the alien</ENT>
                            <ENT>the noncitizen.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">any alien</ENT>
                            <ENT>any noncitizen.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">alien's</ENT>
                            <ENT>noncitizen's.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">aliens</ENT>
                            <ENT>noncitizens.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">the Service</ENT>
                            <ENT>DHS.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>The revisions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 1208.31</SECTNO>
                        <SUBJECT>Reasonable fear of persecution or torture determinations involving noncitizens ordered removed under section 238(b) of the Act and noncitizens whose removal is reinstated under section 241(a)(5) of the Act.</SUBJECT>
                        <STARS/>
                        <P>
                            (g) 
                            <E T="03">Review by immigration judge.</E>
                             The asylum officer's negative decision regarding reasonable fear shall be subject to de novo review by an immigration judge upon the noncitizen's request. The immigration judge's review shall, where relevant, include review of the asylum officer's application of any bars to withholding of removal pursuant to 8 CFR 208.31(c). If the noncitizen requests review of the asylum officer's negative decision regarding reasonable fear, the asylum officer shall serve the noncitizen with a Form I-863, Notice of Referral to Immigration Judge. The record of determination, including copies of the Form I-863, Notice of Referral to Immigration Judge, the asylum officer's notes, the summary of the material facts, and other materials upon which the determination was based shall be provided to the immigration judge with the negative determination. In the absence of exceptional circumstances, such review shall be conducted by the immigration judge within 10 days of the filing of the Form I-863, Notice of Referral to Immigration Judge, and the complete record of determination with the immigration court. Upon review of the asylum officer's negative reasonable fear determination:
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="8" PART="1208">
                    <AMDPAR>5. Amend § 1208.33 by:</AMDPAR>
                    <AMDPAR>a. As shown in the following table, removing the words in the left column and adding in their place the words in the right column wherever they appear; and</AMDPAR>
                    <GPOTABLE COLS="2" OPTS="L2,tp0,p1,7/8,i1" CDEF="s50,r50">
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1"> </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">An alien</ENT>
                            <ENT>A noncitizen.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">an alien</ENT>
                            <ENT>a noncitizen.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">The alien</ENT>
                            <ENT>The noncitizen.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">the alien</ENT>
                            <ENT>the noncitizen.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">alien's</ENT>
                            <ENT>noncitizen's.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <AMDPAR>b. Removing the words “unaccompanied alien child as defined in 6 U.S.C. 279(g)(2)” in paragraph (a)(2)(i) and adding, in their place, the words “unaccompanied child as defined in 8 CFR 1001.1(hh)”;</AMDPAR>
                    <AMDPAR>c. Removing the reference to “8 CFR 214.201(a)” in paragraph (a)(3)(i)(C) and adding in its place “8 CFR 214.201”; and</AMDPAR>
                    <AMDPAR>d. Revising paragraphs (b)(1), (b)(2)(i), and (b)(2)(ii).</AMDPAR>
                    <P>The revisions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 1208.33</SECTNO>
                        <SUBJECT>Lawful pathways condition on asylum eligibility.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(1) Where an asylum officer has issued a negative credible fear determination pursuant to 8 CFR 208.33(b), and the noncitizen has requested immigration judge review of that credible fear determination, the immigration judge shall evaluate the case de novo, as specified in paragraph (b)(2) of this section. In all cases under paragraph (b)(2), the immigration judge's review shall, where relevant, include review of the asylum officer's application of any bars to withholding of removal pursuant to 8 CFR 208.33(b)(2). In doing so, the immigration judge shall take into account the credibility of the statements made by the noncitizen in support of the noncitizen's claim and such other facts as are known to the immigration judge.</P>
                        <P>(2) * * *</P>
                        <P>
                            (i) Where the immigration judge determines that the noncitizen is not covered by the presumption, or that the presumption has been rebutted, the immigration judge shall further determine, consistent with § 1208.30, whether the noncitizen has established a significant possibility of eligibility for asylum under section 208 of the Act, or has established a significant possibility of eligibility for withholding of removal under section 241(b)(3) of the Act or withholding or deferral of removal under the Convention Against Torture with respect to the country or countries of removal identified by DHS pursuant to section 241(b) of the Act. Where the immigration judge determines that the noncitizen has established a significant possibility of eligibility for one of those forms of relief or protection, the immigration judge shall issue a positive credible fear finding. Where the immigration judge determines that the noncitizen has not established a significant possibility of eligibility for 
                            <PRTPAGE P="105403"/>
                            any of those forms of relief or protection, the immigration judge shall issue a negative credible fear finding.
                        </P>
                        <P>(ii) Where the immigration judge determines that the noncitizen is covered by the presumption and that the presumption has not been rebutted, the immigration judge shall further determine whether the noncitizen has established a reasonable possibility of persecution (meaning a reasonable possibility of being persecuted because of their race, religion, nationality, political opinion, or membership in a particular social group) or torture with respect to the country or countries of removal identified by DHS pursuant to section 241(b) of the Act. Where the immigration judge determines that the noncitizen has established a reasonable possibility of persecution or torture, the immigration judge shall issue a positive credible fear finding. Where the immigration judge determines that the noncitizen has not established a reasonable possibility of persecution or torture, the immigration judge shall issue a negative credible fear finding.</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 1208.35</SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="8" PART="1208">
                    <AMDPAR>6. Amend § 1208.35 by removing the reference to “§ 214.11 of this title” in paragraph (a)(2)(i)(C) and adding in its place “§ 214.201 of this title”.</AMDPAR>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: December 17, 2024.</DATED>
                    <NAME>Merrick B. Garland,</NAME>
                    <TITLE>Attorney General.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30500 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-30-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF ENERGY</AGENCY>
                <CFR>10 CFR Parts 207, 218, 429, 431, 490, 501, 601, 810, 820, 824, 851, 1013, 1017, and 1050</CFR>
                <SUBJECT>Inflation Adjustment of Civil Monetary Penalties</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the General Counsel, U.S. Department of Energy.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Energy (“DOE”) publishes this final rule to adjust DOE's civil monetary penalties (“CMPs”) for inflation as mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as further amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (collectively referred to herein as “the Act”). This rule adjusts CMPs within the jurisdiction of DOE to the maximum amount required by the Act.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective on December 27, 2024.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                         Preeti Chaudhari, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW, Washington, DC 20585, (202) 586-0319, 
                        <E T="03">preeti.chaudhari@hq.doe.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Background</FP>
                    <FP SOURCE="FP-2">II. Method of Calculation</FP>
                    <FP SOURCE="FP-2">III. Summary of the Final Rule</FP>
                    <FP SOURCE="FP-2">IV. Final Rulemaking</FP>
                    <FP SOURCE="FP-2">V. Regulatory Review</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Background</HD>
                <P>In order to improve the effectiveness of CMPs and to maintain their deterrent effect, the Federal Civil Penalties Inflation Adjustment Act of 1990, 28 U.S.C. 2461 note (“the Inflation Adjustment Act”), as further amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Pub. L. 114-74) (“the 2015 Act”), requires Federal agencies to adjust each CMP provided by law within the jurisdiction of the agency. The 2015 Act required agencies to adjust the level of CMPs with an initial “catch-up” adjustment through an interim final rulemaking and to make subsequent annual adjustments for inflation, notwithstanding 5 U.S.C. 553. DOE's initial catch-up adjustment interim final rule was published June 28, 2016 (81 FR 41790), and adopted as final without amendment on December 30, 2016 (81 FR 96349). The 2015 Act also provides that any increase in a CMP shall apply only to CMPs, including those whose associated violation predated such increase, which are assessed after the date the increase takes effect.</P>
                <P>
                    In accordance with the 2015 Act, the Office of Management and Budget (OMB) must issue annually guidance on adjustments to civil monetary penalties. This final rule to adjust civil monetary penalties for 2025 is issued in accordance with applicable law and OMB's guidance memorandum on implementation of the 2025 annual adjustment.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         OMB's annual guidance memorandum was issued on December 17, 2024, providing the 2025 adjustment multiplier and addressing how to apply it.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Method of Calculation</HD>
                <P>The method of calculating CMP adjustments applied in this final rule is required by the 2015 Act. Under the 2015 Act, annual inflation adjustments subsequent to the initial catch-up adjustment are to be based on the percent change between the October Consumer Price Index for all Urban Consumers (CPI-U) preceding the date of the adjustment, and the prior year's October CPI-U. Pursuant to the aforementioned OMB guidance memorandum, the adjustment multiplier for 2025 is 1.02598. In order to complete the 2025 annual adjustment, each CMP is multiplied by the 2025 adjustment multiplier. Under the 2015 Act, any increase in CMP must be rounded to the nearest multiple of $1.</P>
                <HD SOURCE="HD1">III. Summary of the Final Rule</HD>
                <P>The following list summarizes DOE authorities containing CMPs, and the penalties before and after adjustment.</P>
                <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s100,xs90,xs90">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">
                            DOE authority containing
                            <LI>civil monetary penalty</LI>
                        </CHED>
                        <CHED H="1">Before adjustment</CHED>
                        <CHED H="1">After adjustment</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">10 CFR 207.7</ENT>
                        <ENT>$12,937</ENT>
                        <ENT>$13,273.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10 CFR 218.42</ENT>
                        <ENT>$28,020</ENT>
                        <ENT>$28,748.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10 CFR 429.120</ENT>
                        <ENT>$560</ENT>
                        <ENT>$575.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10 CFR 431.382</ENT>
                        <ENT>$560</ENT>
                        <ENT>$575.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10 CFR 490.604</ENT>
                        <ENT>$10, 846</ENT>
                        <ENT>$11,128.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10 CFR 501.181</ENT>
                        <ENT>
                            —$114,630
                            <LI>—$9/mcf</LI>
                            <LI>—$45/bbl</LI>
                        </ENT>
                        <ENT>
                            —$117,608
                            <LI>—$9/mcf.</LI>
                            <LI>—$46/bbl.</LI>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10 CFR 601.400 and appendix A</ENT>
                        <ENT>
                            —minimum $24,496
                            <LI>—maximum $244,958</LI>
                        </ENT>
                        <ENT>
                            —minimum $25,132.
                            <LI>—maximum $251,322.</LI>
                        </ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="105404"/>
                        <ENT I="01">10 CFR 810.15</ENT>
                        <ENT>$124,732</ENT>
                        <ENT>$127,973.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10 CFR 820.81</ENT>
                        <ENT>$255,964</ENT>
                        <ENT>$262,614.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10 CFR 824.1</ENT>
                        <ENT>$182,916</ENT>
                        <ENT>$187,668.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10 CFR 824.4</ENT>
                        <ENT>$182,916</ENT>
                        <ENT>$187,668.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10 CFR 851.5 and appendix B</ENT>
                        <ENT>$118,790</ENT>
                        <ENT>$121,876.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10 CFR 1013.3</ENT>
                        <ENT>$13,946</ENT>
                        <ENT>$14,308.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10 CFR 1017.29</ENT>
                        <ENT>$329,408</ENT>
                        <ENT>$337,966.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10 CFR 1050.303</ENT>
                        <ENT>$24,973</ENT>
                        <ENT>$25,622.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            50 U.S.C. 2731 
                            <SU>2</SU>
                        </ENT>
                        <ENT>$11,198</ENT>
                        <ENT>$11,489.</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>2</SU>
                         Implemented by 10 CFR 820.81, 10 CFR 851.5, and appendix B to 10 CFR part 851.
                    </TNOTE>
                </GPOTABLE>
                <HD SOURCE="HD1">IV. Final Rulemaking</HD>
                <P>The 2015 Act requires that annual adjustments for inflation subsequent to the initial “catch-up” adjustment be made notwithstanding 5 U.S.C. 553.</P>
                <HD SOURCE="HD1">V. Regulatory Review</HD>
                <HD SOURCE="HD2">A. Executive Orders 12866, 13563, and 14094</HD>
                <P>This final rule has been determined not to be a significant regulatory action under Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735 (October 4, 1993), as supplemented and reaffirmed by E.O. 13563, “Improving Regulation and Regulatory Review,” 76 FR 3821 (Jan. 21, 2011) and amended by E.O. 14094, “Modernizing Regulatory Review,” 88 FR 21879 (April 11, 2023). Accordingly, this action was not subject to review under that Executive order by the Office of Information and Regulatory Affairs of the Office of Management and Budget.</P>
                <HD SOURCE="HD2">B. National Environmental Policy Act</HD>
                <P>DOE has determined that this final rule is covered under the Categorical Exclusion found in DOE's National Environmental Policy Act regulations at paragraph A5 of appendix A to subpart D, 10 CFR part 1021, which applies to a rulemaking that amends an existing rule or regulation and that does not change the environmental effect of the rule or regulation being amended. Accordingly, neither an environmental assessment nor an environmental impact statement is required.</P>
                <HD SOURCE="HD2">C. Regulatory Flexibility Act</HD>
                <P>
                    The Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.)</E>
                     requires preparation of an initial regulatory flexibility analysis for any rule that by law must be proposed for public comment. As discussed previously, the 2015 Act requires that annual inflation adjustments subsequent to the initial catch-up adjustment be made notwithstanding 5 U.S.C. 553. Because a notice of proposed rulemaking is not required for this action pursuant to 5 U.S.C. 553, or any other law, no regulatory flexibility analysis has been prepared for this final rule.
                </P>
                <HD SOURCE="HD2">D. Paperwork Reduction Act</HD>
                <P>This final rule imposes no new information collection requirements subject to the Paperwork Reduction Act.</P>
                <HD SOURCE="HD2">E. Unfunded Mandates Reform Act of 1995</HD>
                <P>The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) generally requires Federal agencies to examine closely the impacts of regulatory actions on State, local, and tribal governments. Section 201 excepts agencies from assessing effects on State, local or tribal governments or the private sector of rules that incorporate requirements specifically set forth in law. Because this rule incorporates requirements specifically set forth in 28 U.S.C. 2461 note, DOE is not required to assess its regulatory effects under section 201. Unfunded Mandates Reform Act sections 202 and 205 do not apply to this action because they apply only to rules for which a general notice of proposed rulemaking is published. Nevertheless, DOE has determined that this regulatory action does not impose a Federal mandate on State, local, or tribal governments or on the public sector.</P>
                <HD SOURCE="HD2">F. Treasury and General Government Appropriations Act, 1999</HD>
                <P>Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any proposed rule that may affect family well-being. This final rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.</P>
                <HD SOURCE="HD2">G. Executive Order 13132</HD>
                <P>Executive Order 13132, “Federalism,” 64 FR 43255 (August 4, 1999) imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. Agencies are required to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and carefully assess the necessity for such actions. DOE has examined this rule and has determined that it would not preempt State law and would not have a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. No further action is required by Executive Order 13132.</P>
                <HD SOURCE="HD2">H. Executive Order 12988</HD>
                <P>
                    With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (February 7, 1996), imposes on executive agencies the general duty to adhere to the following requirements: (1) eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction. With regard to the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is 
                    <PRTPAGE P="105405"/>
                    unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this rule meets the relevant standards of Executive Order 12988.
                </P>
                <HD SOURCE="HD2">I. Treasury and General Government Appropriations Act, 2001</HD>
                <P>The Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (February 22, 2002), and DOE's guidelines were published at 67 FR 62446 (October 7, 2002). DOE has reviewed this final rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.</P>
                <HD SOURCE="HD2">J. Executive Order 13211</HD>
                <P>Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001) requires Federal agencies to prepare and submit to OMB, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that: (1) is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of the Office of Information and Regulatory Affairs (OIRA) as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use. This regulatory action would not have a significant adverse effect on the supply, distribution, or use of energy and is therefore not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.</P>
                <HD SOURCE="HD2">K. Congressional Notification</HD>
                <P>As required by 5 U.S.C. 801, DOE will submit to Congress a report regarding the issuance of this final rule prior to the effective date set forth at the outset of this rulemaking. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 801(2).</P>
                <HD SOURCE="HD2">L. Approval of the Office of the Secretary</HD>
                <P>The Secretary of Energy has approved publication of this final rule.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects</HD>
                    <CFR>10 CFR Part 207</CFR>
                    <P>Administrative practice and procedure, Energy, Penalties.</P>
                    <CFR>10 CFR Part 218</CFR>
                    <P>Administrative practice and procedure, Penalties, Petroleum allocation.</P>
                    <CFR>10 CFR Part 429</CFR>
                    <P>Confidential business information, Energy conservation, Household appliances, Imports, Reporting and recordkeeping requirements.</P>
                    <CFR>10 CFR Part 431</CFR>
                    <P>Administrative practices and procedure, Confidential business information, Energy conservation, Reporting and recordkeeping requirements.</P>
                    <CFR>10 CFR Part 490</CFR>
                    <P>Administrative practice and procedure, Energy conservation, Penalties.</P>
                    <CFR>10 CFR Part 501</CFR>
                    <P>Administrative practice and procedure, Electric power plants, Energy conservation, Natural gas, Petroleum.</P>
                    <CFR>10 CFR Part 601</CFR>
                    <P>Government contracts, Grant programs, Loan programs, Penalties.</P>
                    <CFR>10 CFR Part 810</CFR>
                    <P>Foreign relations, Nuclear energy, Reporting and recordkeeping requirements.</P>
                    <CFR>10 CFR Part 820</CFR>
                    <P>Administrative practice and procedure, Government contracts, Penalties, Radiation protection.</P>
                    <CFR>10 CFR Part 824</CFR>
                    <P>Government contracts, Nuclear materials, Penalties, Security measures.</P>
                    <CFR>10 CFR Part 851</CFR>
                    <P>Civil penalty, Hazardous substances, Occupational safety and health, Safety, Reporting and recordkeeping requirements.</P>
                    <CFR>10 CFR Part 1013</CFR>
                    <P>Administrative practice and procedure, Claims, Fraud, Penalties.</P>
                    <CFR>10 CFR Part 1017</CFR>
                    <P>Administrative practice and procedure, Government contracts, National defense, Nuclear energy, Penalties, Security measures.</P>
                    <CFR>10 CFR Part 1050</CFR>
                    <P>Decorations, Medals, Awards, Foreign relations, Government employees, Government property, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <HD SOURCE="HD1">Signing Authority</HD>
                <P>
                    This document of the Department of Energy was signed on December 18, 2024, by Samuel Walsh, General Counsel, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE 
                    <E T="04">Federal Register</E>
                     Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <DATED>Signed in Washington, DC, on December 19, 2024.</DATED>
                    <NAME>Treena V. Garrett,</NAME>
                    <TITLE>Federal Register Liaison Officer, U.S. Department of Energy.</TITLE>
                </SIG>
                <P>For the reasons set forth in the preamble, DOE amends chapters II, III, and X of title 10 of the Code of Federal Regulations as set forth below.</P>
                <REGTEXT TITLE="10" PART="207">
                    <PART>
                        <HD SOURCE="HED">PART 207—COLLECTION OF INFORMATION</HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 207 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                             15 U.S.C. 787 
                            <E T="03">et seq.;</E>
                             15 U.S.C. 791 
                            <E T="03">et seq.;</E>
                             E.O. 11790, 39 FR 23185; 28 U.S.C. 2461 note.
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="207">
                    <AMDPAR>2. Section 207.7 is amended by revising the first sentence of paragraph (c)(1) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 207.7 </SECTNO>
                        <SUBJECT>Sanctions.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(1) Any person who violates any provision of this subpart or any order issued pursuant thereto shall be subject to a civil penalty of not more than $13,273 for each violation. * * *</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <PART>
                    <PRTPAGE P="105406"/>
                    <HD SOURCE="HED">PART 218—STANDBY MANDATORY INTERNATIONAL OIL ALLOCATION</HD>
                </PART>
                <REGTEXT TITLE="10" PART="218">
                    <AMDPAR>3. The authority citation for part 218 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                             15 U.S.C. 751 
                            <E T="03">et seq.;</E>
                             15 U.S.C. 787 
                            <E T="03">et seq.;</E>
                             42 U.S.C. 6201 
                            <E T="03">et seq.;</E>
                             42 U.S.C. 7101 
                            <E T="03">et seq.;</E>
                             E.O. 11790, 39 FR 23185; E.O. 12009, 42 FR 46267; 28 U.S.C. 2461 note.
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="218">
                    <AMDPAR>4. Section 218.42 is amended by revising paragraph (b)(1) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 218.42</SECTNO>
                        <SUBJECT> Sanctions.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(1) Any person who violates any provision of this part or any order issued pursuant thereto shall be subject to a civil penalty of not more than $28,748 for each violation.</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="429">
                    <PART>
                        <HD SOURCE="HED">PART 429—CERTIFICATION, COMPLIANCE, AND ENFORCEMENT FOR CONSUMER PRODUCTS AND COMMERCIAL AND INDUSTRIAL EQUIPMENT</HD>
                    </PART>
                    <AMDPAR>5. The authority citation for part 429 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 42 U.S.C. 6291-6317; 28 U.S.C. 2461 note.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="429">
                    <AMDPAR>6. Section 429.120 is amended by revising the first sentence to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 429.120</SECTNO>
                        <SUBJECT> Maximum civil penalty.</SUBJECT>
                        <P>Any person who knowingly violates any provision of § 429.102(a) may be subject to assessment of a civil penalty of no more than $575 for each violation. * * *</P>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="431">
                    <PART>
                        <HD SOURCE="HED">PART 431—ENERGY EFFICIENCY PROGRAM FOR CERTAIN COMMERCIAL AND INDUSTRIAL EQUIPMENT</HD>
                    </PART>
                    <AMDPAR>7. The authority citation for part 431 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 42 U.S.C. 6291-6317; 28 U.S.C. 2461 note.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="431">
                    <AMDPAR>8. Section 431.382 is amended by revising paragraph (b) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 431.382</SECTNO>
                        <SUBJECT> Prohibited acts.</SUBJECT>
                        <STARS/>
                        <P>(b) In accordance with sections 333 and 345 of the Act, any person who knowingly violates any provision of paragraph (a) of this section may be subject to assessment of a civil penalty of no more than $575 for each violation.</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="490">
                    <PART>
                        <HD SOURCE="HED">PART 490—ALTERNATIVE FUEL TRANSPORTATION PROGRAM</HD>
                    </PART>
                    <AMDPAR>9. The authority citation for part 490 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                             42 U.S.C. 7191 
                            <E T="03">et seq.;</E>
                             42 U.S.C. 13201, 13211, 13220, 13251 
                            <E T="03">et seq;</E>
                             28 U.S.C. 2461 note.
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="490">
                    <AMDPAR>10. Section 490.604 is amended by revising paragraph (a) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 490.604 </SECTNO>
                        <SUBJECT>Penalties and Fines.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Civil penalties.</E>
                             Whoever violates § 490.603 shall be subject to a civil penalty of not more than $11,128 for each violation.
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="501">
                    <PART>
                        <HD SOURCE="HED">PART 501—ADMINISTRATIVE PROCEDURES AND SANCTIONS</HD>
                    </PART>
                    <AMDPAR>11. The authority citation for part 501 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>
                             42 U.S.C. 7101 
                            <E T="03">et seq.;</E>
                             42 U.S.C. 8301 
                            <E T="03">et seq.;</E>
                             42 U.S.C. 8701 
                            <E T="03">et seq.;</E>
                             E.O. 12009, 42 FR 46267; 28 U.S.C. 2461 note.
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="501">
                    <AMDPAR>12. Section 501.181 is amended by revising paragraph (c)(1) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 501.181 </SECTNO>
                        <SUBJECT>Sanctions.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(1) Any person who violates any provisions of the Act (other than section 402) or any rule in this subchapter or order under this subchapter or the Act will be subject to the following civil penalty, which may not exceed $117,608 for each violation: Any person who operates a powerplant or major fuel burning installation under an exemption, during any 12-calendar-month period, in excess of that authorized in such exemption will be assessed a civil penalty of up to $9 for each MCF of natural gas or up to $46 for each barrel of oil used in excess of that authorized in the exemption.</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="601">
                    <PART>
                        <HD SOURCE="HED">PART 601—NEW RESTRICTIONS ON LOBBYING</HD>
                    </PART>
                    <AMDPAR>13. The authority citation for part 601 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>31 U.S.C. 1352; 42 U.S.C. 7254 and 7256; 31 U.S.C. 6301-6308; 28 U.S.C. 2461 note. </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="601">
                    <AMDPAR>14. Section 601.400 is amended by revising paragraphs (a), (b), and (e) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 601.400</SECTNO>
                        <SUBJECT>Penalties.</SUBJECT>
                        <P>(a) Any person who makes an expenditure prohibited by this part shall be subject to a civil penalty of not less than $25,132 and not more than $251,322 for each such expenditure.</P>
                        <P>(b) Any person who fails to file or amend the disclosure form (see appendix B to this part) to be filed or amended if required by this part, shall be subject to a civil penalty of not less than $25,132 and not more than $251,322 for each such failure.</P>
                        <STARS/>
                        <P>(e) First offenders under paragraph (a) or (b) of this section shall be subject to a civil penalty of $25,132, absent aggravating circumstances. Second and subsequent offenses by persons shall be subject to an appropriate civil penalty between $25,132 and $251,322, as determined by the agency head or his or her designee.</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="601">
                    <HD SOURCE="HD1">Appendix A to Part 601 [Amended]</HD>
                    <AMDPAR>15. Appendix A to part 601 is amended by removing “$24,496” and “$244,958” in the undesignated paragraph before the heading “Statement for Loan Guarantees and Loan Insurance” and in the last paragraph of the appendix and adding in its place “$25,132” and “$251,322”, respectively. </AMDPAR>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="810">
                    <PART>
                        <HD SOURCE="HED">PART 810—ASSISTANCE TO FOREIGN ATOMIC ENERGY ACTIVITIES</HD>
                    </PART>
                    <AMDPAR>16. The authority citation for part 810 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>
                             Secs. 57, 127, 128, 129, 161, 222, 232, and 234 AEA, as amended by the 
                            <E T="03">Nuclear Nonproliferation Act of 1978,</E>
                             Pub. L. 95-242, 68 Stat. 932, 948, 950, 958, 92 Stat. 126, 136, 137, 138 (42 U.S.C. 2077, 2156, 2157, 2158, 2201, 2272, 2280, 2282), the 
                            <E T="03">Intelligence Reform and Terrorism Prevention Act of 2004,</E>
                             Pub. L. 108-458, 118 Stat. 3768, and sec. 3116 of the 
                            <E T="03">John S. McCain National Defense Authorization Act for Fiscal Year 2019,</E>
                             Pub. L. 115-232; Sec. 104 of the 
                            <E T="03">Energy Reorganization Act of 1974,</E>
                             Pub. L. 93-438; Sec. 301, 
                            <E T="03">Department of Energy Organization Act,</E>
                             Pub. L. 95-91; 
                            <E T="03">National Nuclear Security Administration Act,</E>
                             Pub. L. 106-65, 50 U.S.C. 2401 
                            <E T="03">et seq.,</E>
                             as amended.
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="810">
                    <AMDPAR>17. Section 810.15 is amended by revising paragraph (c) introductory text to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 810.15</SECTNO>
                        <SUBJECT>Violations.</SUBJECT>
                        <STARS/>
                        <P>
                            (c) In accordance with section 234 of the AEA, any person who violates any provision of section 57 b. of the AEA, as implemented under this part, shall be subject to a civil penalty, not to exceed $127,973 per violation, such amount to be adjusted annually for inflation pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. If any violation is a 
                            <PRTPAGE P="105407"/>
                            continuing one, each day from the point at which the violating activity began to the point at which the violating activity was suspended shall constitute a separate violation for the purpose of computing the applicable civil penalty. The mere act of suspending an activity does not constitute admission that the activity was a violation and does not waive the rights and processes outlined in paragraphs (c)(4) through (14) of this section or otherwise impact the right of the person to appeal any civil penalty that may be imposed.
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="820">
                    <PART>
                        <HD SOURCE="HED">PART 820—PROCEDURAL RULES FOR DOE NUCLEAR ACTIVITIES</HD>
                    </PART>
                    <AMDPAR>18. The authority citation for part 820 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>42 U.S.C. 2201; 2282(a); 7191; 28 U.S.C. 2461 note; 50 U.S.C. 2410. </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="810">
                    <AMDPAR>19. Section 820.81 is amended by revising the first sentence to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 820.81</SECTNO>
                        <SUBJECT> Amount of penalty.</SUBJECT>
                        <P>Any person subject to a penalty under 42 U.S.C. 2282a shall be subject to a civil penalty in an amount not to exceed $262,614 for each such violation. * * * </P>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="824">
                    <PART>
                        <HD SOURCE="HED">PART 824—PROCEDURAL RULES FOR THE ASSESSMENT OF CIVIL PENALTIES FOR CLASSIFIED INFORMATION SECURITY VIOLATIONS</HD>
                    </PART>
                    <AMDPAR>20. The authority citation for part 824 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>
                             42 U.S.C. 2201, 2282b, 7101 
                            <E T="03">et seq.,</E>
                             50 U.S.C. 2401 
                            <E T="03">et seq.;</E>
                             28 U.S.C. 2461 note.
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="824">
                    <AMDPAR>21. Section 824.1 is amended by revising the second sentence to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 824.1</SECTNO>
                        <SUBJECT>Purpose and scope.</SUBJECT>
                        <P>* * * Subsection a. provides that any person who has entered into a contract or agreement with the Department of Energy, or a subcontract or subagreement thereto, and who violates (or whose employee violates) any applicable rule, regulations in this chapter, or order under the Act relating to the security or safeguarding of Restricted Data or other classified information, shall be subject to a civil penalty not to exceed $187,668 for each violation. * * * </P>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="824">
                    <AMDPAR>22. Section 824.4 is amended by revising paragraph (c) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO> § 824.4</SECTNO>
                        <SUBJECT>Civil penalties.</SUBJECT>
                        <STARS/>
                        <P>(c) The Director may propose imposition of a civil penalty for violation of a requirement of a regulation or rule under paragraph (a) of this section or a compliance order issued under paragraph (b) of this section, not to exceed $187,668 for each violation.</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="851">
                    <PART>
                        <HD SOURCE="HED">PART 851—WORKER SAFETY AND HEALTH PROGRAM</HD>
                    </PART>
                    <AMDPAR>23. The authority citation for part 851 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>
                             42 U.S.C. 2201(i)(3), (p); 42 U.S.C. 2282c; 42 U.S.C. 5801 
                            <E T="03">et seq.;</E>
                             42 U.S.C. 7101 
                            <E T="03">et seq.;</E>
                             50 U.S.C. 2401 
                            <E T="03">et seq.;</E>
                             28 U.S.C. 2461 note. 
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="851">
                    <AMDPAR>24. Section 851.5 is amended by revising the first sentence of paragraph (a) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 851.5</SECTNO>
                        <SUBJECT>Enforcement.</SUBJECT>
                        <P>(a) A contractor that is indemnified under section 170d. of the AEA (or any subcontractor or supplier thereto) and that violates (or whose employee violates) any requirement of this part shall be subject to a civil penalty of up to $121,876 for each such violation. * * *</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="851">
                    <AMDPAR>25. Appendix B to part 851 is amended by:</AMDPAR>
                    <AMDPAR>a. Revising the last sentences of paragraphs (b)(1) and (2) in section VI; and</AMDPAR>
                    <AMDPAR>b. Revising paragraph 1.(e)(1) in section IX.</AMDPAR>
                    <P>The revisions read as follows:</P>
                    <HD SOURCE="HD1">Appendix B to Part 851—General Statement of Enforcement Policy</HD>
                    <STARS/>
                    <HD SOURCE="HD2">VI. Severity of Violations</HD>
                    <STARS/>
                    <P>(b) * * *</P>
                    <P>(1) * * * A Severity Level I violation would be subject to a base civil penalty of up to 100% of the maximum base civil penalty of $121,876.</P>
                    <P>(2) * * * A Severity Level II violation would be subject to a base civil penalty up to 50% of the maximum base civil penalty ($60,938).</P>
                    <STARS/>
                    <HD SOURCE="HD2">IX. Enforcement Actions</HD>
                    <STARS/>
                    <HD SOURCE="HD2">1. Notice of Violation</HD>
                    <STARS/>
                    <P>(e) * * *</P>
                    <P>
                        (1) DOE may assess civil penalties of up to $121,876 per violation per day on contractors (and their subcontractors and suppliers) that are indemnified by the Price-Anderson Act, 42 U.S.C. 2210(d). 
                        <E T="03">See</E>
                         10 CFR 851.5(a).
                    </P>
                    <STARS/>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="1013">
                    <PART>
                        <HD SOURCE="HED">PART 1013—PROGRAM FRAUD CIVIL REMEDIES AND PROCEDURES</HD>
                    </PART>
                    <AMDPAR>26. The authority citation for part 1013 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P> 31 U.S.C. 3801-3812; 28 U.S.C. 2461 note.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="1013">
                    <AMDPAR>27. Section 1013.3 is amended by revising paragraphs (a)(1)(iv) and (b)(1)(ii) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 1013.3</SECTNO>
                        <SUBJECT>Basis for civil penalties and assessments.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(1) * * *</P>
                        <P>(iv) Is for payment for the provision of property or services which the person has not provided as claimed, shall be subject, in addition to any other remedy that may be prescribed by law, to a civil penalty of not more than $14,308 for each such claim.</P>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(1) * * *</P>
                        <P>(ii) Contains or is accompanied by an express certification or affirmation of the truthfulness and accuracy of the contents of the statement, shall be subject, in addition to any other remedy that may be prescribed by law, to a civil penalty of not more than $14,308 for each such statement.</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="1017">
                    <PART>
                        <HD SOURCE="HED">PART 1017—IDENTIFICATION AND PROTECTION OF UNCLASSIFIED CONTROLLED NUCLEAR INFORMATION</HD>
                    </PART>
                    <AMDPAR>28. The authority citation for part 1017 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                             42 U.S.C. 7101 
                            <E T="03">et seq.;</E>
                             50 U.S.C. 2401 
                            <E T="03">et seq.;</E>
                             42 U.S.C. 2168; 28 U.S.C. 2461 note. 
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="1017">
                    <AMDPAR>29. Section 1017.29 is amended by revising paragraph (c) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO> § 1017.29</SECTNO>
                        <SUBJECT>Civil penalty.</SUBJECT>
                        <STARS/>
                        <P>
                            (c) 
                            <E T="03">Amount of penalty.</E>
                             The Director may propose imposition of a civil penalty for violation of a requirement of a regulation under paragraph (a) of this section or a compliance order issued under paragraph (b) of this section, not to exceed $337,966 for each violation.
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="1050">
                    <PART>
                        <HD SOURCE="HED">PART 1050—FOREIGN GIFTS AND DECORATIONS</HD>
                    </PART>
                    <AMDPAR>30. The authority citation for part 1050 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <PRTPAGE P="105408"/>
                        <HD SOURCE="HED">Authority: </HD>
                        <P> The Constitution of the United States, Article I, Section 9; 5 U.S.C. 7342; 22 U.S.C. 2694; 42 U.S.C. 7254 and 7262; 28 U.S.C. 2461 note.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="10" PART="1050">
                    <AMDPAR>31. Section 1050.303 is amended by revising the last sentence in paragraph (d) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO> § 1050.303</SECTNO>
                        <SUBJECT> Enforcement.</SUBJECT>
                        <STARS/>
                        <P>(d) * * * The court in which such action is brought may assess a civil penalty against such employee in any amount not to exceed the retail value of the gift improperly solicited or received plus $25,622.</P>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30697 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6450-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <CFR>10 CFR Part 430</CFR>
                <DEPDOC>[EERE-2024-BT-STD-0002]</DEPDOC>
                <RIN>RIN 1904-AF69</RIN>
                <SUBJECT>Energy Conservation Program: Energy Conservation Standards for Dishwashers, Residential Clothes Washers, and Consumer Clothes Dryers</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Energy Efficiency and Renewable Energy, Department of Energy.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; confirmation of effective date.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In light of the United States Court of Appeals for the Fifth Circuit granting a petition for review of a final rule published by the U.S. Department of Energy (“DOE”) on January 19, 2022, and remanding the matter to DOE for further proceedings, DOE has considered the factors outlined by the Fifth Circuit on whether “short-cycle” product classes for dishwashers, residential clothes washers, and consumer clothes dryers are warranted under the Energy Policy and Conservation Act and confirms the withdrawal of “short-cycle” product classes in the January 19, 2022, final rule.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The effective date of the final rule published on January 19, 2022 (87 FR 2673) is confirmed as February 18, 2022, without change.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The docket for this rulemaking, which includes 
                        <E T="04">Federal Register</E>
                         notices, comments, and other supporting documents/materials, is available for review at 
                        <E T="03">www.regulations.gov.</E>
                         All documents in the docket are listed in the 
                        <E T="03">www.regulations.gov</E>
                         index. However, not all documents listed in the index may be publicly available, such as information that is exempt from public disclosure.
                    </P>
                    <P>
                        The docket web page can be found at 
                        <E T="03">www.regulations.gov/docket/EERE-2024-BT-STD-0002.</E>
                         The docket web page contains instructions on how to access all documents, including public comments, in the docket.
                    </P>
                    <P>
                        For further information on how to review the docket, contact the Appliance and Equipment Standards Program staff at (202) 287-1445 or by email: 
                        <E T="03">ApplianceStandardsQuestions@ee.doe.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P/>
                    <P>
                        Dr. Carl Shapiro, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 287-5649. Email: 
                        <E T="03">ApplianceStandardsQuestions@ee.doe.gov.</E>
                    </P>
                    <P>
                        Mr. Pete Cochran, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (240) 961-1189. Email: 
                        <E T="03">Peter.Cochran@hq.doe.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Introduction</FP>
                    <FP SOURCE="FP1-2">A. Authority</FP>
                    <FP SOURCE="FP1-2">B. Background</FP>
                    <FP SOURCE="FP-2">II. Discussion</FP>
                    <FP SOURCE="FP1-2">A. Dishwashers</FP>
                    <FP SOURCE="FP1-2">1. Cycle Time as a Performance-Related Feature</FP>
                    <FP SOURCE="FP1-2">2. Justification of Different Standards for Dishwashers With a Short-Cycle Feature</FP>
                    <FP SOURCE="FP1-2">3. Response to Other Comments</FP>
                    <FP SOURCE="FP1-2">a. Historical Cycle Time Trends</FP>
                    <FP SOURCE="FP1-2">B. Residential Clothes Washers</FP>
                    <FP SOURCE="FP1-2">1. Cycle Time as a Performance-Related Feature</FP>
                    <FP SOURCE="FP1-2">2. Justification of Different Standards for Residential Clothes Washers With a Short-Cycle Feature</FP>
                    <FP SOURCE="FP1-2">C. Consumer Clothes Dryers</FP>
                    <FP SOURCE="FP1-2">1. Cycle Time as a Performance-Related Feature</FP>
                    <FP SOURCE="FP1-2">2. Justification of Different Standards for Consumer Clothes Dryers With a Short-Cycle Feature</FP>
                    <FP SOURCE="FP1-2">D. Other Topics Addressed by the Fifth Circuit</FP>
                    <FP SOURCE="FP1-2">1. Water Authority</FP>
                    <FP SOURCE="FP1-2">2. Test Procedure Authority</FP>
                    <FP SOURCE="FP1-2">3. Preservation of Product Utility and Potential for Increased Energy or Water Use</FP>
                    <FP SOURCE="FP1-2">a. Dishwashers</FP>
                    <FP SOURCE="FP1-2">b. Residential Clothes Washers</FP>
                    <FP SOURCE="FP1-2">c. Consumer Clothes Dryers</FP>
                    <FP SOURCE="FP-2">III. Conclusions</FP>
                    <FP SOURCE="FP-2">IV. Procedural Issues and Regulatory Review</FP>
                    <FP SOURCE="FP-2">V. Approval of the Office of the Secretary</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Introduction</HD>
                <P>The following sections briefly discuss the statutory authority underlying this confirmation of withdrawal, as well as some of the historical background relevant to dishwashers, residential clothes washers (“RCWs”), and consumer clothes dryers.</P>
                <HD SOURCE="HD2">A. Authority</HD>
                <P>
                    The U.S. Department of Energy (“DOE”) must follow specific statutory criteria under the Energy Policy and Conservation Act, Public Law 94-163,
                    <SU>1</SU>
                    <FTREF/>
                     as amended, (“EPCA”) for prescribing new or amended standards for covered products, including dishwashers, RCWs, and consumer clothes dryers. Any new or amended standard for a covered product must be designed to achieve the maximum improvement in energy efficiency that the Secretary of Energy (“Secretary”) determines is technologically feasible and economically justified. (42 U.S.C. 6295(o)(2)(A)) Furthermore, DOE may not adopt any standard that would not result in the significant conservation of energy. (42 U.S.C. 6295(o)(3)(B))
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         All references to EPCA in this document refer to the statute as amended through the Energy Act of 2020, Public Law 116-260 (Dec. 27, 2020), which reflect the last statutory amendments that impact parts A and A-1 of EPCA.
                    </P>
                </FTNT>
                <P>In deciding whether a proposed standard is economically justified, DOE must determine whether the benefits of the standard exceed its burdens. (42 U.S.C. 6295(o)(2)(B)(i)) DOE must make this determination after receiving comments on the proposed standard, and by considering, to the greatest extent practicable, the following seven statutory factors:</P>
                <P>(1) The economic impact of the standard on manufacturers and consumers of the products subject to the standard;</P>
                <P>(2) The savings in operating costs throughout the estimated average life of the covered products in the type (or class) compared to any increase in the price, initial charges, or maintenance expenses for the covered products that are likely to result from the standard;</P>
                <P>(3) The total projected amount of energy (or as applicable, water) savings likely to result directly from the standard;</P>
                <P>(4) Any lessening of the utility or the performance of the covered products likely to result from the standard;</P>
                <P>(5) The impact of any lessening of competition, as determined in writing by the Attorney General, that is likely to result from the standard;</P>
                <P>
                    (6) The need for national energy and water conservation; and
                    <PRTPAGE P="105409"/>
                </P>
                <P>(7) Other factors the Secretary considers relevant.</P>
                <FP>(42 U.S.C. 6295(o)(2)(B)(i)(I) through (VII))</FP>
                <P>EPCA, as codified, also contains what is known as an “anti-backsliding” provision, which prevents the Secretary from prescribing any amended standard that either increases the maximum allowable energy use or decreases the minimum required energy efficiency of a covered product. (42 U.S.C. 6295(o)(1)) Also, the Secretary may not prescribe an amended or new standard if interested persons have established by a preponderance of the evidence that the standard is likely to result in the unavailability in the United States in any covered product type (or class) of performance characteristics (including reliability), features, sizes, capacities, and volumes that are substantially the same as those generally available in the United States. (42 U.S.C. 6295(o)(4))</P>
                <P>
                    Additionally, EPCA specifies requirements when promulgating an energy conservation standard for a covered product that has two or more subcategories. A rule prescribing an energy conservation standard for a type (or class) of product must specify a different standard level for a type or class of products that has the same function or intended use if DOE determines that products within such group (A) consume a different kind of energy from that consumed by other covered products within such type (or class); or (B) have a capacity or other performance-related feature which other products within such type (or class) do not have and such feature justifies a higher or lower standard. (42 U.S.C. 6295(q)(1)) In determining whether a performance-related feature justifies a different standard for a group of products, DOE considers such factors as the utility to the consumer of such a feature and other factors DOE deems appropriate. (
                    <E T="03">Id.</E>
                    ) Any rule prescribing such a standard must include an explanation of the basis on which such higher or lower level was established. (42 U.S.C. 6295(q)(2))
                </P>
                <HD SOURCE="HD2">B. Background</HD>
                <P>
                    The Administrative Procedure Act (“APA”), 5 U.S.C. 551 
                    <E T="03">et seq.,</E>
                     provides, among other things, that “[e]ach agency shall give an interested person the right to petition for the issuance, amendment, or repeal of a rule.” (5 U.S.C. 553(e)) Pursuant to this provision of the APA, the Competitive Enterprise Institute (“CEI”) petitioned DOE (“March 2018 Petition”) for the issuance of a rule establishing a new product class under 42 U.S.C. 6295(q) that would cover dishwashers with a cycle time of less than 60 minutes from washing through drying, asserting that it is not technologically feasible to create dishwashers that both meet the current standards and have cycle times of 60 minutes or less.
                    <SU>2</SU>
                    <FTREF/>
                     On October 30, 2020, DOE published a final rule that established a product class for standard-size dishwashers with a cycle time for the normal cycle 
                    <SU>3</SU>
                    <FTREF/>
                     of 60 minutes or less. 85 FR 68723 (“October 2020 Final Rule”). Contrary to CEI's claim in the March 2018 Petition that it is not technologically feasible for a dishwasher with a cycle time of 60 minutes or less to meet the current standards, in the October 2020 Final Rule, DOE identified several dishwashers that had cycles that were less than 60 minutes and met the current standards but asserted that establishing a product class for dishwashers with a normal cycle of 60 minutes or less could spur manufacturer innovation to generate additional product offerings. 
                    <E T="03">Id.</E>
                     at 85 FR 68726. The October 2020 Final Rule additionally specified that the current standards for dishwashers no longer apply to short-cycle products and that DOE intended to conduct the necessary rulemaking to determine standards that would provide the maximum energy efficiency that is technologically feasible and economically justified, and would result in a significant conservation of energy. 
                    <E T="03">Id.</E>
                     at 85 FR 68733, 68741.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         document IDs 0006 and 0007 at 
                        <E T="03">www.regulations.gov/docket/EERE-2018-BT-STD-0005.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The “normal cycle” is specifically defined in section 1 of the DOE test procedure at title 10 of the Code of Federal Regulations (“CFR”), part 430, subpart B, appendix C1 (“appendix C1”), as “the cycle type, including washing and drying temperature options, recommended in the manufacturer's instructions for daily, regular, or typical use to completely wash a full load of normally soiled dishes including the power-dry feature,” among other criteria.
                    </P>
                </FTNT>
                <P>
                    Following the October 2020 Final Rule, having determined that similarities exist between the consumer use of dishwashers, RCWs, and consumer clothes dryers (
                    <E T="03">i.e.,</E>
                     that these products offer several cycles with varying times, and that consumers run these cycles multiple times per week on average), DOE published a final rule on December 16, 2020, that established product classes for top-loading standard-size RCWs and certain classes of consumer clothes dryers with a cycle time of less than 30 minutes, and front-loading standard-size RCWs with a cycle time of less than 45 minutes (“December 2020 Final Rule”). 85 FR 81359. Similar to the October 2020 Final Rule, the December 2020 Final Rule also specified that the current standards for RCWs and consumer clothes dryers no longer apply to short-cycle products. 85 FR 68723, 68742; 85 FR 81359, 81376.
                </P>
                <P>
                    On January 19, 2022, DOE published a final rule (“January 2022 Final Rule”) revoking the October 2020 Final Rule and the December 2020 Final Rule (collectively, “Short-Cycle Final Rules”). In that rule, DOE noted that the appropriate time for establishing a new product class under 42 U.S.C. 6295(q) is during a rulemaking prescribing new or amended standards. 87 FR 2673, 2682. And, as the Short-Cycle Final Rules stated that they were not applying the rulemaking analysis pursuant to the seven factors specified in 42 U.S.C. 6295(o) for the establishment of standards, DOE found that these rules were improperly promulgated. 
                    <E T="03">Id.</E>
                     at 87 FR 2673. The January 2022 Final Rule reinstated the prior product classes and applicable standards for these covered products. 
                    <E T="03">Id.</E>
                     at 87 FR 2686.
                </P>
                <P>
                    On March 17, 2022, various States filed a petition in the United States Court of Appeals for the Fifth Circuit (“Fifth Circuit”) seeking review of the January 2022 Final Rule, which eliminated the short-cycle product classes and reinstated the applicable energy conservation standards. The petitioners argued that the January 2022 Final Rule withdrawing the Short-Cycle Final Rules violated EPCA and was arbitrary and capricious. On January 8, 2024, the Fifth Circuit granted the petition for review and remanded the matter to DOE for further proceedings consistent with the Fifth Circuit's opinion. In remanding the January 2022 Final Rule for further consideration, the Court held that even if the Short-Cycle Final Rules were invalid, DOE was obligated to consider other remedies short of withdrawal. 
                    <E T="03">See Louisiana, et al.</E>
                     v. 
                    <E T="03">United States Department of Energy, et al.,</E>
                     90 F.4th 461, 477 (5th Cir. 2024). Specifically, the Court noted that instead of withdrawing the Short-Cycle Final Rules, DOE could have promulgated energy conservation standards for the short-cycle product classes. 
                    <E T="03">Id.</E>
                     at 476.
                </P>
                <P>
                    As a result, DOE has considered whether short-cycle product classes and standards can be established under the applicable statutory criteria. Under EPCA, DOE establishes product classes based on: (1) fuel type; or (2) performance-related features. (42 U.S.C. 6295(q)(1)) With regards to product classes based on performance-related features, the product must have a feature which other products within such type do not have and such feature must justify a different standard from 
                    <PRTPAGE P="105410"/>
                    that which applies to other products within such type. (
                    <E T="03">Id.).</E>
                     In the Short-Cycle Final Rules, DOE found that cycle time was a performance-related feature and that some products had shorter cycle times than others. 85 FR 68723, 68726; 85 FR 81359, 81361. But the Short-Cycle Final Rules did not determine whether cycle time justified different standards. Instead, the Short-Cycle Final Rules stated DOE would determine specific standards in a separate rulemaking. 
                    <E T="03">Id.</E>
                     Therefore, to establish separate energy conservation standards for short-cycle product classes, DOE must first confirm the determination made in the Short-Cycle Final Rules that cycle time is a performance-related feature for these three covered products. DOE must then determine that a different standard level is justified for short-cycle products, as there is no basis for establishing a product class under 42 U.S.C. 6295(q) that would be subject to the same standard level. Finally, assuming DOE determines that cycle time is a performance-related feature and a different standard level is justified for short-cycle products, DOE must apply the criteria in 42 U.S.C. 6295(o) to prescribe energy conservation standards that, among other things, are technologically feasible and economically justified and would result in significant conservation of energy.
                </P>
                <P>As part of this process, DOE published a request for information on March 11, 2024 (“March 2024 RFI”), seeking data and other information on, among other things, the presence of any short-cycle products in the market and any relationship between cycle time and performance. 89 FR 17338.</P>
                <P>
                    Subsequently, on November 8, 2024, DOE published a proposed confirmation of withdrawal (“November 2024 Proposed Withdrawal”), which considered the factors outlined by the Fifth Circuit and proposed to confirm the elimination of short-cycle product classes in the January 2022 Final Rule. 89 FR 88661. DOE received comments in response to the November 2024 Proposed Withdrawal from the interested parties listed in Table I.1.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Table I.1 excludes two non-substantive comments received from anonymous commenters, which were considered in the development of this confirmation but not cited individually.
                    </P>
                </FTNT>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s100,xs54,12,xs90">
                    <TTITLE>Table I.1—List of Commenters With Written Submissions in Response to the November 2024 Proposed Withdrawal</TTITLE>
                    <BOXHD>
                        <CHED H="1">Commenter(s)</CHED>
                        <CHED H="1">Reference in this final rule</CHED>
                        <CHED H="1">
                            Comment No.
                            <LI>in the docket</LI>
                        </CHED>
                        <CHED H="1">Commenter type</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Alliance for Water Efficiency</ENT>
                        <ENT>AWE</ENT>
                        <ENT>20</ENT>
                        <ENT>Efficiency Organization.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Association of Home Appliance Manufacturers</ENT>
                        <ENT>AHAM</ENT>
                        <ENT>23</ENT>
                        <ENT>Trade Organization.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Appliance Standards Awareness Project, AWE, American Council for an Energy-Efficient Economy, Consumer Federation of America, Earthjustice, and National Consumer Law Center</ENT>
                        <ENT>
                            ASAP 
                            <E T="03">et al</E>
                        </ENT>
                        <ENT>21</ENT>
                        <ENT>Efficiency Organizations.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">California Energy Commission</ENT>
                        <ENT>CEC</ENT>
                        <ENT>17</ENT>
                        <ENT>State Agency.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Pacific Gas and Electric, Southern California Edison, San Diego Gas and Electric (collectively, the California Investor-Owned Utilities)</ENT>
                        <ENT>CA IOUs</ENT>
                        <ENT>22</ENT>
                        <ENT>Utilities.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Competitive Enterprise Institute</ENT>
                        <ENT>CEI</ENT>
                        <ENT>18</ENT>
                        <ENT>Advocacy Organization.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Michael Ravnitzky</ENT>
                        <ENT>Ravnitzky</ENT>
                        <ENT>15</ENT>
                        <ENT>Individual.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Northwest Energy Efficiency Alliance</ENT>
                        <ENT>NEEA</ENT>
                        <ENT>19</ENT>
                        <ENT>Efficiency Organization.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    A parenthetical reference at the end of a comment quotation or paraphrase provides the location of the item in the public record.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         The parenthetical reference provides a reference for information located in the docket for this rulemaking. (Docket No. EERE-2024-BT-STD-0002, which is maintained at: 
                        <E T="03">www.regulations.gov</E>
                        ). The references are arranged as follows: (commenter name, comment docket ID number at page of that document).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Discussion</HD>
                <P>This discussion responds to the Fifth Circuit's January 8, 2024, decision remanding this matter to DOE for further proceedings consistent with its opinion. In remanding the January 2022 Final Rule for further consideration, the Fifth Circuit found the January 2022 Final Rule arbitrary and capricious for two principal reasons:</P>
                <EXTRACT>
                    <P>(1) It failed to adequately consider appliance performance, substitution effects, and the “ample record evidence” that DOE's conservation standards are causing Americans to use more energy and water rather than less; and</P>
                    <P>
                        (2) It rested instead on DOE's view that the Short-Cycle Final Rules were legally invalid—but even if true, that does not excuse DOE from considering other remedies short of repealing the Short-Cycle Final Rules 
                        <E T="03">in toto.</E>
                    </P>
                </EXTRACT>
                <FP>
                    <E T="03">Louisiana,</E>
                     90 F.4th at 477.
                </FP>
                <P>
                    With regards to the second reason, the Court noted that instead of withdrawing the Short-Cycle Final Rules, DOE could have promulgated energy conservation standards for the short-cycle product classes. 
                    <E T="03">Id.</E>
                     at 476.
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE considered whether an alternative to withdrawing the Short-Cycle Final Rules—establishing standards for the short-cycle product classes—would be justified under EPCA. 89 FR 88661, 88664. Specifically, DOE tentatively concluded that the short-cycle features of dishwashers, RCWs, and consumer clothes dryers do not justify standards different from those applicable to those products generally. 
                    <E T="03">Id.</E>
                     DOE also considered the effect of withdrawing the short-cycle product classes on product performance and energy and water use savings, including cleaning and drying performance, the potential for increased substitution (
                    <E T="03">e.g.,</E>
                     by hand washing or pre-washing), and the risk that standards are unintentionally increasing energy use (
                    <E T="03">e.g.,</E>
                     via consumers relying on multiple cycles or unregulated cycles). 
                    <E T="03">Id.</E>
                </P>
                <P>
                    AWE, AHAM, ASAP 
                    <E T="03">et al.,</E>
                     CEC, CA IOUs, NEEA, and Ravnitzky commented in support of the November 2024 Proposed Withdrawal and noted that short-cycle product classes do not warrant different energy conservation standards than those generally applicable to dishwashers, RCWs, and consumer clothes dryers. (AWE, No. 20 at p. 1; AHAM, No. 23 at p. 2; ASAP 
                    <E T="03">et al.,</E>
                     No. 21 at pp. 1-2; CEC, No. 17 at p. 1; CA IOUs, No. 22 at p. 1; NEEA, No. 19 at pp. 1-2; Ravnitzky, No. 15 at p. 1)
                </P>
                <P>
                    CEI asserted that terminating the short-cycle product classes for dishwashers, RCWs, and consumer clothes dryers would ignore the consumer protections in EPCA as well as recent Federal court precedent and should not be finalized. (CEI, No. 18 at p. 1) CEI also commented that the Fifth 
                    <PRTPAGE P="105411"/>
                    Circuit held that DOE's failure to consider any alternative other than refusing to promulgate a rulemaking was arbitrary and capricious. CEI stated that an alternative would have been to set a new standard for short-cycle product classes while taking other relevant features into account, as required by EPCA. (
                    <E T="03">Id.</E>
                     at p. 5)
                </P>
                <P>DOE notes that in the November 2024 Proposed Withdrawal, DOE did, in fact, consider whether an alternative to withdrawing the Short-Cycle Final Rules would be justified under EPCA, as required by the Fifth Circuit's decision remanding the January 2022 Final Rule to DOE. 89 FR 88661. As discussed in the November 2024 Proposed Withdrawal and in the following sections of this document, DOE concludes that the short-cycle features of dishwashers, RCWs, and consumer clothes dryers do not justify standards different from those applicable to these products generally.</P>
                <HD SOURCE="HD2">A. Dishwashers</HD>
                <P>
                    The following sections apply DOE's authority under EPCA at 42 U.S.C. 6295(q) to determine whether a “short-cycle” feature for dishwashers is a performance-related feature that justifies the establishment of a separate product class. DOE considers a short-cycle feature for dishwashers to be a cycle that can completely wash a full load of normally soiled dishes in 60 minutes or less. DOE first reiterates its prior determinations that cycle time is a performance-related feature of dishwashers and details its specific consideration of the short-cycle feature (
                    <E T="03">see</E>
                     section II.A.1 of this document). As discussed in section II.A.2 of this document, DOE determines in this analysis that the short-cycle feature does not justify a different standard. Data and information from the Short-Cycle Final Rules, March 2024 RFI, and dishwashers direct final rule published on April 24, 2024 (“April 2024 Dishwashers Direct Final Rule”; 89 FR 31398) show that products with a normal cycle of less than 60 minutes can meet the current energy conservation standards using the same design strategies as other dishwashers of comparable efficiency without a short-cycle feature. Finally, in section II.A.3 of this document, DOE addresses other pertinent comments received in response to the November 2024 Proposed Withdrawal that pertain to the dishwasher topics discussed in this document.
                </P>
                <HD SOURCE="HD3">1. Cycle Time as a Performance-Related Feature</HD>
                <P>DOE first considered whether cycle time is a performance-related feature of dishwashers in accordance with 42 U.S.C. 6295(q)(1)(B). Consistent with DOE's assessment in the November 2024 Proposed Withdrawal and in previous rulemakings, discussed as follows, DOE reiterates that cycle time is a performance-related feature of dishwashers.</P>
                <P>
                    In a notice of proposed rulemaking (“NOPR”) published on July 16, 2019 (“July 2019 NOPR”), DOE noted that while some individual consumers commented in response to the Notice of Petition for Rulemaking that was published on April 24, 2018 (83 FR 17768) that they were not concerned with a shorter cycle time, other individual consumers expressed dissatisfaction with the amount of time necessary to run their dishwashers. 84 FR 33869, 33873. In the July 2019 NOPR, DOE further discussed that the data and comments from dissatisfied consumers indicated that for many consumers, there is a utility in shorter cycle times to clean a normally soiled load of dishes. 
                    <E T="03">Id.</E>
                     Based on these considerations, DOE concluded that cycle time for dishwashers is a performance-related feature for the purposes of 42 U.S.C. 6295(q). 
                    <E T="03">Id.</E>
                </P>
                <P>
                    DOE reiterated this conclusion in the October 2020 Final Rule. 85 FR 68723, 68726-68732. Specifically, DOE concluded in the October 2020 Final Rule that dishwashers with a normal cycle with a cycle time of 60 minutes or less have a performance-related feature that other dishwashers currently on the market lack. 
                    <E T="03">Id.</E>
                     at 85 FR 68726, citing 84 FR 33869, 33871. As defined in section 1 of appendix C1, the normal cycle refers to the cycle recommended to the consumer to completely wash a full load of normally soiled dishes.
                </P>
                <P>As discussed, CEI petitioned DOE in March 2018 to establish a separate product class for dishwashers for which the normal cycle is less than 60 minutes. In the October 2020 Final Rule, DOE finalized the creation of a new product class for standard-size dishwashers with a normal cycle of 60 minutes or less. 85 FR 68723, 68733. In the January 2022 Final Rule, DOE did not question the validity of those prior determinations that short cycles provide a performance-related feature. 87 FR 2673, 2682.</P>
                <P>
                    In response to the November 2024 Proposed Withdrawal, AHAM commented that cycle time is an important consumer feature. (AHAM, No. 23 at p. 2) The CA IOUs, however, commented that the March 2018 Petition from CEI, the Short-Cycle Final Rules, and the November 2024 Proposed Withdrawal did not include sufficient justification from DOE or CEI for why these specific short-cycle times offered a unique consumer utility. (CA IOUs, No. 22 at p. 2) The CA IOUs requested that DOE assess the merits of the selected cycle time delineations and the consumer utility they may or may not provide in future rulemakings. (
                    <E T="03">Id.</E>
                    )
                </P>
                <P>
                    In response to the comment from the CA IOUs, DOE notes that the specific short-cycle time considered, 60 minutes or less, is less than the average cycle time for this product. As such, DOE believes this short-cycle time can provide utility to some consumers, 
                    <E T="03">e.g.,</E>
                     consumers needing to complete multiple cycles in a limited amount of time. For the reasons stated in the July 2019 NOPR and October 2020 Final Rule, and consistent with the November 2024 Proposed Withdrawal, DOE reconfirms in this confirmation of withdrawal that cycle time is a performance-related feature of dishwashers for the purposes of 42 U.S.C. 6295(q).
                </P>
                <P>The following paragraphs discuss DOE's specific consideration of the short-cycle feature for dishwashers.</P>
                <P>
                    To address the concerns of the Fifth Circuit regarding DOE's previous consideration of “quick” cycles as the basis for concluding whether separate standards are justified for short-cycle dishwashers, for the analysis conducted in support of the November 2024 Proposed Withdrawal, DOE did not consider any “quick” cycles that do not perform equivalently to a normal cycle. In the November 2024 Proposed Withdrawal, DOE considered a dishwasher to have a “short-cycle feature” only if it provides a cycle with the capability of “completely washing” 
                    <SU>6</SU>
                    <FTREF/>
                     a full load of normally soiled dishes in 60 minutes or less, as would be the consumer expectation for a normal cycle. 89 FR 88661, 88665. In accordance with the Fifth Circuit's January 8, 2024, decision, DOE did not consider any “quick” cycles intended 
                    <PRTPAGE P="105412"/>
                    for washing only a partial load of dishes, or a cycle unable to completely wash a full load of normally soiled dishes, to be a short-cycle feature for the purpose of this analysis—even if such cycle has a cycle time of 60 minutes or less. 
                    <E T="03">Id.</E>
                     In this regard, the analyses performed in the November 2024 Proposed Withdrawal differed from the analyses DOE performed in support of the January 2022 Final Rule, in which DOE considered all “quick” cycles with a cycle time of 60 minutes or less, regardless of dish load size or cleaning ability. By considering only cycles that can completely wash a full load of normally soiled dishes, DOE avoided considering “quick” cycles designed for addressing niche applications (
                    <E T="03">e.g.,</E>
                     light soils, delicate items, 
                    <E T="03">etc.</E>
                    ) that are not capable of washing a full load of normally soiled dishes, as would be the consumer expectation for a normal cycle.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         As discussed elsewhere in this document, DOE's test procedure for dishwashers at 10 CFR 430, subpart B, appendix C2 (“appendix C2”), which references the latest industry test standard, defines a minimum cleaning index of 70 as the level that represents “completely washing” a full load of normally soiled dishes—as measured on each of the three soil loads that are tested in the DOE test procedure (
                        <E T="03">i.e.,</E>
                         the heavy, medium, and light soil loads). 
                        <E T="03">See</E>
                         88 FR 3234, 3251-3263. For the purpose of this confirmation of withdrawal, and consistent with the November 2024 Proposed Withdrawal, DOE considers “completely washing a full load of normally soiled dishes” to mean achieving a cleaning index of at least 70 on each of the three soil loads.
                    </P>
                </FTNT>
                <P>In response to the November 2024 Proposed Withdrawal, Ravnitzky commented that, in his experience, he occasionally uses the shorter cycles on his dishwasher when the dishes are not very dirty or when the task needs to be completed quickly. Ravnitzky further commented that these occasions are relatively infrequent and that, for the majority of the time, he relies on the standard cycles to ensure thorough cleaning and drying. (Ravnitzky, No. 15 at p. 1)</P>
                <P>AHAM commented that consumers are satisfied with existing normal cycle times and most products also have short-cycle options for when quicker cycles are needed. (AHAM, No. 23 at p. 1)</P>
                <P>CEI asserted that the November 2024 Proposed Withdrawal repeated the claim from the January 2022 Final Rule that the availability of quick cycles on many dishwasher models obviates the need for the short-cycle product class, which would be applicable to the normal cycle. CEI noted that the Fifth Circuit criticized and rejected this argument and asserted that DOE did not address this concern in the November 2024 Proposed Withdrawal. (CEI, No. 18 at p. 6)</P>
                <P>
                    In response to the comment from CEI, DOE reiterates that it did, in fact, address the concerns of the Fifth Circuit regarding DOE's previous consideration of “quick” cycles as the basis for concluding whether separate standards are justified for short-cycle dishwashers. Specifically, as discussed, DOE's analysis conducted in support of the November 2024 Proposed Withdrawal did not consider any “quick” cycles that do not perform equivalently to a normal cycle. Rather, in the November 2024 Proposed Withdrawal, DOE considered in its determination of a short-cycle feature only those dishwasher cycles that could completely wash a full load of normally soiled dishes in 60 minutes or less, as would be the consumer expectation for a normal cycle.
                    <SU>7</SU>
                    <FTREF/>
                     89 FR 88661, 88665. DOE specifically noted that this distinction to only consider cycles that met both the cleaning performance threshold and cycle time threshold was a key difference in the analyses performed in the November 2024 Proposed Withdrawal from the analyses performed in the January 2022 Final Rule. 89 FR 88661, 88665, 88667-88668.
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Specifically, DOE defined “completely washing” a full load of normally soiled dishes as those cycles that were soiled with the same soil loads as is used in the DOE test procedure to test the normal cycle (
                        <E T="03">i.e.,</E>
                         heavy, medium, and light soil loads as defined in the DOE test procedure at appendix C1 and appendix C2) and achieved a cleaning index of at least 70 on each of the three soil loads as specified in appendix C2. 89 FR 88661, 88665.
                    </P>
                </FTNT>
                <P>In this document, consistent with the November 2024 Proposed Withdrawal, DOE continues to consider a dishwasher to have a short-cycle feature only if it provides any cycle with the capability of completely washing a full load of normally soiled dishes in 60 minutes or less, as would be the consumer expectation for the normal cycle. In the sections that follow, DOE evaluates whether such a short-cycle feature justifies a separate product class in accordance with 42 U.S.C. 6295(q).</P>
                <HD SOURCE="HD3">2. Justification of Different Standards for Dishwashers With a Short-Cycle Feature</HD>
                <P>
                    As discussed, EPCA authorizes DOE to prescribe a higher or lower standard than that which applies (or would apply) for such type (or class) for any group of covered products which have the same function or intended use if DOE determines that products within such group (A) consume a different kind of energy from that consumed by other covered products within such type (or class); or (B) have a capacity or other performance-related feature which other products within such type (or class) do not have and such feature justifies a higher or lower standard. (42 U.S.C. 6295(q)(1)) In determining whether a performance-related feature justifies a different standard for a group of products, DOE considers such factors as the utility to the consumer of such a feature and other factors DOE deems appropriate. (
                    <E T="03">Id.</E>
                    )
                </P>
                <P>
                    A typical application of this provision of EPCA is for DOE to establish comparatively less stringent standards for classes of covered products that have a performance-related feature that inherently uses more energy than products without such feature, and for which DOE has determined that such feature provides a utility to the consumer that justifies the comparatively less stringent standard. For example, when establishing standards for consumer refrigerators, DOE determined through-the-door ice service to be a performance-related feature of refrigerators that provides utility to the consumer and that affects efficiency; 
                    <E T="03">i.e.,</E>
                     inherently uses more energy (
                    <E T="03">see</E>
                     discussion of product class segregation at 52 FR 46367, 46371 (Dec. 7, 1987)). Accordingly, DOE established comparatively less stringent standards for refrigerators with through-the-door ice service than for equivalent refrigerators without such a feature. 54 FR 47916, 47943-47944 (Nov. 17, 1989). DOE has maintained a product class distinction with comparatively less stringent standards for refrigerators with through-the-door ice service through successive amendments to the standards for consumer refrigerators.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Separate refrigerator product class distinctions are made for additional product features as well, such as automatic defrost and transparent doors. 
                        <E T="03">See</E>
                         10 CFR 430.32(a).
                    </P>
                </FTNT>
                <P>
                    In the October 2020 Final Rule, DOE acknowledged that designing a dishwasher with a normal cycle time of 60 minutes or less is achievable and asserted that establishing a short-cycle product class could spur manufacturer innovation to generate additional product offerings to fill the market gap that exists for dishwashers with this feature (
                    <E T="03">i.e.,</E>
                     the ability to clean a load of normally soiled dishes in under 60 minutes). DOE further stated its intent to determine the specific energy and water conservation standards of the new product class in a separate rulemaking. 85 FR 68723, 68724.
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE conducted an analysis of the energy and water use of a short-cycle feature for dishwashers to evaluate whether different (
                    <E T="03">i.e.,</E>
                     comparatively less stringent) standards would be warranted for dishwashers that provide a short-cycle feature. 89 FR 88661, 88666. As discussed in the previous section of this document, DOE has determined that a normal cycle of 60 minutes or less on a dishwasher is a performance-related feature that provides consumer utility for the purpose of consideration of potential product class distinction under the provisions of 42 U.S.C. 6295(q). In the November 2024 Proposed Withdrawal, DOE next evaluated whether dishwashers with a short-cycle feature necessitate more energy and water use 
                    <PRTPAGE P="105413"/>
                    than dishwashers without such feature, which could justify a comparatively less stringent standard for dishwashers that provide such a feature. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    To evaluate the energy and water use of a short-cycle feature in comparison to the currently applicable energy and water standards, in the November 2024 Proposed Withdrawal, DOE considered all data available from recent rulemakings, including data from testing conducted in support of the October 2020 Final Rule 
                    <SU>9</SU>
                    <FTREF/>
                     and the April 2024 Dishwashers Direct Final Rule and confidential data from AHAM. 
                    <E T="03">Id.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         DOE test data are available at 
                        <E T="03">www.regulations.gov/document/EERE-2018-BT-STD-0005-3213</E>
                        .
                    </P>
                </FTNT>
                <P>
                    The data from testing conducted in support of the October 2020 Final Rule included energy and water use, cycle time, and cleaning performance scores. Because there was no established DOE test procedure to evaluate dishwasher cleaning performance at the time of the October 2020 Final Rule, the cleaning performance scores in the October 2020 Final Rule dataset were based on the 2014 ENERGY STAR Test Method for Determining Residential Dishwasher Cleaning Performance 
                    <SU>10</SU>
                    <FTREF/>
                     (“2014 ENERGY STAR Test Method”). 85 FR 68723, 68725.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Test Method for Determining Residential Dishwasher Cleaning Performance. Rev. Feb-2014. Available at 
                        <E T="03">www.energystar.gov/sites/default/files/specs//ENERGY%20STAR%20Final%20Test%20Method%20for%20Determining%20Residential%20Dishwasher%20Cleaning%20Perfor%20%20%20_0.pdf</E>
                        .
                    </P>
                </FTNT>
                <P>
                    In a final rule amending the test procedure for dishwashers published on January 18, 2023 (“January 2023 TP Final Rule”), DOE established a new test procedure at 10 CFR 430, subpart B, appendix C2 (“appendix C2”), which in addition to measuring the energy and water use of a dishwasher, specifies a methodology to evaluate the cleaning performance of a dishwasher and establishes a minimum cleaning index threshold as criteria for a valid test cycle.
                    <SU>11</SU>
                    <FTREF/>
                     In the January 2023 TP Final Rule, DOE discussed that it was implementing this minimum cleaning index threshold as criteria for a valid test cycle to ensure that the measured energy and water results are reflective of a cycle that meets consumer expectations (
                    <E T="03">i.e.,</E>
                     to ensure that the DOE test procedure produces results that are representative of an average use cycle). 88 FR 3234, 3250-3267.
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         DOE notes that manufacturers will be required to use the test procedure at appendix C2 on and after April 23, 2027, which is the compliance date of the amended standards in the April 2024 Dishwashers Direct Final Rule. 
                        <E T="03">See</E>
                         88 FR 3234; 89 FR 31398.
                    </P>
                </FTNT>
                <P>
                    In conducting the analyses for the November 2024 Proposed Withdrawal, DOE identified that the 2014 ENERGY STAR Test Method that was used at the time of the October 2020 Final Rule to evaluate cleaning performance produces test results with greater variability and less repeatability in comparison to test results produced by DOE's appendix C2 test procedure.
                    <SU>12</SU>
                    <FTREF/>
                     For consistency with the analysis conducted for the November 2024 Proposed Withdrawal and to ensure representativeness of the cleaning performance indices resulting from the testing for the October 2020 Final Rule, DOE translated the October 2020 Final Rule test data to be equivalent to test results achieved under appendix C2,
                    <SU>13</SU>
                    <FTREF/>
                     which DOE has established to be representative of an average consumer use cycle. 89 FR 88661, 88666.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Specifically, in addition to scoring soil particles on all items of the test load, the February 2014 ENERGY STAR Test Method also scores spots, streaks, and rack contact marks on glassware. In the January 2023 TP Final Rule, DOE explained that because the DOE test is conducted without rinse aid—which can impact the scoring of spots of streaks on glassware—DOE finalized the cleaning performance test method to exclude the scoring of spots, streaks, and rack contact marks on glassware. 88 FR 3234, 3255-3256.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         DOE's test data translated to be equivalent to test results achieved under appendix C2 is available in the Technical Appendix to this document, available in the docket for this rulemaking at 
                        <E T="03">www.regulations.gov/docket/EERE-2024-BT-STD-0002</E>
                        .
                    </P>
                </FTNT>
                <P>Further, in the October 2020 Final Rule, DOE used the cleaning performance scores produced by the 2014 ENERGY STAR Test Method for comparison purposes only, stating that DOE did not have information at the time to relate the cleaning scores produced by that test method to minimum consumer acceptance of cleaning performance. 85 FR 68723, 68726. It was not until the January 2023 TP Final Rule that DOE determined that a score of 70 as tested according to appendix C2 reflects the threshold of consumer acceptability for cleaning performance of a normal cycle. Accordingly, DOE established in appendix C2 a minimum cleaning index threshold of 70 as a condition for a valid test cycle. 88 FR 3234, 3259-3263. Appendix C2 also requires that, as a condition for a valid test, the threshold cleaning index of 70 be achieved on each of the heavy, medium, and light soil loads required for testing, which collectively represent typical consumer usage patterns of dishwashers.</P>
                <P>Consistent with this determination of the threshold for a consumer-acceptable level of cleaning performance, in the November 2024 Proposed Withdrawal and in this document, DOE only considered a dishwasher as having a “short-cycle feature” if it had a cycle time less than 60 minutes and a per-cycle cleaning index threshold of at least 70.</P>
                <P>
                    From its test sample, DOE identified one unit that provides a “short-cycle feature”—as DOE has described that term in this document—that uses less energy and water than the maximum allowable standard level for standard-size dishwashers. 89 FR 88661, 88666. Specifically, this unit achieves a cleaning index of at least 70 on the heavy, medium, and light soil loads that are required for testing the normal cycle, with a cycle time less than 60 minutes; 
                    <E T="03">i.e.,</E>
                     provides a “short-cycle feature” consistent with consumer expectations of a normal cycle.
                    <SU>14</SU>
                    <FTREF/>
                     This unit's test results demonstrate that providing a short-cycle feature consistent with consumer expectations of a normal cycle (
                    <E T="03">i.e.,</E>
                     a cycle that can completely wash a full load of normally soiled dishes in 60 minutes or less) does not necessitate using more energy and water than a dishwasher without such feature that meets the current standards. DOE further evaluated the technologies and design strategies used by this dishwasher and tentatively concluded that this unit does not incorporate any proprietary technologies or design strategies and is designed no differently than other dishwashers of comparable efficiency without a short-cycle feature. 
                    <E T="03">Id.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         In consideration of the Fifth Circuit's opinion that in the short-cycle rulemakings DOE pointed to existing “quick” cycles that did not address the foundational concerns underlying these rules, DOE considers in this analysis that the other units in the test sample that provide a dishwasher cycle less than 60 minutes, but that do not “completely wash” a full load of normally soiled dishes, do not have what DOE is describing as a “short-cycle feature” in this document, and therefore do not factor into DOE's consideration of whether a separate product class is justified for dishwashers with a short-cycle feature. 
                        <E T="03">See</E>
                         Louisiana, 90 F.4th at 474-75.
                    </P>
                </FTNT>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE tentatively concluded that the availability of this feature currently on the market—at lower energy and water levels than the current standard allows—in a unit with no identifiable proprietary design or control strategy demonstrated that a dishwasher with a short-cycle feature does not inherently use more energy and water than a dishwasher without such feature to achieve an acceptable cleaning performance, and that the current dishwasher standards do not preclude manufacturers from offering a normal cycle of 60 minutes or less. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE discussed that further evaluation of consumer survey data and comments from dishwasher manufacturers indicates that the limited 
                    <PRTPAGE P="105414"/>
                    availability of short-cycle features on the current market is not indicative of energy conservation standards precluding or discouraging the availability of such feature, but rather reflects the prioritization of product offerings by manufacturers commensurate with a relatively low level of market demand for this feature in comparison to other features more important to consumers. 
                    <E T="03">Id.</E>
                     On average, a consumer runs 184 dishwasher cycles per year, or, said another way, consumers run their dishwasher approximately once every two days. 88 FR 3234, 3244. This usage pattern doesn't demonstrate a need for faster cycle times, further supporting the low market demand for the short-cycle feature.
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE re-analyzed the provisions of a previous rulemaking (
                    <E T="03">i.e.,</E>
                     the January 2022 Final Rule) that withdrew short-cycle product and tentatively determined, based on the available test data—which demonstrated that it is feasible to design a short-cycle feature while meeting current standards—as well as stakeholder comments and market survey data, that (1) a short-cycle feature that can completely wash a full load of normally soiled dishes in 60 minutes or less is technologically feasible; (2) current standards do not prevent dishwasher manufacturers from providing such a short-cycle feature; and (3) there is a dishwasher currently available on the market that provides such a short-cycle feature and meets the currently applicable energy and water standard. 89 FR 88661, 88667. Accordingly, DOE did not propose to establish separate energy conservation standards for dishwashers with a short-cycle feature. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE sought comment on these proposed determinations. 
                    <E T="03">Id.</E>
                </P>
                <P>The CA IOUs commented that DOE had demonstrated that the applicable standards for dishwashers do not preclude manufacturers from developing products that meet the intention of the short-cycle product class and agreed that the technological feasibility of developing such products is the appropriate factor when determining if a performance characteristic merits a different standard level. (CA IOUs, No. 22 at p. 2)</P>
                <P>
                    ASAP 
                    <E T="03">et al.</E>
                     commented in support of DOE's proposal to confirm the withdrawal of the short-cycle product class for dishwashers on the basis that there is at least one model available on the market that provides the short-cycle feature and uses less energy and water than the current standard. ASAP 
                    <E T="03">et al.</E>
                     noted that DOE considered a model to have the short-cycle feature only if it meets the consumer expectation of a normal cycle (
                    <E T="03">i.e.,</E>
                     completely washing a full load of normally soiled dishes in 60 minutes or less). ASAP 
                    <E T="03">et al.</E>
                     stated that the availability of such a model demonstrates that the current standards for these products are not precluding manufacturers from offering products with short cycle times and good product performance on a normal cycle. (ASAP 
                    <E T="03">et al.,</E>
                     No. 21 at pp. 1-2)
                </P>
                <P>CEC agreed with DOE that standards do not impact the ability of manufacturers to provide dishwashers with the short-cycle feature, as evidenced by existing product offerings. CEC further asserted that manufacturer comments on the rulemaking make it clear that a short-cycle product class is neither necessary nor warranted for dishwashers, and accordingly, a separate product class is not justified. (CEC, No. 17 at p. 1)</P>
                <P>Ravnitzky supported DOE's tentative determination that a short-cycle feature for dishwashers does not justify a separate product class with separate standards under 42 U.S.C. 6295(q) to not impose separate requirements for short-cycle features. (Ravnitzky, No. 15 at p. 1)</P>
                <P>NEEA supported DOE's proposal in the November 2024 Proposed Withdrawal to eliminate “short-cycle” product classes for dishwashers. NEEA stated that its comments build upon past NEEA letters submitted to DOE, which demonstrated that short-cycle product classes were unnecessary for these products because (1) consumers already have access to short cycle settings on dishwashers; (2) consumers use short cycles relatively infrequently; (3) consumers are satisfied with high-efficiency appliances; and (4) consumers are satisfied with appliances that have fast cycle options. NEEA added that leveraged sales data from the Northwest, consumer use data from regional field studies (“RBSA”), surveys of online retail catalogs, technology research, and laboratory tear-down studies support these conclusions. (NEEA, No. 4 at p. 2)</P>
                <P>AHAM asserted that for its members, the consumer is always top of mind, and accordingly, manufacturers make appliances that last longer, perform better, and respond to consumer needs and preferences. AHAM stated that manufacturers pay careful attention to consumer needs and desires for particular features and utilities and products currently on the market have a demonstrated capability to achieve the recommended energy and water conservation standards and retain consumer satisfaction with a range of performance considerations, utilities, and features. (AHAM, No. 23 at pp. 1-2)</P>
                <P>CEI asserted that DOE recently “relaxed” its test procedure for dishwashers by not including spots, streaks, and rack contact marks in the calculation of the cleaning index. CEI also commented that although DOE presented data showing at least one dishwasher model that has a quick cycle that meets the cleaning index criteria established by the DOE test procedure, CEI stated that it is not aware of any manufacturer claiming that its quick cycle is equivalent to the normal cycle. CEI also questioned why such a cycle would not be designated as the normal cycle. CEI asserted that DOE suggested that a dishwasher with a normal cycle that takes 2 hours or more, accompanied by a quick cycle that can meet the criteria of the new test procedure at appendix C2, is good enough to comply with the law. CEI further asserted that EPCA does not allow for any diminished features and performance resulting from its standards and claimed that a quick cycle meeting the criteria of the appendix C2 test procedure represents a decline in performance as compared to the normal cycle. CEI commented that such a decline justifies creating a separate short-cycle product class for dishwashers. (CEI, No. 18 at p. 6)</P>
                <P>
                    Contrary to CEI's claim, DOE has not “relaxed” its test procedure. As discussed previously, the new appendix C2 test procedure established by the January 2023 TP Final Rule is the first time DOE has finalized a test procedure that evaluates dishwasher cleaning performance and specifies a minimum cleaning index threshold that ensures that test results produced by the test procedure are representative of consumer use and consumer expectations of a normal cycle.
                    <SU>15</SU>
                    <FTREF/>
                     The cleaning performance threshold discussed in the October 2020 Final Rule, which was based on using the 2014 ENERGY STAR Test Method, does not correspond to the cleaning performance threshold that DOE has 
                    <PRTPAGE P="105415"/>
                    since determined to be indicative of consumer-acceptable cleaning performance for a normal cycle. Translating the October 2020 Final Rule data set to reflect cleaning indices equivalent to cleaning indices obtained using the appendix C2 test method was necessary to provide a consistent data set with which to identify dishwasher cycles that meet consumer expectations of a normal cycle.
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         DOE's dishwasher test procedure at appendix C1 and appendix C2 requires that testing be conducted without the use of rinse aid consistent with the specifications in the industry test standard, AHAM DW-1-2020, “Uniform Test Method for Measuring the Energy Consumption of Dishwashers.” In the January 2023 TP Final Rule, DOE found the use of rinse aid, or lack thereof, impacts the scoring of spots or streaks. As a result, DOE adopted a cleaning index calculation that scores only soils and does not include the scores of spots, streaks, or rack contact marks on the glassware. 88 FR 3234, 3248.
                    </P>
                </FTNT>
                <P>
                    Further, DOE did not suggest that a dishwasher with a normal cycle that takes 2 hours or more, accompanied by a quick cycle that provides a short-cycle feature, is “good enough to comply with the law.” Rather, DOE concluded that the availability of a short-cycle feature that meets consumer expectations of a normal cycle (
                    <E T="03">i.e.,</E>
                     completely washing a full load of normally soiled dishes in 60 minutes or less) while using no more energy and water than the current standard level indicates that it is technologically feasible to design a “normal cycle” with a cycle time of 60 minutes or less without diminishing any features or compromising dishwasher performance. In other words, energy conservation standards are not precluding manufacturers from designing a normal cycle with a cycle time of 60 minutes or less, and therefore the short-cycle feature would not justify less stringent standards.
                </P>
                <P>In response to CEI's question about why such a cycle would not be designated on the normal cycle, or why no manufacturer is claiming that its quick cycle is equivalent to the normal cycle, DOE reiterates its conclusion that the limited availability of short-cycle features on the current market is not indicative of energy conservation standards precluding or discouraging the availability of such feature, but rather reflects the prioritization of product offerings by manufacturers commensurate with a relatively low level of market demand for this feature in comparison to other features more important to consumers. 89 FR 88661, 88666.</P>
                <P>In conclusion, based on the available test data—which demonstrate that it is feasible to design a short-cycle feature while meeting current standards—as well as stakeholder comments in response to the March 2024 RFI and November 2024 Proposed Withdrawal and market survey data, DOE has determined that (1) a short-cycle feature that can completely wash a full load of normally soiled dishes in 60 minutes or less is technologically feasible; (2) current standards do not prevent dishwasher manufacturers from providing such a short-cycle feature; and (3) there is a dishwasher currently available on the market that provides such a short-cycle feature and meets the currently applicable energy and water standard.</P>
                <P>For these reasons, DOE has determined that a short-cycle feature for dishwashers does not justify a separate product class with different standards under 42 U.S.C. 6295(q).</P>
                <HD SOURCE="HD3">3. Response to Other Comments</HD>
                <P>In the sections that follow, DOE addresses comments received in response to the November 2024 Proposed Withdrawal that pertain to other dishwasher topics discussed in this document.</P>
                <HD SOURCE="HD3">a. Historical Cycle Time Trends</HD>
                <P>
                    In its March 2018 Petition, CEI presented dishwasher cycle time data compiled from annual Consumer Reports data. These data include the range of cycle times measured by Consumer Reports as well as an approximate market-average cycle time for each year. Based on the Consumer Reports data, CEI concluded that the historical increase in the average normal cycle time demonstrates that current standards have precluded manufacturers from offering products with short cycles as the normal cycle.
                    <SU>16</SU>
                    <FTREF/>
                     In particular, CEI noted that the average cycle time had not been about 1 hour since 1983, before any standards were adopted; average cycle time in 2018 was 2 hours and 20 minutes, and, according to CEI, had more than doubled due to current energy standards. CEI further asserted that when a new energy standard is adopted by DOE, the result is an increase in dishwasher cycle time. CEI also asserted that dishwasher average cycle times of less than 1 hour had been eliminated from the marketplace.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         The March 2018 Petition is available at 
                        <E T="03">www.regulations.gov/document/EERE-2018-BT-STD-0005-0006,</E>
                         page 4.
                    </P>
                </FTNT>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE discussed that market-average cycle time is not an appropriate indicator to demonstrate any causality with standards. Instead, the 
                    <E T="03">minimum</E>
                     available cycle time is a more appropriate indicator to assess any impact of standards on dishwasher cycle time, because the minimum available cycle time on the market can provide an indication of the technological feasibility of providing shorter cycle times while meeting more stringent standards. Whereas trends in market-average cycle times have largely been driven by other factors, discussed in the following paragraphs. 89 FR 88661, 88668.
                </P>
                <P>
                    Based on the data shared by CEI in the March 2018 Petition, DOE noted in the November 2024 Proposed Withdrawal that minimum cycle times (as represented by the lowest cycle time measured by Consumer Reports each year) have generally increased only during periods when standards were not amended. For example, the minimum cycle time—as apparent in the Consumer Reports data—increased from 65 minutes in 1993 to 85 minutes in 2006, a period during which there were no changes to dishwasher standards. Furthermore, the minimum cycle time as measured by Consumer Reports has decreased over the past 15 years, even while standards became more stringent during that time period. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    Additionally, in the November 2024 Proposed Withdrawal, DOE noted that the short-cycle feature currently available on the market has a cycle time (41 minutes) that is lower than the minimum cycle time measured by Consumer Reports in 1983 (55 minutes), prior to the introduction of any standards for dishwashers. DOE stated that this demonstrates that amended standards have not prevented the technological feasibility of providing a short-cycle feature even as dishwasher standards have become more stringent, and even as the market-weighted average cycle time has increased due to other factors (
                    <E T="03">see</E>
                     discussion in the following paragraphs regarding the potential impact of dishwasher sound levels and detergent formulation on cycle time). In other words, the totality of data available indicate that current standards are not precluding manufacturers from offering dishwashers with a short-cycle feature. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    In response to the November 2024 Proposed Withdrawal, CEI commented that DOE should address the issue of longer cycle times that CEI asserted have been caused by previous appliance regulations by creating new standards that are achievable by short-cycle product classes. (CEI, No. 18 at p. 1) CEI also asserted that the impact of previous dishwasher standards on cycle time is an example of a DOE appliance regulation that “crossed the line,” and stated that DOE should withdraw the November 2024 Proposed Withdrawal and instead consider a rulemaking process to establish standards for the short-cycle product classes. (
                    <E T="03">Id.</E>
                     at p. 7)
                </P>
                <P>
                    CEI also commented that dishwashers that can complete a normal cycle in 1 hour or less were widely available prior to the imposition of DOE standards but are not available anymore. Therefore, according to CEI, a separate standard for 
                    <PRTPAGE P="105416"/>
                    short-cycle product classes is required. (
                    <E T="03">Id.</E>
                     at p. 7)
                </P>
                <P>
                    As stated in the November 2024 Proposed Withdrawal, DOE reiterates that based on the data shared by CEI in the March 2018 Petition, minimum cycle times have generally increased during periods when standards were not amended. In fact, minimum cycle time as measured by Consumer Reports has decreased over the past 15 years, even while standards became more stringent during that time period. 89 FR 88661, 88668. The Consumer Reports data shared by CEI in the March 2018 Petition do not support CEI's assumption that minimum cycle times have increased due to DOE standards. On the contrary, the Consumer Reports data specifically fail to show a causal linkage between technologically feasible 
                    <E T="03">(i.e.,</E>
                     minimum) cycle times and DOE standards, because minimum cycle time increases generally occurred without a change in standards, yet decreases in minimum cycle time took place while standards became more stringent. Thus, DOE concludes, consistent with its position in the November 2024 Proposed Withdrawal, that the technological feasibility of providing dishwasher cycles with shorter durations has not been impacted due to DOE standards.
                </P>
                <P>Further, as discussed, DOE has identified at least one model currently available on the market that provides a short-cycle feature and has a cycle time of 41 minutes, demonstrating that dishwasher standards are not preventing manufacturers from designing a dishwasher that can completely wash a normally soiled load in 1 hour or less. Therefore, a short-cycle feature for dishwashers does not justify a separate product class with separate standards under 42 U.S.C. 6295(q).</P>
                <P>
                    Regarding CEI's assertion that dishwashers that can complete a normal cycle in 1 hour or less were widely available prior to the imposition of DOE standards, the data provided by CEI do not support this conclusion. An analysis of the Consumer Reports data presented by CEI in the March 2018 Petition indicates that only 3 out of 16 models from 1983 had cycle times of 60 minutes or less, and only 1 out of 20 models from 1990 had a cycle time of 60 minutes or less. These data do not provide any indication that dishwashers with normal cycle times of 60 minutes or less were “widely available” in the past, particularly since the data do not include any shipments information. Instead, the Consumer Reports data provided by CEI are consistent with DOE's tentative findings in the November 2024 Proposed Withdrawal that there is a lack of correlation solely between cycle time, energy/water use, and cleaning performance. The August 1983 Consumer Reports 
                    <SU>17</SU>
                    <FTREF/>
                     and May 1990 Consumer Reports 
                    <SU>18</SU>
                    <FTREF/>
                     indicate that all 4 models with cycle times of 60 minutes or less had only “average” washing performance based on a rating scale of “worse,” “bad,” “average,” “good,” and “better.” In contrast, some of the units with “good” cleaning performance (
                    <E T="03">i.e.,</E>
                     better than “average”) used less energy and water than units with “average” cleaning performance—and in fact were some of the most energy and water efficient units of that time.
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         Consumer Reports, “Dishwashers,” Consumer Reports, Aug. 1983, at p. 406.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         Consumer Reports, “Dishwashers Plain and Fancy,” Consumer Reports, May 1990, at p. 342.
                    </P>
                </FTNT>
                <P>
                    Specifically, DOE reiterates the discussion provided by ASAP 
                    <E T="03">et al.'</E>
                    s 
                    <SU>19</SU>
                    <FTREF/>
                     comment in response to the March 2024 RFI that was presented in the November 2024 Proposed Withdrawal. DOE notes that ASAP 
                    <E T="03">et al.</E>
                     asserted that the increase in cycle time was likely driven by other factors, such as consumer preference for quieter products and changes to detergent formulation. ASAP 
                    <E T="03">et al.</E>
                     cited 
                    <E T="03">Reviewed,</E>
                    <SU>20</SU>
                    <FTREF/>
                     which stated that older dishwashers had sound levels around 60 decibels, while modern dishwashers average between 40 and 50 decibels. ASAP 
                    <E T="03">et al.</E>
                     also cited 
                    <E T="03">Reviewed</E>
                     to explain that “there are lots of ways to reduce noise, but most of them involve reducing the machine's cleaning power, and that in turn means lengthening cycle times to compensate.” (ASAP 
                    <E T="03">et al.,</E>
                     No. 8 at p. 4) ASAP 
                    <E T="03">et al.</E>
                     also stated that by 2010, many states had banned the sale of dishwasher detergents containing phosphates, which resulted in newer detergents that use enzymes. ASAP 
                    <E T="03">et al.</E>
                     cited information from 
                    <E T="03">Reviewed</E>
                     explaining that enzyme-based detergents require more time to work, lengthening cycle times. (
                    <E T="03">Id.</E>
                    ) ASAP 
                    <E T="03">et al.</E>
                     further commented that short cycle times would likely result in trade-offs with other aspects of dishwasher performance such as cleaning performance or noise. ASAP 
                    <E T="03">et al.</E>
                     asserted that quick cycles would likely be noisier, because one way of reducing cycle time is to increase mechanical action, which in turn increases noise levels. (ASAP 
                    <E T="03">et al.,</E>
                     No. 8 at p. 6)
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Note that when responding to the March 2024 RFI, the comments from ASAP 
                        <E T="03">et al.</E>
                         included Natural Resources Defense Council and New York State Energy Research and Development Authority in addition to the commenters identified in this document.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">Reviewed</E>
                         is part of the USA TODAY Network. 
                        <E T="03">See reviewed.usatoday.com.</E>
                    </P>
                </FTNT>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE recognized that dishwasher manufacturers design dishwashers to achieve many different performance requirements (
                    <E T="03">e.g.,</E>
                     cleaning performance, drying performance, noise, efficiency, cycle time). DOE reiterated that one of the units in DOE's test sample meets the cleaning index threshold specified in appendix C2 while also having a cycle time of less than 60 minutes and meeting the current standards, demonstrating that current standards do not require manufacturers to trade off cleaning performance with cycle time. However, as noted in the November 2024 Proposed Withdrawal, DOE did not collect noise data in its previous testing so that it could not independently corroborate the extent to which there may be a trade-off between noise and cycle time. 89 FR 88661, 88678.
                </P>
                <P>In response to this discussion in the November 2024 Proposed Withdrawal, CEI commented that DOE asserted that cycle times have not increased due to historical dishwasher standards (as conceded by DOE in the past, according to CEI) but they may be a side-effect to creating quieter dishwashers. CEI stated that consumer preference for quieter dishwashers in lieu of longer cycle times was not raised in the January 2022 Final Rule. (CEI, No. 18 at p. 4)</P>
                <P>
                    CEI asserted also that even if dishwasher cycle time has increased to make dishwashers quieter, EPCA would still require a 1-hour standard because EPCA does not allow for the sacrifice of one performance feature in pursuit of another. CEI further asserted that there is public dissatisfaction with longer cycle times and that noise levels would need to be factored into determining the stringency of the standard for the short-cycle product class. (
                    <E T="03">Id.</E>
                     at p. 5)
                </P>
                <P>CEI stated that DOE's reference to stakeholder comments that longer cycle times may have been necessitated by new dishwasher detergent requirements in some States conflicts with DOE's earlier acknowledgement in the 2016 DOE Technical Support Document that longer cycle times are the result of DOE's energy and water conservation standards. CEI further commented that even if this were true, DOE should consider the impact of new detergent formulations when establishing a standard for the dishwashers short-cycle product class rather than foregoing the product class altogether. (CEI, No. 18 at p. 5)</P>
                <P>
                    Contrary to CEI's assertion, DOE did not acknowledge that longer cycle times are the result of DOE's energy and water conservation standards in a technical 
                    <PRTPAGE P="105417"/>
                    support document (“TSD”) posted in the docket of the final determination published on December 13, 2016 (“December 2016 Final Determination”) in which DOE determined that more stringent residential dishwasher standards would not be economically justified at the time. 81 FR 90072. In the December 2016 Final Determination TSD, DOE explained the “control strategies” technology option as follows:
                </P>
                <EXTRACT>
                    <FP>
                        . . . effective dishwashing requires water, heat, mechanical action (spraying of water), time, and detergent. Manufacturers may adjust the controls of a residential dishwasher to limit the amount of water used, or the set-point temperature of the wash or rinse water. This improves efficiency by decreasing the amount of energy associated with water heating. To help compensate for the negative impact on cleaning performance associated with decreasing water use and water temperature, manufacturers will typically increase the cycle time. This allows more time for the smaller volume of water to be circulated within the cabinet, helping to maintain wash performance.
                        <SU>21</SU>
                        <FTREF/>
                    </FP>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             DOE discussed technology options in Chapter 3 of the TSD. Available at 
                            <E T="03">https://www.regulations.gov/document/EERE-2014-BT-STD-0021-0029.</E>
                        </P>
                    </FTNT>
                </EXTRACT>
                <P>
                    This discussion in the December 2016 Final Determination TSD explains that manufacturers 
                    <E T="03">may</E>
                     (emphasis added) adjust dishwasher controls to improve the water and energy efficiency of a dishwasher; this discussion was not intended to suggest that implementing control strategies would be necessary, or would be the only design pathway to improve efficiency. Further, DOE also noted that the implementation of control strategies would 
                    <E T="03">typically</E>
                     (emphasis added) increase cycle time, not that it would necessarily increase cycle time. The discussion in the December 2016 Final Determination TSD describes one potential pathway to DOE evaluated to improve efficiency at the time of the December 2016 Final Determination, but it was not the only pathway to improved efficiency. Manufacturers are free to choose any design options to meet or exceed a given water and energy efficiency standard.
                </P>
                <P>
                    Finally, as discussed in section II.A.2 of this document, DOE's most recent testing and analyses of test data show that it is technologically feasible to achieve cycle times as low as 41 minutes while meeting the current DOE standard and also providing a consumer-acceptable level of cleaning performance (
                    <E T="03">i.e.,</E>
                     it is technologically feasible to design a short-cycle feature while meeting current standards). It is also important to note that, in the April 2024 Dishwashers Final Rule, DOE found that the amended standards adopted in that rule do not have a negative impact on cleaning performance because technology options likely to be used to meet the amended standards for dishwashers would not have a significant adverse impact on the utility of the product to subgroups of consumers and the dishwashers test procedure at appendix C2 requires that a test cycle achieve a minimum cleaning performance threshold to determine if a dishwasher, when tested according to the DOE test procedure, completely washes a normally soiled load of dishes, meaning that the standards cannot compromise the utility that consumers expect from dishwashers. 89 FR 31398, 31436. Therefore, even if there was a potential for a negative impact on cleaning performance associated with decreasing water use and water temperature, that potential is no longer applicable as dishwashers must meet the cleaning performance threshold.
                </P>
                <P>
                    Finally, CEI commented that dishwasher features other than cycle times do not negate DOE's obligation to set a separate standard for short-cycle dishwashers. (CEI, No. 18 at p. 4) CEI referenced comments in the April 2024 Dishwashers Direct Final Rule and data submitted in response to the March 2024 RFI to support CEI's assertion that consumers are not satisfied with current cycle times. (
                    <E T="03">Id.</E>
                     at pp. 4-5) CEI concluded that the DOE should establish a standard for short-cycle dishwashers to respond to the Fifth Circuit's January 8, 2024, decision that DOE did not consider any alternatives than repealing the Short-Cycle Final Rules. (
                    <E T="03">Id.</E>
                     at p. 5)
                </P>
                <P>
                    With respect to the comment from CEI regarding DOE's obligation to set standards for short-cycle dishwashers, DOE notes that its obligation is to follow its statutory authority under EPCA. As DOE stated in the November 2024 Proposed Withdrawal and confirms in this document, DOE reiterated that cycle time is a performance-related feature of dishwashers in accordance with 42 U.S.C. 6295(q)(1)(B), but that is only the first step for establishing a product class under 42 U.S.C. 6295(q). 89 FR 88661, 88665. Contrary to the assertion from CEI, the existence of a performance-related feature is not enough to 
                    <E T="03">justify a separate product class.</E>
                     DOE then needed to evaluate whether a different standard level is justified for short-cycle products. 
                    <E T="03">Id.</E>
                     Because available test data, market survey data, and stakeholder comments in response to the March 2024 RFI and November 2024 Proposed Withdrawal, show that it is technically feasible for a short-cycle feature to completely wash a full load of normally soiled dishes in 60 minutes or less, current standards do not prevent dishwasher manufacturers from providing such a short-cycle feature. 
                    <E T="03">In fact,</E>
                     there is a dishwasher currently available on the market that provides such a short-cycle feature and meets the currently applicable energy and water standards. For these reasons, DOE has determined that a short-cycle feature for dishwashers does not justify a separate product class with separate standards under 42 U.S.C. 6295(q).
                </P>
                <HD SOURCE="HD2">B. Residential Clothes Washers</HD>
                <P>
                    The following sections apply DOE's authority under EPCA at 42 U.S.C. 6295(q) to determine whether a “short-cycle” feature for RCWs is a performance-related feature that justifies the establishment of separate product classes. DOE considers a short-cycle feature for top-loading RCWs to be a cycle that can completely wash a full load of normally soiled cotton clothing in less than 30 minutes, and for front-loading RCWs to be a cycle that can completely wash a full load of normally soiled cotton clothing in less than 45 minutes.
                    <SU>22</SU>
                    <FTREF/>
                     DOE first reiterates its prior determinations that cycle time is a performance-related feature of RCWs and details its specific consideration of the short-cycle feature (
                    <E T="03">see</E>
                     section II.B.1 of this document). As discussed in section II.B.2 of this document, DOE determines in this analysis that the short-cycle feature does not justify a different standard. Data and information from the Short-Cycle Final Rules, the RCW direct final rule published on March 15, 2024 (“March 2024 RCW Direct Final Rule”; 89 FR 19026), and the March 2024 RFI show that RCWs currently available with a short normal cycle (
                    <E T="03">i.e.,</E>
                     with a cycle time less than 30 minutes for top-loading RCWs and less than 45 minutes for front-loading RCWs) can meet the current energy conservation standards using the same design strategies as other RCWs of comparable efficiency without a short-cycle feature.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         This consideration corresponds to DOE's definition of “normal cycle” in section 1 of the DOE test procedure at 10 CFR 430, subpart B, appendix J2 (“appendix J2”), which is defined as “the cycle recommended by the manufacturer [. . .] for normal, regular, or typical use for washing up to a full load of normally soiled cotton clothing,” among other criteria.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">1. Cycle Time as a Performance-Related Feature</HD>
                <P>
                    DOE first considered whether cycle time is a performance-related feature of RCWs in accordance with 42 U.S.C. 6295(q)(1)(B). Consistent with DOE's 
                    <PRTPAGE P="105418"/>
                    assessment in the November 2024 Proposed Withdrawal and in previous rulemakings, discussed as follows, DOE reiterates that cycle time is a performance-related feature of RCWs.
                </P>
                <P>DOE has previously considered cycle time as a consumer utility for the purposes of establishing product classes for RCWs. In a direct final rule published on May 31, 2012, (“May 2012 Direct Final Rule”) DOE determined that the longer cycle times of front-loading RCWs versus cycle times for top-loading RCWs are likely to impact consumer utility. 77 FR 32308, 32319. Because the wash cycle times for front-loaders arise from the reduced mechanical action of agitation as compared to top-loaders, DOE stated that it believes that such longer cycles may be required to achieve the necessary cleaning, and thereby constitute a performance-related utility of front-loading versus top-loading RCWs pursuant to the meaning of 42 U.S.C. 6295(q). 77 FR 32308, 32319.</P>
                <P>In a NOPR published on August 13, 2020 (“August 2020 NOPR”), DOE discussed that consumer use of RCWs is similar to that of dishwashers, in that the products provide consumer utility over discrete cycles with programmed cycle times, and consumers run these cycles multiple times per week on average. As such, the impact of cycle time on consumer utility identified by CEI in its March 2018 Petition regarding dishwashers is also relevant to RCWs. Based on these considerations, DOE concluded that cycle time for RCWs is a performance-related feature for the purposes of 42 U.S.C. 6295(q). 85 FR 49297, 49299.</P>
                <P>
                    DOE reiterated this conclusion in the December 2020 Final Rule. Specifically, DOE concluded in the December 2020 Final Rule that RCWs with a short normal cycle (
                    <E T="03">i.e.,</E>
                     with a cycle time less than 30 minutes for top-loading RCWs and less than 45 minutes for front-loading RCWs) provide a distinct utility to consumers that other RCWs do not provide, and that consumers receive a utility from the short normal cycle feature to support the establishment of new product classes under 42 U.S.C. 6295(q)(1)(B). 85 FR 81359, 81363-81364. The “normal cycle” refers to the cycle recommended to the consumer for normal, regular, or typical use for washing up to a full load of normally soiled cotton clothing. In the January 2022 Final Rule, DOE did not question the validity of those prior determinations made that short cycles provide a performance-related feature. 87 FR 2673, 2682.
                </P>
                <P>
                    In response to the November 2024 Proposed Withdrawal, the CA IOUs stated that they continue to disagree with DOE's determination that cycle time is a performance-related feature. (CA IOUs, No. 22 at p. 2) The CA IOUs further asserted that DOE or CEI did not include sufficient justification in the October 2020 Final Rule for why a 30-minute or 45-minute cycle time threshold offered a unique consumer utility. The CA IOUs stated that DOE should assess the merits of the selected cycle time threshold and the consumer utility that it may or may not provide. (
                    <E T="03">Id.</E>
                     at pp. 2-3)
                </P>
                <P>
                    AHAM commented that it continues to believe that cycle time is an important consumer feature. (AHAM, No. 23 at p. 2) AHAM also commented that consumers are satisfied with existing normal cycle times and most products also have short-cycle options for when quicker cycles are needed. (
                    <E T="03">Id.</E>
                     at p. 1)
                </P>
                <P>Ravnitzky commented that in his experience, he occasionally uses the shorter cycles on his RCW when the clothing is not heavily soiled or when the task needs to be completed quickly. Ravnitzky further commented that these occasions are relatively infrequent and that for the majority of the time, he relies on the standard cycles to ensure thorough cleaning and drying. (Ravnitzky, No. 15 at p. 1)</P>
                <P>
                    In response to the comment from the CA IOUs, DOE notes that the specific short-cycle times considered, less than 30 minutes for top-loading RCWs and less than 45 minutes for front-loading RCWs, are less than the average cycle time for these products.
                    <SU>23</SU>
                    <FTREF/>
                     As such, DOE believes these short-cycle times can provide utility to some consumers, 
                    <E T="03">e.g.,</E>
                     consumers needing to complete multiple cycles in a limited amount of time. For the reasons stated in the May 2012 Direct Final Rule, August 2020 NOPR, and December 2020 Final Rule, and consistent with the November 2024 Proposed Withdrawal, DOE reconfirms in this confirmation of withdrawal that cycle time is a performance-related feature of RCWs for the purposes of 42 U.S.C. 6295(q).
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         The average cycle times among units within DOE's top-loading and front-loading RCW test samples were 49 and 59 minutes, respectively. 
                        <E T="03">See</E>
                         Method 2: Weighted Average Cycle Time column in Table II.1 and Table II.2 of the August 2020 NOPR. 85 FR 49297, 49301-49302.
                    </P>
                </FTNT>
                <P>In the sections that follow, DOE evaluates whether such a short-cycle feature justifies separate product classes in accordance with 42 U.S.C. 6295(q).</P>
                <HD SOURCE="HD3">2. Justification of Different Standards for Residential Clothes Washers With a Short-Cycle Feature</HD>
                <P>
                    As discussed, EPCA authorizes DOE to prescribe a higher or lower standard than that which applies (or would apply) for such type (or class) for any group of covered products which have the same function or intended use if DOE determines that products within such group (A) consume a different kind of energy from that consumed by other covered products within such type (or class); or (B) have a capacity or other performance-related feature which other products within such type (or class) do not have and such feature justifies a higher or lower standard. (42 U.S.C. 6295(q)(1)) In determining whether a performance-related feature justifies a different standard for a group of products, DOE considers such factors as the utility to the consumer of such a feature and other factors DOE deems appropriate. (
                    <E T="03">Id.</E>
                    )
                </P>
                <P>
                    DOE stated in the August 2020 NOPR, and reiterated in the December 2020 Final Rule, that it presumed manufacturers were implementing the shortest possible cycle times that enabled a clothes washer to achieve satisfactory cleaning performance (and other aspects of clothes washer performance) while meeting the applicable energy and water conservation standards. 85 FR 81359, 81361. DOE stated its belief that the current energy conservation standards may have been precluding or discouraging manufacturers from introducing models to the market with substantially shorter cycle times. 
                    <E T="03">Id.</E>
                     DOE further stated in the December 2020 Final Rule that its actions (
                    <E T="03">i.e.,</E>
                     establishing short-cycle product classes for top-loading and front-loading RCWs) were intended to incentivize manufacturers to provide consumers with new options when purchasing RCWs, asserting that creation of these new product classes would incentivize manufacturers to develop innovative products with short cycle times for those consumers that receive a value from the time saved washing and drying their clothing. 
                    <E T="03">Id.</E>
                     at 85 FR 81360-81361. DOE further stated its intent to determine the specific energy and water consumption limits for the new product classes in a separate rulemaking. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE conducted an analysis of the energy and water use of a short-cycle feature for RCWs to evaluate whether different (
                    <E T="03">i.e.,</E>
                     comparatively less stringent) standards would be warranted for RCWs that provide a short-cycle feature. 89 FR 88661, 88670. 
                    <PRTPAGE P="105419"/>
                    As discussed in the previous section of this document, DOE has determined that a normal cycle of less than 30 minutes for top-loading RCWs and less than 45 minutes for front-loading RCWs is a performance-related feature that provides consumer utility for the purpose of consideration of potential product class distinction under the provisions of 42 U.S.C. 6295(q). In the November 2024 Proposed Withdrawal, DOE next evaluated whether RCWs with a short-cycle feature necessitate more energy and water use than RCWs without such feature, which could justify a comparatively less stringent standard for RCWs that provide such a feature. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    To evaluate the energy and water use of a short-cycle feature in comparison to the currently applicable energy and water standards, in the November 2024 Proposed Withdrawal, DOE considered all data available from recent rulemakings, including DOE's data from testing conducted in support of the December 2020 Final Rule and the March 2024 RCW Direct Final Rule and confidential data received from AHAM.
                    <SU>24</SU>
                    <FTREF/>
                      
                    <E T="03">Id.</E>
                     All RCW test data evaluated in this manner was based on testing of the normal cycle as defined in section 1 of appendix J2, corresponding to the cycle recommended by the manufacturer for normal, regular, or typical use for washing up to a full load of normally soiled cotton clothing.
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         DOE test data from the December 2020 Final Rule are available at 
                        <E T="03">www.regulations.gov/document/EERE-2020-BT-STD-0001-0007</E>
                        . Information on the March 2024 RCW Direct Final Rule models is available in the technical support document for the March 2024 RCW Direct Final Rule, which is available at 
                        <E T="03">www.regulations.gov/document/EERE-2017-BT-STD-0014-0510</E>
                        .
                    </P>
                </FTNT>
                <P>
                    From among DOE's test samples, DOE identified 3 top-loading RCWs and 9 front-loading RCWs that provide a short-cycle feature. Specifically, these units have a normal cycle time of less than 30 minutes for the top-loading RCWs and less than 45 minutes for the front-loading RCWs.
                    <SU>25</SU>
                    <FTREF/>
                      
                    <E T="03">Id.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         DOE's cycle time data for RCWs is available in the Technical Appendix to this document, available in the docket for this rulemaking at 
                        <E T="03">www.regulations.gov/docket/EERE-2024-BT-STD-0002</E>
                        .
                    </P>
                </FTNT>
                <P>
                    From AHAM's test sample, DOE identified 1 top-loading standard-size RCW with a normal cycle time of less than 30 minutes and 4 front-loading RCWs with a normal cycle time of less than 45 minutes. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE then assessed the energy and water use of the short-cycle feature on these units in comparison to the currently applicable DOE standards. 
                    <E T="03">Id.</E>
                     For all of these units, the short-cycle feature uses no more energy and water than the maximum allowable standard levels for standard-size RCWs, demonstrating that providing a short-cycle feature consistent with consumer expectations of a normal cycle (
                    <E T="03">i.e.,</E>
                     a cycle that can completely wash a full load of normally soiled cotton clothing in less than 30 or 45 minutes for top-loading and front-loading RCWs respectively) does not necessitate using more energy and water than an RCW without such feature that meets the current standards. DOE further evaluated the technologies and design strategies used by these RCW models and tentatively concluded that these units do not incorporate any proprietary technologies or design strategies and are designed no differently than other RCW models of comparable efficiency without a short-cycle feature. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE tentatively concluded that the availability of this feature currently on the market—at energy and water levels that comply with the current standards—in units with no identifiable proprietary designs or control strategies demonstrates that an RCW with a short-cycle feature does not inherently use more energy and water than an RCW without such feature, and that the current RCW standards do not preclude manufacturers from offering a short-cycle feature (
                    <E T="03">i.e.,</E>
                     a normal cycle time of less than 30 minutes for top-loading RCWs and less than 45 minutes for front-loading RCWs). 
                    <E T="03">Id.</E>
                     On the basis that both top-loading and front-loading RCWs with short-cycle features are currently available on the market with no identifiable proprietary designs or control strategies, DOE tentatively determined that a short-cycle feature is technologically feasible and that current standards do not prevent manufacturers from providing a short-cycle feature. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, based on the available test data—which demonstrate that it is feasible to design a short-cycle feature while meeting current standards—DOE tentatively determined that (1) a short-cycle feature for normal, regular, or typical use for washing up to a full load of normally soiled cotton clothing is technologically feasible; (2) current standards do not prevent RCW manufacturers from providing such a short-cycle feature; and (3) multiple RCW models are currently available on the market that provide such a short-cycle feature that meet the currently applicable energy and water standards. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE requested comment on these proposed determinations. 
                    <E T="03">Id.</E>
                </P>
                <P>The CA IOUs commented that DOE had demonstrated that the applicable standards for RCWs do not preclude manufacturers from developing products that meet the intention of the short-cycle product classes and agreed that the technological feasibility of developing such products is the appropriate factor when determining if a performance characteristic merits a different standard level. (CA IOUs, No. 22 at p. 2)</P>
                <P>
                    ASAP 
                    <E T="03">et al.</E>
                     commented in support of DOE's proposal to confirm the withdrawal of the short-cycle product classes for RCWs on the basis that there is at least one model available on the market that provides the short-cycle feature and uses less energy and water than the current standard. ASAP 
                    <E T="03">et al.</E>
                     stated that the availability of such a model demonstrates that the current standards for these products are not precluding manufacturers from offering products with short cycle times and good product performance on a normal cycle. (ASAP 
                    <E T="03">et al.,</E>
                     No. 21 at pp. 1-2)
                </P>
                <P>CEC agreed with DOE that standards do not impact the ability of manufacturers to provide RCWs with the short-cycle feature, as evidenced by existing product offerings. CEC further asserted that manufacturer comments on the rulemaking make it clear that short-cycle product classes are neither necessary nor warranted for RCWs, and accordingly, separate product classes are not justified. (CEC, No. 17 at p. 1)</P>
                <P>NEEA supported DOE's proposal in the November 2024 Proposed Withdrawal to eliminate “short-cycle” product classes for RCWs. NEEA stated that its comments build upon past NEEA letters submitted to DOE, which demonstrated that short-cycle product classes were unnecessary for these products because (1) consumers already have access to short cycle settings on RCWs; (2) consumers use short cycles relatively infrequently; (3) consumers are satisfied with high-efficiency appliances; (4) consumers are satisfied with appliances that have fast cycle options; and (5) cost-effective technologies are available to improve the efficiency of RCWs while reducing cycle times. NEEA added that leveraged sales data from the Northwest, consumer use data from regional field studies (“RBSA”), surveys of online retail catalogs, technology research, and laboratory tear-down studies support these conclusions. (NEEA, No. 4 at p. 2)</P>
                <P>
                    AHAM asserted that for its members, the consumer is always top of mind, and accordingly, manufacturers make appliances that last longer, perform better, and respond to consumer needs and preferences. AHAM stated that 
                    <PRTPAGE P="105420"/>
                    manufacturers pay careful attention to consumer needs and desires for particular features and utilities, and products currently on the market have a demonstrated capability to achieve the recommended energy and water conservation standards and retain consumer satisfaction with a range of performance considerations, utilities, and features. (AHAM, No. 23 at pp. 1-2)
                </P>
                <P>Ravnitzky supported DOE's tentative determination that a short-cycle feature for RCWs does not justify a separate product class with separate standards under 42 U.S.C. 6295(q) and to not impose separate requirements for short-cycle products. (Ravnitzky, No. 15 at p. 1)</P>
                <P>CEI commented that although its comment focuses on dishwashers (see section II.A of this document), it believes there are equally valid reasons for setting separate new standards protecting faster RCWs. (CEI, No. 18 at p. 3)</P>
                <P>In response to the comment from CEI, DOE notes that all of the data and information that CEI submitted pertained to dishwashers, and that CEI did not provide any data or information specific to RCWs that would support its assertion regarding new standards for RCWs.</P>
                <P>In conclusion, for the reasons discussed in the November 2024 Proposed Withdrawal and in this document, DOE has determined that a short-cycle feature for RCWs does not justify separate product classes with separate standards under 42 U.S.C. 6295(q).</P>
                <HD SOURCE="HD2">C. Consumer Clothes Dryers</HD>
                <P>
                    The following sections apply DOE's authority under EPCA at 42 U.S.C. 6295(q) to determine whether a “short-cycle” feature for consumer clothes dryers is a performance-related feature that justifies the establishment of a separate product class. DOE considers a short-cycle feature for consumer clothes dryers to be a normal cycle that offers cycle times of less than 30 minutes. DOE first reiterates its prior determinations that cycle time is a performance-related feature of consumer clothes dryers and details its specific consideration of the short-cycle feature (
                    <E T="03">see</E>
                     section II.C.1 of this document). As discussed in section II.C.2 of this document, DOE determines in this analysis that the short-cycle feature does not justify a different standard. Data and information from the Short-Cycle Final Rules, the consumer clothes dryers direct final rule published on March 12, 2024 (“March 2024 Dryers Direct Final Rule”; 89 FR 18164), and the March 2024 RFI show that products with a normal cycle of less than 30 minutes can meet the current energy conservation standards using the same design strategies as other consumer clothes dryers of comparable efficiency without a short-cycle feature.
                </P>
                <HD SOURCE="HD3">1. Cycle Time as a Performance-Related Feature</HD>
                <P>DOE first considered whether cycle time is a performance-related feature of consumer clothes dryers in accordance with 42 U.S.C. 6295(q)(1)(B). Consistent with DOE's assessment in the November 2024 Proposed Withdrawal and in previous rulemakings, discussed as follows, DOE reiterates that cycle time is a performance-related feature of consumer clothes dryers.</P>
                <P>In the August 2020 NOPR, DOE discussed that consumer use of consumer clothes dryers is similar to that of dishwashers, in that the products provide consumer utility over discrete cycles with programmed cycle times, and consumers run these cycles multiple times per week on average. As such, the impact of cycle time on consumer utility identified by CEI in its March 2018 Petition regarding dishwashers is also relevant to consumer clothes dryers. Based on these considerations, DOE concluded that cycle time for consumer clothes dryers is a performance-related feature for the purposes of 42 U.S.C. 6295(q). 85 FR 49297, 49299.</P>
                <P>
                    DOE reiterated this conclusion in the December 2020 Final Rule. 85 FR 81359, 81363-81364. Specifically, DOE concluded in the December 2020 Final Rule that consumer clothes dryers with a short normal cycle (
                    <E T="03">i.e.,</E>
                     with a cycle time of less than 30 minutes) provide a distinct utility to consumers that other consumer clothes dryers do not provide, and that consumers receive a utility from the short normal cycle feature to support the establishment of a new product class under 42 U.S.C. 6295(q)(1)(B). 
                    <E T="03">Id.</E>
                     at 85 FR 81363, 81364. The “normal cycle” refers to the cycle recommended by the manufacturer to the consumer for drying cotton or linen clothes, among other criteria. In the January 2022 Final Rule, DOE did not question the validity of those prior determinations made about whether that short cycles provide a performance-related feature. 87 FR 2673, 2682.
                </P>
                <P>
                    In response to the November 2024 Proposed Withdrawal, the CA IOUs stated that they continue to disagree with DOE's determination that cycle time is a performance-related feature. (CA IOUs, No. 22 at p. 2) The CA IOUs commented that the March 2018 Petition from CEI, the Short-Cycle Final Rules, and the November 2024 Proposed Withdrawal did not include sufficient justification from DOE or CEI for why these specific short-cycle times offered a unique consumer utility. (
                    <E T="03">Id.</E>
                    ) The CA IOUs requested that DOE assess the merits of the selected cycle time delineations and the consumer utility they may or may not provide in future rulemakings. (
                    <E T="03">Id.</E>
                    )
                </P>
                <P>
                    AHAM commented that it continues to believe that cycle time is an important consumer feature. (AHAM, No. 23 at p. 2) AHAM also commented that consumers are satisfied with existing normal cycle times and most products also have short-cycle options for when quicker cycles are needed. (
                    <E T="03">Id.</E>
                     at p. 1)
                </P>
                <P>
                    In response to the comment from the CA IOUs, DOE notes that the specific short-cycle time considered, less than 30 minutes for consumer clothes dryers, is less than the average cycle time for this product.
                    <SU>26</SU>
                    <FTREF/>
                     As such, DOE believes this short-cycle can provide utility to some consumers, 
                    <E T="03">e.g.,</E>
                     consumers needing to complete multiple cycles in a limited amount of time. For the reasons stated in the August 2020 NOPR and December 2020 Final Rule, and consistent with the November 2024 Proposed Withdrawal, DOE reconfirms in this confirmation of withdrawal its previous determinations that cycle time is a performance-related feature of consumer clothes dryers for the purposes of 42 U.S.C. 6295(q).
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         The average cycle times among units within DOE's vented electric standard-size and vented gas clothes dryer test samples were 48 and 55 minutes, respectively. 
                        <E T="03">See</E>
                         Table II.3 and Table II.4 of the August 2020 NOPR. 85 FR 49297, 49303-49304.
                    </P>
                </FTNT>
                <P>In the sections that follow, DOE evaluates whether such a short-cycle feature justifies separate product classes in accordance with 42 U.S.C. 6295(q).</P>
                <HD SOURCE="HD3">2. Justification of Different Standards for Consumer Clothes Dryers With a Short-Cycle Feature</HD>
                <P>
                    As discussed, EPCA authorizes DOE to prescribe a higher or lower standard than that which applies (or would apply) for such type (or class) for any group of covered products which have the same function or intended use if DOE determines that products within such group (A) consume a different kind of energy from that consumed by other covered products within such type (or class); or (B) have a capacity or other performance-related feature which other products within such type (or class) do not have and such feature justifies a higher or lower standard. (42 U.S.C. 6295(q)(1)) In determining whether a performance-related feature justifies a different standard for a group of 
                    <PRTPAGE P="105421"/>
                    products, DOE considers such factors as the utility to the consumer of such a feature and other factors DOE deems appropriate. (
                    <E T="03">Id.</E>
                    )
                </P>
                <P>
                    DOE stated in the August 2020 NOPR, and reiterated in the December 2020 Final Rule, that vented electric standard-size and vented gas clothes dryers that comply with the current energy conservation standards exhibit cycle times of approximately 30 minutes or longer. 85 FR 81359, 81361. Based on a presumption that manufacturers were already implementing the shortest possible cycle times that enabled a clothes dryer to achieve satisfactory drying performance (and other aspects of clothes dryer performance) while meeting the applicable energy conservation standards, DOE asserted that the standards may have discouraged manufacturers from developing clothes dryers for consumers that provide the utility of 30-minute-or-less cycle times. 
                    <E T="03">Id.</E>
                     DOE further stated in the December 2020 Final Rule that its actions (
                    <E T="03">i.e.,</E>
                     establishing short-cycle product classes for consumer clothes dryers) were intended to incentivize manufacturers to provide consumers with new options when purchasing clothes dryers, asserting that creation of this new product class would incentivize manufacturers to develop innovative products with short cycle times for those consumers that receive a value from the time saved washing and drying their clothing. 
                    <E T="03">Id.</E>
                     at 85 FR 81360-81361. DOE further stated its intent to determine the specific energy conservation standards of the new product classes in a separate rulemaking. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE conducted an analysis of the energy use of a short-cycle feature for consumer clothes dryers to evaluate whether different (
                    <E T="03">i.e.,</E>
                     comparatively less stringent) standards would be warranted for consumer clothes dryers that provide a short-cycle feature. 89 FR 88661, 88672. As discussed in the previous section of this document, DOE has determined that a short-cycle feature on a consumer clothes dryer is a performance-related feature that provides consumer utility for the purpose of consideration of potential product class distinction under the provisions of 42 U.S.C. 6295(q). In the November 2024 Proposed Withdrawal, DOE next evaluated whether consumer clothes dryers with a short-cycle feature necessitate more energy use than consumer clothes dryers without such feature, which could justify a comparatively less stringent standard for consumer clothes dryers that provide such a feature. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    To evaluate the energy use of a short-cycle feature in comparison to the currently applicable energy standards, in the November 2024 Proposed Withdrawal, DOE considered all data available from recent rulemakings, including DOE's data from testing conducted in support of the December 2020 Final Rule, the March 2024 Dryers Direct Final Rule, and confidential data from AHAM. 
                    <E T="03">Id.</E>
                     at 89 FR 88673. All consumer clothes dryer test data evaluated in this manner was based on testing of the Normal cycle as defined in section 3.3.2 of 10 CFR part 430, subpart B, appendix D2 (“appendix D2”), corresponding to the program labeled “normal” or, for clothes dryers that do not have a “normal” program, the cycle recommended by the manufacturer for drying cotton or linen clothes.
                    <SU>27</SU>
                    <FTREF/>
                     In addition, all test data represent cycles that achieve a final moisture content of 2 percent or less, which DOE has determined to be representative of the consumer-acceptable dryness level after completion of a drying cycle.
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         DOE notes that manufacturers will be required to use the test procedure at appendix D2 on and after March 1, 2028, which is the compliance date of the amended standards in March 2024 Dryers Direct Final Rule. 
                        <E T="03">See</E>
                         86 FR 56608; 89 FR 18164.
                    </P>
                </FTNT>
                <P>
                    None of the units in DOE's test sample had a normal cycle time less than 30 minutes. However, from the confidential data received from AHAM, DOE identified 3 electric standard-size clothes dryers and 1 vented gas standard-size clothes dryer with normal cycle times of less than 30 minutes. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE then assessed the energy use of the short-cycle feature on these units in comparison to the current applicable DOE standards. 
                    <E T="03">Id.</E>
                     For all of these units, the short-cycle feature uses no more energy than the maximum allowable standard levels for standard-size consumer clothes dryers, demonstrating that providing a short-cycle feature consistent with consumer expectations of a normal cycle (
                    <E T="03">i.e.,</E>
                     cycle recommended by the manufacturer to the consumer for drying cotton or linen clothes in less than 30 minutes) does not necessitate using more energy than a consumer clothes dryer without such feature that meets the current standards. In the engineering analysis conducted for the March 2024 Dryers Direct Final Rule, DOE did not identify any proprietary technologies in use among clothes dryers currently on the market. 89 FR 18164, 18178-18179. Therefore, although AHAM's data set did not identify specific model numbers associated with each data point, DOE noted in the November 2024 Proposed Withdrawal that it has no reason to believe that any proprietary technologies or design strategies are being used in those clothes dryer models with cycle times of less than 30 minutes. 89 FR 88661, 88673.
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE tentatively concluded that the availability of a short-cycle feature currently on the market—at energy efficiency levels that comply with the current standards—in units with no identifiable proprietary designs or control strategies demonstrates that a consumer clothes dryer with a short-cycle feature does not inherently use more energy than a consumer clothes dryer without such a feature, and that the current consumer clothes dryer standards do not preclude manufacturers from offering a short-cycle feature (
                    <E T="03">i.e.,</E>
                     a normal cycle time of less than 30 minutes). 
                    <E T="03">Id.</E>
                     On the basis that both vented electric standard-size and vented gas clothes dryers with short-cycle features (
                    <E T="03">i.e.,</E>
                     normal cycles less than 30 minutes) are currently available on the market with no identifiable proprietary designs or control strategies, DOE tentatively determined that a short-cycle feature is technologically feasible and that current standards do not prevent manufacturers from providing a short-cycle feature. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE noted that it was not proposing to add any new regulations for consumer clothes dryers. 
                    <E T="03">Id.</E>
                     Instead, the November 2024 Proposed Withdrawal reanalyzed the provisions of a previous rulemaking (
                    <E T="03">i.e.,</E>
                     the January 2022 Final Rule) that withdrew short-cycle product classes. 
                    <E T="03">Id.</E>
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, based on the available test data—which demonstrate that it is feasible to design a short-cycle feature while meeting current standards—DOE tentatively determined that (1) a short-cycle feature as the normal cycle for drying cotton or linen clothes is technologically feasible; (2) current standards do not prevent consumer clothes dryer manufacturers from providing such a short-cycle feature; and (3) multiple consumer clothes dryer models are currently available on the market that provide such a short-cycle feature that meet the currently applicable energy and water standards. 
                    <E T="03">Id.</E>
                     at 89 FR 88673-88674.
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE requested comment on these proposed determinations. 
                    <E T="03">Id.</E>
                     at 89 FR 88674.
                </P>
                <P>
                    The CA IOUs commented that DOE had demonstrated that the applicable standards for consumer clothes dryers do not preclude manufacturers from developing products that meet the 
                    <PRTPAGE P="105422"/>
                    intention of the short-cycle product classes and agreed that the technological feasibility of developing such products is the appropriate factor when determining if a performance characteristic merits a different standard level. (CA IOUs, No. 22 at p. 2)
                </P>
                <P>
                    ASAP 
                    <E T="03">et al.</E>
                     commented in support of DOE's proposal to confirm the withdrawal of the short-cycle product classes for consumer clothes dryers on the basis that there is at least one model available on the market that provides the short-cycle feature and uses less energy than the current standard. ASAP 
                    <E T="03">et al.</E>
                     noted that DOE considered a model to have the short-cycle feature only if it meets the consumer expectation of a normal cycle in 30 minutes or less. ASAP 
                    <E T="03">et al.</E>
                     stated that the availability of such a model demonstrates that the current standards for these products are not precluding manufacturers from offering products with short cycle times and good product performance on a normal cycle. (ASAP 
                    <E T="03">et al.,</E>
                     No. 21 at pp. 1-2)
                </P>
                <P>CEC agreed with DOE that standards do not impact the ability of manufacturers to provide consumer clothes dryers with the short-cycle feature, as evidenced by existing product offerings. CEC further asserted that manufacturer comments on the rulemaking make it clear that short-cycle product classes are neither necessary nor warranted for consumer clothes dryers, and accordingly, separate product classes are not justified. (CEC, No. 17 at p. 1)</P>
                <P>NEEA supported DOE's proposal in the November 2024 Proposed Withdrawal to eliminate “short-cycle” product classes for consumer clothes dryers. NEEA stated that its comments build upon past NEEA letters submitted to DOE, which demonstrated that short-cycle product classes were unnecessary for these products because (1) consumers already have access to short cycle settings on consumer clothes dryers; (2) consumers use short cycles relatively infrequently; (3) consumers are satisfied with high-efficiency appliances; (4) consumers are satisfied with appliances that have fast cycle options; and (5) cost-effective technologies are available to improve the efficiency of consumer clothes dryers while reducing cycle times. NEEA added that leveraged sales data from the Northwest, consumer use data from regional field studies (“RBSA”), surveys of online retail catalogs, technology research, and laboratory tear-down studies support these conclusions. (NEEA, No. 4 at p. 2)</P>
                <P>AHAM asserted that for its members, the consumer is always top of mind, and accordingly, manufacturers make appliances that last longer, perform better, and respond to consumer needs and preferences. AHAM stated that manufacturers pay careful attention to consumer needs and desires for particular features and utilities and products currently on the market have a demonstrated capability to achieve the recommended energy and water conservation standards and retain consumer satisfaction with a range of performance considerations, utilities, and features. (AHAM, No. 23 at pp. 1-2)</P>
                <P>Ravnitzky supported DOE's tentative determination that a short-cycle feature for consumer clothes dryers does not justify a separate product class with separate standards under 42 U.S.C. 6295(q) and to not impose separate requirements for short-cycle features. (Ravnitzky, No. 15 at p. 1)</P>
                <P>CEI commented that although its comment focuses on dishwashers (see section II.A of this document), it believes there are equally valid reasons for setting separate new standards protecting faster consumer clothes dryers. (CEI, No. 18 at p. 3)</P>
                <P>In response to the comment from CEI, DOE notes that all of the data and information that CEI submitted pertained to dishwashers, and that CEI did not provide any data or information specific to consumer clothes dryers that would support its assertion regarding new standards for consumer clothes dryers.</P>
                <P>In conclusion, for the reasons discussed in the November 2024 Proposed Withdrawal and in this document, DOE has determined that a short-cycle feature for consumer clothes dryers does not justify separate product classes with separate standards under 42 U.S.C. 6295(q).</P>
                <HD SOURCE="HD2">D. Other Topics Addressed by the Fifth Circuit</HD>
                <HD SOURCE="HD3">1. Water Authority</HD>
                <P>
                    In its opinion, the Fifth Circuit stated that “[n]o part of [EPCA] indicates Congress gave DOE power to regulate water use for energy-using appliances (like dishwashers and [RCWs]),” and stated that it is unclear that DOE has any statutory authority to regulate water use in dishwashers and RCWs. 
                    <E T="03">See Louisiana,</E>
                     90 F.4th at 470-471.
                </P>
                <P>
                    In response, DOE notes, as did the Fifth Circuit, that EPCA prescribed initial energy conservation standards with both energy and water use requirements for RCWs and dishwashers. (42 U.S.C. 6295(g)(9)(A) and (10)(A)). In establishing energy conservation standards with both energy and water use performance standards for RCWs and dishwashers, Congress also directed DOE to “determin[e] whether to amend” those standards. (42 U.S.C. 6295(g)(9)(B) and (10)(B)) Congress's directive, in section 6295(g)(9)(B), to consider whether “to amend the standards in effect for RCWs,” and in section 6295(g)(10)(B), to consider whether “to amend the standards for dishwashers,” refers to “the standards” established in the immediately preceding paragraphs, where Congress established energy conservation standards with 
                    <E T="03">both</E>
                     energy and water use performance standards for RCWs and dishwashers. Indeed, the energy and water use performance standards for RCWs (both top-loading and front-loading) are each contained within a single subparagraph, as are the energy and water use performance standards for dishwashers (both standard-size and compact-size). (
                    <E T="03">See id.</E>
                    ) Accordingly, DOE's authority, under 42 U.S.C. 6295(g)(9)(B) and (10)(B), includes consideration of amended energy and water use performance standards for RCWs and dishwashers, respectively.
                </P>
                <P>Similarly, DOE's authority under 42 U.S.C. 6295(m) to amend “standards” for covered products includes amending both the energy and water use performance standards for RCWs and dishwashers. Neither section 6295(g)(9)(B) or (10)(B) nor section 6295(m) limit their application to “energy use standards.” Rather, they direct DOE to consider amending “the standards,” 42 U.S.C. 6295(g)(9)(B) and (10)(B), or simply “standards,” 42 U.S.C. 6295(m)(1)(B), which may include both energy and water use performance standards.</P>
                <P>Accordingly, DOE noted in the November 2024 Proposed Withdrawal that it had considered (where appropriate) whether the relevant short-cycle features justify both different water and energy standards. 89 FR 88661, 88676.</P>
                <P>
                    In response to the November 2024 Proposed Withdrawal, AWE commented supporting DOE's continued attention to dishwasher and RCW water use. AWE asserted that the existing water consumption standards for dishwashers and RCWs are well within DOE's authority, notwithstanding the Fifth Circuit's dictum. (AWE, No. 20 at p. 4) AWE asserted that the Fifth Circuit's suggestion that DOE has authority to regulate water use only for showerheads, faucets, water closets, and urinals is incorrect. (
                    <E T="03">Id.</E>
                     at pp. 1-2)
                </P>
                <P>
                    AWE stated that although the Fifth Circuit's January 8, 2024, decision included dictum suggesting DOE has 
                    <PRTPAGE P="105423"/>
                    authority over water use only for showerheads, faucets, water closets, and urinals, the Fifth Circuit did not have the benefit of argument and full information about the basis for DOE's water regulation, as the hypothesis about DOE's authority was not raised by parties in the litigation. (AWE, No. 20 at p. 1)
                </P>
                <P>
                    AWE stated that, in the April 2024 Dishwashers Direct Final Rule and March 2024 RCW Direct Final Rule, DOE correctly explained that 42 U.S.C. 6295(g)(9) and (10) expressly authorize DOE to amend the water consumption standards initially established by those paragraphs. AWE asserted that the Fifth Circuit briefly mentioned these same provisions but ignored the actual text when it said that their “plain text” give DOE “only [the] power to amend energy-use standards for dishwashers and [RCWs].” (
                    <E T="03">Id.</E>
                    )
                </P>
                <P>
                    AWE asserted that, under 42 U.S.C. 6291(6), DOE is authorized to impose requirements that do not, themselves, specify energy efficiency requirements or energy use—namely, “design requirements” for certain types of products (including dishwashers and RCW) and “any other requirements.” According to AWE, similar to the qualitative design requirement on certain boilers having constant-burning pilots and quantitative design requirement that a showerhead's flow-restricting insert resist a pulling force of 8.0 pounds, a limitation on the per-cycle water consumption of a dishwasher or RCW is qualified as a design requirement because these products' water consumption is important for regulating their energy consumption. AWE asserted that reducing the per-cycle water consumption of dishwashers and RCWs is a requirement that reduces energy consumption, not just water itself, and accordingly, DOE is justified to impose a limit on water consumption as a design requirement. AWE also stated that potable water in a residential pipe embeds the energy needed for water supply, treatment, and distribution of water; and wastewater from the appliance also requires energy for treatment. (
                    <E T="03">Id.</E>
                     at p. 2)
                </P>
                <P>
                    AWE stated that DOE has authority to establish both performance standards and design requirements for a given requirement given the word “or” in the definition of “energy conservation standards at 42 U.S.C. 6291(6). According to AWE, although the Fifth Circuit has declined to read “or” as establishing mutually exclusive alternatives, this would mean only that a given standard is not categorized as either a performance standard or a design standard but not as both, and would not restrict DOE to imposing only one requirement or force DOE to choose one or the other. AWE noted that Congress added “design requirements” to the definition of “energy conservation standards” in the same statute that added dishwashers, RCWs, and consumer clothes dryers as covered products, which then specified design requirements for each of these products (
                    <E T="03">e.g.,</E>
                     dishwashers must provide an option to dry without heat) and required DOE to determine whether those standards should be amended. According to AWE, it is highly unlikely that when Congress added “design requirement” to the definition of “energy conservation standard” while specifying updates to the standards for dishwashers, RCWs, and consumer clothes dryers, if it meant that DOE must choose, for dishwashers, either to retain a design requirement (
                    <E T="03">i.e.,</E>
                     no-heat drying option) or to have a minimum efficiency, and could not require both. (
                    <E T="03">Id.</E>
                     at pp. 2-3)
                </P>
                <P>
                    AWE additionally asserted that the 2007 amendments to EPCA in the Energy Independence and Security Act expressly authorized DOE to set maximum water consumption standards for dishwashers and RCWs, contrary to the Fifth Circuit's statement that these provisions allow DOE to set only energy conservation standards. AWE asserted that Congress established in the statute an energy and water-consumption standard for each product type, and then authorized DOE to amend those standards. AWE stated that Congress intentionally referred to standards more broadly, giving DOE the power to amend both of the standards stated in 42 U.S.C. 6295(g)(9) and (10), consistent with the structure of EPCA overall. (
                    <E T="03">Id.</E>
                     at p. 3)
                </P>
                <P>
                    AWE further asserted that DOE's general authority to revise standards for consumer products, which is specified in 42 U.S.C. 6295(m), also instructs DOE to consider, within six years after “establishing or amending a standard,” whether to amend the “standards” and not “energy conservation standard.” AWE also stated that 42 U.S.C. 6295(n) allows petitions for amendments to “standards” and not “energy conservation standards.” (
                    <E T="03">Id.</E>
                     at pp. 3-4)
                </P>
                <P>
                    AWE further stated that 42 U.S.C. 6295(q), which authorizes product classes, is different than the previously mentioned provisions of EPCA in that it does not allow DOE to create product classes for standards other than energy conservation standards, or to specify class-specific parameters other than energy use or efficiency. According to AWE, if the water-consumption standards for dishwashers and RCWs were authorized solely by 42 U.S.C. 6295(g)(9)-(10), and were not themselves energy conservation standards, DOE would not be allowed to set different water-consumption standards for the putative short-cycle classes. (
                    <E T="03">Id.</E>
                     at p. 4)
                </P>
                <P>DOE agrees that EPCA authorizes DOE to consider amended energy and water use standards for RCWs and dishwashers.</P>
                <P>In conclusion, in conducting the analyses in both the November 2024 Proposed Withdrawal and this confirmation of withdrawal, DOE has considered (where appropriate) whether the relevant short-cycle features justify both different water and energy standards.</P>
                <HD SOURCE="HD3">2. Test Procedure Authority</HD>
                <P>
                    The Fifth Circuit noted that DOE tests only some of the settings on dishwashers and “laundry machines” (
                    <E T="03">i.e.,</E>
                     RCWs and consumer clothes dryers) and stated that DOE concluded in the January 2022 Final Rule that “manufacturers are free to deploy 
                    <E T="03">other, non-tested</E>
                     settings that use as much energy and water as necessary to actually clean consumers' things,” indicating that this could create a loophole for manufacturers to deploy unregulated cycles. 
                    <E T="03">Louisiana,</E>
                     90 F.4th at 474.
                </P>
                <P>Under 42 U.S.C. 6293, EPCA sets forth the criteria and procedures DOE must follow when prescribing or amending test procedures for covered products. EPCA requires that any test procedures prescribed or amended under this section be reasonably designed to produce test results which measure energy efficiency, energy use or water use (in the case of showerheads, faucets, water closets and urinals), or estimated annual operating cost of a covered product during a representative average use cycle or period of use, as determined by the Secretary, and shall not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))</P>
                <P>
                    DOE has established test procedures for dishwashers, RCWs, and consumer clothes dryers in 10 CFR part 430, subpart B, appendices C1 and C2, J and J2, and D1 and D2, respectively. For each test procedure, DOE has determined through its rulemaking process, which included ample manufacturer input, that the tested cycle(s)—
                    <E T="03">i.e.,</E>
                     the normal cycle for dishwashers, RCWs, and consumer clothes dryers—produce representative measures of energy efficiency, energy use or water use, or estimated annual operating cost, as applicable for each product, without the undue burden that 
                    <PRTPAGE P="105424"/>
                    would be associated with requiring every available cycle to be tested.
                </P>
                <P>To ensure that the normal cycle produces measures of energy use, efficiency, and estimated annual operating cost specifically for a representative average use cycle or period of use, DOE has developed definitions and testing instructions in each test procedure to guide the appropriate selection of cycles to be tested, which corresponds to a representative average use cycle of how such appliance are used by consumers in their households.</P>
                <P>For dishwashers, the normal cycle is “[t]he cycle type, including washing and drying temperature options, recommended in the manufacturer's instructions for daily, regular, or typical use to completely wash a full load of normally soiled dishes including the power-dry feature. If no cycle or more than one cycle is recommended in the manufacturer's instructions for daily, regular, or typical use to completely wash a full load of normally soiled dishes, the most energy intensive of these cycles shall be considered the normal cycle. In the absence of a manufacturer recommendation on washing and drying temperature options, the highest energy consumption options must be selected.” Section 1 of appendices C1 and C2.</P>
                <P>
                    In the January 2023 TP Final Rule, DOE noted that it was maintaining the dishwasher test cycle selections and cycle options to test on the normal cycle. DOE additionally added a cleaning performance requirement to validate that the tested cycle was representative of an average use cycle. 88 FR 3234, 3243. Prior to publishing this final rule, in a NOPR published on December 22, 2021 (“December 2021 TP NOPR”), DOE summarized and addressed stakeholder comments regarding the representative test cycle for dishwashers. 86 FR 72738. Specifically, AHAM commented that consumers still most frequently select the normal cycle, and when consumers decide on a cycle selection, they typically use it for most of their cycles. Both GE Appliances and Whirlpool Corporation (“Whirlpool”) supported AHAM's comment that the normal cycle should remain the tested cycle. Both manufacturers submitted confidential data that supported the position that the manufacturer-designated normal cycle still represents consumer preference regarding cycle selection. These confidential data indicated, in the aggregate, that roughly 55 to 75 percent of all dishwasher cycles are conducted on the normal cycle. DOE further observed that among the other selected cycle types, some would be expected to be less energy-intensive than the normal cycle (
                    <E T="03">e.g.,</E>
                     a glassware cycle type), while others would be expected to be more energy-intensive than the normal cycle (
                    <E T="03">e.g.,</E>
                     a pots and pans cycle type). 
                    <E T="03">Id.</E>
                     at 86 FR 72757. The CA IOUs referenced PG&amp;E's 
                    <E T="03">2016 Home Energy Use Survey</E>
                     to support their claim that the tested normal cycle including any power-dry feature, in the current test procedure, is still the cycle most representative of how consumers operate dishwashers. In this survey, PG&amp;E found that 75 percent of households use the normal cycle. The CA IOUs further stated that consumers would be less likely to switch from using the normal cycle if DOE were to incorporate cleaning performance in the test procedure, and recommended DOE investigate incorporating a cleaning performance test. 
                    <E T="03">Id.</E>
                     at 86 FR 72747. In the December 2021 TP NOPR, DOE noted that absent data that reflects national use and frequency of use of other cycle types, DOE was not proposing changes to cycle selections for testing. 
                    <E T="03">Id.</E>
                     Further, according to the U.S. Energy Information Administration's (“EIA's”) 2020 
                    <E T="03">Residential Energy Consumption Survey</E>
                     (“RECS”),
                    <SU>28</SU>
                    <FTREF/>
                     over 80 percent of consumers use normal cycles most of the time.
                </P>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         U.S. Department of Energy-Energy Information Administration, Residential Energy Consumption Survey, 2015 Public Use Microdata Files, 2020. Washington, DC. Available at 
                        <E T="03">www.eia.gov/consumption/residential/data/2020/index.php?view=microdata.</E>
                    </P>
                </FTNT>
                <P>
                    In the December 2021 TP NOPR, DOE noted that it was proposing a minimum cleaning index threshold for a test cycle to be considered valid. That is, if the normal cycle does not meet a specified threshold at any soil-load, DOE proposed that the most energy-intensive cycle be tested and used for certification purposes at that soil load. DOE noted that this alternative approach would better represent an average use cycle by capturing those consumers that may select other cycles for washing dishes if the cleaning performance of the normal cycle does not meet their expectations, because higher energy use provides increased thermal and mechanical action for removing soils, thus correlating generally with improved cleaning performance. 
                    <E T="03">Id.</E>
                     DOE adopted these proposals in the January 2023 TP Final Rule. 88 FR 3234, 3243.
                </P>
                <P>In response to the November 2024 Proposed Withdrawal, the CA IOUs commented supporting the recently updated test procedure for dishwashers. The CA IOUs stated that the update to the dishwasher test procedure to include a cleaning index threshold ensures that consumers continue to receive high-performing efficient products. The CA IOUs asserted that improving the representativeness in the test procedure, ensures that consumers will not need to re-run a dishwasher due to unsatisfactory performance. (CA IOUs, No. 22 at p. 2)</P>
                <P>
                    ASAP 
                    <E T="03">et al.</E>
                     commented that the new test procedure for dishwashers at appendix C2 requiring a minimum cleaning index threshold for a test cycle to be considered valid will ensure that all new dishwashers provide good cleaning performance. (ASAP 
                    <E T="03">et al.,</E>
                     No. 21 at p. 4)
                </P>
                <P>Based on stakeholder comments, nationally representative survey data, and DOE's analyses, DOE reaffirms its previous conclusions that the normal cycle is the representative average use cycle for dishwashers.</P>
                <P>For RCWs, the normal cycle is “the cycle recommended by the manufacturer (considering manufacturer instructions, control panel labeling and other markings on the clothes washer) for normal, regular, or typical use for washing up to a full load of normally soiled cotton clothing. For machines where multiple cycle settings are recommended by the manufacturer for normal, regular, or typical use for washing up to a full load of normally soiled cotton clothing, then the Normal cycle is the cycle selection that results in the lowest [energy efficiency] value.” Section 1 of 10 CFR part 430, subpart B, appendix J (“appendix J”) and appendix J2.</P>
                <P>
                    For the final rule that established 10 CFR part 430, subpart B, appendix J1, which was a precursor to the current appendices J and J2, DOE reviewed Procter &amp; Gamble data indicating that the normal cycle on a typical RCW is used approximately 75 percent of the time, and DOE noted that its test procedure uses the normal cycle to approximate typical use by consumers. 62 FR 45484, 45493 (Aug. 27, 1997). In a test procedure final rule published on August 5, 2015, DOE changed the draft language for the definition of the normal cycle from referencing “the most common consumer cycle” to referencing “the cycle recommended by the manufacturer [. . .] for normal, regular, or typical use,” noting that the updated phrasing represented the same intent. 80 FR 46730, 46742. In the most recently published test procedure for RCWs that established the current appendices J and J2 (“June 2022 TP Final Rule”), DOE noted that its test procedure identifies the “normal cycle” as the cycle representative of consumer use and 
                    <PRTPAGE P="105425"/>
                    requires testing using it. 87 FR 33316, 33351 (June 1, 2022).
                </P>
                <P>In response to the November 2024 Proposed Withdrawal, the CA IOUs commented supporting the recently updated test procedure for RCWs. The CA IOUs stated that the update to the RCW test procedure to include measurements of remaining moisture content for all test cycles ensures that consumers continue to receive high-performing efficient products. (CA IOUs, No. 22 at p. 2)</P>
                <P>Based on stakeholder comments and DOE's analyses, DOE reaffirms its previous conclusions that the normal cycle is the representative average use cycle for RCWs.</P>
                <P>For all consumer clothes dryers in the test procedure at 10 CFR part 430, subpart B, appendix D1 (“appendix D1”) and for timer dryers in the test procedure at appendix D2, the consumer clothes dryer is operated for the test cycle at the maximum temperature setting and, if equipped with a timer, at the maximum time setting. If the consumer clothes dryer does not have a separate temperature setting selection on the control panel, the maximum time settings is used for the drying test cycle. For automatic termination control dryers in the test procedure at appendix D2, the “normal” program shall be selected for the test cycle. Automatic termination control dryers that do not have a “normal” program are tested using the cycle recommended by the manufacturer for drying cotton or linen clothes. Section 3.3 of appendices D1 and D2.</P>
                <P>In a NOPR published on January 2, 2013, DOE first proposed the use of the “normal” program for the drying test cycle in conjunction with test methods that would more accurately measure the energy use of automatic termination control dryers, which comprise the majority of consumer clothes dryer shipments. DOE determined this program to be most representative of consumer use based on data from NEEA's residential laundry field use study, which showed that the average household surveyed used the “normal” or an equivalent program cycle for nearly 60 percent of all drying. 78 FR 152, 170-171. DOE received comments from Samsung stating that the proposed test procedure would be representative of consumer use because it measures the energy use of the most commonly selected cycle (Normal/Cottons and Linens) for automatic termination control dryers. DOE adopted this proposal and established appendix D2 in a final rule published on August 14, 2013. 78 FR 49608, 49624.</P>
                <P>In response to the November 2024 Proposed Withdrawal, the CA IOUs commented supporting the recently updated test procedure for consumer clothes dryers. The CA IOUs stated that the update to the consumer clothes dryers test procedure to include a testing requirement for the automatic termination of all clothes dryers equipped with such a feature ensures that consumers continue to receive high-performing efficient products. CA IOUs asserted that improving the representativeness in the test procedure, ensures that consumers will not need to re-run a consumer clothes dryer due to unsatisfactory performance. (CA IOUs, No. 22 at p. 2)</P>
                <P>
                    ASAP 
                    <E T="03">et al.</E>
                     commented that the new test procedure for consumer clothes dryers at appendix D2 requiring a final moisture content threshold in order to be certified as compliant will ensure that all new consumer clothes dryers provide good drying performance. (ASAP 
                    <E T="03">et al.,</E>
                     No. 21 at p. 4)
                </P>
                <P>Based on stakeholder comments and DOE's analyses, DOE reaffirms its previous conclusions that the normal cycle is the representative average use cycle for consumer clothes dryers.</P>
                <P>DOE has thereby promulgated new and amended test procedures in accordance with EPCA's requirements to ensure that manufacturers are certifying dishwashers, RCWs, and consumer clothes dryers that comply with the currently applicable energy conservation standards. As discussed in section II.D.3 of this document, DOE has also developed provisions within its test procedures for dishwashers, RCWs, and consumer clothes dryers that ensure that the tested cycles maintain product utility that meets consumer expectations.</P>
                <HD SOURCE="HD3">3. Preservation of Product Utility and Potential for Increased Energy or Water Use</HD>
                <P>
                    In its opinion, the Fifth Circuit stated that “Americans who want clean dishes or clothes may use more energy and more water to preclean, reclean, or handwash their stuff before, after, or in lieu of using DOE-regulated appliances,” and that DOE did not adequately respond to this potential for more energy and water use in the January 2022 Final Rule. 
                    <E T="03">Louisiana,</E>
                     90 F.4th at 472-473. In the following sections, DOE addresses stakeholder concerns regarding preservation of product utility for each product type.
                </P>
                <HD SOURCE="HD3">a. Dishwashers</HD>
                <P>
                    In addition to the Fifth Circuit's opinion on product utility, in the November 2024 Proposed Withdrawal, DOE also addressed stakeholder comments on this topic in response to the March 2024 RFI. Specifically, DOE presented comments from the AGs of MT 
                    <E T="03">et al.</E>
                     stating that, according to survey results presented by CEI in response to the July 2019 NOPR,
                    <SU>29</SU>
                    <FTREF/>
                     over 85 percent of consumers hand-wash dishes at least sometimes “because the dishwasher takes too long;” roughly 33 percent of consumers reported that their dishwasher does not clean their dishes well; and 34 percent reported that they run their dishwasher multiple times to get their dishes clean. (AGs of MT 
                    <E T="03">et al.,</E>
                     No. 9 at p. 5)
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         CEI submitted results from a survey it conducted in late 2019 based on 1,062 respondents to understand consumers' dishwasher usage patterns as well as their opinions on dishwasher cycle length. Available as attachment B at 
                        <E T="03">www.regulations.gov/comment/EERE-2021-BT-STD-0002-0239.</E>
                    </P>
                </FTNT>
                <P>
                    DOE also presented data and conclusions from other stakeholders that contradicted the data and conclusions presented by the AGs of MT 
                    <E T="03">et al.</E>
                     89 FR 88661, 88677.
                </P>
                <P>
                    Specifically, with regard to handwashing dishes because the dishwasher takes too long, AHAM submitted data 
                    <SU>30</SU>
                    <FTREF/>
                     indicating that 81 percent of respondents were satisfied with the length of the normal cycle of their dishwashers. (AHAM, No. 5 at p. 3) AHAM also referenced a 2020 University of Michigan study 
                    <SU>31</SU>
                    <FTREF/>
                     and commented that this study showed that recommended practices for dishwasher use are not always performed, with 67 percent of dishwasher owners typically pre-rinsing dishes before loading. However, AHAM stated that its member data do not indicate that consumers are choosing to wash their dishes by hand because of perceived longer cycle times. (
                    <E T="03">Id.</E>
                     at p. 5) AHAM further commented that consumers are satisfied with current cycle times, choosing to rely on their dishwashers regularly. (
                    <E T="03">Id.</E>
                     at p. 6)
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         Appliance Impact Research—Regulatory Findings, conducted for AHAM by DIG Insights (February 2021).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         Gabriela Y Porras 
                        <E T="03">et al.</E>
                         2020. 
                        <E T="03">A Guide to Household Manual and Machine Dishwashing Through a Life Cycle Perspective.</E>
                         Environmental Research 
                        <E T="03">Communications.</E>
                         2 021004.
                    </P>
                </FTNT>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE tentatively concluded that any consumer handwashing or pre-washing is unlikely to have been the result of past or current standards. Further, the amended test procedure at appendix C2 requires test samples to meet a cleaning index threshold consistent with consumer expectations. Accordingly, in the November 2024 Proposed Withdrawal, DOE stated that it did not expect increased handwashing or pre-washing (above levels resulting 
                    <PRTPAGE P="105426"/>
                    from consumer preferences or misunderstandings) in the future. 89 FR 88661, 88678.
                </P>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE also noted that the 2020 Michigan study cited by AHAM discussed the role of behavioral barriers in explaining why certain consumers may be reluctant to switch from handwashing to machine washing, as these consumers believe handwashing outperforms machine washing in terms of resource consumption and cleaning performance. Likewise, in the November 2024 Proposed Withdrawal, DOE noted that findings from the University of Bonn and the Impulse Reach national survey 
                    <E T="51">32 33</E>
                    <FTREF/>
                     also suggest that the primary factor contributing to consumers handwashing dishes is not the dishwasher cycle duration, but rather a misconception by consumers that dishwashers require more energy and water than handwashing. 89 FR 88661, 88678.
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         Berkholz, P., V. Kobersky, and R. Stamminger. 2011. “Comparative analysis of global consumer behaviour in the context of different manual dishwashing methods.” International Journal of Consumer Studies, 37(1), 46-58. 
                        <E T="03">doi.org/10.1111/j.1470-6431.2011.01051.x.</E>
                    </P>
                    <P>
                        <SU>33</SU>
                         Wolf, A. 2011. “Consumers: Dishwashers Second to Kids in Noise.” Twice: This Week in Consumer Electronics, 26(18), 64. 
                        <E T="03">www.twice.com/product/consumers-dishwashers-second-kids-noise-37554.</E>
                    </P>
                </FTNT>
                <P>In response to the November 2024 Proposed Withdrawal, CEI asserted that AHAM and Whirlpool's comment in the April 2024 Dishwashers Direct Final Rule that “energy conservation standards beyond EL 1 will cause rebound consumer behavior, such as running the dishwasher more than once to reach the desired cleanliness, re-rinsing dishes before placing them in the dishwasher, or handwashing, all of which undercut projected energy and water savings” (89 FR 31398, 31435), contradicts AHAM's comment in response to the March 2024 RFI that “consumers are satisfied with current cycle times” and that “consumers are choosing to wash their dishes by hand because of perceived longer cycle times.” (CEI, No. 18 at p. 4).</P>
                <P>
                    DOE notes that while AHAM and Whirlpool had previously commented in response to a NOPR published on May 19, 2023 (88 FR 32514) that energy conservation standards beyond EL 1 would cause rebound consumer behavior, they were also signatories to a Joint Agreement 
                    <SU>34</SU>
                    <FTREF/>
                     submitted to DOE later, on September 25, 2023, that recommended dishwasher standards that exceeded the EL 1 as proposed in the May 2023 NOPR. The dishwasher standards recommended in the Joint Agreement were adopted in the April 2024 Dishwashers Direct Final Rule.
                </P>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         This document is available in the docket at: 
                        <E T="03">www.regulations.gov/comment/EERE-2019-BT-STD-0039-0055.</E>
                    </P>
                </FTNT>
                <P>In response to the November 2024 Proposed Withdrawal, CEI commented that AHAM did not provide its survey questions or scope, which CEI asserted makes AHAM's survey data unreliable. CEI further stated that AHAM asked only if people were “satisfied” with current cycle times, not whether consumers would prefer a faster cycle time. (CEI, No. 18 at p. 5)</P>
                <P>DOE notes that the AHAM survey data are proprietary and DOE is not able to assess the methodology used for AHAM's estimate of consumer satisfaction with cycle times.</P>
                <P>CEI also commented that the 2020 University of Michigan study cited by AHAM showed that 67 percent of consumers pre-wash their dishes, which CEI asserted demonstrates a lack of confidence in the performance of dishwashers. CEI further commented the study cited by AHAM that consumers handwash dishes due to low consumer knowledge were specifically talking about countries other than the United States, and CEI stated that DOE should not use studies that talk about other countries when making claims about the United States. (CEI, No. 18 at p. 4)</P>
                <P>DOE disagrees with CEI's assessment that the 2020 University of Michigan study demonstrated a lack of consumer confidence in dishwasher performance. The 2020 University of Michigan study focused on consumer behavior in using a dishwasher and did not assess participant confidence in dishwasher performance. The authors of the study also note that pre-rinsing was not necessary to achieve acceptable cleaning performance. Although DOE agrees caution is needed in interpreting results from outside of the United States in the context of U.S. dishwasher usage, the results of such studies are still useful in understanding overall consumer perceptions of dishwashers. DOE notes that the 2020 University of Michigan study focuses on U.S. dishwasher users. Additionally, the Berkholz (2011) study includes U.S. participants and provides results by global region.</P>
                <P>CEI commented that the Fifth Circuit opined that the lack of a short-cycle product class not only violates the law and harms consumers but also undercuts the energy and water efficiency goals of DOE's program because the longer cycle times and reduced cleaning performance of currently available models encourage some consumers to “use more energy and more water to preclean, reclean, or handwash their stuff before, after, or in lieu of using DOE-regulated appliances.” (CEI, No. 18 at p. 6)</P>
                <P>
                    CEI asserted that DOE continues to ignore handwashing that occurs due to long cycle times. (
                    <E T="03">Id.</E>
                     at p. 4) CEI also claimed that DOE's conclusion “that any consumer handwashing or pre-washing is unlikely to have been the result of past or current standards” is false and without substantial evidence. (
                    <E T="03">Id.</E>
                     at p. 5)
                </P>
                <P>DOE disagrees with CEI's assertion that efficiency standards have conclusively led to dishwasher users using more energy and water to pre-clean, re-clean, or handwash dishes as a result of longer cycle times. As noted in the November 2024 Proposed Withdrawal, the available research on dishwasher consumer behavior attributes handwashing and pre-washing dishes to a misconception that dishwashers require more energy and water than handwashing. In the absence of data demonstrating a causal relationship between efficiency standards and handwashing behavior, DOE maintains its position that previous or current standards have not influenced handwashing or pre-washing behavior.</P>
                <P>
                    ASAP 
                    <E T="03">et al.</E>
                     stated that there is no evidence that energy conservation standards have resulted in increased energy and water use as stated by the Fifth Circuit, noting that there is no evidence that standards have resulted in consumers running multiple cycles on the same load or that energy and water use have increased as a result of improved efficiency. ASAP 
                    <E T="03">et al.</E>
                     noted that data from RECS 
                    <SU>35</SU>
                    <FTREF/>
                     and the Water Research Foundation 
                    <SU>36</SU>
                    <FTREF/>
                     have shown that the average number of cycles per year for dishwashers, along with dishwasher water use, have declined with improved efficiency. ASAP 
                    <E T="03">et al.</E>
                     also agreed with DOE's tentative conclusion that any handwashing or prewashing is unlikely to have been the result of past or current standards. (ASAP 
                    <E T="03">et al.,</E>
                     No. 21 at pp. 3-4)
                </P>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         U.S. Department of Energy-Energy Information Administration, Residential Energy Consumption Survey, 
                        <E T="03">https://www.eia.gov/consumption/residential/index.php.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         Available at 
                        <E T="03">committee.iso.org/files/live/users/aj/bc/fe/tc282contributor%40iso.org/files/Residential%20End%20Use%20of%20Water</E>
                         (Last accessed on December 11, 2024).
                    </P>
                </FTNT>
                <P>
                    CEI asserted that DOE's analysis in the December 2016 Dishwashers Final Determination TSD regarding shipment declines under new standards presents a flawed view because DOE states it “assumed that those consumers who forego buying a dishwasher because of the higher purchase price would then 
                    <PRTPAGE P="105427"/>
                    wash their dishes by hand,” but, when comparing standards, DOE states, “it would be inappropriate to count energy savings that result from shipments that decline because of higher efficiency cases,” without explaining why it would be inappropriate to count the increased water and energy use that will occur from delayed purchases due to more stringent standards. CEI opined that DOE ignored handwashing due to price and cycle time as inappropriate to consider, which CEI characterized as arbitrary and capricious. (CEI, No. 18 at pp. 6-7)
                </P>
                <P>
                    DOE affirms that its methodology for calculating energy and water savings in the December 2016 Dishwashers Final Determination and the April 2024 Dishwashers Direct Final Rule accounts for increased handwashing for households that choose not to purchase a standards-compliant dishwasher due to a price increase associated with a standard. DOE's statement that it does not “count energy savings that result from shipments that decline because of higher efficiency cases” refers specifically to the reduction in energy and water consumption of dishwasher stock in a standards case with fewer shipments compared to the no-new-standards case. DOE does not include reductions in energy and water savings from reduced product stock in estimates of benefits attributed to a standard. DOE does, however, reduce the energy savings in standards cases to account for households that choose to handwash dishes instead of purchasing a standards-compliant unit in the standards case. 
                    <E T="03">See</E>
                     section 10.3.2 of chapter 10 of the December 2016 Dishwasher Final Determination TSD 
                    <SU>37</SU>
                    <FTREF/>
                     and section 10.4.2 of chapter 10 of the April 2024 Dishwasher Direct Final Rule TSD for additional details on DOE's methodology.
                    <SU>38</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         This document is available in the docket at: 
                        <E T="03">www.regulations.gov/document/EERE-2014-BT-STD-0021-0029.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         This document is available in the docket at: 
                        <E T="03">www.regulations.gov/document/EERE-2019-BT-STD-0039-0061.</E>
                    </P>
                </FTNT>
                <P>CEI also reiterated its survey data, submitted in support of the March 2018 Petition, saying that it was a representative sample of public opinion, in which 82 percent of the people found a dishwasher that cleans in less than 1 hour to be useful; 49 percent of people always or often handwash dishes because the dishwasher takes too long; and 36 percent sometimes do so. CEI commented that 14 percent of people never handwash dishes and opined that it is likely these are the people who complain about dishwasher noise level and their opinion should not govern what the standard should be, according to CEI. (CEI, No. 18 at pp. 4-5)</P>
                <P>
                    AWE commented that the survey results from CEI are unreliable given the lack of information from the State AGs of MT 
                    <E T="03">et al.</E>
                     and CEI on the methodology of the survey necessary for assessing the meaning, significance, reliability, or accuracy of the asserted survey results. AWE noted that information on how the survey was conducted; how participants were selected; whether the survey was online, by phone, or in paper; the extent to which participants responded and how non-responses were handled in data analysis; and how the survey questions were designed was not provided by the State AGs of MT 
                    <E T="03">et al.</E>
                     or CEI. (AWE, No. 20 at pp. 4-5)
                </P>
                <P>DOE agrees with AWE's assertion that it is challenging to interpret the results of CEI's survey due to a lack of information on the survey methodology and techniques used to construct its sample. Although described as a representative sample of public opinion, it is not clear if their sample includes households that do not currently own a dishwasher and how these households would have been handled in the data analysis. Additionally, it is unclear whether CEI performed any weighting analysis to make its raw sample representative of the U.S. population or the U.S. population of dishwasher owners. Regardless, even taking the CEI survey results at face value, there is no evidence provided indicating that standards have impacted consumer behavior towards handwashing dishes. As noted in the November 2024 Proposed Withdrawal, a 2020 study by the University of Michigan discussed the role of behavioral barriers in explaining why certain consumers may be reluctant to switch from handwashing to machine washing, as these consumers believe handwashing outperforms machine washing in terms of resource consumption and cleaning performance. With regards to CEI's survey result indicating 82 percent of respondents would find a dishwasher that cleans in less than 1 hour to be useful, DOE emphasizes that manufacturers already provide quick cycles in current models to meet this preference. As demonstrated in section II.A.2 of this document, it is also technologically feasible to design a short-cycle feature for dishwashers while meeting current standards.</P>
                <P>
                    With regard to the portion of consumers who report their dishwasher does not clean well or they run the dishwasher multiple times to get dishes clean, DOE noted in January 2023 TP Final Rule that the cleaning performance at the completion of a dishwasher cycle influences how a consumer uses the product. DOE acknowledged that if the cleanliness of the dishware after completion of a cleaning cycle does not meet consumer expectations, consumers may alter their use of the dishwasher by selecting a different cycle type that consumes more energy and water, operating the selected cycle type multiple times, or prewashing the dishware items. DOE recognized the need to ensure that the cycle type tested in the DOE test procedure is representative of consumer use as the dishwasher market continuously evolves to higher levels of efficiency. DOE therefore established a new cleaning performance threshold in the newly established appendix C2 test procedure that represents what constitutes “completely washing” a full load of normally soiled dishes (
                    <E T="03">i.e.,</E>
                     a threshold below which the dishwasher would not meet consumer expectations of cleanability). 88 FR 3234, 3250-3267. Under appendix C2, a dishwasher must meet the cleaning performance threshold at all tested soil loads, and thus consumer expectations of cleanability. In the November 2024 Proposed Withdrawal, DOE noted that to the extent that any individual dishwashers on the market have not met consumer expectations for cleanability, such historical performance issues should be remedied moving forward, as the test procedure at appendix C2 ensures that any dishwasher tested for certification will have a valid energy and water representation only if the dishwasher also meets or exceeds a minimum level of cleaning performance. 89 FR 88661, 88678.
                </P>
                <P>
                    AWE noted that in the survey data provided by CEI, 18 percent of respondents purchased dishwashers well before the compliance date of the current standard (
                    <E T="03">i.e.,</E>
                     2013). AWE further noted that CEI's survey results stating that 33 percent of respondents were dissatisfied with the cleaning performance of their dishwashers could be indicative that the majority of those respondents had older dishwashers whose performance may have degraded over time. AWE commented that the AGs of MT 
                    <E T="03">et al.</E>
                     and CEI gave no basis for concluding that current dishwashers, compliant with existing standards, fail to clean dishes adequately. (AWE, No. 20 at p. 5)
                </P>
                <P>CEI stated that dishwasher standards have compromised dishwasher quality in several ways, including poorer cleaning performance, reduced reliability, and cycle length. (CEI, No. 18 at pp. 2-3)</P>
                <P>
                    As discussed in section II.A.3.a of this document, data has shown that 
                    <PRTPAGE P="105428"/>
                    minimum cycle times have not increased due to standards. Further, as discussed in section II.A.2 and elsewhere in this document, DOE has identified a dishwasher basic model that meets the current standard while providing the short-cycle feature; that is, it is technologically feasible to design a dishwasher that provides a cycle time of 60 minutes or less, while achieving a cleaning index of at least 70 on each of the three soil loads specified in the DOE test procedure, and while meeting the current standard. As evidenced by the availability of a dishwasher with this feature currently on the market, designing such a dishwasher does not necessitate compromises to cleaning performance or cycle length.
                </P>
                <P>Additionally, DOE does not have any evidence that dishwasher standards have reduced reliability. In fact, as noted in the November 2024 Proposed Withdrawal, DOE has not found any evidence of average product lifetime being correlated with any specific higher-efficiency design options or efficiency levels. Among the dishwasher standards rulemakings conducted over the course of the last 30 years, the data sources that DOE uses to derive estimates of average product lifetime have not provided any indication of a substantial change in lifetime during this time period. In fact, the data suggest that current product lifetimes are actually longer than the lifetime estimates used in 1991. Specifically, DOE's estimates of average lifetime for dishwashers have been as follows: 12.6 years in the May 1991 Final Rule, 12.3 years in the 2007 Advance Notice of Proposed Rulemaking, 15.4 years in the May 2012 Direct Final Rule, 15.2 years in the December 2016 Final Determination, and 15.2 years in the April 2024 Dishwashers Direct Final Rule. 56 FR 22250, 22276 (May 14, 1991); 72 FR 64432, 64435 (Nov. 15, 2007); 77 FR 31918, 31933 (May 30, 2012); 81 FR 90072, 90088 (Dec. 13, 2016); 89 FR 31398, 31430. 89 FR 88661, 88675. The lifetime data over the past 33 years shows that standards have not compromised dishwasher reliability.</P>
                <P>CEI commented that, while DOE has established a minimum cleaning performance requirement, it should allow manufacturers to exceed the minimum threshold because consumers desire dishwashers that provide excellent cleaning performance. (CEI, No. 18 at p. 4)</P>
                <P>
                    The minimum cleaning index threshold specified in the DOE test procedure at appendix C2 is exactly that; a 
                    <E T="03">minimum</E>
                     threshold. Manufacturers are free to design dishwashers with cleaning performance that exceeds this threshold.
                </P>
                <P>In conclusion, the weight of the evidence available supports the determination that increased re-washing, handwashing, or pre-washing (above levels resulting from consumer preferences or misunderstandings) are unlikely to result in the future as a result of standards; nor does DOE expect any negative impact to cleaning performance or cycle length of dishwashers. Available data from RECS and the Water Foundation show that the average number of cycles for dishwashers has declined over time, indicating households have not needed to run multiple cycles on the same load. The DOE test procedure at appendix C2 requires test samples to meet a cleaning index threshold consistent with consumer expectations, which would ensure a consumer-acceptable level of cleaning performance. Finally, as noted elsewhere in this document, it is technologically feasible to provide the short-cycle feature on dishwashers. Therefore, DOE also does not expect any impact to cycle length.</P>
                <HD SOURCE="HD3">b. Residential Clothes Washers</HD>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE recognized that RCW manufacturers design RCWs to achieve many different performance requirements (
                    <E T="03">e.g.,</E>
                     cleaning performance, rinsing performance, noise, efficiency, cycle time). Manufacturers also provide multiple cycle types to meet different consumer needs (
                    <E T="03">e.g.,</E>
                     normal, heavy, light, quick, delicates). However, DOE reiterates that multiple top-loading RCW models currently on the market provide a cycle time of less than 30 minutes, and multiple front-loading RCW models provide a cycle time of less than 45 minutes, all of which meet the current standards—demonstrating that current standards do not require manufacturers to trade off cycle time with energy and water use. 89 FR 88661, 88678-88679.
                </P>
                <P>
                    ASAP 
                    <E T="03">et al.</E>
                     stated that there is no evidence that energy conservation standards have resulted in increased energy and water use as stated by the Fifth Circuit, noting that there is no evidence that standards have resulted in consumers running multiple cycles on the same load or that energy and water use have increased as a result of improved efficiency. ASAP 
                    <E T="03">et al.</E>
                     noted that data from RECS and the Water Research Foundation has shown that average number of cycles per year for RCWs along with RCW water use has declined with improved efficiency. ASAP 
                    <E T="03">et al.</E>
                     also agreed with DOE's tentative conclusion that any handwashing or prewashing is unlikely to have been the result of past or current standards. (ASAP 
                    <E T="03">et al.,</E>
                     No. 21 at pp. 3-4)
                </P>
                <P>DOE agrees with ASAP's assessment that available nationally representative data from RECS and the Water Research Foundation show that the average numbers of cycles for RCWs has declined over time, indicating that households have not needed to run multiple cycles on the same load as a result of past or current standards.</P>
                <P>
                    Although DOE's current RCW test procedures do not include a measure of cleaning performance, DOE does consider multiple aspects of clothes washer performance as it evaluates potential energy and water conservation standards for RCWs to ensure that no lessening of the utility or performance of the product is likely to result from an amended standard. For example, in support of the NOPR preceding the March 2024 RCW Direct Final Rule, DOE conducted extensive testing to evaluate any potential impacts of amended standards on of several performance characteristics including cycle time, hot wash water temperature, soil and stain removal, and mechanical action.
                    <SU>39</SU>
                    <FTREF/>
                     88 FR 26511 (May 1, 2023).
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         DOE published the results of this testing in a report available at 
                        <E T="03">www.regulations.gov/document/EERE-2017-BT-STD-0014-0059.</E>
                    </P>
                </FTNT>
                <P>
                    Even though DOE's analyses conducted as part the standards rulemaking process have demonstrated that performance can be maintained under the current standards for RCWs, DOE has previously discussed, for example in the June 2022 TP Final Rule, that the cleaning performance at the completion of a wash cycle could influence how a consumer uses the product. If the cleanliness of the clothing after completion of a wash cycle were to not meet consumer expectations, consumers could be expected to alter their use of the clothes washer. For example, consumers could alter the use of the product by choosing cycle modifiers to enhance the performance of the selected cycle; selecting an alternate cycle that consumes more energy and water to provide a higher level of cleaning; operating the selected cycle multiple times; or pre-treating (
                    <E T="03">e.g.,</E>
                     pre-soaking in water) clothing items before loading into the clothes washer to achieve an acceptable level of cleaning. 87 FR 33316, 33352.
                </P>
                <P>
                    As discussed, the dishwasher test procedure defines a cleaning performance threshold that represents what constitutes “completely washing” a full load of normally soiled dishes 
                    <PRTPAGE P="105429"/>
                    (
                    <E T="03">i.e.,</E>
                     a threshold below which the dishwasher would not meet consumer expectations of cleanability). However, the current RCW test procedures do not define what constitutes “washing” up to a full load of normally soiled cotton clothing (
                    <E T="03">i.e.,</E>
                     the cleaning performance). In the June 2022 TP Final Rule, DOE discussed its consideration of adding a cleaning performance metric to its RCW test procedures, but ultimately DOE was unable to make a determination whether existing test procedures for determining cleaning performance would produce results for DOE's purposes that are representative of an average use cycle, as required by EPCA. Furthermore, DOE was unable to assess whether the additional burden resulting from these additional tests would be outweighed by the benefits of incorporating these tests. Therefore, DOE did not include a measure of cleaning performance in the RCW test procedures in the June 2022 TP Final Rule. 87 FR 33316, 33352.
                </P>
                <P>DOE continues, however, to evaluate the potential benefits and burdens of incorporating a measure of performance into its RCW test procedures, akin to the cleaning performance threshold incorporated into the appendix C2 test procedure for dishwashers. Any such amendments to the RCW test procedures would be considered in a separate rulemaking.</P>
                <HD SOURCE="HD3">c. Consumer Clothes Dryers</HD>
                <P>
                    In the November 2024 Proposed Withdrawal, DOE recognized that consumer clothes dryer manufacturers design consumer clothes dryers to achieve many different performance requirements (
                    <E T="03">e.g.,</E>
                     drying performance, noise, efficiency, cycle time). Manufacturers also provide multiple cycle types to meet different consumer needs (
                    <E T="03">e.g.,</E>
                     normal, heavy, light, quick, delicates). However, DOE reiterates that multiple clothes dryer models currently on the market provide a cycle time of less than 30 minutes, all of which meet the current standards—demonstrating that current standards do not require manufacturers to trade off cycle time with energy use. 89 FR 88661, 88679.
                </P>
                <P>
                    ASAP 
                    <E T="03">et al.</E>
                     stated that there is no evidence that energy conservation standards have resulted in increased energy use as stated by the Fifth Circuit, noting that there is no evidence that standards have resulted in consumers running multiple cycles on the same load or that energy use has increased as a result of improved efficiency. ASAP 
                    <E T="03">et al.</E>
                     noted that data from RECS has shown that average number of cycles per year for consumer clothes dryers has declined with improved efficiency. (ASAP 
                    <E T="03">et al.,</E>
                     No. 21 at pp. 3-4)
                </P>
                <P>DOE agrees with ASAP's assessment that available nationally representative data from RECS shows that the average numbers of cycles for consumer clothes dryers has declined over time indicating households have not needed to run multiple cycles on the same load.</P>
                <P>Similar to dishwashers, for consumer clothes dryers DOE noted in the test procedure final rule published on October 8, 2021, that drying performance at the completion of a clothes dryer cycle may influence how a consumer uses the product. 86 FR 56608. DOE acknowledged that if the dryness of the clothes after completion of a during cycle does not meet consumer expectations, consumers may alter their use of their consumer clothes dryer by selecting a different cycle type that consumers more energy, or operating the selected cycle type multiple times. DOE recognized the need to ensure that the cycle type tested in the DOE test procedure is representative of consumer use as the consumer clothes dryer market continuously evolves to higher levels of efficiency. DOE therefore established a 2-percent final moisture content dryness threshold in the appendix D2 test procedure that was shown to be representative of the consumer-acceptable dryness level after completion of a drying cycle. 86 FR 56608, 56627-56628. Under appendix D2, a consumer clothes dryer must achieve this dryness threshold in order for the tested cycle to be considered valid for certifying compliance with the applicable standard.</P>
                <P>To the extent that any individual consumer clothes dryers on the market have not met consumer expectations for dryness, such historical performance issues should be remedied moving forward, as the test procedure at appendix D2 ensures that any consumer clothes dryer tested for certification will have a valid energy and water representation only if the consumer clothes dryer meets or exceeds this threshold of dryness performance.</P>
                <HD SOURCE="HD1">III. Conclusions</HD>
                <P>In conclusion, and for the reasons discussed in the preceding sections of this document, DOE has determined that a short-cycle feature does not justify separate product classes with separate standards under 42 U.S.C. 6295(q) for dishwashers, RCWs, and consumer clothes dryers. Therefore, products with short-cycle features remain subject to the currently applicable standards as specified in 10 CFR 430.32(f), (g), and (h), respectively.</P>
                <HD SOURCE="HD1">IV. Procedural Issues and Regulatory Review</HD>
                <P>DOE has concluded that the determinations made pursuant to the various procedural requirements applicable to the January 2022 Final Rule remain unchanged for this confirmation of that rule. These determinations are set forth in the January 2022 Final Rule. 87 FR 2673, 2686-2688.</P>
                <HD SOURCE="HD1">V. Approval of the Office of the Secretary</HD>
                <P>The Secretary of Energy has approved publication of this final rule; confirmation of effective date.</P>
                <HD SOURCE="HD1">Signing Authority</HD>
                <P>
                    This document of the Department of Energy was signed on December 19, 2024, by Jeffrey Marootian, Principal Deputy Assistant Secretary for Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <DATED>Signed in Washington, DC, on December 19, 2024.</DATED>
                    <NAME>Treena V. Garrett,</NAME>
                    <TITLE>Federal Register Liaison Officer, U.S. Department of Energy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30797 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6450-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">CONSUMER FINANCIAL PROTECTION BUREAU</AGENCY>
                <CFR>12 CFR Part 1003</CFR>
                <SUBJECT>Home Mortgage Disclosure (Regulation C) Adjustment to Asset-Size Exemption Threshold</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Consumer Financial Protection Bureau.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; official interpretation.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Consumer Financial Protection Bureau (CFPB) is amending official commentary interpreting requirements of the CFPB's Regulation C to reflect the asset-size exemption threshold for banks, savings associations, and credit unions based on 
                        <PRTPAGE P="105430"/>
                        the annual percentage change in the average of the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). Based on the 2.9 percent average increase in the CPI-W for the 12-month period ending November 2024, the exemption threshold is adjusted to $58 million from $56 million. Institutions with assets of $58 million or less as of December 31, 2024, are exempt from collecting data in 2025.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective on January 1, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        George Karithanom, Regulatory Implementation &amp; Guidance Program Analyst, Office of Regulations, at (202) 435-7700 or at: 
                        <E T="03">https://reginquiries.consumerfinance.gov.</E>
                         If you require this document in an alternative electronic format, please contact 
                        <E T="03">CFPB_Accessibility@cfpb.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The CFPB is amending Regulation C, which implements the Home Mortgage Disclosure Act of 1975 (HMDA) asset thresholds, to establish the asset-sized exemption threshold for depository financial institutions for 2025. The asset threshold will be $58 million for 2025.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    HMDA requires most mortgage lenders located in metropolitan areas to collect data about their housing-related lending activity.
                    <SU>1</SU>
                    <FTREF/>
                     Annually, lenders must report their data to the appropriate Federal agencies and make the data available to the public. The CFPB's Regulation C implements HMDA.
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         12 U.S.C. 2801-2810.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         12 CFR part 1003.
                    </P>
                </FTNT>
                <P>
                    Prior to 1997, HMDA exempted certain depository institutions as defined in HMDA (
                    <E T="03">i.e.,</E>
                     banks, savings associations, and credit unions) with assets totaling $10 million or less as of the preceding year-end. In 1996, HMDA was amended to expand the asset-size exemption for these depository institutions.
                    <SU>3</SU>
                    <FTREF/>
                     The amendment increased the dollar amount of the asset-size exemption threshold by requiring a one-time adjustment of the $10 million figure based on the percentage by which the CPI-W for 1996 exceeded the CPI-W for 1975, and it provided for annual adjustments thereafter based on the annual percentage increase in the CPI-W, rounded to the nearest multiple of $1 million.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         12 U.S.C. 2808(b).
                    </P>
                </FTNT>
                <P>The definition of “financial institution” in § 1003.2(g) provides that the CFPB will adjust the asset threshold based on the year-to-year change in the average of the CPI-W, not seasonally adjusted, for each 12-month period ending in November, rounded to the nearest $1 million. For 2024, the threshold was $56 million. During the 12-month period ending in November 2024, the average of the CPI-W increased by 2.9 percent. As a result, the exemption threshold is increased to $58 million for 2025. Thus, banks, savings associations, and credit unions with assets of $58 million or less as of December 31, 2024, are exempt from collecting data in 2025. An institution's exemption from collecting data in 2025 does not affect its responsibility to report data it was required to collect in 2024.</P>
                <HD SOURCE="HD1">II. Procedural Requirements</HD>
                <HD SOURCE="HD2">A. Administrative Procedure Act</HD>
                <P>
                    Under the Administrative Procedure Act (APA), notice and opportunity for public comment are not required if the CFPB finds that notice and opportunity for public comment are impracticable, unnecessary, or contrary to the public interest.
                    <SU>4</SU>
                    <FTREF/>
                     Pursuant to this final rule, comment 2(g)-2 in Regulation C, supplement I, is amended to update the exemption threshold. The amendment in this final rule is technical and non-discretionary, and it merely applies the formula established by Regulation C for determining any adjustments to the exemption threshold. For these reasons, the CFPB has determined that publishing a notice of proposed rulemaking and providing opportunity for public comment are unnecessary. Therefore, the amendment is adopted in final form.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         5 U.S.C. 553(b)(B).
                    </P>
                </FTNT>
                <P>
                    Section 553(d) of the APA generally requires publication of a final rule not less than 30 days before its effective date, except in the case of (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) as otherwise provided by the agency for good cause found and published with the rule.
                    <SU>5</SU>
                    <FTREF/>
                     At a minimum, the CFPB has determined that the amendment falls under the third exception to section 553(d). The CFPB finds that there is good cause to make the amendment effective on January 1, 2025. The amendment in this final rule is technical and non-discretionary, and it applies the method previously established in the agency's regulations for determining adjustments to the threshold.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         5 U.S.C. 553(d).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Regulatory Flexibility Act</HD>
                <P>
                    The Regulatory Flexibility Act (RFA) does not apply to a rulemaking where a general notice of proposed rulemaking is not required.
                    <SU>6</SU>
                    <FTREF/>
                     As noted previously, the CFPB has determined that it is unnecessary to publish a general notice of proposed rulemaking for this final rule. Accordingly, the RFA's requirement relating to an initial and final regulatory flexibility analysis does not apply.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         5 U.S.C. 603(a), 604(a).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. Paperwork Reduction Act</HD>
                <P>
                    In accordance with the Paperwork Reduction Act of 1995,
                    <SU>7</SU>
                    <FTREF/>
                     the CFPB reviewed this final rule. The CFPB has determined that this rule does not create any new information collections or substantially revise any existing collections.
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         44 U.S.C. 3506; 5 CFR part 1320.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">D. Congressional Review Act</HD>
                <P>
                    Pursuant to the Congressional Review Act, the CFPB will submit a report containing this rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the United States prior to the rule taking effect.
                    <SU>8</SU>
                    <FTREF/>
                     The Office of Information and Regulatory Affairs (OIRA) has designated this rule as not a “major rule” as defined by 5 U.S.C. 804(2).
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         5 U.S.C. 801 
                        <E T="03">et seq.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD1">List of Subjects in 12 CFR Part 1003 </HD>
                <P>Banks, banking, Credit unions, Mortgages, National banks, Reporting and recordkeeping requirements, Savings associations.</P>
                <HD SOURCE="HD1">Authority and Issuance</HD>
                <P>For the reasons set forth above, the CFPB amends Regulation C, 12 CFR part 1003, as set forth below:</P>
                <PART>
                    <HD SOURCE="HED">PART 1003—HOME MORTGAGE DISCLOSURE (REGULATION C)</HD>
                </PART>
                <REGTEXT TITLE="12" PART="1003">
                    <AMDPAR>1. The authority citation for part 1003 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 12 U.S.C. 2803, 2804, 2805, 5512, 5581.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="12" PART="1003">
                    <AMDPAR>
                        2. Supplement I to part 1003 is amended by revising 
                        <E T="03">2(g) Financial Institution</E>
                         under the heading 
                        <E T="03">Section 1003.2—Definitions</E>
                         to read as follows:
                    </AMDPAR>
                    <HD SOURCE="HD1">Supplement I to Part 1003—Official Interpretations</HD>
                    <STARS/>
                    <HD SOURCE="HD2">Section 1003.2—Definitions</HD>
                    <STARS/>
                    <PRTPAGE P="105431"/>
                    <HD SOURCE="HD2">2(g) Financial Institution</HD>
                    <P>
                        1. 
                        <E T="03">Preceding calendar year and preceding December 31.</E>
                         The definition of financial institution refers both to the preceding calendar year and the preceding December 31. These terms refer to the calendar year and the December 31 preceding the current calendar year. For example, in 2019, the preceding calendar year is 2018 and the preceding December 31 is December 31, 2018. Accordingly, in 2019, Financial Institution A satisfies the asset-size threshold described in § 1003.2(g)(1)(i) if its assets exceeded the threshold specified in comment 2(g)-2 on December 31, 2018. Likewise, in 2020, Financial Institution A does not meet the loan-volume test described in § 1003.2(g)(1)(v)(A) if it originated fewer than 25 closed-end mortgage loans during either 2018 or 2019.
                    </P>
                    <P>
                        2. 
                        <E T="03">Adjustment of exemption threshold for banks, savings associations, and credit unions.</E>
                         For data collection in 2025, the asset-size exemption threshold is $58 million. Banks, savings associations, and credit unions with assets at or below $58 million as of December 31, 2024, are exempt from collecting data for 2025.
                    </P>
                    <P>
                        <E T="03">3. Merger or acquisition—coverage of surviving or newly formed institution.</E>
                         After a merger or acquisition, the surviving or newly formed institution is a financial institution under § 1003.2(g) if it, considering the combined assets, location, and lending activity of the surviving or newly formed institution and the merged or acquired institutions or acquired branches, satisfies the criteria included in § 1003.2(g). For example, A and B merge. The surviving or newly formed institution meets the loan threshold described in § 1003.2(g)(1)(v)(B) if the surviving or newly formed institution, A, and B originated a combined total of at least 200 open-end lines of credit in each of the two preceding calendar years. Likewise, the surviving or newly formed institution meets the asset-size threshold in § 1003.2(g)(1)(i) if its assets and the combined assets of A and B on December 31 of the preceding calendar year exceeded the threshold described in § 1003.2(g)(1)(i). Comment 2(g)-4 discusses a financial institution's responsibilities during the calendar year of a merger.
                    </P>
                    <P>
                        <E T="03">4. Merger or acquisition—coverage for calendar year of merger or acquisition.</E>
                         The scenarios described below illustrate a financial institution's responsibilities for the calendar year of a merger or acquisition. For purposes of these illustrations, a “covered institution” means a financial institution, as defined in § 1003.2(g), that is not exempt from reporting under § 1003.3(a), and “an institution that is not covered” means either an institution that is not a financial institution, as defined in § 1003.2(g), or an institution that is exempt from reporting under § 1003.3(a).
                    </P>
                    <P>i. Two institutions that are not covered merge. The surviving or newly formed institution meets all of the requirements necessary to be a covered institution. No data collection is required for the calendar year of the merger (even though the merger creates an institution that meets all of the requirements necessary to be a covered institution). When a branch office of an institution that is not covered is acquired by another institution that is not covered, and the acquisition results in a covered institution, no data collection is required for the calendar year of the acquisition.</P>
                    <P>ii. A covered institution and an institution that is not covered merge. The covered institution is the surviving institution, or a new covered institution is formed. For the calendar year of the merger, data collection is required for covered loans and applications handled in the offices of the merged institution that was previously covered and is optional for covered loans and applications handled in offices of the merged institution that was previously not covered. When a covered institution acquires a branch office of an institution that is not covered, data collection is optional for covered loans and applications handled by the acquired branch office for the calendar year of the acquisition.</P>
                    <P>iii. A covered institution and an institution that is not covered merge. The institution that is not covered is the surviving institution, or a new institution that is not covered is formed. For the calendar year of the merger, data collection is required for covered loans and applications handled in offices of the previously covered institution that took place prior to the merger. After the merger date, data collection is optional for covered loans and applications handled in the offices of the institution that was previously covered. When an institution remains not covered after acquiring a branch office of a covered institution, data collection is required for transactions of the acquired branch office that take place prior to the acquisition. Data collection by the acquired branch office is optional for transactions taking place in the remainder of the calendar year after the acquisition.</P>
                    <P>iv. Two covered institutions merge. The surviving or newly formed institution is a covered institution. Data collection is required for the entire calendar year of the merger. The surviving or newly formed institution files either a consolidated submission or separate submissions for that calendar year. When a covered institution acquires a branch office of a covered institution, data collection is required for the entire calendar year of the merger. Data for the acquired branch office may be submitted by either institution.</P>
                    <P>
                        <E T="03">5. Originations.</E>
                         Whether an institution is a financial institution depends in part on whether the institution originated at least 25 closed-end mortgage loans in each of the two preceding calendar years or at least 200 open-end lines of credit in each of the two preceding calendar years. Comments 4(a)-2 through -4 discuss whether activities with respect to a particular closed-end mortgage loan or open-end line of credit constitute an origination for purposes of § 1003.2(g).
                    </P>
                    <P>
                        <E T="03">6. Branches of foreign banks—treated as banks.</E>
                         A Federal branch or a State-licensed or insured branch of a foreign bank that meets the definition of a “bank” under section 3(a)(1) of the Federal Deposit Insurance Act (12 U.S.C. 1813(a)) is a bank for the purposes of § 1003.2(g).
                    </P>
                    <P>
                        <E T="03">7. Branches and offices of foreign banks and other entities—treated as nondepository financial institutions.</E>
                         A Federal agency, State-licensed agency, State-licensed uninsured branch of a foreign bank, commercial lending company owned or controlled by a foreign bank, or entity operating under section 25 or 25A of the Federal Reserve Act, 12 U.S.C. 601 and 611 (Edge Act and agreement corporations) may not meet the definition of “bank” under the Federal Deposit Insurance Act and may thereby fail to satisfy the definition of a depository financial institution under § 1003.2(g)(1). An entity is nonetheless a financial institution if it meets the definition of nondepository financial institution under § 1003.2(g)(2).
                    </P>
                    <STARS/>
                </REGTEXT>
                <SIG>
                    <NAME>Brian Shearer,</NAME>
                    <TITLE>Assistant Director, Office of Policy Planning and Strategy, Consumer Financial Protection Bureau. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30652 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4810-25-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <PRTPAGE P="105432"/>
                <AGENCY TYPE="N">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 33</CFR>
                <DEPDOC>[Docket No. FAA-2023-0587; Special Conditions No. 33-23-01-SC]</DEPDOC>
                <SUBJECT>Special Conditions: Safran Electric &amp; Power S.A. Model ENGINeUS 100A1 Electric Engines</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final special conditions.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>These special conditions are issued for the Safran Electric &amp; Power S.A. (Safran) Model ENGINeUS 100A1 electric engines that operate using electrical technology installed on the aircraft for use as an aircraft engine. These engines will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards applicable to aircraft engines. This design feature is the use of an electric motor, motor controller, and high-voltage systems as the primary source of propulsion for an aircraft. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective January 27, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Mark Bouyer, Engine and Propulsion Standards Section, AIR-625, Technical Policy Branch, Policy and Standards Division, Aircraft Certification Service, 1200 District Avenue, Burlington, Massachusetts 01803; telephone (781) 238-7755; 
                        <E T="03">mark.bouyer@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>On November 27, 2020, Safran applied for FAA validation for a type certificate for their Model ENGINeUS 100A1 electric engine. The Safran Model ENGINeUS 100A1 electric engine will be used in a single-engine airplane that will be certified separately from the engine.</P>
                <P>The Safran Model ENGINeUS 100A1 electric engine is comprised of a direct-drive, radial-flux, permanent magnet motor, divided in two sections, each section having a three-phase motor, and one electric power inverter controlling each three-phase motor.</P>
                <HD SOURCE="HD1">Type Certification Basis</HD>
                <P>Under the provisions of 14 CFR 21.17(a)(1), generally, Safran must show that Model ENGINeUS 100A1 electric engines meet the applicable provisions of 14 CFR part 33 in effect on the date of application for a type certificate.</P>
                <P>
                    If the Administrator finds that the applicable airworthiness regulations (
                    <E T="03">e.g.,</E>
                     part 33) do not contain adequate or appropriate safety standards for the Safran Model ENGINeUS 100A1 electric engines because of a novel or unusual design feature, special conditions may be prescribed under the provisions of § 21.16.
                </P>
                <P>Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other engine model that incorporates the same novel or unusual design feature, these special conditions would also apply to the other engine model under § 21.101.</P>
                <P>The FAA issues special conditions, as defined in § 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.17(a)(2).</P>
                <HD SOURCE="HD1">Novel or Unusual Design Features</HD>
                <P>The Safran Model ENGINeUS 100A1 electric engines will incorporate the following novel or unusual design features:</P>
                <P>An electric motor, motor controller, and high-voltage electrical systems that are used as the primary source of propulsion for an aircraft.</P>
                <HD SOURCE="HD1">Discussion</HD>
                <P>Electric propulsion technology is substantially different from the technology used in previously certificated turbine and reciprocating engines. Therefore, these engines introduce new safety concerns that need to be addressed in the certification basis.</P>
                <P>
                    A growing interest within the aviation industry involves electric propulsion technology. As a result, international agencies and industry stakeholders formed Committee F39 under ASTM International, formerly known as American Society for Testing and Materials, to identify the appropriate technical criteria for aircraft engines using electrical technology that has not been previously type certificated for aircraft propulsion systems. ASTM International is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. ASTM International published ASTM F3338-18, “Standard Specification for Design of Electric Propulsion Units for General Aviation Aircraft,” in December 2018.
                    <SU>1</SU>
                    <FTREF/>
                     The FAA used the technical criteria from the ASTM F3338-18, the published Special Conditions No. 33-022-SC for the magniX USA, Inc. Model magni350 and magni650 engines, and information from the Safran Model ENGINeUS 100A1 electric engine design to develop special conditions.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">https://www.astm.org/Standards/F3338.html.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Part 33 Was Developed for Gas-Powered Turbine and Reciprocating Engines</HD>
                <P>Aircraft engines make use of an energy source to drive mechanical systems that provide propulsion for the aircraft. Energy can be generated from various sources such as petroleum and natural gas. The turbine and reciprocating aircraft engines certificated under part 33 use aviation fuel for an energy source. The reciprocating and turbine engine technology that was anticipated in the development of part 33 converts oxygen and fuel to energy using an internal combustion system, which generates heat and mass flow of combustion products for turning shafts that are attached to propulsion devices such as propellers and ducted fans. Part 33 regulations set forth standards for these engines and mitigate potential hazards resulting from failures and malfunctions. The nature, progression, and severity of engine failures are tied closely to the technology that is used in the design and manufacture of aircraft engines. These technologies involve chemical, thermal, and mechanical systems. Therefore, the existing engine regulations in part 33 address certain chemical, thermal, and mechanically induced failures that are specific to air and fuel combustion systems operating with cyclically loaded, high-speed, high-temperature, and highly stressed components.</P>
                <HD SOURCE="HD2">Safran's Electric Engines Are Novel or Unusual</HD>
                <P>
                    The existing part 33 airworthiness standards for aircraft engines date back to 1965. As discussed in the previous paragraphs, these airworthiness standards are based on fuel-burning reciprocating and turbine engine technology. The Safran Model ENGINeUS 100A1 electric engines are neither turbine nor reciprocating engines. These engines have a novel or unusual design feature, which is the use of electrical sources of energy instead of fuel to drive the mechanical systems that provide propulsion for aircraft. The 
                    <PRTPAGE P="105433"/>
                    Safran aircraft engine is subject to operating conditions produced by chemical, thermal, and mechanical components working together, but the operating conditions are unlike those observed in internal combustion engine systems. Therefore, part 33 does not contain adequate or appropriate safety standards for the Safran Model ENGINeUS 100A1 electric engine's novel or unusual design feature.
                </P>
                <P>
                    Safran's aircraft engines will operate using electrical power instead of air and fuel combustion to propel the aircraft. These electric engines will be designed, manufactured, and controlled differently than turbine or reciprocating aircraft engines. They will be built with an electric motor, motor controller, and high-voltage electrical systems that draw energy from electrical storage or electrical energy generating systems. The electric motor is a device that converts electrical energy into mechanical energy by electric current flowing through windings (wire coils) in the motor, producing a magnetic field that interacts with permanent magnets mounted on the engine's main rotor. The controller is a system that consists of two main functional elements: the motor controller and an electric power inverter to drive the motor.
                    <SU>2</SU>
                    <FTREF/>
                     The high-voltage electrical system is a combination of wires and connectors that integrate the motor and controller.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Sometimes the entire system is referred to as an inverter. Throughout this document, it is referred to as the controller.
                    </P>
                </FTNT>
                <P>In addition, the technology comprising these high-voltage and high-current electronic components introduces potential hazards that do not exist in turbine and reciprocating aircraft engines. For example, high-voltage transmission lines, electromagnetic shields, magnetic materials, and high-speed electrical switches are necessary to use the physical properties of an electric engine for propelling an aircraft. However, this technology also exposes the aircraft to potential failures that are not common to gas-powered turbine and reciprocating engines, technological differences which could adversely affect safety if not addressed through these special conditions.</P>
                <HD SOURCE="HD2">Safran's Electric Engines Require a Mix of Part 33 Standards and Special Conditions</HD>
                <P>
                    Although Safran's electric aircraft engines use novel or unusual design features that the FAA did not envisage during the development of its existing part 33 airworthiness standards, these engines share some basic similarities, in configuration and function, to engines that use the combustion of air and fuel, and therefore require similar provisions to prevent common hazards (
                    <E T="03">e.g.,</E>
                     fire, uncontained high energy debris, and loss of thrust control). However, the primary failure concerns and the probability of exposure to these common hazards are different for the Safran Model ENGINeUS 100A1 electric engine. This creates a need to develop special conditions to ensure the engine's safety and reliability.
                </P>
                <P>The requirements in part 33 ensure that the design and construction of aircraft engines, including the engine control systems, are proper for the type of aircraft engines considered for certification. However, part 33 does not fully address aircraft engines like the Safran Model ENGINeUS 100A1 electric engine, which operates using electrical technology as the primary means of propelling the aircraft. This necessitates the development of special conditions that provide adequate airworthiness standards for these aircraft engines.</P>
                <P>The requirements in part 33, subpart B, are applicable to reciprocating and turbine aircraft engines. Subparts C and D are applicable to reciprocating aircraft engines. Subparts E through G are applicable to turbine aircraft engines. As such, subparts B through G do not adequately address the use of aircraft engines that operate using electrical technology. Special conditions are needed to ensure a level of safety for electric engines that is commensurate with these subparts, as those regulatory requirements do not contain adequate or appropriate safety standards for electric aircraft engines that are used to propel aircraft.</P>
                <HD SOURCE="HD1">FAA Special Conditions for the Safran Engine Design</HD>
                <P>
                    <E T="03">Applicability:</E>
                     Special condition no. 1 requires Safran to comply with part 33, except for those airworthiness standards specifically and explicitly applicable only to reciprocating and turbine aircraft engines.
                </P>
                <P>
                    <E T="03">Engine Ratings and Operating Limitations:</E>
                     Special condition no. 2, in addition to compliance with § 33.7(a), requires Safran to establish engine operating limits related to the power, torque, speed, and duty cycles specific to Safran Model ENGINeUS 100A1 electric engines. The duty or duty cycle is a statement of the load(s) to which the engine is subjected, including, if applicable, starting, no-load and rest, and de-energized periods, including their durations or cycles and sequence in time. This special condition also requires Safran to declare cooling fluid grade or specification, power supply requirements, and to establish any additional ratings that are necessary to define the Safran Model ENGINeUS 100A1 electric engine capabilities required for safe operation of the engine.
                </P>
                <P>
                    <E T="03">Materials:</E>
                     Special condition no. 3 requires Safran to comply with § 33.15, which sets requirements for the suitability and durability of materials used in the engine, and which would otherwise be applicable only to reciprocating and turbine aircraft engines.
                </P>
                <P>
                    <E T="03">Fire Protection:</E>
                     Special condition no. 4 would require Safran to comply with § 33.17, which sets requirements to protect the engine and certain parts and components of the airplane against fire, and which would otherwise be applicable only to reciprocating and turbine aircraft engines. Additionally, this special condition requires Safran to ensure that the high-voltage electrical wiring interconnect systems that connect the controller to the motor are protected against arc faults. An arc fault is a high-power discharge of electricity between two or more conductors. This discharge generates heat, which can break down the wire's insulation and trigger an electrical fire. Arc faults can range in power from a few amps up to thousands of amps and are highly variable in strength and duration.
                </P>
                <P>
                    <E T="03">Durability:</E>
                     Special condition no. 5 requires the design and construction of Safran Model ENGINeUS 100A1 electric engines to minimize the development of an unsafe condition between maintenance intervals, overhaul periods, and mandatory actions described in the Instructions for Continued Airworthiness (ICA).
                </P>
                <P>
                    <E T="03">Engine Cooling:</E>
                     Special condition no. 6 requires Safran to comply with § 33.21, which requires the engine design and construction to provide necessary cooling, and which would otherwise be applicable only to reciprocating and turbine aircraft engines. Additionally, this special condition requires Safran to document the cooling system monitoring features and usage in the engine installation manual (see § 33.5) if cooling is required to satisfy the safety analysis described in special condition no. 17. Loss of cooling to an aircraft engine that operates using electrical technology can result in rapid overheating and abrupt engine failure, with critical consequences to safety.
                </P>
                <P>
                    <E T="03">Engine Mounting Attachments and Structure:</E>
                     Special condition no. 7 requires Safran and the design to comply with § 33.23, which requires the applicant to define, and the design to withstand, certain load limits for the engine mounting attachments and 
                    <PRTPAGE P="105434"/>
                    related engine structure. These requirements would otherwise be applicable only to reciprocating and turbine aircraft engines.
                </P>
                <P>
                    <E T="03">Accessory Attachments:</E>
                     Special condition no. 8 requires the design to comply with § 33.25, which sets certain design, operational, and maintenance requirements for the engine's accessory drive and mounting attachments, and which would otherwise be applicable only to reciprocating and turbine aircraft engines.
                </P>
                <P>
                    <E T="03">Rotor Overspeed:</E>
                     Special condition no. 9 requires Safran to establish by test, validated analysis, or a combination of both, that—
                </P>
                <P>(1) the rotor overspeed must not result in a burst, rotor growth, or damage that results in a hazardous engine effect;</P>
                <P>(2) rotors must possess sufficient strength margin to prevent burst; and</P>
                <P>(3) operating limits must not be exceeded in service.</P>
                <P>The special condition associated with rotor overspeed is necessary because of the differences between turbine engine technology and the technology of these electric engines. Turbine rotor speed is driven by expanding gas and aerodynamic loads on rotor blades. Therefore, the rotor speed or overspeed results from interactions between thermodynamic and aerodynamic engine properties. The speed of an electric engine is directly controlled by electric current, and an electromagnetic field created by the controller. Consequently, electric engine rotor response to power demand and overspeed-protection systems is quicker and more precise. Also, the failure modes that can lead to overspeed between turbine engines and electric engines are vastly different, and therefore this special condition is necessary.</P>
                <P>
                    <E T="03">Engine Control Systems:</E>
                     Special condition no. 10(b) requires Safran to ensure that these engines do not experience any unacceptable operating characteristics, such as unstable speed or torque control, or exceed any of their operating limitations.
                </P>
                <P>The FAA originally issued § 33.28 at amendment 33-15 to address the evolution of the means of controlling the fuel supplied to the engine, from carburetors and hydro-mechanical controls to electronic control systems. These electronic control systems grew in complexity over the years, and as a result, the FAA amended § 33.28 at amendment 33-26 to address these increasing complexities. The controller that forms the controlling system for these electric engines is significantly simpler than the complex control systems used in modern turbine engines. The current regulations for engine control are inappropriate for electric engine control systems; therefore, the special condition no. 10(b) associated with controlling these engines is necessary.</P>
                <P>
                    Special condition no. 10(c) requires Safran to develop and verify the software and complex electronic hardware used in programmable logic devices, using proven methods that ensure that the devices can provide the accuracy, precision, functionality, and reliability commensurate with the hazard that is being mitigated by the logic. RTCA DO-254, “Design Assurance Guidance for Airborne Electronic Hardware,” dated April 19, 2000,
                    <SU>3</SU>
                    <FTREF/>
                     distinguishes between complex and simple electronic hardware.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">https://my.rtca.org/NC__Product?id=a1B36000001IcjTEAS</E>
                        .
                    </P>
                </FTNT>
                <P>Special condition no. 10(d) requires data from assessments of all functional aspects of the control system to prevent errors that could exist in software programs that are not readily observable by inspection of the code. Also, Safran must use methods that will result in the expected quality that ensures the engine control system performs the intended functions throughout the declared operational envelope.</P>
                <P>
                    The environmental limits referred to in special condition no. 10(e) include temperature, vibration, high-intensity radiated fields (HIRF), and all others addressed in RTCA DO-160G, “Environmental Conditions and Test Procedures for Airborne Electronic/Electrical Equipment and Instruments,” dated December 8, 2010, which includes RTCA DO-160G, Change 1—“Environmental Conditions and Test Procedures for Airborne Equipment,” dated December 16, 2014, and “DO-357—User Guide: Supplement to DO-160G,” dated December 16, 2014.
                    <SU>4</SU>
                    <FTREF/>
                     Special condition 10(e) requires Safran to demonstrate by system or component tests in special condition no. 27 any environmental limits that cannot be adequately substantiated by the endurance demonstration, validated analysis, or a combination thereof.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">https://my.rtca.org/NC__Product?id=a1B36000001IcnSEAS</E>
                        .
                    </P>
                </FTNT>
                <P>
                    Special condition no. 10(f) requires Safran to evaluate various control system failures to ensure that such failures will not lead to unsafe engine conditions. The FAA issued Advisory Circular (AC) 33.28-3, 
                    <E T="03">“</E>
                    Guidance Material for 14 CFR 33.28, Engine Control Systems,” on May 23, 2014 (AC 33.28-3), for reciprocating and turbine engines.
                    <SU>5</SU>
                    <FTREF/>
                     This AC provides guidance for defining an engine control system failure when showing compliance with the requirements of § 33.28. AC 33.28-3 also includes objectives for control system integrity requirements, criteria for a loss of thrust control (LOTC) and loss of power control (LOPC) event, and an acceptable LOTC/LOPC rate. The electrical and electronic failures and failure rates did not account for electric engines when the FAA issued this AC, and therefore performance-based special conditions are established to allow fault accommodation criteria to be developed for electric engines.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">https://www.faa.gov/documentLibrary/media/Advisory_Circular/AC_33_28-3.pdf.</E>
                    </P>
                </FTNT>
                <P>The phrase “in the full-up configuration” used in special condition no. 10(f)(2) refers to a system without any fault conditions present. The electronic control system must, when in the full-up configuration, be single-fault tolerant, as determined by the Administrator, for electrical, electrically detectable, and electronic failures involving LOPC events.</P>
                <P>The term “local” in the context of “local events” used in special condition no. 10(f)(4) means failures or malfunctions leading to events in the intended aircraft installation such as fire, overheat, or failures leading to damage to engine control system components. These “local events” must not result in a hazardous engine effect due to engine control system failures or malfunctions.</P>
                <P>Special condition no. 10(g) requires Safran to conduct a safety assessment of the control system to support the safety analysis in special condition no. 17. This control system safety assessment provides engine response to failures, and rates of these failures that can be used at the aircraft-level safety assessment.</P>
                <P>Special condition no. 10(h) requires Safran to provide appropriate protection devices or systems to ensure that engine operating limits will not be exceeded in service.</P>
                <P>
                    Special condition no. 10(i) is necessary to ensure that the controllers are self-sufficient and isolated from other aircraft systems. The aircraft-supplied data supports the analysis at the aircraft level to protect the aircraft from common mode failures that could lead to major propulsion power loss. The exception “other than power command signals from the aircraft,” noted in special condition no. 10(i), is based on the FAA's determination that the engine controller has no reasonable means to determine the validity of any in-range signals from the electrical power system. In many cases, the engine control system can detect a faulty signal from the aircraft, but the engine control 
                    <PRTPAGE P="105435"/>
                    system typically accepts the power command signal as a valid value.
                </P>
                <P>The term “independent” in the context of “fully independent engine systems” referenced in special condition no. 10(i) means the controllers should be self-sufficient and isolated from other aircraft systems or provide redundancy that enables the engine control system to accommodate aircraft data system failures. In the case of loss, interruption, or corruption of aircraft-supplied data, the engine must continue to function in a safe and acceptable manner without hazardous engine effects.</P>
                <P>The term “accommodated,” in the context of “detected and accommodated,” referenced in special condition 10(i)(2) is to assure that, upon detecting a fault, the system continues to function safely.</P>
                <P>Special condition no. 10(j) requires Safran to show that the loss of electric power from the aircraft will not cause the electric engine to malfunction in a manner hazardous to the aircraft. The total loss of electric power to the electric engine may result in an engine shutdown.</P>
                <P>
                    <E T="03">Instrument Connection:</E>
                     Special condition no. 11 requires Safran to comply with § 33.29(a), (e), and (g), which set certain requirements for the connection and installation of instruments to monitor engine performance. The remaining requirements in § 33.29 apply only to technologies used in reciprocating and turbine aircraft engines.
                </P>
                <P>Instrument connections (wires, wire insulation, potting, grounding, connector designs, etc.) must not introduce unsafe features or characteristics to the aircraft. Special condition no. 11 requires the safety analysis to include potential hazardous effects from failures of instrument connections to function properly. The outcome of this analysis might identify the need for design enhancements or additional ICA to ensure safety.</P>
                <P>
                    <E T="03">Stress Analysis:</E>
                     Section 33.62 requires applicants to perform a stress analysis on each turbine engine. This regulation is explicitly applicable only to turbine engines and turbine engine components, and it is not appropriate for the Safran Model ENGINeUS 100A1 electric engines. However, a stress analysis particular to these electric engines is necessary to account for stresses resulting from electric technology used in the engine.
                </P>
                <P>Special condition no. 12 requires a mechanical, thermal, and electrical stress analysis to show that the engine has a sufficient design margin to prevent unacceptable operating characteristics. Also, the applicant must determine the maximum stresses in the engine by tests, validated analysis, or a combination thereof, and show that they do not exceed minimum material properties.</P>
                <P>
                    <E T="03">Critical and Life-Limited Parts:</E>
                     Special condition no. 13 requires Safran to show whether rotating or moving components, bearings, shafts, static parts, and non-redundant mount components should be classified, designed, manufactured, and managed throughout their service life as critical or life-limited parts.
                </P>
                <P>The term “low-cycle fatigue,” referenced in special condition no. 13(a)(2), is a decline in material strength from exposure to cyclic stress at levels beyond the stress threshold the material can sustain indefinitely. This threshold is known as the “material endurance limit.” Low-cycle fatigue typically causes a part to sustain plastic or permanent deformation during the cyclic loading and can lead to cracks, crack growth, and fracture. Engine parts that operate at high temperatures and high mechanical stresses simultaneously can experience low-cycle fatigue coupled with creep. Creep is the tendency of a metallic material to permanently move or deform when it is exposed to the extreme thermal conditions created by hot combustion gasses, and substantial physical loads such as high rotational speeds and maximum thrust. Conversely, high-cycle fatigue is caused by elastic deformation, small strains caused by alternating stress, and a much higher number of load cycles compared to the number of cycles that cause low-cycle fatigue.</P>
                <P>The engineering plan referenced in special condition no. 13(b)(1) informs the manufacturing and service management processes of essential information that ensures the life limit of a part is valid. The engineering plan provides methods for verifying the characteristics and qualities assumed in the design data using methods that are suitable for the part criticality. The engineering plan informs the manufacturing process of the attributes that affect the life of the part. The engineering plan, manufacturing plan, and service management plan are related in that assumptions made in the engineering plan are linked to how a part is manufactured and how that part is maintained in service. For example, environmental effects on life limited electric engine parts, such as humidity, might not be consistent with the assumptions used to design the part. Safran must ensure that the engineering plan is complete, available, and acceptable to the Administrator.</P>
                <P>The term “manufacturing plan,” referenced in special condition no. 13(b)(2), is the collection of data required to translate documented engineering design criteria into physical parts, and to verify that the parts comply with the properties established by the design data. Because engines are not intentionally tested to failure during a certification program, documents and processes used to execute production and quality systems required by § 21.137 guarantee inherent expectations for performance and durability. These systems limit the potential manufacturing outcomes to parts that are consistently produced within design constraints.</P>
                <P>The manufacturing plan and service management plan ensure that essential information from the engineering plan, such as the design characteristics that safeguard the integrity of critical and life-limited parts, is consistently produced and preserved over the lifetime of those parts. The manufacturing plan includes special processes and production controls to prevent inclusion of manufacturing-induced anomalies, which can degrade the part's structural integrity. Examples of manufacturing-induced anomalies are material contamination, unacceptable grain growth, heat-affected areas, and residual stresses.</P>
                <P>The service-management plan ensures the method and assumptions used in the engineering plan to determine the part's life remain valid by enabling corrections identified from in-service experience, such as service-induced anomalies and unforeseen environmental effects, to be incorporated into the design process. The service-management plan also becomes the ICA for maintenance, overhaul, and repairs of the part.</P>
                <P>
                    <E T="03">Lubrication System:</E>
                     Special condition no. 14 requires Safran to ensure that the lubrication system is designed to function properly between scheduled maintenance intervals and to prevent contamination of the engine bearings. This special condition also requires Safran to demonstrate the unique lubrication attributes and functional capability of the Safran Model ENGINeUS 100A1 electric engine design.
                </P>
                <P>
                    The corresponding part 33 regulations include provisions for lubrication systems used in reciprocating and turbine engines. The part 33 requirements account for safety issues associated with specific reciprocating and turbine engine system configurations. These regulations are not appropriate for the Safran Model ENGINeUS 100A1 electric engines. For example, electric engines do not have a 
                    <PRTPAGE P="105436"/>
                    crankcase or lubrication oil sump. Electric engine bearings are sealed, so they do not require an oil circulation system. The lubrication system in these engines is also independent of the propeller pitch control system. Therefore, special condition no. 14 incorporates only certain requirements from the part 33 regulations.
                </P>
                <P>
                    <E T="03">Power Response:</E>
                     Special condition no. 15 requires the design and construction of the Safran Model ENGINeUS 100A1 electric engines to enable an increase from the minimum—
                </P>
                <P>(1) power setting to the highest rated power without detrimental engine effects, and</P>
                <P>(2) within a time interval appropriate for the intended aircraft application.</P>
                <P>The engine control system governs the increase or decrease in power in combustion engines to prevent too much (or too little) fuel from being mixed with air before combustion. Due to the lag in rotor response time, improper fuel/air mixtures can result in engine surges, stalls, and exceedances above rated limits and durations. Failure of the combustion engine to provide thrust, maintain rotor speeds below rotor burst thresholds, and keep temperatures below limits can have engine effects detrimental to the aircraft. Similar detrimental effects are possible in the Safran Model ENGINeUS 100A1 electric engines, but the causes are different. Electric engines with reduced power response time can experience insufficient thrust to the aircraft, shaft over-torque, and over-stressed rotating components, propellers, and critical propeller parts. Therefore, this special condition is necessary.</P>
                <P>
                    <E T="03">Continued Rotation:</E>
                     Special condition no. 16 requires Safran to design the Model ENGINeUS 100A1 electric engines such that, if the main rotating systems continue to rotate after the engine is shut down while in-flight, this continued rotation will not result in any hazardous engine effects.
                </P>
                <P>The main rotating system of the Safran Model ENGINeUS 100A1 electric engines consists of the rotors, shafts, magnets, bearings, and wire windings that convert electrical energy to shaft torque. For the initial aircraft application, this rotating system must continue to rotate after the power source to the engine is shut down. The safety concerns associated with this special condition are substantial asymmetric aerodynamic drag that can cause aircraft instability, loss of control, and reduced efficiency; and may result in a forced landing or inability to continue safe flight.</P>
                <P>
                    <E T="03">Safety Analysis:</E>
                     Special condition no. 17 requires Safran to comply with § 33.75(a)(1) and (a)(2), which require the applicant to conduct a safety analysis of the engine, and which would otherwise be applicable only to turbine aircraft engines. Additionally, this special condition requires Safran to assess its engine design to determine the likely consequences of failures that can reasonably be expected to occur. The failure of such elements, and associated prescribed integrity requirements, must be stated in the safety analysis.
                </P>
                <P>A primary failure mode is the manner in which a part is most likely going to fail. Engine parts that have a primary failure mode, a predictable life to the failure, and a failure consequence that results in a hazardous effect, are life-limited or critical parts. Some life-limited or critical engine parts can fail suddenly in their primary failure mode, from prolonged exposure to normal engine environments such as temperature, vibration, and stress, if those engine parts are not removed from service before the damage mechanisms progress to a failure. Due to the consequence of failure, these parts are not allowed to be managed by on-condition or probabilistic means because the probability of failure cannot be sensibly estimated in numerical terms. Therefore, the parts are managed by compliance with integrity requirements, such as mandatory maintenance (life limits, inspections, inspection techniques), to ensure the qualities, features, and other attributes that prevent the part from failing in its primary failure mode are preserved throughout its service life. For example, if the number of engine cycles to failure are predictable and can be associated with specific design characteristics, such as material properties, then the applicant can manage the engine part with life limits.</P>
                <P>Complete or total power loss is not assumed to be a minor engine event, as it is in the turbine engine regulation § 33.75, to account for experience data showing a potential for higher hazard levels from power loss events in single-engine general aviation aircraft. The criteria in these special conditions apply to an engine that continues to operate at partial power after a single electrical or electronic fault or failure. Total loss of power is classified at the aircraft level using special condition nos. 10(g) and 33(h).</P>
                <P>
                    <E T="03">Ingestion:</E>
                     Special condition no. 18 requires Safran to ensure that these engines will not experience unacceptable power loss or hazardous engine effects from ingestion. The associated regulations for turbine engines, §§ 33.76, 33.77, and 33.78, are based on potential performance impacts and damage from birds, ice, rain, and hail being ingested into a turbine engine that has an inlet duct, which directs air into the engine for combustion, cooling, and thrust. By contrast, the Safran Model ENGINeUS 100A1 electric engines are not configured with inlet ducts.
                </P>
                <P>An “unacceptable” power loss, as used in special condition no. 18(b), is such that the power or thrust required for safe flight of the aircraft becomes unavailable to the pilot. The specific amount of power loss that is required for safe flight depends on the aircraft configuration, speed, altitude, attitude, atmospheric conditions, phase of flight, and other circumstances where the demand for thrust is critical to safe operation of the aircraft.</P>
                <P>
                    <E T="03">Liquid and Gas Systems:</E>
                     Special condition no. 19 requires Safran to ensure that systems used for lubrication or cooling of engine components are designed and constructed to function properly. Also, if a system is not self-contained, the interfaces to that system would be required to be defined in the engine installation manual. Systems for the lubrication or cooling of engine components can include heat exchangers, pumps, fluids, tubing, connectors, electronic devices, temperature sensors and pressure switches, fasteners and brackets, bypass valves, and metallic chip detectors. These systems allow the electric engine to perform at extreme speeds and temperatures for durations up to the maintenance intervals without exceeding temperature limits or predicted deterioration rates.
                </P>
                <P>
                    <E T="03">Vibration Demonstration:</E>
                     Special condition no. 20 requires Safran to ensure the engine—
                </P>
                <P>(1) is designed and constructed to function throughout its normal operating range of rotor speeds and engine output power without inducing excessive stress caused by engine vibration, and</P>
                <P>(2) design undergoes a vibration survey.</P>
                <P>
                    The vibration demonstration is a survey that characterizes the vibratory attributes of the engine. It verifies that the stresses from vibration do not impose excessive force or result in natural frequency responses on the aircraft structure. The vibration demonstration also ensures internal vibrations will not cause engine components to fail. Excessive vibration force occurs at magnitudes and forcing functions or frequencies, which may result in damage to the aircraft. Stress margins to failure add conservatism to the highest values predicted by analysis for additional protection from failure 
                    <PRTPAGE P="105437"/>
                    caused by influences beyond those quantified in the analysis. The result of the additional design margin is improved engine reliability that meets prescribed thresholds based on the failure classification. The amount of margin needed to achieve the prescribed reliability rates depends on an applicant's experience with a product. The FAA considers the reliability rates when deciding how much vibration is “excessive.”
                </P>
                <P>
                    <E T="03">Overtorque:</E>
                     Special condition no. 21 requires Safran to demonstrate that the engine is capable of continued operation without the need for maintenance if it experiences a certain amount of overtorque.
                </P>
                <P>Safran's electric engine converts electrical energy to shaft torque, which is used for propulsion. The electric motor, controller, and high-voltage systems control the engine torque. When the pilot commands power or thrust, the engine responds to the command and adjusts the shaft torque to meet the demand. During the transition from one power or thrust setting to another, a small delay, or latency, occurs in the engine response time. While the engine dwells in this time interval, it can continue to apply torque until the command to change the torque is applied by the engine control. The allowable amount of overtorque during operation depends on the engine's response to changes in the torque command throughout its operating range.</P>
                <P>
                    <E T="03">Calibration Assurance:</E>
                     Special condition no. 22 requires Safran to subject the engine to calibration tests to establish its power characteristics and the conditions both before and after the endurance and durability demonstrations specified in special condition nos. 23 and 26. The calibration test requirements specified in § 33.85 only apply to the endurance test specified in § 33.87, which is applicable only to turbine engines. The FAA determined that the methods used for accomplishing those tests for turbine engines are not appropriate for electric engines. The calibration tests in § 33.85 have provisions applicable to ratings that are not relevant to the Safran Model ENGINeUS 100A1 electric engines. Special condition no. 22 allows Safran to demonstrate the endurance and durability of the electric engine either together or independently, whichever is most appropriate for the engine qualities being assessed. Consequently, the special condition applies the calibration requirement to both the endurance and durability tests.
                </P>
                <P>
                    <E T="03">Endurance Demonstration:</E>
                     Special condition no. 23 requires Safran to perform an endurance demonstration test that is acceptable to the Administrator. The Administrator will evaluate the extent to which the test exposes the engine to failures that could occur when the engine is operated at up to its rated values, and determine if the test is sufficient to show that the engine design will not exhibit unacceptable effects in service, such as significant performance deterioration, operability restrictions, and engine power loss or instability, when it is run repetitively at rated limits and durations in conditions that represent extreme operating environments.
                </P>
                <P>
                    <E T="03">Temperature Limit:</E>
                     Special condition no. 24 requires Safran to ensure the engine can endure operation at its temperature limits plus an acceptable margin. An “acceptable margin,” as used in the special condition, is the amount of temperature above that required to prevent the least capable engine allowed by the type design, as determined by § 33.8, from failing due to temperature-related causes when operating at the most extreme engine and environmental thermal conditions.
                </P>
                <P>
                    <E T="03">Operation Demonstration:</E>
                     Special condition no. 25 requires the engine to demonstrate safe operating characteristics throughout its declared flight envelope and operating range. Engine operating characteristics define the range of functional and performance values the Safran Model ENGINeUS 100A1 electric engines can achieve without incurring hazardous effects. The characteristics are requisite capabilities of the type design that qualify the engine for installation into aircraft and that determine aircraft installation requirements. The primary engine operating characteristics are assessed by the tests and demonstrations that would be required by these special conditions. Some of these characteristics are shaft output torque, rotor speed, power consumption, and engine thrust response. The engine performance data Safran will use to certify the engine must account for installation loads and effects. These are aircraft-level effects that could affect the engine characteristics that are measured when the engine is tested on a stand or in a test cell. These effects could result from elevated inlet cowl temperatures, aircraft maneuvers, flowstream distortion, and hard landings. For example, an engine that is run in a sea-level, static test facility could demonstrate more capability for some operating characteristics than it will have when operating on an aircraft in certain flight conditions. Discoveries like this during certification could affect engine ratings and operating limits. Therefore, the installed performance defines the engine performance capabilities.
                </P>
                <P>
                    <E T="03">Durability Demonstration:</E>
                     Special condition no. 26 requires Safran to subject the engine to a durability demonstration. The durability demonstration must show that the engine is designed and constructed to minimize the development of any unsafe condition between maintenance intervals or between engine replacement intervals if maintenance or overhaul is not defined. The durability demonstration also verifies that the ICA is adequate to ensure the engine, in its fully deteriorated state, continues to generate rated power or thrust, while retaining operating margins and sufficient efficiency, to support the aircraft safety objectives. The amount of deterioration an engine can experience is restricted by operating limitations and managed by the engine ICA. Section 33.90 specifies how maintenance intervals are established; it does not include provisions for an engine replacement. Electric engines and turbine engines deteriorate differently. Therefore, Safran will use different test effects to develop maintenance, overhaul, or engine replacement information for their electric engine.
                </P>
                <P>
                    <E T="03">System and Component Tests:</E>
                     Special condition no. 27 requires Safran to show that the systems and components of the engine perform their intended functions in all declared engine environments and operating conditions.
                </P>
                <P>
                    Sections 33.87 and 33.91, which are specifically applicable to turbine engines, have conditional criteria to decide if additional tests will be required after the engine tests. The criteria are not suitable for electric engines. Part 33 associates the need for additional testing with the outcome of the § 33.87 endurance test because it is designed to address safety concerns in combustion engines. For example, § 33.91(b) requires the establishment of temperature limits for components that require temperature-controlling provisions, and § 33.91(a) requires additional testing of engine systems and components where the endurance test does not fully expose internal systems and components to thermal conditions that verify the desired operating limits. Exceeding temperature limits is a safety concern for electric engines. The FAA determined that the § 33.87 endurance test is not appropriate for testing the electronic components of electric engines because mechanical energy is generated differently by electronic systems than it is by the thermal conditions in turbine engines. 
                    <PRTPAGE P="105438"/>
                    Additional safety considerations also need to be addressed in the test. Therefore, special condition no. 27 is a performance-based requirement that allows Safran to determine when engine systems and component tests are necessary and to determine the appropriate limitations of those systems and components used in the Safran Model ENGINeUS 100A1 electric engine.
                </P>
                <P>
                    <E T="03">Rotor Locking Demonstration:</E>
                     Special condition no. 28 requires the engine to demonstrate reliable rotor locking performance and that no hazardous effects will occur if the engine uses a rotor locking device to prevent shaft rotation.
                </P>
                <P>Some engine designs enable the pilot to prevent a propeller shaft or main rotor shaft from turning while the engine is running, or the aircraft is in-flight. This capability is needed for some installations that require the pilot to confirm the functionality of certain flight systems before takeoff. The Safran engine installations are not limited to aircraft that will not require rotor locking. Section 33.92 prescribes a test that may not include the appropriate criteria to demonstrate sufficient rotor locking capability for these engines. Therefore, this special condition is necessary.</P>
                <P>The special condition does not define “reliable” rotor locking but allows Safran to classify the hazard as major or minor and assign the appropriate quantitative criteria that meet the safety objectives required by special condition no. 17 and the applicable portions of § 33.75.</P>
                <P>
                    <E T="03">Teardown Inspection:</E>
                     Special condition no. 29 requires Safran to perform a teardown or non-teardown evaluation after the endurance, durability, and overtorque demonstrations, based on the criteria in special condition no. 29(a) or (b).
                </P>
                <P>Special condition no. 29(b) includes restrictive criteria for “non-teardown evaluations” to account for electric engines, sub-assemblies, and components that cannot be disassembled without destroying them. Some electrical and electronic components like Safran's are constructed in an integrated fashion that precludes the possibility of tearing them down without destroying them. The special condition indicates that, if a teardown cannot be performed in a non-destructive manner, then the inspection or replacement intervals must be established based on the endurance and durability demonstrations. The procedure for establishing maintenance should be agreed upon between the applicant and the FAA prior to running the relevant tests. Data from the endurance and durability tests may provide information that can be used to determine maintenance intervals and life limits for parts. However, if life limits are required, the lifing procedure is established by special condition no. 13, Critical and Life-Limited Parts, which corresponds to § 33.70. Therefore, the procedure used to determine which parts are life-limited, and how the life limits are established, requires FAA approval, as it does for § 33.70. Sections 33.55 and 33.93 do not contain similar requirements because reciprocating and turbine engines can be completely disassembled for inspection.</P>
                <P>
                    <E T="03">Containment:</E>
                     Special condition no. 30 requires the engine to have containment features that protect against likely hazards from rotating components, unless Safran can show the margin to rotor burst does not justify the need for containment features. Rotating components in electric engines are typically disks, shafts, bearings, seals, orbiting magnetic components, and the assembled rotor core. However, if the margin to rotor burst does not unconditionally rule out the possibility of a rotor burst, then the special condition requires Safran to assume a rotor burst could occur and design the stator case to contain the failed rotors, and any components attached to the rotor that are released during the failure. In addition, Safran must also determine the effects of subsequent damage precipitated by a main rotor failure and characterize any fragments that are released forward or aft of the containment features. Further, decisions about whether the Safran engine requires containment features, and the effects of any subsequent damage following a rotor burst, should be based on test or validated analysis. The fragment energy levels, trajectories, and size are typically documented in the installation manual because the aircraft will need to account for the effects of a rotor failure in the aircraft design. The intent of this special condition is to prevent hazardous engine effects from structural failure of rotating components and parts that are built into the rotor assembly.
                </P>
                <P>
                    <E T="03">General Conduct of Tests:</E>
                     Special condition no. 32 requires Safran to include scheduled maintenance in the engine ICA, include any maintenance, in addition to the scheduled maintenance that was needed during the test to satisfy the applicable test requirements, and conduct any additional tests that the Administrator finds necessary, as warranted by the test results.
                </P>
                <P>For example, certification endurance test shortfalls might be caused by omitting some prescribed engine test conditions, or from accelerated deterioration of individual parts arising from the need to force the engine to operating conditions that drive the engine above the engine cycle values of the type design. If an engine part fails during a certification test, the entire engine might be subjected to penalty runs, with a replacement or newer part design installed on the engine, to meet the test requirements. Also, the maintenance performed to replace the part, so that the engine could complete the test, would be included in the engine ICA. In another example, if the applicant replaces a part before completing an engine certification test because of a test facility failure and can substantiate the part to the Administrator through bench testing, they might not need to substantiate the part design using penalty runs with the entire engine.</P>
                <P>The term “excessive” is used to describe the frequency of unplanned engine maintenance, and the frequency of unplanned test stoppages, to address engine issues that prevent the engine from completing the tests in special condition nos. 32(b)(1) and (2), respectively. Excessive frequency is an objective assessment from the FAA's analysis of the amount of unplanned maintenance needed for an engine to complete a certification test. The FAA's assessment may include the reasons for the unplanned maintenance, such as the effects test facility equipment may have on the engine, the inability to simulate a realistic engine operating environment, and the extent to which an engine requires modifications to complete a certification test. In some cases, the applicant may be able to show that unplanned maintenance has no effect on the certification test results, or they might be able to attribute the problem to the facility or test-enabling equipment that is not part of the type design. In these cases, the ICA will not be affected. However, if Safran cannot reconcile the amount of unplanned service, then the FAA may consider the unplanned maintenance required during the certification test to be “excessive,” prompting the need to add the unplanned maintenance to mandatory ICA to comply with the certification requirements.</P>
                <P>
                    <E T="03">Engine electrical systems:</E>
                     The current requirements in part 33 for electronic engine control systems were developed to maintain an equivalent level of safety demonstrated by engines that operate with hydromechanical engine control systems. At the time § 33.28 was 
                    <PRTPAGE P="105439"/>
                    codified, the only electrical systems used on turbine engines were low-voltage, electronic engine control systems (EEC) and high-energy spark-ignition systems. Electric aircraft engines use high-voltage, high-current electrical systems and components that are physically located in the motor and motor controller. Therefore, the existing part 33 control system requirements do not adequately address all the electrical systems used in electric aircraft engines. Special condition no. 33 is established using the existing engine control systems requirement as a basis. It applies applicable airworthiness criteria from § 33.28 and incorporates airworthiness criteria that recognize and focus on the electrical power system used in the engine.
                </P>
                <P>Special condition no. 33(b) ensures that all aspects of an electrical system, including generation, distribution, and usage, do not experience any unacceptable operating characteristics.</P>
                <P>Special condition no. 33(c) requires the electrical power distribution aspects of the electrical system to provide the safe transfer of electrical energy throughout the electric engine.</P>
                <P>The term “abnormal conditions” used in special condition no. 33(c)(2) is intended to be consistent with the definitions in MIL-STD-704F “Aircraft Electric Power Characteristics” which defines normal operation and abnormal operation. MIL-STD-704F is a standard that ensures compatibility between power sources that provide power to the aircraft's electrical systems and airborne equipment that receive power from the power source. This standard also establishes technical criteria for aircraft electric power. The term “abnormal conditions” refers to various engine operating conditions such as:</P>
                <P>• System or component characteristics outside of normal statistical variation from circumstances such as systems degradation, installation error, and engine response to fault conditions;</P>
                <P>• Unusual environmental conditions from extreme temperature, humidity, vibration, lightning, high-intensity radiated field (HIRF), atmospheric neutron radiation; and</P>
                <P>• Unusual and infrequent events such as landing on icy runways, rejected take-offs or go-arounds, extended ground idling or taxiing in a hot environment, and abrupt load changes from foreign object damage or engine contamination.</P>
                <P>The phrase “safe transmission of electric energy” used in special condition no. 33(c)(3) refers to the transmission of electrical energy in a manner that supports the operation of the electric engine(s) and the aircraft safety objectives without detrimental effects such as uncontrolled fire or structural failure due to severe overheating.</P>
                <P>Special condition no. 33(d) requires the engine electrical system to be designed such that the loss, malfunction, or interruption of the electrical power source, or power conditions that exceed design limits, will not result in a hazardous engine effect.</P>
                <P>Special condition no. 33(e) requires Safran to identify and declare, in the engine installation manual, the characteristics of any electrical power supplied from the aircraft to the engine, or electrical power supplied from the engine to the aircraft via energy regeneration, and any other characteristics necessary for safe operation of the engine.</P>
                <P>Special condition no. 33(f) requires Safran to demonstrate that systems and components will operate properly up to environmental limits, using special conditions, when such limits cannot be adequately substantiated by the endurance demonstration, validated analysis, or a combination thereof. The environmental limits referred to in this special condition include temperature, vibration, HIRF, and others addressed in RTCA DO-160G, “Environmental Conditions and Test Procedures for Airborne Electronic/Electrical Equipment and Instruments.”</P>
                <P>Special condition 33(g) requires Safran to evaluate various electric engine system failures to ensure that these failures will not lead to unsafe engine conditions. The evaluation includes single-fault tolerance, ensures no single electrical or electronic fault or failure would result in hazardous engine effects, and ensures that any failure or malfunction leading to local events in the intended aircraft application do not result in certain hazardous engine effects. The special condition also implements integrity requirements, criteria for LOTC/LOPC events, and an acceptable LOTC/LOPC rate.</P>
                <P>Special condition 33(h) requires Safran to conduct a safety assessment of the engine electrical system to support the safety analysis in special condition no. 17. This safety assessment provides engine response to failures, and rates of these failures, which can be used at the aircraft safety assessment level.</P>
                <HD SOURCE="HD1">Discussion of Comments</HD>
                <P>
                    The FAA issued a notice of proposed special conditions (NPSC) Docket No. FAA-2023-0587 for the Safran Model ENGINeUS 100A1 electric engines, which was published in the 
                    <E T="04">Federal Register</E>
                     on March 20, 2024 (89 FR 19763).
                </P>
                <P>The FAA received responses from four commenters, Airbus Helicopters (Airbus), Ampaire Inc. (Ampaire), Kite Magnetics Pty Ltd. (Kite Magnetics), and magniX USA, Inc. (magniX).</P>
                <P>The FAA received one comment from Airbus that stated proposed special condition no. 4, Fire Protection, does not prescribe safety criteria for flammable cooling fluids and suggested that a fireproof wall, cooling fluid shut-off valve, fluid draining system, and fire detection system may be necessary because a potential ignition source (electrical failure) and flammable fluids share the same area in the aircraft.</P>
                <P>The FAA does not concur with Airbus's comment that special condition no. 4 does not prescribe safety criteria for flammable cooling fluids. Special condition no. 4 incorporates § 33.17(b) through (g) into the Safran electric engine certification basis, which include provisions for flammable fluid. The FAA also revised special condition no 4. slightly to clarify that § 33.17(b) through (g) are required as part of that special condition.</P>
                <P>The FAA received several comments from Ampaire.</P>
                <P>Ampaire asked if the FAA determined that the definition of propeller options for part 33 electric propulsion systems are sufficiently covered by existing reciprocating and gas turbine regulations.</P>
                <P>These special conditions are applicable to the Safran electric engine, which will be used with fixed pitch propellers. The existing requirements for reciprocating and gas turbine regulations are sufficient for the conventional fixed-pitch propellers and therefore no other propeller options are required. No changes were made as a result of this comment.</P>
                <P>Ampaire regarded proposed special condition no. 10(f)(4) regarding engine control system failures as very similar to the corresponding part 33 regulation (§ 33.28(d)(4)), but noted that special condition is harder to understand without examples that describe the term “local events” such as those provided in the original part 33 regulation. Ampaire recommended adding the examples to special condition no. 10(f)(4) or including other more relevant examples.</P>
                <P>
                    The examples Ampaire requested are already in the preamble discussion for special condition no. 10(f)(4). The FAA did not intend to create a new definition of “local events.” As explained in the preamble, the term “local events” means failures or malfunctions leading to events in the intended aircraft installation such as fire, overheat, or 
                    <PRTPAGE P="105440"/>
                    failures leading to damage to engine control system components. No changes were made as a result of this comment.
                </P>
                <P>Ampaire stated a system safety assessment is required by § 33.28 but there is no requirement in part 33 to add the rates of hazardous and major faults in the installation manual. Ampaire asked the FAA to explain why this requirement is included in special condition no. 10(g) for the Safran electric engine but not in part 33 for reciprocating and gas turbine engines.</P>
                <P>The FAA added the requirement because electric engines enable a wide variety of new aircraft propulsion features, and the engine control system safety assessment is tied to these new propulsion features, which support aircraft that combine vertical takeoff and landing, multi-engine distributed-propulsion, propeller lift and tilt-wing functions, and zero velocity inflight maneuvering capabilities. The effects of an engine failure, such as power loss from an engine, and hazards to the aircraft are contingent on the aircraft design. Therefore, the hazards identified in the safety analysis, as well as the hazard level rates, are included in the engine installation manual to ensure any assumptions about aircraft capabilities that mitigate the effects of engine failures are taken into account when deciding if an engine can be installed in an aircraft. No changes were made as a result of this comment.</P>
                <P>Ampaire asked the FAA to explain why the reference to special condition no. 31, Operation with variable pitch propeller, is included in the magniX special condition no. 17(d)(1), Safety analysis, but not the Safran proposed special condition no. 17(d)(1).</P>
                <P>Safran's electric engine will be used with a fixed-pitch propeller, and therefore special condition no. 31 is not applicable to the Safran engine type design. No changes were made as a result of this comment.</P>
                <P>Ampaire stated proposed special condition no. 23, Endurance demonstration, implies that endurance testing requires a demonstration of energy regeneration, but energy regeneration might not be a feature for some electric engines that operate normally at their limits. Ampaire suggested replacing the second sentence in special condition no. 23 with “The endurance demonstration must include dwellings and increases and decreases of the engine's power settings for sufficient durations that produce the extreme physical conditions the engine experiences at rated performance levels, operational limits, and at any other conditions or power settings including energy regeneration that are required to verify the limit capabilities of the engine.”</P>
                <P>The FAA concurs with Ampaire's comment that energy regeneration might not be a feature for some electric engines that operate at their limits. The phrase “that produce the extreme physical conditions” in special condition no. 23 indicates the endurance test addresses engine properties where the extreme physical conditions can occur including conditions that cause the engine to operate at its limits of energy regeneration. As a result of this comment, the FAA changed special condition no. 23 in accordance with Ampaire's recommendation.</P>
                <P>Ampaire requested the FAA revise special condition nos. 33(c)(1) and (d) for electrical power distribution and protection systems, respectively, by adding the conditional statement “due to a single fault” and explained electrical power distribution within the part 33 powerplant may take several faults to result in total loss. Ampaire also stated that electric power distribution outside the part 33 powerplant is the subject of part 23 aircraft certification.</P>
                <P>The FAA does not concur with Ampaire's request to revise special condition nos. 33(c)(1) and (d) to provide protection from potential consequences resulting only from single electrical faults. Special condition nos. 33(g)(2) and (3), Electrical system failures, have safety criteria that already address single faults in all the engine electrical systems. The safety criteria in special condition no. 33(c)(1) and (d) are for loss of function in electrical power distribution systems, and the criteria apply regardless of the cause of system failures or malfunctions. Also, part 33 has provisions for electrical power supplied to electrical control systems, and therefore this special condition is within the scope of engine requirements. No changes were made as a result of this comment.</P>
                <P>Ampaire asked the FAA to explain the regulatory significance of the term “detrimental” as it is used in proposed special condition no. 33, Engine electrical systems, and whether the term relates to hazard levels.</P>
                <P>The FAA intends the term “detrimental” to have the same meaning as the meaning of the term as it is commonly used in the English language. The term is used extensively in existing FAA regulations and guidance. There is no intent to change how the term is used in these special conditions. Also, there is no correlation between the term “detrimental” and engine failure effect hazard levels. The term is intended to capture all engine effects that could result in an unsafe engine condition. No changes were made as a result of this comment.</P>
                <P>The FAA received several comments from magniX.</P>
                <P>MagniX noted proposed special condition nos. 1(b) and (c) state that a means of compliance, which may include consensus standards, must be “accepted by the Administrator” and “in a form and manner acceptable to the Administrator.” MagniX explained that these paragraphs are directly out of 14 CFR 23.2010, which contains performance-based language. MagniX also explained that part 33 and the Safran special conditions are prescriptive regulations, not performance-based. MagniX further indicated that requiring a performance-based process for establishing means of compliance with prescriptive regulations is unnecessary and overly burdensome to applicants and regulators. MagniX recommended the FAA not adopt proposed special condition nos. 1(b) and (c).</P>
                <P>The FAA does not concur with magniX's recommendation. The FAA considers special condition nos. 1(b) and (c) to be essential for achieving an equivalent level of safety to the level of safety provided by the part 33 engine requirements. The Safran electric engine criteria are a combination of part 33 requirements and special conditions to the requirements in part 33. Special conditions are developed under the provisions of § 21.16, which are issued when the applicable regulations do not contain adequate or appropriate safety standards. Special condition nos. 1(b) and (c) will be used to incorporate the additional details that apply to the Safran engine design using accepted means of compliance. No changes were made as a result of this comment.</P>
                <P>
                    MagniX stated proposed special condition nos. 10(g), 15(b), and 17(f) would require applicants to declare proprietary information in the engine installation manual, these documentation requirements establish a precedent beyond that required of their existing reciprocating or turbine engine counterparts, and these requirements increase the risk that sensitive information is disclosed. MagniX explained that while it is understood this information is used during aircraft-level certification efforts, traditional data sharing agreements sufficiently provide the integrator with the required information while respecting the proprietary nature of the data. MagniX also stated requiring these additional data in the engine installation manual overly constrains the means of 
                    <PRTPAGE P="105441"/>
                    compliance and introduces commercial risk. MagniX recommended the FAA not adopt the requirement to include these specific disclosures in the engine installation manual. MagniX proposed that these data be provided to integrators through generic “installation instructions” in lieu of the engine installation manual and explained this will allow specific proprietary disclosures in other installation documents such as interface control drawings, technical memorandums, or other installer requested documentation.
                </P>
                <P>Special condition nos. 10(g), 15(b), and 17(f) do not require the disclosure of sensitive information. As discussed in the NPSC, the documentation requirements in special conditions nos. 10(g), 15(b), and 17(f) are expected to ensure that the engine is used safely and properly by constraining the installation of electric engines to only aircraft types (configurations, flight capabilities, etc.) that were used by the engine manufacturer to determine the engine ratings, limits, performance characteristics, as well as the reliability and criticality of engine systems and parts.</P>
                <P>These documentation requirements are intended, and the FAA finds necessary, to ensure enough information is included to safeguard compatibility between the electric engine and aircraft, and to prevent the engine from being used in an aircraft type that requires safety features or performance characteristics that are not available from an engine that was type-certificated for an aircraft that does not require the same safety features or performance characteristics. The FAA modified the proposed special conditions to clarify the requirement by specifying the information identified in special condition nos. 6 “Engine cooling,” 10 “Engine control systems,” 15 “Power response,” 17 “Safety analysis,” 18 “Ingestion,” 19 “Liquid and gas systems,” 30 “Containment,” and 33 “Engine electrical systems” must be documented and provided to the installer as part of the requirements in § 33.5.</P>
                <P>The FAA received several comments from Kite Magnetics.</P>
                <P>Kite Magnetics stated that special condition no. 14 for the lubrication system of the Safran Model ENGINeUS 100A1 electric engine should focus specifically on the unique lubrication attributes and inherent functional capabilities of the Safran electric engine design, rather than apply requirements for the entire lubrication system. Kite Magnetics suggested changing special condition no. 14 to apply component-level requirements that would be better suited for the unique attributes of electric engines such as the Safran Model ENGINe US 100A1, promote clarity and relevance of the special condition to critical aspects of the lubrication system pertinent to electric engines, and avoid unnecessary requirements that do not apply to this engine type.</P>
                <P>The FAA does not concur with Kite Magnetics' comment that the special conditions for an electric engine lubrication system should be established at the component level. These special conditions are engine-level requirements; however, the means of compliance to the special conditions can involve component-level assessments using special condition no. 27, System and component tests, which can focus on the unique lubrication attributes and inherent functional capabilities of the Safran electric engine design. No changes were made as a result of this comment.</P>
                <P>Kite Magnetics stated the language “Any system or device that provides, uses, conditions, or distributes electrical power, and is part of the engine type design” in proposed special condition no. 33(a) could imply that energy storage systems (ESS) are part of the engine electrical system. Kite Magnetics explained that ESS fall under the category of systems that provide electrical power and may be perceived as part of the engine's electrical system. However, Kite Magnetics noted that an ESS is a distinct system that supports the engine's electrical power needs, but it is not inherently integrated into the engine's core electrical system design. Kite Magnetics requested confirmation that special condition 33(a) does not apply to ESS. Kite Magnetics did not request changes to this special condition.</P>
                <P>The FAA confirms special condition 33(a) does not apply to ESS. No changes were made as a result of this comment.</P>
                <P>Kite Magnetics requested clarification regarding the components and devices that are considered part of the engine's electrical power distribution system, as outlined in proposed special condition no. 33(c). Kite Magnetics explained this request is intended to ensure a clear understanding of the scope and components included within the electrical power distribution system. Kite Magnetics did not request changes to this special condition.</P>
                <P>The FAA confirms special condition no. 33(c) applies only to the electrical power distribution systems that are part of Safran's electric engine type design. However, the partition between the engine and aircraft electrical power distribution systems must be clearly described and documented with the data provided for showing compliance to § 33.5(a). No changes were made as a result of this comment.</P>
                <P>The FAA also determined that the following changes are necessary.</P>
                <P>The phrase “In addition” is added to special condition no. 4, Fire protection, to connect the introduction sentence to (a) and (b) and avoid confusion.</P>
                <P>The phrase “as defined in special condition no. 17 of these special conditions” is also added where the term “hazardous engine effects” is mentioned in these special conditions.</P>
                <P>The applicability of special condition no. 33(b) “Electrical systems” to electrical load shedding is clarified to affect the electrical system only when required.</P>
                <P>The term “electrical power plant” is changed to “powerplant” in special condition no. 33(c)(1), which is a term used in part 23, subpart E.</P>
                <P>Definitions of the terms “abnormal condition” used in special condition no. 33(c)(2) and “safe transmission” used in special condition no. 33(c)(3) are included in the preamble discussion for special condition no. 33.</P>
                <P>Special condition no. 33 was modified to provide flexibility in electric engine protection system designs. Special condition no. 33(c)(3) is changed to, “The system must provide mechanical or automatic means of isolating a faulted electrical-energy generation or storage device from leading to hazardous engine effects, as defined in special condition no. 17(d)(2) of these special conditions, or detrimental effects in the intended aircraft application.” The phrase, “or detrimental engine effects in the intended aircraft application” is also relocated to special condition no. 33(c)(3) to maintain the connection with special condition no. 33(g).</P>
                <P>Special condition nos. 33(e)(1) and (e)(2) are both required and therefore “or” is replaced with “and” in special condition no. 33(e)(1), “Electrical power characteristics.”</P>
                <P>The documentation requirement in special condition no. 10(g) is also applied to special condition no. 33 (h) “Engine Electrical Systems—System Safety Assessment.”</P>
                <P>The FAA did not adopt proposed special condition no. 31 “Operation with a variable pitch propeller” because the Safran Model ENGINeUS 100A1 electric engine will not use a variable pitch propeller.</P>
                <P>
                    Except as discussed above, these special conditions are adopted as proposed.
                    <PRTPAGE P="105442"/>
                </P>
                <HD SOURCE="HD1">Applicability</HD>
                <P>As discussed above, these special conditions are applicable to Safran Model ENGINeUS 100A1 electric engines. Should Safran apply at a later date for a change to the type certificate to include another model on the same type certificate, incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.</P>
                <HD SOURCE="HD1">Conclusion</HD>
                <P>This action affects only Safran Model ENGINeUS 100A1 electric engines. It is not a rule of general applicability.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 33</HD>
                    <P>Aircraft, Aviation safety, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <HD SOURCE="HD1">Authority Citation</HD>
                <P>The authority citation for these special conditions is as follows:</P>
                <REGTEXT TITLE="14" PART="33">
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.</P>
                    </AUTH>
                    <HD SOURCE="HD1">The Special Conditions</HD>
                    <AMDPAR>Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Safran Model ENGINeUS 100A1 electric engines. The applicant must also comply with the certification procedures set forth in part 21.</AMDPAR>
                    <HD SOURCE="HD1">(1) Applicability</HD>
                    <P>(a) Unless otherwise noted in these special conditions, the engine design must comply with the airworthiness standards for aircraft engines set forth in part 33, except for those airworthiness standards that are specifically and explicitly applicable only to reciprocating and turbine aircraft engines or as specified herein.</P>
                    <P>(b) The applicant must comply with this part using a means of compliance, which may include consensus standards, accepted by the Administrator.</P>
                    <P>(c) The applicant requesting acceptance of a means of compliance must provide the means of compliance to the FAA in a form and manner acceptable to the Administrator.</P>
                    <HD SOURCE="HD1">(2) Engine Ratings and Operating Limits</HD>
                    <P>In addition to § 33.7(a), the engine ratings and operating limits must be established and included in the type certificate data sheet based on:</P>
                    <P>(a) Shaft power, torque, rotational speed, and temperature for:</P>
                    <P>(1) Rated takeoff power;</P>
                    <P>(2) Rated maximum continuous power; and</P>
                    <P>(3) Rated maximum temporary power and associated time limit.</P>
                    <P>(b) Duty cycle and the rating at that duty cycle. The duty cycle must be declared in the engine type certificate data sheet.</P>
                    <P>(c) Cooling fluid grade or specification.</P>
                    <P>(d) Power-supply requirements.</P>
                    <P>(e) Any other ratings or limitations that are necessary for the safe operation of the engine.</P>
                    <HD SOURCE="HD1">(3) Materials</HD>
                    <P>The engine design must comply with § 33.15.</P>
                    <HD SOURCE="HD1">(4) Fire Protection</HD>
                    <P>The engine design must comply with § 33.17(b) through (g). In addition—</P>
                    <P>(a) The design and construction of the engine and the materials used must minimize the probability of the occurrence and spread of fire during normal operation and failure conditions and must minimize the effect of such a fire.</P>
                    <P>(b) High-voltage electrical wiring interconnect systems must be protected against arc faults that can lead to hazardous engine effects as defined in special condition no. 17(d)(2) of these special conditions. Any non-protected electrical wiring interconnects must be analyzed to show that arc faults do not cause a hazardous engine effect.</P>
                    <HD SOURCE="HD1">(5) Durability</HD>
                    <P>The engine design and construction must minimize the development of an unsafe condition of the engine between maintenance intervals, overhaul periods, or mandatory actions described in the applicable ICA.</P>
                    <HD SOURCE="HD1">(6) Engine Cooling</HD>
                    <P>The engine design and construction must comply with § 33.21. In addition, if cooling is required to satisfy the safety analysis as described in special condition no. 17 of these special conditions, the cooling system monitoring features and usage must be documented in the and provided to the installer as part of the requirements in § 33.5.</P>
                    <HD SOURCE="HD1"> (7) Engine Mounting Attachments and Structure</HD>
                    <P>The engine mounting attachments and related engine structures must comply with § 33.23.</P>
                    <HD SOURCE="HD1"> (8) Accessory Attachments</HD>
                    <P>The engine must comply with § 33.25.</P>
                    <HD SOURCE="HD1">(9) Overspeed</HD>
                    <P>(a) A rotor overspeed must not result in a burst, rotor growth, or damage that results in a hazardous engine effect, as defined in special condition no. 17(d)(2) of these special conditions. Compliance with this paragraph must be shown by test, validated analysis, or a combination of both. Applicable assumed rotor speeds must be declared and justified.</P>
                    <P>(b) Rotors must possess sufficient strength with a margin to burst above certified operating conditions and above failure conditions leading to rotor overspeed. The margin to burst must be shown by test, validated analysis, or a combination thereof.</P>
                    <P>(c) The engine must not exceed the rotor speed operational limitations that could affect rotor structural integrity.</P>
                    <HD SOURCE="HD1">(10) Engine Control Systems</HD>
                    <P>
                        (a) 
                        <E T="03">Applicability.</E>
                         The requirements of this special condition apply to any system or device that is part of the engine type design that controls, limits, monitors, or protects engine operation, and is necessary for the continued airworthiness of the engine.
                    </P>
                    <P>
                        (b) 
                        <E T="03">Engine control.</E>
                         The engine control system must ensure that the engine does not experience any unacceptable operating characteristics or exceed its operating limits, including in failure conditions where the fault or failure results in a change from one control mode to another, from one channel to another, or from the primary system to the back-up system, if applicable.
                    </P>
                    <P>
                        (c) 
                        <E T="03">Design Assurance.</E>
                         The software and complex electronic hardware, including programmable logic devices, must be—
                    </P>
                    <P>(1) Designed and developed using a structured and systematic approach that provides a level of assurance for the logic commensurate with the hazard associated with the failure or malfunction of the systems in which the devices are located; and</P>
                    <P>(2) Substantiated by a verification methodology acceptable to the Administrator.</P>
                    <P>
                        (d) 
                        <E T="03">Validation.</E>
                         All functional aspects of the control system must be substantiated by test, analysis, or a combination thereof, to show that the engine control system performs the intended functions throughout the declared operational envelope.
                    </P>
                    <P>
                        (e) 
                        <E T="03">Environmental Limits.</E>
                         Environmental limits that cannot be adequately substantiated by endurance demonstration, validated analysis, or a combination thereof must be demonstrated by the system and component tests in special condition no. 27 of these special conditions.
                    </P>
                    <P>
                        (f) 
                        <E T="03">Engine control system failures.</E>
                         The engine control system must—
                        <PRTPAGE P="105443"/>
                    </P>
                    <P>(1) Have a maximum rate of loss of power control (LOPC) that is suitable for the intended aircraft application. The estimated LOPC rate must be documented and provided to the installer as part of the requirements in § 33.5;</P>
                    <P>(2) When in the full-up configuration, be single-fault tolerant, as determined by the Administrator, for electrical, electrically detectable, and electronic failures involving LOPC events;</P>
                    <P>(3) Not have any single failure that results in hazardous engine effects as defined in special condition no. 17(d)(2) of these special conditions; and</P>
                    <P>(4) Ensure failures or malfunctions that lead to local events in the aircraft do not result in hazardous engine effects, as defined in special condition no. 17(d)(2) of these special conditions, due to engine control system failures or malfunctions.</P>
                    <P>
                        (g) 
                        <E T="03">System safety assessment.</E>
                         The applicant must perform a system safety assessment. This assessment must identify faults or failures that affect normal operation, together with the predicted frequency of occurrence of these faults or failures. The intended aircraft application must be taken into account to assure that the assessment of the engine control system safety is valid. The rates of hazardous and major faults must be documented and provided to the installer as part of the requirements in § 33.5.
                    </P>
                    <P>
                        (h) 
                        <E T="03">Protection systems.</E>
                         The engine control devices and systems' design and function, together with engine instruments, operating instructions, and maintenance instructions, must ensure that engine operating limits that can lead to a hazard will not be exceeded in service.
                    </P>
                    <P>
                        (i) 
                        <E T="03">Aircraft supplied data.</E>
                         Any single failure leading to loss, interruption, or corruption of aircraft-supplied data (other than power-command signals from the aircraft), or aircraft-supplied data shared between engine systems within a single engine or between fully independent engine systems, must—
                    </P>
                    <P>(1) Not result in a hazardous engine effect, as defined in special condition no. 17(d)(2) of these special conditions, for any engine installed on the aircraft; and</P>
                    <P>(2) Be able to be detected and accommodated by the control system.</P>
                    <P>
                        (j) 
                        <E T="03">Engine control system electrical power.</E>
                    </P>
                    <P>(1) The engine control system must be designed such that the loss, malfunction, or interruption of the control system electrical power source will not result in a hazardous engine effect, unacceptable transmission of erroneous data, or continued engine operation in the absence of the control function. Hazardous engine effects are defined in special condition no. 17(d)(2) of these special conditions. The engine control system must be capable of resuming normal operation when aircraft-supplied power returns to within the declared limits.</P>
                    <P>(2) The applicant must identify, document, and provide to the installer as part of the requirements in § 33.5, the characteristics of any electrical power supplied from the aircraft to the engine control system, including transient and steady-state voltage limits, and any other characteristics necessary for safe operation of the engine.</P>
                    <HD SOURCE="HD1"> (11) Instrument Connection</HD>
                    <P>The applicant must comply with § 33.29(a), (e), and (g).</P>
                    <P>(a) In addition, as part of the system safety assessment of special condition nos. 10(g) and 33(h) of these special conditions, the applicant must assess the possibility and subsequent effect of incorrect fit of instruments, sensors, or connectors. Where practicable, the applicant must take design precautions to prevent incorrect configuration of the system.</P>
                    <P>(b) The applicant must provide instrumentation enabling the flight crew to monitor the functioning of the engine cooling system unless evidence shows that:</P>
                    <P>(1) Other existing instrumentation provides adequate warning of failure or impending failure;</P>
                    <P>(2) Failure of the cooling system would not lead to hazardous engine effects before detection; or</P>
                    <P>(3) The probability of failure of the cooling system is extremely remote.</P>
                    <HD SOURCE="HD1"> (12) Stress Analysis</HD>
                    <P>(a) A mechanical and thermal stress analysis, as well as an analysis of the stress caused by electromagnetic forces, must show a sufficient design margin to prevent unacceptable operating characteristics and hazardous engine effects as defined in special condition no. 17(d)(2) of these special conditions.</P>
                    <P>(b) Maximum stresses in the engine must be determined by test, validated analysis, or a combination thereof, and must be shown not to exceed minimum material properties.</P>
                    <HD SOURCE="HD1"> (13) Critical and Life-Limited Parts</HD>
                    <P>(a) The applicant must show, by a safety analysis or means acceptable to the Administrator, whether rotating or moving components, bearings, shafts, static parts, and non-redundant mount components should be classified, designed, manufactured, and managed throughout their service life as critical or life-limited parts.</P>
                    <P>(1) Critical part means a part that must meet prescribed integrity specifications to avoid its primary failure, which is likely to result in a hazardous engine effect as defined in special condition no. 17(d)(2) of these special conditions.</P>
                    <P>(2) Life-limited parts may include but are not limited to a rotor or major structural static part, the failure of which can result in a hazardous engine effect, as defined in special condition no. 17(d)(2) of these special conditions, due to a low-cycle fatigue (LCF) mechanism. A life limit is an operational limitation that specifies the maximum allowable number of flight cycles that a part can endure before the applicant must remove it from the engine.</P>
                    <P>(b) In establishing the integrity of each critical part or life-limited part, the applicant must provide to the Administrator the following three plans for approval:</P>
                    <P>(1) an engineering plan, as defined in § 33.70(a);</P>
                    <P>(2) a manufacturing plan, as defined in § 33.70(b); and</P>
                    <P>(3) a service-management plan, as defined in § 33.70(c).</P>
                    <HD SOURCE="HD1"> (14) Lubrication System</HD>
                    <P>(a) The lubrication system must be designed and constructed to function properly between scheduled maintenance intervals in all flight attitudes and atmospheric conditions in which the engine is expected to operate.</P>
                    <P>(b) The lubrication system must be designed to prevent contamination of the engine bearings and lubrication system components.</P>
                    <P>(c) The applicant must demonstrate by test, validated analysis, or a combination thereof, the unique lubrication attributes and functional capability of (a) and (b).</P>
                    <HD SOURCE="HD1"> (15) Power Response</HD>
                    <P>(a) The design and construction of the engine, including its control system, must enable an increase—</P>
                    <P>(1) From the minimum power setting to the highest rated power without detrimental engine effects;</P>
                    <P>(2) From the minimum obtainable power while in-flight and while on the ground to the highest rated power within a time interval determined to be appropriate for the intended aircraft application; and</P>
                    <P>(3) From the minimum torque to the highest rated torque without detrimental engine effects in the intended aircraft application.</P>
                    <P>
                        (b) The results of (a)(1), (a)(2), and (a)(3) of this special condition must be 
                        <PRTPAGE P="105444"/>
                        documented and provided to the installer as part of the requirements in § 33.5.
                    </P>
                    <HD SOURCE="HD1"> (16) Continued Rotation</HD>
                    <P>If the design allows any of the engine main rotating systems to continue to rotate after the engine is shut down while in-flight, this continued rotation must not result in any hazardous engine effects, as defined in special condition no. 17(d)(2) of these special conditions.</P>
                    <HD SOURCE="HD1"> (17) Safety Analysis</HD>
                    <P>(a) The applicant must comply with § 33.75(a)(1) and (a)(2) using the failure definitions in special condition no. 17(d) of these special conditions.</P>
                    <P>(b) The primary failure of certain single elements cannot be sensibly estimated in numerical terms. If the failure of such elements is likely to result in hazardous engine effects, then compliance may be shown by reliance on the prescribed integrity requirements of § 33.15 and special condition nos. 9 and 13 of these special conditions, as applicable. These instances must be stated in the safety analysis.</P>
                    <P>(c) The applicant must comply with § 33.75(d) and (e) using the failure definitions in special condition no. 17(d) of these special conditions, and the ICA in § 33.4.</P>
                    <P>(d) Unless otherwise approved by the Administrator, the following definitions apply to the engine effects when showing compliance with this condition:</P>
                    <P>(1) A minor engine effect does not prohibit the engine from performing its intended functions in a manner consistent with § 33.28(b)(1)(i), (b)(1)(iii), and (b)(1)(iv), and the engine complies with the operability requirements of special condition no. 15 and special condition no. 25 of these special conditions, as appropriate.</P>
                    <P>(2) The engine effects in § 33.75(g)(2) are hazardous engine effects with the addition of:</P>
                    <P>(i) Electrocution of the crew, passengers, operators, maintainers, or others; and</P>
                    <P>(ii) Blockage of cooling systems that could cause the engine effects described in § 33.75(g)(2) and special condition 17(d)(2)(i) of these special conditions.</P>
                    <P>(3) Any other engine effect is a major engine effect.</P>
                    <P>(e) The intended aircraft application must be taken into account when performing the safety analysis.</P>
                    <P>(f) The results of the safety analysis, and the assumptions about the aircraft application used in the safety analysis, must be documented and provided to the installer as part of the requirements in § 33.5.</P>
                    <HD SOURCE="HD1"> (18) Ingestion</HD>
                    <P>(a) Rain, ice, and hail ingestion must not result in an abnormal operation such as shutdown, power loss, erratic operation, or power oscillations throughout the engine operating range.</P>
                    <P>(b) Ingestion from other likely sources (birds, induction system ice, foreign objects—ice slabs) must not result in hazardous engine effects defined by special condition no. 17(d)(2) of these special conditions, or unacceptable power loss.</P>
                    <P>(c) If the design of the engine relies on features, attachments, or systems that the installer may supply, for the prevention of unacceptable power loss or hazardous engine effects, as defined in special condition no. 17(d)(2) of these special conditions, following potential ingestion, then the features, attachments, or systems must be documented and provided to the installer as part of the requirements in § 33.5.</P>
                    <HD SOURCE="HD1"> (19) Liquid and Gas Systems</HD>
                    <P>(a) Each system used for lubrication or cooling of engine components must be designed and constructed to function properly in all flight attitudes and atmospheric conditions in which the engine is expected to operate.</P>
                    <P>(b) If a system used for lubrication or cooling of engine components is not self-contained, the interfaces to that system must be defined, documented, and provided to the installer as part of the requirements in § 33.5.</P>
                    <P>(c) The applicant must establish by test, validated analysis, or a combination of both that all static parts subject to significant pressure loads will not:</P>
                    <P>(1) Exhibit permanent distortion beyond serviceable limits, or exhibit leakage that could create a hazardous condition when subjected to normal and maximum working pressure with margin;</P>
                    <P>(2) Exhibit fracture or burst when subjected to the greater of maximum possible pressures with margin.</P>
                    <P>(d) Compliance with special condition no. 19(c) of these special conditions must take into account:</P>
                    <P>(1) The operating temperature of the part;</P>
                    <P>(2) Any other significant static loads in addition to pressure loads;</P>
                    <P>(3) Minimum properties representative of both the material and the processes used in the construction of the part; and</P>
                    <P>(4) Any adverse physical geometry conditions allowed by the type design, such as minimum material and minimum radii.</P>
                    <P>(e) Approved coolants and lubricants must be documented and provided to the installer as part of the requirements in § 33.5.</P>
                    <HD SOURCE="HD1"> (20) Vibration Demonstration</HD>
                    <P>(a) The engine must be designed and constructed to function throughout its normal operating range of rotor speeds and engine output power, including defined exceedances, without inducing excessive stress in any of the engine parts because of vibration and without imparting excessive vibration forces to the aircraft structure.</P>
                    <P>(b) Each engine design must undergo a vibration survey to establish that the vibration characteristics of those components subject to induced vibration are acceptable throughout the declared flight envelope and engine operating range for the specific installation configuration. The possible sources of the induced vibration that the survey must assess are mechanical, aerodynamic, acoustical, internally induced electromagnetic, installation induced effects that can affect the engine vibration characteristics, and likely environmental effects. This survey must be shown by test, validated analysis, or a combination thereof.</P>
                    <HD SOURCE="HD1"> (21) Overtorque</HD>
                    <P>When approval is sought for a transient maximum engine overtorque, the applicant must demonstrate by test, validated analysis, or a combination thereof, that the engine can continue operation after operating at the maximum engine overtorque condition without maintenance action. Upon conclusion of overtorque tests conducted to show compliance with this special condition, or any other tests that are conducted in combination with the overtorque test, each engine part or individual groups of components must meet the requirements of special condition no. 29 of these special conditions.</P>
                    <HD SOURCE="HD1"> (22) Calibration Assurance</HD>
                    <P>Each engine must be subjected to calibration tests to establish its power characteristics, and the conditions both before and after the endurance and durability demonstrations specified in special conditions nos. 23 and 26 of these special conditions.</P>
                    <HD SOURCE="HD1"> (23) Endurance Demonstration</HD>
                    <P>
                        The applicant must subject the engine to an endurance demonstration, acceptable to the Administrator, to demonstrate the engine's limit capabilities. The endurance demonstration must include increases and decreases of the engine's power 
                        <PRTPAGE P="105445"/>
                        settings, energy regeneration, and dwellings at the power settings and energy regeneration for sufficient durations that produce the extreme physical conditions the engine experiences at rated performance levels, operational limits, and at any other conditions or power settings, including energy regeneration, which are required to verify the limit capabilities of the engine.
                    </P>
                    <HD SOURCE="HD1"> (24) Temperature Limit</HD>
                    <P>The engine design must demonstrate its capability to endure operation at its temperature limits plus an acceptable margin. The applicant must quantify and justify the margin to the Administrator. The demonstration must be repeated for all declared duty cycles and ratings, and operating environments, which would impact temperature limits.</P>
                    <HD SOURCE="HD1"> (25) Operation Demonstration</HD>
                    <P>The engine design must demonstrate safe operating characteristics, including but not limited to power cycling, starting, acceleration, and overspeeding throughout its declared flight envelope and operating range. The declared engine operational characteristics must account for installation loads and effects.</P>
                    <HD SOURCE="HD1"> (26) Durability Demonstration</HD>
                    <P>The engine must be subjected to a durability demonstration to show that each part of the engine has been designed and constructed to minimize any unsafe condition of the system between overhaul periods, or between engine replacement intervals if the overhaul is not defined. This test must simulate the conditions in which the engine is expected to operate in service, including typical start-stop cycles, to establish when the initial maintenance is required.</P>
                    <HD SOURCE="HD1"> (27) System and Component Tests</HD>
                    <P>The applicant must show that systems and components that cannot be adequately substantiated in accordance with the endurance demonstration or other demonstrations will perform their intended functions in all declared environmental and operating conditions.</P>
                    <HD SOURCE="HD1"> (28) Rotor Locking Demonstration</HD>
                    <P>If shaft rotation is prevented by locking the rotor(s), the engine must demonstrate:</P>
                    <P>(a) Reliable rotor locking performance;</P>
                    <P>(b) Reliable rotor unlocking performance; and</P>
                    <P>(c) That no hazardous engine effects, as specified in special condition no. 17(d)(2) of these special conditions, will occur.</P>
                    <HD SOURCE="HD1"> (29) Teardown Inspection</HD>
                    <P>(a) Teardown evaluation.</P>
                    <P>(1) After the endurance and durability demonstrations have been completed, the engine must be completely disassembled. Each engine component and lubricant must be eligible for continued operation in accordance with the information submitted for showing compliance with § 33.4.</P>
                    <P>(2) Each engine component, having an adjustment setting and a functioning characteristic that can be established independent of installation on or in the engine, must retain each setting and functioning characteristic within the established and recorded limits at the beginning of the endurance and durability demonstrations.</P>
                    <P>(b) Non-Teardown evaluation. If a teardown cannot be performed for all engine components in a non-destructive manner, then the inspection or replacement intervals for these components and lubricants must be established based on the endurance and durability demonstrations and must be documented in the ICA in accordance with § 33.4.</P>
                    <HD SOURCE="HD1"> (30) Containment</HD>
                    <P>The engine must be designed and constructed to protect against likely hazards from rotating components as follows—</P>
                    <P>(a) The design of the stator case surrounding rotating components must provide for the containment of the rotating components in the event of failure, unless the applicant shows that the margin to rotor burst precludes the possibility of a rotor burst.</P>
                    <P>(b) If the margin to burst shows that the stator case must have containment features in the event of failure, then the stator case must provide for the containment of the failed rotating components. The applicant must define by test, validated analysis, or a combination thereof, and document and provide to the installer as part of the requirements in § 33.5, the energy level, trajectory, and size of fragments released from damage caused by the main-rotor failure, and that pass forward or aft of the surrounding stator case.</P>
                    <HD SOURCE="HD1">(31) [RESERVED]</HD>
                    <HD SOURCE="HD1"> (32) General Conduct of Tests</HD>
                    <P>(a) Maintenance of the engine may be made during the tests in accordance with the service and maintenance instructions submitted in compliance with § 33.4.</P>
                    <P>(b) The applicant must subject the engine or its parts to any additional tests that the Administrator finds necessary if—</P>
                    <P>(1) The frequency of engine service is excessive;</P>
                    <P>(2) The number of stops due to engine malfunction is excessive;</P>
                    <P>(3) Major engine repairs are needed; or</P>
                    <P>(4) Replacement of an engine part is found necessary during the tests, or due to the teardown inspection findings.</P>
                    <P>(c) Upon completion of all demonstrations and testing specified in these special conditions, the engine and its components must be—</P>
                    <P>(1) Within serviceable limits;</P>
                    <P>(2) Safe for continued operation; and</P>
                    <P>(3) Capable of operating at declared ratings while remaining within limits.</P>
                    <HD SOURCE="HD1"> (33) Engine Electrical Systems</HD>
                    <P>
                        (a) 
                        <E T="03">Applicability.</E>
                         Any system or device that provides, uses, conditions, or distributes electrical power, and is part of the engine type design, must provide for the continued airworthiness of the engine, and must maintain electric engine ratings.
                    </P>
                    <P>
                        (b) 
                        <E T="03">Electrical systems.</E>
                         The electrical system must ensure the safe generation and transmission of power, and electrical load shedding if load shedding is required, and that the engine does not experience any unacceptable operating characteristics or exceed its operating limits.
                    </P>
                    <P>
                        (c) 
                        <E T="03">Electrical power distribution.</E>
                    </P>
                    <P>(1) The engine electrical power distribution system must be designed to provide the safe transfer of electrical energy throughout the powerplant. The system must be designed to provide electrical power so that the loss, malfunction, or interruption of the electrical power source will not result in a hazardous engine effect, as defined in special condition no. 17(d)(2) of these special conditions.</P>
                    <P>(2) The system must be designed and maintained to withstand normal and abnormal conditions during all ground and flight operations.</P>
                    <P>(3) The system must provide mechanical or automatic means of isolating a faulted electrical energy generation or storage device from leading to hazardous engine effects, as defined in special condition no. 17(d)(2) of these special conditions, or detrimental effects in the intended aircraft application.</P>
                    <P>
                        (d) 
                        <E T="03">Protection systems.</E>
                         The engine electrical system must be designed such that the loss, malfunction, interruption of the electrical power source, or power conditions that exceed design limits, will not result in a hazardous engine effect, as defined in special condition no. 17(d)(2) of these special conditions.
                        <PRTPAGE P="105446"/>
                    </P>
                    <P>
                        (e) 
                        <E T="03">Electrical power characteristics.</E>
                         The applicant must identify, declare, document, and provide to the installer as part of the requirements in § 33.5, the characteristics of any electrical power supplied from—
                    </P>
                    <P>(1) the aircraft to the engine electrical system, for starting and operating the engine, including transient and steady-state voltage limits, and</P>
                    <P>(2) the engine to the aircraft via energy regeneration, and any other characteristics necessary for safe operation of the engine.</P>
                    <P>
                        (f) 
                        <E T="03">Environmental limits.</E>
                         Environmental limits that cannot adequately be substantiated by endurance demonstration, validated analysis, or a combination thereof must be demonstrated by the system and component tests in special condition no. 27 of these special conditions.
                    </P>
                    <P>
                        (g) 
                        <E T="03">Electrical system failures.</E>
                         The engine electrical system must—
                    </P>
                    <P>(1) Have a maximum rate of LOPC that is suitable for the intended aircraft application;</P>
                    <P>(2) When in the full-up configuration, be single-fault tolerant, as determined by the Administrator, for electrical, electrically detectable, and electronic failures involving LOPC events;</P>
                    <P>(3) Not have any single failure that results in hazardous engine effects; and</P>
                    <P>(4) Ensure failures or malfunctions that lead to local events in the intended aircraft application do not result in hazardous engine effects, as defined in special condition no. 17(d)(2) of these special conditions, due to electrical system failures or malfunctions.</P>
                    <P>
                        (h) 
                        <E T="03">System safety assessment.</E>
                         The applicant must perform a system safety assessment. This assessment must identify faults or failures that affect normal operation, together with the predicted frequency of occurrence of these faults or failures. The intended aircraft application must be taken into account to assure the assessment of the engine system safety is valid. The rates of hazardous and major faults must be declared, documented, and provided to the installer as part of the requirements in § 33.5.
                    </P>
                </REGTEXT>
                <SIG>
                    <DATED>Issued in Kansas City, Missouri, on December 19, 2024.</DATED>
                    <NAME>Patrick R. Mullen,</NAME>
                    <TITLE>Manager, Technical Policy Branch, Policy and Standards Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30855 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 61</CFR>
                <DEPDOC>[Docket No. FAA-2024-2580; Amdt. No. 61-158A]</DEPDOC>
                <RIN>RIN 2120-AM06</RIN>
                <SUBJECT>Regulatory Updates to BasicMed; Correction</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Correcting amendment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>On November 18, 2024, the Federal Aviation Administration (FAA) published a final rule titled “Regulatory Updates to BasicMed.” That document implemented the provisions of sections 815 and 828 of the FAA Reauthorization Act of 2024. The final rule's revision to the part 61 authority citation that cites the 2024 FAA Reauthorization Act was erroneously overwritten by another rulemaking action revising part 61. This document corrects the amendatory instruction and revises the part 61 authority citation to be inclusive of the intended updates promulgated in the BasicMed final rule.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This correction is effective December 27, 2024.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Bradley C. Zeigler, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-1100; email: 
                        <E T="03">Bradley.C.Zeigler@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On October 1, 2024, the FAA published the final rule 
                    <E T="03">Removal of Expiration Date on a Flight Instructor Certificate; Additional Qualification Requirements To Train Initial Flight Instructor Applicants; and Other Provisions</E>
                     in the 
                    <E T="04">Federal Register</E>
                     (89 FR 80020) (hereinafter the CFI rule). That final rule removed the expiration date on flight instructor certificates to align with other airman certificates. Additional amendments included updating renewal requirements to recent experience requirements, introducing a new method for establishing recent flight instructor experience, and allowing instructors with a lapse of no more than three months to reinstate privileges via an approved flight instructor refresher course instead of a practical test. The final rule also added two new methods for flight instructors to qualify to train initial applicants.
                </P>
                <P>As part of the amendments made in the CFI rule, the FAA revised the authority citation for part 61 by removing 49 U.S.C. 106(g) as that paragraph had been removed and reserved as part of the FAA Reauthorization Act of 2024. The final rule added section 820 of Public Law 118-63 to the authority citation. Section 820 of the FAA Reauthorization Act of 2024 required the FAA to promulgate the CFI final rule within 18 months after the date of enactment of the Act, to at a minimum, update part 61, Code of Federal Regulations, to remove the expiration date on the flight instructor certificate and replace the requirement that a flight instructor renews their flight instructor certificate with appropriate recent experience requirements. The CFI rule became effective on December 1, 2024.</P>
                <P>
                    Subsequently, on November 18, 2024, the FAA published the final rule 
                    <E T="03">Regulatory Updates to BasicMed</E>
                     (89 FR 90572) (hereinafter the BasicMed rule). That final rule implemented the provisions of sections 815 and 828 of the FAA Reauthorization Act of 2024. In the BasicMed rule, the FAA revised the authority citation for part 61 by adding sections 815 and 828 of Public Law 118-63 to the authority citation for part 61. The BasicMed final rule became effective on the date of publication, November 18, 2024.
                </P>
                <P>However, when the CFI rule became effective on December 1, 2024, and the authority citation for part 61 was revised in accordance with the instructions contained in the CFI rule, those revisions inadvertently removed the revisions made in the BasicMed final rule which published after, but became effective before, the CFI rule. Therefore, this correction revises the authority citation for part 61 to include both the revisions from the CFI rule and the BasicMed rule.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 61</HD>
                    <P>Aircraft, Airmen, Aviation safety, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <PART>
                    <HD SOURCE="HED">PART 61—CERTIFICATION: PILOTS, FLIGHT INSTRUCTORS, AND GROUND INSTRUCTORS</HD>
                </PART>
                <REGTEXT TITLE="14" PART="61">
                    <AMDPAR>1. The authority citation for part 61 is revised to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 49 U.S.C. 106(f), 40113, 44701-44703, 44707, 44709-44711, 44729, 44903, 45102-45103, 45301-45302; Sec. 2307, Pub. L. 114-190, 130 Stat. 615 (49 U.S.C. 44703 note); sec. 318, Pub. L. 115-254, 132 Stat. 3186 (49 U.S.C. 44703 note); sec. 820, Pub. L. 118-63, 138 Stat. 1330 (49 U.S.C. 44939 note); secs. 815 and 828, Pub. L. 118-63, 138 Stat. 1328, 1336 (49 U.S.C. 44703 note).</P>
                    </AUTH>
                </REGTEXT>
                <SIG>
                    <PRTPAGE P="105447"/>
                    <P>Issued under authority provided by 49 U.S.C. 106(f), 44701(a), and 44703 in Washington, DC.</P>
                    <NAME>Brandon Roberts,</NAME>
                    <TITLE>Executive Director, Office of Rulemaking.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30940 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 120</CFR>
                <DEPDOC>[Docket No. FAA-2020-1058]</DEPDOC>
                <RIN>RIN 2120-AK09</RIN>
                <SUBJECT>Drug and Alcohol Testing of Certificated Repair Station Employees Located Outside of the United States; Correction</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; correction.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        On December 18, 2024, the Federal Aviation Administration (FAA) published a final rule in the 
                        <E T="04">Federal Register</E>
                         titled “Drug and Alcohol Testing of Certificated Repair Station Employees Located Outside of the United States”.
                    </P>
                    <P>The final rule inadvertently mischaracterized two commenters which does not accurately reflect their respective memberships. This document makes those corrections.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective January 17, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Nancy Rodriguez Brown, Office of Aerospace Medicine, Drug Abatement Division, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone (202) 267-8442; email: 
                        <E T="03">drugabatement@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On December 18, 2024, the FAA published the final rule Drug and Alcohol Testing of Certificated Repair Station Employees Located Outside of the United States (RIN 2120-AK09) in the 
                    <E T="04">Federal Register</E>
                     at 89 FR 103416. That document requires certificated repair stations located outside the territory of the United States (U.S.) whose employees perform safety-sensitive maintenance functions on certain air carrier aircraft to conduct alcohol and controlled substance testing in a manner acceptable to the Administrator and consistent with the applicable laws of the country in which the repair station is located. The document also directs the repair station to comply with the requirements of the Drug and Alcohol Testing Program published by the FAA and the Procedures for Transportation Workplace Drug Testing Programs published by the Department of Transportation, as proposed. However, the documents also allows foreign governments, on behalf of certificated repair stations within their territories, and individual foreign repair stations subject to the rule to obtain the Administrator's recognition of a compatible alternative that contains minimum criteria in lieu of compliance with certain components of the Drug and Alcohol Testing Program.
                </P>
                <P>In that final rule, the FAA inadvertently mischaracterized two commenters which does not accurately reflect their respective memberships. This document makes those corrections</P>
                <HD SOURCE="HD1">Correction</HD>
                <P>
                    In the final rule FR Doc. 2024-29837, beginning on page 103416, in the 
                    <E T="04">Federal Register</E>
                     of December 18, 2024, make the following correction: On page 103423 in the first column, in the first full paragraph, correct the last sentence to read as: “The 17 supporting commenters included transportation labor groups and unions (International Brotherhood of Teamsters (Teamsters), Transport Workers Union of America (TWU), and Transportation Trades Department, AFL-CIO (TTD)), a pilots' union (Allied Pilots Association (APA)), a trade association (National Drug &amp; Alcohol Screening Association (NDASA)), a Substance Abuse Professional (SAP) Directory service (SAPList), a software provider (Nexus 33 Group LLC), and 10 individuals.”
                </P>
                <P>Issued under authority provided by 49 U.S.C. 106(f), 45102, 44731(d) in Washington, DC.</P>
                <SIG>
                    <NAME>Brandon Roberts,</NAME>
                    <TITLE>Executive Director, Office of Rulemaking.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30848 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 135</CFR>
                <DEPDOC>[Docket No. FAA-2019-0360; Amdt. No. 135-145A]</DEPDOC>
                <RIN>RIN 2120-AL12</RIN>
                <SUBJECT>Removal of Check Pilot Medical Certificate Requirement; Correction</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Correcting amendments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>On June 18, 2024, the Federal Aviation Administration (FAA) published a final rule titled “Removal of Check Pilot Medical Certificate Requirement,” which was corrected on July 16, 2024. That final rule removed inconsistencies applicable to the qualification requirements for check pilots and flight instructors in domestic, flag, and supplemental operations and flight instructors in commuter and on demand operations so that check pilots, check flight engineers, and flight instructors can continue to perform their functions in aircraft without a medical certificate unless they are serving as required flightcrew members. It also removed the medical certificate requirement for flight instructors in commuter and on-demand operations who perform their functions in aircraft and are not serving as required flightcrew members. The final rule inadvertently failed to revise two section headings. This document makes those corrections.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This correction is effective December 27, 2024.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Joshua Jackson, Aviation Safety Inspector, Air Transportation Division, Flight Standards Service, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: 202-267-8166; email: 
                        <E T="03">joshua.jackson@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On June 18, 2024, the FAA published a final rule titled “Removal of Check Pilot Medical Certificate Requirement.” 
                    <SU>1</SU>
                    <FTREF/>
                     That final rule removed inconsistencies applicable to the qualification requirements for check pilots and flight instructors in domestic, flag, and supplemental operations and flight instructors in commuter and on demand operations so that check pilots, check flight engineers, and flight instructors can continue to perform their functions in aircraft without a medical certificate unless they are serving as required flightcrew members. It also removed the medical certificate requirement for flight instructors in commuter and on-demand operations who perform their functions in aircraft and are not serving as required flightcrew members. This is the second set of corrections. The first set of corrections was published in the 
                    <E T="04">Federal Register</E>
                     on July 16, 2024 (89 FR 57729). This document augments the previously published corrections.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Removal of Check Pilot Medical Certificate Requirement final rule, 89 FR 51416 (Jun. 18, 2024), corrected at 89 FR 57729 (Jul. 16, 2024).
                    </P>
                </FTNT>
                <P>
                    After publication of the final rule, the FAA determined that the revisions to the section headings for §§ 135.339 and 
                    <PRTPAGE P="105448"/>
                    135.340 had inadvertently not been made. The final rule intended to revise the section heading for § 135.339 by removing the obsolete terminology “check airmen (aircraft), check airmen (simulator)” and replacing them with “check pilots.” This would rename the heading to that section from “§ 135.339 Initial and transition training and checking: Check airmen (aircraft), check airmen (simulator),” to “§ 135.339 Initial and transition training and checking: Check pilots.” Similarly, the section heading for § 135.340 was also intended to be revised by removing the obsolete terminology “flight instructors (aircraft)” and “flight instructors (simulator)” and replacing those terms with “flight instructor. This would rename the heading to that section from “§ 135.340 Initial and transition training and checking: Flight instructors (aircraft), flight instructors (simulator)” to “§ 135.340 Initial and transition training and checking: Flight instructors.” However, the FAA failed to include the instruction to revise the section heading in the amendatory instructions for both sections. This document makes those corrections.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 135</HD>
                    <P>Aircraft, Airmen, Aviation safety, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <P>Accordingly, 14 CFR part 135 is corrected by making the following correcting amendments:</P>
                <PART>
                    <HD SOURCE="HED">PART 135—OPERATING REQUIREMENTS: COMMUTER AND ON DEMAND OPERATIONS AND RULES GOVERNING PERSONS ON BOARD SUCH AIRCRAFT</HD>
                </PART>
                <REGTEXT TITLE="14" PART="135">
                    <AMDPAR>1. The authority citation for part 135 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 49 U.S.C. 106(f), 40113, 41706, 44701-44702, 44705, 44709, 44711-44713, 44715-44717, 44722, 44730, 45101-45105; Pub. L. 112-95, 126 Stat. 58 (49 U.S.C. 44730).</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="14" PART="135">
                    <AMDPAR>2. Amend § 135.339 by revising the section heading to read as follows:</AMDPAR>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 135.339</SECTNO>
                    <SUBJECT>Initial and transition training and checking: Check pilots.</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="14" PART="135">
                    <AMDPAR>3. Amend § 135.340 by revising the section heading to read as follows:</AMDPAR>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 135.340</SECTNO>
                    <SUBJECT>Initial and transition training and checking: Flight instructors.</SUBJECT>
                </SECTION>
                <SIG>
                    <P>Issued under authority provided by 49 U.S.C. 106(f), 44701(a), and 44703 in Washington, DC.</P>
                    <NAME>Brandon Roberts,</NAME>
                    <TITLE>Executive Director, Office of Rulemaking.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30939 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Bureau of Industry and Security</SUBAGY>
                <CFR>15 CFR Parts 742, 743, and 774</CFR>
                <DEPDOC>[Docket No. 241204-0310]</DEPDOC>
                <RIN>RIN 0694-AJ60</RIN>
                <SUBJECT>Commerce Control List Additions and Revisions; Implementation of Controls on Advanced Technologies Consistent With Controls Implemented by International Partners; Correction</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Industry and Security, Department of Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Correcting amendment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        On September 6, 2024, BIS published in the 
                        <E T="04">Federal Register</E>
                         an interim final rule entitled “Commerce Control List Additions and Revisions; Implementation of Controls on Advanced Technologies Consistent with Controls Implemented by International Partners” (RIN 0694-AJ60) that contained inadvertent errors. This rule corrects those errors.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective December 27, 2024.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P/>
                    <P>
                        <E T="03">For general questions contact:</E>
                         Sharron Cook at 202-482-2440 or 
                        <E T="03">RPD2@bis.doc.gov.</E>
                    </P>
                    <P>
                        <E T="03">For technical questions contact:</E>
                    </P>
                    <P>
                        Category 2: Sean Ghannadian at 202-482-3429 or 
                        <E T="03">Sean.Ghannadian@bis.doc.gov.</E>
                    </P>
                    <P>
                        Category 3: Carlos Monroy at 202-482-3246 or 
                        <E T="03">Carlos.Monroy@bis.doc.gov.</E>
                    </P>
                    <P>
                        Category 4: Aaron Amundson at 202-482-0707 or 
                        <E T="03">Aaron.Amundson@bis.doc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On September 6, 2024, BIS published in the 
                    <E T="04">Federal Register</E>
                     the interim final rule “Commerce Control List Additions and Revisions; Implementation of Controls on Advanced Technologies Consistent with Controls Implemented by International Partners” (RIN 0694-AJ60) (89 FR 72926). That rule contained inadvertent errors in §§ 742.4, 742.6, and 743.7 of the Export Administration Regulations (15 CFR parts 730 through 774) (EAR) and in Export Control Classification Numbers (ECCNs) 2B910 and 3C908 of the Commerce Control List (CCL) in supplement no. 1 to part 774 of the EAR.
                </P>
                <HD SOURCE="HD1">Corrections</HD>
                <P>In column 1 of 89 FR 72938, under the section heading “§ 742.4 National security,” there is an incorrect citation. This rule amends the regulatory text in § 742.4(a)(5)(ii)(A) by replacing the reference to “general order no. 4” with “general order no. 6.”</P>
                <P>
                    In columns 1 and 2 of 89 FR 72938, also under the section heading “§ 742.4 National security,” the paragraph designations in § 742.4 are incorrect. This rule revises paragraph (a)(5)(ii)(B)(
                    <E T="03">1</E>
                    ) to clarify the reference to quantum items eligible for the deemed export and deemed reexport exclusion by breaking the “technology” parenthetical referencing ECCNs 4D906 and 4E906 into separate list entries for ECCN 4D906 and ECCN 4E906.
                </P>
                <P>In column 3 of 89 FR 72938, under the section heading “§ 742.6 Regional stability,” there is an incorrect citation in § 742.6(a)(10)(ii)(A). This rule amends § 742.6(a)(10)(ii)(A) by replacing the reference to “general order no. 4” with “general order no. 6.”</P>
                <P>In column 2 of 89 FR 72939, under the part heading “Part 743—Special Reporting and Notification”, the paragraph designations in § 743.7 are incorrect. This rule amends § 743.7 by redesignating paragraphs (c)(1)(A) through (C) as paragraphs (c)(1)(i) through (iii), and redesignating paragraphs (c)(2)(A) through (D) as paragraphs (c)(2)(i) through (iv).</P>
                <P>In column 2 of 89 FR 72940, in the CCL of the EAR, ECCN 2B910.d contains an error. This rule corrects ECCN 2B910.d by replacing the citation to 2B010.c with 2B910.c.</P>
                <P>
                    In column 1 of 89 FR 72951, in the CCL of the EAR, the license requirement table in ECCN 3C908 contains inadvertent errors (
                    <E T="03">i.e.,</E>
                     the duplication of the Regional Stability (RS) license requirement paragraph and omission of an Anti-terrorism (AT) license requirement paragraph). This rule corrects ECCN 3C908 by removing the duplicate RS license requirement paragraph and adding the missing AT license requirement paragraph.
                </P>
                <HD SOURCE="HD1">Export Control Reform Act of 2018</HD>
                <P>
                    On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which included the Export Control Reform Act of 2018 (ECRA) (codified, as amended, at 50 U.S.C. 4801-4852). ECRA provides the legal basis for BIS's principal authorities and serves as the authority under which BIS issues this rule. In particular, Section 1753 of ECRA (50 U.S.C. 4812) authorizes the regulation of exports, reexports, and transfers (in-country) of items subject to U.S. jurisdiction. Further, Section 1754(a)(1)-(16) of ECRA (50 U.S.C. 4813(a)(1)-(16)) 
                    <PRTPAGE P="105449"/>
                    authorizes, inter alia, the establishment of a list of controlled items; the prohibition of unauthorized exports, reexports, and transfers (in-country); the requirement of licenses or other authorizations for exports, reexports, and transfers (in-country) of controlled items; apprising the public of changes in policy, regulations, and procedures; and any other action necessary to carry out ECRA that is not otherwise prohibited by law. Pursuant to section 1762(a) of ECRA (50 U.S.C. 4821(a)), these changes can be imposed in a final rule without prior notice and comment. The revisions, including the addition of the missing AT license requirement paragraph to ECCN 3C908, made through this rulemaking fall within the authorizations conferred by ECRA as described above.
                </P>
                <HD SOURCE="HD1">Rulemaking Requirements</HD>
                <P>1. This correction has not been designated a “significant regulatory action” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094.</P>
                <P>2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This rule involves collections currently approved by OMB under the following control numbers:</P>
                <P>• 0694-0088, “Simplified Network Application Processing System,” which carries a burden-hour estimate of 29.6 minutes for a manual or electronic submission;</P>
                <P>• 0694-0137 “License Exceptions and Exclusions,” which carries a burden-hour estimate average of 1.5 hours per submission (Note: submissions for License Exceptions are rarely required);</P>
                <P>• 0694-0096 “Five Year Records Retention Period,” which carries a burden-hour estimate of less than 1 minute; and</P>
                <P>• 0607-0152 “Automated Export System (AES) Program,” which carries a burden-hour estimate of 3 minutes per electronic submission.</P>
                <P>
                    Additional information regarding these collections of information—including all background materials—can be found at: 
                    <E T="03">https://www.reginfo.gov/public/do/PRAMain</E>
                     and using the search function to enter either the title of the collection or the OMB Control Number.
                </P>
                <P>3. This rule does not contain policies with federalism implications as that term is defined in Executive Order 13132.</P>
                <P>4. Pursuant to section 1762 of ECRA (50 U.S.C. 4821), this action is exempt from the Administrative Procedure Act (APA) (5 U.S.C. 553) requirements for notice of proposed rulemaking, opportunity for public participation and delay in effective date. While Section 1762 of ECRA provides sufficient authority for such an exemption, this action is also independently exempt from these APA requirements because it involves a military or foreign affairs function of the United States (5 U.S.C. 553(a)(1)).</P>
                <P>
                    5. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601, 
                    <E T="03">et seq.</E>
                    ) are not applicable. Accordingly, no regulatory flexibility analysis is required, and none has been prepared.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects</HD>
                    <CFR>15 CFR Part 742</CFR>
                    <P>Exports, Terrorism.</P>
                    <CFR>15 CFR Part 743</CFR>
                    <P>Administrative practice and procedure, Exports, Reporting and recordkeeping.</P>
                    <CFR>15 CFR Part 774</CFR>
                    <P>Exports, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <AMDPAR>Accordingly, parts 742, 743, and 774 of the EAR (15 CFR parts 730 through 774) are corrected by making the following correcting amendments:</AMDPAR>
                <PART>
                    <HD SOURCE="HED">PART 742—CONTROL POLICY—CCL BASED CONTROLS</HD>
                </PART>
                <REGTEXT TITLE="15" PART="742">
                    <AMDPAR>1. The authority citation for part 742 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>
                            50 U.S.C. 4801-4852; 50 U.S.C. 4601 
                            <E T="03">et seq.;</E>
                             50 U.S.C. 1701 
                            <E T="03">et seq.;</E>
                             22 U.S.C. 3201 
                            <E T="03">et seq.;</E>
                             42 U.S.C. 2139a; 22 U.S.C. 7201 
                            <E T="03">et seq.;</E>
                             22 U.S.C. 7210; Sec. 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320; Notice of November 1, 2023, 88 FR 75475 (November 3, 2023).
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="15" PART="742">
                    <AMDPAR>2. Section 742.4 is amended by:</AMDPAR>
                    <AMDPAR>a. Removing the phase “general order no. 4” and adding in its place “general order no. 6” in paragraph (a)(5)(ii)(A); and</AMDPAR>
                    <AMDPAR>
                        b. Revising paragraph (a)(5)(ii)(B)(
                        <E T="03">1</E>
                        ).
                    </AMDPAR>
                    <P>The revision reads as follows:</P>
                    <SECTION>
                        <SECTNO>§ 742.4</SECTNO>
                        <SUBJECT>National security.</SUBJECT>
                        <STARS/>
                        <P>(a) * * *</P>
                        <P>(5) * * *</P>
                        <P>(ii) * * *</P>
                        <P>(B) * * *</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) 
                            <E T="03">Limited exclusion.</E>
                             There is a limited deemed export or deemed reexport exclusion from the license requirements in paragraph (a)(5)(i) of this section for the following “software” or “technology” ECCNs unless for foreign persons whose most recent citizenship or permanent residency is a destination specified in Country Group D:1 or D:5: ECCNs 2D910; 2E910; 3D001 (“software” for “EUV” masks and reticles in ECCN 3B001.q); 3D901 (for “software” for quantum items in ECCNs 3A901.b and 3B904 and for scanning electron microscopes (SEM) in ECCN 3B903); 3D907 “software” designed to extract “GDSII” or equivalent data; 3E001 (“technology” for “EUV” masks and reticles in ECCN 3B001.q); and 3E901 (for “technology” for quantum items in 3A901, 3A904, 3B904, 3C907, 3C908, and 3C909, and for SEMs in ECCN 3B903); 3E905 (“technology” according to the General Technology Note for the “development” or “production” of integrated circuits or devices, using “Gate all-around Field-Effect Transistor” (“GAAFET”) structures); 4D906 “software” (for quantum items in 4A906), and 4E906 “technology” (for quantum items in ECCNs 4A906 or 4D906).
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="15" PART="742">
                    <SECTION>
                        <SECTNO>§ 742.6</SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>3. Section 742.6 is amended by removing the phase “general order no. 4” and adding in its place “general order no. 6” in paragraph (a)(10)(ii)(A).</AMDPAR>
                </REGTEXT>
                <PART>
                    <HD SOURCE="HED">PART 743—SPECIAL REPORTING AND NOTIFICATION</HD>
                </PART>
                <REGTEXT TITLE="15" PART="743">
                    <AMDPAR>4. The authority citation for part 743 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                             50 U.S.C. 4801-4852; 50 U.S.C. 4601 
                            <E T="03">et seq.;</E>
                             50 U.S.C. 1701 
                            <E T="03">et seq.;</E>
                             E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13637, 78 FR 16129, 3 CFR, 2014 Comp., p. 223; 78 FR 16129.
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="15" PART="743">
                    <SECTION>
                        <SECTNO>§ 743.7</SECTNO>
                        <SUBJECT> [Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>5. Section 743.7 is amended by:</AMDPAR>
                    <AMDPAR>a. Redesignating paragraphs (c)(1)(A) through (C) as paragraphs (c)(1)(i) through (iii); and</AMDPAR>
                    <AMDPAR>b. Redesignating paragraphs (c)(2)(A) through (D) as paragraphs (c)(2)(i) through (iv).</AMDPAR>
                </REGTEXT>
                <REGTEXT TITLE="15" PART="774">
                    <PART>
                        <PRTPAGE P="105450"/>
                        <HD SOURCE="HED">PART 774—THE COMMERCE CONTROL LIST</HD>
                    </PART>
                    <AMDPAR>6. The authority citation for part 774 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>
                             50 U.S.C. 4801-4852; 50 U.S.C. 4601 
                            <E T="03">et seq.;</E>
                             50 U.S.C. 1701 
                            <E T="03">et seq.;</E>
                             10 U.S.C. 8720; 10 U.S.C. 8730(e); 22 U.S.C. 287c, 22 U.S.C. 3201 
                            <E T="03">et seq.;</E>
                             22 U.S.C. 6004; 42 U.S.C. 2139a; 15 U.S.C. 1824; 50 U.S.C. 4305; 22 U.S.C. 7201 
                            <E T="03">et seq.;</E>
                             22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783.
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="15" PART="774">
                    <AMDPAR>7. Supplement no. 1 to part 774 is amended by revising ECCNs 2B910 and 3C908 to read as follows:</AMDPAR>
                    <HD SOURCE="HD1">Supplement No. 1 to Part 774—The Commerce Control List</HD>
                    <STARS/>
                    <EXTRACT>
                        <FP SOURCE="FP-2">
                            <E T="04">2B910 Additive manufacturing equipment, designed to produce metal or metal alloy components, having all of the following (see List of Items Controlled), and “specially designed” “components” therefor.</E>
                        </FP>
                        <HD SOURCE="HD1">License Requirements</HD>
                        <FP SOURCE="FP-2">
                            <E T="03">Reason for Control:</E>
                             NS, RS, AT
                        </FP>
                        <GPOTABLE COLS="2" OPTS="L0,tp0,i1" CDEF="s10,r10">
                            <TTITLE> </TTITLE>
                            <BOXHD>
                                <CHED H="1">
                                    <E T="03">Control(s)</E>
                                </CHED>
                                <CHED H="1">
                                    <E T="03">Country chart</E>
                                    <LI>
                                        <E T="03">(see Supp. No. 1</E>
                                    </LI>
                                    <LI>
                                        <E T="03">to part 738)</E>
                                    </LI>
                                </CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">NS applies to entire entry</ENT>
                                <ENT>
                                    Worldwide control.
                                    <LI>
                                        <E T="03">See § 742.4(a)(5) and (b)(10) of the EAR.</E>
                                    </LI>
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">RS applies to entire entry</ENT>
                                <ENT>
                                    Worldwide control.
                                    <LI>
                                        <E T="03">See § 742.6(a)(10) and (b)(11) of the EAR.</E>
                                    </LI>
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">AT applies to entire entry</ENT>
                                <ENT>AT Column 1.</ENT>
                            </ROW>
                        </GPOTABLE>
                        <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                        <FP SOURCE="FP-1">
                            <E T="03">LVS:</E>
                             N/A
                        </FP>
                        <FP SOURCE="FP-1">
                            <E T="03">GBS:</E>
                             N/A
                        </FP>
                        <FP SOURCE="FP-1">
                            <E T="03">IEC:</E>
                             Yes, see § 740.2(a)(22) and § 740.24 of the EAR.
                        </FP>
                        <HD SOURCE="HD1">Special Conditions for STA</HD>
                        <P>
                            <E T="03">STA:</E>
                             License Exception STA may not be used to ship any item in this ECCN to any of the destinations listed in Country Group A:5 or A:6 (See Supplement No.1 to part 740 of the EAR).
                        </P>
                        <HD SOURCE="HD1">List of Items Controlled</HD>
                        <P>
                            <E T="03">Related Controls:</E>
                             For related “technology” see ECCN 2E910.
                        </P>
                        <P>
                            <E T="03">Related Definitions:</E>
                             N/A
                        </P>
                        <P>
                            <E T="03">Items:</E>
                        </P>
                        <P>a. Having at least one of the following consolidation sources:</P>
                        <P>a.1. “Laser”;</P>
                        <P>
                            a.2. Electron beam; 
                            <E T="03">or</E>
                        </P>
                        <P>a.3. Electric arc;</P>
                        <P>b. Having a controlled process atmosphere of any of the following:</P>
                        <P>
                            b.1. Inert gas; 
                            <E T="03">or</E>
                        </P>
                        <P>b.2. Vacuum (equal to or less than 100 Pa);</P>
                        <P>c. Having any of the following `in-process monitoring' equipment in a `co-axial configuration' or `paraxial configuration':</P>
                        <P>c.1. Imaging camera with a peak response in the wavelength range exceeding 380 nm but not exceeding 14,000 nm;</P>
                        <P>
                            c.2. Pyrometer designed to measure temperatures greater than 1,273.15K (1,000 °C); 
                            <E T="03">or</E>
                        </P>
                        <P>
                            c.3. Radiometer or spectrometer with a peak response in the wavelength range exceeding 380 nm but not exceeding 3,000 nm; 
                            <E T="03">and</E>
                        </P>
                        <P>d. A closed loop control system designed to modify the consolidation source parameters, build path, or equipment settings during the build cycle in response to feedback from `in-process monitoring' equipment specified in 2B910.c.</P>
                        <P>
                            <E T="04">Technical Notes:</E>
                        </P>
                        <P>
                            <E T="03">For the purposes of 2B910:</E>
                        </P>
                        <P>
                            <E T="03">1. `In-process monitoring', also known as in-situ process monitoring, pertains to the observation and measurement of the additive manufacturing process including electromagnetic, or thermal, emissions from the melt pool.</E>
                        </P>
                        <P>
                            <E T="03">2. `Co-axial configuration', also known as on-axis or inline configuration, pertains to one or more sensors that are mounted in an optical path shared by the “laser” consolidation source.</E>
                        </P>
                        <P>
                            <E T="03">3. `Paraxial configuration' pertains to one or more sensors that are physically mounted onto or integrated into the “laser”, electron beam, or electric arc consolidation source component.</E>
                        </P>
                        <P>
                            <E T="03">4. For both `co-axial configuration' and `paraxial configuration', the field of view of the sensor(s) is fixed to the moving reference frame of the consolidation source and moves in the same scan trajectories of the consolidation source throughout the build process.</E>
                        </P>
                        <STARS/>
                        <FP SOURCE="FP-2">
                            <E T="04">3C908 Fluorides, hydrides, chlorides, of silicon or germanium, containing any of the following (See List of Items Controlled).</E>
                        </FP>
                        <HD SOURCE="HD1">License Requirements</HD>
                        <FP SOURCE="FP-1">
                            <E T="03">Reason for Control:</E>
                             NS, RS, AT
                        </FP>
                        <GPOTABLE COLS="2" OPTS="L0,tp0,i1" CDEF="s10,r10">
                            <TTITLE> </TTITLE>
                            <BOXHD>
                                <CHED H="1">
                                    <E T="03">Control(s)</E>
                                </CHED>
                                <CHED H="1">
                                    <E T="03">Country chart</E>
                                    <LI>
                                        <E T="03">(see Supp. No. 1</E>
                                    </LI>
                                    <LI>
                                        <E T="03">to part 738)</E>
                                    </LI>
                                </CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">NS applies to entire entry</ENT>
                                <ENT>
                                    Worldwide control.
                                    <LI>
                                        <E T="03">See § 742.4(a)(5) and (b)(10) of the EAR.</E>
                                    </LI>
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">RS applies to entire entry</ENT>
                                <ENT>
                                    Worldwide control.
                                    <LI>
                                        <E T="03">See § 742.6(a)(10) and (b)(11) of the EAR.</E>
                                    </LI>
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">AT applies to entire entry</ENT>
                                <ENT>AT Column 1.</ENT>
                            </ROW>
                        </GPOTABLE>
                        <HD SOURCE="HD1">List Based License Exceptions (See Part 740 for a Description of All License Exceptions)</HD>
                        <FP SOURCE="FP-1">
                            <E T="03">LVS:</E>
                             N/A
                        </FP>
                        <FP SOURCE="FP-1">
                            <E T="03">GBS:</E>
                             N/A
                        </FP>
                        <FP SOURCE="FP-1">
                            <E T="03">IEC:</E>
                             Yes, see § 740.2(a)(22) and § 740.24 of the EAR.
                        </FP>
                        <HD SOURCE="HD1">Special Conditions for STA</HD>
                        <FP SOURCE="FP-1">
                            <E T="03">STA:</E>
                             License Exception STA may not be used to ship any item in this ECCN to any of the destinations listed in Country Group A:5 or A:6 (See Supplement No. 1 to part 740 of the EAR).
                        </FP>
                        <HD SOURCE="HD1">List of Items Controlled</HD>
                        <FP SOURCE="FP-1">
                            <E T="03">Related Controls:</E>
                             See ECCN 3E901 for related technology controls for the “development” or “production” of this ECCN.
                        </FP>
                        <FP SOURCE="FP-1">
                            <E T="03">Related Definitions:</E>
                             N/A
                        </FP>
                        <FP SOURCE="FP-1">
                            <E T="03">Items:</E>
                        </FP>
                        <P>
                            a. Silicon having an isotopic impurity less than 0.08% of silicon isotopes other than silicon-28 or silicon-30; 
                            <E T="03">or</E>
                        </P>
                        <P>b. Germanium having an isotopic impurity less than 0.08% of germanium isotopes other than germanium-70, germanium-72, germanium-74, or germanium-76.</P>
                        <STARS/>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <NAME>Matthew S. Borman,</NAME>
                    <TITLE>Principal Deputy Assistant Secretary for Strategic Trade and Economic Security.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30723 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-33-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE TREASURY</AGENCY>
                <SUBAGY>Internal Revenue Service</SUBAGY>
                <CFR>26 CFR Part 1</CFR>
                <DEPDOC>[TD 9992]</DEPDOC>
                <RIN>RIN 1545-BQ36</RIN>
                <SUBJECT>Guidance on the Definition of Domestically Controlled Qualified Investment Entities; Correction</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Internal Revenue Service (IRS), Treasury.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; correcting amendment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This document contains corrections to Treasury Decision 9992, which was published in the 
                        <E T="04">Federal Register</E>
                         for Thursday, April 25, 2024. Treasury Decision 9992 issued final regulations that address the determination of whether a qualified investment entity is domestically controlled, including the treatment of qualified foreign pension funds for this purpose.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>These corrections are effective on December 27, 2024 and for dates of applicability see §§ 1.897-1(a)(2) and 1.1445-2(e).</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Concerning these final regulations, Milton Cahn at (202) 317-4934 (not a toll-free number).</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>The final regulations (TD 9992) that are the subject of this correction are under section 897 of the Code.</P>
                <HD SOURCE="HD1">Corrections to the Regulations</HD>
                <P>Accordingly, 26 CFR part 1 is corrected by making the following correcting amendment:</P>
                <LSTSUB>
                    <PRTPAGE P="105451"/>
                    <HD SOURCE="HED">List of Subjects in 26 CFR Part 1</HD>
                    <P>Income taxes, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <REGTEXT TITLE="26" PART="1">
                    <AMDPAR>
                        <E T="04">Paragraph 1.</E>
                         The authority citation for part 1 continues to read in part as follows:
                    </AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 26 U.S.C. 7805 * * *</P>
                    </AUTH>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 1.897-1</SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="26" PART="1">
                    <P>
                        <E T="04">Par. 2.</E>
                         Section 1.897-1 is amended in paragraph (c)(3)(vi)(E) by removing the language “property interest, or” and adding the language “property interest or” in its place. 
                    </P>
                </REGTEXT>
                <SIG>
                    <NAME>Oluwafunmilayo A. Taylor,</NAME>
                    <TITLE>Section Chief, Publications and Regulations Section, Associate Chief Counsel, (Procedure and Administration). </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30928 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4830-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Coast Guard</SUBAGY>
                <CFR>33 CFR Part 165</CFR>
                <DEPDOC>[Docket Number USCG-2024-0979]</DEPDOC>
                <RIN>RIN 1625-AA00</RIN>
                <SUBJECT>Safety Zone; Beaufort River, Beaufort, SC</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Coast Guard, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Temporary final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Coast Guard is establishing a temporary safety zone for certain navigable waters of the Beaufort River in Beaufort, SC, for a barge-based fireworks display. The safety zone will encompass all waters within a 150-yard radius of the fireworks barge. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by a fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port, Sector Charleston.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective from 8 p.m. through 10 p.m. on December 31, 2024, or in the case of a weather issues, the rule is effective from 8 p.m. through 10 p.m. on January 1, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        To view documents mentioned in this preamble as being available in the docket, go to 
                        <E T="03">https://www.regulations.gov,</E>
                         type USCG-2024-0979 in the search box and click “Search.” Next, in the Document Type column, select “Supporting &amp; Related Material.”
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        If you have questions about this rule, call or email Petty Officer Adam Krukowski, Sector Charleston, Waterways Management Division, U.S. Coast Guard; telephone 843-740-3180 extension 3339, email 
                        <E T="03">Adam.B.Krukowski@uscg.mil.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Table of Abbreviations</HD>
                <EXTRACT>
                    <FP SOURCE="FP-1">CFR Code of Federal Regulations</FP>
                    <FP SOURCE="FP-1">DHS Department of Homeland Security</FP>
                    <FP SOURCE="FP-1">FR Federal Register</FP>
                    <FP SOURCE="FP-1">NPRM Notice of proposed rulemaking</FP>
                    <FP SOURCE="FP-1">§ Section </FP>
                    <FP SOURCE="FP-1">U.S.C. United States Code</FP>
                </EXTRACT>
                <HD SOURCE="HD1">II. Background Information and Regulatory History</HD>
                <P>The Coast Guard is issuing this temporary rule under the authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. The Coast Guard was not informed of the need for a large-based fireworks display with sufficient time to go through the full notice and comment rulemaking process. Immediate action is needed to respond to the potential safety hazards associated with a large-based fireworks display, in Beaufort, SC. It is impracticable to publish an NPRM because we must establish this safety zone by December 31, 2024, or an alternate weather contingency date of January 1, 2025.</P>
                <P>
                    Also, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the 
                    <E T="04">Federal Register</E>
                    . Delaying the effective date of this rule would be impracticable because immediate action is necessary to protect personnel, vessels, and the marine environment from the potential safety hazards associated with the barge-based fireworks display located in the Beaufort River, in Beaufort, SC.
                </P>
                <HD SOURCE="HD1">III. Legal Authority and Need for Rule</HD>
                <P>The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector Charleston (COTP) has determined that potential hazards associated with a barge-based fireworks display on December 31, 2024, or on an alternate weather contingency date of January 1, 2025, will be a safety concern for anyone within a 150-yard radius of the fireworks barge. This rule is needed to ensure the safety of vessels and persons in the navigable waters before, during, and after a barge-based fireworks display.</P>
                <HD SOURCE="HD1">IV. Discussion of the Rule</HD>
                <P>This rule establishes a safety zone from 8 p.m. through 10 p.m. on December 31, 2024, or on a weather contingency date of January 1, 2025, from 8 p.m. through 10 p.m. The safety zone will cover all navigable waters within 150 yards of the fireworks barge on the Beaufort River in Beaufort, SC. The duration of the zone is intended to ensure the safety of vessels and persons before, during, and after the fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.</P>
                <HD SOURCE="HD1">V. Regulatory Analyses</HD>
                <P>We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.</P>
                <HD SOURCE="HD2">A. Regulatory Planning and Review</HD>
                <P>Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).</P>
                <P>This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone Although the rule restricts access to a small, designated area of the Beaufort River encompassed by the safety zone, the effect of this rule will not be significant because the local waterways users will be notified to ensure the safety zone will result in minimal impact for the 2 hours in the evening when vessel traffic is normally low. Additionally, vessel traffic will be able to safely transit around the safety zone.</P>
                <HD SOURCE="HD2">B. Impact on Small Entities</HD>
                <P>
                    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations 
                    <PRTPAGE P="105452"/>
                    that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
                </P>
                <P>While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.</P>
                <P>
                    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section.  
                </P>
                <P>Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.</P>
                <HD SOURCE="HD2">C. Collection of Information</HD>
                <P>This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).</P>
                <HD SOURCE="HD2">D. Federalism and Indian Tribal Governments</HD>
                <P>A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.</P>
                <P>Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.</P>
                <HD SOURCE="HD2">E. Unfunded Mandates Reform Act</HD>
                <P>The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.</P>
                <HD SOURCE="HD2">F. Environment</HD>
                <P>
                    We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves This rule involves a safety zone lasting only 2 hours that will prohibit entry within 150 yards of a fireworks barge. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the 
                    <E T="02">ADDRESSES</E>
                     section of this preamble.
                </P>
                <HD SOURCE="HD2">G. Protest Activities</HD>
                <P>
                    The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 33 CFR Part 165</HD>
                    <P>Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.</P>
                </LSTSUB>
                <P>For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS</HD>
                </PART>
                <REGTEXT TITLE="33" PART="165">
                    <AMDPAR>1. The authority citation for part 165 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="33" PART="165">
                    <AMDPAR>2. Add § 165.T07-0979 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 165.T07-0979 </SECTNO>
                        <SUBJECT>Safety Zone; Beaufort River, Beaufort, SC.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Location.</E>
                             The following area is a safety zone: All waters of the Beaufort River, from surface to bottom, within a 150-yard radius of a fireworks barge located at approximate position latitude 32°25′37″ N longitude 080°40′20″ W. These coordinates are based on the 1984 World Geodetic System.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Definitions.</E>
                             As used in this section, 
                            <E T="03">designated representative</E>
                             means a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel and a Federal, State, and local officer designated by or assisting the Captain of the Port Charleston (COTP) in the enforcement of the safety zone.
                        </P>
                        <P>
                            (c) 
                            <E T="03">Regulations.</E>
                             (1) Under the general safety zone regulations in subpart C of this part, you may not enter the safety zone described in paragraph (a) of this section unless authorized by the COTP or the COTP's designated representative.
                        </P>
                        <P>(2) To seek permission to enter, contact the COTP or the COTP's representative by Marine Band Radio VHF-FM channel 16 (156.8 MHz). Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.</P>
                        <P>
                            (d) 
                            <E T="03">Enforcement period.</E>
                             This rule will be enforced from 8 p.m. until 10 p.m. on December 31, 2024, or in the case of a weather issues, the rule will be enforced from 8 p.m. until 10 p.m. on January 1, 2025.
                        </P>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <NAME>F.J. DelRosso,</NAME>
                    <TITLE>Captain, U.S. Coast Guard, Captain of the Port Sector Charleston.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30980 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-04-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <PRTPAGE P="105453"/>
                <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Coast Guard</SUBAGY>
                <CFR>33 CFR Part 165</CFR>
                <DEPDOC>[Docket Number USCG-2024-1075]</DEPDOC>
                <RIN>RIN 1625-AA00</RIN>
                <SUBJECT>Safety Zone; Erie Canal, North Tonawanda, NY</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Coast Guard, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Temporary final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Coast Guard is establishing a temporary safety zone for navigable waters within a 125-foot radius of Main Street Bridge over the Erie Canal in North Tonawanda, NY. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by falling debris from a fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port, Sector Eastern Great Lakes.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective from 11:45 p.m. on December 31, 2024 through 1:15 a.m. on January 1, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        To view documents mentioned in this preamble as being available in the docket, go to 
                        <E T="03">https://www.regulations.gov,</E>
                         type USCG-2024-1075 in the search box and click “Search.” Next, in the Document Type column, select “Supporting &amp; Related Material.”
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        If you have questions about this rule, call or email Lieutenant William Kelley, Waterways Management Division Chief, U.S. Coast Guard Sector Eastern Great Lakes; telephone 716-931-4680, email 
                        <E T="03">D09-SMB-SECBuffalo-WWM@uscg.mil.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Table of Abbreviations</HD>
                <EXTRACT>
                    <FP SOURCE="FP-1">CFR Code of Federal Regulations</FP>
                    <FP SOURCE="FP-1">DHS Department of Homeland Security</FP>
                    <FP SOURCE="FP-1">FR Federal Register</FP>
                    <FP SOURCE="FP-1">NPRM Notice of proposed rulemaking</FP>
                    <FP SOURCE="FP-1">§ Section </FP>
                    <FP SOURCE="FP-1">U.S.C. United States Code</FP>
                </EXTRACT>
                <HD SOURCE="HD1">II. Background Information and Regulatory History</HD>
                <P>The Coast Guard is issuing this temporary rule under the authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the required safety zone will be implemented with too little time for a comment period.</P>
                <P>
                    Also, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the 
                    <E T="04">Federal Register</E>
                    . Delaying the effective date of this rule would be impracticable the date of the required safety zone will occur within less than 30 days of publication.
                </P>
                <HD SOURCE="HD1">III. Legal Authority and Need for Rule</HD>
                <P>The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port, Sector Eastern Great Lakes (COTP) has determined that potential hazards associated with a fireworks display over the Erie Canal in North Tonawanda, NY, will be a safety concern for anyone within a 125-foot radius of the land-based launch site on the Main Street Bridge in North Tonawanda, NY. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the fireworks display is occurring.</P>
                <HD SOURCE="HD1">IV. Discussion of the Rule</HD>
                <P>This rule establishes a safety zone from 11:45 p.m. December 31, 2024, through 1:15 a.m. on January 1, 2025. The safety zone will cover all navigable waters within 125 feet of the Main Street Bridge, over the Erie Canal in North Tonawanda, NY 43°01′17.96″ N, 78°52′41.04″ W. All geographic coordinates are North American Datum of 1983 (NAD 1983). The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters from falling debris from a fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.</P>
                <HD SOURCE="HD1">V. Regulatory Analyses</HD>
                <P>We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.</P>
                <HD SOURCE="HD2">A. Regulatory Planning and Review</HD>
                <P>Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).</P>
                <P>This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessels will not be permitted to transit within the 1.5 hour time allotted. This is during a time of year when the locks systems on the Erie Canal are not functioning, so no through-traffic is expected.</P>
                <HD SOURCE="HD2">B. Impact on Small Entities</HD>
                <P>The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.</P>
                <P>While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.</P>
                <P>
                    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section.
                </P>
                <P>
                    Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against 
                    <PRTPAGE P="105454"/>
                    small entities that question or complain about this rule or any policy or action of the Coast Guard.
                </P>
                <HD SOURCE="HD2">C. Collection of Information</HD>
                <P>This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).</P>
                <HD SOURCE="HD2">D. Federalism and Indian Tribal Governments  </HD>
                <P>A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.</P>
                <P>Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.</P>
                <HD SOURCE="HD2">E. Unfunded Mandates Reform Act</HD>
                <P>The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.</P>
                <HD SOURCE="HD2">F. Environment</HD>
                <P>
                    We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting only 1.5 hours that will prohibit entry within 125 feet of the Main Street Bridge, over the Erie Canal, in North Tonawanda, NY. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the 
                    <E T="02">ADDRESSES</E>
                     section of this preamble.
                </P>
                <HD SOURCE="HD2">G. Protest Activities</HD>
                <P>
                    The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 33 CFR Part 165</HD>
                    <P>Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.</P>
                </LSTSUB>
                <P>For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS</HD>
                </PART>
                <REGTEXT TITLE="33" PART="165">
                    <AMDPAR>1. The authority citation for part 165 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3. </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="33" PART="165">
                    <AMDPAR>2. Add § 165.T24-1075 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 165.T24-1075 </SECTNO>
                        <SUBJECT>Safety Zone; Erie Canal, North Tonawanda, NY.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Location.</E>
                             The following area is a safety zone: All waters of the Erie Canal, from surface to bottom, encompassed withing a circular zone in a 125-foot radius from a point at 43°01′17.96″ N, 78°52′41.04″ W. All geographic coordinates are North American Datum of 1983 (NAD 1983).
                        </P>
                        <P>
                            (b) 
                            <E T="03">Definitions.</E>
                             As used in this section, 
                            <E T="03">designated representative</E>
                             means a Coast Guard Patrol Commander, including a Coast Guard coxswain, petty officer, or other officer operating a Coast Guard vessel and a Federal, State, and local officer designated by or assisting the Captain of the Port, Sector Eastern Great Lakes (COTP) in the enforcement of the safety zone.
                        </P>
                        <P>
                            (c) 
                            <E T="03">Regulations.</E>
                             (1) Under the general safety zone regulations in subpart C of this part, you may not enter the safety zone described in paragraph (a) of this section unless authorized by the COTP or the COTP's designated representative.
                        </P>
                        <P>(2) To seek permission to enter, contact the COTP or the COTP's representative by phone at (716) 843-9560. Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.</P>
                        <P>(d) Enforcement period. This section will be enforced from 11:45 p.m. on December 31, 2024 through 1:15 a.m. January 1 2025.</P>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: December 18, 2024.</DATED>
                    <NAME>M.I. Kuperman,</NAME>
                    <TITLE>Captain, U.S. Coast Guard Captain of the Port Sector Eastern Great Lakes.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30753 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-04-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Coast Guard</SUBAGY>
                <CFR>33 CFR Part 165</CFR>
                <DEPDOC>[Docket Number USCG-2022-0058]</DEPDOC>
                <RIN>RIN 1625-AA87</RIN>
                <SUBJECT>Security Zone, Port of Miami, Florida</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Coast Guard, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Coast Guard is changing the existing Port of Miami fixed security zone regulation that encompasses certain navigable waters of the Miami Main Channel in Miami, FL. The change is designed to extend the existing fixed security zone eastward along the Miami Main Channel. The extension was established to include the new cruise ship terminal at the Port of Miami added in December 2024. This action extends existing fixed security zone approximately 840 yards eastward along the Miami Main Channel.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective December 27, 2024.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        To view documents mentioned in this preamble as being available in the docket, go to 
                        <E T="03">https://www.regulations.gov,</E>
                         type USCG-2022-0058 in the search box and click “Search.” Next, in the Document Type column, select “Supporting &amp; Related Material.”
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        If you have questions on this rule, call or email Lieutenant Guerschom Etienne, Waterways Management Division Chief, U.S. Coast Guard; telephone (305) 535-4307, email 
                        <E T="03">Guerschom.Etienne@uscg.mil.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">
                    SUPPLEMENTARY INFORMATION:
                    <PRTPAGE P="105455"/>
                </HD>
                <HD SOURCE="HD1">I. Table of Abbreviations</HD>
                <EXTRACT>
                    <FP SOURCE="FP-1">CFR Code of Federal Regulations</FP>
                    <FP SOURCE="FP-1">DHS Department of Homeland Security</FP>
                    <FP SOURCE="FP-1">FR Federal Register</FP>
                    <FP SOURCE="FP-1">ICW Intercoastal Waterway</FP>
                    <FP SOURCE="FP-1">NPRM Notice of proposed rulemaking</FP>
                    <FP SOURCE="FP-1">§ Section </FP>
                    <FP SOURCE="FP-1">U.S.C. United States Code</FP>
                </EXTRACT>
                <HD SOURCE="HD1">II. Background Information and Regulatory History</HD>
                <P>The Port of Miami is undergoing an expansion project that will create new cruise ship terminals at the eastern end of the Port and outside the existing security zone. The Captain of the Port (COTP) Miami identified a need to amend the existing security zone to address the Port of Miami's cruise ship terminal expansion. In response, on August 16, 2022, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Security Zone; Port of Miami” (87 FR 50278). There we stated why we issued the NPRM and invited comments on our proposed regulatory action related to this security zone. During the comment period that ended September 15, 2022, we received no comments.</P>
                <P>
                    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the 
                    <E T="04">Federal Register</E>
                    . Delaying the effective date of this rule would be impracticable and contrary to the public interest. This rule must be immediately effective to guard against potential security concerns associated with the new cruise ship terminal at the Port of Miami which was added in December 2024.
                </P>
                <HD SOURCE="HD1">III. Legal Authority and Need for Rule</HD>
                <P>The Coast Guard is issuing this rule under the authority in 46 U.S.C. 70051 and 70124. The Captain of the Port Miami (COTP) has determined it is necessary to extend the existing Port of Miami fixed security zone eastward approximately 840 yards to cover all navigable waters in the Main Ship Channel from approximately Watson Island to just west of the Biscayne Bay Pilots Station.</P>
                <HD SOURCE="HD1">IV. Discussion of Comments, Changes, and the Rule</HD>
                <P>As noted above, we received no comments on our NPRM published August 16, 2022. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.</P>
                <P>This rule amends an established fixed security zone that encompasses all waters in the Main Ship Channel from approximately Star Island to just west of the Biscayne Bay Pilots Station. The fixed security zone is in effect when two or more passenger vessels, vessels carrying cargoes of particular hazard, or vessels carrying LHG, enter or moor within this zone.</P>
                <P>When the security zone is in effect, persons and vessels shall not enter or transit the security zone along the Miami Main Channel unless authorized by Captain of the Port of Miami or a designated representative. Persons and vessels may transit the Miami Main Channel when only one passenger vessel, one vessel carrying cargoes of particular hazard or one vessel carrying LHG is berthed. The public will be able to reach law enforcement vessels via VHF-FM marine channel 16.</P>
                <HD SOURCE="HD1">V. Regulatory Analyses</HD>
                <P>We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.</P>
                <HD SOURCE="HD2">A. Regulatory Planning and Review</HD>
                <P>Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).</P>
                <P>This regulatory action determination is based on the limited nature of the security zone, specifically: persons and vessels may transit the Miami Main Channel when less than two passenger vessel is berthed, less than two vessel carrying cargoes of hazard, or vessel carrying LHG is berthed in the channel. Additionally, persons and vessels may operate within the security zone when authorized by Captain of the Port of Miami or a designated representative.</P>
                <HD SOURCE="HD2">B. Impact on Small Entities</HD>
                <P>The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.</P>
                <P>
                    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section.
                </P>
                <P>Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.</P>
                <HD SOURCE="HD2">C. Collection of Information</HD>
                <P>This rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).</P>
                <HD SOURCE="HD2">D. Federalism and Indian Tribal Governments</HD>
                <P>A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.</P>
                <P>Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.</P>
                <HD SOURCE="HD2">E. Unfunded Mandates Reform Act</HD>
                <P>
                    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In 
                    <PRTPAGE P="105456"/>
                    particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
                </P>
                <HD SOURCE="HD2">F. Environment</HD>
                <P>
                    We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves increasing the size of an existing security zone along the Miami Main Channel. Such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the 
                    <E T="02">ADDRESSES</E>
                     section of this preamble.
                </P>
                <HD SOURCE="HD2">G. Protest Activities</HD>
                <P>
                    The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 33 CFR Part 165</HD>
                    <P>Harbors, Marine Safety, Navigation (water), Reporting and Record keeping requirements, Security measures, Waterways.</P>
                </LSTSUB>
                <P>For the reasons discussed in the preamble, the Coast Guard amending 33 CFR part 165 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS</HD>
                </PART>
                <REGTEXT TITLE="33" PART="165">
                    <AMDPAR>1. The authority citation for part 165 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="33" PART="165">
                    <AMDPAR>2. In §  165.760, revise paragraph (b)(2) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 165.760</SECTNO>
                        <SUBJECT>Security Zones; Port of Palm Beach, Port Everglades, and Port of Miami, Florida.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>
                            (2) 
                            <E T="03">Fixed security zone in Port of Miami, Florida.</E>
                             A fixed security zone encompassing all navigable waters within the Miami Main Channel between Star Island to just west of the Biscayne Bay Pilots Station. The security zone is formed by an imaginary line starting at the northwest corner in position 25°46.33′ N, 080°09.16′ W; thence in an easterly direction to the northeast corner in position 25°46.17′ N, 080°08.77′ W; thence in a southerly direction to the southeast corner in position 25°46.04′ N, 080°08.75′ W; thence in a northwesterly direction to the southwest corner in position 25°46.23′ N, 080°09.16′ W, thence in a northerly direction back to the northwest corner.
                        </P>
                        <P>(i) When the security zone is in effect, persons and vessels shall not enter or transit the security zone along the Miami Main Channel unless authorized by Captain of the Port of Miami or a designated representative.</P>
                        <P>(ii) Persons and vessels may transit the Miami Main Channel when only one passenger vessel is berthed in the channel, one vessel carrying cargoes of hazard is berthed in the channel, or one vessel carrying LHG is berthed in the channel.</P>
                        <P>(iii) Law enforcement vessels can be contacted on VHF Marine Band Radio, Channel 16 (156.8 MHz).</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <NAME>C.R. Cederholm,</NAME>
                    <TITLE>Captain, U.S. Coast Guard, Captain of the Port Miami.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30598 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-04-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 52</CFR>
                <DEPDOC>[EPA-R10-OAR-2024-0372; FRL-12293-02-R10]</DEPDOC>
                <SUBJECT>Air Plan Approval; WA; Excess Emissions, Startup, Shutdown, and Malfunction Revisions, Energy Facility Site Evaluation Council</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA) is approving Washington State Implementation Plan (SIP) revisions to the Energy Facility Site Evaluation Council (EFSEC) air quality regulations submitted by the State of Washington, through the Department of Ecology (Ecology) on June 15, 2023. The revisions were submitted in response to the EPA's June 12, 2015 “SIP call” in which the EPA found substantially inadequate a Washington SIP provision providing affirmative defenses that operate to limit the jurisdiction of the Federal court in an enforcement action related to excess emissions during startup, shutdown, and malfunction (SSM) events. The EPA's approval of the SIP revisions includes removal of the substantially inadequate provision which corrects the EFSEC deficiency identified in the 2015 SSM SIP call and the EPA's January 2022 finding of failure to submit. Washington withdrew some portions of the revisions submitted that were not identified in the 2015 SSM SIP call and therefore the EPA is not approving those withdrawn portions.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective January 27, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The EPA has established a docket for this action under Docket ID No. EPA-R10-OAR-2024-0372. All documents in the docket are listed on the 
                        <E T="03">https://www.regulations.gov</E>
                         website. Although listed in the index, some information is not publicly available, 
                        <E T="03">e.g.,</E>
                         Confidential Business Information or other information the disclosure of which is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available at 
                        <E T="03">https://www.regulations.gov,</E>
                         or please contact the person listed in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section for additional availability information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Randall Ruddick, EPA Region 10, 1200 Sixth Avenue (Suite 155), Seattle, WA 98101, (206) 553-1999; or email 
                        <E T="03">ruddick.randall@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Throughout this document whenever “we,” or “our,” is used, it refers to the EPA.</P>
                <HD SOURCE="HD1">Table of Contents </HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Background</FP>
                    <FP SOURCE="FP-2">II. Public Comment and the EPA's Response</FP>
                    <FP SOURCE="FP-2">III. Final Action</FP>
                    <FP SOURCE="FP-2">IV. Incorporation by Reference</FP>
                    <FP SOURCE="FP-2">V. Statutory and Executive Order Reviews</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    On October 22, 2024 (89 FR 84322), the EPA proposed to approve State Implementation Plan (SIP) revisions to 
                    <PRTPAGE P="105457"/>
                    the Energy Facility Site Evaluation Council (EFSEC) air quality regulations submitted by the State of Washington, through the Department of Ecology (Ecology) on June 15, 2023. In that proposal, we also proposed to determine that one of the SIP revisions, the removal of EFSEC's adoption by reference of WAC 173-400-107, corrects the deficiency with respect to EFSEC that we identified in our June 12, 2015 action entitled “State Implementation Plans: Response to Petition for Rulemaking; Restatement and Update of EPA's SSM Policy Applicable to SIPs; Findings of Substantial Inadequacy; and SIP Calls to Amend Provisions Applying to Excess Emissions During Periods of Startup, Shutdown, and Malfunction” 
                    <SU>1</SU>
                    <FTREF/>
                     (“2015 SSM SIP call”) and our January 12, 2022, Findings of Failure to Submit 
                    <SU>2</SU>
                    <FTREF/>
                     (FFS). The remaining SIP revisions submitted with the removal of EFSEC's adoption by reference of WAC 173-400-107 on June 15, 2023, were not specified in the 2015 SSM SIP call. The reasons for our proposed approval and determination can be found in the proposed action and will not be fully restated here. The public comment period closed on November 21, 2024. We received one comment outside the scope of our proposed action; therefore, we are finalizing our action as proposed.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         80 FR 33839, June 12, 2015.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Findings of Failure To Submit State Implementation Plan Revisions in Response to the 2015 Findings of Substantial Inadequacy and SIP Calls To Amend Provisions Applying To Excess Emissions During Periods of Startup, Shutdown, and Malfunction, 87 FR 1680 (January 12, 2022), available at 
                        <E T="03">https://www.regulations.gov,</E>
                         Docket ID No. EPA-HQ-OAR-2021-0863.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Public Comment and the EPA's Response</HD>
                <P>
                    <E T="03">Comment:</E>
                     The commenter appears to support the EPA finalizing approval of revisions to EFSEC's regulations but voiced concern about the amount of time it took to get to this approval from issuance of the 2015 SSM SIP call. The commenter also raised concerns about implementation “of the statute” and the allowance of “significant pollutant emissions despite the good-faith intentions of both Federal and state agencies.” The commenter went on to suggest “New rules surrounding revision timelines could help effectively allocate agency efforts in the exercise of its authority while retaining the necessary period for due process and public participation.
                </P>
                <P>
                    <E T="03">Response:</E>
                     The EPA acknowledges the commenter's concerns. However, the concerns raised by the commenter are outside the scope of this action. Moreover, the commenter does not indicate that the EPA's proposed approval action of the SIP submission should be changed or should not be finalized as proposed. Rather, the comment appears to support finalizing the proposed approval. Therefore, we are finalizing our action as proposed.
                </P>
                <HD SOURCE="HD1">III. Final Action</HD>
                <P>
                    The EPA is approving and incorporating by reference in the Washington SIP the revisions Washington submitted on June 15, 2023, except for those withdrawn by Washington.
                    <SU>3</SU>
                    <FTREF/>
                     This action includes removal of the adoption by reference of WAC 173-400-107—the provision identified as inconsistent with Clean Air Act (CAA) requirements in our 2015 SSM SIP call—from the EFSEC air quality regulations contained in Chapter 463-78 Washington Administrative Code (WAC) 
                    <E T="03">General and Operating Permit Regulations for Air Pollution Sources.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         See 
                        <E T="03">201_state submittal supplement_EFSEC Partial Withdrawal Request Letter—Ecology.pdf</E>
                         and 
                        <E T="03">202_state submittal supplement_EFSEC Partial Withdrawal Request Letter—EFSEC.pdf</E>
                         included in the docket for this action.
                    </P>
                </FTNT>
                <P>Once this action becomes effective, the Washington SIP will no longer include the following regulations for EFSEC's jurisdiction:</P>
                <P>• WAC 173-400-070, Emission Standards for Certain Source Categories—sets forth maximum allowable standards for emissions units within the categories listed;</P>
                <P>• WAC 173-400-107, Excess Emissions—established a pathway to determine excess emissions unavoidable, excuse them from penalty, and in certain instances precluded them from being considered violations.</P>
                <P>
                    This action also approves and incorporates by reference at 40 CFR 52.2470(c)—
                    <E T="03">Table 3—Additional Regulations Approved for the Energy Facilities Site Evaluation Council (EFSEC) Jurisdiction,</E>
                     the following revised regulations:
                </P>
                <P>• WAC 463-78-005(2), Adoption by Reference (State effective August 28, 2020)—which adopts certain regulations in Chapter 173-400 WAC by reference.</P>
                <P>The revised Chapter 173-400 WAC provisions approved for EFSEC's jurisdiction are:</P>
                <P>• WAC 173-400-030, Definitions (State effective September 16, 2018)—which establishes definitions used throughout Chapter 173-400 WAC;</P>
                <P>• WAC 173-400-081, Emission Limits during Startup and Shutdown (State effective September 16, 2018)—which establishes pathway for developing emissions limits that apply during startup and shutdown;</P>
                <P>• WAC 173-400-082, Alternative Emission Limit That Exceeds an Emission Standard in the SIP (State effective September 16, 2018)—which establishes pathway for an owner or operator to request an alternative emissions limit;</P>
                <P>• WAC 173-400-136 Use of Emission Reduction Credits (ERC) (State effective December 29, 2012)—which identifies permissible use and sets certain conditions of use of ERCs;</P>
                <P>• WAC 173-400-171 Public Involvement (State effective September 16, 2018)—which sets forth certain requirements for public involvement.</P>
                <P>These SIP revisions apply specifically to the jurisdiction of the Washington State Energy Facility Site Evaluation Council.</P>
                <HD SOURCE="HD1">IV. Incorporation by Reference</HD>
                <P>
                    In this document, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference as described in section III of this preamble. The EPA has made, and will continue to make, these materials generally available through 
                    <E T="03">https://www.regulations.gov</E>
                     and at the EPA Region 10 Office (please contact the person identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this preamble for more information). Therefore, these materials have been approved by the EPA for inclusion in the SIP, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the Clean Air Act as of the effective date of the final rule of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         62 FR 27968 (May 22, 1997).
                    </P>
                </FTNT>
                <P>Also in this document, the EPA is removing regulatory text from incorporated by reference, as described in section III. of this preamble.</P>
                <HD SOURCE="HD1">V. Statutory and Executive Order Reviews</HD>
                <P>
                    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve State choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:
                    <PRTPAGE P="105458"/>
                </P>
                <P>• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);</P>
                <P>
                    • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>
                    • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);</P>
                <P>• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);</P>
                <P>• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a State program;</P>
                <P>• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and</P>
                <P>• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA.</P>
                <P>Executive Order 12898 (Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on communities with environmental justice (EJ) concerns to the greatest extent practicable and permitted by law. The EPA defines EJ as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” The EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.” The air agency did not evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. The EPA did not perform an EJ analysis and did not consider EJ in this action. Due to the nature of the action being taken here, this action is expected to have a neutral to positive impact on the air quality of the affected area. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of Executive Order 12898 of achieving environmental justice for communities with EJ concerns.</P>
                <P>The SIP is not approved to apply on any Indian reservation land in Washington except as specifically noted below and is also not approved to apply in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on Tribal governments or preempt Tribal law. Washington's SIP is approved to apply on non-trust land within the exterior boundaries of the Puyallup Indian Reservation, also known as the 1873 Survey Area. Under the Puyallup Tribe of Indians Settlement Act of 1989, 25 U.S.C. 1773, Congress explicitly provided State and local agencies in Washington authority over activities on non-trust lands within the 1873 Survey Area.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 52</HD>
                    <P>Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.</P>
                </LSTSUB>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>
                         42 U.S.C. 7401 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: December 17, 2024.</DATED>
                    <NAME>Daniel Opalski,</NAME>
                    <TITLE>Acting Regional Administrator, Region 10.</TITLE>
                </SIG>
                <P>For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS</HD>
                </PART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>1. The authority citation for part 52 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                             42 U.S.C. 7401 
                            <E T="03">et seq.</E>
                        </P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart WW—Washington</HD>
                </SUBPART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>2. In § 52.2470, in paragraph (c), amend table 3 by:</AMDPAR>
                    <AMDPAR>a. Revising entries “78-005” and “173-400-030”;</AMDPAR>
                    <AMDPAR>b. Removing entries “173-400-030(30) &amp; (36)” and “173-400-070”;</AMDPAR>
                    <AMDPAR>c. Revising entry “173-400-081”;</AMDPAR>
                    <AMDPAR>d. Adding entry “173-400-082” in numerical order;</AMDPAR>
                    <AMDPAR>e. Removing entry “173-400-107”; and</AMDPAR>
                    <AMDPAR>f. Revising entries “173-400-136” and “173-400-171”.</AMDPAR>
                    <P>The revisions and additions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 52.2470</SECTNO>
                        <SUBJECT> Identification of plan.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <GPOTABLE COLS="5" OPTS="L1,nj,i1" CDEF="xs60,r50,12,r50,r75">
                            <TTITLE>Table 3—Additional Regulations Approved for the Energy Facilities Site Evaluation Council (EFSEC) Jurisdiction</TTITLE>
                            <TDESC>[See the SIP-approved provisions of WAC 463-78-020 for jurisdictional applicability]</TDESC>
                            <BOXHD>
                                <CHED H="1">State citation</CHED>
                                <CHED H="1">Title/subject</CHED>
                                <CHED H="1">
                                    State
                                    <LI>effective</LI>
                                    <LI>date</LI>
                                </CHED>
                                <CHED H="1">EPA approval date</CHED>
                                <CHED H="1">Explanations</CHED>
                            </BOXHD>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Washington Administrative Code, Chapter 463-78—General and Operating Permit Regulations for Air Pollution Sources</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="01">78-005</ENT>
                                <ENT>Adoption by Reference</ENT>
                                <ENT>8/28/20</ENT>
                                <ENT>
                                    12/27/24, [INSERT FIRST PAGE OF 
                                    <E T="02">FEDERAL REGISTER</E>
                                     CITATION]
                                </ENT>
                                <ENT>Subsection (2) only. See below for the updated Chapter 173-400 WAC provisions adopted by reference and submitted to the EPA for approval.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW RUL="s">
                                <PRTPAGE P="105459"/>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Washington Administrative Code, Chapter 173-400—Regulations Incorporated by Reference in WAC 463-78-005</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-030</ENT>
                                <ENT>Definitions</ENT>
                                <ENT>9/16/18</ENT>
                                <ENT>
                                    12/27/24, [INSERT FIRST PAGE OF 
                                    <E T="02">FEDERAL REGISTER</E>
                                     CITATION]
                                </ENT>
                                <ENT>Except: 173-400-030(96).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-081</ENT>
                                <ENT>General Standards for Maximum Emissions</ENT>
                                <ENT>9/16/18</ENT>
                                <ENT>
                                    12/27/24, [INSERT FIRST PAGE OF 
                                    <E T="02">FEDERAL REGISTER</E>
                                     CITATION]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-082</ENT>
                                <ENT>General Standards for Maximum Emissions</ENT>
                                <ENT>9/16/18</ENT>
                                <ENT>
                                    12/27/24, [INSERT FIRST PAGE OF 
                                    <E T="02">FEDERAL REGISTER</E>
                                     CITATION]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-136</ENT>
                                <ENT>Use of Emission Reduction Credits (ERC)</ENT>
                                <ENT>12/29/12</ENT>
                                <ENT>
                                    12/27/24, [INSERT FIRST PAGE OF 
                                    <E T="02">FEDERAL REGISTER</E>
                                     CITATION]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">173-400-171</ENT>
                                <ENT>Public Notice and Opportunity for Public Comment</ENT>
                                <ENT>9/16/18</ENT>
                                <ENT>
                                    12/27/24, [INSERT FIRST PAGE OF 
                                    <E T="02">FEDERAL REGISTER</E>
                                     CITATION]
                                </ENT>
                                <ENT>Except: The part of 173-400-171(3)(b) that says, • “or any increase in emissions of a toxic air pollutant above the acceptable source impact level for that toxic air pollutant as regulated under chapter 173-460 WAC”; 173-400-171(12).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30536 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 52</CFR>
                <DEPDOC>[EPA-R05-OAR-2023-0633]; FRL-11928-02-R5]</DEPDOC>
                <SUBJECT>Air Plan Approval; Indiana; Update to CFR References</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA) is approving a request submitted by the Indiana Department of Environmental Management (IDEM) on December 14, 2023, to revise the Indiana State Implementation Plan (SIP). The submission revises and updates the Indiana Administrative Code (IAC) definition of “References to the Code of Federal Regulations,” from the 2018 edition to the 2022 edition. EPA proposed to approve this action on August 18, 2024, and received no adverse comments.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective on January 27, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2023-0633. All documents in the docket are listed on the 
                        <E T="03">https://www.regulations.gov</E>
                         website. Although listed in the index, some information is not publicly available, 
                        <E T="03">i.e.,</E>
                         Confidential Business Information (CBI), Proprietary Business Information (PBI), or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available either through 
                        <E T="03">https://www.regulations.gov</E>
                         or at the Environmental Protection Agency, Region 5, Air and Radiation Division, 77 West Jackson Boulevard, Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. We recommend that you telephone Nicole Naber, at (312) 886-6609 before visiting the Region 5 office.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Nicole Naber, Air and Radiation Division (AR18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6609, 
                        <E T="03">naber.nicole@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.</P>
                <HD SOURCE="HD1">I. Background Information.</HD>
                <P>On August 16, 2024 (89 FR 66661), EPA proposed to approve revisions to 326 IAC 1-1-3, definition of “References to Code of Federal Regulations.” IDEM updated the reference to the CFR in 326 IAC 1-1-3 from the 2018 edition to the 2022 edition. This is an administrative change that allows Indiana to reference a more current version of the CFR.</P>
                <P>
                    By incorporating by reference 326 IAC 1-1-3 to reference the 2022 version of the CFR, the provisions in title 326 of 
                    <PRTPAGE P="105460"/>
                    the IAC will be consistent with the applicable CFR regulations. Because this action updates Indiana rules to be more consistent with EPA's current regulations, EPA is approving these revisions. An explanation of the Clean Air Act (CAA) requirements, a detailed analysis of the revisions, and EPA's reasons for proposing approval were provided in the notice of proposed rulemaking and will not be restated here. The public comment period for this proposed rule ended on September 16, 2024. EPA received no comments on the proposal.
                </P>
                <HD SOURCE="HD1">II. Final Action</HD>
                <P>EPA is approving the December 14, 2023, submission as a revision to the Indiana SIP. Specifically, EPA is approving 326 IAC 1-1-3 References to the Code of Federal Regulations, effective October 20, 2023.</P>
                <HD SOURCE="HD1">III. Incorporation by Reference</HD>
                <P>
                    In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Indiana Regulations described in section I of this preamble and set forth in the amendments to 40 CFR part 52 below. EPA has made, and will continue to make, these documents generally available through 
                    <E T="03">https://www.regulations.gov,</E>
                     and at the EPA Region 5 Office (please contact the person identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         62 FR 27968 (May 22, 1997).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Statutory and Executive Order Reviews</HD>
                <P>Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:</P>
                <P>• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993), and 14094 (88 FR 21879, April 11, 2023);</P>
                <P>
                    • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>
                    • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);</P>
                <P>• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);</P>
                <P>• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;</P>
                <P>• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and</P>
                <P>• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA.</P>
                <P>In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).</P>
                <P>Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on communities with environmental justice (EJ) concerns to the greatest extent practicable and permitted by law. EPA defines EJ as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”</P>
                <P>IDEM did not evaluate EJ considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. EPA did not perform an EJ analysis and did not consider EJ in this action. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of E.O. 12898 of achieving EJ for communities with EJ concerns.</P>
                <P>This action is subject to the Congressional Review Act, and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).</P>
                <P>Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 25, 2025. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 52</HD>
                    <P>Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Debra Shore,</NAME>
                    <TITLE>Regional Administrator, Region 5.</TITLE>
                </SIG>
                <P>For the reasons stated in the preamble, title 40 CFR part 52 is amended as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS</HD>
                </PART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>1. The authority citation for part 52 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                            42 U.S.C. 7401 
                            <E T="03">et seq.</E>
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="40" PART="52">
                    <PRTPAGE P="105461"/>
                    <AMDPAR>2. In § 52.770, the table in paragraph (c) is amended by revising the entry for “1-1-3” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 52.770</SECTNO>
                        <SUBJECT>Identification of plan.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <GPOTABLE COLS="05" OPTS="L1,nj,i1" CDEF="xs50,r50,12,r50,r25">
                            <TTITLE>EPA-Approved Indiana Regulations</TTITLE>
                            <BOXHD>
                                <CHED H="1">
                                    Indiana
                                    <LI>citation</LI>
                                </CHED>
                                <CHED H="1">Subject</CHED>
                                <CHED H="1">
                                    Indiana
                                    <LI>effective date</LI>
                                </CHED>
                                <CHED H="1">EPA approval date</CHED>
                                <CHED H="1">Notes</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">1-1-3</ENT>
                                <ENT>References to the Code of Federal Regulations</ENT>
                                <ENT>10/20/2023</ENT>
                                <ENT O="xl">
                                    [INSERT DATE OF PUBLICATION IN THE 
                                    <E T="02">FEDERAL REGISTER</E>
                                    ], 
                                    <LI>
                                        [INSERT FIRST PAGE OF 
                                        <E T="02">FEDERAL REGISTER</E>
                                         CITATION]
                                    </LI>
                                </ENT>
                                <ENT/>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30729 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 52</CFR>
                <DEPDOC>[EPA-R08-OAR-2024-0207; FRL-12341-02-R8]</DEPDOC>
                <SUBJECT>Air Plan Approval; Revisions to Colorado Common Provisions Regulation</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA) is approving revisions to the Common Provisions Regulation of the Colorado State Implementation Plan (SIP). These revisions were submitted by the State of Colorado in response to the EPA's June 12, 2015, Findings of Substantial Inadequacy and “SIP calls” for certain provisions in the SIP related to affirmative defenses applicable to excess emissions during startup, shutdown, and malfunction (SSM) events. The EPA is approving these SIP revisions because the Agency has determined that they are in accordance with the requirements for SIP provisions under the Clean Air Act (CAA or the Act).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective on January 27, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The EPA has established a docket for this action under Docket ID No. EPA-R08-OAR-2024-0207. All documents in the docket are listed on the 
                        <E T="03">https://www.regulations.gov</E>
                         website. Although listed in the index, some information is not publicly available, 
                        <E T="03">e.g.,</E>
                         Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available through 
                        <E T="03">https://www.regulations.gov,</E>
                         or please contact the person identified in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section for additional availability information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Adam Clark, Air and Radiation Division, EPA, Region 8, Mailcode 8ARD-AQ, 1595 Wynkoop Street, Denver, Colorado, 80202-1129, telephone number: (303) 312-7104, email address: 
                        <E T="03">clark.adam@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Throughout this document whenever “we,” “us,” or “our” is used, we mean the EPA.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>The background for this action is discussed in detail in our October 30, 2024 proposal (89 FR 86305). In that document we proposed to approve revisions to the Common Provisions Regulation portion of Colorado's SIP. We did not receive comments on this proposal.</P>
                <HD SOURCE="HD1">II. Final Action</HD>
                <P>
                    The EPA is approving the portion of Colorado's June 26, 2023, SIP submission revising the Colorado SIP by removing Common Provisions Regulation sections II.E. and II.J. from the SIP by making them State-only. We are approving the SIP revisions because we have determined that they are consistent with the requirements for SIP provisions under the CAA. The EPA is further determining that finalizing such SIP revisions would correct the deficiencies identified in the EPA's June 12, 2015 Findings of Substantial Inadequacy and SIP Calls.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         “State Implementation Plans: Response to Petition for Rulemaking; Restatement and Update of EPA's SSM Policy Applicable to SIPs; Findings of Substantial Inadequacy; and SIP Calls to Amend Provisions Applying to Excess Emissions During Periods of Startup, Shutdown and Malfunction,” (80 FR 33839, June 12, 2015).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Incorporation by Reference</HD>
                <P>
                    In this action, we are including in a final rule regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5 the EPA is incorporating by reference the revisions that would designate them as State-only, and thus remove from “5 CCR 1001-02, Common Provisions Regulation” of the Colorado SIP, sections II.E., “Affirmative Defense Provision for Excess Emissions During Malfunctions,” and II.J., “Affirmative Defense Provision for Excess Emissions During Startup and Shutdown.” The EPA has made, and will continue to make, these documents generally available electronically through 
                    <E T="03">https://www.regulations.gov</E>
                     and in hard copy at the EPA Region 8 office.
                </P>
                <HD SOURCE="HD1">IV. Statutory and Executive Order Reviews</HD>
                <P>Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve State choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:</P>
                <P>• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);</P>
                <P>
                    • Does not impose an information collection burden under the provisions 
                    <PRTPAGE P="105462"/>
                    of the Paperwork Reduction Act (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>
                    • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);</P>
                <P>• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);</P>
                <P>• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a State program;</P>
                <P>• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);</P>
                <P>• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and</P>
                <P>In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).</P>
                <P>Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, Feb. 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. The EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” The EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”</P>
                <P>Colorado did not evaluate EJ considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. The EPA did not perform an EJ analysis and did not consider EJ in this action. Due to the nature of the action being taken here, this action is expected to have a neutral to positive impact on the air quality of the affected area. Consideration of EJ is not required as part of this final action, and there is no information in the record inconsistent with the stated goal of E.O. 12898 of achieving EJ for people of color, low-income populations, and Indigenous peoples.</P>
                <P>
                    The Congressional Review Act (CRA), 5 U.S.C. 801 
                    <E T="03">et seq.,</E>
                     as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the 
                    <E T="04">Federal Register</E>
                    . A major rule cannot take effect until 60 days after it is published in the 
                    <E T="04">Federal Register</E>
                    . This action is not a “major rule” as defined by 5 U.S.C. 804(2).
                </P>
                <P>Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 25, 2025. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 52</HD>
                    <P>Environmental protection, Air pollution control, Carbon monoxide, Greenhouse gases, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds. </P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: December 17, 2024. </DATED>
                    <NAME>KC Becker,</NAME>
                    <TITLE>Regional Administrator, Region 8.</TITLE>
                </SIG>
                <P>For the reasons stated in the preamble, the Environmental Protection Agency is amending 40 CFR part 52 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS </HD>
                </PART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>1. The authority citation for part 52 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                             42 U.S.C. 7401 
                            <E T="03">et seq.</E>
                        </P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart G-Colorado</HD>
                </SUBPART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>2. In § 52.320, the table in paragraph (c) is amended by revising the entry “II. General” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 52.320</SECTNO>
                        <SUBJECT> Identification of plan.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <GPOTABLE COLS="5" OPTS="L1,tp0,i1" CDEF="s50,12,12,12,xs100">
                            <TTITLE> </TTITLE>
                            <BOXHD>
                                <CHED H="1">Title</CHED>
                                <CHED H="1">
                                    State
                                    <LI>effective</LI>
                                    <LI>date</LI>
                                </CHED>
                                <CHED H="1">EPA effective date</CHED>
                                <CHED H="1">
                                    Final rule
                                    <LI>citation/date</LI>
                                </CHED>
                                <CHED H="1">Comments</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">5 CCR 1001-02, Common Provisions Regulation</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <PRTPAGE P="105463"/>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">II. General</ENT>
                                <ENT>2/14/2023</ENT>
                                <ENT>1/27/2025</ENT>
                                <ENT>
                                    [insert 
                                    <E T="02">Federal Register</E>
                                     citation], 12/27/2025
                                </ENT>
                                <ENT>Previous SIP approval 1/25/2016 except for II.I. and II.J.5. Substantive changes removing II.E. and II.J. approved 12/27/2025.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30695 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 52</CFR>
                <DEPDOC>[EPA-R04-OAR-2023-0339; FRL-12355-02-R4]</DEPDOC>
                <SUBJECT>Air Plan Approval; KY; Revisions to Jefferson County Control of Open Burning</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA) is approving changes to the Jefferson County portion of the Kentucky State Implementation Plan (SIP) submitted by the Commonwealth of Kentucky through the Kentucky Division for Air Quality (KDAQ) on May 30, 2023. The changes were submitted by KDAQ on behalf of the Louisville Metro Air Pollution Control District (District, also referred to herein as Jefferson County). EPA is approving changes to the District's rules which clarify that a fire for general agricultural production must be a controlled burn; to allow the use of District-approved accelerants to start certain fires; and to adjust paragraph numbering. EPA is approving the changes pursuant to the Clean Air Act (CAA or Act) and its implementing regulations.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective January 27, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2023-0339. All documents in the docket are listed on the 
                        <E T="03">regulations.gov</E>
                         website. Although listed in the index, some information may not be publicly available, 
                        <E T="03">i.e.,</E>
                         Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through 
                        <E T="03">www.regulations.gov</E>
                         or in hard copy at the Air Regulatory Management Section, Air Planning and Implementation Branch, Air and Radiation Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. EPA requests that, if at all possible, you contact the person listed in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding Federal holidays.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Simone Jarvis, Air Regulatory Management Section, Air Planning and Implementation Branch, Air and Radiation Division, Region 4, U.S. Environmental Protection Agency, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is (404) 562-8393. Ms. Jarvis can also be reached via electronic mail at 
                        <E T="03">Jarvis.Simone@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    On May 31, 2023,
                    <SU>1</SU>
                    <FTREF/>
                     KDAQ, on behalf of the District, submitted changes to the Jefferson County portion of the Kentucky SIP for EPA approval.
                    <E T="51">2 3</E>
                    <FTREF/>
                     In this rulemaking, EPA is approving changes to Regulation 1.11, 
                    <E T="03">Control of Open Burning.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         EPA received the May 30, 2023, submittal on May 31, 2023. For clarity, throughout this document EPA will refer to the May 31, 2023, submission by its cover letter date of May 30, 2023.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         The May 30, 2023, submittal also contains changes to Jefferson County Regulation 1.02, 
                        <E T="03">Definitions,</E>
                         in the Jefferson County portion of the Kentucky SIP. EPA addressed those changes in a separate rulemaking. 
                        <E T="03">See</E>
                         89 FR 41319 (May 13, 2024).
                    </P>
                    <P>
                        <SU>3</SU>
                         In 2003, the City of Louisville and Jefferson County governments merged, and the “Jefferson County Air Pollution Control District” was renamed the “Louisville Metro Air Pollution Control District.” However, to be consistent with the terminology used in the subheading in Table 2 of 40 CFR 52.920(c), throughout this document we refer to the District regulations contained in the Jefferson County portion of the Kentucky SIP as the “Jefferson County” regulations.
                    </P>
                </FTNT>
                <P>
                    Through a notice of proposed rulemaking (NPRM) published on October 31, 2024 (89 FR 86771), EPA proposed to approve changes to the District's Regulation 1.11, 
                    <E T="03">Control of Open Burning,</E>
                     which included three changes. The first change was the addition of the phrase “
                    <E T="03">i.e.,</E>
                     a controlled burn” to Section 2.1.4 to clarify that “a fire for general agricultural production” must be a controlled burn. The second change was the addition of an exception to Section 2.4 allowing the use of District-approved liquid accelerants to start fires for general agricultural production for weed abatement, disease control, or pest prevention or for recognized silvicultural, range, native grassland, or wildlife management practices that have been approved by the District pursuant to Section 2.1.4. The third and final change renumbers the paragraph breaks for subsections 2.1.8 and 2.1.9 and removes subsection 2.1.10. These numbering changes do not affect the language of the rule or otherwise have any substantive impact.
                </P>
                <P>In this rulemaking, EPA is finalizing its approval of the District's May 31, 2023, request to incorporate Version 11 of Regulation 1.11 into the SIP, replacing Version 10, the version of the rule currently in the SIP. EPA's rationale for approving the changes is described in the October 31, 2024, NPRM. Comments on the October 31, 2024, NPRM were due on or before December 2, 2024. No comments were received on the October 31, 2024, NPRM, adverse or otherwise.</P>
                <HD SOURCE="HD1">II. Incorporation by Reference</HD>
                <P>
                    In this document, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, and as discussed in Section I of this preamble, EPA is finalizing the incorporation by reference of Jefferson County Regulation 1.11, Version 11, 
                    <E T="03">Control of Open Burning,</E>
                     District-effective on March 15, 2023, which clarifies that a fire for general 
                    <PRTPAGE P="105464"/>
                    agricultural production must be a controlled burn; allows the use of District-approved accelerants to start certain fires; and adjusts paragraph numbering. EPA has made, and will continue to make, these materials generally available through 
                    <E T="03">www.regulations.gov</E>
                     and at the EPA Region 4 Office (please contact the person identified in the 
                    <E T="02">For Further Information Contact</E>
                     section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         62 FR 27968 (May 22, 1997).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Final Action</HD>
                <P>
                    EPA is approving the aforementioned changes to Regulation 1.11, 
                    <E T="03">Control of Open Burning,</E>
                     submitted to EPA on May 31, 2023. EPA has determined that the requested changes in Kentucky's May 31, 2023, SIP revision will not interfere with any applicable requirement concerning attainment, or any other applicable requirement of the CAA.
                </P>
                <HD SOURCE="HD1">IV. Statutory and Executive Order Reviews</HD>
                <P>Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:</P>
                <P>• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);</P>
                <P>
                    • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>
                    • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);</P>
                <P>• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);</P>
                <P>• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;</P>
                <P>• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and</P>
                <P>• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA.</P>
                <P>In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).</P>
                <P>Executive Order 12898 (Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, Feb. 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on communities with environmental justice (EJ) concerns to the greatest extent practicable and permitted by law. Executive Order 14096 (Revitalizing Our Nation's Commitment to Environmental Justice for All, 88 FR 25251, April 26, 2023) builds on and supplements E.O. 12898 and defines EJ as, among other things, the just treatment and meaningful involvement of all people, regardless of income, race, color, national origin, or Tribal affiliation, or disability in agency decision-making and other Federal activities that affect human health and the environment.</P>
                <P>The District did not evaluate EJ considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. EPA did not perform an EJ analysis and did not consider EJ in this action. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of E.O. 12898/14096 of achieving EJ for communities with EJ concerns.</P>
                <P>This action is subject to the Congressional Review Act, and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).</P>
                <P>Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 25, 2025. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 52</HD>
                    <P>Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds. </P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Jeaneanne Gettle,</NAME>
                    <TITLE>Acting Regional Administrator, Region 4. </TITLE>
                </SIG>
                  
                <P>For the reasons stated in the preamble, the EPA amends 40 CFR part 52 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS </HD>
                </PART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>1. The authority citation for part 52 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>
                            42 U.S.C. 7401 
                            <E T="03">et seq.</E>
                              
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="40" PART="52">
                    <SUBPART>
                        <HD SOURCE="HED">Subpart S—Kentucky</HD>
                    </SUBPART>
                    <AMDPAR>2. In § 52.920(c), in Table 2 under the center heading “Reg 1—General Provisions” revise the entry for 1.11 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 52.920 </SECTNO>
                        <SUBJECT> Identification of plan.</SUBJECT>
                        <STARS/>
                        <P>
                            (c) * * *
                            <PRTPAGE P="105465"/>
                        </P>
                        <GPOTABLE COLS="6" OPTS="L1,i1" CDEF="xs25,r50,12,r50,12,12">
                            <TTITLE>
                                Table 2 to Paragraph (
                                <E T="01">c</E>
                                )—EPA-Approved Jefferson County Regulations for Kentucky
                            </TTITLE>
                            <BOXHD>
                                <CHED H="1">Reg</CHED>
                                <CHED H="1">Title/subject</CHED>
                                <CHED H="1">EPA approval date</CHED>
                                <CHED H="1">
                                    <E T="02">Federal Register</E>
                                     notice
                                </CHED>
                                <CHED H="1">
                                    District
                                    <LI>effective date</LI>
                                </CHED>
                                <CHED H="1">Explanation</CHED>
                            </BOXHD>
                            <ROW EXPSTB="05" RUL="s">
                                <ENT I="21">Reg 1—General Provisions</ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">1.11</ENT>
                                <ENT>Control of Open Burning</ENT>
                                <ENT>12/27/24</ENT>
                                <ENT>
                                    [Insert first page of 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>3/15/2023</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30741 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 55</CFR>
                <DEPDOC>[EPA-R01-OAR-2024-0367; FRL-12222-02-R1]</DEPDOC>
                <SUBJECT> Outer Continental Shelf Air Regulations; Amendment to State Requirements Incorporated by Reference; Massachusetts</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA) is updating a portion of the Outer Continental Shelf (OCS) Air Regulations. Requirements applying to OCS sources located within 25 miles of states' seaward boundaries must be updated periodically to remain consistent with the requirements of the corresponding onshore area (COA), as mandated by the Clean Air Act. The portion of the OCS air regulations that is being updated pertains to the requirements for OCS sources for which Massachusetts is the designated COA. This final rule removes two Commonwealth of Massachusetts provisions from the compilation of requirements incorporated by reference in the Code of Federal Regulations and listed in the appendix to the Federal OCS air regulations.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective on January 27, 2025. The incorporation by reference of a certain publication listed in this rule is approved by the Director of the Federal Register as of January 27, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        EPA has established a docket for this action under Docket Identification No. EPA-R01-OAR-2024-0367. All documents in the docket are listed on the 
                        <E T="03">https://www.regulations.gov</E>
                         website. Although listed in the index, some information is not publicly available, 
                        <E T="03">i.e.,</E>
                         CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available at 
                        <E T="03">https://www.regulations.gov</E>
                         or at the U.S. Environmental Protection Agency, EPA Region 1 Regional Office, Air and Radiation Division, 5 Post Office Square—Suite 100, Boston, MA. EPA requests that if at all possible, you contact the contact listed in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays and facility closures due to COVID-19.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Patrick Collins, Air and Radiation Division, U.S. Environmental Protection Agency, EPA Region 1, U.S. Environmental Protection Agency, EPA Region 1 Regional Office, Air and Radiation Division, 5 Post Office Square—Suite 100, Boston, MA 02109, (617) 918-1196, 
                        <E T="03">collins.patrick@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.</P>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Background and Purpose</FP>
                    <FP SOURCE="FP-2">II. Final Action</FP>
                    <FP SOURCE="FP-2">III. Incorporation by Reference</FP>
                    <FP SOURCE="FP-2">IV. Statutory and Executive Order Reviews</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Background and Purpose</HD>
                <P>On September 4, 1992, the EPA promulgated 40 CFR part 55,1 which established requirements to control air pollution from OCS sources in order to attain and maintain federal and state ambient air quality standards and to comply with the provisions of part C of title I of the Clean Air Act (CAA). The regulations at 40 CFR part 55 apply to all OCS sources offshore of the states except those located in the Gulf of Mexico west of 87.5 degrees longitude. Section 328 of the CAA requires that for such sources located within 25 miles of a state's seaward boundary, the requirements shall be the same as would be applicable if the sources were located in the COA. Because the OCS requirements are based on onshore requirements, and onshore requirements may change, section 328(a)(1) of the CAA requires that the EPA update the OCS requirements as necessary to maintain consistency with onshore requirements.</P>
                <P>On September 17, 2008 (73 FR 53718), the EPA finalized a consistency update of the OCS air regulations pertaining to the requirements of OCS sources in the Commonwealth of Massachusetts. The update was the result of a Notice of Intent (NOI) being submitted on December 7, 2007 by Cape Wind Associates, LLC. The rules incorporated by reference into Appendix A of 40 CFR part 55 were applicable provisions of 310 Code of Massachusetts Regulations (CMR) 4.00: Timely Action Schedule and Fee Provisions; 310 CMR 6.00: Ambient Air Quality Standards for the Commonwealth of Massachusetts; 310 CMR 7.00: Air Pollution Control; and 310 CMR 8:00: The Prevention and/or Abatement of Air Pollution Episode and Air Pollution Incident Emergencies.</P>
                <P>On August 24, 2010 (75 FR 51968), the EPA finalized a consistency update of the OCS regulations pertaining to the requirements of OCS sources in the Commonwealth of Massachusetts. This update was the result of EPA's annual review of the Commonwealth of Massachusetts regulations. The rules incorporated by reference into Appendix A of 40 CFR part 55 were updates and new requirements of 310 CMR 4.00: Timely Action Schedule and Fee Provisions; 310 CMR 6.00: Ambient Air Quality Standards for the Commonwealth of Massachusetts; 310 CMR 7.00: Air Pollution Control; and 310 CMR 8:00: The Prevention and/or Abatement of Air Pollution Episode and Air Pollution Incident Emergencies.</P>
                <P>
                    A similar action occurred on November 13, 2018 (83 FR 56259) after 
                    <PRTPAGE P="105466"/>
                    the submittal of an NOI on December 11, 2017 by Vineyard Wind, LLC, leading to further updates to Appendix A of 40 CFR part 55. The rules incorporated through this action were applicable provisions of 310 CMR 4.00: Timely Action Schedule and Fee Provisions; 310 CMR 6.00: Ambient Air Quality Standards for the Commonwealth of Massachusetts; 310 CMR 7.00: Air Pollution Control; and 310 CMR 8.00: The Prevention and/or Abatement of Air Pollution Episode and Air Pollution Incident Emergencies, as amended through March 9, 2018.
                </P>
                <P>Lastly, on November 15, 2022 (87 FR 68364) the EPA finalized action to incorporate updates to 40 CFR part 55 after receipt of an NOI on September 9, 2021 by Sunrise Wind, LLC. This final rule incorporated applicable provisions of 310 CMR 4.00: Timely Action Schedule and Fee Provisions; 310 CMR 6.00: Ambient Air Quality Standards for the Commonwealth of Massachusetts; and 310 CMR 7.00: Air Pollution Control, as amended through March 5, 2021.</P>
                <P>EPA has received subsequent NOIs for projects and conducted periodic reviews of Massachusetts regulations to ensure all applicable requirements for OCS sources as they relate to attainment and maintenance of federal or state ambient air quality standards and the requirements of part C of title I of the CAA are incorporated by reference into the Massachusetts section of Appendix A in 40 CFR part 55. These evaluations have not led to additional requirements incorporated by reference into Appendix A, because either a Massachusetts regulation did not change or because any changes to a previously incorporated regulation were not applicable to the attainment and maintenance of federal or state ambient air quality standards for OCS sources.</P>
                <P>However, through EPA's implementation of the OCS air permitting program, we have become aware that 310 CMR 4.03: Annual Compliance Assurance Fee and 310 CMR 7.12: U Source Registration are unnecessarily incorporated into Appendix A of 40 CFR part 55. These two regulations are either (1) implemented by existing EPA programs and thus duplicative or (2) not rationally related to the attainment or maintenance of federal or state ambient air quality standards or to the requirements of part C of title I of the CAA. EPA is removing these previously approved regulations incorporated into Appendix A of 40 CFR part 55 since our last amendment on November 15, 2022. See 87 FR 68364.  </P>
                <P>
                    The specific requirements of the consistency update and the rationale for EPA's action are explained in the September 11, 2024, NPRM (89 FR 73617). One comment was received but is not germane to the EPA's action; the comment is available at 
                    <E T="03">www.regulations.gov</E>
                     under the Docket for this action (Docket ID No. EPA-R01-OAR-2024-0367).
                </P>
                <HD SOURCE="HD1">II. Final Action</HD>
                <P>The EPA is taking final action to remove two regulations currently incorporated by reference in Appendix A of Part 55 for OCS sources where the Commonwealth of Massachusetts is the COA. The regulations that the EPA is removing are specific provisions within: (1) 310 CMR 4.00: Timely Action Schedule and Fee Provisions; and (2) 310 CMR 7.00: Air Pollution Control. Based on a review of Part 55 (1) 310 CMR 4.03: Annual Compliance Assurance Fee is duplicative of existing federal rules and (2) 310 CMR 7.12: U Source Registration is no longer determined to be rationally related to the attainment and maintenance of Federal or State ambient air quality standards or to the requirements of part C of title I of the Act. Further, these changes are being made to ensure consistency of the OCS permitting program in accordance with Part 55 requirements.</P>
                <HD SOURCE="HD1">III. Incorporation by Reference</HD>
                <P>
                    In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of “Commonwealth of Massachusetts Requirements Applicable to OCS Sources,” dated September 11, 2024, which provides the text of the MassDEP air rules in effect as of September 11, 2024, that would apply to OCS source. The EPA has made, and will continue to make, these materials available through 
                    <E T="03">www.regulations.gov</E>
                     and at the EPA Region 1 Regional Office (please contact the person identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this preamble for more information).
                </P>
                <HD SOURCE="HD1">IV. Statutory and Executive Order Reviews</HD>
                <P>
                    Under the Clean Air Act, the Administrator is required to establish requirements to control air pollution from OCS sources located within 25 miles of states' seaward boundaries that are the same as onshore air pollution control requirements. To comply with this statutory mandate, the EPA must incorporate applicable onshore rules into 40 CFR part 55 as they exist onshore. 
                    <E T="03">See</E>
                     42 U.S.C. 7627(a)(1); 40 CFR 55.12. Thus, in promulgating OCS consistency updates, the EPA's role is to maintain consistency between OCS regulations and the regulations of onshore areas, provided that they meet the criteria of the CAA. Accordingly, this action simply updates the existing OCS requirements to make them consistent with requirements onshore, without the exercise of any policy direction by the EPA. For that reason, this action:
                </P>
                <P>• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);</P>
                <P>
                    • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);</P>
                <P>• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);</P>
                <P>• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);</P>
                <P>• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);</P>
                <P>• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and</P>
                <P>• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).</P>
                <P>
                    In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, nor does it impose substantial direct compliance costs on tribal governments or preempt tribal law.
                    <PRTPAGE P="105467"/>
                </P>
                <P>
                    The Congressional Review Act, 5 U.S.C. 801 
                    <E T="03">et seq.,</E>
                     as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the 
                    <E T="04">Federal Register</E>
                    . A major rule cannot take effect until 60 days after it is published in the 
                    <E T="04">Federal Register</E>
                    . This action is not a “major rule” as defined by 5 U.S.C. 804(2).
                </P>
                <P>Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 25, 2025. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)</P>
                <P>
                    This action does not impose any new information collection burden under the Paperwork Reduction Act. 
                    <E T="03">See</E>
                     44 U.S.C 3501. The Office of Management and Budget (OMB) has previously approved the information collection activities contained in the existing regulation at 40 CFR part 55 and, by extension, this update to part 55, and has assigned OMB control number 2060-0249.
                    <SU>1</SU>
                    <FTREF/>
                     This action does not impose a new information burden under the Paperwork Reduction Act because this action only updates the state rules that are incorporated by reference into 40 CFR part 55, Appendix A.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         OMB's approval of the ICR can be viewed at 
                        <E T="03">www.reginfo.gov.</E>
                    </P>
                </FTNT>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 55</HD>
                    <P>Environmental protection, Administrative practice and procedure, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Outer continental shelf, Ozone, Particulate matter, Permits, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>David Cash,</NAME>
                    <TITLE>Regional Administrator, EPA Region 1.</TITLE>
                </SIG>
                <P>Part 55 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 55—OUTER CONTINENTAL SHELF AIR REGULATIONS</HD>
                </PART>
                <REGTEXT TITLE="40" PART="55">
                    <AMDPAR>1. The authority citation for part 55 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>
                            Section 328 of the Clean Air Act (42 U.S.C. 7401 
                            <E T="03">et seq.</E>
                            ) as amended by Public Law 101-549. 
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="40" PART="55">
                    <AMDPAR>2. Section 55.14 is amended by revising paragraph (e)(11)(i)(A) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§  55.14</SECTNO>
                        <SUBJECT> Requirements that apply to OCS sources located within 25 miles of States' seaward boundaries, by State.</SUBJECT>
                        <STARS/>
                        <P>(e) * * *</P>
                        <P>(11) * * *</P>
                        <P>(i) * * *</P>
                        <P>(A) Commonwealth of Massachusetts Requirements Applicable to OCS Sources, September 11, 2024.</P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
                <REGTEXT TITLE="40" PART="55">
                    <AMDPAR>3. Appendix A to part 55 is amended by revising paragraph (a)(1) under the heading “Massachusetts” to read as follows:</AMDPAR>
                    <HD SOURCE="HD1">Appendix A to Part 55—Listing of State and Local Requirements Incorporated by Reference Into Part 55, by State</HD>
                    <EXTRACT>
                        <STARS/>
                        <HD SOURCE="HD1">Massachusetts</HD>
                        <P>(a) * * *</P>
                        <P>(1) The following Commonwealth of Massachusetts requirements are applicable to OCS Sources, September 11, 2024, Commonwealth of Massachusetts—Department of Environmental Protection.</P>
                        <P>The following sections of 310 CMR 4.00, 310 CMR 6.00, 310 CMR 7.00 and 310 CMR 8.00:</P>
                        <HD SOURCE="HD1">310 CMR 4.00: Timely Action Schedule and Fee Provisions</HD>
                        <P>Section 4.01: Purpose, Authority and General Provisions (Effective 5/1/2020)</P>
                        <P>Section 4.02: Definitions (Effective 5/1/2020)</P>
                        <P>Section 4.04: Permit Application Schedules and Fee (Effective 5/1/2020)</P>
                        <P>Section 4.10: Appendix: Schedules for Timely Action and Permit Application Fees (Effective 5/1/2020)</P>
                        <HD SOURCE="HD1">310 CMR 6.00: Ambient Air Quality Standards for the Commonwealth of Massachusetts</HD>
                        <P>Section 6.01: Definitions (Effective 6/14/2019)</P>
                        <P>Section 6.02: Scope (Effective 6/14/2019)</P>
                        <P>Section 6.03: Reference Conditions (Effective 6/14/2019)</P>
                        <P>Section 6.04: Standards (Effective 6/14/2019)</P>
                        <HD SOURCE="HD1">310 CMR 7.00: Air Pollution Control</HD>
                        <P>Section 7.00: Statutory Authority; Legend; Preamble; Definitions (Effective 3/5/2021)</P>
                        <P>Section 7.01: General Regulations to Prevent Air Pollution (Effective 3/5/2021)</P>
                        <P>Section 7.02: U Plan Approval and Emission Limitations (Effective 3/5/2021)</P>
                        <P>Section 7.03: U Plan Approval Exemptions: Construction Requirements (Effective 3/5/2021)</P>
                        <P>Section 7.04: U Fossil Fuel Utilization Facilities (Effective 3/5/2021)</P>
                        <P>Section 7.05: U Fuels All Districts (Effective 3/5/2021)</P>
                        <P>Section 7.06: U Visible Emissions (Effective 3/5/2021)</P>
                        <P>Section 7.07: U Open Burning (Effective 3/5/2021)</P>
                        <P>Section 7.08: U Incinerators (Effective 3/5/2021)</P>
                        <P>Section 7.09: U Dust, Odor, Construction and Demolition (Effective 3/5/2021)</P>
                        <P>Section 7.11: U Transportation Media (Effective 3/5/2021)</P>
                        <P>Section 7.13: U Stack Testing (Effective 3/5/2021)</P>
                        <P>Section 7.14: U Monitoring Devices and Reports (Effective 3/5/2021)</P>
                        <P>Section 7.18: U Volatile and Halogenated Organic Compounds (Effective 3/5/2021)</P>
                        <P>
                            Section 7.19: U Reasonably Available Control Technology (RACT) for Sources of Oxides of Nitrogen (NO
                            <E T="52">X</E>
                            ) (Effective 3/5/2021)
                        </P>
                        <P>Section 7.24: U Organic Material Storage and Distribution (Effective 3/5/2021)</P>
                        <P>Section 7.25: U Best Available Controls for Consumer and Commercial Products (Effective 3/5/2021)</P>
                        <P>Section 7.26: Industry Performance Standards (Effective 3/5/2021)</P>
                        <P>Section 7.60: U Severability (Effective 3/5/2021)</P>
                        <P>7.70: Massachusetts CO Budget Trading Program (Effective 3/5/2021)</P>
                        <P>7.71: Reporting of Greenhouse Gas Emissions (Effective 3/5/2021)</P>
                        <P>7.72: Reducing Sulfur Hexafluoride Emissions from Gas-insulated Switchgear (Effective 3/5/2021)</P>
                        <P>Section 7.00: Appendix A (Effective 3/5/2021)</P>
                        <P>Section 7.00: Appendix B (Effective 3/5/2021)</P>
                        <P>Section 7.00: Appendix C (Effective 3/5/2021)</P>
                        <HD SOURCE="HD1">310 CMR 8.00: The Prevention and/or Abatement of Air Pollution Episode and Air Pollution Incident Emergencies</HD>
                        <P>Section 8.01: Introduction (Effective 3/9/2018)</P>
                        <P>Section 8.02: Definitions (Effective 3/9/2018)</P>
                        <P>Section 8.03: Air Pollution Episode Criteria (Effective 3/9/2018)</P>
                        <P>Section 8.04: Air Pollution Episode Potential Advisories (Effective 3/9/2018)</P>
                        <P>Section 8.05: Declaration of Air Pollution Episodes and Incidents (Effective 3/9/2018)</P>
                        <P>Section 8.06: Termination of Air Pollution Episodes and Incident Emergencies (Effective 3/9/2018)</P>
                        <P>Section 8.07: Emission Reductions Strategies (Effective 3/9/2018)</P>
                        <P>
                            Section 8.08: Emission Reduction Plans (Effective 3/9/2018)
                            <PRTPAGE P="105468"/>
                        </P>
                        <P>Section 8.15: Air Pollution Incident Emergency (Effective 3/9/2018)</P>
                        <P>Section 8.30: Severability (Effective 3/9/2018)</P>
                        <STARS/>
                    </EXTRACT>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30800 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 62</CFR>
                <DEPDOC>[EPA-R10-OAR-2023-0224; FRL-10859-02-R10]</DEPDOC>
                <SUBJECT>Partial Approval, Partial Disapproval and Promulgation of State Plans for Designated Facilities and Pollutants; Spokane Regional Clean Air Agency; Control of Emissions From Existing Large Municipal Waste Combustors</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA) is taking final action to partially approve and partially disapprove a July 18, 2022, Clean Air Act (CAA) State Plan submitted by the Spokane Regional Clean Air Agency (SRCAA) to establish emission limits for existing large municipal waste combustors (MWC) and to provide for the implementation and enforcement of these limits. SRCAA submitted this State Plan to fulfill its requirements under the CAA in response to the EPA's May 10, 2006, promulgation of Emissions Guidelines and Compliance Times for Large MWC Constructed on or before September 20, 1994 (Emission Guidelines). The EPA is partially approving the State Plan because it meets the requirements of the Emission Guidelines for existing large MWC known to operate in Spokane County, Washington. The EPA is partially disapproving the State Plan because it omits requirements for fluidized bed combustors and air curtain incinerators, which are required elements of a State Plan. This action is being taken under the CAA.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective on January 27, 2025. The incorporation by reference of certain material listed in the rule is approved by the Director of the Federal Register as of January 27, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The EPA has established a docket for this action under Docket ID No. EPA-R10-OAR-2023-0224. All documents in the docket are listed on the 
                        <E T="03">https://www.regulations.gov</E>
                         website. Although listed in the index, some information is not publicly available, 
                        <E T="03">e.g.,</E>
                         Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available through 
                        <E T="03">https://www.regulations.gov,</E>
                         or please contact the person identified in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section for additional availability information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Bryan Holtrop (he/him), at (206) 553-4473 or by email at 
                        <E T="03">holtrop.bryan@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Throughout this document, “we,” “us” and “our” refer to the EPA.</P>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Proposed Action</FP>
                    <FP SOURCE="FP-2">II. Public Comments and EPA Responses</FP>
                    <FP SOURCE="FP-2">III. EPA Action</FP>
                    <FP SOURCE="FP-2">IV. Incorporation by Reference</FP>
                    <FP SOURCE="FP-2">V. Statutory and Executive Order Reviews</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Proposed Action</HD>
                <P>On December 13, 2023 (88 FR 86312), the EPA proposed to approve a section 111(d) State Plan submitted by the SRCAA on July 18, 2022, for existing large municipal waste combustors. SRCAA's submitted State Plan was in response to the May 10, 2006, promulgation of the amended emission guidelines (EG) requirements for Large MWC, 40 CFR part 60, subpart Cb (71 FR 27324). Included within the State Plan are regulations under SRCAA Regulation I, Article VI, Section 6.17, entitled “Standards for Municipal Solid Waste Combustors,” effective July 7, 2022. On July 18, 2022, SRCAA submitted the State Plan.</P>
                <P>We proposed to partially approve this plan because we determined that it complies with the relevant CAA requirements, except requirements applicable to fluidized bed combustors and air curtain incinerators. Because these requirements were omitted, we also proposed to partially disapprove the State Plan submittal. Our proposed action contains more information on the plan and our evaluation.</P>
                <HD SOURCE="HD1">II. Public Comments and EPA Responses</HD>
                <P>The EPA's proposed action provided a 30-day public comment period. During this period, we received no comments.</P>
                <HD SOURCE="HD1">III. EPA Action</HD>
                <P>For the reasons discussed in our proposed rulemaking and in this action, we are finalizing the partial approval and partial disapproval of SWCAA's State Plan for large MWC, which includes SRCAA Regulation I, Article VI, Section 6.17, effective July 7, 2022. Upon the effective date of this action, SWCAA's State Plan will apply to designated large MWC, as defined in 40 CFR 60.32b, in Spokane County, Washington, with the exception of fluidized bed combustors and air curtain incinerators, which will remain subject to Federal Plan requirements under 40 CFR part 62, subpart FFF. We are finalizing this approval because we have determined the State Plan meets the applicable requirements under 40 CFR part 60, subparts B and Cb, except for the requirements noted as the basis for our partial disapproval above.</P>
                <HD SOURCE="HD1">IV. Incorporation by Reference</HD>
                <P>
                    In accordance with the requirements of 1 CFR 51.5, the EPA is finalizing regulatory text that includes the incorporation by reference of SRCAA Regulation I, Article VI, Section 6.17, “Standards for Municipal Solid Waste Combustors” with an effective date of July 7, 2022. These regulatory provisions are part of the CAA State Plan applicable to existing Large MWC in Spokane County, Washington as discussed in Section I of this preamble. They establish requirements related to emission limitations, compliance times, testing, monitoring, reporting, and recordkeeping applicable to Large MWC in Spokane County, Washington that commenced construction on or before September 20, 1994. These provisions set forth requirements meeting criteria required by the amended Emissions Guidelines for existing Large MWC codified at 40 CFR part 60, subpart Cb. The EPA has made, and will continue to make, the entire SRCAA State Plan, generally available through 
                    <E T="03">https://www.regulations.gov,</E>
                     Docket No. EPA-R10-OAR-2023-0224, and at the EPA Region 10 Office (please contact the person identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this preamble for more information). This incorporation by reference has been approved by the Office of the Federal Register, and the State Plan is Federally enforceable under the CAA as of the effective date of this final rule.
                </P>
                <HD SOURCE="HD1">V. Statutory and Executive Order Reviews</HD>
                <P>
                    In reviewing State Plan submissions, the EPA's role is to approve State choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:
                    <PRTPAGE P="105469"/>
                </P>
                <P>• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);</P>
                <P>
                    • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>
                    • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);</P>
                <P>• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);</P>
                <P>• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);</P>
                <P>• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and</P>
                <P>• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA.</P>
                <P>Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on communities with environmental justice (EJ) concerns to the greatest extent practicable and permitted by law. Executive Order 14096 (Revitalizing Our Nation's Commitment to Environmental Justice for All, 88 FR 25251, April 26, 2023) builds on and supplements Executive Order 12898 and defines EJ as, among other things, the just treatment and meaningful involvement of all people, regardless of income, race, color, national origin, or Tribal affiliation, or disability in agency decision-making and other Federal activities that affect human health and the environment.”</P>
                <P>The air agency did not evaluate environmental justice considerations as part of its submittal; the Clean Air Act and applicable implementing regulations neither prohibit nor require such an evaluation. The EPA did not perform an EJ analysis and did not consider EJ in this action. Due to the nature of this action, it is expected to have a neutral to positive impact on the air quality of the affected area. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of Executive Order 12898 of achieving environmental justice for communities with EJ concerns.</P>
                <P>In addition, the SRCAA State Plan is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, this rule would not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).</P>
                <P>
                    The Congressional Review Act, 5 U.S.C. 801 
                    <E T="03">et seq.,</E>
                     as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the 
                    <E T="04">Federal Register</E>
                    . A major rule cannot take effect until 60 days after it is published in the 
                    <E T="04">Federal Register</E>
                    . This action is not a “major rule” as defined by 5 U.S.C. 804(2).
                </P>
                <P>Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 25, 2025. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 62</HD>
                    <P>Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Waste treatment and disposal.</P>
                </LSTSUB>
                <SIG>
                    <DATED>Dated: December 17, 2024.</DATED>
                    <NAME>Daniel Opalski,</NAME>
                    <TITLE>Acting Regional Administrator, Region 10.</TITLE>
                </SIG>
                <P>For the reasons stated in the preamble, the Environmental Protection Agency amends 40 CFR part 62 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 62—APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED FACILITIES AND POLLUTANTS</HD>
                </PART>
                <REGTEXT TITLE="40" PART="62">
                    <AMDPAR>1. The authority citation for part 62 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>
                             42 U.S.C. 7401 
                            <E T="03">et seq.</E>
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="40" PART="62">
                    <AMDPAR>2. Add §§ 62.11880, 62.11881, and 61.18822 to subpart WW to read as follows:</AMDPAR>
                    <CONTENTS>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart WW—Washington</HD>
                            <SECHD>Sec.</SECHD>
                            <SECTNO>62.11880 </SECTNO>
                            <SUBJECT>Identification of plan—Spokane Regional Clean Air Agency.</SUBJECT>
                            <SECTNO>62.11881 </SECTNO>
                            <SUBJECT>Identification of sources—Spokane Regional Clean Air Agency.</SUBJECT>
                            <SECTNO>62.11882 </SECTNO>
                            <SUBJECT>Effective date—Spokane Regional Clean Air Agency.</SUBJECT>
                            <STARS/>
                        </SUBPART>
                    </CONTENTS>
                    <SECTION>
                        <SECTNO>§ 62.11880 </SECTNO>
                        <SUBJECT>Identification of plan—Spokane Regional Clean Air Agency.</SUBJECT>
                        <P>(a) The plan for the control of emissions from existing large municipal waste combustors, submitted by the Spokane Regional Clean Air Agency on July 18, 2022, to implement the emission guideline of 40 CFR part 60, subpart Cb, applies to all existing Large MWC in Spokane County, Washington meeting the requirements as stated in their State regulations. The plan includes the regulatory provisions cited in paragraph (b)(2) of this section, which the EPA incorporates by reference.</P>
                        <P>
                            (b)(1) The material incorporated by reference in this section was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the EPA Docket Center—Public Reading Room, EPA West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004, (202) 566-1744; the U.S. EPA, Region 10 office, (206) 553-1200; or the source in paragraph (b)(2) of this section. You may inspect the material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit 
                            <E T="03">www.archives.gov/federal-register/cfr/ibr-locations</E>
                             or email 
                            <E T="03">fr.inspection@nara.gov.</E>
                        </P>
                        <P>
                            (2) Spokane Regional Clean Air Agency, 1610 S Technology Blvd., Suite 101, Spokane, WA 99224; phone: (509) 
                            <PRTPAGE P="105470"/>
                            477-4727; website: 
                            <E T="03">https://spokanecleanair.org.</E>
                        </P>
                        <P>(i) SRCAA Regulation I, Article VI, Section 6.17: Standards for Municipal Solid Waste Combustors, effective July 7, 2022.</P>
                        <P>(ii) [Reserved]</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 62.11881 </SECTNO>
                        <SUBJECT>Identification of sources—Spokane Regional Clean Air Agency.</SUBJECT>
                        <P>The plan in § 62.11880 applies to all existing large municipal waste combustors in the Spokane County, Washington, excluding Indian country, constructed on or before September 20, 1994.</P>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 62.11882 </SECTNO>
                        <SUBJECT>Effective date—Spokane Regional Clean Air Agency.</SUBJECT>
                        <P>The effective date of the plan identified in § 62.11880 and submitted on July 18, 2022, by the Spokane Regional Clean Air Agency for existing large municipal waste combustors is January 27, 2025.</P>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30535 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 180</CFR>
                <DEPDOC>[EPA-HQ-OPP-2023-0596; FRL-12457-01-OCSPP]</DEPDOC>
                <SUBJECT>Ethiprole; Pesticide Tolerances</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This regulation establishes a tolerance (without U.S. registrations) for residues of ethiprole in or on sugarcane. Bayer CropScience LP requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        This regulation is effective December 27, 2024. Objections and requests for hearings must be received on or before February 25, 2025 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                        ).
                    </P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2023-0596, is available at 
                        <E T="03">http://www.regulations.gov</E>
                         or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room and the OPP Docket is (202) 566-1744. For the latest status information on EPA/DC services, docket access, visit 
                        <E T="03">https://www.epa.gov/dockets.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Charles Smith, Director, Registration Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 566-1030; email address: 
                        <E T="03">RDFRNotices@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">I. General Information</HD>
                <HD SOURCE="HD2">A. Does this action apply to me?</HD>
                <P>You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:</P>
                <P>• Crop production (NAICS code 111).</P>
                <P>• Animal production (NAICS code 112).</P>
                <P>• Food manufacturing (NAICS code 311).</P>
                <P>• Pesticide manufacturing (NAICS code 32532).</P>
                <HD SOURCE="HD2">B. How can I Get electronic access to other related information?</HD>
                <P>
                    You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the 
                    <E T="04">Federal Register</E>
                     Office's e-CFR site at 
                    <E T="03">https://www.ecfr.gov/current/title-40.</E>
                </P>
                <HD SOURCE="HD2">C. How can I file an objection or hearing request?</HD>
                <P>Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2023-0596 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before February 25, 2025. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).</P>
                <P>In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2023-0596, by one of the following methods:</P>
                <P>
                    • 
                    <E T="03">Federal eRulemaking Portal: http://www.regulations.gov.</E>
                     Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.
                </P>
                <P>
                    • 
                    <E T="03">Mail:</E>
                     OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.
                </P>
                <P>
                    • 
                    <E T="03">Hand Delivery:</E>
                     To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at 
                    <E T="03">http://www.epa.gov/dockets/where-send-comments-epa-dockets.</E>
                </P>
                <P>
                    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, are available at 
                    <E T="03">http://www.epa.gov/dockets.</E>
                </P>
                <HD SOURCE="HD1">II. Summary of Petitioned-For Tolerance</HD>
                <P>
                    In the 
                    <E T="04">Federal Register</E>
                     of July 1, 2024 (89 FR 54398) (FRL-11682-05-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3F9067) by Bayer CropScience LP, 800 N Lindbergh Blvd., St. Louis, MO 63167. The petition requested to amend 40 CFR part 180 by establishing a tolerance for residues of ethiprole in or on the raw agricultural commodity sugarcane at 0.1 parts per million (ppm).
                </P>
                <P>
                    That document referenced a summary of the petition, which is available in the docket, 
                    <E T="03">http://www.regulations.gov.</E>
                     There were no comments received in response to the notice of filing. Based upon review of the data supporting the petition, EPA has revised the tolerance from 0.1 ppm to 0.07 ppm. The reason for this change is explained in Unit IV.C.
                </P>
                <HD SOURCE="HD1">III. Aggregate Risk Assessment and Determination of Safety</HD>
                <P>
                    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA 
                    <PRTPAGE P="105471"/>
                    defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . . ”
                </P>
                <P>Consistent with FFDCA section 408(b)(2)(D), and the factors specified therein, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for ethiprole including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with ethiprole follows.</P>
                <P>
                    In an effort to streamline its publications in the 
                    <E T="04">Federal Register</E>
                    <E T="03">,</E>
                     EPA is not reprinting sections that repeat what has been previously published for tolerance rulemaking of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemaking, and EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.
                </P>
                <P>
                    EPA has previously published tolerance rulemakings for ethiprole, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to ethiprole and established tolerances for residues of that chemical. EPA is incorporating previously published sections of those rulemakings that remain unchanged, as described further in this rulemaking. Specific information on the risk assessment conducted in support of this action, including on the studies received and the nature of the adverse effects caused by ethiprole, can be found in the document titled “
                    <E T="03">Ethiprole. Human Health Risk Assessment for Tolerance without U.S. Registration in/on Imported Sugarcane”</E>
                     which is available in the docket for this action at 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>
                    <E T="03">Toxicological profile.</E>
                     For a discussion of the Toxicological Profile of ethiprole, see Unit III.A. of the rulemaking published in the 
                    <E T="04">Federal Register</E>
                     of June 28, 2019 (84 FR 30933) (FRL-9985-41).
                </P>
                <P>
                    <E T="03">Toxicological points of departure/Levels of concern.</E>
                     For a summary of the Toxicological Points of Departure/Levels of Concern used for the safety assessment of ethiprole, see Unit III.B. of the June 28, 2019, rulemaking.
                </P>
                <P>
                    <E T="03">Exposure assessment.</E>
                     Much of the exposure assessment remains unchanged from the rulemaking published in the June 28, 2019, rulemaking, although the new exposure assessment incorporates the additional dietary exposure from the petitioned-for tolerance. Other changes are described below.
                </P>
                <P>Acute and chronic dietary exposure assessments were conducted using DEEM-FCID Version 4.02. This software uses 2005-2010 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). Unrefined acute and chronic dietary exposure and risk assessments were conducted using tolerance-level residues, empirical and default processing factors, and assuming 100% crop treated.</P>
                <P>
                    <E T="03">Drinking water and non-occupational exposures.</E>
                     There are no registered or proposed U.S. uses of ethiprole. As a result, estimated drinking water concentrations (EDWCs) were not included in the dietary exposure and risk assessments because residues of ethiprole and its degradates are not anticipated to be present in U.S. drinking water.
                </P>
                <P>A residential handler and residential post-application assessment is not necessary since the action is to establish an import tolerance without a U.S. registration on sugarcane.</P>
                <P>
                    <E T="03">Cumulative exposure.</E>
                     Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to ethiprole and any other substances and ethiprole does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that ethiprole has a common mechanism of toxicity with other substances.
                </P>
                <P>
                    In 2016, EPA's Office of Pesticide Programs released a guidance document titled, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis (
                    <E T="03">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework</E>
                    ). This document provides guidance on how to screen groups of pesticides for cumulative evaluation using a two-step approach beginning with the evaluation of available toxicological information and if necessary, followed by a risk-based screening approach. This framework supplements the existing guidance documents for establishing common mechanism groups (CMGs) and conducting cumulative risk assessments (CRAs).
                </P>
                <P>
                    <E T="03">Ethiprole is a phenyl-pyrazole insecticide.</E>
                     As part of the ongoing process to review registered pesticides, the Agency intends to apply this framework to determine if the available toxicological data for ethiprole suggests a candidate CMG may be established with other pesticides. If a CMG is established, a screening-level toxicology and exposure analysis may be conducted to provide an initial screen for multiple pesticide exposure.
                </P>
                <P>
                    <E T="03">Safety Factor for Infants and Children.</E>
                     EPA continues to conclude that there is reliable data showing that the safety of infants and children would be adequately protected if the Food Quality Protection Act (FQPA) safety factor were reduced from 10X to 1X. The reasons for that decision are articulated in Unit III.D. of the June 28, 2019, rulemaking.
                </P>
                <P>
                    <E T="03">Aggregate risks and determination of safety.</E>
                     EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing dietary exposure estimates to the acute population-adjusted dose (aPAD) and chronic population-adjusted dose (cPAD). Short-, intermediate-, and chronic-term aggregate risks are evaluated by comparing the estimated total food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure (MOE) exists.
                </P>
                <P>
                    Acute dietary (food only) risks are below the Agency's level of concern of 100% of the aPAD; they are 2.4% of the aPAD for all infants (less than 1 year old), which is the population subgroup with the highest exposure estimate. Chronic dietary (food only) risks are below the Agency's level of concern of 100% of the cPAD; they are 6% of the cPAD for all infants less than one year 
                    <PRTPAGE P="105472"/>
                    old, which is the population subgroup with the highest exposure estimate.
                </P>
                <P>The short- and intermediate-term aggregate risks combine chronic dietary (food and drinking water) and short- and intermediate-term residential exposures. Since there are no U.S. registrations, aggregate risk is the same as the chronic dietary risk, which is below the Agency's level of concern.</P>
                <P>Because ethiprole is classified as “Suggestive Evidence of Carcinogenicity, but Not Sufficient to Assess Human Carcinogenicity Potential,” EPA has concluded that a cancer aggregate assessment was not required.</P>
                <P>Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to ethiprole residues.</P>
                <HD SOURCE="HD1">IV. Other Considerations</HD>
                <HD SOURCE="HD2">A. Analytical Enforcement Methodology</HD>
                <P>For a discussion of the available analytical enforcement method, see Unit IV.A. of the June 28, 2019, rulemaking.</P>
                <HD SOURCE="HD2">B. International Residue Limits</HD>
                <P>In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4).</P>
                <P>Codex, Canada, and Mexico have not established MRLs for residues of ethiprole on sugarcane commodities; therefore, there are no harmonization issues at this time.</P>
                <HD SOURCE="HD2">C. Revisions to Petitioned-For Tolerances</HD>
                <P>Review of the field trial data determined one of the nine independent sugarcane field trials was to be a replicate; therefore, the residues were averaged, and the pair of sites was taken to be one independent trial. The Organization for Economic Cooperation and Development (OECD) MRL calculator recommended a tolerance of 0.07 ppm for residues of ethiprole in sugarcane.</P>
                <HD SOURCE="HD1">V. Conclusion</HD>
                <P>Therefore, a tolerance is established for residues of ethiprole in or on sugarcane at 0.07 ppm.</P>
                <HD SOURCE="HD1">VI. Statutory and Executive Order Reviews</HD>
                <P>
                    This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, titled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, titled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), or to Executive Order 13045, titled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ), nor does it require any special considerations under Executive Order 12898, titled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).
                </P>
                <P>
                    Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ), do not apply.
                </P>
                <P>
                    This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal governments, on the relationship between the National Government and the States or Tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, titled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, titled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <P>This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).</P>
                <HD SOURCE="HD1">VII. Congressional Review Act</HD>
                <P>
                    Pursuant to the Congressional Review Act (5 U.S.C. 801 
                    <E T="03">et seq.</E>
                    ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the 
                    <E T="04">Federal Register</E>
                    . This action is not a “major rule” as defined by 5 U.S.C. 804(2).
                </P>
                <HD SOURCE="HD1">List of Subjects in 40 CFR Part 180</HD>
                <P>Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides, and pests, Reporting and recordkeeping requirements.</P>
                <SIG>
                    <DATED>Dated: December 16, 2024.</DATED>
                    <NAME>Charles Smith,</NAME>
                    <TITLE>Director, Registration Division, Office of Pesticide Programs. </TITLE>
                </SIG>
                <P>Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter 1 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 180—TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD</HD>
                </PART>
                <REGTEXT TITLE="40" PART="180">
                    <AMDPAR>1. The authority citation for part 180 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>21 U.S.C. 321(q), 346a and 371.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="40" PART="180">
                    <AMDPAR>2. In § 180.652, amend the table in paragraph (a) by adding a table heading and adding in alphabetical order the commodity “Sugarcane” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 180.652</SECTNO>
                        <SUBJECT>Ethiprole; tolerances for residues.</SUBJECT>
                        <P>(a) * * *</P>
                        <GPOTABLE COLS="2" OPTS="L1,nj,i1" CDEF="s50,12">
                            <TTITLE>
                                Table 1 to Paragraph 
                                <E T="01">(a)</E>
                            </TTITLE>
                            <BOXHD>
                                <CHED H="1">Commodity</CHED>
                                <CHED H="1">
                                    Parts per
                                    <LI>million</LI>
                                </CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*    *    *    *    *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">
                                    Sugarcane 
                                    <SU>1</SU>
                                </ENT>
                                <ENT>0.07</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*    *    *    *    *</ENT>
                            </ROW>
                            <TNOTE>
                                <SU>1</SU>
                                 There are no U.S. registrations for this commodity as of December 27, 2024.
                            </TNOTE>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30581 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <PRTPAGE P="105473"/>
                <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Coast Guard</SUBAGY>
                <CFR>46 CFR Parts 10, 11, 12, 13, 15, 16, 30, 35, and 39</CFR>
                <DEPDOC>[Docket No. USCG-2021-0097]</DEPDOC>
                <RIN>RIN 1625-AC75</RIN>
                <SUBJECT>Electronic Submission of Mariner Course Completion Data; Correction</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Coast Guard, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; correction.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Coast Guard is correcting a final rule that appeared in the 
                        <E T="04">Federal Register</E>
                         on November 25, 2024. The document required Coast Guard-approved training providers to electronically submit course completion data to the Coast Guard within 5 business days of completion, as well as making numerous editorial changes. The document contained four mistakes that require correction.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This correction is effective January 17, 2025.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For information about this document call or email Mr. Brian T. Eichelberger, Office of Merchant Mariner Credentialing, Coast Guard; telephone 202-372-1450, email 
                        <E T="03">Brian.T.Eichelberger@uscg.mil.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    In FR Doc. 2024-24271, appearing on page 93040 in the 
                    <E T="04">Federal Register</E>
                     of Monday, November 25, 2024, the following corrections are made:
                </P>
                <HD SOURCE="HD1">Corrections</HD>
                <P>
                    1. On page 93040, in the first column, in the 
                    <E T="02">DATES</E>
                     section, the date “November 25, 2026” is corrected to read “January 19, 2027.”
                </P>
                <PART>
                    <HD SOURCE="HED">PART 10—[Corrected]</HD>
                </PART>
                <REGTEXT TITLE="46" PART="10">
                    <AMDPAR>2. On page 93054, in the first column, in part 10, in amendatory instruction 2, the set-out table is corrected to read as follows:</AMDPAR>
                    <GPOTABLE COLS="2" OPTS="L2,nj,tp0,p7,7/8,i1" CDEF="s50,r50">
                        <TTITLE> </TTITLE>
                        <BOXHD>
                            <CHED H="1">Remove</CHED>
                            <CHED H="1">Add</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Certificate of registry</ENT>
                            <ENT>Certificate of Registry.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">certificate of registry</ENT>
                            <ENT>Certificate of Registry.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">merchant mariner credential</ENT>
                            <ENT>Merchant Mariner Credential.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">merchant mariner credentials</ENT>
                            <ENT>Merchant Mariner Credentials.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Merchant mariner's document</ENT>
                            <ENT>Merchant Mariner's Document.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">merchant mariner's document</ENT>
                            <ENT>Merchant Mariner's Document.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Merchant mariner credential</ENT>
                            <ENT>Merchant Mariner Credential.</ENT>
                        </ROW>
                    </GPOTABLE>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 11.315 </SECTNO>
                    <SUBJECT>[Corrected]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="46" PART="11">
                    <AMDPAR>3. On page 93073, in the second and third columns below Table 1 to § 11.315(d), in amendatory instruction 40, paragraph (a)(3) is corrected to be read as follows:</AMDPAR>
                    <P>“(3) Provide evidence of having satisfactorily completed approved training in the following subject areas:</P>
                    <P>(i) Medical First-aid Provider.</P>
                    <P>(ii) Basic and Advanced Firefighting in accordance with § 11.303.</P>
                    <P>(iii) Proficiency in Survival Craft and Rescue Boats other than Fast Rescue Boats (PSC) or Proficiency in Survival Craft and Rescue Boats other than Lifeboats and Fast Rescue Boats (PSC-Limited).</P>
                    <P>(iv) Radar Observer, if serving on a vessel with this equipment.</P>
                    <P>(v) Leadership and managerial skills.</P>
                    <P>(vi) ECDIS, if serving on a vessel with this equipment.</P>
                    <P>(vii) Radar Observer, if serving on a vessel with this equipment.</P>
                    <P>(viii) ARPA, if serving on a vessel with this equipment.”</P>
                </REGTEXT>
                <SECTION>
                    <SECTNO>§ 11.319 </SECTNO>
                    <SUBJECT>[Corrected]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="46" PART="11">
                    <AMDPAR>4. On page 93074, in the first column, in amendatory instruction 41, the instruction “Amend § 11.319 by revising the section heading, paragraph (a), and table 1 to § 11.317(d) to read as follows:” is corrected to read “Amend § 11.319 by revising the section heading, paragraph (a), and table 1 to § 11.319(d) to read as follows:”</AMDPAR>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: December 18, 2024.</DATED>
                    <NAME>Michael Cunningham,</NAME>
                    <TITLE>Chief, Office of Regulations and Administrative Law, U.S. Coast Guard.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30599 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-04-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL COMMUNICATIONS COMMISSION</AGENCY>
                <CFR>47 CFR Part 20</CFR>
                <DEPDOC>[WT Docket No. 23-388; FCC 24-112; FR ID 257122]</DEPDOC>
                <SUBJECT>Achieving 100% Wireless Handset Model Hearing Aid Compatibility</SUBJECT>
                <HD SOURCE="HD2">Correction</HD>
                <P>In rule document 2024-25088, appearing on pages 89832 through 89868 in the issue of Wednesday, November 13, 2024, make the following corrections:</P>
                <SECTION>
                    <SECTNO>§ 20.19</SECTNO>
                    <SUBJECT>[Corrected]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="47" PART="20">
                    <AMDPAR>1. On page 89865, in the first column, in paragraph 20.19(b)(3)(i), on the second line, “December 12, 2028” should read “December 13, 2028”.</AMDPAR>
                    <AMDPAR>2. On the same page, in the same column, in paragraph 20.19(b)(3)(ii), on the first line, “December 12, 2028” should read “December 13, 2028”.</AMDPAR>
                    <AMDPAR>3. On the same page, in the same column, in paragraph 20.19(b)(4), on the third line, “December 12,” should read “December 13,”.</AMDPAR>
                    <AMDPAR>4. On page 89866, in the first column, in paragraph 20.19(c)(5), on the fourth line, “June 12, 2028” should read “June 13, 2028”.</AMDPAR>
                    <AMDPAR>5. On the same page, in the same column, in paragraph 20.19(c)(6), on the fourth line, “June 12, 2028” should read “June 13, 2028”.</AMDPAR>
                    <AMDPAR>6. On the same page, in the second column, in paragraph 20.19(e)(4), on the seventh and eighth lines, “June 12, 2028” should read “June 13, 2028”.</AMDPAR>
                    <AMDPAR>7. On page 89867, in the first column, in paragraph 20.19 (b)(3)(iii)(C), on the first line, “December 12, 2028” should read “December 13, 2028”.</AMDPAR>
                    <AMDPAR>8. On the same page, in the third column, in paragraph 20.19(i)(5), on the sixth line, “June 12, 2028” should read “June 13, 2028”.</AMDPAR>
                </REGTEXT>
            </PREAMB>
            <FRDOC>[FR Doc. C1-2024-25088 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6712-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">FEDERAL COMMUNICATIONS COMMISSION</AGENCY>
                <CFR>47 CFR Part 36</CFR>
                <DEPDOC>[WC Docket Nos. 10-90, 23-328, 14-58, 09-197; WT Docket No. 10-208; FCC 23-87; FR ID 269499]</DEPDOC>
                <SUBJECT>Connect America Fund, Alaska Connect Fund, ETC Annual Reports and Certifications, Telecommunications Carriers Eligible To Receive Universal Service Support, Universal Service Reform—Mobility Fund; Correction</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Communications Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Correcting amendment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This document corrects an error in the regulatory text of a 
                        <E T="04">Federal Register</E>
                         document that amended existing rules and requirements governing the management and administration of the Federal Communications Commission's (Commission) Universal Service Fund high-cost program. The summary was published in the 
                        <E T="04">Federal Register</E>
                         on April 10, 2024, and this document corrects the final regulations in that document.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective December 27, 2024.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Jesse Jachman, Wireline Competition Bureau, (202) 418-7400.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <PRTPAGE P="105474"/>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This summary contains a correction to the regulatory text of a 
                    <E T="04">Federal Register</E>
                     document, 89 FR 25147, April 10, 2024. See also the announcement of effective date published at 89 FR 92846, November 25, 2024.
                </P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 47 CFR Part 36</HD>
                    <P>Communications common carriers, Reporting and recordkeeping requirements, Telecommunications, Telephone, Uniform System of Accounts.</P>
                </LSTSUB>
                <P>Accordingly, 47 CFR part 36 is corrected by making the following correcting amendment:</P>
                <PART>
                    <HD SOURCE="HED">PART 36—JURISDICTIONAL SEPARATIONS PROCEDURES; STANDARD PROCEDURES FOR SEPARATING TELECOMMUNICATIONS PROPERTY COSTS, REVENUES, EXPENSES, TAXES AND RESERVES FOR TELECOMMUNICATIONS COMPANIES</HD>
                </PART>
                <REGTEXT TITLE="47" PART="36">
                    <AMDPAR>1. The authority citation for part 36 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 47 U.S.C. 151, 152, 154(i) and (j), 201, 205, 220, 221(c), 254, 303(r), 403, 410, and 1302 unless otherwise noted.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="47" PART="36">
                    <AMDPAR>2. In § 36.4 revise paragraph (c) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 36.4</SECTNO>
                        <SUBJECT>Streamlining procedures for processing petitions for waiver of study area boundaries.</SUBJECT>
                        <STARS/>
                        <P>
                            (c) 
                            <E T="03">Petitions for waiver required.</E>
                             Local exchange carriers seeking a change in study area boundaries must file a study area petition consistent with the procedures set out in paragraphs (a) and (b) of this section notwithstanding any prior exemption from such waiver requests including, but not limited to, when a company is combining previously unserved territory with one of its study areas or a holding company is consolidating existing study areas within the same state. The Wireline Competition Bureau or the Office of Economics and Analytics are permitted to accept study area boundary corrections without a waiver.
                        </P>
                    </SECTION>
                </REGTEXT>
                <SIG>
                    <FP>Federal Communications Commission.</FP>
                    <NAME>Marlene Dortch,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30967 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6712-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">FEDERAL COMMUNICATIONS COMMISSION</AGENCY>
                <CFR>47 CFR Part 64</CFR>
                <DEPDOC>[CG Docket Nos. 22-408, 03-123, and 13-24; FCC 24-81; FR ID 269113]</DEPDOC>
                <SUBJECT>TRS Fund Support for Internet Protocol Captioned Telephone Service Compensation; Correction</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Communications Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Correcting amendment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This document corrects the final rule portion of 
                        <E T="04">Federal Register</E>
                         document published on September 4, 2024. This document inadvertently has an error in the ending year for the supplemental compensation for CA-assisted internet Protocol Captioned Telephone Service (IP CTS). This document corrects the final regulations.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective on December 27, 2024.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Michael Scott, Consumer and Governmental Affairs Bureau, (202) 418-1264, 
                        <E T="03">Michael.Scott@fcc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This document corrects the final rule document published at 89 FR 71848, September 4, 2024. It corrects the ending date for the per-minute Supplemental Compensation Rate for CA-assisted IP CTS in 47 CFR 64.641(c)(2) to June 30, 2029 from the erroneous June 30, 2027.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 47 CFR Part 64</HD>
                    <P>Individuals with disabilities, Telecommunications, Telephones.</P>
                </LSTSUB>
                <SIG>
                    <FP>Federal Communications Commission.</FP>
                    <NAME>Marlene Dortch,</NAME>
                    <TITLE>Secretary, Office of the Secretary.</TITLE>
                </SIG>
                <HD SOURCE="HD1">Final Rules</HD>
                <P>Accordingly, 47 CFR part 64 is corrected by making the following correcting amendment:</P>
                <PART>
                    <HD SOURCE="HED">PART 64 MISCELLANEOUS RULES RELATING TO COMMON CARRIERS</HD>
                </PART>
                <REGTEXT TITLE="47" PART="64">
                    <AMDPAR>1. The authority citation for part 64 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P> 47 U.S.C. 151, 152, 154, 201, 202, 217, 218, 220, 222, 225, 226, 227, 227b, 228, 251(a), 251(e), 254(k), 255, 262, 276, 403(b)(2)(B), (c), 616, 620, 716, 1401-1473, unless otherwise noted; Pub. L. 115-141, Div. P, sec. 503, 132 Stat. 348, 1091; Pub. L. 117-338, 136 Stat. 6156.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="47" PART="64">
                    <SUBPART>
                        <HD SOURCE="HED">Subpart F—Telecommunications Relay Services and Related Customer Premises Equipment for Persons With Disabilities</HD>
                    </SUBPART>
                    <AMDPAR>2. Amend § 64.641 by revising paragraph (c)(2)(i) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 64.641</SECTNO>
                        <SUBJECT>Compensation for internet Protocol Captioned Telephone Service.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(2) * * *</P>
                        <P>(i) For each succeeding TRS Fund Year through June 30, 2029, the per-minute Supplemental Compensation Rate for CA-assisted IP CTS shall be determined in accordance with the following equation:</P>
                        <HD SOURCE="HD3">Equation 2 to Paragraph (c)(2)(i)</HD>
                        <FP SOURCE="FP-2">
                            L
                            <E T="52">FY</E>
                             = L
                            <E T="52">FY-1</E>
                             * (1 + AF
                            <E T="52">FY</E>
                            )
                        </FP>
                        <P>
                            Where L
                            <E T="52">FY</E>
                             is the CA-assisted Compensation Level for the new Fund Year, L
                            <E T="52">FY-1</E>
                             is the CA-assisted Compensation Level for the previous Fund Year, and AF
                            <E T="52">FY</E>
                             is the Adjustment Factor for the new Fund Year, as defined by paragraph (b)(3) of this section.
                        </P>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30498 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6712-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">GENERAL SERVICES ADMINISTRATION</AGENCY>
                <CFR>48 CFR Parts 501 and 552</CFR>
                <DEPDOC>[GSAR Case 2024-G502; Docket No. GSA-GSAR-2024-0022; Sequence No. 1]</DEPDOC>
                <RIN>RIN 3090-AK81</RIN>
                <SUBJECT>General Services Administration Acquisition Regulation (GSAR); Update to OMB Approval Table</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Acquisition Policy, General Services Administration (GSA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The General Services Administration is issuing this final rule to the General Services Administration Acquisition Regulation to correct and update the table of approved acquisition related information collection number references from the Office of Management and Budget under the Paperwork Reduction Act.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Effective:</E>
                         January 27, 2025.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For clarification of content, contact Ms. Adina Torberntsson, Procurement Analyst, at 
                        <E T="03">gsarpolicy@gsa.gov</E>
                         or 720-475-0568. For information pertaining to status or publication schedules, contact the Regulatory Secretariat at 
                        <PRTPAGE P="105475"/>
                        <E T="03">GSARegSec@gsa.gov</E>
                         or 202-501-4755. Please cite GSAR Case 2024-G502.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    During its normal regulatory review, GSA discovered that several of the Office of Management and Budget (OMB) Control Numbers (No.) listed in the General Services Administration Acquisition Regulation (GSAR) reference table at 501.106 were either omitted, incorrect, or had been updated (
                    <E T="03">i.e.,</E>
                     Federal Acquisition Regulation (FAR) OMB Control Nos. (9000 series) that are applicable to GSA acquisition requirements). For any OMB Control No. added to the table via this final rule, an approved OMB Control No. already existed. However, the approved OMB Control No. was simply not reflected at 501.106 as intended.
                </P>
                <HD SOURCE="HD2">Miscellaneous Updates to GSAR 501.106, Table 1</HD>
                <P>GSAR 511.171 and the corresponding OMB Control No. 3090-0300 are added to the table.</P>
                <P>GSAR 511.204(c) is updated to remove the paragraph (c); it will now read as 511.204.</P>
                <P>GSAR 514.201-1 is updated to remove the subsection 1; it will now read as 514.201.</P>
                <P>GSAR 515.209-70(b) is updated to remove the subsection 70; it will now read as 515.209.</P>
                <P>GSAR 516.506 is updated to add OMB Control No. 3090-0163.</P>
                <P>GSAR 516.506 and the corresponding OMB Control Numbers are updated to reflect the inclusion of 3090-0163. The other OMB Control Nos. associated with GSAR 516.506 remain the same.</P>
                <P>GSAR 532.111 and the corresponding OMB Control No. 3090-0080 are added to the table.</P>
                <P>GSAR 532.908 and the corresponding OMB Control No. 3090-0080 are added to the table.</P>
                <P>GSAR 536.572 and the corresponding OMB Control No. 3090-0308 are added to the table.</P>
                <P>GSAR 536.7002-4 and the corresponding OMB Control No. 3090-0274 are added to the table.</P>
                <P>GSAR 536.7107 and the corresponding OMB Control No. 3090-0320 are added to the table.</P>
                <P>GSAR 538.273 and the corresponding OMB Control Numbers are updated to reflect the removal of 3090-0262, and the inclusion of 3090-0248 and 3090-0302. The other OMB Control Nos. associated with GSAR 538.273 remain the same.</P>
                <P>GSAR 546.302-71 is updated to remove the subsection 71; it will now read as 546.302.</P>
                <P>Clause 552.204-9 and the corresponding OMB Control Nos. 3090-0283 and 3090-0287 are added to the table.</P>
                <P>Clause 552.211-13(a) is updated to remove the paragraph (a); it will now read as 552.211-13.</P>
                <P>Clause 552.211-70(b) is updated to remove the paragraph (b) and revise the OMB Control No.; it will now be read as 552.211-70 with OMB Control No. 9000-0062.</P>
                <P>Clause 552.232-5 is updated with the corresponding OMB Control Nos. 9000-0070 and 9000-0102 removed and replaced with 9000-0073. The other OMB Control No. associated with 552.232-5 remains the same.</P>
                <P>Clause 552.223-70 is changed to clause 552.223-72, which is associated with OMB Control No. 3090-0205.</P>
                <P>Clause 552.236-15 is updated with the corresponding OMB Control No. changed to 9000-0062.</P>
                <P>Clause 552.238-74 and the corresponding OMB Control No. 3090-0250 are added to the table.</P>
                <P>Clause 552.238-77 and the corresponding OMB Control No. 3090-0250 are added to the table.</P>
                <P>Clause 552.238-85 and the corresponding OMB Control Nos. 3090-0235 and 3090-0306 are added to the table.</P>
                <P>Clause 552.238-86 and the corresponding OMB Control No. 3090-0250 are added to the table.</P>
                <P>Clause 552.238-91 and the corresponding OMB Control No. 3090-0250 are added to the table.</P>
                <P>Clause 552.238-100 and the corresponding OMB Control No. 3090-0250 are added to the table.</P>
                <P>Clause 552.238-103 and the corresponding OMB Control No. 3030-0248 are added to the table.</P>
                <P>Clause 552.238-104 and the corresponding OMB Control No. 3090-0250 are added to the table.</P>
                <P>Clause 552.238-107 and the corresponding OMB Control No. 3090-0250 are added to the table.</P>
                <P>Clause 552.238-108 and the corresponding OMB Control No. 3090-0250 are added to the table.</P>
                <P>Provision 552.238-118 and corresponding OMB Control No. 3090-0303 are added to the table.</P>
                <P>Clause 552.238-119 and the corresponding OMB Control No. 3090-0303 are added to the table.</P>
                <P>Provision 552.270-1 and the corresponding OMB Control No. 3090-0086 are added to the table.</P>
                <P>GSAR 570.117 and the corresponding OMB Control No. 3090-0086 are added to the table.</P>
                <P>GSAR 570.702 and the corresponding OMB Control No. 3090-0086 are added to the table.</P>
                <P>GSAR 570.703(c) is updated to remove the paragraph (c); it will now read as 570.703.</P>
                <P>GSAR 570.802(b) and (c) are updated to remove the paragraphs (b) and (c); it will now read as 570.802.</P>
                <P>GSA Form GSA-176 and its corresponding OMB Control No. 3090-0287 are added to the table.</P>
                <P>GSA Form GSA-308 and its corresponding OMB Control No. 3090-0027 are added to the table.</P>
                <P>GSA Form GSA-850 and its corresponding OMB Control No. 3090-0283 are added to the table.</P>
                <P>GSA Form GSA-2419 is updated with the corresponding OMB Control No. changed to 9000-0073.</P>
                <P>GSA Form GSA-3665 and its corresponding OMB Control No. 3090-0283 are added to the table.</P>
                <P>Lastly, GSA Form GSA-7437 and its corresponding OMB Control No. 3090-0274 are added to the table. OMB Control No. Update to GSAR Provision 552.270.1.</P>
                <P>Further review identified that the OMB Control No. referenced in GSAR provision 552.270-1 was incorrect.</P>
                <P>The current OMB Control No. 3090-0163 referenced in GSAR provision 552.270-1(f) is not accurate and is not needed in the provision. This OMB Control No. applies to procurement-related information collections associated with solicitations issued for various supplies and services in accordance with the Federal Acquisition Regulation (FAR) Part 12, 14, 15 and 16 procedures.</P>
                <P>3090-0163 was therefore replaced with OMB Control No. 3090-0086 in the table at 501.106 as it is specific to GSA lease solicitation information, which is used to obtain information about property being offered for lease to house Federal agencies and to obtain pricing information regarding offered services and lease commissions. Therefore, OMB Control No. 3090-0086 is more appropriate for the GSAR prescription 570.702 and GSAR provision 552.270-1.</P>
                <P>GSAR provision 552.270-1 is amended to remove the paragraph (f), which currently references the incorrect OMB Control No. Additionally, including an OMB Control No. is not a normal convention for a provision or clause; therefore, to be consistent with GSAR provisions and clauses, this paragraph is removed.</P>
                <HD SOURCE="HD1">II. Publication of This Final Rule for Public Comment Is Not Required</HD>
                <P>
                    The statute that applies to the publication of the GSAR is the Office of Federal Procurement Policy statute (codified at title 41 of the United States Code). Specifically, 41 U.S.C. 1707(a)(1) 
                    <PRTPAGE P="105476"/>
                    requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it relates to the expenditure of appropriated funds, and has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure, or form, or has a significant cost or administrative impact on contractors or offerors. This rule is not required to be published for public comment because GSA is not issuing a new regulation; rather, this rule is technical in nature and is merely updating information in the table located at GSAR 501.106 and removing an incorrect OMB Control No. reference at GSAR provision 552.270-1.
                </P>
                <HD SOURCE="HD1">III. Executive Order 12866, 13563 and 14094</HD>
                <P>Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. E.O. 14094 supplements and reaffirms the principles, structures, and definitions governing contemporary regulatory review established in E.O. 12866 and E.O. 13563. The Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) has determined this rule is not a significant regulatory action and, therefore, is not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993.</P>
                <HD SOURCE="HD1">IV. Congressional Review Act</HD>
                <P>
                    The Congressional Review Act, 5 U.S.C. 801 
                    <E T="03">et seq.,</E>
                     as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a “major rule” may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The General Services Administration will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. A major rule cannot take effect until 60 days after it is published in the 
                    <E T="04">Federal Register</E>
                    . OIRA has determined this rule is not a “major rule” under 5 U.S.C. 804(2). The Office of Information and Regulatory Affairs in the Office of Management and Budget has determined that this is not a major rule under 5 U.S.C. 804.
                </P>
                <HD SOURCE="HD1">V. Regulatory Flexibility Act</HD>
                <P>
                    The Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    ) does not apply to this rule because an opportunity for public comment is not required to be given for this rule under 41 U.S.C. 1707(a)(1). Accordingly, no regulatory flexibility analysis is required and none has been prepared.
                </P>
                <HD SOURCE="HD1">VI. Paperwork Reduction Act</HD>
                <P>The Paperwork Reduction Act (44 U.S.C. chapter 35) does apply; however these changes to the GSAR do not impose additional information collection requirements to the paperwork burden previously approved under the Office of Management and Budget Control Numbers referenced in the rule.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 48 CFR Parts 501 and 552</HD>
                    <P>Government procurement.</P>
                </LSTSUB>
                <SIG>
                    <NAME>Jeffrey A. Koses,</NAME>
                    <TITLE>Senior Procurement Executive, Office of Acquisition Policy, Office of Government-wide Policy, General Services Administration.</TITLE>
                </SIG>
                <P>Therefore, GSA amends 48 CFR parts 501 and 552 as set forth below:</P>
                <REGTEXT TITLE="48" PART="501">
                    <AMDPAR>1. The authority citation for 48 CFR parts 501 and 552 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>40 U.S.C. 121(c).</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="48" PART="501">
                    <AMDPAR>2. In section 501.106, revise table 1 to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>501.106 </SECTNO>
                        <SUBJECT>OMB approval under the Paperwork Reduction Act.</SUBJECT>
                        <STARS/>
                        <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s50,xs100">
                            <TTITLE>Table 1 to 501.106</TTITLE>
                            <BOXHD>
                                <CHED H="1">GSAR reference</CHED>
                                <CHED H="1">OMB control No.</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">509.105-1</ENT>
                                <ENT>3090-0007</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">511.171</ENT>
                                <ENT>3090-0300</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">511.204</ENT>
                                <ENT>3090-0246</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">512.301</ENT>
                                <ENT>3090-0163</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">514.201</ENT>
                                <ENT>3090-0163</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">515.209</ENT>
                                <ENT>3090-0163</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">515.408</ENT>
                                <ENT>3090-0235</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">516.506</ENT>
                                <ENT>3090-0248, 3090-0306, 3090-0163</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">523.370</ENT>
                                <ENT>3090-0205</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">532.111</ENT>
                                <ENT>3090-0080</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">532.905-70</ENT>
                                <ENT>3090-0080</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">532.908</ENT>
                                <ENT>3090-0080</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">536.572</ENT>
                                <ENT>3090-0308</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">536.7002-4</ENT>
                                <ENT>3090-0274</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">536.7107</ENT>
                                <ENT>3090-0320</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">538.273</ENT>
                                <ENT>3090-0163, 3090-0235, 3090-0248, 3090-0250, 3090-0302, 3090-0303, 3090-0306</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">542.1107</ENT>
                                <ENT>3090-0027</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">546.302</ENT>
                                <ENT>3090-0027</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.204-9</ENT>
                                <ENT>3090-0283, 3090-0287</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.211-13</ENT>
                                <ENT>9000-0026</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.211-70</ENT>
                                <ENT>9000-0062</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.211-77</ENT>
                                <ENT>3090-0246</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.215-73</ENT>
                                <ENT>3090-0163</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.216-72</ENT>
                                <ENT>3090-0248</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.216-73</ENT>
                                <ENT>3090-0248</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.216-75</ENT>
                                <ENT>3090-0306</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.223-72</ENT>
                                <ENT>3090-0205</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.232-5</ENT>
                                <ENT>3090-0080, 9000-0073</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.232-72</ENT>
                                <ENT>3090-0080</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.236-15</ENT>
                                <ENT>9000-0062</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.236-72</ENT>
                                <ENT>3090-0308</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.236-79</ENT>
                                <ENT>3090-0320</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.236-80</ENT>
                                <ENT>9000-0034</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-72</ENT>
                                <ENT>3090-0163</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-73</ENT>
                                <ENT>3090-0250</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-74</ENT>
                                <ENT>3090-0250</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-77</ENT>
                                <ENT>3090-0250</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-78</ENT>
                                <ENT>3090-0262</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-80</ENT>
                                <ENT>3090-0235, 3090-0306</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-81</ENT>
                                <ENT>3090-0235, 3090-0306</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-82</ENT>
                                <ENT>3090-0302</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-83</ENT>
                                <ENT>3090-0235, 3090-0306</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-84</ENT>
                                <ENT>3090-0303</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-85</ENT>
                                <ENT>3090-0235, 3090-0306</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-86</ENT>
                                <ENT>3090-0250</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-87</ENT>
                                <ENT>3090-0303</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-91</ENT>
                                <ENT>3090-0250</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-95</ENT>
                                <ENT>3090-0303</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-96</ENT>
                                <ENT>3090-0303</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-97</ENT>
                                <ENT>3090-0303</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-99</ENT>
                                <ENT>3090-0303</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-100</ENT>
                                <ENT>3090-2050</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-103</ENT>
                                <ENT>3090-0248</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-104</ENT>
                                <ENT>3090-0250</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-107</ENT>
                                <ENT>3090-0250</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-108</ENT>
                                <ENT>3090-0250</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-111</ENT>
                                <ENT>3090-0303</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-118</ENT>
                                <ENT>3090-0303</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-119</ENT>
                                <ENT>3090-0303</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.238-120</ENT>
                                <ENT>3090-0235, 3090-0306</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.242-70</ENT>
                                <ENT>3090-0027</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.246-70</ENT>
                                <ENT>3090-0027</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.246-71</ENT>
                                <ENT>3090-0027</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.270-1</ENT>
                                <ENT>3090-0086</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">552.270-33</ENT>
                                <ENT>3090-0324</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">570-117</ENT>
                                <ENT>3090-0086</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">570-702</ENT>
                                <ENT>3090-0086</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">570.703</ENT>
                                <ENT>3090-0324</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">570.802</ENT>
                                <ENT>3090-0086</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">GSA-176</ENT>
                                <ENT>3090-0287</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">GSA-308</ENT>
                                <ENT>3090-0027</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">GSA-527</ENT>
                                <ENT>3090-0007</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">GSA-850</ENT>
                                <ENT>3090-0283</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">GSA-1142</ENT>
                                <ENT>3090-0080</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">GSA-1217</ENT>
                                <ENT>3090-0086</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">GSA-1364</ENT>
                                <ENT>3090-0086</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">GSA-1678</ENT>
                                <ENT>3090-0027</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">GSA-2419</ENT>
                                <ENT>9000-0102</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">GSA-3665</ENT>
                                <ENT>3090-0283</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">GSA-7437</ENT>
                                <ENT>3090-0274</ENT>
                            </ROW>
                        </GPOTABLE>
                    </SECTION>
                </REGTEXT>
                <PART>
                    <PRTPAGE P="105477"/>
                    <HD SOURCE="HED">PART 552—SOLICITATION PROVISIONS AND CONTRACT CLAUSES</HD>
                </PART>
                <REGTEXT TITLE="48" PART="552">
                    <AMDPAR>3. Amend section 552-270-1 by—</AMDPAR>
                    <AMDPAR>a. Revising the date of the provision; and</AMDPAR>
                    <AMDPAR>b. Removing paragraph (f).</AMDPAR>
                    <P>The revision reads as follows:</P>
                    <P>552.270-1 Instructions to Offerors—Acquisition of Leasehold Interests in Real Property.</P>
                    <STARS/>
                    <HD SOURCE="HD1">Instructions to Offerors—Acquisition of Leasehold Interests in Real Property (JAN 2025)</HD>
                    <STARS/>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30670 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6820-61-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <CFR>50 CFR Part 217</CFR>
                <DEPDOC>[Docket No. 241003-0261]</DEPDOC>
                <RIN>RIN 0648-BM74</RIN>
                <SUBJECT>Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to U.S. Navy Repair and Replacement of the Q8 Bulkhead at Naval Station Norfolk</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; delay of effective and expiration dates; correction.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        NMFS published a final rule on October 9, 2024, for the taking of marine mammals incidental to the Q8 bulkhead repair and replacement project at Naval Station (NAVSTA) Norfolk in Norfolk, Virginia over the course of 5 years (
                        <E T="03">i.e.,</E>
                         2025-2029). The Navy has requested the effective date of the rule be modified from January 1, 2025, to August 4, 2025, and modify the expiration date from December 31, 2029 to August 3, 2030.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The effective date of the regulations published at 89 FR 81848, October 9, 2024, is delayed until August 4, 2025, and the expiration date is revised to August 3, 2030. This correction is effective August 4, 2025, and expires August 3, 2030.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        A copy of the Navy's application and any supporting documents, as well as a list of the references cited in this document, may be obtained online at: 
                        <E T="03">https://www.fisheries.noaa.gov/action/incidental-take-authorization-us-navys-construction-activities-q8-bulkhead-naval-station</E>
                        . In case of problems accessing these documents, please call the contact listed below.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Craig Cockrell, Office of Protected Resources, NMFS, (301) 427-8401.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 
                    <E T="03">et seq.</E>
                    ) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.
                </P>
                <P>On July 3, 2024 NMFS published the proposed rule to authorize the taking of marine mammals incidental to the Q8 bulkhead repair and replacement project at NAVSTA Norfolk. During the 30-day comment period of the proposed rule NMFS received two comments. NMFS responded to the two comments in the original final rule (89 FR 81848, October 9, 2024).</P>
                <P>NMFS published the final rule on October 9, 2024 (89 FR 81848), which allows for authorization of the take of small numbers of four marine mammal species incidental to the Q8 bulkhead repair and replacement project. This project involves work on the bulkhead from Piers 12 and 14 to restore function of this Navy dock system. Vibratory and impact hammers will be used for pile removal and installation. Sounds produced from these pile removal and installation activities may result in the incidental take of marine mammals, by Level B harassment only. Approximately 378 piles will be removed and 836 piles will be installed. Work will be conducted in 3 phases over 212 non-consecutive days to complete the pile removal and installation activities.</P>
                <P>The original effective dates finalized in the rule (89 FR 81848, October 9, 2024) were January 1, 2025 through December 31, 2029. Recently, the Navy's construction schedule has been delayed, and as such, the Navy has requested NMFS delay and modify the effective dates. This final rule will delay the effective date from January 1, 2025 to August 4, 2025 and modify the expiration date from December 31, 2029 to August 3, 2030. This delay and modification of effective dates do not change the duration of the incidental take regulations or change any of the findings and take estimates or the requirements for mitigation, monitoring, and reporting, in the original final rule.</P>
                <HD SOURCE="HD1">Administrative Procedures Act</HD>
                <P>The Assistant Administrator for Fisheries (AA) finds that there is good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), because prior notice and opportunity for public comment on this temporary delay is unnecessary and contrary to the public interest. Such procedures are unnecessary because the final rule that published on October 9, 2024 (89 FR 81848), has already been subject to notice and comment, and all that remains is to notify the public of this delay and modification to the effective dates of the previously noticed regulations. Providing additional prior notice and opportunity for public comment is contrary to the public interest because there is a need to immediately implement this action to delay the original January 1, 2025 effective date and modify the expiration date of the regulations contained in 50 CFR 217.231. Failure to modify the effective dates risks a potential lapse in coverage for the Navy's construction activities for the Q8 bulkhead repair and replacement project at NAVSTA Norfolk.</P>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Samuel D. Rauch, III,</NAME>
                    <TITLE>Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.</TITLE>
                </SIG>
                <P>For reasons set forth in the preamble, NMFS amends 50 CFR part 217 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 217—REGULATIONS GOVERNING THE TAKING AND IMPORTING OF MARINE MAMMALS</HD>
                </PART>
                <REGTEXT TITLE="50" PART="217">
                    <AMDPAR>1. The authority citation for part 217 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>
                            16 U.S.C. 1361 
                            <E T="03">et seq.,</E>
                             unless otherwise noted. 
                        </P>
                    </AUTH>
                </REGTEXT>
                <SUBPART>
                    <HD SOURCE="HED">Subpart X—Taking and Importing Marine Mammals Incidental to Navy Construction of the Q8 Bulkhead Repair and Replacement Project at Naval Station Norfolk at Norfolk, Virginia</HD>
                </SUBPART>
                <REGTEXT TITLE="50" PART="217">
                    <AMDPAR>2. Revise § 217.231 to read as follows:</AMDPAR>
                    <SECTION>
                        <PRTPAGE P="105478"/>
                        <SECTNO>§ 217.231 </SECTNO>
                        <SUBJECT>Effective dates.</SUBJECT>
                        <P>Regulations under this subpart are effective from August 4, 2025, through August 3, 2030.</P>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30823 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <CFR>50 CFR Part 679</CFR>
                <DEPDOC>[Docket No. 240304-0068; RTID 0648-XE549]</DEPDOC>
                <SUBJECT>Fisheries of the Exclusive Economic Zone Off Alaska; Inseason Adjustment to the 2025 Bering Sea and Aleutian Islands Pollock, Atka Mackerel, and Pacific Cod Total Allowable Catch Amounts</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Temporary rule; inseason adjustment; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>NMFS is adjusting the 2025 total allowable catch (TAC) amounts for the Bering Sea and Aleutian Islands (BSAI) pollock, Atka mackerel, and Pacific cod fisheries. This action is necessary because NMFS has determined these TACs are incorrectly specified, and will ensure the BSAI pollock, Atka mackerel, and Pacific cod TACs are the appropriate amounts based on the best scientific information available. This action is consistent with the goals and objectives of the Fishery Management Plan for Groundfish of the BSAI (FMP).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        Effective 0001 hours, Alaska local time (A.l.t.), January 1, 2025, until the effective date of the final 2025 and 2026 harvest specifications for BSAI groundfish, unless otherwise modified or superseded through publication of a notification in the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                    <P>Comments must be received at the following address no later than 4:30 p.m., A.l.t., January 13, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments on this document, identified by NOAA-NMFS-2023-0124, by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Electronic Submission:</E>
                         Submit all electronic public comments via the Federal e-Rulemaking Portal. Visit 
                        <E T="03">https://www.regulations.gov</E>
                         and type NOAA-NMFS-2023-0124 in the Search box. Click on the “Comment” icon, complete the required fields, and enter or attach your comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Submit written comments to Gretchen Harrington, Assistant Regional Administrator, Sustainable Fisheries Division, Alaska Region NMFS, Attn: Records Office. Mail comments to P.O. Box 21668, Juneau, AK 99802-1668.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         (907) 586-7465; Attn: Gretchen Harrington.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on 
                        <E T="03">https://www.regulations.gov</E>
                         without change. All personal identifying information (
                        <E T="03">e.g.,</E>
                         name, address, 
                        <E T="03">etc.</E>
                        ), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter“N/A” in the required fields if you wish to remain anonymous).
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Steve Whitney, 907-586-7228.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the FMP prepared by the North Pacific Fishery Management Council (Council) under authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of both 50 CFR part 600 and 50 CFR part 679.</P>
                <P>The final 2024 and 2025 harvest specifications for groundfish in the BSAI (89 FR 17287, March 11, 2024) set the 2025 Bering Sea (BS) pollock TAC at 1,325,000 metric tons (mt), the 2025 BSAI Atka mackerel TAC at 66,165 mt, the 2025 BS Pacific cod TAC at 132,726 mt, and the 2024 Aleutian Islands (AI) Pacific cod TAC at 8,080 mt. In December 2024, the Council recommended a 2025 BS pollock TAC of 1,375,000 mt, which is more than the 1,325,000 mt TAC established by the final 2024 and 2025 harvest specifications for groundfish in the BSAI. The Council also recommended a 2025 BSAI Atka mackerel TAC of 82,000 mt, which is more than the 66,165 mt TAC established by the final 2024 and 2025 harvest specifications for groundfish in the BSAI. Furthermore, the Council recommended a 2025 BS Pacific cod TAC of 133,602 mt, and an AI Pacific cod TAC of 8,694 mt, which is more than the BS Pacific cod TAC of 132,726 mt, and more than the AI Pacific cod TAC of 8,080 mt established by the final 2024 and 2025 harvest specifications for groundfish in the BSAI. The Council's recommended 2025 TACs, and the area and seasonal apportionments, are based on the Stock Assessment and Fishery Evaluation report (SAFE), dated November 2024, which NMFS has determined is the best scientific information available for these fisheries.</P>
                <P>Steller sea lions occur in the same location as the pollock, Atka mackerel, and Pacific cod fisheries and are listed as endangered under the Endangered Species Act. Pollock, Atka mackerel, and Pacific cod are a principal prey species for Steller sea lions in the BSAI. The seasonal apportionment of pollock, Atka mackerel, and Pacific cod harvest is necessary to ensure the groundfish fisheries are not likely to cause jeopardy of extinction or adverse modification of critical habitat for Steller sea lions. NMFS published regulations and the revised harvest limit amounts for pollock, Atka mackerel, and Pacific cod fisheries to implement Steller sea lion protection measures to insure that groundfish fisheries of the BSAI are not likely to jeopardize the continued existence of the western distinct population segment of Steller sea lions or destroy or adversely modify their designated critical habitat (79 FR 70286, November 25, 2014).</P>
                <P>In accordance with § 679.25(a)(1)(iii), (a)(2)(i)(B), and (a)(2)(iv), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that, based on the November 2024 SAFE report for these fisheries, the current BSAI pollock, Atka mackerel, and Pacific cod TACs are incorrectly specified. Pursuant to § 679.25(a)(1)(iii), the Regional Administrator is adjusting the 2025 BS pollock TAC to 1,375,000 mt, the 2025 BSAI Atka mackerel TAC to 82,000 mt, the 2025 BS Pacific cod TAC to 133,602 mt, and the 2025 AI Pacific cod TAC to 8,694 mt. Therefore, table 2 of the final 2024 and 2025 harvest specifications for groundfish in the BSAI (89 FR 17287, March 11, 2024) is revised consistent with this adjustment.</P>
                <P>
                    Pursuant to § 679.20(a)(5)(i) and (iii), table 5 of the final 2024 and 2025 harvest specifications for groundfish in the BSAI (89 FR 17287, March 11, 2024) is revised for the 2025 BS and AI allocations of pollock TAC to the directed pollock fisheries, the Community Development Quota (CDQ) directed fishing allowances (DFA), and the incidental catch allowance (ICA) consistent with this adjustment.
                    <PRTPAGE P="105479"/>
                </P>
                <GPOTABLE COLS="5" OPTS="L2,nj,i1" CDEF="s100,13,10,12,10">
                    <TTITLE>
                        Table 5—Final 2025 Allocations of Pollock TACs to the Directed Pollock Fisheries and to the CDQ Directed Fishing Allowances 
                        <SU>1</SU>
                    </TTITLE>
                    <TDESC>[Amounts are in metric tons]</TDESC>
                    <BOXHD>
                        <CHED H="1">Area and sector</CHED>
                        <CHED H="1">
                            2025
                            <LI>Allocations</LI>
                        </CHED>
                        <CHED H="1">
                            2025 A season 
                            <SU>1</SU>
                        </CHED>
                        <CHED H="2">A season DFA</CHED>
                        <CHED H="2">
                            SCA harvest limit 
                            <SU>2</SU>
                        </CHED>
                        <CHED H="1">
                            2025 B 
                            <LI>
                                season 
                                <SU>1</SU>
                            </LI>
                        </CHED>
                        <CHED H="2">B season DFA</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">
                            BS subarea TAC 
                            <SU>1</SU>
                        </ENT>
                        <ENT>1,375,000</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CDQ DFA</ENT>
                        <ENT>137,500</ENT>
                        <ENT>61,875</ENT>
                        <ENT>38,500</ENT>
                        <ENT>75,625</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            ICA 
                            <SU>1</SU>
                        </ENT>
                        <ENT>46,000</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Total BS non-CDQ DFA</ENT>
                        <ENT>1,191,500</ENT>
                        <ENT>536,175</ENT>
                        <ENT>333,620</ENT>
                        <ENT>655,325</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AFA Inshore</ENT>
                        <ENT>595,750</ENT>
                        <ENT>268,088</ENT>
                        <ENT>166,810</ENT>
                        <ENT>327,663</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            AFA Catcher/Processors (CPs) 
                            <SU>3</SU>
                        </ENT>
                        <ENT>476,600</ENT>
                        <ENT>214,470</ENT>
                        <ENT>133,448</ENT>
                        <ENT>262,130</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Catch by CPs</ENT>
                        <ENT>436,089</ENT>
                        <ENT>196,240</ENT>
                        <ENT>n/a</ENT>
                        <ENT>239,849</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Catch by Catcher Vessels (CVs) 
                            <SU>3</SU>
                        </ENT>
                        <ENT>40,511</ENT>
                        <ENT>18,230</ENT>
                        <ENT>n/a</ENT>
                        <ENT>22,281</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Unlisted CP Limit 
                            <SU>4</SU>
                        </ENT>
                        <ENT>2,383</ENT>
                        <ENT>1,072</ENT>
                        <ENT>n/a</ENT>
                        <ENT>1,311</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AFA Motherships</ENT>
                        <ENT>119,150</ENT>
                        <ENT>53,618</ENT>
                        <ENT>33,362</ENT>
                        <ENT>65,533</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Excessive Harvesting Limit 
                            <SU>5</SU>
                        </ENT>
                        <ENT>208,513</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Excessive Processing Limit 
                            <SU>6</SU>
                        </ENT>
                        <ENT>357,450</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AI subarea ABC</ENT>
                        <ENT>46,051</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            AI subarea TAC 
                            <SU>1</SU>
                        </ENT>
                        <ENT>19,000</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CDQ DFA</ENT>
                        <ENT>1,900</ENT>
                        <ENT>1,900</ENT>
                        <ENT>n/a</ENT>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="01">ICA</ENT>
                        <ENT>3,000</ENT>
                        <ENT>1,500</ENT>
                        <ENT>n/a</ENT>
                        <ENT>1,500</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Aleut Corporation</ENT>
                        <ENT>14,100</ENT>
                        <ENT>14,100</ENT>
                        <ENT>n/a</ENT>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Area harvest limit 
                            <SU>7</SU>
                        </ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">541</ENT>
                        <ENT>13,815</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">542</ENT>
                        <ENT>6,908</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">543</ENT>
                        <ENT>2,303</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Bogoslof District ICA 
                            <SU>8</SU>
                        </ENT>
                        <ENT>250</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <TNOTE>
                        <E T="02">Note:</E>
                         Seasonal or sector apportionments may not total precisely due to rounding.
                    </TNOTE>
                    <TNOTE>
                        <SU>1</SU>
                         Pursuant to § 679.20(a)(5)(i)(A), the BS subarea pollock TAC, after subtracting the CDQ DFA (10 percent) and the ICA (46,000 mt), is allocated as a DFA as follows: inshore sector—50 percent, catcher/processor sector (CP)—40 percent, and mothership sector—10 percent. In the BS subarea, 45 percent of the DFA and CDQ DFA are allocated to the A season (January 20-June 10) and 55 percent of the DFA and CDQ DFA are allocated to the B season (June 10-November 1). When the AI pollock ABC equals or exceeds 19,000 mt, the annual TAC is equal to 19,000 mt (§ 679.20(a)(5)(iii)(B)(1)). Pursuant to § 679.20(a)(5)(iii)(B)(2), the AI subarea pollock TAC, after subtracting first for the CDQ DFA (10 percent) and second for the ICA (3,000 mt), is allocated to the Aleut Corporation for a pollock directed fishery. In the AI subarea, the A season is allocated no more than 40 percent of the AI pollock ABC.
                    </TNOTE>
                    <TNOTE>
                        <SU>2</SU>
                         In the BS subarea, pursuant to § 679.20(a)(5)(i)(C), no more than 28 percent of each sector's annual DFA may be taken from the SCA before noon, April 1. The SCA is defined at § 679.22(a)(7)(vii).
                    </TNOTE>
                    <TNOTE>
                        <SU>3</SU>
                         Pursuant to § 679.20(a)(5)(i)(A)(
                        <E T="03">4</E>
                        ), 8.5 percent of the allocation to listed CPs shall be available for harvest only by eligible catcher vessels with a CP endorsement delivering to listed CPs, unless there is a CP sector cooperative contract for the year.
                    </TNOTE>
                    <TNOTE>
                        <SU>4</SU>
                         Pursuant to § 679.20(a)(5)(i)(A)(
                        <E T="03">4</E>
                        )(
                        <E T="03">iii</E>
                        ), the AFA unlisted CPs are limited to harvesting not more than 0.5 percent of the CP sector's allocation of pollock.
                    </TNOTE>
                    <TNOTE>
                        <SU>5</SU>
                         Pursuant to § 679.20(a)(5)(i)(A)(
                        <E T="03">6</E>
                        ), NMFS establishes an excessive harvesting share limit equal to 17.5 percent of the sum of the non-CDQ pollock DFAs.
                    </TNOTE>
                    <TNOTE>
                        <SU>6</SU>
                         Pursuant to § 679.20(a)(5)(i)(A)(
                        <E T="03">7</E>
                        ), NMFS establishes an excessive processing share limit equal to 30.0 percent of the sum of the non-CDQ pollock DFAs.
                    </TNOTE>
                    <TNOTE>
                        <SU>7</SU>
                         Pursuant to § 679.20(a)(5)(iii)(B)(
                        <E T="03">6</E>
                        ), NMFS establishes harvest limits for pollock in the A season in Area 541 of no more than 30 percent, in Area 542 of no more than 15 percent, and in Area 543 of no more than 5 percent of the AI pollock ABC.
                    </TNOTE>
                    <TNOTE>
                        <SU>8</SU>
                         Pursuant to § 679.22(a)(7)(B), the Bogoslof District is closed to directed fishing for pollock. The amounts specified are for incidental catch only and are not apportioned by season or sector.
                    </TNOTE>
                </GPOTABLE>
                <P>Pursuant to § 679.20(a)(8), table 8 of the final 2024 and 2025 harvest specifications for groundfish in the BSAI (89 FR 17287, March 11, 2024) is revised for the 2025 seasonal and spatial allowances, gear shares, CDQ reserve, incidental catch allowance, jig, BSAI trawl limited access, and Amendment 80 allocations of the BSAI Atka mackerel TAC consistent with this adjustment.</P>
                <GPOTABLE COLS="5" OPTS="L2,nj,i1" CDEF="s100,r25,12,12,12">
                    <TTITLE>Table 8—Final 2025 Seasonal and Spatial Allowances, Gear Shares, CDQ Reserve, Incidental Catch Allowance, and Amendment 80 Allocations of the BSAI Atka Mackerel TAC</TTITLE>
                    <TDESC>[Amounts are in metric tons]</TDESC>
                    <BOXHD>
                        <CHED H="1">
                            Sector 
                            <SU>1</SU>
                        </CHED>
                        <CHED H="1">
                            Season 
                            <SU>2</SU>
                             
                            <SU>3</SU>
                             
                            <SU>4</SU>
                        </CHED>
                        <CHED H="1">2025 Allocation by area</CHED>
                        <CHED H="2">Eastern AI District/BS</CHED>
                        <CHED H="2">
                            Central AI
                            <LI>
                                District 
                                <SU>5</SU>
                            </LI>
                        </CHED>
                        <CHED H="2">Western AI District</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">TAC</ENT>
                        <ENT>n/a</ENT>
                        <ENT>39,000</ENT>
                        <ENT>24,443</ENT>
                        <ENT>18,557</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CDQ reserve</ENT>
                        <ENT>Total</ENT>
                        <ENT>4,173</ENT>
                        <ENT>2,615</ENT>
                        <ENT>1,986</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>A</ENT>
                        <ENT>2,087</ENT>
                        <ENT>1,308</ENT>
                        <ENT>993</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Critical Habitat</ENT>
                        <ENT>n/a</ENT>
                        <ENT>785</ENT>
                        <ENT>596</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>B</ENT>
                        <ENT>2,087</ENT>
                        <ENT>1,308</ENT>
                        <ENT>993</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Critical Habitat</ENT>
                        <ENT>n/a</ENT>
                        <ENT>785</ENT>
                        <ENT>596</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="105480"/>
                        <ENT I="01">Non-CDQ TAC</ENT>
                        <ENT>n/a</ENT>
                        <ENT>34,827</ENT>
                        <ENT>21,828</ENT>
                        <ENT>16,571</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ICA</ENT>
                        <ENT>Total</ENT>
                        <ENT>800</ENT>
                        <ENT>100</ENT>
                        <ENT>20</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Jig 
                            <SU>6</SU>
                        </ENT>
                        <ENT>Total</ENT>
                        <ENT>170</ENT>
                        <ENT/>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="01">BSAI trawl limited access</ENT>
                        <ENT>Total</ENT>
                        <ENT>3,386</ENT>
                        <ENT>2,173</ENT>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>A</ENT>
                        <ENT>1,693</ENT>
                        <ENT>1,086</ENT>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Critical Habitat</ENT>
                        <ENT>n/a</ENT>
                        <ENT>652</ENT>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>B</ENT>
                        <ENT>1,693</ENT>
                        <ENT>1,086</ENT>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Critical Habitat</ENT>
                        <ENT>n/a</ENT>
                        <ENT>652</ENT>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="01">Amendment 80 sector</ENT>
                        <ENT>Total</ENT>
                        <ENT>30,471</ENT>
                        <ENT>19,555</ENT>
                        <ENT>16,551</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>A</ENT>
                        <ENT>15,236</ENT>
                        <ENT>9,777</ENT>
                        <ENT>8,276</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Critical Habitat</ENT>
                        <ENT>n/a</ENT>
                        <ENT>5,866</ENT>
                        <ENT>4,965</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>B</ENT>
                        <ENT>15,236</ENT>
                        <ENT>9,777</ENT>
                        <ENT>8,276</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Critical Habitat</ENT>
                        <ENT>n/a</ENT>
                        <ENT>5,866</ENT>
                        <ENT>4,965</ENT>
                    </ROW>
                    <TNOTE>
                        <E T="02">Note:</E>
                         Seasonal or sector apportionments may not total precisely due to rounding.
                    </TNOTE>
                    <TNOTE>
                        <SU>1</SU>
                         Section 679.20(a)(8)(ii) allocates the Atka mackerel TACs, after subtracting the CDQ reserves, ICAs, and jig gear allocation, to the Amendment 80 and BSAI trawl limited access sectors. The allocation of the ITAC for Atka mackerel to the Amendment 80 and BSAI trawl limited access sectors is established in table 33 to 50 CFR part 679 and § 679.91. The CDQ reserve is 10.7 percent of the TAC for use by CDQ participants (see § 679.20(b)(1)(ii)(C)).
                    </TNOTE>
                    <TNOTE>
                        <SU>2</SU>
                         Sections 679.20(a)(8)(ii)(A) and 679.22(a) establish temporal and spatial limitations for the Atka mackerel fishery.
                    </TNOTE>
                    <TNOTE>
                        <SU>3</SU>
                         The seasonal allowances of Atka mackerel for the CDQ reserve, BSAI trawl limited access sector, and Amendment 80 sector are 50 percent in the A season and 50 percent in the B season.
                    </TNOTE>
                    <TNOTE>
                        <SU>4</SU>
                         Section 679.23(e)(3) authorizes directed fishing for Atka mackerel with trawl gear during the A season from January 20 to June 10 and the B season from June 10 to December 31.
                    </TNOTE>
                    <TNOTE>
                        <SU>5</SU>
                         Section 679.20(a)(8)(ii)(C)(
                        <E T="03">1</E>
                        )(
                        <E T="03">i</E>
                        ) limits no more than 60 percent of the annual TACs in Areas 542 and 543 to be caught inside of Steller sea lion protection areas; section 679.20(a)(8)(ii)(C)(
                        <E T="03">1</E>
                        )(
                        <E T="03">ii</E>
                        ) equally divides the annual harvest limits between the A and B seasons as defined at § 679.23(e)(3); and section 679.20(a)(8)(ii)(C)(
                        <E T="03">2</E>
                        ) requires that the TAC in Area 543 shall be no more than 65 percent of ABC in Area 543.
                    </TNOTE>
                    <TNOTE>
                        <SU>6</SU>
                         Sections 679.2 and 679.20(a)(8)(i) require that up to 2 percent of the Eastern AI District and the BS subarea TAC be allocated to jig gear after subtracting the CDQ reserve and the ICA. NMFS sets the amount of this allocation for 2025 at 0.5 percent. The jig gear allocation is not apportioned by season.
                    </TNOTE>
                </GPOTABLE>
                <P>Pursuant to § 679.20(a)(7), table 10 of the final 2024 and 2025 harvest specifications for groundfish in the BSAI (89 FR 17287, March 11, 2024) is revised for the 2025 gear shares and seasonal allowances of the BSAI Pacific cod TAC, CDQ DFAs, and Pacific cod trawl cooperatives (PCTC) DFAs consistent with this adjustment.</P>
                <GPOTABLE COLS="6" OPTS="L2,nj,p7,7/8,i1" CDEF="s50,7,13,13,xs88,7">
                    <TTITLE>Table 10—Final 2025 Sector Allocations and Seasonal Allowances of the BSAI Pacific Cod TAC</TTITLE>
                    <TDESC>[Amounts are in metric tons]</TDESC>
                    <BOXHD>
                        <CHED H="1">Sector</CHED>
                        <CHED H="1">Percent</CHED>
                        <CHED H="1">
                            2025 share of
                            <LI>gear sector</LI>
                            <LI>total</LI>
                        </CHED>
                        <CHED H="1">
                            2025 share of
                            <LI>sector total</LI>
                        </CHED>
                        <CHED H="1">2025 seasonal allowances</CHED>
                        <CHED H="2">Season</CHED>
                        <CHED H="2">Amount</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Total BS TAC</ENT>
                        <ENT>n/a</ENT>
                        <ENT>133,602</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BS CDQ</ENT>
                        <ENT>n/a</ENT>
                        <ENT>14,295</ENT>
                        <ENT>n/a</ENT>
                        <ENT>See § 679.20(a)(7)(i)(B)</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BS non-CDQ TAC</ENT>
                        <ENT>n/a</ENT>
                        <ENT>119,307</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Total AI TAC</ENT>
                        <ENT>n/a</ENT>
                        <ENT>8,694</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AI CDQ</ENT>
                        <ENT>n/a</ENT>
                        <ENT>930</ENT>
                        <ENT>n/a</ENT>
                        <ENT>See § 679.20(a)(7)(i)(B)</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AI non-CDQ TAC</ENT>
                        <ENT>n/a</ENT>
                        <ENT>7,764</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Western AI Limit</ENT>
                        <ENT>n/a</ENT>
                        <ENT>3,173</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Total BSAI non-CDQ TAC 
                            <SU>1</SU>
                        </ENT>
                        <ENT>100</ENT>
                        <ENT>127,070</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Total hook-and-line/pot gear</ENT>
                        <ENT>60.8</ENT>
                        <ENT>77,259</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Hook-and-line/pot ICA 
                            <SU>2</SU>
                        </ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>500</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Hook-and-line/pot sub-total</ENT>
                        <ENT>n/a</ENT>
                        <ENT>76,759</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Hook-and-line catcher/processors</ENT>
                        <ENT>48.7</ENT>
                        <ENT>n/a</ENT>
                        <ENT>61,483</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">A-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Jan-1-Jun 10</ENT>
                        <ENT>31,356</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">B-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Jun 10-Dec 31</ENT>
                        <ENT>30,127</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Hook-and-line catcher vessels ≥60 ft (18.288 meters) LOA</ENT>
                        <ENT>0.2</ENT>
                        <ENT>n/a</ENT>
                        <ENT>252</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">A-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Jan 1-Jun 10</ENT>
                        <ENT>129</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">B-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Jun 10-Dec 31</ENT>
                        <ENT>124</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Pot catcher/processors</ENT>
                        <ENT>1.5</ENT>
                        <ENT>n/a</ENT>
                        <ENT>1,894</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">A-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Jan 1-Jun 10</ENT>
                        <ENT>966</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">B-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Sept 1-Dec 31</ENT>
                        <ENT>928</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Pot catcher vessels ≥60 ft LOA</ENT>
                        <ENT>8.4</ENT>
                        <ENT>n/a</ENT>
                        <ENT>10,605</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">A-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Jan 1-Jun 10</ENT>
                        <ENT>5,408</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">B-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Sept 1-Dec 31</ENT>
                        <ENT>5,196</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Catcher vessels &lt;60 ft LOA using hook-and-line or pot gear</ENT>
                        <ENT>2</ENT>
                        <ENT>n/a</ENT>
                        <ENT>2,525</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Trawl catcher vessels 
                            <SU>3</SU>
                        </ENT>
                        <ENT>22.1</ENT>
                        <ENT>28,083</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">A-Season ICA</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Jan 20-Apr 1</ENT>
                        <ENT>1,500</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">A-season PCTC</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Jan 20-Apr 1</ENT>
                        <ENT>19,281</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">B-season ICA</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Apr 1-Jun 10</ENT>
                        <ENT>700</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">B-season PCTC</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Apr 1-Jun 10</ENT>
                        <ENT>2,389</ENT>
                    </ROW>
                    <ROW>
                        <PRTPAGE P="105481"/>
                        <ENT I="03">C-season trawl catcher vessels</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Jun 10-Nov 1</ENT>
                        <ENT>4,212</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">AFA trawl catcher/processors</ENT>
                        <ENT>2.3</ENT>
                        <ENT>2,923</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">A-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Jan 20-Apr 1</ENT>
                        <ENT>2,192</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">B-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Apr 1-Jun 10</ENT>
                        <ENT>731</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">C-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Jun 10-Nov 1</ENT>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="01">Amendment 80</ENT>
                        <ENT>13.4</ENT>
                        <ENT>17,027</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">A-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Jan 20-Apr 1</ENT>
                        <ENT>12,771</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">B-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Apr 1-Jun 10</ENT>
                        <ENT>4,257</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">C-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Jun 10-Dec 31</ENT>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="01">Jig</ENT>
                        <ENT>1.4</ENT>
                        <ENT>1,779</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">A-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Jan 1-Apr 30</ENT>
                        <ENT>1,067</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">B-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Apr 30-Aug 31</ENT>
                        <ENT>356</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">C-season</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>Aug 31-Dec 31</ENT>
                        <ENT>356</ENT>
                    </ROW>
                    <TNOTE>
                        <E T="02">Note:</E>
                         Seasonal or sector apportionments may not total precisely due to rounding.
                    </TNOTE>
                    <TNOTE>
                        <SU>1</SU>
                         The sector allocations and seasonal allowances for BSAI Pacific cod TAC are based on the sum of the BS and AI Pacific cod TACs, after subtraction of the reserves for the CDQ Program. If the TAC for Pacific cod in either the BS or AI is or will be reached, then directed fishing will be prohibited for non-CDQ Pacific cod in that subarea, even if a BSAI allowance remains (§ 679.20(d)(1)(iii)).
                    </TNOTE>
                    <TNOTE>
                        <SU>2</SU>
                         The ICA for the hook-and-line and pot sectors is deducted from the aggregate portion of Pacific cod TAC allocated to the hook-and-line and pot sectors. The Regional Administrator approves an ICA of 500 mt based on anticipated incidental catch by these sectors in other fisheries.
                    </TNOTE>
                    <TNOTE>
                        <SU>3</SU>
                         The A and B season trawl CV Pacific cod allocation is allocated to the Pacific Cod Trawl Cooperative Program after subtraction of the A and B season ICAs (§ 679.131(b)(1)). The Regional Administrator approves for the A and B seasons, ICAs of 1,500 mt and 700 mt, respectively, to account for projected incidental catch of Pacific cod by trawl catcher vessels engaged in directed fishing for groundfish other than PCTC Program Pacific cod.
                    </TNOTE>
                </GPOTABLE>
                <HD SOURCE="HD1">Classification</HD>
                <P>NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b), and is exempt from review under Executive Order 12866.</P>
                <P>Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would allow for harvests that exceed the appropriate allocations for pollock, Atka mackerel, and Pacific cod in the BSAI based on the best scientific information available. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of December 9, 2024.</P>
                <P>Without this inseason adjustment, NMFS could not allow the fishery for pollock, Atka mackerel, and Pacific cod in the BSAI to be harvested in an expedient manner and in accordance with the regulatory schedule. Under § 679.25(c)(2), interested persons are invited to submit written comments on this action to the above address until January 13, 2025.</P>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>
                        16 U.S.C. 1801 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Kelly Denit,</NAME>
                    <TITLE>Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30714 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <CFR>50 CFR Part 679</CFR>
                <DEPDOC>[Docket No. 240227-0061; RTID 0648-XE563]</DEPDOC>
                <SUBJECT>Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Pacific Cod in the Central Regulatory Area of the Gulf of Alaska</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Temporary rule; reallocation.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>NMFS is reallocating the projected unused amount of Pacific cod from catcher vessels using trawl gear to catcher vessels greater than or equal to 50 feet (ft) (15.2 meters (m)) length overall using hook-and-line gear and to catcher/processors using trawl gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to allow the 2024 total allowable catch (TAC) of Pacific cod to be harvested.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective December 20, 2024, through 2400 hours, Alaska local time (A.l.t.), December 31, 2024.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Abby Jahn, 907-586-7228.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>NMFS manages the groundfish fishery in the GOA according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR parts 600 and 679.</P>
                <P>The 2024 Pacific cod TAC specified for catcher vessels using trawl gear in the Central Regulatory Area of the GOA is 6,293 metric tons (mt), as established by the final 2024 and 2025 harvest specifications for groundfish in the GOA (89 FR 15484, March 4, 2024).</P>
                <P>The 2024 Pacific cod TAC specified for catcher vessels greater than or equal to 50 feet (15.2 m) length overall using hook-and-line gear is 1,015 mt as established by the final 2024 and 2025 harvest specifications for groundfish in the GOA (89 FR 15484, March 4, 2024).</P>
                <P>The 2024 Pacific cod TAC specified for catcher/processors using trawl gear is 635 mt as established by the final 2024 and 2025 harvest specifications for groundfish in the GOA (89 FR 15484, March 4, 2024). The final 2024 and 2025 harvest specifications also establishes a directed fishing closure for catcher/processors using trawl gear.</P>
                <P>
                    The Administrator, Alaska Region, NMFS has determined that catcher vessels using trawl gear will not be able to harvest 230 mt of the 2024 Pacific cod TAC allocated to those vessels under § 679.20(a)(12)(i)(B)(
                    <E T="03">4</E>
                    ).
                </P>
                <P>
                    Therefore, in accordance with § 679.20(a)(12)(ii)(B), NMFS apportions 100 mt of Pacific cod from catcher vessels using trawl gear to the annual amount specified for catcher vessels 
                    <PRTPAGE P="105482"/>
                    greater than or equal to 50 feet (15.2 m) length overall using hook-and-line gear and 130 mt of Pacific cod from catcher vessels using trawl gear to the annual amount specified for catcher/processors using trawl gear.
                </P>
                <P>The harvest specifications for 2024 Pacific cod included in the final 2024 and 2025 harvest specifications for groundfish in the Central Regulatory Area of the GOA (89 FR 15484, March 4, 2024) is revised as follows: 6,063 mt to catcher vessels using trawl gear, 1,115 mt to catcher vessels greater than or equal to 50 feet (15.2 m) length overall using hook-and-line gear, and 765 mt to catcher/processors using trawl gear.</P>
                <HD SOURCE="HD1">Classification</HD>
                <P>NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b), and is exempt from review under Executive Order 12866.</P>
                <P>Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would allow for harvests that exceed the originally specified apportionment of the Pacific cod TAC. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of December 19, 2024.</P>
                <P>The Assistant Administrator for Fisheries, NOAA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.</P>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>
                        16 U.S.C. 1801 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: December 20, 2024.</DATED>
                    <NAME>Kelly Denit,</NAME>
                    <TITLE>Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30977 Filed 12-20-24; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </RULE>
    </RULES>
    <VOL>89</VOL>
    <NO>248</NO>
    <DATE>Friday, December 27, 2024</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <PRORULES>
        <PRORULE>
            <PREAMB>
                <PRTPAGE P="105483"/>
                <AGENCY TYPE="F">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 39</CFR>
                <DEPDOC>[Docket No. FAA-2024-2712; Project Identifier AD-2024-00145-E]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; General Electric Company Engines</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FAA proposes to adopt a new airworthiness directive (AD) for certain General Electric Company (GE) Model CF34-8C1, CF34-8C5, CF34-8C5A1, CF34-8C5A2, CF34-8C5A3, CF34-8C5B1, CF34-8E2, CF34-8E2A1, CF34-8E5, CF34-8E5A1, CF34-8E5A2, CF34-8E6, and CF34-8E6A1 engines. This proposed AD was prompted by a predicted reduction in the cyclic life of the combustion chamber assembly (CCA) forward flange. This proposed AD would require fluorescent penetrant inspections (FPIs) of the CCA for any indications and replacement if necessary. The FAA is proposing this AD to address the unsafe condition on these products.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The FAA must receive comments on this proposed AD by February 10, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         (202) 493-2251.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        <E T="03">AD Docket:</E>
                         You may examine the AD docket at 
                        <E T="03">regulations.gov</E>
                         under Docket No. FAA-2024-2712; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, any comments received, and other information. The street address for Docket Operations is listed above.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Alexei Marqueen, Aviation Safety Engineer, FAA, 2200 South 216th Street, Des Moines, WA 98198; phone: (781) 238-7178; email: 
                        <E T="03">alexei.t.marqueen@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the 
                    <E T="02">ADDRESSES</E>
                     section. Include “Docket No. FAA-2024-2712; Project Identifier AD-2024-00145-E” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may revise this proposal because of those comments.
                </P>
                <P>Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.</P>
                <HD SOURCE="HD1">Confidential Business Information</HD>
                <P>CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Alexei Marqueen, Aviation Safety Engineer, FAA, 2200 South 216th Street, Des Moines, WA 98198. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.</P>
                <HD SOURCE="HD1">Background</HD>
                <P>The FAA received a report from the manufacturer that an analysis was conducted during a ream repair of the aft flange bolt hole of the high-pressure compressor. The analysis determined that the cyclic life of the CCA forward flange bolt holes adjacent to the compressor case horizontal split line is lower than the current certified limit. This condition, if not addressed, could result in failure of the CCA before reaching the published life limit, uncontained release of the CCA, damage to the engine, and damage to the airplane.</P>
                <HD SOURCE="HD1">FAA's Determination</HD>
                <P>The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.</P>
                <HD SOURCE="HD1">Proposed AD Requirements in This NPRM</HD>
                <P>This proposed AD would require FPIs of the CCA forward flange for any indications and replacement as applicable.</P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD, if adopted as proposed, would affect 2,988 engines installed on airplanes of U.S. registry.</P>
                <P>
                    The FAA estimates the following costs to comply with this proposed AD:
                    <PRTPAGE P="105484"/>
                </P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,r50,12,12,12">
                    <TTITLE>Estimated Costs</TTITLE>
                    <BOXHD>
                        <CHED H="1">Action</CHED>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">
                            Cost per
                            <LI>product</LI>
                        </CHED>
                        <CHED H="1">Cost on U.S. operators</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">FPI the CCA forward flange</ENT>
                        <ENT>8 work-hours × $85 per hour = $680</ENT>
                        <ENT>$0</ENT>
                        <ENT>$680</ENT>
                        <ENT>$2,031,840</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The FAA estimates an average CCA utilization of 2,143 part cycles per year. Based on this life estimate, the FAA is providing an estimated annual cost to replace these parts. The FAA estimates that 369 affected engines will require CCA replacement at 28,500 part cycles since new (PCSN), 855 affected engines will require CCA replacement at 25,500 PCSN, and 1,764 affected engines will require CCA replacement at 40,000 PCSN. The following summarizes the costs of the proposed AD over the analysis timeframe, for the 12 years spanning 2024-2036. The cost of early CCA removals, required by this proposed AD, analyzed over 2024 through 2036, are $265 million at a 2% financial discount rate.</P>
                <GPOTABLE COLS="5" OPTS="L2,tp0,i1" CDEF="s50,r50,12,12,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Action</CHED>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">
                            Cost per
                            <LI>product</LI>
                        </CHED>
                        <CHED H="1">
                            Cost on U.S. operators
                            <LI>annualized</LI>
                            <LI>(2% discount rate)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Replace the CCA (prorated part cost)</ENT>
                        <ENT>8 work-hours × $85 per hour = $680</ENT>
                        <ENT>$646,900</ENT>
                        <ENT>$647,580</ENT>
                        <ENT>$24,544,532</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.</P>
                <P>For the reasons discussed above, I certify this proposed regulation:</P>
                <P>(1) Is not a “significant regulatory action” under Executive Order 12866,</P>
                <P>(2) Would not affect intrastate aviation in Alaska, and</P>
                <P>(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <HD SOURCE="HD1">List of Subjects in 14 CFR Part 39</HD>
                <P>Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety</P>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 39 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(g), 40113, 44701.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 39.13</SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The FAA amends § 39.13 by adding the following new airworthiness directive:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">General Electric Company:</E>
                         Docket No. FAA-2024-2712; Project Identifier AD-2024-00145-E.
                    </FP>
                    <HD SOURCE="HD1">(a) Comments Due Date</HD>
                    <P>The FAA must receive comments on this airworthiness directive (AD) by February 10, 2025.</P>
                    <HD SOURCE="HD1">(b) Affected ADs</HD>
                    <P>None.</P>
                    <HD SOURCE="HD1">(c) Applicability</HD>
                    <P>This AD applies to the following General Electric Company (GE) Model engines:</P>
                    <P>(1) CF34-8C1, CF34-8C5, CF34-8C5A1, CF34-8C5A2, CF34-8C5A3, and CF34-8C5B1 engines with an installed combustion chamber assembly (CCA) having part number (P/N) 4145T11G08, 4145T11G10, 4180T27G02, 4180T27G04, or 4923T82G02; and</P>
                    <P>(2) CF34-8E2, CF34-8E2A1, CF34-8E5, CF34-8E5A1, CF34-8E5A2, CF34-8E6, and CF34-8E6A1 engines with an installed CCA having P/N 4145T11G08, 4145T11G09, 4180T27G01, or 4180T27G03.</P>
                    <HD SOURCE="HD1">(d) Subject</HD>
                    <P>Joint Aircraft System Component (JASC) Code 7240, Turbine Engine Combustion Section.</P>
                    <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                    <P>This AD was prompted by a predicted reduction in the cyclic life of the CCA forward flange. The FAA is issuing this AD to prevent failure of the CCA. The unsafe condition, if not addressed, could result in failure of the CCA before reaching the published life limit, uncontained release of the CCA, damage to the engine, and damage to the airplane.</P>
                    <HD SOURCE="HD1">(f) Compliance</HD>
                    <P>Comply with this AD within the compliance times specified, unless already done.</P>
                    <HD SOURCE="HD1">(g) Required Actions</HD>
                    <P>(1) For affected Group 1 engines with an installed CCA having less than 15,000 part cycles since new (PCSN) as of the effective date of this AD, before the accumulation of 28,500 PCSN, remove the CCA from service and replace with P/N 4180T27G08 or a later approved P/N.</P>
                    <P>(2) For affected Group 2 engines with an installed CCA having less than 15,000 PCSN as of the effective date of this AD, before the accumulation of 25,500 PCSN, remove the CCA from service and replace with P/N 4180T27G07 or a later approved P/N.</P>
                    <P>
                        (3) For affected Group 1 and 2 engines with an installed CCA having between 15,000 PCSN and 24,999 PCSN as of the effective date of this AD, before the accumulation of 25,000 PCSN, perform a fluorescent penetrant inspection (FPI) on the forward flange of the CCA for any indications.
                        <PRTPAGE P="105485"/>
                    </P>
                    <P>(4) If no indications are found during the FPI required by paragraph (g)(3) of this AD, within 15,000 part cycles from the date of the FPI, remove the CCA from service and replace with P/N 4180T27G07, 4180T27G08, or a later approved P/N, as applicable.</P>
                    <P>(5) For affected Group 1 and 2 engines with an installed CCA having more than 25,000 PCSN as of the effective date of this AD, at the next engine shop visit after the effective date of this AD, perform an FPI on the forward flange of the CCA for any indications.</P>
                    <P>(6) If no indications are found during the FPI required by paragraph (g)(5) of this AD, within 15,000 part cycles from the date of the FPI and not to exceed 41,100 PCSN, remove the CCA from service and replace with P/N 4180T27G07, 4180T27G08, or a later approved P/N, as applicable.</P>
                    <P>(7) If an indication is found during any FPI required by paragraph (g)(3) or (5) of this AD, before further flight, remove the CCA from service and replace with P/N 4180T27G07, P/N 4180T27G08, or a later approved P/N, as applicable.</P>
                    <HD SOURCE="HD1">(h) Definitions</HD>
                    <P>For the purpose of this AD:</P>
                    <P>(1) “Group 1 engines” are GE Model CF34-8C1, CF34-8C5, CF34-8C5A1, CF34-8C5A2, CF34-8C5A3, and CF34-8C5B1 engines.</P>
                    <P>(2) “Group 2 engines” are GE Model CF34-8E2, CF34-8E2A1, CF34-8E5, CF34-8E5A1, CF34-8E5A2, CF34-8E6, and CF34-8E6A1 engines.</P>
                    <P>(3) An “engine shop visit” is the induction of an engine into the shop for maintenance involving the separation of major mating engine case flanges, except for the following situations, which do not constitute an engine shop visit:</P>
                    <P>(i) Separation of engine flanges solely for the purposes of transportation of the engine without subsequent maintenance.</P>
                    <P>(ii) Separation of engine flanges solely for the purposes of replacing the fan or propulsor without subsequent maintenance.</P>
                    <HD SOURCE="HD1">(i) Installation Prohibition</HD>
                    <P>After the effective date of this AD, do not reinstall any CCAs that were removed as a result of paragraphs (g)(1), (2), (4), (6), and (7) of this AD in any engine.</P>
                    <HD SOURCE="HD1">(j) Alternative Methods of Compliance (AMOCs)</HD>
                    <P>
                        (1) The Manager, AIR-520 Continued Operational Safety Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the AIR-520 Continued Operational Safety Branch, send it to the attention of the person identified in paragraph (k) of this AD and email to: 
                        <E T="03">AMOC@faa.gov</E>
                        .
                    </P>
                    <P>(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.</P>
                    <HD SOURCE="HD1">(k) Additional Information</HD>
                    <P>
                        For more information about this AD, contact Alexei Marqueen, Aviation Safety Engineer, FAA, 2200 South 216th Street, Des Moines, WA 98198; phone: (781) 238-7178; email: 
                        <E T="03">alexei.t.marqueen@faa.gov.</E>
                    </P>
                    <HD SOURCE="HD1">(l) Material Incorporated by Reference</HD>
                    <P>None.</P>
                </EXTRACT>
                <SIG>
                    <DATED>Issued on December 19, 2024.</DATED>
                    <NAME>Suzanne Masterson,</NAME>
                    <TITLE>Deputy Director, Integrated Certificate Management Division, Aircraft Certification ervice.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30785 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 39</CFR>
                <DEPDOC>[Docket No. FAA-2024-2713; Project Identifier AD-2024-00328-T]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; The Boeing Company Airplanes</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FAA proposes to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 777-200, -200LR, -300, -300ER, and 777F series airplanes. This proposed AD was prompted by a report indicating that an airplane experienced a glideslope (G/S) beam anomaly during an instrument landing system (ILS) approach, which resulted in a higher-than-expected descent rate during the final segment of an ILS approach. The flightcrew might follow misleading flight director (F/D) guidance after disconnecting the autopilot, without reference to the other available information and flight deck indications. This proposed AD would require installing new autopilot flight director computer (AFDC) operational program software (OPS) and doing a software configuration check. The FAA is proposing this AD to address the unsafe condition on these products.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The FAA must receive comments on this proposed AD by February 25, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         202-493-2251.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        <E T="03">AD Docket:</E>
                         You may examine the AD docket at 
                        <E T="03">regulations.gov</E>
                         under Docket No. FAA-2024-2713; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, any comments received, and other information. The street address for Docket Operations is listed above.
                    </P>
                    <P>
                        <E T="03">Material Incorporated by Reference:</E>
                    </P>
                    <P>
                        • For Boeing material identified in this proposed AD, contact Boeing Commercial Airplanes, Attention: Contractual &amp; Data Services (C&amp;DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; website 
                        <E T="03">myboeingfleet.com.</E>
                    </P>
                    <P>
                        • You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available at 
                        <E T="03">regulations.gov</E>
                         under Docket No. FAA-2024-2713.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Michael Closson, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; phone: 206-231-3973; email: 
                        <E T="03">Michael.P.Closson@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the 
                    <E T="02">ADDRESSES</E>
                     section. Include “Docket No. FAA-2024-2713; Project Identifier AD-2024-00328-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.
                </P>
                <P>
                    Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to 
                    <E T="03">regulations.gov,</E>
                     including any personal 
                    <PRTPAGE P="105486"/>
                    information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.
                </P>
                <HD SOURCE="HD1">Confidential Business Information</HD>
                <P>
                    CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Michael Closson, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; phone: 206-231-3973; email: 
                    <E T="03">Michael.P.Closson@faa.gov.</E>
                     Any commentary that the FAA receives that is not specifically designated as CBI will be placed in the public docket for this rulemaking.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>The FAA has received a report indicating that a Model 787-8 airplane captured an anomalous G/S beam during an ILS approach, which resulted in a higher-than-expected descent rate during the final segment of an ILS approach due to persistent inertial coasting, which can result in misleading flight director guidance. When the autopilot was disconnected, the F/D continued to command a flight path away from the G/S without warning, which the flightcrew appeared to follow. Both GLIDESLOPE and TOO LOW TERRAIN alerts annunciated while the airplane continued to descend. Ultimately, the flightcrew was able to recover the airplane and conducted a Go-Around procedure. No injuries to passengers or crew, or damage to the airframe, was reported.</P>
                <P>It has been determined that Model 777 airplanes can experience the same anomaly. G/S beam anomalies that occur in a discrete G/S capture window can result in reversion to inertial paths in which the auto-flight vertical guidance diverges from the G/S beam at higher-than-expected descent rates. The flightcrew may follow the misleading F/D guidance after disconnecting the A/P, without reference to the other available information and flight deck indications. This condition, if not addressed, could result in a late touchdown, a runway excursion, or controlled flight into terrain.</P>
                <HD SOURCE="HD1">Related Rulemaking</HD>
                <P>The FAA may consider issuing additional rulemaking to address the identified unsafe condition on additional Boeing airplane models with the same G/S issue.</P>
                <HD SOURCE="HD1">FAA's Determination</HD>
                <P>The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.</P>
                <HD SOURCE="HD1">Material Incorporated by Reference Under 1 CFR Part 51</HD>
                <P>
                    The FAA reviewed Boeing Alert Requirements Bulletin 777-22A0046 RB, dated October 25, 2022. This material specifies procedures for installing new AFDC OPS, doing a software configuration check, and making sure that the correct software part number is installed in the correct location. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD1">Proposed AD Requirements in This NPRM</HD>
                <P>
                    This proposed AD would require accomplishing the actions specified in the material already described, except for any differences identified as exceptions in the regulatory text of this proposed AD. For information on the procedures and compliance times, see this material at 
                    <E T="03">regulations.gov</E>
                     under Docket No. FAA-2024-2713.
                </P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD, if adopted as proposed, would affect 266 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:</P>
                <GPOTABLE COLS="5" OPTS="L2,nj,i1" CDEF="s50,r50,10,12,12">
                    <TTITLE>Estimated Costs</TTITLE>
                    <BOXHD>
                        <CHED H="1">Action</CHED>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">
                            Cost per
                            <LI>product</LI>
                        </CHED>
                        <CHED H="1">
                            Cost on U.S.
                            <LI>operators</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Software installation and configuration check</ENT>
                        <ENT>2 work-hours × $85 per hour = $170</ENT>
                        <ENT>$13</ENT>
                        <ENT>$183</ENT>
                        <ENT>$48,678</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.</P>
                <P>For the reasons discussed above, I certify this proposed regulation:</P>
                <P>(1) Is not a “significant regulatory action” under Executive Order 12866,</P>
                <P>(2) Would not affect intrastate aviation in Alaska, and</P>
                <P>(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 39</HD>
                    <P>Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.</P>
                </LSTSUB>
                <PRTPAGE P="105487"/>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 39 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(g), 40113, 44701.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 39.13</SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The FAA amends § 39.13 by adding the following new airworthiness directive:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">The Boeing Company:</E>
                         Docket No. FAA-2024-2713; Project Identifier AD-2024-00328-T.
                    </FP>
                    <HD SOURCE="HD1">(a) Comments Due Date</HD>
                    <P>The FAA must receive comments on this airworthiness directive (AD) by February 10, 2025.</P>
                    <HD SOURCE="HD1">(b) Affected ADs</HD>
                    <P>None.</P>
                    <HD SOURCE="HD1">(c) Applicability</HD>
                    <P>This AD applies to The Boeing Company Model 777-200, -200LR, -300, -300ER, and 777F series airplanes, certificated in any category, as identified in Boeing Alert Requirements Bulletin 777-22A0046 RB, dated October 25, 2022.</P>
                    <HD SOURCE="HD1">(d) Subject</HD>
                    <P>Air Transport Association (ATA) of America Code 22, Auto flight.</P>
                    <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                    <P>This AD was prompted by a report indicating that an airplane experienced a glideslope (G/S) beam anomaly during an instrument landing system (ILS) approach, which resulted in a higher-than-expected descent rate during the final segment of an ILS approach. The FAA is issuing this AD to address misleading flight director guidance that the flightcrew might follow after disconnecting the autopilot, without reference to the other available information and flight deck indications. The unsafe condition, if not addressed, could result in a late touchdown, a runway excursion, or controlled flight into terrain.</P>
                    <HD SOURCE="HD1">(f) Compliance</HD>
                    <P>Comply with this AD within the compliance times specified, unless already done.</P>
                    <HD SOURCE="HD1">(g) Required Actions</HD>
                    <P>Except as specified in paragraph (h) of this AD: At the applicable times specified in paragraph 3., “Compliance,” of Boeing Alert Requirements Bulletin 777-22A0046 RB, dated October 25, 2022, do all applicable actions identified in, and in accordance with, the Accomplishment Instructions of Boeing Alert Requirements Bulletin 777-22A0046 RB, dated October 25, 2022.</P>
                    <NOTE>
                        <HD SOURCE="HED">Note 1 to paragraph (g):</HD>
                        <P> Guidance for accomplishing the actions required by this AD can be found in Boeing Alert Service Bulletin 777-22A0046, dated October 25, 2022, which is referred to in Boeing Alert Requirements Bulletin 777-22A0046 RB, dated October 25, 2022.</P>
                    </NOTE>
                    <HD SOURCE="HD1">(h) Exception to Service Information Specifications</HD>
                    <P>Where the Compliance Time column of the table in the “Compliance” paragraph of Boeing Alert Requirements Bulletin 777-22A0046 RB, dated October 25, 2022, refers to “the Original Issue date of Requirements Bulletin 777-22A0046 RB,” this AD requires using the effective date of this AD.</P>
                    <HD SOURCE="HD1">(i) Alternative Methods of Compliance (AMOCs)</HD>
                    <P>
                        (1) The Manager, AIR-520, Continued Operational Safety Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or responsible Flight Standards Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j)(1) of this AD. Information may be emailed to: 
                        <E T="03">AMOC@faa.gov.</E>
                    </P>
                    <P>(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the responsible Flight Standards Office.</P>
                    <P>(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by The Boeing Company Organization Designation Authorization (ODA) that has been authorized by the Manager, AIR-520, Continued Operational Safety Branch, FAA, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.</P>
                    <HD SOURCE="HD1">(j) Related Information</HD>
                    <P>
                        (1) For more information about this AD, contact Michael Closson, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; phone: 206-231-3973; email: 
                        <E T="03">Michael.P.Closson@faa.gov.</E>
                    </P>
                    <P>(2) Material identified in this AD that is not incorporated by reference is available at the address specified in paragraph (k)(3) of this AD.</P>
                    <HD SOURCE="HD1">(k) Material Incorporated by Reference</HD>
                    <P>(1) The Director of the Federal Register approved the incorporation by reference of the material listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.</P>
                    <P>(2) You must use this material as applicable to do the actions required by this AD, unless the AD specifies otherwise.</P>
                    <P>(i) Boeing Alert Requirements Bulletin 777-22A0046 RB, dated October 25, 2022.</P>
                    <P>(ii) [Reserved]</P>
                    <P>
                        (3) For Boeing material identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual &amp; Data Services (C&amp;DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; website 
                        <E T="03">myboeingfleet.com</E>
                        .
                    </P>
                    <P>(4) You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.</P>
                    <P>
                        (5) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit 
                        <E T="03">www.archives.gov/federal-register/cfr/ibr-locations</E>
                         or email 
                        <E T="03">fr.inspection@nara.gov.</E>
                    </P>
                </EXTRACT>
                <SIG>
                    <DATED>Issued on December 19, 2024.</DATED>
                    <NAME>Suzanne Masterson,</NAME>
                    <TITLE>Deputy Director, Integrated Certificate Management Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30918 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 39</CFR>
                <DEPDOC>[Docket No. FAA-2024-2714; Project Identifier MCAI-2024-00405-T]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Deutsche Aircraft GmbH (Type Certificate Previously Held by 328 Support Services GmbH; AvCraft Aerospace GmbH; Fairchild Dornier GmbH; Dornier Luftfahrt GmbH) Airplanes</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FAA proposes to adopt a new airworthiness directive (AD) for all Deutsche Aircraft GmbH (Type Certificate previously held by 328 Support Services GmbH; AvCraft Aerospace GmbH; Fairchild Dornier GmbH; Dornier Luftfahrt GmbH) Model 328-100 and Model 328-300 airplanes. This proposed AD was prompted by a report of a nose landing gear (NLG) uplock bracket assembly cracking. This proposed AD would require an inspection of the affected part and applicable on-condition actions, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference (IBR). The FAA is proposing this AD to address the unsafe condition on these products.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The FAA must receive comments on this proposed AD by February 10, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
                        <PRTPAGE P="105488"/>
                    </P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         202-493-2251.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        <E T="03">AD Docket:</E>
                         You may examine the AD docket at regulations.gov under Docket No. FAA-2024-2714; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, the mandatory continuing airworthiness information (MCAI), any comments received, and other information. The street address for Docket Operations is listed above.
                    </P>
                    <P>
                        <E T="03">Material Incorporated by Reference:</E>
                    </P>
                    <P>
                        • For EASA material identified in this proposed AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email 
                        <E T="03">ADs@easa.europa.eu;</E>
                         website 
                        <E T="03">easa.europa.eu.</E>
                         You may find this material on the EASA website at 
                        <E T="03">ad.easa.europa.eu.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Joe Salameh, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: 206-231-3536; email: 
                        <E T="03">joe.salameh@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the 
                    <E T="02">ADDRESSES</E>
                     section. Include “Docket No. FAA-2024-2714; Project Identifier MCAI-2024-00405-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this proposal because of those comments.
                </P>
                <P>
                    Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to 
                    <E T="03">regulations.gov,</E>
                     including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.
                </P>
                <HD SOURCE="HD1">Confidential Business Information</HD>
                <P>
                    CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Joe Salameh, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: 206-231-3536; email: 
                    <E T="03">joe.salameh@faa.gov.</E>
                     Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2024-0137, dated July 11, 2024 (EASA AD 2024-0137) (also referred to as the MCAI), to correct an unsafe condition for all Deutsche Aircraft GmbH Model 328-100 and Model 328-300 airplanes. The MCAI states an occurrence of NLG uplock bracket assembly cracking was discovered which, if not addressed, could result in uncommanded NLG extension which, in combination with a one engine inoperative condition during initial climb, may result in reduced climb performance, with possible impact with terrain or obstacle.</P>
                <P>The FAA is proposing this AD to address the unsafe condition on these products.</P>
                <P>
                    You may examine the MCAI in the AD docket at 
                    <E T="03">regulations.gov</E>
                     under Docket No. FAA-2024-2714.
                </P>
                <HD SOURCE="HD1">Material Incorporated by Reference Under 1 CFR Part 51</HD>
                <P>
                    EASA AD 2024-0137 specifies procedures for a detailed inspection for any discrepancy (
                    <E T="03">i.e.,</E>
                     any corrosion, crack, dent, nick, deformation, and measurement not within specified dimensions of the referenced service information) of the NLG uplock bracket assembly, part number 001A322D3100002, and applicable on-condition actions. The on-condition actions include additional detailed inspections for any discrepancy of the fasteners (which includes corrosion, cracks, dents, nicks, and deformation), replacement of the fasteners, and contacting Deutsche Aircraft GmbH for instructions and doing those instructions. EASA AD 2024-0137 also states that the AD is considered to be an interim measure and further AD action may follow. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD1">FAA's Determination</HD>
                <P>This product has been approved by the aviation authority of another country and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop in other products of the same type design.</P>
                <HD SOURCE="HD1">Proposed AD Requirements in This NPRM</HD>
                <P>This proposed AD would require accomplishing the actions specified in EASA AD 2024-0137 described previously.</P>
                <HD SOURCE="HD1">Explanation of Required Compliance Information</HD>
                <P>
                    In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2024-0137 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2024-0137 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2024-0137 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2024-0137. 
                    <PRTPAGE P="105489"/>
                    Material required by EASA AD 2024-0137 for compliance will be available at regulations.gov under Docket No. FAA-2024-2714 after the FAA final rule is published.
                </P>
                <HD SOURCE="HD1">Interim Action</HD>
                <P>The FAA considers that this proposed AD would be an interim action.</P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD, if adopted as proposed, would affect 30 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,12,r50,r50">
                    <TTITLE>Estimated Costs for Required Actions</TTITLE>
                    <BOXHD>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">Cost per product</CHED>
                        <CHED H="1">Cost on U.S. operators</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Up to 18 work-hours × $85 per hour = $1,530</ENT>
                        <ENT>$0</ENT>
                        <ENT>Up to $1,530</ENT>
                        <ENT>Up to $45,900.</ENT>
                    </ROW>
                </GPOTABLE>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s50,12C,12C">
                    <TTITLE>Estimated Costs of On-Condition Actions</TTITLE>
                    <BOXHD>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">
                            Cost per
                            <LI>product</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">2 work-hours × $85 per hour = $170</ENT>
                        <ENT>$117</ENT>
                        <ENT>$287</ENT>
                    </ROW>
                    <TNOTE>* The FAA has received no definitive data on which to base the cost estimates for the on-condition instructions specified in this proposed AD.</TNOTE>
                </GPOTABLE>
                <HD SOURCE="HD1">Paperwork Reduction Act</HD>
                <P>A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to take approximately 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. All responses to this collection of information are mandatory. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Information Collection Clearance Officer, Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.</P>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.</P>
                <P>For the reasons discussed above, I certify this proposed regulation:</P>
                <P>(1) Is not a “significant regulatory action” under Executive Order 12866,</P>
                <P>(2) Would not affect intrastate aviation in Alaska, and</P>
                <P>(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 39</HD>
                    <P>Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.</P>
                </LSTSUB>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 39 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(g), 40113, 44701.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 39.13</SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The FAA amends § 39.13 by adding the following new airworthiness directive:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">Deutsche Aircraft GmbH (Type Certificate Previously Held by 328 Support Services GmbH; AvCraft Aerospace GmbH; Fairchild Dornier GmbH; Dornier Luftfahrt GmbH):</E>
                         Docket No. FAA-2024-2714; Project Identifier MCAI-2024-00405-T.
                    </FP>
                    <HD SOURCE="HD1">(a) Comments Due Date</HD>
                    <P>The FAA must receive comments on this airworthiness directive (AD) by February 10, 2025.</P>
                    <HD SOURCE="HD1">(b) Affected ADs</HD>
                    <P>None.</P>
                    <HD SOURCE="HD1">(c) Applicability</HD>
                    <P>This AD applies to all Deutsche Aircraft GmbH (Type Certificate previously held by 328 Support Services GmbH; AvCraft Aerospace GmbH; Fairchild Dornier GmbH; Dornier Luftfahrt GmbH) Model 328-100 and Model 328-300 airplanes, certificated in any category.</P>
                    <HD SOURCE="HD1">(d) Subject</HD>
                    <P>Air Transport Association (ATA) of America Code 32, Landing gear.</P>
                    <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                    <P>
                        This AD was prompted by a report of nose landing gear (NLG) uplock bracket assembly cracking. The FAA is issuing this AD to address this unsafe condition which, if not addressed, could result in uncommanded NLG extension which, in combination with a one engine inoperative condition during initial climb, may result in reduced climb 
                        <PRTPAGE P="105490"/>
                        performance, with possible impact with terrain or obstacle.
                    </P>
                    <HD SOURCE="HD1">(f) Compliance</HD>
                    <P>Comply with this AD within the compliance times specified, unless already done.</P>
                    <HD SOURCE="HD1">(g) Requirements</HD>
                    <P>Except as specified in paragraph (h) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, European Union Aviation Safety Agency (EASA) AD 2024-0137, dated July 11, 2024 (EASA AD 2024-0137).</P>
                    <HD SOURCE="HD1">(h) Exceptions to EASA AD 2024-0137</HD>
                    <P>(1) Where EASA AD 2024-0137 refers to its effective date, this AD requires using the effective date of this AD.</P>
                    <P>(2) This AD does not adopt the “Remarks” section of EASA AD 2024-0137.</P>
                    <P>(3) Where paragraph (2) of EASA AD 2024-0137 specifies corrective actions if “any discrepancy, as defined in the SB, is detected,” for this AD, replace that text with “any corrosion, crack, dent, nick, deformation, or measurement not within specified dimensions of the SB is detected.”</P>
                    <P>(4) Where paragraph (3) of EASA AD 2024-0137 specifies additional actions if “any discrepancy is detected,” for this AD, replace that text with “any discrepancy, which includes corrosion, cracks, dents, nicks, and deformation, is detected.”</P>
                    <P>(5) Paragraph (4) of EASA AD 2024-0137 specifies to report inspection results to Deutsche Aircraft GmbH within a certain compliance time. For this AD, report inspection results at the applicable time specified in paragraph (h)(5)(i) or (ii) of this AD.</P>
                    <P>(i) If the inspection was done on or after the effective date of this AD: Submit the report within 30 days after the inspection.</P>
                    <P>(ii) If the inspection was done before the effective date of this AD: Submit the report within 30 days after the effective date of this AD.</P>
                    <HD SOURCE="HD1">(i) Additional AD Provisions</HD>
                    <P>The following provisions also apply to this AD:</P>
                    <P>
                        (1) 
                        <E T="03">Alternative Methods of Compliance (AMOCs):</E>
                         The Manager, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or responsible Flight Standards Office, as appropriate. If sending information directly to the manager of the International Validation Branch, send it to the attention of the person identified in paragraph (j) of this AD and email to: 
                        <E T="03">AMOC@faa.gov</E>
                        . Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the responsible Flight Standards Office.
                    </P>
                    <P>
                        (2) 
                        <E T="03">Contacting the Manufacturer:</E>
                         For any requirement in this AD to obtain instructions from a manufacturer, the instructions must be accomplished using a method approved by the Manager, International Validation Branch, FAA; or EASA; or Deutsche Aircraft GmbH's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.
                    </P>
                    <HD SOURCE="HD1">(j) Additional Information</HD>
                    <P>
                        For more information about this AD, contact Joe Salameh, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: 206-231-3536; email: 
                        <E T="03">joe.salameh@faa.gov.</E>
                    </P>
                    <HD SOURCE="HD1">(k) Material Incorporated by Reference</HD>
                    <P>(1) The Director of the Federal Register approved the incorporation by reference of the material listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.</P>
                    <P>(2) You must use this material as applicable to do the actions required by this AD, unless this AD specifies otherwise.</P>
                    <P>(i) European Union Aviation Safety Agency (EASA) AD 2024-0137, dated July 12, 2024.</P>
                    <P>(ii) [Reserved]</P>
                    <P>
                        (3) For EASA material identified in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email 
                        <E T="03">ADs@easa.europa.eu;</E>
                         website 
                        <E T="03">easa.europa.eu.</E>
                         You may find this material on the EASA website at 
                        <E T="03">ad.easa.europa.eu.</E>
                    </P>
                    <P>(4) You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.</P>
                    <P>
                        (5) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit 
                        <E T="03">www.archives.gov/federal-register/cfr/ibr-locations</E>
                         or email 
                        <E T="03">fr.inspection@nara.gov</E>
                        .
                    </P>
                </EXTRACT>
                <SIG>
                    <DATED>Issued on December 19, 2024.</DATED>
                    <NAME>Victor Wicklund,</NAME>
                    <TITLE>Deputy Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30763 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Food and Drug Administration</SUBAGY>
                <CFR>21 CFR Part 730</CFR>
                <DEPDOC>[Docket No. FDA-2023-N-4225]</DEPDOC>
                <RIN>RIN 0910-AI82</RIN>
                <SUBJECT>Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, Department of Health and Human Services (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Food and Drug Administration (FDA, the Agency, or we) is proposing to require testing of talc-containing cosmetic products using standardized testing methods for detecting and identifying asbestos that may be present as a contaminant in talc. We are also proposing corresponding adulteration provisions. Asbestos is a potential contaminant in talc, which is used in certain cosmetic products, and is a known human carcinogen. This proposed rule, if finalized, will help protect users of talc-containing cosmetic products from harmful exposure to asbestos given the potential for contamination of these products.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Either electronic or written comments on the proposed rule must be submitted by March 27, 2025. Submit written comments (including recommendations) on information collection issues under the Paperwork Reduction Act of 1995 by January 27, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The 
                        <E T="03">https://www.regulations.gov</E>
                         electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 27, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
                    </P>
                </ADD>
                <HD SOURCE="HD2">Electronic Submissions</HD>
                <P>Submit electronic comments in the following way:</P>
                <P>
                    • 
                    <E T="03">Federal eRulemaking Portal:</E>
                      
                    <E T="03">https://www.regulations.gov</E>
                    . Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 
                    <E T="03">https://www.regulations.gov</E>
                     will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).</P>
                <HD SOURCE="HD2">Written/Paper Submissions</HD>
                <P>
                    Submit written/paper submissions as follows:
                    <PRTPAGE P="105491"/>
                </P>
                <P>
                    • 
                    <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E>
                     Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
                </P>
                <P>• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”</P>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the Docket No. FDA-2023-N-4225 for “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products.” Received comments, those filed in a timely manner (see 
                    <E T="02">ADDRESSES</E>
                    ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at 
                    <E T="03">https://www.regulations.gov</E>
                     or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
                </P>
                <P>
                    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on 
                    <E T="03">https://www.regulations.gov</E>
                    . Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: 
                    <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E>
                </P>
                <P>
                    <E T="03">Docket:</E>
                     For access to the docket to read background documents, the plain language summary of the proposed rule of not more than 100 words as required by the “Providing Accountability Through Transparency Act,” or the electronic and written/paper comments received, go to 
                    <E T="03">https://www.regulations.gov</E>
                     and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
                </P>
                <P>
                    Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) to the Office of Management and Budget (OMB) at 
                    <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E>
                     Find this particular information collection by selecting “Currently Under Review—Open for Public Comments” or by using the search function. The title of this proposed collection is “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products.”
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P/>
                    <P>
                        <E T="03">With regard to the proposed rule:</E>
                         Jennifer Ross, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-0002, 301-796-4880 (this is not a toll-free number), 
                        <E T="03">QuestionsAboutMoCRA@fda.hhs.gov.</E>
                    </P>
                    <P>
                        <E T="03">With regard to the information collection:</E>
                         Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
                        <E T="03">PRAStaff@fda.hhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Executive Summary</FP>
                    <FP SOURCE="FP1-2">A. Purpose of the Proposed Rule</FP>
                    <FP SOURCE="FP1-2">B. Summary of the Major Provisions of the Proposed Rule</FP>
                    <FP SOURCE="FP1-2">C. Legal Authority</FP>
                    <FP SOURCE="FP1-2">D. Costs and Benefits</FP>
                    <FP SOURCE="FP-2">II. Table of Abbreviations/Commonly Used Acronyms in This Document</FP>
                    <FP SOURCE="FP-2">III. Background</FP>
                    <FP SOURCE="FP1-2">A. Introduction</FP>
                    <FP SOURCE="FP1-2">B. Need for the Regulation</FP>
                    <FP SOURCE="FP1-2">C. History of the Rulemaking</FP>
                    <FP SOURCE="FP1-2">D. Incorporation by Reference</FP>
                    <FP SOURCE="FP-2">IV. Legal Authority</FP>
                    <FP SOURCE="FP-2">V. Description of the Proposed Rule</FP>
                    <FP SOURCE="FP1-2">A. Who is subject to this section? (Proposed § 730.3(a))</FP>
                    <FP SOURCE="FP1-2">B. What definitions apply to this section? (Proposed § 730.3(b))</FP>
                    <FP SOURCE="FP1-2">C. What test methods must you use? (Proposed § 730.3(c))</FP>
                    <FP SOURCE="FP1-2">D. How does one determine if a sample has tested positive for asbestos? (Proposed § 730.3(d))</FP>
                    <FP SOURCE="FP1-2">E. Is there an alternative to performing finished product testing for detecting and identifying asbestos in a talc-containing cosmetic product? (Proposed § 730.3(e))</FP>
                    <FP SOURCE="FP1-2">F. How frequently must tests be performed? (Proposed § 730.3(f))</FP>
                    <FP SOURCE="FP1-2">G. Proposed Records/Record Retention Requirements (Proposed § 730.3(g))</FP>
                    <FP SOURCE="FP1-2">H. Proposed Enforcement Provisions (Proposed § 730.3 (h), (i), and (j))</FP>
                    <FP SOURCE="FP-2">VI. Proposed Effective Date</FP>
                    <FP SOURCE="FP-2">VII. Preliminary Economic Analysis of Impacts</FP>
                    <FP SOURCE="FP-2">VIII. Analysis of Environmental Impact</FP>
                    <FP SOURCE="FP-2">IX. Paperwork Reduction Act of 1995</FP>
                    <FP SOURCE="FP-2">X. Federalism</FP>
                    <FP SOURCE="FP-2">XI. Consultation and Coordination With Indian Tribal Governments</FP>
                    <FP SOURCE="FP-2">XII. References</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Executive Summary</HD>
                <HD SOURCE="HD2">A. Purpose of the Proposed Rule</HD>
                <P>We are issuing this proposed rule pursuant to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which requires the promulgation of proposed and final regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. This proposed rule, if finalized, will help protect users of talc-containing cosmetic products from harmful exposure to asbestos given the potential for asbestos contamination of these products.</P>
                <HD SOURCE="HD2">B. Summary of the Major Provisions of the Proposed Rule</HD>
                <P>The proposed rule describes the test methods that, if finalized, manufacturers of talc-containing cosmetic products will be required to use to detect and identify asbestos in these products. The proposed rule would require manufacturers to test a representative sample of each batch or lot of a talc-containing cosmetic product for asbestos using both Polarized Light Microscopy (PLM) (with dispersion staining) and Transmission Electron Microscopy (TEM)/Energy Dispersive Spectroscopy (EDS)/Selected Area Electron Diffraction (SAED).</P>
                <P>
                    The proposed rule also contains provisions that would allow manufacturers flexibility to either test each batch or lot of the talc cosmetic ingredient, or rely on a certificate of analysis for each batch or lot from a qualified talc supplier prior to using the talc to manufacture a talc-containing cosmetic, provided that the analytical methods used to test the talc include both PLM and TEM/EDS/SAED. It is FDA's understanding based on discussions and meetings with industry representatives that it is common industry practice to test talc prior to adding it during the manufacture of cosmetic products so as to avoid manufacturing and distributing talc-containing cosmetic products that contain asbestos. We specifically invite comment on existing industry practices and the utility of this approach.
                    <PRTPAGE P="105492"/>
                </P>
                <P>Additionally, the proposed rule contains provisions that would require manufacturers to keep records to demonstrate compliance with the rule.</P>
                <P>Finally, the proposed rule contains enforcement provisions. Failure of a manufacturer to operate in compliance with both the testing and recordkeeping requirements would render the product adulterated under the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act.) Further, because there is no established safe level below which asbestos could not cause adverse health effects, FDA has determined that asbestos at any level in talc-containing cosmetic products may render these products injurious to users. As such, the proposed rule would codify in regulations that if asbestos is present in a talc-containing cosmetic product, or in talc used in a cosmetic product, that cosmetic is adulterated under the FD&amp;C Act. Likewise, if asbestos is present in talc intended for use in a cosmetic, the talc is adulterated under the FD&amp;C Act.</P>
                <P>We seek comments on all aspects of this proposed rule.</P>
                <HD SOURCE="HD2">C. Legal Authority</HD>
                <P>On December 29, 2022, the President signed the Consolidated Appropriations Act, 2023 into law, which included MoCRA. Among other provisions, MoCRA mandated the establishment and requirement of standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. We are also issuing these regulations pursuant to section 601(c), section 601(a), and section 701(a) of the FD&amp;C Act.</P>
                <HD SOURCE="HD2">D. Costs and Benefits</HD>
                <P>This proposed rule, if finalized, would require testing of talc-containing cosmetic products using standardized testing method(s) for detecting and identifying asbestos that may be present as a contaminant in talc. Benefits include potential public health benefits to consumers from fewer asbestos exposures. To the extent the proposed rule would reduce exposures, the health benefits would include fewer illnesses, such as mesothelioma, lung cancer, larynx cancer, and ovarian cancer. We lack data to quantify these public health benefits, so we instead discuss qualitatively. Additionally, we quantify benefits to manufacturers of talc-containing cosmetics from fewer recalls. We quantify costs to talc suppliers and to cosmetics manufacturers to read and understand the rule and to test talc for asbestos. We estimate that the annualized monetized benefits over 10 years would range from $0.00 million to $1.39 million at a 7 percent discount rate, with a primary estimate of $0.06 million, and from $0.00 million to $1.39 million at a 3 percent discount rate, with a primary estimate of $0.06 million. The annualized costs would range from $1.29 million to $6.78 million at a 7 percent discount rate, with a primary estimate of $3.54 million, and from $1.30 million to $6.78 million at a 3 percent discount rate, with a primary estimate of $3.55 million.</P>
                <HD SOURCE="HD1">II. Table of Abbreviations/Commonly Used Acronyms in This Document</HD>
                <GPOTABLE COLS="2" OPTS="L2,nj,tp0,p7,7/8,i1" CDEF="s35,r100">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Abbreviation/acronym</CHED>
                        <CHED H="1">What it means</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">APA</ENT>
                        <ENT>Administrative Procedure Act.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">CTFA</ENT>
                        <ENT>Cosmetic, Toiletry, and Fragrance Association.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">EDS</ENT>
                        <ENT>Energy Dispersive Spectroscopy.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">EO</ENT>
                        <ENT>Executive Order.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">EPA</ENT>
                        <ENT>Environmental Protection Agency.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FD&amp;C Act</ENT>
                        <ENT>Federal Food, Drug, and Cosmetic Act.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">IEC</ENT>
                        <ENT>International Electrotechnical Commission.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">IR</ENT>
                        <ENT>Infrared Spectroscopy.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ISO</ENT>
                        <ENT>International Organization for Standardization.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">IWGACP</ENT>
                        <ENT>Interagency Working Group on Asbestos in Consumer Products.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">MoCRA</ENT>
                        <ENT>Modernization of Cosmetics Regulation Act of 2022.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">OIRA</ENT>
                        <ENT>Office of Information and Regulatory Affairs.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">OMB</ENT>
                        <ENT>Office of Management and Budget.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">PLM</ENT>
                        <ENT>Polarized Light Microscopy.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SAED</ENT>
                        <ENT>Selected Area Electron Diffraction.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">SEM</ENT>
                        <ENT>Scanning Electron Microscope.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">TEM</ENT>
                        <ENT>Transmission Electron Microscope.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">USP</ENT>
                        <ENT>U.S. Pharmacopeia.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">XRD</ENT>
                        <ENT>X-Ray Diffraction.</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">III. Background</HD>
                <HD SOURCE="HD2">A. Introduction</HD>
                <P>MoCRA, enacted on December 29, 2022, requires the promulgation of proposed and final regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.</P>
                <HD SOURCE="HD2">B. Need for the Regulation</HD>
                <P>Talc is used in various cosmetic products. Talc is mined as a naturally occurring hydrous magnesium silicate. Asbestos is found in the same rock types that host talc deposits (Refs. 1, 2) and so may be found in commercial talc mines and may be inseparable from talc in the mining process. As a result, talc used in cosmetic products sometimes contains asbestos fibers from serpentine or amphibole minerals present in proximity to talc deposits (Refs. 3, 4).</P>
                <P>
                    Asbestos is a known human carcinogen, and its health risks are well-documented (Refs. 5 to 10). There is general agreement among U.S. Federal Agencies (Refs. 8, 11), and the World Health Organization (Ref. 12), that there is no established safe threshold for adverse health effects from asbestos exposure. Because there is no established safe level below which asbestos could not cause adverse health effects, asbestos at any level in talc-containing cosmetic products may render these products injurious to users. For this reason, we conduct testing for asbestos in talc-containing cosmetic products and have issued safety alerts when such products have tested positive for asbestos (see: 
                    <E T="03">https://www.fda.gov/cosmetics/cosmetics-recalls-alerts/fda-advises-consumers-stop-using-certain-cosmetic-products</E>
                    ). In addition, we are concerned about even low levels of asbestos in cosmetics, given that such products are applied to the body and used by many people on a regular, daily basis, throughout their lives. The risk of harmful effects from asbestos is higher with repeated and long-term exposure to the carcinogen (Ref. 8).
                </P>
                <P>Inhalation is the primary pathway of exposure to asbestos in talc-containing cosmetic products, although ingestion and perineal exposures also occur. Exposure to asbestos by inhalation can cause sequelae ranging from inflammation to pleural disease and diseases such asbestosis, lung cancer, and mesothelioma. These effects rarely occur acutely, but they typically occur one or more decades later. Once inside the body through inhalation, ingestion, or perineal exposure, asbestos can migrate through tissues and organs to secondary sites of exposure where progressive cell damage can occur that may lead to diseases in other parts of the body that are remote from the sites of primary exposure, including cancers of the larynx, gastrointestinal tract, and ovaries (Refs. 9, 13, 14, 15, 16). Positive associations have been observed between exposure to asbestos and cancer of the pharynx, stomach, and colorectum (Ref. 9).</P>
                <P>
                    The presence of asbestos found as a result of independent testing of talc-containing cosmetics products indicates any asbestos that may be present in the talc ore is difficult to remove during processing to manufacture talc for use in cosmetics (Ref. 17). FDA monitors for asbestos in talc-containing cosmetic products, including sampling of products reported to contain asbestos by various laboratories using PLM and TEM/EDS/SAED microscopy methods. For example, in 2010, FDA's contract laboratory tested 34 talc-containing cosmetic powder products, including body powders, face powders, foundation, eye shadow, and blush, and samples of talc as an ingredient used in 
                    <PRTPAGE P="105493"/>
                    cosmetics from suppliers and found no asbestos contamination using PLM and TEM/EDS/SAED (Ref. 18). In 2019, FDA's contract laboratory tested 52 talc-containing powder cosmetic products, including body powders, face powders, eye shadows, blushes, bronzers, and face makeup using PLM and TEM/EDS/SAED. In March, June, August, and October 2019, FDA confirmed the presence of asbestos in nine talc-containing cosmetic products, which were voluntarily recalled by the companies (Ref. 19).
                </P>
                <P>
                    In considering existing voluntary consensus standards or published methods for testing for asbestos in talc, we did not find any standardized testing method that laboratories can follow without modification to test for asbestos in talc-containing cosmetic products. Specifically, we found that the published standards and methods to test for asbestos in talc (
                    <E T="03">i.e.,</E>
                     Talc USP monograph and CTFA method J4-1) have long-recognized shortcomings in specificity and sensitivity compared with electron microscopy-based methods (Refs. 17, 20, and 21). Furthermore, even when the most sensitive electron microscopy methods are used, laboratories testing the same product may reach different conclusions about the presence of asbestos. These differences may be attributed to a lack of a standardized testing method that provides unambiguous guidelines for detecting and identifying asbestos fibers and lack of homogeneity of asbestos found in samples. The absence of a standardized testing method for the determination of the presence of asbestos in talc and talc-containing cosmetic products has led many analytical laboratories to combine and/or adapt published test methods developed for the determination of the presence of asbestos in air or building materials (Refs. 20, 21). This could, at least in part, account for discrepancies in laboratory findings that have been reported.
                </P>
                <P>This proposed rule, if finalized, would require testing of talc-containing cosmetic products, and would require such testing be performed for detecting and identifying asbestos that may be present as a contaminant in talc using both PLM and TEM/EDS/SAED microscopy methods. The proposed rule would also require referring to images in standards for identifying asbestos fibers to help ensure that the results are accurately and consistently interpreted. Using both of these test methods for detecting and identifying asbestos would substantially improve a manufacturer's ability to detect the presence of asbestos in talc-containing cosmetic products as compared to testing using only one of the methods alone, or not testing at all. Such testing would in turn improve a manufacturer's ability to take action to prevent the distribution of such products if asbestos is detected.</P>
                <HD SOURCE="HD2">C. History of Rulemaking</HD>
                <P>In developing this proposed rule, FDA carefully considered the scientific evidence and complex policy issues related to detecting and identifying asbestos in talc and talc-containing cosmetic products. FDA's activities have included forming an Interagency Working Group on Asbestos in Consumer Products (IWGACP) in the fall of 2018 and holding a public meeting entitled “Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc” in February 2020 where preliminary scientific opinions of the IWGACP were presented. Subsequently, FDA released the IWGACP's final scientific opinions in a White Paper (Ref. 22) and related Technical Appendices in January 2022 (Ref. 13), both of which were peer-reviewed (Ref. 23). The IWGACP concluded that X-ray diffraction (XRD) or infrared (IR) spectroscopy followed by PLM if XRD or IR is positive for amphibole or serpentine minerals are not specific or sensitive enough to detect the presence of asbestos (Ref. 22). This proposed rule is based in part on FDA's consideration of those scientific opinions and is also informed by presentations/comments at a Public Meeting on Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc (Ref. 24) and comments to the docket from that public meeting. Additionally, FDA relied on other studies reported in the scientific literature as noted in the reference section (including for example Refs. 25 to 30), as well as on FDA's scientific and regulatory experience in overseeing the safety of cosmetic products containing talc. Further, FDA is promulgating this proposed rule pursuant to section 3505 of MoCRA, which requires FDA to promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.</P>
                <HD SOURCE="HD2">D. Incorporation by Reference</HD>
                <P>We propose to incorporate by reference the following annexes from consensus standards, with the approval of the Director of the Federal Register in accordance with the Administrative Procedure Act (APA), 5 U.S.C. 552(a), and 1 CFR part 51:</P>
                <P>• Annex D in ISO 22262-1:2012(E), “Air quality—Bulk materials—Part 1: Sampling and qualitative determination of asbestos in commercial bulk materials,” First edition, July 1, 2012 (Ref. 31).</P>
                <P>• Annex C in ISO 10312:2019(E), “Ambient air—Determination of asbestos fibres—Direct-transfer transmission electron microscopy method,” Second edition, October 10, 2019 (Ref. 32). Specifically, we would require the use of Figure C.1 in ISO 10312:2019(E), Annex C.</P>
                <P>The International Organization for Standardization (ISO) is an independent, nongovernmental international organization with a membership of national standards bodies. For an overview of ISO 22262-1:2012(E) and ISO 10312:2019(E), see section V.C of this document.</P>
                <P>
                    The annexes of the consensus standards proposed to be incorporated by reference are available to the public in two different ways. Interested parties may: (1) examine these readily available standards at Dockets Management Staff, administered by the Federal Dockets Management System (FDMS), at (see 
                    <E T="02">ADDRESSES</E>
                    ), (2) purchase copies of these standards from International Organization for Standardization, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland; phone: +41-22-749-01-11; email: 
                    <E T="03">customerservice@iso.org;</E>
                     website: 
                    <E T="03">https://www.iso.org/store.html.</E>
                </P>
                <P>FDA is proposing to incorporate by reference the specified annexes in ISO 22262-1:2012(E) and ISO 10312:2019(E). Any future revisions to these standards affecting the specified annexes would need to be evaluated to determine the impact of the changes and whether this proposed rule, if finalized, should be amended. If deemed necessary and appropriate, FDA will update the final regulation in accordance with the APA (5 U.S.C. 553) and obtain approval of any changes to the incorporation by reference in accordance with 1 CFR part 51.</P>
                <HD SOURCE="HD1">IV. Legal Authority</HD>
                <P>
                    We are issuing this proposed rule pursuant to section 3505 of MoCRA, under section 601 of the FD&amp;C Act (21 U.S.C. 361), and under section 701 of the FD&amp;C Act (21 U.S.C. 371). Section 3505 of MoCRA requires the promulgation of proposed and final regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. These proposed regulations would require testing of talc-containing cosmetic products using PLM and TEM/
                    <PRTPAGE P="105494"/>
                    EDS/SAED testing methods for detecting and identifying asbestos that may be present as a contaminant in talc.
                </P>
                <P>Section 201 (i) of the FD&amp;C Act defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body . . . for cleansing, beautifying, promoting attractiveness, or altering the appearance.” This definition includes skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors, deodorants, and components of cosmetic products, but excludes soap.</P>
                <P>Under section 601(c) of the FD&amp;C Act, a cosmetic is adulterated if “it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” Asbestos is a known human carcinogen, and its health risks are well-documented (Refs. 5 to 10). Because there is no established safe level below which asbestos could not cause adverse health effects (Refs. 8, 11, 12), asbestos at any level in talc-containing cosmetic products may render these products injurious to users. In addition, we are concerned about even low levels of asbestos in cosmetics, given that such products are applied directly to the body and used by many people on a regular, daily basis, throughout their lives. The risk of harmful effects from asbestos is higher with repeated and long-term exposure to the carcinogen (Ref. 8). Exposure to asbestos can cause a range of adverse health effects that may injure users, including causing sequelae ranging from inflammation to pleural diseases and diseases such asbestosis, lung cancer, and mesothelioma. Once inside the body through inhalation, ingestion, or perineal exposure, asbestos can migrate through tissues and organs to secondary sites of exposure where progressive cell damage can occur that may lead to diseases in other parts of the body that are remote from the sites of primary exposure, including cancers of the larynx, gastrointestinal tract, and ovaries (Refs. 9, 13, 14, 15, 16). Positive associations have been observed between exposure to asbestos and cancer of the pharynx, stomach, and colorectum (Ref. 9).</P>
                <P>There is no established safe exposure threshold for asbestos (Refs. 8, 11, 12). Asbestos is found in the same rock types that host talc deposits from which the talc in talc-containing cosmetic products is mined (Refs. 1, 2). As a result of the mining process, talc used in cosmetic products may contain asbestos fibers from serpentine or amphibole minerals present in proximity to talc deposits (Refs. 3, 4). Indeed, FDA has confirmed the presence of asbestos in some talc-containing cosmetic products. Specifically, in 2019, FDA surveyed 52 talc-containing cosmetic products and confirmed the presence of asbestos in nine of these products (Ref. 19). FDA considers the proposed testing techniques to be suitable methods for detecting and identifying asbestos in talc or cosmetic products that contain talc. FDA is not aware of any other equally suitable methods. Therefore, we are proposing this rule to codify in our regulations that a talc-containing cosmetic product is adulterated under section 601(c) of the FD&amp;C Act if the product has been prepared, packed, or held under conditions that could allow the product to contain asbestos, including by not testing and maintaining records of such testing for asbestos, a substance that is injurious to the health of consumers and known to be naturally occurring in talc.</P>
                <P>Under section 601(a) of the FD&amp;C Act, a cosmetic is adulterated if “it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or, under such conditions of use as are customary or usual . . .”. Individuals can be exposed to asbestos during use of cosmetics that contain talc, should the talc used to manufacture the product contain asbestos. As such, asbestos may cause injury to users under the expressly indicated, customary, or usual conditions of use of a cosmetic product. Therefore, FDA currently considers that a cosmetic product that is manufactured using talc that contains asbestos contains a poisonous or deleterious substance that may be injurious to users under expressly indicated, customary, or usual use conditions. To make this conclusion explicit in our regulations, we are proposing to codify in our regulations that if asbestos is present in a talc-containing cosmetic product, or in talc used in a cosmetic product, that cosmetic product is adulterated under section 601(a) of the FD&amp;C Act. Likewise, as section 201(i)(2) of the FD&amp;C Act (21 U.S.C. 321(i)(2)) states that “cosmetic” includes “articles intended for use as a component” of a cosmetic, we are also proposing to codify in our regulations that if asbestos is present in talc intended for use in a cosmetic, that talc, as an article intended for use as a component ingredient of a cosmetic, is an adulterated cosmetic under 601(a) of the FD&amp;C Act.</P>
                <P>Under section 701(a) of the FD&amp;C Act, we may promulgate regulations for the efficient enforcement of the FD&amp;C Act. A regulation that requires testing methods to detect and identify asbestos in talc-containing cosmetics and that clearly establishes FDA's conclusion that a cosmetic containing asbestos is adulterated would help prevent talc-containing cosmetics from containing asbestos, a substance that may injure users. This would allow for the efficient enforcement of the FD&amp;C Act.</P>
                <P>Further, we are proposing to use our authority under 701(a) of the FD&amp;C Act to promulgate requirements to keep asbestos testing records for at least 3 years after the date the record was created. We are proposing under 701(a) of the FD&amp;C Act to require that records be made available within 1 business day for inspection and copying upon request, either at the place of business of the manufacturer during inspection or remotely through electronic delivery. We chose 1 business day to be largely consistent with other FDA regulations that require production within 1 business day. As an example, 21 CFR 1.1455(c) regarding food traceability records requires records production within 24 hours. We seek comment on this proposed timeframe.</P>
                <P>The proposed recordkeeping requirements are necessary for both FDA and manufacturers to ensure that manufacturers are complying with the testing requirements of the proposed rule. Therefore, these proposed recordkeeping requirements are necessary for the efficient enforcement of the FD&amp;C Act because they will aid both manufacturers and FDA in ensuring that a talc-containing cosmetic is not adulterated.</P>
                <P>
                    In addition, because the underlying testing requirements are necessary to minimize the likelihood of adulteration of a talc-containing cosmetic product, access to records that demonstrate that a manufacturer has followed those requirements is essential to the efficient enforcement of the FD&amp;C Act as it allows us to confirm compliance. Likewise, the ability to copy these records is essential to the efficient enforcement of the FD&amp;C Act as this allows FDA to confirm compliance. This may be necessary, for example, if our investigator needs assistance in reviewing a certain record from relevant experts in headquarters. Otherwise, we would have to rely solely on our investigator's notes and reports when drawing conclusions. In addition, copying records will facilitate followup regulatory actions. Therefore, at this 
                    <PRTPAGE P="105495"/>
                    time, we have concluded that the ability to access and copy records is necessary to efficiently enforce the rule and thereby help prevent the introduction into interstate commerce of adulterated talc-containing cosmetics. We also conclude at this time that requiring delivery within 1 business day through electronic means rather than solely during in-person inspections will enable us to efficiently and effectively monitor compliance with the testing requirements to help prevent adulteration of talc-containing cosmetics and is therefore also authorized by section 701(a) of the FD&amp;C Act. We seek comment on the proposed timeframes.
                </P>
                <HD SOURCE="HD1">V. Description of the Proposed Rule</HD>
                <P>We propose to amend chapter I of title 21 of the Code of Federal Regulations by adding part 730 to subchapter G entitled “Requirements for Talc-Containing Cosmetic Products.” If finalized, proposed § 730.3 entitled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products” would require testing of talc-containing cosmetic products using standardized testing methods for detecting and identifying asbestos that may be present as a contaminant in talc, pursuant to section 3505 of MoCRA and sections 601 and 701 of the FD&amp;C Act.</P>
                <HD SOURCE="HD2">A. Who is subject to this section? (Proposed § 730.3(a))</HD>
                <P>We propose that the requirements under this rule would apply to all manufacturers of a talc-containing cosmetic product. We note that section 3505 of MoCRA is not included in the exemptions provided under section 613(a) of the FD&amp;C Act for certain cosmetic products and facilities that are subject to the requirements of chapter V of the FD&amp;C Act (Drugs and Devices). Therefore, cosmetic products that are subject to the requirements of chapter V of the FD&amp;C Act, such as cosmetic products that are also drugs, are subject to this proposed rule.</P>
                <HD SOURCE="HD2">B. What definitions apply to this section? (Proposed § 730.3(b))</HD>
                <P>For the purpose of this regulation, we propose to define two terms in this rule: “asbestos” and “representative sample.” Asbestos refers to a unique asbestiform morphology that occurs when certain minerals crystallize. We define “asbestos” to mean amosite, chrysotile, crocidolite, asbestiform tremolite, actinolite, anthophyllite, winchite, and richterite, and other amphibole minerals in the asbestiform habit (Ref. 26, 27). We consider an asbestiform habit to be a habit of growth that ultimately leads to formation of respirable narrow fibers that are hazardous.</P>
                <P>Many published definitions of asbestos, including certain definitions in other Federal Agencies' regulations, were considered in defining asbestos in this proposed rule (Refs. 26, 27). Generally speaking, published definitions of asbestos can be categorized as either commercial or mineralogical. For commercial uses, the term asbestos encompasses six minerals that are valued both because of their unique properties and because their abundance in certain regions makes it commercially feasible to mine them. The six commercial minerals targeted for detection and identification in other Federal asbestos regulations are the serpentine mineral chrysotile and the following five amphibole minerals: “amosite” (cummingtonite-grunerite asbestos), crocidolite (riebeckite asbestos), tremolite asbestos, actinolite asbestos, and anthophyllite asbestos. In a strictly mineralogical sense, asbestos also refers to minerals identifiable as being among the amphibole or serpentine group and having a unique fibrous morphology resulting from an asbestiform habit of growth (Ref. 27). Therefore, we propose applying a mineralogical definition of asbestos in talc and talc-containing cosmetic products because the commercial definitions of asbestos in other federal regulations do not include all hazardous asbestiform amphibole minerals that might be detected and identified using the proposed testing methods.</P>
                <P>In applying the mineralogical approach to identifying asbestos in talc and talc-containing cosmetic products, we propose to add winchite and richterite to the six commercial minerals in our definition of asbestos. Winchite and richterite have been identified in samples of talc taken from certain regions (Refs. 13, 17, 28), and asbestiform winchite and richterite as impurities in other minerals have been associated with the same diseases associated with commercial asbestos types (Refs. 6, 7).</P>
                <P>We also propose to include “other asbestiform amphibole minerals” in our definition of asbestos. Inclusion of all asbestiform amphibole minerals is based on the cumulative understanding developed over the past five decades indicating association of the particle morphology of asbestiform amphiboles with adverse health effects (Refs. 29, 30). Our proposal is also in recognition that amphiboles are extremely diverse in chemical composition (Ref. 33) and subtle differences in chemical composition have been observed in amphibole asbestos minerals found in association with talc (Ref. 28).</P>
                <P>Because all types of amphibole minerals in cosmetic products have potential to release fibers exhibiting size and shape consistent with asbestiform morphology, the inclusion of “other asbestiform amphibole minerals” in our definition of asbestos would help ensure that testing for asbestos in talc-containing cosmetic products would detect and identify these fibers as asbestos even if mineral nomenclature (Ref. 33) changes over time.</P>
                <P>We propose to define “representative sample” to mean a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled. Rather than specify an exact number of units necessary to comprise a “representative sample”, this definition provides firms with the flexibility to determine the appropriate sample amount-for any given testing situation, that would ensure the sample represents the material. This definition is also near- identical with FDA's existing regulations defining “representative sample” in other product areas (See 21 CFR 210.3(b)(21) and 106.3).</P>
                <P>We request comment on the proposed definitions and if they provide sufficient clarity for manufacturers.</P>
                <HD SOURCE="HD2">C. What test methods must you use? (Proposed § 730.3(c))</HD>
                <P>
                    We propose to require manufacturers of talc-containing cosmetic products to test for asbestos using PLM (with dispersion staining) and TEM/EDS/SAED. The requirement for the use of PLM and TEM/EDS/SAED in tandem is consistent with established scientific opinions recognizing the limitations of PLM in the realm of analysis for asbestos in talc and talc-containing cosmetic products, which may result in false negative test results. Such limitations are mentioned and discussed in, 
                    <E T="03">e.g.,</E>
                     Cosmetic, Toiletry, and Fragrance Association (CTFA) Method J4-1 “Asbestiform Amphibole Minerals in Cosmetic Talc” (Ref. 34), a 
                    <E T="03">Notice of Intent to Revise</E>
                     the Talc U.S. Pharmacopeia monograph (Talc USP) test for asbestos (Ref. 35), and “IWGACP Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc” (Refs. 13, 22). For the reasons described below, we have determined the additional use of TEM/EDS/SAED will ensure sensitivity and specificity not afforded by PLM alone.
                </P>
                <P>
                    We propose that manufacturers must use an analytical approach that includes PLM and TEM/EDS/SAED. TEM/EDS/
                    <PRTPAGE P="105496"/>
                    SAED and PLM are complementary methods, giving different information about the different particles (size ranges). Although PLM has much lower magnification than TEM/EDS/SAED by about two orders of magnitude, PLM provides for a larger amount of sample to be analyzed in comparison to when a sample is prepared for TEM/EDS/SAED analysis. Therefore, combining TEM, which enables detection of smaller fibers, with PLM, which enables testing of larger samples, gives the best chance of detecting asbestos. Thus, we are proposing that both methods must be used.
                </P>
                <P>
                    For PLM testing, detecting and identifying asbestos would be required to be based on comparison of optical crystallographic properties (
                    <E T="03">i.e.,</E>
                     color and pleochroism, refractive indices, birefringence, extinction characteristics, and sign of elongation) and particle morphology with data for and images of asbestos in indicated references. Specifically, we would require reference to PLM images of asbestos from ISO 22262-1:2012(E) (Annex D) as visual aids to assist the analyst for identifying asbestos particles (Ref. 31). For TEM/EDS/SAED, detecting and identifying asbestos would be required to be based on comparison of elemental composition, crystal structure of particles, and particle morphology with data for and images of asbestos in indicated references. Specifically, we would require reference to images of asbestos ISO 10312:2019(E) (Figure C.1 in Annex C) (Ref. 32) for TEM/EDS/SAED analysis of asbestos as visual aids to assist the analyst for classifying various types of asbestos structures (
                    <E T="03">i.e.,</E>
                     particles).
                </P>
                <P>In developing the proposed rule, we considered whether existing voluntary consensus standards for testing talc for asbestos were suitable for inclusion in the proposed rule as the standardized testing method for detection and identification of asbestos in talc-containing cosmetic products. For the purposes of this proposed rule, in line with the ISO/International Electrotechnical Commission (IEC)'s Guide 2:2004, “Standardization and related activities—General vocabulary,” we consider a standard to be a document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines, or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context (Ref. 36). Among standards, we consider a voluntary consensus standard to be one that is developed or adopted by standards development organizations according to strict consensus principles. Taken together as such, we evaluated existing voluntary consensus standards by reviewing published asbestos testing methods established by nationally or internationally recognized standard development organizations and that generally only apply to the context of very narrow or specific situations in which asbestos is known to be present.</P>
                <P>In addition to these standards, we also evaluated other existing published methods, such as those that had not been developed or adopted by consensus, for testing talc for asbestos. As discussed below, among such published standards and methods reviewed by FDA at the time of writing this proposed rule, including those applicable to “talc” as an ingredient in consumer products, we did not find any that can be recognized in its entirety as an appropriate standardized testing method to test for asbestos in talc or talc-containing cosmetics.</P>
                <P>The CTFA method entitled “Asbestiform Amphibole Minerals in Cosmetic Talc” (J4-1) and the Talc USP test for asbestos are the only published methods to test for asbestos in talc used in cosmetics and pharmaceuticals, respectively. As described below, we concluded these methods are not suitable for the purpose of this proposed rule.</P>
                <P>The J4-1 method was developed as a PLM test method for asbestos in talc used as a cosmetic ingredient and was not intended to be used to test cosmetic products containing talc. As a result, J4-1 does not include a method of sample preparation intended to remove ingredients in cosmetic products that may interfere with the detection and identification of asbestos.</P>
                <P>Additionally, J4-1 has significant shortcomings with respect to testing for asbestos in talc to be used as an ingredient in a cosmetic product. First, as its title notes, it is intended only to test for asbestiform amphibole minerals and not for chrysotile asbestos. On review of the protocol, we did not find it to have any utility to test for chrysotile or detect chrysotile with adequate sensitivity. Second, the J4-1 protocol requires that talc first be screened for amphibole by X-Ray Diffraction Analysis (XRD). J4-1 only requires the talc to be subsequently tested by PLM for asbestiform amphibole if the sample is found to first contain amphibole by the XRD screening. As stated in the J4-1 protocol, the XRD screening method has a nominal limit of detection of amphibole of 0.5 percent by weight. Thus, if the talc contains less than 0.5 percent asbestos by weight, potentially representing billions of asbestos fibers per gram of talc, the asbestos would not be detected (Ref. 37). In summary, reliance on XRD, absent any additional microscopic analysis, can lead to false-negative results for talc containing chrysotile asbestos at any level or amphibole asbestos at levels below 0.5 percent.</P>
                <P>If XRD testing of talc comes up positive, the talc then has to be tested by PLM to determine if the amphibole is asbestiform. FDA is concerned that a PLM method alone does not provide sufficient sensitivity to enable detection of chrysotile and asbestiform amphibole minerals at the levels that might be present in talc intended for use in cosmetics and talc-containing cosmetics. Asbestos mineral particles in talc and talc-containing cosmetics can be too small to be detected and identified by PLM alone. Use of TEM/EDS/SAED in tandem with PLM is intended to improve detection of chrysotile and asbestiform amphibole should any of these minerals be present in talc intended for use in cosmetics or cosmetics manufactured using that talc raw material.</P>
                <P>
                    We also evaluated a test entitled “Absence of Asbestos” in the current Talc USP monograph (Talc USP test for asbestos) that includes three procedures, including a pair of optional procedures to screen for amphibole and serpentine. In the current Talc USP test for asbestos (Ref. 38), analysts are given the option to perform either Procedure 1—infrared spectroscopy (IR) (Identification Tests—General Chapter USP &lt;191&gt;)—or Procedure 2—XRD [Characterization of Crystalline and Partially Crystalline Solids by X-Ray Powder Diffraction (XRPD)—General Chapter USP &lt;941&gt;]. If the procedure chosen gives a positive result, then optical microscopy (Optical Microscopy—General Chapter USP &lt;776&gt;) must be performed to confirm whether the sample is to be regarded as meeting the requirement for 
                    <E T="03">Absence of Asbestos.</E>
                     It appears that the XRD method has a nominal limit of detection of no less than 0.5 percent and that the IR method might have a limit of detection of nominally 1 percent. Like explained above regarding the J4-1 method, reliance on screening using XRD, or IR as in the USP method, absent any additional microscopic analysis, can lead to false-negative results. Moreover, the optical microscopy method specified in USP &lt;776&gt; does not require the use of polarized light. Use of optical microscopy without polarized light lacks specificity, so could lead to misidentification of the mineral particles present in talc or a talc-containing cosmetic product.
                    <PRTPAGE P="105497"/>
                </P>
                <P>
                    Amid concerns pertaining to lack of sensitivity and specificity in the test for 
                    <E T="03">Absence of Asbestos,</E>
                     USP has formed two successive expert panels to develop improvements to the Talc USP test for asbestos. Each expert panel has highlighted concerns with the IR, XRD, and optical microscopy methods in the Talc USP test (Refs. 21, 35). Culminating the efforts of these two expert panels, in March 2022 USP published a proposal in Pharmacopeial Forum (Ref. 39), which aims to change the name of the “Absence of Asbestos” test to “Test for Asbestos” to account for residual limitations in sensitivity and specificity. In addition, the proposal aims to improve the analytical approach by deleting the optional IR test, improving the XRD test to deal with interference that hinders detection of serpentine, and improving the optical microscopy test to require the use of polarized light for the detection and identification of asbestos.
                </P>
                <P>
                    Lastly, USP's proposed protocol will require the analyst to use PLM, even if the XRD test is negative. To accommodate this proposal to amend the Talc USP monograph, USP has issued two new General Chapters. General Chapter &lt;901&gt; (Ref. 40) describes the analytical procedures for XRD and PLM in detail and a complementary General Information Chapter &lt;1901&gt; (Ref. 41) includes images of chrysotile and tremolite asbestos detected by PLM. Additionally, in the briefing to &lt;901&gt;, USP proposes that a third talc expert panel be convened to develop an electron microscopy test method to complement the PLM method, which promises to improve the sensitivity and specificity of the protocol for asbestos even further. However, as noted above, despite demonstrated improvements in sensitivity and specificity, the capability for detection and identification of asbestos in talc used to manufacture cosmetic products using the XRD and PLM techniques described in chapters &lt;901&gt; and &lt;1901&gt; (
                    <E T="03">i.e.,</E>
                     without using TEM/EDS/SAED) remains limited.
                </P>
                <P>FDA is proposing to require the use of TEM/EDS/SAED in addition to PLM with dispersion staining because many of the particles of chrysotile and asbestiform amphibole minerals that might be found in raw material talc and talc-containing cosmetic products are not detectable by PLM. Electron microscopy, including transmission electron microscopy (TEM/EDS/SAED) and scanning electron microscopy (SEM/EDS), overcomes the resolution limitations of PLM and has the ability to detect extremely small asbestos fibers. The minimum fiber width that can be routinely characterized by TEM/EDS/SAED is on the order of 0.04 μm, corresponding to the typical width of single chrysotile fibrils. SEM/EDS can be a complementary approach to TEM/EDS/SAED to provide additional information on amphibole mineral particle morphology. However, due to its limitations with respect to obtaining high-quality SAED patterns helpful to identify chrysotile and amphibole minerals, SEM/EDS can only be regarded as a complementary technique but not as a substitute for TEM/EDS/SAED. To have a comprehensive assessment, the IWGACP had advised that the development of a standardized approach should include both optical and electron microscopy. FDA's proposal to require manufacturers of talc-containing cosmetic products to test for asbestos using PLM (optical microscopy) and TEM/EDS/SAED (electron microscopy) is therefore aligned with IWGACP scientific opinions no. 1 and no. 3 on testing approach (Ref. 22).</P>
                <P>
                    Since 2019, FDA's contract laboratory has tested more than 200 samples of talc-containing cosmetic products using a TEM/EDS/SAED method that can reliably detect a single asbestos fiber in a sample aliquot, providing the confidence needed in the method proposed. All laboratory reports representing testing of samples of cosmetic products by FDA's contract laboratory from 2019-2023 are posted on the FDA website (
                    <E T="03">https://www.fda.gov/news-events/fda-brief/fda-brief-fda-releases-final-report-talc-containing-cosmetic-products-tested-asbestos</E>
                    ). These reports provided an estimated limit of detection as the smallest single asbestos fiber that can be detected and identified by TEM/EDS/SAED, and provide an estimated limit of quantification by TEM/EDS/SAED as four such fibers.
                </P>
                <P>The limit of detection and limit of quantification calculation is dependent upon the amount of sample viewed by the analyst on a TEM grid, which is based on the method of sample preparation. Recognizing that laboratories may prepare samples for TEM/EDS/SAED differently depending on the type of sample, we propose to require that, when testing talc or talc-containing cosmetics for asbestos, at least 0.1 micrograms of talc or talc-containing cosmetic product be viewed on a TEM grid on which the sample is uniformly distributed. Based on our discussions with our own and other contract testing labs, we believe this requirement would be consistent with general practice by asbestos testing laboratories expert in TEM/EDS/SAED microscopy and would help ensure consistency across laboratories.</P>
                <P>
                    The testing of over 200 samples by FDA's contract laboratory established the TEM/EDS/SAED method's sensitivity to detect one asbestos particle (
                    <E T="03">i.e.,</E>
                     fiber) per 0.1 micrograms of talc. Further, under our proposed requirement to analyze at least 0.1 micrograms of the sample, detection of a single asbestos fiber corresponds to an estimated 10
                    <SU>7</SU>
                     fibers per gram of talc or talc-containing cosmetic product, representing approximately 10
                    <E T="51">−5</E>
                     percent of asbestos by weight (Ref. 19). Therefore, we believe that the limit of detection of a single asbestos fiber in a sample is the appropriate basis for determining if a sample should be regarded to be positive for asbestos. When testing for asbestos in talc or a talc-containing cosmetic product, suitable negative controls (use of laboratory blanks) can provide assurance that a single asbestos fiber detected is a true positive finding.
                </P>
                <P>We note that FDA has used the limit of quantification as the basis for determining that a sample is positive. However, based on FDA's historical testing data and our current better understanding of the sensitivity, accuracy, and precision of the methods discussed above, we are proposing to use the limit of detection corresponding to detection of a single asbestos fiber as the basis for a positive sample. We request comment on this proposed requirement.</P>
                <P>
                    FDA acknowledges that there may be significant challenges in developing reference materials for the identification of asbestos in talc and talc-containing cosmetics. FDA finds that printed images or drawings depicting morphology of asbestos fibers and bundles, appearing in certain published asbestos testing standards, especially those written to address situations in which asbestos is known to be present, provide useful visual aids for comparison. For example, ISO 22262-1:2012(E) specifies methodology for using PLM to detect and identify asbestos added to fabricate commercial bulk materials such as fireproofing and thermal insulation (see Annex A). With respect to asbestos morphology, Annex D in ISO 22262-1:2012(E) (Ref. 31) appears to contain useful PLM images of chrysotile and asbestiform amphiboles. ISO 13012:2019(E) specifies a TEM/EDS/SAED method for the determination of airborne asbestos fibers and structures in a wide range of ambient air situations, including the interior atmospheres of buildings undergoing removal of previously installed asbestos insulation. Figure C.1 
                    <PRTPAGE P="105498"/>
                    in Annex C in ISO 10312:2019(E) (Ref. 32) appears to contain useful depictions of the morphology of asbestos detected and identified by TEM/EDS/SAED. Therefore, FDA is proposing to require the use of these images to assist the analyst in detecting and identifying asbestos.
                </P>
                <HD SOURCE="HD2">D. How does one determine if a sample has tested positive for asbestos? (Proposed § 730.3(d))</HD>
                <P>We propose to require manufacturers to test for asbestos using both PLM and TEM/EDS/SAED. If asbestos is detected using either method, then the sample would be required to be regarded as positive for asbestos. As explained above, we are proposing that the limit of detection of asbestos would be the basis for determining that a sample has tested positive. Thus, we propose that if any asbestos is detected when the sample is tested as required in § 730.3(c), the sample must be regarded as positive for asbestos.</P>
                <HD SOURCE="HD2">E. Is there an alternative to performing finished product testing for detecting and identifying asbestos in a talc-containing cosmetic product? (Proposed § 730.3(e))</HD>
                <P>We propose to provide manufacturers flexibility to test the talc or rely on a certificate of analysis from the talc supplier, prior to using the talc in the manufacture of a talc-containing cosmetic product. We are proposing that a manufacturer relying on such a certificate would satisfy the testing requirements of the rule. If a manufacturer chooses to rely on a talc certificate of analysis, they must qualify the supplier by establishing and maintaining the reliability of the supplier's certificate of analysis through verification of the results of the supplier's tests for asbestos in accordance with § 730.3(f). Testing of the talc intended to be used as a cosmetic ingredient can help prevent the manufacturing of cosmetic products that contain asbestos. Thus, FDA is providing talc-containing cosmetic product manufacturers with a flexible and efficacious approach to testing that will enable them to comply with the proposed requirements and minimize the likelihood that their talc-containing cosmetic products will contain asbestos.</P>
                <HD SOURCE="HD2">F. How frequently must tests be performed? (Proposed § 730.3(f))</HD>
                <P>We propose, at a minimum, that a manufacturer test a representative sample of each batch or lot of each talc-containing cosmetic product or talc ingredient for asbestos in accordance with § 730.3(c). If a manufacturer relies on the supplier's certificate of analysis in accordance with § 730.3(e), a manufacturer must at least, upon receipt of the supplier's initial certificate of analysis and subsequently annually thereafter, verify the reliability of the reported asbestos test results based on testing by the manufacturer or another laboratory as required in § 730.3(c).</P>
                <HD SOURCE="HD2">G. Proposed Records/Record Retention Requirements (Proposed § 730.3(g))</HD>
                <P>The record requirements section would establish certain requirements for manufacturers to keep records of testing for asbestos that show test data, including raw data, and to describe in detail how samples were tested. Raw data would include microscopy images, spectra, diffraction patterns and bench sheets that are used by the manufacturer or another asbestos testing lab in accordance with standardized methods the manufacturer or testing lab follow and the manufacturer or the testing lab's requirements for quality assurance. If the manufacturer chooses to rely on a certificate of analysis for the talc supplier, records must include any certificate of analysis received from the supplier for testing of the talc used to make the finished product, and documentation of how the manufacturer qualified the supplier by establishing and maintaining the reliability of the supplier's certificate of analysis through verification of the results of the supplier's tests for asbestos in accordance with § 730.3(f).</P>
                <P>This section would also require that records be made available within 1 business day, upon request, to an authorized FDA representative for inspection and copying and that they be written in English or an English translation be made available upon request. Records that would be required under this section must be retained for a period of 3 years after the date such record was created. FDA is soliciting comment on whether the timeframe for manufacturers to retain the records under this section is sufficient for FDA to ensure compliance with the rule, including specific comment on the length of time between when talc used in cosmetic products is tested and when such cosmetic products reach consumers, and specific comment on the length of time consumers retain or use their cosmetic products. FDA generally verifies compliance with recordkeeping requirements during inspections. Thus, the timeframe for recordkeeping is based upon consideration of the estimated inspection timeframe. FDA monitors for asbestos in talc-containing cosmetic products by sampling a relatively small number of products annually, and conducts “for cause” inspections. Thus, FDA estimates a period of up to 3 years from the time the record was created to when FDA may request the record.</P>
                <P>Records would be retained either as originals or as true copies such as photocopies, microfilm, microfiche, or other reproductions that preserve the content and meaning of the data, including associated metadata and audit trails. Electronic records would be required to comply with 21 CFR part 11. Where reduction techniques are used, suitable reader, computer, and copying equipment should be readily accessible to FDA during an inspection. Documents and records that can be immediately retrieved from another location as originals or true copies, including by computer or other electronic means, would meet the requirement to make these records available to FDA. We also propose to require that records be sent electronically, or through another delivery method that delivers the records within 1 business day, to FDA upon request, rather than provide such records at the place of business. We believe that remote access by FDA would be relatively less burdensome on manufacturers compared to an FDA visit to a manufacturer's place of business.</P>
                <HD SOURCE="HD2">H. Proposed Enforcement Provisions (Proposed § 730.3(h), (i), and (j))</HD>
                <P>
                    Manufacturers would be required to keep testing records, including any certificates of analysis and qualification and verification documentation, for 3 years after the record was created. Manufacturers would be required to provide these records to us, including electronically, within 1 business day upon request. Failure to test for asbestos in a talc-containing cosmetic product or to maintain testing records would render the product adulterated under section 601(c) of the FD&amp;C Act. Further, if asbestos is present in a talc-containing cosmetic product, or in talc used in a cosmetic product, that cosmetic product is adulterated under section 601(a) of the FD&amp;C Act. Likewise, if asbestos is present in talc intended for use in a cosmetic, that talc is adulterated under section 601(a) of the FD&amp;C Act. Finally, confirmation of asbestos presence, for example through testing conducted on behalf of FDA, similarly means the talc or talc-containing cosmetic product tested is adulterated under section 601(a) of the FD&amp;C Act. It is a prohibited act under section 301(a) of the FD&amp;C Act to introduce or deliver for introduction an adulterated cosmetic into interstate commerce.
                    <PRTPAGE P="105499"/>
                </P>
                <HD SOURCE="HD1">VI. Proposed Effective Date</HD>
                <P>
                    We propose that any final rule that may be issued based on this proposal become effective 30 days after the date of publication of the final rule in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <HD SOURCE="HD1">VII. Preliminary Economic Analysis of Impacts</HD>
                <P>We have examined the impacts of the proposed rule under Executive Order (E.O.) 12866, E.O. 13563, E.O. 14094, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).</P>
                <P>E.O.s 12866, 13563, and 14094 direct us to assess all benefits, costs, and transfers of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Rules are “significant” under E.O. 12866, section 3(f)(1) (as amended by E.O. 14094), if they “have an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of the Office of Information and Regulatory Affairs (OIRA) for changes in gross domestic product); or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities.” OIRA has determined that this proposed rule is not a significant regulatory action under E.O. 12866, section 3(f)(1).</P>
                <P>The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the proposed rule would impose small costs on affected firms, relative to annual revenue, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.</P>
                <P>The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes estimates of anticipated impacts, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The 2023 threshold after adjustment for inflation is $183 million, using the most current (2023) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.</P>
                <P>The proposed rule, if finalized, would require testing of talc-containing cosmetic products using standardized testing method(s) to detect and identify asbestos that may be present as a contaminant in talc. We summarize the benefits, costs, and transfers of the proposed rule in table 1.</P>
                <P>
                    The benefits of the proposed rule include potential public health benefits from fewer asbestos exposures. To the extent the proposed rule would reduce exposures to asbestos, health benefits would include fewer asbestos-related illnesses, such as mesothelioma, lung cancer, larynx cancer, and ovarian cancer. We lack data to quantify these public health benefits, so we instead discuss them qualitatively. Benefits would also include cost savings to manufacturers of talc-containing cosmetics from fewer recalls each year. At a 7 percent discount rate, the present value of monetized benefits over 10 years would range from $0.00 million to $10.42 million, with a primary estimate of $0.48 million.
                    <SU>1</SU>
                    <FTREF/>
                     At a 3 percent discount rate, the present value of monetized benefits over 10 years would range from $0.00 million to $12.25 million, with a primary estimate of $0.56 million. Annualized monetized benefits over 10 years would range from $0.00 million to $1.39 million at a 7 percent discount rate, with a primary estimate of $0.06 million, and from $0.00 million to $1.39 million at a 3 percent discount rate, with a primary estimate of $0.06 million.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         From the Office of Management and Budget's Circular A-4, the “ending point for your analysis should be far enough in the future to encompass, to the extent feasible, all the important benefits and costs likely to result from all regulatory alternatives being assessed.” We estimate that this proposed rule would have one-time costs immediately following the publication of the rule, then recurring benefits and costs following the effective date of the proposed rule. We therefore choose a 10-year time horizon to encompass all important benefits and costs.
                    </P>
                </FTNT>
                <P>The costs of the proposed rule include monetized costs to read and understand the rule, monetized asbestos testing costs, and monetized costs of subsequent testing conducted on new batches of talc when an initial sample of talc tests positive for asbestos. We expect that talc producers, talc suppliers, and manufacturers of talc-containing cosmetics would all read and understand the rule. Also, we assume that all manufacturers of talc-containing cosmetics would rely on certificates of analysis from talc suppliers to comply with asbestos testing requirements in the proposed rule. As a result, talc suppliers would incur costs to regularly test lots or batches of talc for asbestos, and manufacturers of talc-containing cosmetics would incur costs to maintain qualified talc-suppliers. At a 7 percent discount rate, the present value of monetized costs over 10 years would range from $9.72 million to $50.97 million, with a primary estimate of $26.58 million. At a 3 percent discount rate, the present value of monetized costs over 10 years would range from $11.41 million to $59.85 million, with a primary estimate of $31.20 million. Annualized monetized costs over 10 years would range from $1.29 million to $6.78 million at a 7 percent discount rate, with a primary estimate of $6.78 million, and from $1.30 million to $6.81 million at a 3 percent discount rate, with a primary estimate of $3.55 million.</P>
                <P>We request both comment and data on the assumptions underlying our analysis.</P>
                <GPOTABLE COLS="8" OPTS="L2,nj,p7,7/8,i1" CDEF="s50,9,9,9,9,9,9,xs48">
                    <TTITLE>Table 1—Summary of Benefits, Costs, and Distributional Effects of the Proposed Rule</TTITLE>
                    <TDESC>[millions of dollars]</TDESC>
                    <BOXHD>
                        <CHED H="1">Category</CHED>
                        <CHED H="1">
                            Primary 
                            <LI>estimate</LI>
                        </CHED>
                        <CHED H="1">
                            Low 
                            <LI>estimate</LI>
                        </CHED>
                        <CHED H="1">
                            High 
                            <LI>estimate</LI>
                        </CHED>
                        <CHED H="1">Units</CHED>
                        <CHED H="2">
                            Year 
                            <LI>dollars</LI>
                        </CHED>
                        <CHED H="2">
                            Discount 
                            <LI>rate</LI>
                            <LI>(%)</LI>
                        </CHED>
                        <CHED H="2">
                            Period 
                            <LI>covered</LI>
                            <LI>(years)</LI>
                        </CHED>
                        <CHED H="1">Notes</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="22">Benefits:</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Annualized Monetized ($m/year)</ENT>
                        <ENT>$0.06</ENT>
                        <ENT>$0.00</ENT>
                        <ENT>$1.39</ENT>
                        <ENT>2023</ENT>
                        <ENT>7</ENT>
                        <ENT>10</ENT>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>0.06</ENT>
                        <ENT>0.00</ENT>
                        <ENT>1.39</ENT>
                        <ENT>2023</ENT>
                        <ENT>3</ENT>
                        <ENT>10</ENT>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="03">Annualized Quantified</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>2023</ENT>
                        <ENT>7</ENT>
                        <ENT/>
                        <ENT/>
                    </ROW>
                    <ROW RUL="s">
                        <ENT I="22"> </ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>2023</ENT>
                        <ENT>3</ENT>
                        <ENT/>
                        <ENT/>
                    </ROW>
                    <ROW RUL="s">
                        <PRTPAGE P="105500"/>
                        <ENT I="03">Qualitative </ENT>
                        <ENT A="05">Benefits from reduced consumer exposure to asbestos.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">Costs:</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Annualized Monetized ($m/year)</ENT>
                        <ENT>3.54</ENT>
                        <ENT>1.29</ENT>
                        <ENT>6.78</ENT>
                        <ENT>2023</ENT>
                        <ENT>7</ENT>
                        <ENT>10</ENT>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>3.55</ENT>
                        <ENT>1.30</ENT>
                        <ENT>6.78</ENT>
                        <ENT>2023</ENT>
                        <ENT>3</ENT>
                        <ENT>10</ENT>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="03">Annualized Quantified</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="03">Qualitative</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                    </ROW>
                    <ROW>
                        <ENT I="22">Transfers:</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="03">Federal Annualized Monetized ($m/year)</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="22"> </ENT>
                        <ENT A="L02">From:</ENT>
                        <ENT A="L03">To:</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="03">Other Annualized Monetized ($m/year)</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="22"> </ENT>
                        <ENT A="L02">From:</ENT>
                        <ENT A="L03">To:</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">Effects:</ENT>
                    </ROW>
                    <ROW EXPSTB="07">
                        <ENT I="03">State, Local, or Tribal Government: None.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Small Business: Not significant.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Wages: None.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Growth: None.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    We have developed a Preliminary Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full preliminary analysis of economic impacts is available in the docket for this proposed rule (Ref. 42) and at 
                    <E T="03">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</E>
                    .
                </P>
                <HD SOURCE="HD1">VIII. Analysis of Environmental Impact</HD>
                <P>We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.</P>
                <HD SOURCE="HD1">IX. Paperwork Reduction Act of 1995</HD>
                <P>This proposed rule contains information collection provisions that are subject to review by the OMB under the PRA (44 U.S.C. 3501-3521). The title, description, and respondent description of these provisions are shown in the following paragraphs with an estimate of the annual recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.</P>
                <P>FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.</P>
                <P>
                    <E T="03">Title:</E>
                     Recordkeeping of Tests for Asbestos in Talc-Containing Cosmetic Products.
                </P>
                <P>
                    <E T="03">Description of Respondents:</E>
                     The respondents to this information collection are manufacturers of a talc-containing cosmetic products marketed in the United States.
                </P>
                <P>
                    <E T="03">Description:</E>
                     The proposed rule would add 21 CFR part 730 to subchapter G to require manufacturers of a talc-containing cosmetic product to make and keep written records of testing for asbestos to verify that talc-containing cosmetic products comply with requirements of the FD&amp;C Act. Examples of these records include test data including raw data, detail of how samples of the talc-containing cosmetic product or talc used in the product were tested, the test method used, the result of the test, and if applicable, a supplier's certificate of analysis. Raw data must include microscopy images, spectra, diffraction patterns, and bench sheets. If a manufacturer relied on a supplier's certificate of analysis from a qualified talc supplier, records must include any certificate of analysis received from the supplier for testing of the talc used to make the finished product, and documentation of how a manufacturer qualified the supplier by establishing and maintaining the reliability of the supplier's certificate of analysis through verification of the results of the supplier's tests for asbestos.
                </P>
                <P>Manufacturers must provide these records upon request from FDA for inspection and copying. Upon request, manufacturers must provide to FDA within a reasonable time an English translation of records maintained in a language other than English. If requested in writing by FDA, a manufacturer must send records electronically, or through another means that delivers the records within 1 business day, rather than making the records available for review at their place of business.</P>
                <P>
                    We estimate the recordkeeping burden of this collection of information as follows:
                    <PRTPAGE P="105501"/>
                </P>
                <GPOTABLE COLS="6" OPTS="L2,nj,i1" CDEF="s100,12C,12C,12C,12C,12C">
                    <TTITLE>
                        Table 2—Estimated Annual Recordkeeping Burden 
                        <SU>1</SU>
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1">21 CFR part; activity</CHED>
                        <CHED H="1">Number of recordkeepers</CHED>
                        <CHED H="1">Number of records per recordkeeper</CHED>
                        <CHED H="1">Total annual records</CHED>
                        <CHED H="1">
                            Average 
                            <LI>burden per </LI>
                            <LI>recordkeeping </LI>
                            <LI>(hours)</LI>
                        </CHED>
                        <CHED H="1">Total hours</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">730; recordkeeping of tests for asbestos in talc-containing cosmetic products including certificate of analysis</ENT>
                        <ENT>801</ENT>
                        <ENT>17.43</ENT>
                        <ENT>13,961</ENT>
                        <ENT>18</ENT>
                        <ENT>251,298</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
                    </TNOTE>
                </GPOTABLE>
                <P>The estimates in table 2 are consistent with the analysis in table 5 of the Preliminary Regulatory Impact Analysis (Ref. 42). In table 5 of the Preliminary Regulatory Impact Analysis, FDA estimates that there are 801 manufacturers and 13,961 products adjusted for private label products. For the purpose of this analysis, we are assuming that each batch of talc or lot of talc will supply a cosmetic product for 1 year, or that each batch or lot of talc-containing cosmetic product will be 1 year's supply of cosmetic product. Each batch or lot of talc or product, as applicable, must have a record of testing for asbestos. With 13,961 products, we estimate that each batch or lot of talc or product, as applicable, will be tested annually, creating 13,961 records. With this estimation, we calculate that each of the 801 manufacturers will create and maintain 17.43 (17-18) records. We estimate that creating and maintaining such records takes about 18 hours, based on FDA's experience with retail sampling of talc-containing cosmetic products for the presence of asbestos. Thus, we calculate the total burden will be 251,298 hours (801 manufacturers × 17.43 records/manufacturer = 13,961.43, rounded to 13,961 records; 13,961 × 18 hours).</P>
                <P>
                    To ensure that comments on information collection are received, OMB recommends that comments be submitted at 
                    <E T="03">https://www.reginfo.gov/public/do/PRAMain</E>
                     (see 
                    <E T="02">ADDRESSES</E>
                    ). Find this particular information collection by selecting “Currently Under Review—Open for Public Comments” or by using the search function. The title of this proposed collection is “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products.”
                </P>
                <P>
                    In compliance with the PRA (44 U.S.C. 3407(d)), we have submitted the information collection provisions of this proposed rule to OMB for review. These information collection requirements will not be effective until FDA publishes a final rule, OMB approves the information collection requirements, and the rule goes into effect. FDA will announce OMB approval of these requirements in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <HD SOURCE="HD1">X. Federalism</HD>
                <P>We have analyzed this proposed rule in accordance with the principles set forth in E.O. 13132. We have determined that the proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the E.O. and, consequently, a federalism summary impact statement is not required.</P>
                <HD SOURCE="HD1">XI. Consultation and Coordination With Indian Tribal Governments</HD>
                <P>We have analyzed this proposed rule in accordance with the principles set forth in E.O. 13175. We have tentatively determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action.</P>
                <HD SOURCE="HD1">XII. References</HD>
                <P>
                    The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see 
                    <E T="02">ADDRESSES</E>
                    ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at 
                    <E T="03">https://www.regulations.gov.</E>
                     References without asterisks are not on public display at 
                    <E T="03">https://www.regulations.gov</E>
                     because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. Although FDA verified the website addresses in this document, please note that websites are subject to change over time.
                </P>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        1. *Robinson, G.R., Jr., B.S. Van Gosen, and N.K. Foley, “Ultramafic-hosted Talc-Magnesite deposits”. U.S. Geological Survey presentation at 42nd Forum on the Geology of Industrial Minerals, May 7-13, 2006, in Asheville, NC (USA). Available at: 
                        <E T="03">https://pubs.usgs.gov/of/2006/1229/of2006-1229.pdf</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        2. *“Where is Asbestos Found?” Agency for Toxic Substances and Disease Registry web page on Naturally Occurring Asbestos. Available at: 
                        <E T="03">https://archive.cdc.gov/www_atsdr_cdc_gov/csem/asbestos/where_is_asbestos_found.html#:~:text=Asbestos%20is%20also%20present%20in,deep%20to%20be%20disturbed%20easily</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        3. *Virta, R.L., “Asbestos: Geology, Mineralogy, Mining and Uses.”. U.S. Geological Survey Report No. 02-149, 2002. Available at: 
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                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">4. Segrave, A.M., 2021. “Overview of the Geology of Cosmetic Talc Formation and Morphology of Amphiboles”. ASTM Selected Technical Papers No. 1632, Asbestos and Other Elongate Mineral Particles. J. R. Millette and J. S. Webber. Available at: Overview of the Geology of Cosmetic Talc Formation and Morphology of Amphiboles | Asbestos and Other Elongate Mineral Particles—New and Continuing Challenges in the 21st Century | ASTM eBooks | ASME Digital Collection.</FP>
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                        5. * National Toxicology Program, 2021. “Asbestos.”. In: 
                        <E T="03">Report on Carcinogens. Fifteenth Edition.</E>
                         U.S. Department of Health and Human Services, Public Health Service, National Toxicology Program. Available at: 
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                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        6. * “Toxicological Review of Libby Amphibole Asbestos, Environmental Protection Agency (EPA) Integrated Risk Information System (IRIS) EPA/635/R-11/002F,” 2014. Available at: 
                        <E T="03">https://cfpub.epa.gov/ncea/iris/iris_documents/documents/toxreviews/1026tr.pdf</E>
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                    </FP>
                    <FP SOURCE="FP-2">
                        7. * Filetti, V, E. Vitale, G. Broggi, et al. “Update of In-Vitro, In-Vivo and Ex-Vivo Fluoro-edenite Effects on Malignant Mesothelioma: A Systematic Review (Review)”, Biomedical Reports, 13(6):60, December 2020. Available at: 
                        <E T="03">https://pmc.ncbi.nlm.nih.gov/articles/PMC7605121/.</E>
                        <PRTPAGE P="105502"/>
                    </FP>
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                        8. * “Toxicological Profile for Asbestos”, 2001. Agency for Toxic Substances and Disease Registry of the U.S. Department of Health and Human Services Centers for Disease Control. 
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                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        9. * “Arsenic, Metals, Fibres, and Dusts—Volume 100C, A Review of Human Carcinogens—Asbestos (Chrysotile, Amosite, Crocidolite, Tremolite, Actinolite, and Anthophyllite),” pp. 219-309, 2012. International Agency for Research on Cancer (IARC). Lyon, France. Available at: 
                        <E T="03">https://publications.iarc.fr/Book-And-Report-Series/Iarc-Monographs-On-The-Identification-Of-Carcinogenic-Hazards-To-Humans/Arsenic-Metals-Fibres-And-Dusts-2012</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        10. “Asbestos—Selected Cancers”, National Academies of Science and Medicine Consensus Study Report, 2006. Available at: 
                        <E T="03">https://nap.nationalacademies.org/catalog/11665/asbestos-selected-cancers</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        11. * “Asbestos—Overview” Occupational Safety and Health Administration (
                        <E T="03">https://www.osha.gov/asbestos</E>
                        ).
                    </FP>
                    <FP SOURCE="FP-2">
                        12. * “Asbestos—Hazards and Safe Practice for Clear-Up After Tsunami”. World Health Organization Regional Office of Southeast Asia. May 3, 2006. Available at: 
                        <E T="03">https://www.who.int/docs/default-source/chemical-safety/asbestos/asbestos--hazards-and-safe-practice-for-clear-up-after-tsunami.pdf</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        13. * Interagency Workgroup for Asbestos in Consumer Products (IWGACP), January 13, 2022. “Appendices to White Paper: IWGACP Scientific Opinions on Testing Methods for Asbestos in Cosmetics Products Containing Talc.” Available at: 
                        <E T="03">https://www.regulations.gov/document/FDA-2020-N-0025-0054</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        14. * Cook, P.M., and G.F. Olson. “Ingested Mineral Fibers: Elimination in Human Urine,” 
                        <E T="03">Science,</E>
                         204: 195-198, 1979.Available at: 
                        <E T="03">https://www.ncbi.nlm.nih.gov/pubmed/219478</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        15. Heller, D.S., R.E. Gordon, C. Westhoff, and S. Gerber. “Asbestos Exposure and Ovarian Fiber Burden,” 
                        <E T="03">American Journal of Industrial Medicine,</E>
                         29: 435-439, 1996. Available at: 
                        <E T="03">https://www.ncbi.nlm.nih.gov/pubmed/8732916.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        16. Suzuki, Y. and N. Kohyama. “Translocation of Inhaled Asbestos Fibers from the Lung to Other Tissues”, 
                        <E T="03">American Journal of Industrial Medicine,</E>
                         19: 701-704, 1991.Available at: 
                        <E T="03">https://www.ncbi.nlm.nih.gov/pubmed/1882849.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        17. Fitzgerald, S.M., “Comparing Historical and Recent Accelerated Concerns Regarding Asbestos in Talc,” 2021. ASTM Selected Technical Papers Series, No. 1632, Asbestos and Other Elongate Mineral Particles. J.R. Millette and J.S. Webber, ed. Available at: 
                        <E T="03">https://asmedigitalcollection.asme.org/astm-ebooks/book/2238/chapter-abstract/27896558/Comparing-Historical-and-Recent-Accelerated?redirectedFrom=fulltext.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        18. * FDA. “Talc.” Previous Activity—FDA's Talc Survey of 2009-2010. Available at: 
                        <E T="03">https://www.fda.gov/cosmetics/cosmetic-ingredients/talc#64f0201d159f9</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        19. * FDA. “FDA In Brief: FDA Releases Final Report of Talc-containing Cosmetic Products Tested for Asbestos.” Available at: 
                        <E T="03">https://www.fda.gov/news-events/fda-brief/fda-brief-fda-releases-final-report-talc-containing-cosmetic-products-tested-asbestos</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        20. * Millette, J.R. “Procedure for the Analysis of Talc for Asbestos.” 
                        <E T="03">The Microscope,</E>
                         63(1), pp. 11-20, 2015. Available at: 
                        <E T="03">https://jifsan.umd.edu/files/wordpress/wp-content/uploads/2018/11/Asbestos-2018-Millette-GeneralReference-4.pdf</E>
                         (accessed 12/11/2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        21. * Block, L.H., D. Beckers, J. Ferret, et al. “Stimuli to the Revision Process, Modernization of Asbestos Testing in USP Talc,” USP-PF 40(4), pp. 455-472, 2014. Available at: 
                        <E T="03">https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/pf-legacy-pdf/pf-2014_vol-40.pdf</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        22. * Interagency Workgroup for Asbestos in Consumer Products (IWGACP), January 13, 2022. “White Paper: IWGACP Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc.” Available at: 
                        <E T="03">https://www.regulations.gov/document/FDA-2020-N-0025-0053</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        23. * FDA. “Peer Review Report External Peer Review Comment and FDA Responses” 2024. Available at: 
                        <E T="03">https://www.fda.gov/science-research/peer-review-scientific-information-and-assessments/completed-peer-reviews.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        24. * FDA. “Public Meeting on Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc”. Available at: 
                        <E T="03">https://www.fda.gov/cosmetics/cosmetics-news-events//public-meeting-testing-methods-asbestos-/talc-and-cosmetic-products-containing-talc-02042020</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        25. Miller, E., E.M. Beckett, D. Cheatham, et al. “A Review of the Mesotheliogenic Potency of Cleavage Fragments Found in Talc,” 
                        <E T="03">Toxicology and Industrial Health,</E>
                         40(7): 398-424, 2024. Available at: 
                        <E T="03">https://journals.sagepub.com/doi/abs/10.1177/07482337241246924.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        26. * Lowers, H. and G. Meeker, 2002, “Tabulation of Asbestos Related Terminology.” Available at: 
                        <E T="03">https://pubs.usgs.gov/of/2002/ofr-02-458/OFR-02-458-508.pdf</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        27. * Campbell, W.J., R.L. Blake, L.L. Brown, et al., 1977, “Selected Silicate Minerals and Their Asbestiform Varieties,” U.S. Bureau of Mines (Department of the Interior) Information Circular 8751. #18—Selected Silicate Minerals and Their Asbestiform Varieties. Available at: 
                        <E T="03">https://babel.hathitrust.org/cgi/pt?id=mdp.39015078453563&amp;view=2up&amp;seq=1</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        28. * Van Gosen, B.S., H.A. Lowers, and S.J. Sutley, 2004. “A USGS Study of Talc Deposits and Associated Amphibole Asbestos Within Mined Deposits of the Southern Death Valley Region, California.” U.S. Geological Survey Open-File Report 2004-1092. Available at: 
                        <E T="03">https://pubs.usgs.gov/of/2004/1092/</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        29. * Baumann, F., J.-P. Ambrosi, M. Carbone. “Asbestos Is Not Just Asbestos: An Unrecognised Health Hazard.” 
                        <E T="03">The Lancet. Oncology,</E>
                         14(7): 576-578, 2013. Available at: 
                        <E T="03">https://pubmed.ncbi.nlm.nih.gov/23725699/</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        30. * National Institute for Occupational Safety and Health (NIOSH), 2011. Asbestos Fibers and Other Elongate Mineral Particles: State of the Science and Roadmap for Research. In 
                        <E T="03">Current Intelligence Bulletin 62.</E>
                         Department of Health and Human Services. Centers for Disease Control and Prevention. Publication No. 2011-159. April. Available at: 
                        <E T="03">https://www.cdc.gov/niosh/docs/2011-159/pdfs/2011-159.pdf</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">31. ISO 22262-1:2012—Air quality—Bulk materials—Part 1: Sampling and qualitative determination of asbestos in commercial bulk materials. Annex D (pp. 43-51).</FP>
                    <FP SOURCE="FP-2">32. ISO 10312:2019—Ambient air—Determination of asbestos fibres—Direct transfer transmission electron microscopy method. Annex C (pp. 34-36).</FP>
                    <FP SOURCE="FP-2">
                        33. * International Mineralogical Association. Amphibole Supergroup: Mineral information, data and localities. Available at: 
                        <E T="03">https://www.mindat.org/min-207.html</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        34. * CIR Expert Panel Meeting March 18-19, 2013, See Safety Assessment of Talc as Used in Cosmetics, CTFA Method J4-1 (1976) “Asbestiform Amphibole Minerals in Cosmetic Talc,” pp. 66-82. Available at: 
                        <E T="03">https://www.cir-safety.org/sites/default/files/032013_web_w2.pdf</E>
                        ) (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        35. * USP-NF Compendial Notices, Intent to Revise Talc USP Monograph Asbestos Test Method, July 31, 2020; updated December 18, 2020. Available at: 
                        <E T="03">https://www.uspnf.com/notices/talc-nitr-20200731</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">36. ISO/IEC Guide 2:2004 “Standardization and related activities—General vocabulary.” ISO/IEC. November 2004.</FP>
                    <FP SOURCE="FP-2">
                        37. * Rosner, D, G. Markowitz, and M. Chowkwanyun, July 2019. “Nondetected: The Politics of Measurement of Asbestos in Talc, 1971-1976,” 
                        <E T="03">American Journal of Public Health</E>
                         Available at: 
                        <E T="03">https://pmc.ncbi.nlm.nih.gov/articles/PMC6603445/</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        38. USP-NF “Talc.” Absence of Asbestos Test Method, Official May 1, 2022.
                        <PRTPAGE P="105503"/>
                    </FP>
                    <FP SOURCE="FP-2">
                        39. * USP-NF Compendial Notices, “Talc, &lt;901&gt; Detection of Asbestos in Pharmaceutical Talc, &lt;1901&gt; Theory and Practice of Asbestos Detection in Pharmaceutical Talc,” May 2023. Available at: 
                        <E T="03">https://www.uspnf.com/notices/talc-official-dates-20230601</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        40. * USP-NF Compendial Notices, “General Chapter Prospectus: &lt;901&gt; Detection of Asbestos in Pharmaceutical Talc,” posted April 2021; updated August 2021. USP-NF. Available at: 
                        <E T="03">https://www.uspnf.com/notices/gc-901-prospectus-20210430</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        41. * USP-NF Compendial Notices, “General Chapter Prospectus: &lt;1901&gt; Theory and Practice of Asbestos Detection in Pharmaceutical Talc,” posted April 2021; updated August 2021. USP-NF. Available at: 
                        <E T="03">https://www.uspnf.com/notices/gc-1901-prospectus-20210430</E>
                         (accessed December 11, 2024).
                    </FP>
                    <FP SOURCE="FP-2">
                        42. * FDA. Preliminary Regulatory Impact Analysis; Initial Regulatory Flexibility Analysis; Unfunded Mandates Reform Act Analysis; Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Proposed Rule. Available at: 
                        <E T="03">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.</E>
                    </FP>
                </EXTRACT>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 21 CFR Part 730</HD>
                    <P>Cosmetics, Incorporation by reference, Recording and recordkeeping requirements, Testing.</P>
                </LSTSUB>
                <P>Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs, FDA proposes to amend chapter I of title 21 of the Code of Federal Regulations by adding part 730 to subchapter G to read as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 730—REQUIREMENTS FOR TALC-CONTAINING COSMETIC PRODUCTS</HD>
                    <CONTENTS>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart A—Testing Methods</HD>
                            <SECHD>Sec.</SECHD>
                            <SECTNO>730.1-730.2</SECTNO>
                            <SUBJECT>[Reserved]</SUBJECT>
                            <SECTNO>730.3</SECTNO>
                            <SUBJECT>Testing methods for detecting and identifying asbestos in talc-containing cosmetic products.</SUBJECT>
                            <SECTNO>730.4-730.100</SECTNO>
                            <SUBJECT>[Reserved]</SUBJECT>
                            <SECTNO>Subparts B through K</SECTNO>
                            <SUBJECT>[Reserved]</SUBJECT>
                        </SUBPART>
                    </CONTENTS>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P> 21 U.S.C. 321, 331, 352, 355, 361, 362, 371, 374; sec. 3505, Pub. L. 117-328, 136 Stat. 4459.</P>
                    </AUTH>
                    <SUBPART>
                        <HD SOURCE="HED">Subpart A—Testing Methods</HD>
                        <SECTION>
                            <SECTNO>§§ 730.1-730.2</SECTNO>
                            <SUBJECT>[Reserved]</SUBJECT>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§ 730.3</SECTNO>
                            <SUBJECT>Testing methods for detecting and identifying asbestos in talc-containing cosmetic products.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">Who is subject to this section?</E>
                                 You are subject to this section if you manufacture a talc-containing cosmetic product.
                            </P>
                            <P>
                                (b) 
                                <E T="03">What definitions apply to this section?</E>
                                 For purposes of this section:
                            </P>
                            <P>
                                (1) 
                                <E T="03">Asbestos</E>
                                 means amosite, chrysotile, crocidolite; asbestiform tremolite, actinolite, anthophyllite, winchite, and richterite; and other asbestiform amphibole minerals.
                            </P>
                            <P>
                                (2) 
                                <E T="03">Representative sample</E>
                                 means a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled.
                            </P>
                            <P>
                                (c) 
                                <E T="03">What test methods must you use?</E>
                                 (1) You must use an analytical approach that includes both Polarized Light Microscopy (PLM) (with dispersion staining), and Transmission Electron Microscopy (TEM)/Energy Dispersive Spectroscopy (EDS)/Selected Area Electron Diffraction (SAED). You must conduct the tests on either a representative sample of each batch or lot of the talc-containing cosmetic product or on a representative sample of each batch or lot of the talc ingredient that will be incorporated into the talc-containing cosmetic product.
                            </P>
                            <P>
                                (i) 
                                <E T="03">Use of PLM method.</E>
                                 Detecting and identifying asbestos must be based on comparison of optical crystallographic properties (
                                <E T="03">i.e.,</E>
                                 color and pleochroism, refractive indices, birefringence, extinction characteristics and sign of elongation) and particle morphology with data for and images of asbestos in Annex D of ISO 22262-1:2012(E). Images of asbestos from ISO 22262-1:2012(E) (Annex D) for PLM analysis of asbestos must be used as visual aids to assist the analyst.
                            </P>
                            <P>
                                (ii) 
                                <E T="03">Use of TEM/EDS/SAED method.</E>
                                 You must examine an area containing at least 0.1 micrograms of talc on a TEM grid on which the sample is uniformly distributed. Detecting and identifying asbestos must be based on comparison of elemental composition, crystal structure of particles, and particle morphology with data for and images of asbestos in Figure C.1 in Annex C of ISO 10312:2019(E). Images of asbestos from ISO 10312:2019(E) (Figure C.1 in Annex C) must be used as visual aids to assist the analyst.
                            </P>
                            <P>(2) [Reserved]</P>
                            <P>
                                (d) 
                                <E T="03">How does one determine if a sample has tested positive for asbestos?</E>
                                 If asbestos is detected based on use of PLM or based on the use of TEM/EDS/SAED as required in paragraph (c) of this section, the sample must be regarded as positive for asbestos and therefore asbestos must be regarded as present in the material represented by that sample.
                            </P>
                            <P>
                                (e) 
                                <E T="03">Is there an alternative to performing finished product testing for detecting and identifying asbestos in your talc-containing cosmetic product?</E>
                                 If you manufacture a talc-containing cosmetic product and do not perform testing for detecting and identifying asbestos in your talc-containing cosmetic product before you release the product, all the talc in your product must have been tested in accordance with paragraph (c) of this section prior to using the talc in the manufacture of a talc-containing cosmetic product. You may rely on a certificate of analysis from the supplier of the talc ingredient if you qualify the supplier by establishing and maintaining the reliability of the supplier's certificate of analysis through verification of the results of the supplier's tests for asbestos in accordance with paragraph (f) of this section. The certificate of analysis must at minimum state that:
                            </P>
                            <P>(1) The supplier uses an analytical approach that includes both PLM and TEM/EDS/SAED as described in paragraph (c) of this section; and</P>
                            <P>(2) The certificate of analysis is specific to the talc purchased by the manufacturer, including identification of a lot or batch number for the talc being tested, the date or date range when the test(s) were performed, and the results of each test.</P>
                            <P>
                                (f) 
                                <E T="03">How frequently must tests be performed?</E>
                                 At a minimum, you must test a representative sample of each batch or lot of each talc-containing cosmetic product or talc ingredient for asbestos in accordance with paragraph (c) of this section. If you rely on the supplier's certificate of analysis in accordance with paragraph (e) of this section, you must at least upon receipt of the supplier's initial certificate of analysis and subsequently annually thereafter verify the reliability of the reported asbestos test results based on testing by you or another laboratory as required in paragraph (c).
                            </P>
                            <P>
                                (g) 
                                <E T="03">What records must be kept?</E>
                                 You must keep records of testing for asbestos that show test data, including raw data. The record must describe in detail how samples of the product or talc used in your product were tested, the test method used, and the result of the test. Raw data must include microscopy images, spectra, diffraction patterns and bench sheets. If you rely on a supplier's certificate of analysis, records must include any certificate of analysis received from the supplier for testing of the talc used to make the finished product, and documentation of how you qualified the supplier by establishing and maintaining the reliability of the supplier's certificate of analysis through verification of the results of the supplier's tests for asbestos in 
                                <PRTPAGE P="105504"/>
                                accordance with paragraph (f) of this section. You must keep such records for, at a minimum, 3 years after the date such record was created. You must make all records required under this subpart available within 1 business day to an authorized FDA representative, upon request, for inspection and copying. Upon FDA request, you must provide within a reasonable time an English translation of records maintained in a language other than English.
                            </P>
                            <P>(1) Records must be kept as original records, as true copies (such as photocopies or other accurate reproductions of the original records), or as electronic records.</P>
                            <P>(2) Electronic records must comply with part 11 of this chapter.</P>
                            <P>(3) Documents and records must be retrieved as originals or true copies, and available for copying by FDA, including by computer or other electronic means, using equipment readily accessible to FDA during an inspection. If requested in writing by FDA, you must send records electronically, or through another means that delivers the records within 1 business day, rather than making the records available for review at your place of business.</P>
                            <P>
                                (h) 
                                <E T="03">What consequences result from failing to test talc ingredients or talc-containing product for asbestos or failing to rely on and verify a certificate of analysis from the talc ingredient supplier</E>
                                ? Failure of a manufacturer to test a talc ingredient or a talc-containing product in compliance with paragraph (c) of this section renders the product adulterated under section 601(c) of the Federal Food, Drug, and Cosmetic Act.
                            </P>
                            <P>
                                (i) 
                                <E T="03">What consequences result from failing to comply with the recordkeeping requirements?</E>
                                 Failure of a manufacturer to operate in compliance with the requirements of paragraph (g) of this section renders the cosmetic product adulterated under section 601(c) of the Federal Food, Drug, and Cosmetic Act.
                            </P>
                            <P>
                                (j) 
                                <E T="03">What consequences result from the presence of asbestos in a talc-containing cosmetic product, or in talc used in that cosmetic product, or from the presence of asbestos in talc intended for use in cosmetics?</E>
                                 If asbestos is present in a talc-containing cosmetic product or in talc used in that cosmetic product, that cosmetic product is adulterated under section 601(a) of the Federal Food, Drug, and Cosmetic Act. If asbestos is present in talc intended for use in a cosmetic, that talc is adulterated under section 601(a) of the Federal Food, Drug, and Cosmetic Act.
                            </P>
                            <P>
                                (k) 
                                <E T="03">Incorporation by reference.</E>
                                 Material listed in this paragraph (k) is incorporated by reference into this section with approval of the Director of the 
                                <E T="04">Federal Register</E>
                                 under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at the Food and Drug Administration and at the National Archives and Records Administration (NARA). Contact the Food and Drug Administration between 9 a.m. and 4 p.m. Monday through Friday at: Dockets Management Staff, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852; phone: 240-402-7500; email: 
                                <E T="03">DMSInbox@fda.hhs.gov.</E>
                                 For information on the availability of this material at NARA, visit 
                                <E T="03">www.archives.gov/federal-register/cfr/ibr-locations</E>
                                 or email 
                                <E T="03">fr.inspection@nara.gov.</E>
                                 The material may be obtained from The International Organization for Standardization (ISO), BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva, Switzerland; phone: +41-22-749-01-11; email: 
                                <E T="03">customerservice@iso.org;</E>
                                 website: 
                                <E T="03">https://www.iso.org/store.html.</E>
                            </P>
                            <P>(1) ISO 22262-1:2012(E), “Air quality—Bulk materials—Part 1: Sampling and qualitative determination of asbestos in commercial bulk materials,” Annex D, Asbestos identification by PLM and dispersion staining in commercial materials, First edition, July 1, 2012.</P>
                            <P>(2) ISO 10312:2019(E), “Ambient air—Determination of asbestos fibres—Direct transfer transmission electron microscopy method,” Annex C, Structure counting criteria, Figure C.1, Second edition, October 10, 2019.</P>
                        </SECTION>
                        <SECTION>
                            <SECTNO>§§ 730.4-730.100</SECTNO>
                            <SUBJECT>[Reserved]</SUBJECT>
                        </SECTION>
                    </SUBPART>
                    <SUBPART>
                        <HD SOURCE="HED">Subparts B Through K [Reserved]</HD>
                    </SUBPART>
                    <SIG>
                        <DATED>Dated: December 17, 2024.</DATED>
                        <NAME>Robert M. Califf,</NAME>
                        <TITLE>Commissioner of Food and Drugs.</TITLE>
                    </SIG>
                </PART>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30544 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4164-01-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Employment and Training Administration</SUBAGY>
                <CFR>29 CFR Parts 29 and 30</CFR>
                <DEPDOC>[Docket No. ETA-2023-0004]</DEPDOC>
                <RIN>RIN 1205-AC13</RIN>
                <SUBJECT>National Apprenticeship System Enhancements; Withdrawal</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Employment and Training Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Withdrawal of proposed rule and termination of rulemaking proceeding.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Labor (the Department) is withdrawing its notice of proposed rulemaking (NPRM or proposed rule), which proposed to revise the Federal regulations implementing the National Apprenticeship Act of 1937 (NAA).</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The Department is withdrawing the proposed rule published on January 17, 2024 (89 FR 3118), as of December 27, 2024.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The docket is available at 
                        <E T="03">https://www.regulations.gov</E>
                        —Docket No. ETA-2023-0004.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Michelle Paczynski, Administrator, Office of Policy Development and Research, U.S. Department of Labor, Employment and Training Administration, 200 Constitution Avenue NW, Room N-5641, Washington, DC 20210, Telephone: 202-693-3700 (voice) (this is not a toll-free number). For persons with a hearing or speech disability who need assistance to use the telephone system, please dial 711 to access telecommunications relay services.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    The NAA (29 U.S.C. 50) authorizes the Secretary of the Department of Labor (the Secretary) to “formulate and promote the furtherance of labor standards necessary to safeguard the welfare of apprentices, to extend the application of such standards by encouraging the inclusion thereof in contracts of apprenticeship, to bring together employers and labor for the formulation of programs of apprenticeship, [and] to cooperate with State agencies engaged in the formulation and promotion of standards of apprenticeship.” Under this authority, the Department established the registered apprenticeship program. The Department set forth labor standards designed to facilitate these statutory directives through its implementing regulations at 29 CFR part 29. Those regulations prescribe minimum quality and content requirements with respect to a program's standards of apprenticeship and its apprenticeship agreements; establish procedures concerning the registration, cancellation, and deregistration of apprenticeship programs; and set forth a mechanism for the recognition of State Apprenticeship Agencies (SAAs) as Registration Agencies authorized to register and 
                    <PRTPAGE P="105505"/>
                    oversee registered apprenticeship programs in a State. A companion regulation, at 29 CFR part 30, also implements the NAA by setting forth minimum Equal Employment Opportunity in Apprenticeship requirements that registered apprenticeship programs must follow to obtain and maintain registration status.
                </P>
                <HD SOURCE="HD1">Summary of the Notice of Proposed Rulemaking</HD>
                <P>
                    On January 17, 2024, the Department published an NPRM titled “National Apprenticeship System Enhancements” in the 
                    <E T="04">Federal Register</E>
                     (89 FR 3118) proposing to revise the regulations for registered apprenticeship at 29 CFR parts 29 and 30 by enhancing worker protections and equity, improving the quality of registered apprenticeship programs, revising the State governance provisions, and more clearly establishing critical pipelines to registered apprenticeship programs, such as by creating registered career and technical education (CTE) apprenticeships. The NPRM invited written comments from the public concerning the proposed rulemaking through March 18, 2024.
                </P>
                <HD SOURCE="HD1">Summary of Comments</HD>
                <P>The Department received comment submissions from 2,115 commenters, which included 9 form letters that accounted for 1,760 comments, and 333 unique comments (substantive and non-substantive). Additionally, 22 comments were duplicates or not related to the subject of this rulemaking. The commenters represented a range of stakeholders from the public, non-profit, and private sectors, and individuals, including current and former apprentices. Among other things, commenters focused on three primary areas: (1) the scope and nature of the proposed program quality enhancements and worker protections, and the impact and burdens on program sponsors and employers in making those enhancements, (2) proposed changes to the governance structure of SAAs, and (3) the proposal to create a new model of registered CTE apprenticeship.</P>
                <HD SOURCE="HD1">Rationale for Withdrawal</HD>
                <P>The Department has considered the detailed feedback, analysis, proposed alternatives, and dialogue generated by the publication of the NPRM. The Department broadly notes that the breadth and diversity of stakeholders commenting, as well as the unique perspectives provided, is a testament to the strength and growth of the registered apprenticeship model overall as a solution to America's workforce needs across a wide range of industries. The Department believes that the dialogue spurred by the NPRM demonstrates a need for a robust and modernized approach to registered apprenticeship with more clearly defined roles and responsibilities, more points of entry, and improved accessibility for employers to join or register programs and for job seekers to become apprentices in those programs.</P>
                <P>Through this rulemaking, the Department sought to strengthen the National Apprenticeship System and balance the needs of all apprenticeship stakeholders. The Department engaged in stakeholder outreach prior to the development of the proposed rule. The Department believes that commenters have raised some ideas and concepts—particularly regarding the impact and value of the proposed quality enhancements, proposed SAA governance provisions, and the registered CTE apprenticeship proposal—that would benefit from more outreach and dialogue with interested parties and the regulated community before it develops a new regulatory proposal updating the governing regulations for the National Apprenticeship System and registered apprenticeship programs. Therefore, the Department is withdrawing the proposed rule.</P>
                <HD SOURCE="HD1">Conclusion</HD>
                <P>
                    By withdrawing the proposed rule, the Department is eliminating the pending nature of this rulemaking. The Department intends to engage with all interested parties to discuss and consider future enhancements and impacts for the quality and expansion of registered apprenticeship and the roles and responsibilities of stakeholders in the National Apprenticeship System. If the Department decides to revise parts 29 and 30 at a later date, it will issue a new NPRM in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <P>
                    Accordingly, the NPRM published in the 
                    <E T="04">Federal Register</E>
                     on January 17, 2024, at 89 FR 3118 is withdrawn.
                </P>
                <SIG>
                    <NAME>José Javier Rodríguez,</NAME>
                    <TITLE>Assistant Secretary for Employment and Training, Labor.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31078 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-FR-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF EDUCATION</AGENCY>
                <CFR>34 CFR Part 300</CFR>
                <DEPDOC>[Docket ID ED-2022-OSERS-0052]</DEPDOC>
                <RIN>RIN 1820-AB82</RIN>
                <SUBJECT>Assistance to States for the Education of Children With Disabilities; Withdrawal</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Special Education and Rehabilitative Services, Department of Education.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Withdrawal of notice of proposed rulemaking.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Secretary is withdrawing a notice of proposed rulemaking, which proposed to amend regulations under Part B of the Individuals with Disabilities Education Act (Part B of IDEA or the Act) that govern the Assistance to States for the Education of Children with Disabilities program, including the Preschool Grants program. Specifically, the Secretary proposed to amend the IDEA Part B regulations to remove the requirement for public agencies to obtain parental consent prior to accessing for the first time a child's or parent's public benefits or insurance to provide or pay for required IDEA Part B services.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        The notice of proposed rulemaking published in the 
                        <E T="04">Federal Register</E>
                         at 88 FR 31659 on May 18, 2023, is withdrawn as of December 23, 2024.
                    </P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Rebecca Walawender, U.S. Department of Education, 400 Maryland Ave. SW, Room 5130, Potomac Center Plaza, Washington, DC 20202. Telephone: (202) 245-7399. Email: 
                        <E T="03">Rebecca.Walawender@ed.gov.</E>
                    </P>
                    <P>If you are deaf, hard of hearing, or have a speech disability and wish to access telecommunications relay services, please dial 7-1-1.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background </HD>
                <P>
                    On May 18, 2023, the Department published in the 
                    <E T="04">Federal Register</E>
                     a notice of proposed rulemaking (NPRM) proposing to amend the IDEA regulations at 34 CFR 300.154(d)(2)(iv), which requires a Local Educational Agency to obtain informed written parental consent before it accesses the child's or parent's public benefits or insurance (
                    <E T="03">e.g.,</E>
                     Medicaid, Children's Health Insurance Program) for the first time for the provision of Medicaid-reimbursable services identified on a child's individualized education program (IEP). 88 FR 31659. This consent provision was initially added to 
                    <PRTPAGE P="105506"/>
                    the 2006 final Part B regulations implementing the 2004 reauthorization of IDEA and was further revised in 2013. A correction to the docket ID for the May 18, 2023, NPRM was published on May 26, 2023. 88 FR 34100.
                </P>
                <P>The comment period closed on August 1, 2023. The Department received over 9,700 public comments in response to the NPRM. There were two large write-in campaigns, including one from a national parents' rights organization, totaling more than 8,000 comments opposing the proposed change. Of the remaining 1,700 comments, in general, half (including major national membership organizations representing educators and service providers) were in support, and the other half (including major disability rights organizations and parent organizations) were in opposition.</P>
                <HD SOURCE="HD1">Withdrawal of the Notice of Proposed Rulemaking</HD>
                <P>After publication of the NPRM, the Department carefully considered the comments received. A number of commenters raised concerns about instances where students with disabilities were denied reimbursement for and access to Medicaid services provided outside of school as a result of the student's school accessing the student's public benefits for services provided in school. In light of these comments, the Department decided to focus our time and attention on providing technical assistance and working with Federal agencies, States and other partners to improve implementation of school-based Medicaid rather than engage in further rulemaking.</P>
                <P>As part of our technical assistance efforts, the Department engaged with stakeholders to better understand the existing implementation challenges for school-based Medicaid, and we also worked closely with the Centers for Medicare and Medicaid Services within the U.S. Department of Health and Human Services to address the barriers related to accessing Medicaid for services outside of school. However, at this time, and with the limited time and resources remaining during this administration, the Department has not been able to fully analyze and develop responsive ways to address the State and local policies and practices that may be contributing to barriers in accessing Medicaid reimbursement for services provided outside of school.</P>
                <P>
                    For the above-stated independent reasons, the Department is withdrawing the NPRM published in the 
                    <E T="04">Federal Register</E>
                     at 88 FR 31659 on May 18, 2023. Withdrawal of this NPRM does not preclude the Department from issuing rulemaking on this subject in the future or commit the Department to any future course of action.
                </P>
                <P>
                    <E T="03">Accessible Format:</E>
                     On request to the program contact person listed under 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    , individuals with disabilities can obtain this document in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3 file, braille, large print, audiotape, compact disc, or other accessible format.
                </P>
                <P>
                    <E T="03">Electronic Access to This Document:</E>
                     The official version of this document is the document published in the 
                    <E T="04">Federal Register</E>
                    . You may access the official edition of the 
                    <E T="04">Federal Register</E>
                     and the Code of Federal Regulations at 
                    <E T="03">www.govinfo.gov.</E>
                     At this site you can view this document, as well as all other Department documents published in the 
                    <E T="04">Federal Register</E>
                    , in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.
                </P>
                <P>
                    You may also access Department documents published in the 
                    <E T="04">Federal Register</E>
                     by using the article search feature at 
                    <E T="03">www.federalregister.gov.</E>
                     Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.
                </P>
                <SIG>
                    <NAME>Miguel Cardona,</NAME>
                    <TITLE>Secretary of Education.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31187 Filed 12-23-24; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 4000-01-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 52</CFR>
                <DEPDOC>[EPA-R04-OAR-2021-0930; FRL-10403-01-R4]</DEPDOC>
                <SUBJECT>Air Plan Approval; Florida; Second Planning Period Regional Haze Plan</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Environmental Protection Agency (EPA) is proposing to approve regional haze state implementation plan (SIP) revisions submitted by the Florida Department of Environmental Protection (FDEP) on October 8, 2021, and supplemented on June 14, 2024, and October 28, 2024, as satisfying applicable requirements under the Clean Air Act (CAA or Act) and EPA's Regional Haze Rule (RHR) for the program's second planning period. Florida's SIP submissions for the second planning period address the requirement that states must periodically revise their long-term strategies (LTSs) for making reasonable progress toward the national goal of preventing any future, and remedying any existing, anthropogenic impairment of visibility, including regional haze, in mandatory Class I Federal areas. These SIP submissions also address other applicable requirements for the second planning period of the regional haze program. EPA is taking this action pursuant to sections 110 and 169A of the Act.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Written comments must be received on or before January 27, 2025.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit your comments, identified by Docket ID No. EPA-R04-OAR-2021-0930, at 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from 
                        <E T="03">Regulations.gov</E>
                        . EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (
                        <E T="03">i.e.,</E>
                         on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit 
                        <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Pearlene Williams-Miles, Multi-Air Pollutant Coordination Section, Air Planning and Implementation Branch, Air and Radiation Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. Ms. Williams-Miles can be reached via telephone at (404) 562-9144 or electronic mail at 
                        <E T="03">williamsmiles.pearlene@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. What action is EPA proposing?</FP>
                    <FP SOURCE="FP-2">II. Background and Requirements for Regional Haze Plans</FP>
                    <FP SOURCE="FP1-2">A. Regional Haze Background</FP>
                    <FP SOURCE="FP1-2">
                        B. Roles of Agencies in Addressing Regional Haze
                        <PRTPAGE P="105507"/>
                    </FP>
                    <FP SOURCE="FP-2">III. Requirements for Regional Haze Plans for the Second Planning Period</FP>
                    <FP SOURCE="FP1-2">A. Identification of Class I Areas</FP>
                    <FP SOURCE="FP1-2">B. Calculations of Baseline, Current, and Natural Visibility Conditions; Progress to Date; and the Uniform Rate of Progress (URP)</FP>
                    <FP SOURCE="FP1-2">C. Long-Term Strategy (LTS) for Regional Haze</FP>
                    <FP SOURCE="FP1-2">D. Reasonable Progress Goals (RPGs)</FP>
                    <FP SOURCE="FP1-2">E. Monitoring Strategy and Other State Implementation Plan Requirements</FP>
                    <FP SOURCE="FP1-2">F. Requirements for Periodic Reports Describing Progress Toward the RPGs</FP>
                    <FP SOURCE="FP1-2">G. Requirements for State and Federal Land Manager (FLM) Coordination</FP>
                    <FP SOURCE="FP-2">IV. EPA's Evaluation of Florida's Regional Haze Submissions for the Second Planning Period</FP>
                    <FP SOURCE="FP1-2">A. Identification of Class I Areas</FP>
                    <FP SOURCE="FP1-2">B. Calculations of Baseline, Current, and Natural Visibility Conditions; Progress to Date; and the URP</FP>
                    <FP SOURCE="FP1-2">C. LTS for Regional Haze</FP>
                    <FP SOURCE="FP1-2">D. RPGs</FP>
                    <FP SOURCE="FP1-2">E. Monitoring Strategy and Other Regional Haze Plan Requirements</FP>
                    <FP SOURCE="FP1-2">F. Requirements for Periodic Reports Describing Progress Toward the RPGs</FP>
                    <FP SOURCE="FP1-2">G. Requirements for State and FLM Coordination</FP>
                    <FP SOURCE="FP-2">V. Incorporation by Reference</FP>
                    <FP SOURCE="FP-2">VI. Proposed Action</FP>
                    <FP SOURCE="FP-2">VII. Statutory and Executive Order Reviews</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. What action is EPA proposing?</HD>
                <P>
                    On October 8, 2021, and supplemented on June 14, 2024, and October 28, 2024, FDEP submitted revisions to its SIP to address regional haze for the second planning period. FDEP made these SIP submissions to satisfy the requirements of the CAA's regional haze program pursuant to CAA sections 169A and 169B and 40 CFR 51.308.
                    <SU>1</SU>
                    <FTREF/>
                     EPA is proposing to find that the Florida regional haze SIP submissions for the second planning period (“Haze Plan”) meet the applicable statutory and regulatory requirements, and thus, EPA also proposes to approve Florida's submissions.
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         The 2021 Plan includes a request to remove source-specific and Best Available Retrofit Technology (BART) limits and conditions from the Florida SIP, which Florida provided to address BART and source-specific reasonable progress requirements during the first planning period. On June 14, 2024, FDEP withdrew this request. Thus, EPA will not act on this portion of Florida's 2021 Plan. FDEP's request to withdraw the portion of the 2021 plan that requests the removal of the first period planning period source specific and BART limits may be found the Materials to be Removed section of the 2024 Supplement.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         “Haze Plan” collectively refers to the October 8, 2021, June 14, 2024, and October 28, 2024, SIP submissions. The phrase “2021 Plan” refers to the October 8, 2021, SIP submission; “2024 Supplement” refers to the June 14, 2024, SIP submission which supplements the 2021 Plan; and “Second 2024 Supplement” refers to the October 28, 2024, SIP submission which also supplements the 2021 Plan. Each submission contains an administrative file which provides the specific permit conditions FDEP requests for incorporation into the Florida SIP under the Materials to be Incorporated into the SIP section.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Background and Requirements for Regional Haze Plans</HD>
                <HD SOURCE="HD2">A. Regional Haze Background</HD>
                <P>
                    In the 1977 CAA Amendments, Congress created a program for protecting visibility in the nation's mandatory Class I Federal areas, which include certain national parks and wilderness areas.
                    <SU>3</SU>
                    <FTREF/>
                      
                    <E T="03">See</E>
                     CAA 169A. The CAA establishes as a national goal the “prevention of any future, and the remedying of any existing, impairment of visibility in mandatory class I Federal areas which impairment results from manmade air pollution.” 
                    <E T="03">See</E>
                     CAA 169A(a)(1). The CAA further directs EPA to promulgate regulations to assure reasonable progress toward meeting this national goal. 
                    <E T="03">See</E>
                     CAA 169A(a)(4). On December 2, 1980, EPA promulgated regulations to address visibility impairment in mandatory Class I Federal areas (hereinafter referred to as “Class I areas”) that is “reasonably attributable” to a single source or small group of sources. (45 FR 80084, December 2, 1980) These regulations, codified at 40 CFR 51.300 through 51.307, represented the first phase of EPA's efforts to address visibility impairment. In 1990, Congress added section 169B to the CAA to further address visibility impairment, specifically, impairment from regional haze. 
                    <E T="03">See</E>
                     CAA 169B. EPA promulgated the RHR, codified at 40 CFR 51.308,
                    <SU>4</SU>
                    <FTREF/>
                     on July 1, 1999. 
                    <E T="03">See</E>
                     64 FR 35714, July 1, 1999. These regional haze regulations are a central component of EPA's comprehensive visibility protection program for Class I areas.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Areas statutorily designated as mandatory Class I Federal areas consist of national parks exceeding 6,000 acres, wilderness areas and national memorial parks exceeding 5,000 acres, and all international parks that were in existence on August 7, 1977. 
                        <E T="03">See</E>
                         CAA 162(a). There are 156 mandatory Class I areas. The list of areas to which the requirements of the visibility protection program apply is in 40 CFR part 81, subpart D.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         In addition to the generally applicable regional haze provisions at 40 CFR 51.308, EPA also promulgated regulations specific to addressing regional haze visibility impairment in Class I areas on the Colorado Plateau at 40 CFR 51.309. The latter regulations are applicable only for specific jurisdictions' regional haze plans submitted no later than December 17, 2007, and thus are not relevant here.
                    </P>
                </FTNT>
                <P>
                    Regional haze is visibility impairment that is produced by a multitude of anthropogenic sources and activities which are located across a broad geographic area and that emit pollutants that impair visibility. Visibility impairing pollutants include fine and coarse particulate matter (PM) (
                    <E T="03">e.g.,</E>
                     sulfates, nitrates, organic carbon, elemental carbon, and soil dust) and their precursors (
                    <E T="03">e.g.,</E>
                     sulfur dioxide (SO
                    <E T="52">2</E>
                    ), nitrogen oxides (NO
                    <E T="52">X</E>
                    ), and, in some cases, volatile organic compounds (VOC) and ammonia (NH
                    <E T="52">3</E>
                    )). Precursor pollutants react in the atmosphere to form fine particulate matter (particles less than or equal to 2.5 micrometers (µm) in diameter, PM
                    <E T="52">2.5</E>
                    ), which impairs visibility by scattering and absorbing light. Visibility impairment reduces the perception of clarity and color, as well as visible distance.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         There are several ways to measure the amount of visibility impairment, 
                        <E T="03">i.e.,</E>
                         haze. One such measurement is the deciview, which is the principal metric defined and used by the RHR. Under many circumstances, a change in one deciview will be perceived by the human eye to be the same on both clear and hazy days. The deciview is unitless. It is proportional to the logarithm of the atmospheric extinction of light, which is the perceived dimming of light due to its being scattered and absorbed as it passes through the atmosphere. Atmospheric light extinction (bext) is a metric used for expressing visibility and is measured in inverse megameters (Mm
                        <E T="51">−1</E>
                        ). EPA's “Guidance on Regional Haze State Implementation Plans for the Second Implementation Period” (“2019 Guidance”) offers the flexibility for the use of light extinction in certain cases. Light extinction can be simpler to use in calculations than deciviews since it is not a logarithmic function. 
                        <E T="03">See, e.g.,</E>
                         2019 Guidance at 16, 19, 
                        <E T="03">https://www.epa.gov/visibility/guidance-regional-haze-state-implementation-plans-second-implementation-period,</E>
                         EPA Office of Air Quality Planning and Standards, Research Triangle Park (August 20, 2019). The formula for the deciview is 10 ln (bext)/10 Mm
                        <E T="51">−1</E>
                        ). 
                        <E T="03">See</E>
                         40 CFR 51.301.
                    </P>
                </FTNT>
                <P>
                    To address regional haze visibility impairment, the 1999 RHR established an iterative planning process that requires both states in which Class I areas are located and states “the emissions from which may reasonably be anticipated to cause or contribute to any impairment of visibility” in a Class I area to periodically submit SIP revisions to address such impairment. 
                    <E T="03">See</E>
                     CAA 169A(b)(2); 
                    <SU>6</SU>
                    <FTREF/>
                      
                    <E T="03">see also</E>
                     40 CFR 51.308(b), (f) (establishing submission dates for iterative regional haze SIP revisions); 64 FR 35768, July 1, 1999. Under the CAA, each SIP submission must contain “a long-term (ten to fifteen years) strategy for making reasonable progress toward meeting the national goal,” CAA 169A(b)(2)(B); the initial round of SIP submissions also had to address the statutory requirement that certain older, larger sources of visibility impairing pollutants install and operate BART. CAA 169A(b)(2)(A); 40 CFR 51.308(d), (e). States' first regional haze SIPs were due by December 17, 2007, 40 
                    <PRTPAGE P="105508"/>
                    CFR 51.308(b), with subsequent SIP submissions containing updated LTS originally due July 31, 2018, and every ten years thereafter. 
                    <E T="03">See</E>
                     64 FR 35768, July 1, 1999. EPA established in the 1999 RHR that all states either have Class I areas within their borders or “contain sources whose emissions are reasonably anticipated to contribute to regional haze in a Class I area”; therefore, all states must submit regional haze SIPs.
                    <SU>7</SU>
                    <FTREF/>
                      
                    <E T="03">Id.</E>
                     at 35721.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         The RHR expresses the statutory requirement for states to submit plans addressing out-of-state Class I areas by providing that states must address visibility impairment “in each mandatory Class I Federal area located outside the State that may be affected by emissions from within the State.” 
                        <E T="03">See</E>
                         40 CFR 51.308(d), (f).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         In addition to each of the 50 states, EPA also concluded that the Virgin Islands and District of Columbia must also submit regional haze SIPs because they either contain a Class I area or contain sources whose emissions are reasonably anticipated to contribute regional haze in a Class I area. 
                        <E T="03">See</E>
                         40 CFR 51.300(b), (d)(3).
                    </P>
                </FTNT>
                <P>
                    Much of the focus in the first planning period of the regional haze program, which ran from 2007 through 2018, was on satisfying states' BART obligations. First planning period SIPs were additionally required to contain LTSs for making reasonable progress toward the national visibility goal, of which BART is one component. The core required elements for the first planning period SIPs (other than BART) are laid out in 40 CFR 51.308(d). Those provisions require that states containing Class I areas establish RPGs that are measured in deciviews and reflect the anticipated visibility conditions at the end of the period including from implementation of states' LTSs. The first planning period RPGs were required to provide for an improvement in visibility for the most impaired days over the period of the implementation plan and ensure no degradation in visibility for the least impaired days over the same period. In establishing the RPGs for any Class I area in a state, the state was required to consider four statutory factors (also referenced herein as “the four factors”): the costs of compliance, the time necessary for compliance, the energy and non-air quality environmental impacts of compliance, and the remaining useful life of any potentially affected sources. 
                    <E T="03">See</E>
                     CAA 169A(g)(1); 40 CFR 51.308(d)(1).
                </P>
                <P>
                    States were also required to calculate baseline (using the five-year period of 2000-2004) and natural visibility conditions (
                    <E T="03">i.e.,</E>
                     visibility conditions without anthropogenic visibility impairment) for each Class I area, and to calculate the linear rate of progress needed to attain natural visibility conditions, assuming a starting point of baseline visibility conditions in 2004 and ending with natural conditions in 2064. This linear interpolation is known as the uniform rate of progress (URP) and is used as a tracking metric to help states assess the amount of progress they are making toward the national visibility goal over time in each Class I area.
                    <SU>8</SU>
                    <FTREF/>
                      
                    <E T="03">See</E>
                     40 CFR 51.308(d)(1)(i)(B), (d)(2). The 1999 RHR also provided that states' LTSs must include the “enforceable emissions limitations, compliance, schedules, and other measures as necessary to achieve the reasonable progress goals.” 
                    <E T="03">See</E>
                     40 CFR 51.308(d)(3). In establishing their LTSs, states are required to consult with other states that also contribute to visibility impairment in a given Class I area and include all measures necessary to obtain their shares of the emission reductions needed to meet the RPGs. 
                    <E T="03">See</E>
                     40 CFR 51.308(d)(3)(i), (ii). Section 51.308(d) also contains seven additional factors states must consider in formulating their LTSs, 40 CFR 51.308(d)(3)(v), as well as provisions governing monitoring and other implementation plan requirements. 
                    <E T="03">See</E>
                     40 CFR 51.308(d)(4). Finally, the 1999 RHR required states to submit periodic progress reports—SIP revisions due every five years that contain information on states' implementation of their regional haze plans and an assessment of whether anything additional is needed to make reasonable progress, 
                    <E T="03">see</E>
                     40 CFR 51.308(g), (h)—and to consult with the FLMs 
                    <SU>9</SU>
                    <FTREF/>
                     responsible for each Class I area according to the requirements in CAA 169A(d) and 40 CFR 51.308(i).
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         EPA established the URP framework in the 1999 RHR to provide “an equitable analytical approach” to assess the rate of visibility improvement at Class I areas across the country. The start point for the URP analysis is 2004 and the endpoint was calculated based on the amount of visibility improvement that was anticipated to result from implementation of existing CAA programs over the period from the mid-1990s to approximately 2005. Assuming this rate of progress would continue into the future, EPA determined that natural visibility conditions would be reached in 60 years, or 2064 (60 years from the baseline starting point of 2004). However, EPA did not establish 2064 as the year by which the national goal 
                        <E T="03">must</E>
                         be reached. 
                        <E T="03">See</E>
                         64 FR 35731-32. That is, the URP and the 2064 date are not enforceable targets but are rather tools that “allow for analytical comparisons between the rate of progress that would be achieved by the state's chosen set of control measures and the URP.” 
                        <E T="03">See</E>
                         82 FR 3078, 3084, January 10, 2017.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         EPA's regulations define “Federal Land Manager” as “the Secretary of the department with authority over the Federal Class I area (or the Secretary's designee) or, with respect to Roosevelt-Campobello International Park, the Chairman of the Roosevelt-Campobello International Park Commission.” 
                        <E T="03">See</E>
                         40 CFR 51.301.
                    </P>
                </FTNT>
                <P>
                    On January 10, 2017, EPA promulgated revisions to the RHR (82 FR 3078) that apply for the second and subsequent planning periods. The 2017 rulemaking made several changes to the requirements for regional haze SIPs to clarify states' obligations and streamline certain regional haze requirements. The revisions to the regional haze program for the second and subsequent planning periods focused on the requirement that states' SIPs contain LTSs for making reasonable progress toward the national visibility goal. The reasonable progress requirements as revised in the 2017 rulemaking (referred to here as the 2017 RHR Revisions) are codified at 40 CFR 51.308(f). Among other changes, the 2017 RHR Revisions adjusted the deadline for states to submit their second planning period SIPs from July 31, 2018, to July 31, 2021, clarified the order of analysis and the relationship between RPGs and the LTSs, and focused on making visibility improvements on the days with the most 
                    <E T="03">anthropogenic</E>
                     visibility impairment, as opposed to the days with the most visibility impairment overall. EPA also revised requirements of the visibility protection program related to periodic progress reports and FLM consultation. The specific requirements applicable to second planning period regional haze SIP submissions are addressed in detail below.
                </P>
                <P>
                    EPA provided guidance to the states for their second planning period SIP submissions in the preamble to the 2017 RHR Revisions as well as in subsequent stand-alone guidance documents. In August 2019, EPA issued its 2019 Guidance.
                    <SU>10</SU>
                    <FTREF/>
                     On July 8, 2021, EPA issued a memorandum containing “Clarifications Regarding Regional Haze State Implementation Plans for the Second Implementation Period” (“2021 Clarifications Memo”).
                    <SU>11</SU>
                    <FTREF/>
                     Additionally, EPA further clarified the recommended procedures for processing ambient visibility data and optionally adjusting the URP to account for international anthropogenic and prescribed fire impacts in two technical guidance documents: the December 2018 “Technical Guidance on Tracking Visibility Progress for the Second Implementation Period of the Regional Haze Program” (“2018 Visibility Tracking Guidance”),
                    <SU>12</SU>
                    <FTREF/>
                     and the June 2020 “Recommendation for the Use of Patched and Substituted Data and Clarification of Data Completeness for Tracking Visibility Progress for the 
                    <PRTPAGE P="105509"/>
                    Second Implementation Period of the Regional Haze Program” and associated Technical Addendum (“2020 Data Completeness Memo”).
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See</E>
                         footnote 4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         “Clarifications Regarding Regional Haze State Implementation Plans for the Second Implementation Period.” EPA Office of Air Quality Planning and Standards, Research Triangle Park (July 8, 2021). 
                        <E T="03">https://www.epa.gov/system/files/documents/2021-07/clarifications-regarding-regional-haze-state-implementation-plans-for-the-second-implementation-period.pdf.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         “Technical Guidance on Tracking Visibility Progress for the Second Implementation Period of the Regional Haze Program.” 
                        <E T="03">https://www.epa.gov/visibility/technical-guidance-tracking-visibility-progress-second-implementation-period-regional.</E>
                         EPA Office of Air Quality Planning and Standards, Research Triangle Park (December 20, 2018).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         “Recommendation for the Use of Patched and Substituted Data and Clarification of Data Completeness for Tracking Visibility Progress for the Second Implementation Period of the Regional Haze Program.” 
                        <E T="03">https://www.epa.gov/visibility/memo-and-technical-addendum-ambient-data-usage-and-completeness-regional-haze-program.</E>
                         EPA Office of Air Quality Planning and Standards, Research Triangle Park (June 3, 2020).
                    </P>
                </FTNT>
                <P>
                    As explained in the 2021 Clarifications Memo, EPA intends the second planning period of the regional haze program to secure meaningful reductions in visibility impairing pollutants that build on the significant progress states have achieved to date. The Agency also recognizes that analyses regarding reasonable progress are state-specific and that, based on states' and sources' individual circumstances, what constitutes reasonable reductions in visibility impairing pollutants will vary from state to state. While there exist many opportunities for states to leverage both ongoing and upcoming emission reductions under other CAA programs, the Agency expects states to undertake rigorous reasonable progress analyses that identify further opportunities to advance the national visibility goal consistent with the statutory and regulatory requirements. 
                    <E T="03">See, generally,</E>
                     2021 Clarifications Memo. This is consistent with Congress's determination that a visibility protection program is needed in addition to the CAA's National Ambient Air Quality Standards (NAAQS) and Prevention of Significant Deterioration (PSD) programs, as further emission reductions may be necessary to adequately protect visibility in Class I areas throughout the country.
                    <SU>14</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See, e.g.,</E>
                         H.R. Rep No. 95-294 at 205 (“In determining how to best remedy the growing visibility problem in these areas of great scenic importance, the committee realizes that as a matter of equity, the national ambient air quality standards cannot be revised to adequately protect visibility in all areas of the country.”) (“the mandatory class I increments of [the PSD program] do not adequately protect visibility in class I areas”).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Roles of Agencies in Addressing Regional Haze</HD>
                <P>
                    Because the air pollutants affecting visibility in Class I areas can be transported over long distances, successful implementation of the regional haze program requires long-term, regional coordination among multiple jurisdictions and agencies that have responsibility for Class I areas and the emissions that impact visibility in those areas. In order to address regional haze, states need to develop strategies in coordination with one another, considering the effect of emissions from one jurisdiction on the air quality in another. Five regional planning organizations (RPOs),
                    <SU>15</SU>
                    <FTREF/>
                     which include representation from state and tribal governments, EPA, and FLMs, were developed in the lead-up to the first planning period to address regional haze. RPOs evaluate technical information to better understand how emissions from state and tribal land impact Class I areas across the country, pursue the development of regional strategies to reduce emissions of PM and other pollutants leading to regional haze, and help states meet the consultation requirements of the RHR.
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         RPOs are sometimes also referred to as “multi-jurisdictional organizations,” or MJOs. For the purposes of this document, the terms RPO and MJO are synonymous.
                    </P>
                </FTNT>
                <P>
                    The Southeastern States Air Resource Managers, Inc. (SESARM), one of the five RPOs described above, is a collaborative effort of state and local agencies and tribal governments established to initiate and coordinate activities associated with the management of regional haze, visibility, and other air quality issues in the Southeast. SESARM's coalition to conduct regional haze work is referred to as Visibility Improvement State and Tribal Association of the Southeast (VISTAS).
                    <SU>16</SU>
                    <FTREF/>
                     Member states, local air agencies, and tribal governments of VISTAS are Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee, Virginia, and West Virginia; the local air agencies, represented by the President of Metro 4 or designee; 
                    <SU>17</SU>
                    <FTREF/>
                     and the Tribes located within the VISTAS region, represented by the Eastern Band of the Cherokee Indians. The Federal partner members of VISTAS are EPA, U.S. National Park Service (NPS), U.S. Fish and Wildlife Service (FWS), and U.S. Forest Service (USFS).
                    <SU>18</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         The VISTAS technical work under SESARM is described at this website: 
                        <E T="03">https://www.metro4-sesarm.org/content/vistas-regional-haze-program.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         Metro 4 is a Tennessee corporation which represents the local air pollution control agencies in EPA's Region 4 in the Southeast. 
                        <E T="03">See https://www.metro4-sesarm.org/content/metro-4-about-us.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         The NPS, FWS, and USFS are collectively referred to as the “Federal Land Managers” or “FLMs” throughout this document.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. Requirements for Regional Haze Plans for the Second Planning Period</HD>
                <P>
                    Under the CAA and EPA's regulations, all 50 states, the District of Columbia, and the U.S. Virgin Islands are required to submit regional haze SIPs satisfying the applicable requirements for the second planning period of the regional haze program by July 31, 2021. Each state's SIP must contain a LTS for making reasonable progress toward meeting the national goal of remedying any existing and preventing any future anthropogenic visibility impairment in Class I areas. 
                    <E T="03">See</E>
                     CAA 169A(b)(2)(B). To this end, 40 CFR 51.308(f) lays out the process by which states determine what constitutes their LTSs, with the order of the requirements in 40 CFR 51.308(f)(1) through (3) generally mirroring the order of the steps in the reasonable progress analysis 
                    <SU>19</SU>
                    <FTREF/>
                     and (f)(4) through (6) containing additional related requirements.
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         EPA explained in the 2017 RHR Revisions that the Agency was adopting new regulatory language in 40 CFR 51.308(f) that, unlike the structure in § 51.308(d), “tracked the actual planning sequence.” 
                        <E T="03">See</E>
                         82 FR 3091, January 10, 2017.
                    </P>
                </FTNT>
                <P>
                    Broadly speaking, a state first must identify the Class I areas within the state and determine the Class I areas outside the state in which visibility may be affected by emissions from the state. These are the Class I areas that must be addressed in the state's LTS. 
                    <E T="03">See</E>
                     40 CFR 51.308(f) introductory text, (f)(2). For each Class I area within its borders, a state must then calculate the baseline, current, and natural visibility conditions for that area, as well as the visibility improvement made to date and the URP. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(1). Each state having a Class I area and/or emissions that may affect visibility in a Class I area must then develop a LTS that includes the enforceable emission limitations, compliance schedules, and other measures that are necessary to make reasonable progress in such areas. A reasonable progress determination is based on applying the four factors in CAA section 169A(g)(1) to sources of visibility impairing pollutants that the state has selected to assess for controls for the second planning period.
                </P>
                <P>
                    Additionally, as further explained below, the RHR at 40 CFR 51.3108(f)(2)(iv) separately provides five “additional factors” 
                    <SU>20</SU>
                    <FTREF/>
                     that states must consider in developing their long-term strategies. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(2). A state evaluates potential emission reduction measures for those selected sources and determines which are necessary to make reasonable progress. Those measures are then incorporated into the state's LTS. After a state has developed its LTS, it then establishes RPGs for each Class I area within its borders by modeling the visibility impacts of all reasonable progress 
                    <PRTPAGE P="105510"/>
                    controls at the end of the second planning period, 
                    <E T="03">i.e.,</E>
                     in 2028, as well as the impacts of other requirements of the CAA. The RPGs include reasonable progress controls not only for sources in the state in which the Class I area is located, but also for sources in other states that contribute to visibility impairment in that area. The RPGs are then compared to the baseline visibility conditions and the URP to ensure that progress is being made toward the statutory goal of preventing any future and remedying any existing anthropogenic visibility impairment in Class I areas. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(2) and (3).
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         The five “additional factors” for consideration in § 51.308(f)(2)(iv) are distinct from the four factors listed in CAA section 169A(g)(1) and 40 CFR 51.308(f)(2)(i) that states must consider and apply to sources in determining reasonable progress.
                    </P>
                </FTNT>
                <P>
                    In addition to satisfying the requirements at 40 CFR 51.308(f) related to reasonable progress, the regional haze SIP revisions for the second planning period must address the requirements in 40 CFR 51.308(g)(1) through (5) pertaining to periodic reports describing progress toward the RPGs, 40 CFR 51.308(f)(5), as well as requirements for FLM consultation that apply to all visibility protection SIPs and SIP revisions. 
                    <E T="03">See</E>
                     40 CFR 51.308(i).
                </P>
                <P>
                    A state must submit its regional haze SIP and subsequent SIP revisions to EPA according to the requirements applicable to all SIP revisions under the CAA and EPA's regulations. 
                    <E T="03">See</E>
                     CAA 169A(b)(2); CAA 110(a). Upon EPA approval, a SIP is enforceable by the Agency and the public under the CAA. If EPA finds that a state fails to make a required SIP revision, or if EPA finds that a state's SIP is incomplete or if disapproves the SIP, the Agency must promulgate a Federal implementation plan (FIP) that satisfies the applicable requirements. 
                    <E T="03">See</E>
                     CAA 110(c)(1).
                </P>
                <HD SOURCE="HD2">A. Identification of Class I Areas</HD>
                <P>
                    The first step in developing a regional haze SIP is for a state to determine which Class I areas, in addition to those within its borders, “may be affected” by emissions from within the state. In the 1999 RHR, EPA determined that all states contribute to visibility impairment in at least one Class I area, 64 FR 35720-22, and explained that the statute and regulations lay out an “extremely low triggering threshold” for determining “whether States should be required to engage in air quality planning and analysis as a prerequisite to determining the need for control of emissions from sources within their State.” 
                    <E T="03">Id.</E>
                     at 35721.
                </P>
                <P>
                    A state must determine which Class I areas must be addressed by its SIP by evaluating the total emissions of visibility impairing pollutants from all sources within the state. While the RHR does not require this evaluation to be conducted in any particular manner, EPA's 2019 Guidance provides recommendations for how such an assessment might be accomplished, including by, where appropriate, using the determinations previously made for the first planning period. 
                    <E T="03">See</E>
                     2019 Guidance at 8-9. In addition, the determination of which Class I areas may be affected by a state's emissions is subject to the requirement in 40 CFR 51.308(f)(2)(iii) to “document the technical basis, including modeling, monitoring, cost, engineering, and emissions information, on which the State is relying to determine the emission reduction measures that are necessary to make reasonable progress in each mandatory Class I Federal area it affects.”
                </P>
                <HD SOURCE="HD2">B. Calculations of Baseline, Current, and Natural Visibility Conditions; Progress to Date; and the Uniform Rate of Progress (URP)</HD>
                <P>
                    As part of assessing whether a SIP submission for the second planning period is providing for reasonable progress toward the national visibility goal, the RHR contains requirements in 40 CFR 51.308(f)(1) related to tracking visibility improvement over time. The requirements of this subsection apply only to states having Class I areas within their borders; the required calculations must be made for each such Class I area. EPA's 2018 Visibility Tracking Guidance 
                    <SU>21</SU>
                    <FTREF/>
                     provides recommendations to assist states in satisfying their obligations under 40 CFR 51.308(f)(1); specifically, in developing information on baseline, current, and natural visibility conditions, and in making optional adjustments to the URP to account for the impacts of international anthropogenic emissions and prescribed fires. 
                    <E T="03">See</E>
                     82 FR 3103-05.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         The 2018 Visibility Tracking Guidance references and relies on parts of the 2003 Tracking Guidance: “Guidance for Tracking Progress Under the Regional Haze Rule” which can be found at 
                        <E T="03">https://www.epa.gov/sites/default/files/2021-03/documents/tracking.pdf.</E>
                         EPA Office of Air Quality Planning and Standards, Research Triangle Park (September 2003).
                    </P>
                </FTNT>
                <P>
                    The RHR requires tracking of visibility conditions on two sets of days: the clearest and the most impaired days. Visibility conditions for both sets of days are expressed as the average deciview index for the relevant five-year period (the period representing baseline or current visibility conditions).
                    <SU>22</SU>
                    <FTREF/>
                     The RHR provides that the relevant sets of days for visibility tracking purposes are the 20 percent clearest days (the 20 percent of monitored days in a calendar year with the lowest values of the deciview index) and 20 percent most impaired days (the 20 percent of monitored days in a calendar year with the highest amounts of anthropogenic visibility impairment).
                    <SU>23</SU>
                    <FTREF/>
                      
                    <E T="03">See</E>
                     40 CFR 51.301. A state must calculate visibility conditions for both the 20 percent clearest days and 20 percent most impaired days for the baseline period of 2000-2004 and the most recent five-year period for which visibility monitoring data are available (representing current visibility conditions). 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(1)(i), (iii). States must also calculate natural visibility conditions for the clearest and most impaired days 
                    <SU>24</SU>
                    <FTREF/>
                     by estimating the conditions that would exist on those two sets of days absent anthropogenic visibility impairment. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(1)(ii). Using all these data, states must then calculate, for each Class I area, the amount of progress made since the baseline period (2000-2004) and how much improvement is left to achieve in order to reach natural visibility conditions.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         The “deciview index” means a value for a day that is derived from calculated or measured light extinction, such that uniform increments of the index correspond to uniform incremental changes in perception across the entire range of conditions, from pristine to very obscured. The deciview index is calculated using Interagency Monitoring of Protected Visual Environments (IMPROVE) aerosol measurements. 
                        <E T="03">See</E>
                         40 CFR 51.301.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         This notice also refers to the 20 percent clearest and 20 percent most anthropogenically impaired days as the “clearest” and “most impaired” or “most anthropogenically impaired” days, respectively.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         The RHR at 40 CFR 51.308(f)(1)(ii) contains an error related to the requirement for calculating two sets of natural conditions values. The rule says, “most impaired days or the clearest days” where it should say “most impaired days and clearest days.” This is an error that was intended to be corrected in the 2017 RHR Revisions but did not get corrected in the final rule language. This is supported by the preamble text at 82 FR 3098: “In the final version of 40 CFR 51.308(f)(1)(ii), an occurrence of `or' has been corrected to `and' to indicate that natural visibility conditions for both the most impaired days and the clearest days must be based on available monitoring information.”
                    </P>
                </FTNT>
                <P>
                    Using the data for the set of most impaired days only, states must plot a line between visibility conditions in the baseline period and natural visibility conditions for each Class I area to determine the URP—the amount of visibility improvement, measured in deciviews, that would need to be achieved during each planning period in order to achieve natural visibility conditions by the end of 2064. The URP is used in later steps of the reasonable progress analysis for informational purposes and to provide a non-enforceable benchmark against which to assess a Class I area's rate of visibility improvement.
                    <SU>25</SU>
                    <FTREF/>
                     Additionally, in the 
                    <PRTPAGE P="105511"/>
                    2017 RHR Revisions, EPA provided states the option of proposing to adjust the endpoint of the URP to account for impacts of anthropogenic sources outside the United States and/or impacts of certain types of wildland prescribed fires. These adjustments, which must be approved by EPA, are intended to avoid any perception that states should compensate for impacts from international anthropogenic sources and to give states the flexibility to determine that limiting the use of wildland prescribed fire is not necessary for reasonable progress. 
                    <E T="03">See</E>
                     82 FR 3107, footnote 116.
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         Being on or below the URP is not a “safe harbor”; 
                        <E T="03">i.e.,</E>
                         achieving the URP does not mean that 
                        <PRTPAGE/>
                        a Class I area is making “reasonable progress” and does not relieve a state from using the four statutory factors to determine what level of control is needed to achieve such progress. 
                        <E T="03">See, e.g.,</E>
                         82 FR 3093.
                    </P>
                </FTNT>
                <P>EPA's 2018 Visibility Tracking Guidance can be used to help satisfy the 40 CFR 51.308(f)(1) requirements, including in developing information on baseline, current, and natural visibility conditions, and in making optional adjustments to the URP. In addition, the 2020 Data Completeness Memo provides recommendations on the data completeness language referenced in 40 CFR 51.308(f)(1)(i) and provides updated natural conditions estimates for each Class I area.</P>
                <HD SOURCE="HD2">C. Long-Term Strategy (LTS) for Regional Haze</HD>
                <P>
                    The core component of a regional haze SIP submission is a LTS that addresses regional haze in each Class I area within a state's borders and each Class I area that may be affected by emissions from the state. The LTS “must include the enforceable emissions limitations, compliance schedules, and other measures that are necessary to make reasonable progress, as determined pursuant to (f)(2)(i) through (iv).” 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(2). The amount of progress that is “reasonable progress” is based on applying the four statutory factors in CAA section 169A(g)(1) in an evaluation of potential control options for sources of visibility impairing pollutants, which is referred to as a “four-factor” analysis (FFA). The outcome of that analysis is the emission reduction measures that a particular source or group of sources needs to implement in order to make reasonable progress toward the national visibility goal. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(2)(i). Emission reduction measures that are necessary to make reasonable progress may be either new, additional control measures for a source or the existing emission reduction measures that a source is already implementing. 
                    <E T="03">See</E>
                     2019 Guidance at 43; 2021 Clarifications Memo at 8-10. Such measures must be represented by “enforceable emissions limitations, compliance schedules, and other measures” in a state's LTS in its SIP. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(2).
                </P>
                <P>
                    Section 51.308(f)(2)(i) provides the requirements for the FFA. The first step of this analysis entails selecting the sources to be evaluated for emission reduction measures; to this end, the RHR requires states to consider “major and minor stationary sources or groups of sources, mobile sources, and area sources” of visibility impairing pollutants for potential control analysis (
                    <E T="03">i.e.,</E>
                     FFA). 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(2)(i). A threshold question at this step is which visibility impairing pollutants will be analyzed. As EPA previously explained, consistent with the first planning period, EPA generally expects that each state will analyze at least SO
                    <E T="52">2</E>
                     and NO
                    <E T="52">X</E>
                     in selecting sources and determining control measures. 
                    <E T="03">See</E>
                     2019 Guidance at 12 and 2021 Clarifications Memo at 4. A state that chooses not to consider at least these two pollutants should demonstrate why such consideration would be unreasonable. 
                    <E T="03">See</E>
                     2021 Clarifications Memo at 4.
                </P>
                <P>
                    While states have the option to analyze 
                    <E T="03">all</E>
                     sources, the 2019 Guidance explains that “an analysis of control measures is not required for every source in each implementation period,” and that “[s]electing a set of sources for analysis of control measures in each implementation period is consistent with the Regional Haze Rule, which sets up an iterative planning process and anticipates that a state may not need to analyze control measures for all its sources in a given SIP revision.” 
                    <E T="03">See</E>
                     2019 Guidance at 9. However, given that source selection is the basis of all subsequent control determinations, a reasonable source selection process “should be designed and conducted to ensure that source selection results in a set of pollutants and sources the evaluation of which has the potential to meaningfully reduce their contributions to visibility impairment.” 
                    <E T="03">See</E>
                     2021 Clarifications Memo at 3.
                </P>
                <P>
                    EPA explained in the 2021 Clarifications Memo that each state has an obligation to submit a LTS that addresses the regional haze visibility impairment that results from emissions from within that state. Thus, source selection should focus on the in-state contribution to visibility impairment and be designed to capture a meaningful portion of the state's total contribution to visibility impairment in Class I areas. A state should not decline to select its largest in-state sources on the basis that there are even larger out-of-state contributors. 
                    <E T="03">See</E>
                     2021 Clarifications Memo at 4.
                    <SU>26</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         Similarly, in responding to comments on the 2017 RHR Revisions EPA explained that “[a] state should not fail to address its many relatively low-impact sources merely because it only has such sources and another state has even more low-impact sources and/or some high impact sources.” Responses to Comments on Protection of Visibility: Amendments to Requirements for State Plans; Proposed Rule (81 FR 26942, May 4, 2016). (December 2016), Docket Number EPA-HQ-OAR-2015-0531, U.S. Environmental Protection Agency at 87-88, available at 
                        <E T="03">www.regulations.gov.</E>
                    </P>
                </FTNT>
                <P>Thus, while states have discretion to choose any source selection methodology that is reasonable, whatever choices they make should be reasonably explained. To this end, 40 CFR 51.308(f)(2)(i) requires that a state's SIP submission include “a description of the criteria it used to determine which sources or groups of sources it evaluated.” The technical basis for source selection, which may include methods for quantifying potential visibility impacts such as emissions divided by distance metrics, trajectory analyses, residence time analyses, and/or photochemical modeling, must also be appropriately documented, as required by 40 CFR 51.308(f)(2)(iii).</P>
                <P>
                    Once a state has selected the set of sources, the next step is to determine the emissions reduction measures for those sources that are necessary to make reasonable progress for the second planning period.
                    <SU>27</SU>
                    <FTREF/>
                     This is accomplished by considering the four factors—“the costs of compliance, the time necessary for compliance, and the energy and non-air quality environmental impacts of compliance, and the remaining useful life of any existing source subject to such requirements.” 
                    <E T="03">See</E>
                     CAA 169A(g)(1). EPA has explained that the FFA is an assessment of potential emission reduction measures (
                    <E T="03">i.e.,</E>
                     control options) for sources; “use of the terms `compliance' and `subject to such requirements' in section 169A(g)(1) strongly indicates that Congress intended the relevant determination to be the requirements with which sources would have to comply in order to satisfy the CAA's reasonable progress mandate.” 
                    <E T="03">See</E>
                     82 FR 3091. Thus, for each source a state has selected for an FFA,
                    <SU>28</SU>
                    <FTREF/>
                     it must consider a “meaningful 
                    <PRTPAGE P="105512"/>
                    set” of technically feasible control options for reducing emissions of visibility impairing pollutants. 
                    <E T="03">Id.</E>
                     at 3088. The 2019 Guidance provides that “[a] state must reasonably pick and justify the measures that it will consider, recognizing that there is no statutory or regulatory requirement to consider all technically feasible measures or any particular measures. A range of technically feasible measures available to reduce emissions would be one way to justify a reasonable set.” 
                    <E T="03">See</E>
                     2019 Guidance at 29.
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         The CAA provides that, “[i]n determining reasonable progress there shall be taken into consideration” the four statutory factors. 
                        <E T="03">See</E>
                         CAA 169A(g)(1). However, in addition to four-factor analyses for selected sources, groups of sources, or source categories, a state may also consider additional emission reduction measures for inclusion in its LTS, 
                        <E T="03">e.g.,</E>
                         from other newly adopted, on-the-books, or on-the-way rules and measures for sources not selected for four-factor analysis for the second planning period.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         “Each source” or “particular source” is used here as shorthand. While a source-specific analysis 
                        <PRTPAGE/>
                        is one way of applying the four factors, neither the statute nor the RHR requires states to evaluate individual sources. Rather, states have “the flexibility to conduct four-factor analyses for specific sources, groups of sources or even entire source categories, depending on state policy preferences and the specific circumstances of each state.” 
                        <E T="03">See</E>
                         82 FR 3088. However, not all approaches to grouping sources for four-factor analysis are necessarily reasonable; the reasonableness of grouping sources in any particular instance will depend on the circumstances and the manner in which grouping is conducted. If it is feasible to establish and enforce different requirements for sources or subgroups of sources, and if relevant factors can be quantified for those sources or subgroups, then states should make a separate reasonable progress determination for each source or subgroup. 2021 Clarifications Memo at 7-8.
                    </P>
                </FTNT>
                <P>
                    EPA's 2021 Clarifications Memo provides further guidance on what constitutes a reasonable set of control options for consideration: “A reasonable four-factor analysis will consider the full range of potentially reasonable options for reducing emissions.” 
                    <E T="03">See</E>
                     2021 Clarifications Memo at 7. In addition to add-on controls and other retrofits (
                    <E T="03">i.e.,</E>
                     new emission reduction measures for sources), EPA explained that states should generally analyze efficiency improvements for sources' existing measures as control options in their FFAs, as in many cases such improvements are reasonable given that they typically involve only additional operation and maintenance costs. Additionally, the 2021 Clarifications Memo provides that states that have assumed a higher emission rate than a source has achieved or could potentially achieve using its existing measures should also consider lower emission rates as potential control options. That is, a state should consider a source's recent actual and projected emission rates to determine if it could reasonably attain lower emission rates with its existing measures. If so, the state should analyze the lower emission rate as a control option for reducing emissions. 
                    <E T="03">See</E>
                     2021 Clarifications Memo at 7. EPA's recommendations to analyze potential efficiency improvements and achievable lower emission rates apply to both sources that have been selected for FFA and those that have forgone an FFA on the basis of existing “effective controls.” 
                    <E T="03">See</E>
                     2021 Clarifications Memo at 5, 10.
                </P>
                <P>
                    After identifying a reasonable set of potential control options for the sources it has selected, a state then collects information on the four factors with regard to each option identified. EPA has also explained that, in addition to the four statutory factors, states have flexibility under the CAA and RHR to reasonably consider visibility benefits as an additional factor alongside the four statutory factors.
                    <SU>29</SU>
                    <FTREF/>
                     The 2019 Guidance provides recommendations for the types of information that can be used to characterize the four factors (with or without visibility), as well as ways in which states might reasonably consider and balance that information to determine which of the potential control options is necessary to make reasonable progress. 
                    <E T="03">See</E>
                     2019 Guidance at 30-36. The 2021 Clarifications Memo contains further guidance on how states can reasonably consider modeled visibility impacts or benefits in the context of an FFA. 
                    <E T="03">See</E>
                     2021 Clarifications Memo at 12-13, 14-15. Specifically, EPA explained that while visibility can reasonably be used when comparing and choosing between multiple reasonable control options, it should not be used to summarily reject controls that are reasonable given the four statutory factors. 
                    <E T="03">See</E>
                     2021 Clarifications Memo at 13. Ultimately, while states have discretion to reasonably weigh the factors and to determine what level of control is needed, 40 CFR 51.308(f)(2)(i) provides that a state “must include in its implementation plan a description of how the four factors were taken into consideration in selecting the measure for inclusion in its long-term strategy.”
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         
                        <E T="03">See, e.g.,</E>
                         Responses to Comments on Protection of Visibility: Amendments to Requirements for State Plans; Proposed Rule (81 FR 26942, May 4, 2016), (December 2016), Docket Number EPA-HQ-OAR-2015-0531, U.S. Environmental Protection Agency at 186; 2019 Guidance at 36-37.
                    </P>
                </FTNT>
                <P>
                    As explained above, 40 CFR 51.308(f)(2)(i) requires states to determine the emission reduction measures for sources that are necessary to make reasonable progress by considering the four factors. Pursuant to 40 CFR 51.308(f)(2), measures that are necessary to make reasonable progress toward the national visibility goal must be included in a state's LTS and in its SIP.
                    <SU>30</SU>
                    <FTREF/>
                     If the outcome of an FFA is a new, additional emission reduction measure for a source, that new measure is necessary to make reasonable progress toward remedying existing anthropogenic visibility impairment and must be included in the SIP. If the outcome of an FFA is that no new measures are reasonable for a source, continued implementation of the source's existing measures is generally necessary to prevent future emission increases and thus to make reasonable progress toward the second part of the national visibility goal: preventing future anthropogenic visibility impairment. 
                    <E T="03">See</E>
                     CAA 169A(a)(1). That is, when the result of an FFA is that no new measures are necessary to make reasonable progress, the source's existing measures are generally necessary to make reasonable progress and must be included in the SIP. However, there may be circumstances in which a state can demonstrate that a source's existing measures are 
                    <E T="03">not</E>
                     necessary to make reasonable progress. Specifically, if a state can demonstrate that a source will continue to implement its existing measures and will not increase its emission rate, it may not be necessary to have those measures in the LTS in order to prevent future emission increases and future visibility impairment. EPA's 2021 Clarifications Memo provides further explanation and guidance on how states may demonstrate that a source's existing measures are not necessary to make reasonable progress. 
                    <E T="03">See</E>
                     2021 Clarifications Memo at 8-10. If the state can make such a demonstration, it need not include a source's existing measures in the LTS or its SIP.
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         States may choose to, but are not required to, include measures in their long-term strategies beyond just the emission reduction measures that are necessary for reasonable progress. 
                        <E T="03">See</E>
                         2021 Clarifications Memo at 16. For example, states with smoke management programs may choose to submit their SMP to EPA for inclusion in their SIPs but are not required to do so. 
                        <E T="03">See, e.g.,</E>
                         82 FR 3108-09 (requirement to consider smoke management practices and smoke management programs under 40 CFR 51.308(f)(2)(iv) does not require states to adopt such practices or programs into their SIPs, although they may elect to do so).
                    </P>
                </FTNT>
                <P>
                    As with source selection, the characterization of information on each of the factors is also subject to the documentation requirement in 40 CFR 51.308(f)(2)(iii). The reasonable progress analysis, including source selection, information gathering, characterization of the four statutory factors (and potentially visibility), balancing of the four factors, and selection of the emission reduction measures that represent reasonable progress, is a technically complex exercise, but also a flexible one that provides states with bounded discretion to design and implement approaches appropriate to their circumstances. Given this flexibility, 40 CFR 51.308(f)(2)(iii) plays an important function in requiring a state to document the technical basis for 
                    <PRTPAGE P="105513"/>
                    its decision making so that the public and EPA can comprehend and evaluate the information and analysis the state relied upon to determine what emission reduction measures must be in place to make reasonable progress. The technical documentation must include the modeling, monitoring, cost, engineering, and emissions information on which the state relied to determine the measures necessary to make reasonable progress. This documentation requirement can be met through the provision of and reliance on technical analyses developed through a regional planning process, so long as that process and its output has been approved by all state participants. In addition to the explicit regulatory requirement to document the technical basis of their reasonable progress determinations, states are also subject to the general principle that those determinations must be reasonably moored to the statute.
                    <SU>31</SU>
                    <FTREF/>
                     That is, a state's decisions about the emission reduction measures that are necessary to make reasonable progress must be consistent with the statutory goal of remedying existing and preventing future visibility impairment.
                </P>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         
                        <E T="03">See Arizona ex rel. Darwin</E>
                         v. 
                        <E T="03">U.S. EPA,</E>
                         815 F.3d 519, 531 (9th Cir. 2016); 
                        <E T="03">Nebraska</E>
                         v. 
                        <E T="03">U.S. EPA</E>
                        , 812 F.3d 662, 668 (8th Cir. 2016); 
                        <E T="03">North Dakota</E>
                         v. 
                        <E T="03">EPA,</E>
                         730 F.3d 750, 761 (8th Cir. 2013); 
                        <E T="03">Oklahoma</E>
                         v. 
                        <E T="03">EPA,</E>
                         723 F.3d 1201, 1206, 1208-10 (10th Cir. 2013); cf. also 
                        <E T="03">Nat'l Parks Conservation Ass'n</E>
                         v. 
                        <E T="03">EPA,</E>
                         803 F.3d 151, 165 (3d Cir. 2015); 
                        <E T="03">Alaska Dep't of Envtl. Conservation</E>
                         v. 
                        <E T="03">EPA,</E>
                         540 U.S. 461, 485, 490 (2004).
                    </P>
                </FTNT>
                <P>
                    The four statutory factors (and potentially visibility) are used to determine what emission reduction measures for selected sources must be included in a state's LTS for making reasonable progress. Additionally, the RHR at 40 CFR 51.3108(f)(2)(iv) separately provides five “additional factors” 
                    <SU>32</SU>
                    <FTREF/>
                     that states must consider in developing their LTSs: (1) emission reductions due to ongoing air pollution control programs, including measures to address reasonably attributable visibility impairment (RAVI); (2) measures to reduce the impacts of construction activities; (3) source retirement and replacement schedules; (4) basic smoke management practices for prescribed fire used for agricultural and wildland vegetation management purposes and smoke management programs; and (5) the anticipated net effect on visibility due to projected changes in point, area, and mobile source emissions over the period addressed by the LTS. The 2019 Guidance provides that a state may satisfy this requirement by considering these additional factors in the process of selecting sources for an FFA, when performing that analysis, or both, and that not every one of the additional factors needs to be considered at the same stage of the process. 
                    <E T="03">See</E>
                     2019 Guidance at 21. EPA provided further guidance on the five additional factors in the 2021 Clarifications Memo, explaining that a state should generally not reject cost-effective and otherwise reasonable controls merely because there have been emission reductions since the first planning period owing to other ongoing air pollution control programs or merely because visibility is otherwise projected to improve at Class I areas. Additionally, states generally should not rely on these additional factors to summarily assert that the state has already made sufficient progress and, therefore, no sources need to be selected or no new controls are needed regardless of the outcome of FFAs. 
                    <E T="03">See</E>
                     2021 Clarifications Memo at 13.
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         The five “additional factors” for consideration in § 51.308(f)(2)(iv) are distinct from the four factors listed in CAA section 169A(g)(1) and 40 CFR 51.308(f)(2)(i) that states must consider and apply to sources in determining reasonable progress.
                    </P>
                </FTNT>
                <P>
                    Because the air pollution that causes regional haze crosses state boundaries, 40 CFR 51.308(f)(2)(ii) requires a state to consult with other states that also have emissions that are reasonably anticipated to contribute to visibility impairment in a given Class I area. Consultation allows for each state that impacts visibility in an area to share whatever technical information, analyses, and control determinations may be necessary to develop coordinated emission management strategies. This coordination may be managed through inter- and intra-RPO consultation and the development of regional emissions strategies; additional consultations between states outside of RPO processes may also occur. If a state, pursuant to consultation, agrees that certain measures (
                    <E T="03">e.g.,</E>
                     a certain emission limitation) are necessary to make reasonable progress at a Class I area, it must include those measures in its SIP. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(2)(ii)(A). Additionally, the RHR requires that states that contribute to visibility impairment at the same Class I area consider the emission reduction measures the other contributing states have identified as being necessary to make reasonable progress for their own sources. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(2)(ii)(B). If a state has been asked to consider or adopt certain emission reduction measures, but ultimately determines those measures are not necessary to make reasonable progress, that state must document in its SIP the actions taken to resolve the disagreement. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(2)(ii)(C). EPA will consider the technical information and explanations presented by the submitting state and the state with which it disagrees when considering whether to approve the state's SIP. 
                    <E T="03">See id.;</E>
                     2019 Guidance at 53. Under all circumstances, a state must document in its SIP submission all substantive consultations with other contributing states. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(2)(ii)(C).
                </P>
                <HD SOURCE="HD2">D. Reasonable Progress Goals (RPGs)</HD>
                <P>
                    RPGs “measure the progress that is projected to be achieved by the control measures states have determined are necessary to make reasonable progress based on a four-factor analysis.” 
                    <E T="03">See</E>
                     82 FR 3091. Their primary purpose is to assist the public and EPA in assessing the reasonableness of states' LTSs for making reasonable progress toward the national visibility goal. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(3)(iii) and (iv). States in which Class I areas are located must establish two RPGs—one representing visibility conditions on the clearest days and one representing visibility on the most anthropogenically impaired days—for each area within their borders. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(3)(i). The two RPGs, measured in deciviews, are intended to reflect the projected impacts, on each set of days, of the emission reduction measures the state with the Class I area and other contributing states have included in their LTSs for the second planning period.
                    <SU>33</SU>
                    <FTREF/>
                     The RPGs also account for the projected impacts of implementing other CAA requirements, including non-SIP based requirements. Because RPGs are the modeled result of the measures in states' LTSs (as well as other measures required under the CAA), they cannot be determined before states have conducted their FFAs and determined the control measures that are necessary to make reasonable progress.
                    <SU>34</SU>
                    <FTREF/>
                      
                    <E T="03">See</E>
                     2021 Clarifications Memo at 6.
                </P>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         RPGs are intended to reflect the projected impacts of the measures all contributing states include in their long-term strategies. However, due to the timing of analyses and of control determinations by other states, other on-going emissions changes, a particular state's RPGs may not reflect all control measures and emissions reductions that are expected to occur by the end of the planning period. The 2019 Guidance provides recommendations for addressing the timing of RPG calculations when states are developing their long-term strategies on disparate schedules, as well as for adjusting RPGs using a post-modeling approach. 
                        <E T="03">See</E>
                         2019 Guidance at 47-48.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         The 2019 Guidance allows for the possibility of post-modeling adjustments to the RPGs to account for the fact that final LTS decisions for the State or for other States may not be known until late in the process, or even after SIPs are submitted. 
                        <E T="03">See</E>
                         2019 Guidance at 46-48. 
                        <E T="03">See</E>
                         also, 82 FR 3078, 3080 (January 10, 2017).
                    </P>
                </FTNT>
                <P>
                    For the second planning period, the RPGs are set for 2028. RPGs are not enforceable targets, 40 CFR 
                    <PRTPAGE P="105514"/>
                    51.308(f)(3)(iii); rather, they “provide a way for the states to check the projected outcome of the [long-term strategy] against the goals for visibility improvement.” 
                    <E T="03">See</E>
                     2019 Guidance at 46. While states are not legally obligated to achieve the visibility conditions described in their RPGs, 40 CFR 51.308(f)(3)(i) requires that “[t]he long-term strategy and the reasonable progress goals must provide for an improvement in visibility for the most impaired days since the baseline period and ensure no degradation in visibility for the clearest days since the baseline period.” Thus, states are required to have emission reduction measures in their LTSs that are projected to achieve visibility conditions on the most impaired days that are better than the baseline period and shows no degradation on the clearest days compared to the clearest days from the baseline period. The baseline period for the purpose of this comparison is the baseline visibility condition—the annual average visibility condition for the period 2000-2004. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(1)(i), 82 FR 3097-98.
                </P>
                <P>
                    So that RPGs may also serve as a metric for assessing the amount of progress a state is making toward the national visibility goal, the RHR requires states with Class I areas to compare the 2028 RPG for the most impaired days to the corresponding point on the URP line (representing visibility conditions in 2028 if visibility were to improve at a linear rate from conditions in the baseline period of 2000-2004 to natural visibility conditions in 2064). If the most impaired days RPG in 2028 is above the URP (
                    <E T="03">i.e.,</E>
                     if visibility conditions are improving more slowly than the rate described by the URP), each state that contributes to visibility impairment in the Class I area must demonstrate, based on the FFA required under 40 CFR 51.308(f)(2)(i), that no additional emission reduction measures would be reasonable to include in its LTS. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(3)(ii). To this end, 40 CFR 51.308(f)(3)(ii) requires that each state contributing to visibility impairment in a Class I area that is projected to improve more slowly than the URP provide “a robust demonstration, including documenting the criteria used to determine which sources or groups [of] sources were evaluated and how the four factors required by paragraph (f)(2)(i) were taken into consideration in selecting the measures for inclusion in its long-term strategy.” The 2019 Guidance provides suggestions about how such a “robust demonstration” might be conducted. 
                    <E T="03">See</E>
                     2019 Guidance at 50-51.
                </P>
                <P>
                    The 2017 RHR, 2019 Guidance, and 2021 Clarifications Memo also explain that projecting an RPG that is on or below the URP based on only on-the-books and/or on-the-way control measures (
                    <E T="03">i.e.,</E>
                     control measures already required or anticipated before the FFA is conducted) is not a “safe harbor” from the CAA's and RHR's requirement that all states must conduct an FFA to determine what emission reduction measures constitute reasonable progress.
                    <SU>35</SU>
                    <FTREF/>
                     The URP is a planning metric used to gauge the amount of progress made thus far and the amount left before reaching natural visibility conditions. However, the URP is not based on consideration of the four statutory factors and therefore cannot answer the question of whether the amount of progress being made in any particular planning period is “reasonable progress.” 
                    <E T="03">See</E>
                     82 FR 3093, 3099-3100; 2019 Guidance at 22; 2021 Clarifications Memo at 15-16.
                </P>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         In lieu of conducting an FFA, states may elect to show the source has existing effective controls for the particular pollutants under evaluation or that the source is shutting down by the end of the planning period (or close to it).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">E. Monitoring Strategy and Other State Implementation Plan Requirements</HD>
                <P>
                    Section 51.308(f)(6) requires states to have certain strategies and elements in place for assessing and reporting on visibility. Individual requirements under this subsection apply either to states with Class I areas within their borders, states with no Class I areas but that are reasonably anticipated to cause or contribute to visibility impairment in any Class I area, or both. A state with Class I areas within its borders must submit with its SIP revision a monitoring strategy for measuring, characterizing, and reporting regional haze visibility impairment that is representative of all Class I areas within the state. SIP revisions for such states must also provide for the establishment of any additional monitoring sites or equipment needed to assess visibility conditions in Class I areas, as well as reporting of all visibility monitoring data to EPA at least annually. Compliance with the monitoring strategy requirement may be met through a state's participation in the IMPROVE monitoring network, which is used to measure visibility impairment caused by air pollution at the 156 Class I areas covered by the visibility program. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(6) introductory text, (f)(6)(i) and (iv). The IMPROVE monitoring data is used to determine the 20 percent most anthropogenically impaired and 20 percent clearest sets of days every year at each Class I area and tracks visibility impairment over time.
                </P>
                <P>
                    All states' SIPs must provide for procedures by which monitoring data and other information are used to determine the contribution of emissions from within the state to regional haze visibility impairment in affected Class I areas. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(6)(ii), (iii). 
                    <E T="03">S</E>
                    ection 51.308(f)(6)(v) further requires that all states' SIPs provide for a statewide inventory of emissions of pollutants that are reasonably anticipated to cause or contribute to visibility impairment in any Class I area; the inventory must include emissions for the most recent year for which data are available and estimates of future projected emissions. States must also include commitments to update their inventories periodically. The inventories themselves do not need to be included as elements in the SIP and are not subject to EPA review as part of the Agency's evaluation of a SIP revision.
                    <SU>36</SU>
                    <FTREF/>
                     All states' SIPs must also provide for any other elements, including reporting, recordkeeping, and other measures, that are necessary for states to assess and report on visibility. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(6)(vi). Per the 2019 Guidance, a state may note in its regional haze SIP that its compliance with the Air Emissions Reporting Rule (AERR) in 40 CFR part 51, subpart A, satisfies the requirement to provide for an emissions inventory for the most recent year for which data are available. To satisfy the requirement to provide estimates of future projected emissions, a state may explain in its SIP how projected emissions were developed for use in establishing RPGs for its own and nearby Class I areas.
                    <SU>37</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>36</SU>
                         
                        <E T="03">See</E>
                         “Step 8: Additional requirements for regional haze SIPs” in 2019 Guidance at 55.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>37</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    Separate from the requirements related to monitoring for regional haze purposes under 40 CFR 51.308(f)(6), the RHR also contains a requirement at 40 CFR 51.308(f)(4) related to any additional monitoring that may be needed to address visibility impairment in Class I areas from a single source or a small group of sources. This is called “reasonably attributable visibility impairment” 
                    <SU>38</SU>
                    <FTREF/>
                     or RAVI. Under this provision, if EPA or the FLM of an affected Class I area has advised a state that additional monitoring is needed to assess RAVI, the state must include in 
                    <PRTPAGE P="105515"/>
                    its SIP revision for the second planning period an appropriate strategy for evaluating such impairment.
                </P>
                <FTNT>
                    <P>
                        <SU>38</SU>
                         EPA's visibility protection regulations define “reasonably attributable visibility impairment” as “visibility impairment that is caused by the emission of air pollutants from one, or a small number of sources.” 
                        <E T="03">See</E>
                         40 CFR 51.301.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">F. Requirements for Periodic Reports Describing Progress Toward the RPGs</HD>
                <P>
                    Section 51.308(f)(5) requires a state's regional haze SIP revision to address the requirements of paragraphs 40 CFR 51.308(g)(1) through (5) so that the plan revision due in 2021 will serve also as a progress report addressing the period since submission of the progress report for the first planning period. The regional haze progress report requirement is designed to inform the public and EPA about a state's implementation of its existing LTS and whether such implementation is in fact resulting in the expected visibility improvement. 
                    <E T="03">See</E>
                     81 FR 26942, 26950 (May 4, 2016) (82 FR 3119, January 10, 2017). To this end, every state's SIP revision for the second planning period is required to describe the status of implementation of all measures included in the state's LTS, including BART and reasonable progress emission reduction measures from the first planning period, and the resulting emissions reductions. 
                    <E T="03">See</E>
                     40 CFR 51.308(g)(1) and (2).
                </P>
                <P>
                    A core component of the progress report requirements is an assessment of changes in visibility conditions on the clearest days and most impaired days. For second planning period progress reports, 40 CFR 51.308(g)(3) requires states with Class I areas within their borders to first determine current visibility conditions for each area on the most impaired and clearest days, 40 CFR 51.308(g)(3)(i)(B), and then to calculate the difference between those current conditions and baseline (2000-2004) visibility conditions in order to assess progress made to date. 
                    <E T="03">See</E>
                     40 CFR 51.308(g)(3)(ii)(B). States must also assess the changes in visibility impairment for the clearest days and most impaired days since they submitted their first planning period progress reports. 
                    <E T="03">See</E>
                     40 CFR 51.308(g)(3)(iii)(B), (f)(5). Since different states submitted their first planning period progress reports at different times, the starting point for this assessment will vary state by state.
                </P>
                <P>
                    Similarly, states must provide analyses tracking the change in emissions of pollutants contributing to visibility impairment from all sources and activities within the state over the period since they submitted their first planning period progress reports. 
                    <E T="03">See</E>
                     40 CFR 51.308(g)(4), (f)(5). Changes in emissions should be identified by the type of source or activity. Section 51.308(g)(5) also addresses changes in emissions since the period addressed by the previous progress report and requires states' SIP revisions to include an assessment of any significant changes in anthropogenic emissions within or outside the state. This assessment must include an explanation of whether these changes in emissions were anticipated and whether they have limited or impeded progress in reducing emissions and improving visibility relative to what the state projected based on its LTS for the first planning period.
                </P>
                <HD SOURCE="HD2">G. Requirements for State and Federal Land Manager (FLM) Coordination</HD>
                <P>
                    CAA section 169A(d) requires that before a state holds a public hearing on a proposed regional haze SIP revision, it must consult with the appropriate FLM or FLMs; pursuant to that consultation, the state must include a summary of the FLMs' conclusions and recommendations in the notice to the public. Consistent with this statutory requirement, the RHR also requires that states “provide the [FLM] with an opportunity for consultation, in person and at a point early enough in the State's policy analyses of its long-term strategy emission reduction obligation so that information and recommendations provided by the [FLM] can meaningfully inform the State's decisions on the long-term strategy.” 
                    <E T="03">See</E>
                     40 CFR 51.308(i)(2). Consultation that occurs 120 days prior to any public hearing or public comment opportunity will be deemed “early enough,” but the RHR provides that in any event the opportunity for consultation must be provided at least 60 days before a public hearing or comment opportunity. This consultation must include the opportunity for the FLMs to discuss their assessment of visibility impairment in any Class I area and their recommendations on the development and implementation of strategies to address such impairment. 
                    <E T="03">See</E>
                     40 CFR 51.308(i)(2). In order for EPA to evaluate whether FLM consultation meeting the requirements of the RHR has occurred, the SIP submission should include documentation of the timing and content of such consultation. The SIP revision submitted to EPA must also describe how the state addressed any comments provided by the FLMs. 
                    <E T="03">See</E>
                     40 CFR 51.308(i)(3). Finally, a SIP revision must provide procedures for continuing consultation between the state and FLMs regarding the state's visibility protection program, including development and review of SIP revisions, five-year progress reports, and the implementation of other programs having the potential to contribute to impairment of visibility in Class I areas. 
                    <E T="03">See</E>
                     40 CFR 51.308(i)(4).
                </P>
                <HD SOURCE="HD1">IV. EPA's Evaluation of Florida's Regional Haze Submissions for the Second Planning Period</HD>
                <P>
                    On October 8, 2021, June 14, 2024, and October 28, 2024, FDEP submitted revisions to the Florida SIP to address the State's regional haze obligations for the second planning period, which runs through 2028, in accordance with CAA section 169A and the RHR at 40 CFR 51.308(f).
                    <SU>39</SU>
                    <FTREF/>
                     The following sections contain EPA's evaluation of Florida's Haze Plan with respect to the requirements of the CAA and RHR for the second planning period of the regional haze program.
                </P>
                <FTNT>
                    <P>
                        <SU>39</SU>
                         On December 30, 2011, EPA proposed a limited disapproval of the Florida regional haze SIP since Florida had relied on requirements of the Clean Air Interstate Rule to satisfy certain regional haze requirements. 
                        <E T="03">See</E>
                         76 FR 82219. However, EPA determined not to finalize the limited disapproval for Florida because the State had requested additional time to modify its SIP to address the change in applicability of the Cross-State Air Pollution Rule to Florida in the final rule published on August 8, 2011. 
                        <E T="03">See</E>
                         76 FR 48208. EPA then proposed a limited approval of Florida's first period regional haze plan submission on May 25, 2012. 
                        <E T="03">See</E>
                         77 FR 31240. Later, on August 29, 2013, EPA approved Florida's first period regional haze plan submitted to EPA on March 19, 2010, as amended on August 31, 2010, and September 17, 2012. 
                        <E T="03">See</E>
                         78 FR 53250.
                    </P>
                </FTNT>
                <P>
                    Florida has three mandatory Class I areas within its borders: Everglades National Park (Everglades), Chassahowitzka National Wilderness Area (Chassahowitzka), and St. Marks National Wilderness Area (St. Marks).
                    <SU>40</SU>
                    <FTREF/>
                     The following sections describe Florida's Haze Plan, including analyses conducted by VISTAS and Florida's determinations based on those analyses, Florida's assessment of progress made since the first planning period in reducing emissions of visibility impairing pollutants, and the visibility improvement progress at its Class I areas and nearby Class I areas.
                </P>
                <FTNT>
                    <P>
                        <SU>40</SU>
                         Bradwell Bay Wilderness Area is one of only two Class I areas in the country for which visibility is not considered an important value. As such, the RHR does not apply to Bradwell Bay Wilderness Area. 
                        <E T="03">See</E>
                         44 FR 69122, (November 3, 1979).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">A. Identification of Class I Areas</HD>
                <P>
                    <E T="03">1. RHR Requirement:</E>
                     Section 169A(b)(2) of the CAA requires each state in which any Class I area is located or “the emissions from which may reasonably be anticipated to cause or contribute to any impairment of visibility” in a Class I area to have a plan for making reasonable progress toward the national visibility goal. The RHR implements this statutory requirement at 40 CFR 51.308(f), which provides that each state's plan “must 
                    <PRTPAGE P="105516"/>
                    address regional haze in each mandatory Class I Federal area located within the State and in each mandatory Class I Federal area located outside the State that may be affected by emissions from within the State,” and (f)(2), which requires each state's plan to include a LTS that addresses regional haze in such Class I areas. To develop a state's LTS, a state must first determine which Class I areas may be affected by its own emissions. For out-of-state Class I areas, states must assess their visibility impacts on a statewide basis, which is discussed in section IV.A.2 below, and on a source specific basis, which is discussed in IV.C.2 below.
                </P>
                <P>
                    <E T="03">2. State Assessment:</E>
                     To address 40 CFR 51.308(f)(2), Florida identified Class I areas affected by statewide emissions of the primary visibility impairing pollutants and then consulted states with Class I areas affected by Florida's statewide emissions. Specifically, FDEP presented the results of Particulate Matter Source Apportionment Technology (PSAT) 
                    <SU>41</SU>
                    <FTREF/>
                     modeling, which VISTAS conducted to estimate the projected impact of statewide SO
                    <E T="52">2</E>
                     and NO
                    <E T="52">X</E>
                     emissions across all emissions sectors in 2028 on total light extinction for the 20 percent most impaired days in all Class I areas in the VISTAS modeling domain.
                    <SU>42</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>41</SU>
                         PSAT is Particulate Matter Source Apportionment Technology, which is an option in the photochemical visibility impact modeling performed by VISTAS that is a methodology to track the fate of both primary and secondary PM. PSAT allows emissions to be tracked (“tagged”) for individual facilities as well as various combinations of sectors and geographic areas (
                        <E T="03">e.g.,</E>
                         by state). The PSAT results provide the modeled contribution of each of the tagged sources or groups of sources to the total visibility impacts.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>42</SU>
                         FDEP did not include directly emitted PM data in this analysis because the PSAT analyses performed by VISTAS tagged statewide emissions of SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">X</E>
                         and did not tag primary (directly emitted) direct PM emissions in the analysis after concluding that SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">X</E>
                         emissions, particularly from point sources, are projected to have the largest impact on visibility impairment in 2028.
                    </P>
                </FTNT>
                <P>
                    In table 10-1 on page 297 of Florida's 2021 Plan, Florida listed the top 10 Class I areas outside of the State that are impacted by Florida sources' emissions of SO
                    <E T="52">2</E>
                     and NO
                    <E T="52">X</E>
                    , ranked by absolute impact in Mm
                    <E T="51">−1</E>
                    . The top 10 areas impacted by Florida's statewide emissions of SO
                    <E T="52">2</E>
                     and NO
                    <E T="52">X</E>
                     are located in the following six States: Alabama (Sipsey National Wilderness Area); Georgia (Cohutta National Wilderness Area (Cohutta), Okefenokee National Wilderness Area (Okefenokee), and Wolf Island National Wilderness Area (Wolf Island)); Louisiana (Breton National Wilderness Area (Breton)); North Carolina (Shining Rock National Wilderness Area and Swanquarter National Wilderness Area); North Carolina/Tennessee (Great Smoky Mountains National Park and Joyce Kilmer-Slickrock National Wilderness Area (Joyce Kilmer)); and South Carolina (Cape Romain National Wilderness Area (Cape Romain)).
                    <SU>43</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>43</SU>
                         The visibility impacts projected in 2028 to the top three Class I areas impacted by Florida's SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">X</E>
                         emissions (excluding the three Florida Class I areas) are: 14.2 percent at Okefenokee (Georgia); 8.8 percent at Wolf Island (Georgia); and 4.1 percent at Cape Romain (South Carolina).
                    </P>
                </FTNT>
                <P>
                    Florida consulted with the VISTAS states (
                    <E T="03">see</E>
                     section 10.1 and appendix F-1 of the 2021 Plan) and the Mid-Atlantic/Northeast Visibility Union (MANE-VU) states (
                    <E T="03">see</E>
                     section 10.3 and appendix F-4 of the 2021 Plan). Similarly, FDEP participated in multistate conference calls with the Central States Air Resource Agencies Association to discuss its statewide impacts to Class I areas, including Breton in Louisiana. In addition to these interstate consultations related to Florida's statewide visibility impacts to Class I areas, Florida consulted with Georgia on specific Florida sources impacting visibility at Georgia's Class I areas. FDEP documented consultations with these states in section 10 and appendix F of the 2021 Plan. Florida's interstate consultation is further discussed in section IV.C.2.e of this proposed rulemaking and section I.F of EPA's Technical Support Document (TSD).
                </P>
                <P>
                    <E T="03">3. EPA Evaluation:</E>
                     EPA proposes to find that Florida adequately addressed 40 CFR 51.308(f)(2) regarding identification of its statewide visibility impacts to Class I areas outside of the State and consulting with states with Class I areas which may reasonably be anticipated to cause or contribute to any impairment of visibility due to Florida's emissions. EPA proposes to find that the State's approach of focusing on SO
                    <E T="52">2</E>
                     and NO
                    <E T="52">X</E>
                     impacts from Florida on the basis that, for current visibility conditions evaluated for the 2014-2018 period, ammonium sulfate is the dominant visibility impairing pollutant at most of the VISTAS Class I areas followed by organic carbon and ammonium nitrate (depending on the area), is reasonable.
                    <SU>44</SU>
                    <FTREF/>
                     VISTAS focused on controllable emissions from point sources and thus initially considered impacts from sulfates and nitrates on regional haze at Class I areas affected by VISTAS states. EPA proposes to find that FDEP satisfied the part of 40 CFR 51.308(f)(2) related to the identification of Class I areas outside of Florida that may be affected by emissions from within the State and consultation with affected states because the State analyzed its statewide sulfate and nitrate contributions to total visibility impairment at out-of-state Class I areas in table 10-1 of the 2021 Plan; and the State completed consultation with VISTAS and MANE-VU states via the RPO processes, and, in some cases, on a state-to-state basis and documented those consultations.
                    <SU>45</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>44</SU>
                         
                        <E T="03">See</E>
                         figures 2-12 and 2-13 of the 2021 Plan for the VISTAS Class I areas. 
                        <E T="03">See</E>
                         also section IV.C.2.a of this document.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>45</SU>
                         
                        <E T="03">See</E>
                         section IV.C.2.e of this document and section I.F of EPA's TSD for additional detail regarding consultation.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Calculations of Baseline, Current, and Natural Visibility Conditions; Progress to Date; and the URP</HD>
                <P>
                    <E T="03">1. RHR Requirement:</E>
                     Section 51.308(f)(1) requires states to determine the following for “each mandatory Class I Federal area located within the State”: baseline visibility conditions for the clearest days and most impaired days, natural visibility conditions for the clearest days and most impaired days, progress to date for the clearest days and most impaired days, the differences between current visibility conditions and natural visibility conditions, and the URP. This section also provides the option for states to propose adjustments to the URP line for a Class I area to account for visibility impacts from anthropogenic sources outside the United States and/or the impacts from wildland prescribed fires that were conducted for certain, specified objectives. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(1)(vi)(B).
                </P>
                <P>
                    <E T="03">2. State Assessment:</E>
                     In the 2021 Plan, Florida calculated the baseline visibility conditions (2000-2004) in table 2-3; current visibility conditions (2014-2018) in table 2-5; and natural visibility conditions in table 2-2 for the 20 percent most impaired and 20 percent clearest days for the State's Class I areas in deciviews, as shown in table 1, below. Florida also calculated the actual progress made toward natural visibility conditions to date since the baseline period (current minus baseline), and the additional progress needed to reach natural visibility conditions from current conditions (natural minus current), in deciviews, in table 2-6 (for the 20 percent most impaired days) and table 2-7 (for the 20 percent clearest days) as shown in table 2, below.
                    <PRTPAGE P="105517"/>
                </P>
                <GPOTABLE COLS="7" OPTS="L2,i1" CDEF="s50,10,10,10,12,10,12">
                    <TTITLE>
                        Table 1—Baseline, Current, and Natural Visibility Conditions in Florida's Class I Areas in Deciviews (
                        <E T="01">dv</E>
                        )
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1">Class I area</CHED>
                        <CHED H="1">
                            Baseline
                            <LI>clearest</LI>
                            <LI>20%</LI>
                        </CHED>
                        <CHED H="1">
                            Baseline
                            <LI>most</LI>
                            <LI>impaired</LI>
                            <LI>20%</LI>
                        </CHED>
                        <CHED H="1">
                            Current
                            <LI>clearest</LI>
                            <LI>20%</LI>
                        </CHED>
                        <CHED H="1">
                            Current most
                            <LI>impaired</LI>
                            <LI>20%</LI>
                        </CHED>
                        <CHED H="1">
                            Natural
                            <LI>clearest</LI>
                            <LI>20%</LI>
                        </CHED>
                        <CHED H="1">
                            Natural most
                            <LI>impaired</LI>
                            <LI>20%</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Chassahowitzka</ENT>
                        <ENT>15.60</ENT>
                        <ENT>24.52</ENT>
                        <ENT>12.41</ENT>
                        <ENT>17.41</ENT>
                        <ENT>6.00</ENT>
                        <ENT>9.03</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Everglades</ENT>
                        <ENT>11.69</ENT>
                        <ENT>19.52</ENT>
                        <ENT>10.37</ENT>
                        <ENT>14.90</ENT>
                        <ENT>5.22</ENT>
                        <ENT>8.33</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">St. Marks</ENT>
                        <ENT>14.34</ENT>
                        <ENT>24.68</ENT>
                        <ENT>11.15</ENT>
                        <ENT>17.39</ENT>
                        <ENT>5.37</ENT>
                        <ENT>9.13</ENT>
                    </ROW>
                </GPOTABLE>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,14,16,14,16">
                    <TTITLE>
                        Table 2—Actual Progress for Visibility Conditions in Florida's Class I Areas in Deciviews (
                        <E T="01">dv</E>
                        )
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1">Class I area</CHED>
                        <CHED H="1">
                            Current minus
                            <LI>baseline for</LI>
                            <LI>clearest 20%</LI>
                        </CHED>
                        <CHED H="1">
                            Current minus
                            <LI>baseline for most</LI>
                            <LI>impaired 20%</LI>
                        </CHED>
                        <CHED H="1">
                            Natural minus
                            <LI>current for</LI>
                            <LI>clearest 20%</LI>
                        </CHED>
                        <CHED H="1">
                            Natural minus
                            <LI>current for most</LI>
                            <LI>impaired 20%</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Chassahowitzka</ENT>
                        <ENT>−3.19</ENT>
                        <ENT>−7.11</ENT>
                        <ENT>−6.41</ENT>
                        <ENT>−8.38</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Everglades</ENT>
                        <ENT>−1.32</ENT>
                        <ENT>−4.62</ENT>
                        <ENT>−5.15</ENT>
                        <ENT>−6.57</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">St. Marks</ENT>
                        <ENT>−3.19</ENT>
                        <ENT>−7.29</ENT>
                        <ENT>−5.78</ENT>
                        <ENT>−8.26</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    Additionally, figures 3-1, 3-2, and 3-3 of the 2021 Plan provide the URP figures on the 20 percent most impaired days for Chassahowitzka, Everglades, and St. Marks, respectively. The URPs were developed using EPA guidance and data collected from the IMPROVE monitoring network, which is used to measure visibility impairment caused by air pollution at the 156 Class I areas covered by the visibility program. All Florida Class I areas are projected to be below the 2028 URP values for the second planning period based on VISTAS' modeling. However, due to issues in the VISTAS model performance for Everglades, Florida relied on visibility modeling completed by EPA in 2019 for this Class I area.
                    <SU>46</SU>
                    <FTREF/>
                     EPA modeling tended to have better performance for Everglades due to the use of an expanded modeling domain, updated boundary conditions (including marine offshore emissions), and a more recent base year, allowing for more accurate 2028 emissions and visibility projections. Thus, Florida is relying on EPA's regional haze modeling for Everglades visibility projections and RPG development.
                </P>
                <FTNT>
                    <P>
                        <SU>46</SU>
                         
                        <E T="03">See</E>
                         Memorandum from Richard A, Wayland, Office of Air Quality Planning and Standards, to Regional Air Division Directors re: Availability of Modeling Data and Associated Technical Support Document for the EPA's Updated 2028 Visibility Air Quality Modeling (September 19, 2019), available at: 
                        <E T="03">https://www.epa.gov/sites/default/files/2019-10/documents/updated_2028_regional_haze_modeling-tsd-2019_0.pdf.</E>
                    </P>
                </FTNT>
                <P>
                    <E T="03">3. EPA Evaluation:</E>
                     EPA is proposing to find that Florida's Haze Plan meets the requirements of 40 CFR 51.308(f)(1) because the State provides for its three Class I areas: baseline, current and natural visibility conditions for the 20 percent clearest days and most impaired days, progress to date for the 20 percent clearest days and most impaired days, the differences between the current visibility condition and natural visibility condition, and the URP for each Class I area in Florida. Further, FDEP provided a reasonable explanation for using EPA's modeling for 2028 for Everglades is appropriate in this instance as mentioned above.
                    <SU>47</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>47</SU>
                         
                        <E T="03">See</E>
                         section 6.6, “Model Performance for Everglades,” on pp. 146-154 of Florida's 2021 Plan.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. LTS for Regional Haze</HD>
                <P>
                    1. 
                    <E T="03">RHR Requirement:</E>
                     Each state having a Class I area within its borders or emissions that may affect visibility in a Class I area must develop a LTS for making reasonable progress toward the national visibility goal. 
                    <E T="03">See</E>
                     CAA 169A(b)(2)(B). As explained in the Background section of this document, reasonable progress is achieved when all states contributing to visibility impairment in a Class I area are implementing the measures determined—through application of the four statutory factors to sources of visibility impairing pollutants—to be necessary to make reasonable progress. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(2)(i). Each state's LTS must include the enforceable emission limitations, compliance schedules, and other measures that are necessary to make reasonable progress. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(2).
                </P>
                <P>
                    All new (
                    <E T="03">i.e.,</E>
                     additional) measures that are the outcome of FFAs are necessary to make reasonable progress and must be in the LTS. If the outcome of an FFA and other measures necessary to make reasonable progress is that no new measures are reasonable for a source, that source's existing measures are necessary to make reasonable progress, unless the state can demonstrate that the source will continue to implement those measures and will not increase its emission rate. Existing measures that are necessary to make reasonable progress must also be in the LTS. In developing its LTS, a state must also consider the five additional factors in 40 CFR 51.308(f)(2)(iv). As part of its reasonable progress determinations, the state must describe the criteria used to determine which sources or group of sources were evaluated (
                    <E T="03">i.e.,</E>
                     subjected to FFA) for the second planning period and how the four factors were taken into consideration in selecting the emission reduction measures for inclusion in the LTS. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(2)(iii).
                </P>
                <P>
                    States may rely on technical information developed by the RPOs of which they are members to select sources for FFA and to satisfy the documentation requirements under 40 CFR 51.308(f). Where an RPO has performed source selection and/or FFAs (or considered the five additional factors in 40 CFR 51.308(f)(2)(iv)) for its member states, those states may rely on the RPO's analyses for the purpose of satisfying the requirements of 40 CFR 51.308(f)(2)(i) so long as the states have a reasonable basis to do so and all state participants in the RPO process have approved the technical analyses. 
                    <E T="03">See</E>
                     40 CFR 51.308(f)(2)(iii).
                </P>
                <P>States may also satisfy the requirement of 40 CFR 51.308(f)(2)(ii) to engage in interstate consultation with other states that have emissions that are reasonably anticipated to contribute to visibility impairment in a given Class I area under the auspices of intra- and inter-RPO engagement.</P>
                <P>
                    The consultation requirements of 40 CFR 51.308(f)(2)(ii) provide that states must consult with other states that are reasonably anticipated to contribute to visibility impairment in a Class I area to develop coordinated emission management strategies containing the emission reductions measures that are 
                    <PRTPAGE P="105518"/>
                    necessary to make reasonable progress. Section 51.308(f)(2)(ii)(A) and (B) require states to consider the emission reduction measures identified by other states as necessary for reasonable progress and to include agreed upon measures in their SIPs, respectively. Section 51.308(f)(2)(ii)(C) speaks to what happens if states cannot agree on what measures are necessary to make reasonable progress.
                </P>
                <P>The documentation requirement of 40 CFR 51.308(f)(2)(iii) provides that states may meet their obligations to document the technical bases on which they are relying to determine the emission reductions measures that are necessary to make reasonable progress through an RPO, as long as the process has been “approved by all State participants.” Section 51.308(f)(2)(iii) also requires that the emissions information considered to determine the measures that are necessary to make reasonable progress include information on emissions for the most recent year for which the state has submitted triennial emissions data to EPA (or a more recent year), with a 12-month exemption period for newly submitted data.</P>
                <P>
                    <E T="03">2. State Assessment:</E>
                     To develop Florida's LTS, FDEP set criteria to identify sources to evaluate for potential controls outlined in section II.B, selected sources based on those criteria, considered the four CAA factors for the selected sources (or demonstrated the sources have existing effective controls as explained in IV.C.2.b. below), provided emissions limits and supporting conditions for incorporation into the SIP, and evaluated the five additional factors at 40 CFR 51.308(f)(2)(iv).
                </P>
                <P>
                    <E T="03">a. Source Selection Criteria:</E>
                     With respect to 40 CFR 51.308(f)(2)(i), Florida, through VISTAS, used a two-step source selection process: (1) Area of Influence (AoI) analysis,
                    <SU>48</SU>
                    <FTREF/>
                     and (2) PSAT 
                    <SU>49</SU>
                    <FTREF/>
                     modeling for sources exceeding an AoI threshold. Florida considered the four factors (or demonstrated the sources have existing effective controls as explained in IV.C.2.b. below) for sources that exceeded both the AoI and PSAT thresholds. Both sulfates and nitrates were considered in the source selection process. To identify sources having the most impact on visibility at Class I areas for PSAT modeling, Florida used an AoI threshold of greater than or equal to five percent for sulfate and nitrate combined area for all sources within and outside of the State. Sources selected at the AoI screening step for PSAT modeling are listed in table 7-11 of the 2021 Plan. Of these 18 sources, 17 sources located within Florida exceeded the AoI threshold for any Class I area in the State: Cemex Miami Cement Plant, Duke Crystal River Power Plant (Duke-Crystal River), FPL Turkey Point, Georgia-Pacific—Foley Cellulose Perry Mill (Foley), Gulf Clean Energy Center—Crist Generating Plant, Homestead City Utilities, Jacksonville Electric Authority—Northside Generating Station (JEA Northside), Mosaic Fertilizer, LLC—New Wales (Mosaic-New Wales), Mosaic Fertilizer, LLC—Riverview (Mosaic-Riverview), Mosaic Fertilizer, LLC—Bartow (Mosaic-Bartow), Nutrien White Springs Agricultural Chemicals, Inc. (Nutrien), Rayonier Performance Fibers LLC, Tallahassee City Purdom Generating Station, Tampa Electric Company—Big Bend Power Station (TECO-Big Bend), Titan-Pennsuco, WestRock Fernandina Beach Paper Mill (WestRock-Fernandina), and WestRock Panama City Paper Mill (WestRock-Panama City).
                </P>
                <FTNT>
                    <P>
                        <SU>48</SU>
                         The AoI represents the geographical area around a Class I area in which emissions sources located in the AoI have the potential to contribute to visibility impairment at that Class I area. Emissions data from sources in the AoI is then evaluated to determine which of those sources are most likely contributing to visibility impairment at that Class I area. VISTAS used AoI analysis for all point source facilities in the VISTAS modeling domain to determine the relative visibility impairment impacts at each Class I area associated with sulfate and nitrate. The results of the facility-level AoI analyses were then used to rank and prioritize facilities for further evaluation via PSAT.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>49</SU>
                         PSAT modeling is a type of photochemical modeling which quantifies individual facility visibility impacts to an area. 
                        <E T="03">See</E>
                         footnote 40. FDEP applied its PSAT threshold by facility. In the regional haze SIPs developed for the first round of planning, many VISTAS states used the AoI approach and a one percent threshold by unit. Florida followed a different approach using emissions (tons per year) divided by distance (kilometers) (Q/d) but showed that this approach screened in a similar number of units to the AoI approach, and therefore, had similar screening stringency.
                    </P>
                </FTNT>
                <P>
                    Florida, in coordination with the other VISTAS states, selected sources for further evaluation using a PSAT threshold of greater than or equal to one percent visibility impact for sulfate or nitrate. Sources both within and outside of Florida that were identified for an emissions control analysis are listed in tables 7-25 and 7-26 of the 2021 Plan, and Mosaic Fertilizer, LLC-South Pierce (Mosaic-South Pierce) is identified in section 7.6.4.1 of the 2024 Supplement. Twelve sources were selected by FDEP for an emissions control analysis. In addition, FDEP identified two additional sources in Georgia and Kentucky that were requested by FDEP for further analysis as part of the interstate consultation process. The 12 sources in Florida are: Duke-Crystal River, Foley, JEA Northside, Lakeland CD McIntosh Jr. Power Plant (CD McIntosh),
                    <SU>50</SU>
                    <FTREF/>
                     Mosaic-Bartow, Mosaic-New Wales, Mosaic-South Pierce, Nutrien, Seminole Electric Cooperative Incorporated (Seminole), TECO-Big Bend, WestRock-Fernandina, and WestRock-Panama City.
                    <SU>51</SU>
                    <FTREF/>
                     Because no sources exceeded the State's PSAT threshold for nitrates and because ammonium sulfate continues to be the dominant visibility impairing pollutant at Class I areas potentially impacted by Florida sources (as discussed in the following paragraphs), FDEP focused solely on evaluating potential SO
                    <E T="52">2</E>
                     controls to address regional haze in potentially affected Class I areas. FDEP allowed the selected facilities to either demonstrate that units emitting greater than five tons per year (tpy) of SO
                    <E T="52">2</E>
                     were already effectively controlled or complete an FFA for this pollutant.
                </P>
                <FTNT>
                    <P>
                        <SU>50</SU>
                         The fossil fuel steam generating unit No. 3 (EU006) at CD McIntosh was permanently shut down in 2021. 
                        <E T="03">See</E>
                         appendices G-3 and G-5h of the 2021 Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>51</SU>
                         In June 2022, the WestRock-Panama City facility announced its intention to permanently cease operations. 
                        <E T="03">See</E>
                         section 7.8.4 of the 2024 supplement. FDEP included documentation for closure of the WestRock-Panama City facility in its 2024 Supplement. In addition, on October 18, 2024, FDEP sent a site inspection report and other supporting documentation for the WestRock-Panama City closure as an addendum to the 2024 Supplement. The inspection report documents the permanent closure and inoperable status of the facility and notes that any project to restore the facility would be subjected to mandatory New Source Review and that multiple new source performance standards would inevitably apply. This additional documentation may be found in the docket for this proposed rulemaking.
                    </P>
                </FTNT>
                <P>
                    FDEP determined that during the 2014 to 2018 timeframe, Florida's Class I areas were impacted most heavily by sulfate. 
                    <E T="03">See</E>
                     figures 2-9 through 2-11 of the 2021 Plan. In Florida's AoI analysis, Florida used extinction-weighted residence time plots to allow for a separate analysis of sulfates and nitrates. Figures 7-42, 7-43, and 7-44 of the 2021 Plan contain the sulfate extinction weighted residence time for Chassahowitzka, St. Marks, and Everglades, respectively, for the 20 percent most impaired days from 2011 to 2016. Figures 7-45, 7-46, and 7-47 contain the nitrate extinction weighted residence time for Chassahowitzka, St. Marks, and Everglades, respectively, for the 20 percent most impaired days from 2011 to 2016. The sulfate extinction weighted residence times are significantly higher (approximately ten times higher) than the nitrate extinction weighted residence times on the 20 percent most impaired days during this time period, demonstrating the importance of focusing on SO
                    <E T="52">2</E>
                     emission reductions.
                    <PRTPAGE P="105519"/>
                </P>
                <P>
                    The Haze Plan shows the VISTAS modeled projections demonstrating that ammonium sulfate is expected to remain the dominant visibility impairing pollutant through 2028, by a factor of four or greater over ammonium nitrate at Class I areas in Florida.
                    <SU>52</SU>
                    <FTREF/>
                     In section 7.4 of the 2021 Plan, FDEP explains the VISTAS analyses relied upon to support the State's focus on SO
                    <E T="52">2</E>
                     control evaluations. Section 10.4.1 provides the State's responses to FLM comments on the exclusion of NOx control evaluations from the FFAs.
                    <SU>53</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>52</SU>
                         
                        <E T="03">See</E>
                         figures 2-9 through 2-12 of the 2021 Plan. Figures 2-9 through 2-11 provide 2014-2018 speciated PM data for Florida's Class I areas showing that ammonium sulfate is the dominant visibility impairing pollutant. Figures 2-11 and 2-12 provide speciated PM data for 2014-2018 for the VISTAS Class I areas and neighboring areas on the 20 percent most impaired days and 20 percent clearest days, respectively.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>53</SU>
                         
                        <E T="03">See</E>
                         section 2.5.2 (particularly figures 2-6 through 2-8 for 2009-2013) and section 2.4.1 of the 2021 Plan related to ammonium nitrate.
                    </P>
                </FTNT>
                <P>Additionally, in section 2.6 of the 2021 Plan, FDEP reviewed visibility monitoring data for the period 2014-2018 for Chassahowitzka, Everglades, and St. Marks. Figures 2-9 through 2-11 show the reconstructed light extinction for the 20 percent most impaired days at each Florida Class I areas, respectively. The data indicates that sulfates are the primary visibility impacting species in Florida's Class I areas during the 2014-2018 timeframe.</P>
                <P>
                    Furthermore, figures 7-22 (Chassahowitzka), 7-23 (St. Marks), and 7-24 (Everglades) in the 2021 Plan show that the majority of 2028 predicted nitrate light extinction on the 20 percent most impaired days at Florida's Class I areas is not caused by NO
                    <E T="52">X</E>
                     emissions from electric generating unit (EGU) and non-EGU point sources.
                    <SU>54</SU>
                    <FTREF/>
                     At Chassahowitzka, St. Marks, and the Everglades, projected total sulfate extinction is greater than 10 Mm
                    <E T="51">−1</E>
                     and projected total nitrate extinction is less than five Mm
                    <E T="51">−1</E>
                    .
                </P>
                <FTNT>
                    <P>
                        <SU>54</SU>
                         Figures 7-20 and 7-21 provides the 2028 visibility impairment from sulfate and nitrate on the 20 percent most impaired days for all 18 Class I areas in VISTAS. The figures show the EGU and non-EGU contributions to total nitrate derived light extinction in 2028.
                    </P>
                </FTNT>
                <P>
                    Section I.A of the TSD to this proposed rulemaking provides a summary of the State's source selection criteria, including the technical rationale for the State's focus on SO
                    <E T="52">2</E>
                     controls for the second planning period and the outcomes of the State's source selection process.
                </P>
                <P>
                    <E T="03">b. Consideration of the Four CAA Factors:</E>
                </P>
                <P>
                    As discussed in section IV.C.2.b.ii (
                    <E T="03">Existing, Effective Control Demonstrations</E>
                    ) below, eight of the 12 selected facilities in Florida demonstrated that some or all of the selected units are effectively controlled for SO
                    <E T="52">2.</E>
                     FDEP stated that there is a low likelihood that cost-effective technological advancements exist that could provide further reasonable emission reductions for these sources. For the remaining selected sources, FDEP fully considered the four CAA factors as discussed in section IV.C.2.b.i below.
                    <SU>55</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>55</SU>
                         As mentioned above, two of the 12 selected facilities permanently shut down (CD McIntosh Unit 3 and WestRock-Panama City).
                    </P>
                </FTNT>
                <P>
                    <E T="03">i. FFAs:</E>
                     Florida considered each of the four CAA factors for Foley, JEA Northside (Unit 3),
                    <SU>56</SU>
                    <FTREF/>
                     and WestRock-Fernandina and described how the four factors were taken into consideration in selecting the measures for inclusion in the State's LTS. Florida is proposing selected permit conditions summarized below for incorporation into the SIP as measures necessary for reasonable progress for the second planning period. 
                    <E T="03">See</E>
                     section I.B of the TSD to this proposed rulemaking for additional details.
                </P>
                <FTNT>
                    <P>
                        <SU>56</SU>
                         JEA Northside Unit 3 was selected for FFA and Units 1 and 2 were shown to be effectively controlled for SO
                        <E T="52">2</E>
                        .
                    </P>
                </FTNT>
                <P>
                    <E T="03">(a) Foley:</E>
                     Foley is a softwood Kraft Process Pulp Mill that manufactured bleached market pulps and dissolving cellulose pulps. FDEP requested that the facility complete an FFA for five units expected to emit more than five tpy of SO
                    <E T="52">2</E>
                     in 2028. FDEP evaluated emissions reductions measures for SO
                    <E T="52">2</E>
                     for the No. 1 Power Boiler; No. 1 Bark Boiler; and Nos. 2, 3, and 4 Recovery Furnaces.
                    <E T="51">57 58</E>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>57</SU>
                         FDEP determined that an FFA was not needed for Bark Boiler No. 2 because annual SO
                        <E T="52">2</E>
                         emissions from this unit are significantly lower than five tpy, Florida's threshold for the second planning period for determining which units are subject to an FFA for any selected source.
                    </P>
                    <P>
                        <SU>58</SU>
                         On January 19, 2024, FDEP published in the Florida Administrative Register a public notice of hearing for consideration of a proposed SIP revision, which included the FFA for Foley. The comment period for this proposed SIP revision closed on March 8, 2024. However, in April 2024, the Foley facility announced its intent to permanently cease operations. FDEP provided documentation of the closure in their 2024 Supplement. 
                        <E T="03">See</E>
                         section 7.8.3. However, because Foley is in an ongoing process to dismantle the facility, FDEP was unable to provide documentation to EPA that the facility was inoperable. Thus, FDEP provided the FFA for Foley that was originally part of the January 19, 2024, public engagement plan.
                    </P>
                </FTNT>
                <P>
                    <E T="03">No. 1 Power Boiler:</E>
                     The No. 1 Power Boiler serves as the secondary control device for low volume, high concentration (LVHC) non-condensable gas (NCG) and fires natural gas, No. 6 fuel oil, tall oil, and on-specification used oil. When NCGs are routed to the No. 1 Power Boiler, a pre-scrubber is used to assist with reduction of total reduced sulfur (TRS) which in turn limits SO
                    <E T="52">2</E>
                     production. The Mill identified a wet scrubber and a dry sorbent injection (DSI) system as available and feasible controls for this unit. The cost evaluation for the wet scrubber resulted in an estimated cost effectiveness of $13,547/ton to reduce actual SO
                    <E T="52">2</E>
                     emissions by approximately 80 tpy. FDEP determined that installation of a wet scrubber on No. 1 Power Boiler is not cost effective. As for the DSI system, the cost evaluation resulted in an estimated cost-effectiveness value of $21,727/ton to reduce actual SO
                    <E T="52">2</E>
                     emissions by approximately 73 tpy, which FDEP considered not cost effective. FDEP, however, determined that existing low-sulfur fuel restrictions on this unit were necessary for reasonable progress as follows: fire only natural gas except during specified times when natural gas is unavailable or there is a physical problem at the mill that prevents the firing of natural gas, in which case the unit may fire liquid fuels; tall oil is prohibited; No. 6 fuel oil purchases must meet a sulfur content limit of no more than 1.02 percent; and the unit is only permitted to burn LVHC NCG when the No. 1 Bark Boiler is unavailable or when necessary for compliance with 40 CFR part 63, subpart S, such as for monitoring for detectable leaks for the closed vent system. Florida has identified permit conditions for these restrictions for incorporation into the SIP.
                </P>
                <P>Regarding the other CAA factors, there is no time necessary to comply with the low-sulfur fuel option, and the use of low sulfur fuel did not result in non-air environmental impacts. For the wet scrubber and DSI options, FDEP states that it may take up to four years to secure funding, make the required technical changes, and perform testing and monitoring to ensure proper system operation for the installation of wet scrubbers and DSI systems. Energy and non-air environmental impacts include additional electrical costs associated with DSI and scrubber operation, and additional fresh water and wastewater disposal use for the wet scrubber. Additionally, the No. 1 Power Boiler is assumed to have 30 years or more of remaining useful life, and an interest rate of 3.25 was used when considering the annualized costs of controls.</P>
                <P>
                    <E T="03">No. 1 Bark Boiler:</E>
                     The No. 1 Bark Boiler serves as the primary control device for LVHC NCGs and provides the Mill with 200,000 pounds per hour (lbs/hr) (24-hour block average basis) of steam. The No. 1 Bark Boiler fires natural gas, No. 6 fuel oil, tall oil, and on-specification used oil and is equipped with a cyclone collector and 
                    <PRTPAGE P="105520"/>
                    a wet venturi scrubber. Currently, permit conditions for No. 1 Bark Boiler require the wet venturi scrubber to meet pH and flow rate restrictions only when the TRS pre-scrubber is not operational. For the FFA, FDEP evaluated one control option which consists of running the existing wet venturi scrubber whenever NCGs or oil are combusted in the No. 1 Bark Boiler, maintaining a minimum pH of 8 (three-hour block average), and flow rate of 1,000 gallons per minute (gpm) (three-hour block average), rather than only when the TRS pre-scrubber is unavailable. The increase in the operation of the wet scrubber requires an increase in the amount of time caustic is added to the wet scrubber which requires the addition of an antiscalant to minimize fouling and scaling due to caustic buildup in the boiler. FDEP evaluated these operational changes as technically feasible, and the cost evaluation resulted in an estimated annualized cost effectiveness of $2,627/ton to remove approximately 96 tpy of SO
                    <E T="52">2</E>
                     emissions. FDEP determined this control to be cost effective. Implementing the increased operation of the wet scrubber requires adding additional caustic and scalant to the scrubber control system, which could be done with within 12 months with no negative non-air environmental impacts. The No. 1 Bark Boiler is assumed to have 30 years or more of remaining useful life, and an interest rate of 3.25 percent was used when considering the annualized costs of controls. Florida has identified permit conditions for these requirements for incorporation into the SIP.
                </P>
                <P>FDEP also determined that certain existing measures are necessary for reasonable progress and proposed for incorporation into the SIP low sulfur fuel restrictions that are similar to the restrictions proposed for No. 1 Power, except the No. 1 Bark Boiler is permitted to burn wood in addition to natural gas as the primary fuel type. FDEP is proposing permit conditions reflecting these requirements for incorporation into the SIP.</P>
                <P>
                    <E T="03">Nos 2, 3, and 4 Recovery Furnaces:</E>
                     The three recovery furnaces are low-odor, non-direct contact evaporator units that burn the organic material present in black liquor (a byproduct in the Kraft Mill process). The furnaces fire natural gas, No. 6 fuel oil, No. 2 fuel oil, tall oil, ultra-low sulfur diesel, on-specification used oil, and methanol (methanol is only fired in select furnaces). Foley considered adding several common flue gas desulfurization (FGD) systems to the recovery furnaces, including spray dryer absorbers (SDA), DSI, and conventional wet scrubbers. Considering the antiquated design of the furnaces, FDEP found the addition of a wet scrubber to be the only feasible control technology.
                </P>
                <P>
                    FDEP identified a wet scrubber as a potential control option for the recovery furnaces, but noted that it is not aware of the installation of a wet scrubber on any recovery furnaces across the country. The cost effectiveness to add a wet scrubber was estimated at values of: $7,779/ton to reduce SO
                    <E T="52">2</E>
                     by approximately 592 tons annually for Recovery Furnace No. 2; $5,197/ton to reduce SO
                    <E T="52">2</E>
                     by approximately 1,050 tons annually for Recovery Furnace No. 3; and $6,587/ton to reduce SO
                    <E T="52">2</E>
                     by approximately 831 tons annually for Recovery Furnace No. 4. FDEP determined that adding a wet scrubber was not cost effective. FDEP estimated that it would take up to four years to install new controls at the recovery furnaces. Typical energy and non-air quality impacts of compliance include caustic and sulfuric acid costs, additional electrical costs associated with scrubber operation, additional fresh water for scrubber needs and wastewater disposal. It is assumed that the recovery furnaces have at least 30 years of remaining useful life, and an interest rate of 3.5 percent was used when considering the annualized costs of controls.
                </P>
                <P>
                    FDEP determined that the following existing measures at the recovery furnaces are necessary for reasonable progress: burn black liquor as the primary fuel; natural gas and liquid fuels may supplement recovery operations; a maximum sulfur content of 1.02 percent for purchased No. 6 fuel oil; and a SO
                    <E T="52">2</E>
                     emissions cap of 3,200 tons per consecutive 12 operating months as measured by a continuous emissions monitoring system (CEMS).
                </P>
                <P>
                    <E T="03">State Conclusions:</E>
                     Regarding the No. 1 Power Boiler, FDEP determined that there were no cost-effective emission reductions for the No. 1 Power Boiler and determined that the existing measures at the No. 1 Power Boiler are necessary for reasonable progress. Thus, FDEP proposed low-sulfur fuel restrictions for incorporation into the SIP for the No. 1 Power Boiler as described above.
                </P>
                <P>Regarding the No. 1 Bark Boiler, FDEP determined that continuously running the wet venturi scrubber with added caustic and scalant to maintain a minimum pH of 8 is cost-effective and, therefore, the State has determined that these controls are necessary for reasonable progress. FDEP also determined that certain existing low sulfur fuel restrictions are necessary for reasonable progress and proposed low sulfur fuel restrictions that are similar to the restrictions proposed for the No. 1 Power Boiler.</P>
                <P>Regarding the Nos. 2, 3, and 4 Recovery Furnaces, after conducting a site visit at Foley and discussing the physical constraints and reviewing the costs, FDEP determined that installation of a wet scrubber located after the electro-static precipitator (ESP) is not cost-effective and, therefore, the existing measures described above for the Nos. 2, 3 and 4 Recovery Furnaces are necessary for reasonable progress.</P>
                <P>
                    FDEP identified permit conditions reflecting these new and existing SO
                    <E T="52">2</E>
                     measures in the “Materials to be Incorporated into the SIP” section of the Second 2024 Supplement for incorporation into the regulatory portion of the Florida SIP.
                </P>
                <P>
                    <E T="03">(b) JEA Northside (Unit 3):</E>
                     JEA Northside is a power plant located in north Jacksonville. The main sources of SO
                    <E T="52">2</E>
                     emissions at JEA Northside are Nos. 1 and 2 (EU 026 and EU 027) circulating fluidized-bed (CFB) Boilers and the No. 3 (EU 003) Boiler. FDEP conducted an FFA for JEA Northside's No. 3 Boiler. For the Nos. 1 and 2 CFB Boilers, Florida relied on an existing effective controls demonstration, as discussed below in section IV.C.2.b.ii.
                </P>
                <P>
                    The No. 3 Boiler is a natural gas-fired electric utility steam generating unit as defined in 40 CFR 63.10042 that fires natural gas and limited amounts of No. 6 fuel oil. The FFA for the No. 3 Boiler identified the following available controls: using lower sulfur No. 6 fuel oil (from 1.8 percent to 1.0 percent), using ultra-low sulfur No. 2 fuel oil, or installing a wet FGD system. The cost effectiveness values for each control option are as follows: switching to a lower sulfur No. 6 fuel oil is $3,053/ton of SO
                    <E T="52">2</E>
                     removed, reducing emissions by 49.9 tpy; switching to No. 2 fuel oil is $7,334/ton of SO
                    <E T="52">2</E>
                     removed, reducing emissions by 122.81 tpy; and installing a wet FGD system is $177,856/ton of SO
                    <E T="52">2</E>
                     removed.
                    <SU>59</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>59</SU>
                         FDEP provided these cost effectiveness values because FDEP contends the costs provided by JEA were not justified adequately or were inconsistent with EPA's “Air Pollution Control Cost Manual” (Cost Manual) in the cost analysis. In all calculations, JEA used a seven percent interest rate instead of 3.25 percent (the current bank prime interest rate), used a 20-year lifetime instead of a more conservative 30-year lifetime, and included property taxes, insurance, and administration costs in the direct operating costs, which FDEP contends were not justified.
                    </P>
                </FTNT>
                <P>
                    Regarding the other CAA factors, FDEP estimated that it would take nine months to one year to complete a switch to No. 2 or No. 6 fuel oil because a boiler outage of approximately two to 
                    <PRTPAGE P="105521"/>
                    three months would be necessary to perform the new burner installation, and the State found no non-air environmental impacts from a switch. FDEP estimates installing a wet FGD system would take 36 months based on EPA's Integrated Planning Model (IPM) estimates and the need for engineering design, equipment procurement, and installation, and testing. Regarding energy and non-air environmental impacts of the wet FGD, FDEP states that there are energy penalties due to the pressure drop through the absorbers and the energy usage by auxiliary systems and estimates that the total energy impacts would be about 30,000 megawatt-hours for the maximum possible operation of Unit 3 currently authorized. Operation of wet FGD will also require the delivery, handling, and storage of limestone; the handling and disposal of FGD by-product (
                    <E T="03">i.e.,</E>
                     gypsum); and the use of process water. FDEP determined the remaining useful life factor for each control option to be 30 years and used a 3.25 percent interest rate when considering the annualized costs of controls.
                </P>
                <P>
                    <E T="03">State Conclusions:</E>
                     Regarding JEA Northside Unit 3, FDEP determined that switching to No. 2 fuel oil and installing a wet FGD system are not cost effective, and therefore, are not necessary for reasonable progress. FDEP determined that switching to a lower sulfur No. 6 fuel oil is cost effective, and selected it as a measure necessary for reasonable progress for JEA Northside Unit 3.
                </P>
                <P>
                    FDEP identified permit conditions reflecting this new SO
                    <E T="52">2</E>
                     measure in the “Materials to be Incorporated into the SIP” section of the 2021 Plan for incorporation into the regulatory portion of the Florida SIP.
                    <SU>60</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>60</SU>
                         See p. 13 of 34 of the “Materials to be Incorporated into the SIP” section to the administrative file of the 2021 Plan.
                    </P>
                </FTNT>
                <P>
                    <E T="03">(c) WestRock-Fernandina:</E>
                     WestRock-Fernandina is a fully integrated Kraft linerboard mill that produces linerboard from wood pulp and pulp derived from recycled corrugated containers. The Mill conducted projects totaling $15.9 million in capital costs in 2016 and 2017 to reduce both actual and allowable SO
                    <E T="52">2</E>
                     emissions so that modeled allowable emissions would demonstrate compliance with the 2010 SO
                    <E T="52">2</E>
                     NAAQS. Table 7-31 in the 2021 Plan shows the decrease in emissions levels that have occurred since the 2016-2017 timeframe. The last line in table 7-31 contains the updated, projected emissions from this facility. The largest SO
                    <E T="52">2</E>
                     sources at the Mill are the No. 5 and No. 7 Power Boilers and the No. 4 and No. 5 Recovery Boilers.
                </P>
                <P>
                    The No. 5 Power Boiler burns carbonaceous fuel such as biomass, natural gas, ultra-low sulfur diesel (ULSD), or No. 2 fuel oil. Currently, this unit is prohibited from using No. 6 fuel oil or being used as a backup NCG control device unless otherwise approved by FDEP's Division of Air Resource Management. Additionally, an engineering analysis must be submitted providing reasonable assurance that the boiler can comply with SO
                    <E T="52">2</E>
                     emissions standards of 15.0 lb/hour based on a 3-hour block average, as determined by data collected from a CEMS, during all periods of operation except when operating as a backup control device firing NCGs. The FFA for the No. 5 Power Boiler identified installation of a wet scrubber, installation of a wet scrubber with a stack liner, or installation of a DSI system as potential additional controls. The cost effectiveness values of these additional controls are as follows: installing a wet scrubber is $285,615/ton of SO
                    <E T="52">2</E>
                     removed; installing a wet scrubber with stack liner is $298,499/ton of SO
                    <E T="52">2</E>
                     removed; and installing DSI is $277,093/ton of SO
                    <E T="52">2</E>
                     removed. According to the FFA, it would take at least four years to install a wet scrubber or DSI system, and there are energy and non-air environmental impacts that would result from installing these controls, such as an increase in water and electricity usage and wastewater generation. The No. 5 Power Boiler is assumed to have a remaining useful life of 20 years or more; however, FDEP conservatively used a lifetime of 30 years to annualize costs and used a 3.25 percent interest rate when considering the annualized costs of controls. FDEP determined that these controls are not cost effective.
                </P>
                <P>
                    The No. 7 Power Boiler serves as a backup NCG control device and fires coal, oil, or natural gas. The FFA for the No. 7 Power Boiler identified reducing coal usage to 125 tons per day (tpd), installing a wet scrubber after the existing ESP, installing a DSI with an existing ESP, installing SDA with new fabric filter, or removing all coal firing as potentially available controls. The cost effectiveness values of these controls are as follows: reducing coal usage is a cost savings of $1,868/ton of SO
                    <E T="52">2</E>
                     removed; installing a wet scrubber is $5,641/ton of SO
                    <E T="52">2</E>
                     removed, reducing emissions by 1,222 tpy; installing a wet scrubber with stack liner is $6,028/ton of SO
                    <E T="52">2</E>
                     removed, reducing emissions by 1,222 tpy; installing DSI is $8,776/ton of SO
                    <E T="52">2</E>
                     removed, reducing emissions by 748 tpy; installing an SDA is $16,398/ton of SO
                    <E T="52">2</E>
                     removed, reducing emissions by 1,184 tpy; and removing all coal firing is $7,374/ton of SO
                    <E T="52">2</E>
                     removed, reducing emissions by 1,171 tpy. WestRock-Fernandina indicated they would need until 2024 to fully implement the coal reduction option but could begin limiting coal usage as early as 2022, because the Mill is contractually obligated to purchase a set amount of coal through 2021. There were no energy or non-air quality environmental impacts associated with the reduction of coal usage. The installation of a wet scrubber would increase water and electricity usage and wastewater generation. The installation of a DSI system or an SDA system would increase solid waste and electricity usage. The No. 7 Power Boiler fly ash is currently used in cement manufacturing but would have to be landfilled if contaminated with sorbent. The No. 7 Power Boiler has approximately 20 years or more of useful life remaining; however, FDEP conservatively used a useful life of 30 years to annualize the costs. FDEP used a 3.25 percent interest rate, a 98 percent control efficiency for FGD, a 60 percent control efficiency for DSI, a 95 percent control efficiency for SDA, and a 97 percent control efficiency for removing all coal in the calculations for No. 7 Power Boiler.
                </P>
                <P>
                    The No. 4 Recovery Boiler fires black liquor solids or No. 2 fuel oil and uses natural gas or No. 2 fuel oil for startup. No. 5 Recovery Boiler fires black liquor solids or No. 6 fuel oil and burns natural gas or No. 2 fuel oil for startup only. Currently, the SO
                    <E T="52">2</E>
                     emissions from Nos. 4 and 5 Recovery Boilers recovery boilers shall not exceed 150.0 lb/hour based on a 3-hour block average as determined by data collected from a certified CEMS or other methods approved by the Division of Air Resource Management. Alternatively, Nos. 4 and 5 Recovery Boilers may comply with the combined SO
                    <E T="52">2</E>
                     emissions cap which shall not exceed 300.0 lb/hour based on a 3-hour block average as determined by data collected from a certified CEMS. The FFA for the Nos. 4 and 5 Recovery Boilers identified the installation of wet scrubber as a potential additional control for each recovery boiler. FDEP determined that the cost effectiveness for the wet scrubber is $282,375/ton of SO
                    <E T="52">2</E>
                     removed for the No. 4 Recovery Boiler and $169,425/ton of SO
                    <E T="52">2</E>
                     removed for the No. 5 Recovery Boiler.
                    <SU>61</SU>
                    <FTREF/>
                     FDEP 
                    <PRTPAGE P="105522"/>
                    determined that WestRock-Fernandina would need a minimum of four years to install a wet scrubber and concluded that there are energy and non-air environmental impacts associated with the installation of a wet scrubber, including increased water and electricity usage and wastewater generation. The Nos. 4 and 5 Recovery Boilers are assumed to have 20 years of remaining useful life.
                </P>
                <FTNT>
                    <P>
                        <SU>61</SU>
                         FDEP provided these cost effectiveness values because it contends that the costs provided by Westrock were not justified adequately or were inconsistent with the Cost Manual in the cost analysis provided by WestRock-Fernandina. 
                        <PRTPAGE/>
                        WestRock used a 4.75% interest rate instead of 3.25% (the current bank prime interest rate), used a 15-year lifetime for equipment, and included property taxes without sufficient justification.
                    </P>
                </FTNT>
                <P>
                    <E T="03">State Conclusions:</E>
                     For WestRock-Fernandina's No. 7 Power Boiler, FDEP determined that removing all coal-firing or installing a wet scrubber, DSI, or SDA are not cost effective, and are therefore not necessary for reasonable progress. For the No. 7 Power Boiler, FDEP determined that reducing coal usage to 125 tpd is cost effective and is a measure that is necessary for reasonable progress.
                    <SU>62</SU>
                    <FTREF/>
                     Thus, FDEP identified the permit conditions reflecting this new SO
                    <E T="52">2</E>
                     measure for WestRock-Fernandina's No. 7 Power Boiler in the “Materials to be Incorporated into the SIP” sections 
                    <SU>63</SU>
                    <FTREF/>
                     of the 2021 Plan and appendix A-1 of the 2024 Supplement for incorporation into the regulatory portion of the Florida SIP. These conditions may be found in permit number 0890003-072-AC of the 2021 Plan and 0890003-074-AC and of the 2024 Supplement.
                </P>
                <FTNT>
                    <P>
                        <SU>62</SU>
                         FDEP is also proposing for incorporation into the SIP an interim coal usage restriction of 250 tpd. The 250 tpd coal usage limitation became effective on January 1, 2022, and was included in the 2021 Plan. It was intended as an interim measure that would apply until the facility could meet the 125 tpd usage restriction, which became effective on April 24, 2024. The facility is now subject to the more restrictive 125 tpd coal cap.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>63</SU>
                         
                        <E T="03">See</E>
                         pp. 15-16 of the administrative file of the 2021 Plan.
                    </P>
                </FTNT>
                <P>
                    For WestRock-Fernandina's No. 5 Power Boiler, FDEP determined that neither the installation of a wet scrubber—with or without the stack liner—nor the installation of a DSI system were cost effective. Likewise, FDEP determined that installation of wet scrubber for Nos. 4 and 5 Recovery Boilers was not cost effective. Therefore, FDEP determined that existing measures at the No. 5 Power Boiler and the Nos. 4 and 5 Recovery Boilers are necessary for reasonable progress. These existing measures, contained in permit number 0890003-046-AC, were already incorporated into the SIP through the Nassau County Florida SO
                    <E T="52">2</E>
                     Attainment Plan SIP revision approved by EPA on July 3, 2017 (82 FR 30749).
                    <SU>64</SU>
                    <FTREF/>
                     A list of the specific conditions included for regional haze informational purposes may be found in the “Materials Submitted for Informational Purposes Only” section, in appendix A-6 of the 2024 Supplement.
                </P>
                <FTNT>
                    <P>
                        <SU>64</SU>
                         According to section 7.8.2 of the 2021 Plan, WestRock-Fernandina conducted projects totaling $15.9 million in capital costs in 2016 and 2017 to reduce both actual and allowable SO
                        <E T="52">2</E>
                         emissions so that modeled allowable emissions would demonstrate compliance with the 2010 SO
                        <E T="52">2</E>
                         NAAQS. With these projects, the SO
                        <E T="52">2</E>
                         emission limit for the No. 5 Power Boiler was reduced from 550 pounds per hour (lb/hr) to 15 lb/hr. In 2020, the facility increased the black liquor solids content, which helps stabilize operation of the recovery boilers, thus, allowing for improved SO
                        <E T="52">2</E>
                         emissions.
                    </P>
                </FTNT>
                <P>
                    <E T="03">ii. Existing, Effective Control Demonstrations:</E>
                     As described in section 7.6.4.1 of the 2021 Plan, FDEP proposed existing SO
                    <E T="52">2</E>
                     measures as necessary for reasonable progress for incorporation into the Florida SIP for the affected units at the following eight facilities: Duke-Crystal River, JEA Northside, Mosaic-Bartow, Mosaic-New Wales, Mosaic-South Pierce, Nutrien, Seminole, and TECO-Big Bend. FDEP contends that these sources are effectively controlled and are unlikely to have additional controls available for reasonable progress.
                </P>
                <P>
                    Regarding Duke-Crystal River, Florida is proposing for adoption into the SIP permit conditions that require compliance with a limit of 0.20 pound per million British thermal units (lb/MMBtu) of SO
                    <E T="52">2</E>
                     for the fossil fuel steam generating Unit 4 and Unit 5 in lieu of performing a detailed FFA for these units. This emission limit is the alternative emission limit currently applicable to Duke-Crystal River under the Mercury and Air Toxics Standards (MATS) rule.
                    <SU>65</SU>
                    <FTREF/>
                     Including this emission limit in the SIP would also have the effect of removing the hydrogen chloride MATS compliance option for Duke-Crystal River. Florida concluded that these units are effectively controlled for SO
                    <E T="52">2</E>
                     emissions and that additional reasonable controls are unlikely to be found. Therefore, Florida is proposing for adoption into the SIP permit conditions for the 0.20 lb/MMBtu SO
                    <E T="52">2</E>
                     emission limitation and additional permit conditions that allow the citrus combined cycle station Units 1A, 1B, 2A, and 2B to combust only pipeline natural gas.
                    <SU>66</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>65</SU>
                         The MATS rule is located at 40 CFR part 63, subpart UUUUU. The MATS rule provides the 0.20 lb/MMBtu SO
                        <E T="52">2</E>
                         limit as an alternative to meeting an emission limit for hydrogen chloride.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>66</SU>
                         The permits are located in appendix G-3a1-2 of the 2021 Plan.
                    </P>
                </FTNT>
                <P>
                    Regarding JEA Northside, Florida proposed for adoption into the SIP permit conditions for Units 1 and 2 that include an SO
                    <E T="52">2</E>
                     limit of 0.15 lb/MMBtu, and the MATS-based SO
                    <E T="52">2</E>
                     emission limit of 0.20 lb/MMBtu.
                    <SU>67</SU>
                    <FTREF/>
                     Florida is proposing both the SO
                    <E T="52">2</E>
                     limit of 0.15 lb/MMBtu and the SO
                    <E T="52">2</E>
                     emission limit of 0.20 lb/MMBtu as reflecting effective controls for JEA Northside Units 1 and 2 because the SO
                    <E T="52">2</E>
                     emission limit of 0.15 lb/MMBtu had exemptions during period of startup, shutdown, and malfunction. The MATS limit applies continuously and has work practice standards which apply during startup and shutdown. Florida concluded that this unit is effectively controlled for SO
                    <E T="52">2</E>
                     emissions and that additional reasonable controls are unlikely to be found. Therefore, Florida is proposing for incorporation into the SIP permit conditions for the 0.20 lb/MMBtu emission limitation.
                </P>
                <FTNT>
                    <P>
                        <SU>67</SU>
                         The permits are located in appendix G-3c1-2 of the 2021 Plan and appendix A-2 of the 2024 Supplement. 
                        <E T="03">See</E>
                         section 7.6.4.1 and appendix A-2 of the 2024 Supplement.
                    </P>
                </FTNT>
                <P>
                    Regarding Mosaic-Bartow, Florida reviewed existing SO
                    <E T="52">2</E>
                     measures at three sulfuric acid plants (SAPs) at the facility, Nos. 4 through 6. This facility reduced SO
                    <E T="52">2</E>
                     emissions to bring the Hillsborough-Polk nonattainment area into attainment for the 2010 SO
                    <E T="52">2</E>
                     NAAQS, including upgrades to the catalyst beds. The SO
                    <E T="52">2</E>
                     generated in these systems is catalytically oxidized to sulfur trioxide (SO
                    <E T="52">3</E>
                    ) over the catalyst beds at a rate of 99.7 percent or higher. The facility is required to comply with a three-unit cap of 1,100 pounds/hour on a 24-hour block average as determined by continuous emission monitoring system (CEMS). Each SAP at the facility is required to meet a limit of four pounds (lbs) SO
                    <E T="52">2</E>
                     per ton of 100 percent sulfuric acid produced. Florida states that this limit is consistent with the SO
                    <E T="52">2</E>
                     best available control technology (BACT) determinations for sulfur burning, double-absorption sulfuric acid plants with cesium-promoted catalysts at a range of 3.0 to 4.0 lbs per ton in EPA's RACT/BACT/LAER Clearinghouse (RBLC) database.
                    <SU>68</SU>
                    <FTREF/>
                     Florida concluded that these units are effectively controlled for SO
                    <E T="52">2</E>
                     emissions and that additional reasonable controls are unlikely to be found. These SO
                    <E T="52">2</E>
                     limits are already incorporated into Florida's SIP.
                    <SU>69</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>68</SU>
                         The RBLC is located at: 
                        <E T="03">www.epa.gov/catc/ractbactlaer-clearinghouse-rblc-basic-information.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>69</SU>
                         
                        <E T="03">See</E>
                         85 FR 9666 (February 20, 2020); 40 CFR 52.520(d).
                    </P>
                </FTNT>
                <P>
                    Regarding Mosaic-New Wales, Florida reviewed existing SO
                    <E T="52">2</E>
                     measures at five SAPs at the facility, Nos. 1 through 5. This facility also reduced SO
                    <E T="52">2</E>
                     emissions to bring the Hillsborough-Polk nonattainment area into attainment for the 2010 SO
                    <E T="52">2</E>
                     NAAQS. The facility was required to comply with a five-unit SO
                    <E T="52">2</E>
                      
                    <PRTPAGE P="105523"/>
                    emissions cap of 1,090 lbs per hour on a 24-hour block average as determined by CEMS. SAP Nos. 1-3 are each required to meet an SO
                    <E T="52">2</E>
                     limit of 3.5 lbs per ton of 100 percent sulfuric acid produced on a 24-hr rolling average and four lbs per ton on a three-hour rolling average. SAPs 4 and 5 are each required to meet a limit of four lbs per ton of sulfuric acid produced. Florida affirms that this limit is consistent with the SO
                    <E T="52">2</E>
                     BACT determinations for sulfur burning, double-absorption sulfuric acid plants with cesium-promoted catalysts which appear in a range of 3.0 to 4.0 lbs per ton of sulfuric acid produced in EPA's RBLC database. Florida concluded that these units are effectively controlled for SO
                    <E T="52">2,</E>
                     and additional reasonable controls are unlikely to be found. These SO
                    <E T="52">2</E>
                     limits are already incorporated into Florida's SIP.
                    <SU>70</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>70</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    Regarding Mosaic-South Pierce, FDEP requested that the facility evaluate whether any additional measures were available to reduce SO
                    <E T="52">2</E>
                    .
                    <SU>71</SU>
                    <FTREF/>
                     Specifically, FDEP requested that Mosaic-South Pierce complete an FFA for SAPs Nos. 10 and 11 or demonstrate that those units were already effectively controlled for SO
                    <E T="52">2</E>
                    . Sulfuric Acid Plants Nos. 10 and 11 are double absorption sulfuric acid systems equipped with two absorption towers in series to react SO
                    <E T="52">3</E>
                     with water to produce sulfuric acid. The SO
                    <E T="52">2</E>
                     generated in a double absorption system's sulfur furnace is catalytically oxidized to SO
                    <E T="52">3</E>
                     over catalyst beds at a very high rate (99.7 percent or greater), which results in relatively low SO
                    <E T="52">2</E>
                     emissions as compared to a single absorption system. The second bed uses a cesium-promoted catalyst, which increases the overall SO
                    <E T="52">2</E>
                    -to-SO
                    <E T="52">3</E>
                     conversion rate. FDEP determined that the SAPs Nos. 10 and 11 at Mosaic-South Pierce are effectively controlled for SO
                    <E T="52">2</E>
                     based on a review of EPA's RBLC database which identified the combination of dual absorption design and cesium-promoted catalysts as BACT for sulfur-burning, non-single absorption column sulfuric acid plants and are therefore unlikely to have additional SO
                    <E T="52">2</E>
                     controls identified as part of an FFA. Florida has identified permit conditions for incorporation into the SIP that prohibit combined SO
                    <E T="52">2</E>
                     emissions from SAPs 10 and 11 from exceeding 750 lbs SO
                    <E T="52">2</E>
                     per hour on a 24-hour block average as determined by CEMS.
                    <SU>72</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>71</SU>
                         On February 1, 2023, the FDEP requested that Mosaic evaluate whether any additional measures were available to reduce SO
                        <E T="52">2</E>
                         emission from the Mosaic-South Pierce facility. 
                        <E T="03">See</E>
                         section 7.6.4.1 of the 2024 Supplement.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>72</SU>
                         The permit is located in appendix A-5 of the 2024 Supplement.
                    </P>
                </FTNT>
                <P>
                    Regarding Nutrien, this facility has recently completed significant work to reduce SO
                    <E T="52">2</E>
                     emissions to achieve SO
                    <E T="52">2</E>
                     limits imposed by a consent decree entered on February 26, 2015.
                    <SU>73</SU>
                    <FTREF/>
                     As part of the consent decree, Nutrien was required to reduce SO
                    <E T="52">2</E>
                     emissions and meet more stringent SO
                    <E T="52">2</E>
                     emission limits at SAPs C, D, E, and F. Nutrien elected to permanently shut down SAPs C and D in 2014, reducing SO
                    <E T="52">2</E>
                     emissions from these SAPs to zero. On March 31, 2017, FDEP issued permit No. 0470002-107-AC to Nutrien to complete upgrades on SAP E and SAP F, which included changing out and augmenting the converter catalyst in the SAPs, allowing them to meet new SO
                    <E T="52">2</E>
                     emission limits of 2.6 lbs per ton on a three-hour rolling average (excluding startups and shutdowns) and 2.3 lbs per ton limit on a 365-day rolling average (including startups and shutdowns), as required by the consent decree. Nutrien was required to comply with these limits on January 1, 2018, for SAP F and January 1, 2020, for SAP E. Additionally, on January 1, 2023, an 840 lbs/hour SO
                    <E T="52">2</E>
                     limit on a 24-hour block averaging period was applied to the combined emissions from SAP E and F.
                    <SU>74</SU>
                    <FTREF/>
                     Florida states that these limits are consistent with recent BACT determinations made for similar double-absorption, sulfur-burning SAPs. Florida concluded that this unit is effectively controlled for SO
                    <E T="52">2</E>
                     emissions and that additional reasonable controls are unlikely to be found. Florida did not identify the permit conditions from Permit No. 0470002-132-AC, issued on September 22, 2022, for incorporation into the SIP because they have already been incorporated through Florida's Supplemental SSM SIP as approved by EPA on August 4, 2023 (88 FR 51702).
                    <SU>75</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>73</SU>
                         The consent decree entered on February 26, 2015, is located in the docket for this proposed rulemaking. This consent decree terminated on April 3, 2023.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>74</SU>
                         
                        <E T="03">See</E>
                         section 7.6.4.1 of the 2024 Supplement.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>75</SU>
                         Permit No. 0470002-132-AC, issued on September 22, 2022, to Nutrien is located in appendix A-4 of the 2024 Supplement.
                    </P>
                </FTNT>
                <P>
                    Regarding TECO-Big Bend, this facility has accepted the MATS SO
                    <E T="52">2</E>
                     limit of 0.20 lb/MMBtu for fossil fuel steam generators No. 3 (EU003) 
                    <SU>76</SU>
                    <FTREF/>
                     and No. 4 (EU004). This emission limit is the alternative emission limit currently applicable to TECO-Big Bend under the MATS rule. Including this emission limit in the SIP would also have the effect of removing the hydrogen chloride MATS compliance option for TECO-Big Bend. Florida concluded that this unit is effectively controlled for SO
                    <E T="52">2</E>
                     emissions and that additional reasonable controls are unlikely to be found. Therefore, Florida identified permit conditions with these SO
                    <E T="52">2</E>
                     limits for Unit 4 at TECO-Big Bend for incorporation into the Florida SIP.
                    <SU>77</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>76</SU>
                         Since submission of the 2021 Plan, Unit 3 at TECO-Big Bend retired on April 26, 2023. The Clean Air Markets Division (CAMD) Acid Rain Retired Unit Exemption Form is included in the docket for this proposed rulemaking. For additional information regarding the shutdown and demolition of Unit 3, see the May 16, 2024 news release from TECO titled “Tampa Electric has Demolished Old Chimneys at Big Bend Power Plant”, available at: 
                        <E T="03">https://www.tampaelectric.com/mediacenter/2024/Tampa-Electric-has-Demolished-Old-Chimneys-at-Big-Bend-Power-Plant/#:~:text=The%20skyline%20of%20Apollo%20Beach,new%20view%20is%20Dramatically%20different.%E2%80%9D.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>77</SU>
                         The permits are located in appendix G-3 of the 2021 Plan and the permit conditions proposed for adoption into the SIP are listed under the “Materials to be Incorporated into the SIP” section in filename “Final SIP 2021-01 Regional Haze.pdf” included with the 2021 Plan.
                    </P>
                </FTNT>
                <P>
                    Regarding Seminole, this facility accepted the MATS SO
                    <E T="52">2</E>
                     limit of 0.20 lb/MMBtu for the steam electric generator No. 1 (EU001) and No. 2 (EU002) in the same manner as discussed with TECO-Big Bend in the preceding paragraph. Florida concluded that this unit is effectively controlled for SO
                    <E T="52">2</E>
                     emissions and that additional reasonable controls are unlikely to be found. Therefore, Florida identified permit conditions with these SO
                    <E T="52">2</E>
                     limits for incorporation into the Florida SIP.
                    <SU>78</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>78</SU>
                         The permits are located in appendix G-3h of the 2021 Plan and the permit conditions proposed for adoption into the SIP are listed under the “Materials to be Incorporated into the SIP” section in filename “Final SIP 2021-01 Regional Haze.pdf” included with the 2021 Plan.
                    </P>
                </FTNT>
                <P>Section I.B of the TSD to this proposed rulemaking provides a more detailed summary of the State's assessment of Florida's FFAs and existing effective controls, and the associated emissions control measures proposed for incorporation into the Florida SIP.</P>
                <P>
                    c. 
                    <E T="03">Documentation of Technical Basis:</E>
                     With respect to emissions information documentation pursuant to 40 CFR 51.308(f)(2)(iii), section 4 of the 2021 Plan explains the State's use of emissions inventories to develop the plan with additional documentation provided in appendix B. Florida, through VISTAS, developed a 2011 statewide base year emissions inventory which was used to project emissions out to 2028, the end of the second planning period.
                    <SU>79</SU>
                    <FTREF/>
                     FDEP also evaluated emissions data from 2017, the year of the most recent triennial emissions data available 
                    <PRTPAGE P="105524"/>
                    at the time of the development of the 2021 Plan. Statewide emissions from the 2014 and 2017 National Emissions Inventories (NEIs) are provided in tables 13-11, 13-12, and 13-13 of the 2021 Plan for PM
                    <E T="52">2.5,</E>
                     NO
                    <E T="52">X</E>
                    , and SO
                    <E T="52">2</E>
                    , respectively.
                </P>
                <FTNT>
                    <P>
                        <SU>79</SU>
                         Table 4-1 provides a summary of the 2011 baseline emissions inventory for Florida.
                    </P>
                </FTNT>
                <P>
                    With respect to cost and engineering information documentation pursuant to 40 CFR 51.308(f)(2)(iii), section 7.8 of the Haze Plan details the State's analysis of the FFAs for Foley, JEA Northside, and WestRock-Fernandina located in appendix G which evaluated the four factors, including the cost of compliance factor, and provided detailed cost calculations for potential new control measures assessed as part of the engineering analyses. In addition, section 7.6.4.1 of the 2021 Plan describes the State's analysis of seven sources with existing, effective SO
                    <E T="52">2</E>
                     measures: Duke-Crystal River, JEA Northside (Units 1 and 2), Mosaic-Bartow, Mosaic-New Wales, Nutrien, Seminole, and TECO-Big Bend 
                    <SU>80</SU>
                    <FTREF/>
                     and the 2024 Supplement summarizes existing, effective SO
                    <E T="52">2</E>
                     measures at Mosaic-South Pierce in section 7.6.4.1 on pages 5-6 of the narrative and in appendix B-2 of the 2024 Supplement.
                </P>
                <FTNT>
                    <P>
                        <SU>80</SU>
                         FDEP also included the shutdown of Unit 3 of CD McIntosh in section 7.6.4.1, “Effective Controls Analyses,” of the 2021 Plan.
                    </P>
                </FTNT>
                <P>With respect to monitoring information documentation pursuant to 40 CFR 51.308(f)(2)(iii), the State assessed baseline (2000-2004), current (2014-2018), and natural visibility conditions for Florida's Class I areas in section 2 of the 2021 Plan with supporting information located in appendix C.</P>
                <P>With respect to modeling information documentation pursuant to 40 CFR 51.308(f)(2)(iii), sections 5 and 6 of the 2021 Plan describe the modeling methods used to develop the plan with additional documentation provided in appendix E and results of the RPG modeling in section 8 of the plan. Appendix D contains AoI analyses documentation. Section I.E of the TSD to this proposed rulemaking provides a more detailed summary of the State's assessment of documentation of the technical basis for the 2021 Plan under 40 CFR 51.308(f)(2)(iii).</P>
                <P>
                    <E T="03">d. Assessment of the Five Additional Factors in 40 CFR 51.308(f)(2)(iv):</E>
                </P>
                <P>With respect to 40 CFR 51.308(f)(2)(iv), Florida considered each of the five additional factors in developing the State's LTS and evaluated their relevancy for the second period. With respect to 40 CFR 51.308(f)(2)(iv)(A), FDEP assessed emission reductions due to ongoing air pollution control programs, including measures to address RAVI, in the development of the State's 2011 baseline and 2028 projected emission inventories. The impact of these existing and on the way air pollution control programs are reflected in the 2028 RPGs for the Florida Class I areas, except for the measures listed in section 8.2 of the 2021 Plan.</P>
                <P>
                    With respect to 40 CFR 51.308(f)(2)(iv)(B), FDEP evaluated measures in the State designed to mitigate the impacts of construction activities in section 7.9.2 of the 2021 Plan. Florida's rules for air quality control include requirements to prevent fugitive dust from becoming airborne and also limit the opacity of fugitive emissions to equal to or less than 20 percent. The requirements of Florida rule 62-296.320, F.A.C., General Pollutant Emission Limiting Standards, include preventive measures for construction activities to prevent fugitive dust from becoming airborne.
                    <SU>81</SU>
                    <FTREF/>
                     FDEP also noted that fine soils were a relatively minor contributor to visibility impairment at the Class I areas in Florida from the baseline period of 2000-2004 through to the recent period of 2014-2018, as discussed in section 2.4.2 and shown in figures 2-1 through 2-5 (2000-2004 period); figures 2-6 through 2-8 (2009-2013 period); and figures 2-9 through 2-13 (2014-2018 period) of the 2021 Plan. Thus, any fine soil contributions to regional haze from Florida construction activities are relatively minor.
                </P>
                <FTNT>
                    <P>
                        <SU>81</SU>
                         Florida's air quality rules are available at 
                        <E T="03">https://floridadep.gov/air/air-business-planning/content/current-air-rules.</E>
                    </P>
                </FTNT>
                <P>With respect to 40 CFR 51.308(f)(2)(iv)(C), FDEP discussed source retirement and replacement schedules in section 8.2.2 of the 2021 Plan, which describes existing and planned source retirements by 2028.</P>
                <P>
                    With respect to 40 CFR 51.308(f)(2)(iv)(D), FDEP explained that particulate organic matter (POM) is the second most important contributor to fine particle mass and light extinction on the 20 percent most impaired and 20 percent clearest days in Florida Class I areas during the baseline period. POM and elemental carbon (a component of PM
                    <E T="52">2.5</E>
                    ) are associated with wildfires, prescribed wildland fires, agricultural burning, and biogenic emissions from vegetation. Elemental carbon is a relatively minor contributor to visibility impairment at the Class I areas in Florida as discussed in section 2.4.2 and demonstrated in figures 2-1 through 2-5. Florida has a certified Smoke Management Plan (SMP) which was most recently updated in 2013. The Florida Forest Service operates a burn authorization program that considers the potential for smoke from the burn impacting smoke sensitive receptors (
                    <E T="03">e.g.,</E>
                     airports, roads, hospitals, and urban areas). The SMP contains provisions to help minimize air pollutant and regional haze impacts. Florida's SMP may be found in appendix G-4 of the 2021 Plan for reference only.
                </P>
                <P>With respect to 40 CFR 51.308(f)(2)(iv)(E), in section 7 of the 2021 Plan, FDEP evaluates the anticipated net effect on visibility due to projected changes in point, area, and mobile source emissions over the period addressed by the LTS in development of the 2028 RPGs for the Florida Class I areas. Section 7.2 of the 2021 Plan identifies control measures included in the VISTAS 2028 emissions inventory. The 2028 RPGs are identified in section 8 of the 2021 Plan and section 8.2.2 includes source retirements and replacements for Florida sources. Section I.D of the TSD to this proposed rulemaking provides a more detailed summary of the State's assessment of the five additional factors in 40 CFR 51.308(f)(2)(iv).</P>
                <P>
                    <E T="03">e. Interstate Consultation:</E>
                     FDEP consulted with states and RPOs that identified Florida sources as impacting those states' (or states within the RPOs') Class I areas. FDEP consulted with the two states with one or more sources exceeding Florida's PSAT threshold at one or more of Florida's Class I areas.
                </P>
                <P>
                    <E T="03">i. State/RPOs Requesting Consultation with Florida:</E>
                </P>
                <P>
                    <E T="03">a. MANE-VU's Ask:</E>
                     The following summarizes the conclusions of consultation related to the MANE-VU Ask 
                    <SU>82</SU>
                    <FTREF/>
                     for Florida. Section I.F of the TSD to this rulemaking provides a more detailed summary of the State's assessment of Florida's interstate consultation pursuant to 40 CFR 51.308(f)(2)(ii).
                </P>
                <FTNT>
                    <P>
                        <SU>82</SU>
                         MANE-VU refers to the emission reduction measures identified in other states as being necessary to make reasonable progress as “Asks.” The MANE-VU Ask to states outside of the MANE-VU Region is available at 
                        <E T="03">https://otcair.org/manevu/Upload/Publication/Formal%20Actions/MANE-VU%20Inter-Regional%20Ask%20Final%208-25-2017.pdf.</E>
                    </P>
                </FTNT>
                <P>
                    In a letter dated August 25, 2017, MANE-VU requested that 14 states, including Florida, address the “Asks” outlined in the letter on the basis that Florida sources exceeded the visibility impact threshold set by MANE-VU for at least one Class I area in the MANE-VU region. On October 16, 2017, MANE-VU initiated consultations with the states including Florida. Florida 
                    <PRTPAGE P="105525"/>
                    disagreed with MANE-VU's assertion that Florida's statewide emissions are impacting visibility at MANE-VU Class I areas. Florida's viewpoints are reflected in the January 27, 2018, letter from VISTAS to MANE-VU. To resolve the disagreement, Florida sent a response letter on January 19, 2018, to MANE-VU and noted several disagreements with MANE-VU's analysis. Florida documented the State's responses and viewpoints with respect to the MANE-VU Ask in section 10 and appendices F-4 of the 2021 Plan. Florida believes that the State fulfilled the consultation requirements under 40 CFR 51.308(f)(2)(ii) by the State's participation in a series of five MANE-VU consultation calls held during the period from October 20, 2017, to March 23, 2018, and by the State's documented responses to MANE-VU. Thus, FDEP determined that no further action is required under the RHR to address MANE-VU's requests.
                </P>
                <P>
                    b. 
                    <E T="03">Georgia's Request for Consultation with Florida:</E>
                </P>
                <P>
                    In a letter dated November 24, 2020, the Georgia Environmental Protection Division requested that FDEP share Florida's FFA for its sources that impact Georgia's Class I areas—Cohutta, Okefenokee, and Wolf Island. Georgia, through VISTAS analysis, identified five Florida sources that had greater than one percent sulfate impact on at least one of Georgia's Class I areas,
                    <SU>83</SU>
                    <FTREF/>
                     including Nutrien, Foley, WestRock-Fernandina, JEA Northside, and Seminole. As described above, the Haze Plan includes FFAs or existing effective control analyses for these five facilities and identifies permit conditions that are incorporated into Florida's SIP or are proposed for incorporation into the SIP. The permit conditions proposed for incorporation are identified in the “Materials to be Incorporated into the SIP” sections of the 2021 Plan, the 2024 Supplement, and the Second 2024 Supplement for incorporation into the regulatory portion of the Florida SIP.
                </P>
                <FTNT>
                    <P>
                        <SU>83</SU>
                         None of Florida's sources exceeded the one percent PSAT nitrate emissions threshold.
                    </P>
                </FTNT>
                <P>Florida responded to Georgia in a letter dated December 18, 2020, acknowledging that the Florida sources identified by Georgia met Florida's selection criteria and would be evaluated in FFAs.</P>
                <P>
                    <E T="03">ii. Other States with Sources Contributing to Regional Haze at Florida's Class I Areas:</E>
                </P>
                <P>
                    Consultation with other states with sources contributing to regional haze at Florida's Class I areas is discussed in section 10 and appendix F of the 2021 Plan. As listed in table 7-26 of the 2021 Plan, Florida requested an FFA of two sources in two other states because these sources exceeded the State's sulfate PSAT threshold at one or more of Florida's Class I areas: Georgia Power Company—Plant Bowen (Plant Bowen) in Georgia and Tennessee Valley Authority-Shawnee Fossil Plant (TVA-Shawnee) in Kentucky. At the time of plan submission, FDEP documented in section 10 of the 2021 Plan that the State had not yet received a response from Georgia related to Plant Bowen or from Kentucky for TVA-Shawnee.
                    <SU>84</SU>
                    <FTREF/>
                     Additionally, FDEP consulted with Alabama on Sanders Lead Co. since that facility had initially ranked greater than Florida's one percent threshold for PSAT contribution. Alabama provided additional information in a letter showing that this facility's recent SO
                    <E T="52">2</E>
                     emissions have significantly reduced from the initial 2028 projections.
                    <SU>85</SU>
                    <FTREF/>
                     In the 2021 plan, FDEP stated that a scrubber went online in late 2019 and reduced the worst-case potential emissions from 7,961.1 tpy to approximately 1,400 tpy of SO
                    <E T="52">2</E>
                     which brought Sanders Lead Co. well below the one percent PSAT. Therefore, Alabama did not select the facility for a control evaluation.
                </P>
                <FTNT>
                    <P>
                        <SU>84</SU>
                         Regarding Plant Bowen, on August 11, 2022, Georgia submitted a final regional haze plan for the second planning period which included an FFA for Plant Bowen that concluded existing SO
                        <E T="52">2</E>
                         measures for Units 1-4 at the facility are necessary for reasonable progress for the second period. EPA approved Georgia's regional haze plan on November 21, 2024. 
                        <E T="03">See</E>
                         89 FR 92038. Kentucky has not yet submitted a final regional haze plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>85</SU>
                         The December 7, 2020, letter from the Alabama Department of Environmental Management confirming the lowered SO
                        <E T="52">2</E>
                         emission rates can be found in appendix F-1c of the 2021 Plan.
                    </P>
                </FTNT>
                <P>
                    <E T="03">3. EPA Evaluation:</E>
                     EPA reviewed Florida's FFAs, determinations of controls necessary for reasonable progress, and submitted permit conditions. Based on this review, EPA proposes to determine that Florida's LTS meets the requirements of 40 CFR 51.308(f)(2)(i) through (iv).
                </P>
                <P>
                    <E T="03">a. Source Selection Criteria:</E>
                     EPA proposes to find that Florida has satisfied the requirements of 40 CFR 51.308(f)(2)(i) with respect to its description of source selection criteria, the outcomes of the source selection process, and the basis for using the AoI and PSAT thresholds and other criteria to select sources. Specifically, Florida provided: appendix B, which details how the State, in conjunction with VISTAS, created emissions inventories relied upon by the State for its Haze Plan; appendix C, which provides monitoring and meteorological data used to support selection of sources; and appendix D, which provides analyses supporting the AoI approach. In addition, FDEP summarized in the 2021 Plan the specific data that Florida used for its source selection analyses, including the AoI and PSAT analyses and results. FDEP followed EPA's 2019 Guidance recommendations to use 2028 emissions projections to select sources and checked the accuracy of its 2028 estimations by electing to evaluate differences between 2017-2019 emissions and 2028 emissions projections in section 7.6.5 of the 2021 Plan.
                </P>
                <P>
                    EPA proposes to find that Florida captured a reasonable set of in-state sources contributing to visibility impairment at Class I areas for the following reasons. AoI and PSAT are acceptable and well-established methods for selecting sources for a control analysis and they enable the identification of the sources that have the largest impacts on visibility at Class I areas in Florida and neighboring states.
                    <SU>86</SU>
                    <FTREF/>
                     Using a five percent AoI threshold and a one percent PSAT threshold, the State identified twelve Florida sources for a control evaluation that are projected to have the highest impact on visibility at both in-state and out-of-state Class I areas at the end of the second planning period.
                </P>
                <FTNT>
                    <P>
                        <SU>86</SU>
                         The State used the AoI process because it identifies the largest sources with potential visibility impacts to Class I areas and then used sophisticated photochemical source apportionment modeling to identify specific sources for control evaluations. 
                        <E T="03">See</E>
                         also 2019 Guidance, pp. 12-13.
                    </P>
                </FTNT>
                <P>
                    Additionally, statewide SO
                    <E T="52">2</E>
                     emissions are expected to decrease in the second planning period from 2017 levels of 78,173 tpy of SO
                    <E T="52">2</E>
                     to projected 2028 levels of 66,979 tpy of SO
                    <E T="52">2</E>
                     (approximately a 14 percent reduction), and statewide NO
                    <E T="52">X</E>
                     emissions are expected to decrease from 2017 levels of 414,369 tpy NO
                    <E T="52">X</E>
                     to projected 2028 levels of 265,453 tpy NO
                    <E T="52">X</E>
                     (approximately a 36 percent reduction).
                    <SU>87</SU>
                    <FTREF/>
                     Additional emissions reductions which have not been reflected in the 2028 emissions projections and 2028 RPGs include the following: CD McIntosh, which permanently shut down Unit 3 in 2021; Foley, which had permanently ceased operations by May 2024; 
                    <SU>88</SU>
                    <FTREF/>
                     OUC Stanton, which announced that it will end coal-firing by the end of 2027; and WestRock—Panama City, which 
                    <PRTPAGE P="105526"/>
                    permanently ceased operations in June 2022. Specific to second planning period visibility improvement, visibility conditions in Florida's Class I areas in 2028 are estimated to improve since the 2014-2018 period by 0.62 deciview (Chassahowitzka), 0.95 deciview (Everglades), and 0.96 deciview (St. Marks). When considered in relation to the amount of visibility improvement needed to reach natural conditions starting from the 2014-2018 period, these projected visibility improvements expected during the second planning period represent approximately the following amount of progress: 7.40 percent improvement (Chassahowitzka), 13.70 percent improvement (Everglades), and 11.62 percent improvement (St. Marks).
                    <SU>89</SU>
                    <FTREF/>
                     Based upon a comparison of the most recently available 20 percent most impaired days IMPROVE data (2018-2022) 
                    <SU>90</SU>
                    <FTREF/>
                     to the 20 percent most impaired days data from the end of the first planning period (2014-2018),
                    <SU>91</SU>
                    <FTREF/>
                     in the first four years of the second planning period Florida's Class I areas have already achieved the following amount of additional progress towards natural conditions: 4.5 percent (Chassahowitzka), 8.1 percent (Everglades), and 16.59 percent (St. Marks).
                    <SU>92</SU>
                    <FTREF/>
                     Also, Florida is appropriately focused on controlling point source SO
                    <E T="52">2</E>
                     emissions based on data showing ammonium sulfate is the dominant visibility impairing pollutant at the Florida Class I areas
                    <E T="52">.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>87</SU>
                         Florida's statewide emissions of SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">X</E>
                         decreased during the period from 2011 to 2017 from 172,701 tpy SO
                        <E T="52">2</E>
                         to 78,173 tpy SO
                        <E T="52">2</E>
                         and decreased from 608,366 to 414,369 tpy NO
                        <E T="52">X</E>
                        . 
                        <E T="03">See</E>
                         tables 4-1, 13-12, and 13-13 of the 2021 Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>88</SU>
                         In appendix C-2 of the 2024 Supplement, Foley stated in a letter dated May 22, 2024, that the mill has ceased production operations as a pulp and paper mill.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>89</SU>
                         
                        <E T="03">See</E>
                         visibility data for the 20 percent most impaired days data from table 8-1 and 2-6 of the 2021 Plan. Percentage of progress toward natural conditions = [((2014-2018 IMPROVE data)−(2028 RPG))/((2014-2018 IMPROVE data)−(Natural visibility conditions))] × 100. Example calculation for Chassahowitzka [(17.41−16.79)/(17.41−9.03)] × 100 = 7.4 percent.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>90</SU>
                         The 2018-2022 IMPROVE data for the 20 percent most impaired days was obtained from under the header “Means for Impairment Metric:”. The IMPROVE data includes visibility monitoring data for each Class I area. This data was filtered for each Class I area, listed as “CHAS1” (Chassahowitzka), “EVER1” (Everglades), and “SAMA1” (St. Marks), respectively, (in column “A”, titled “site”). Then data was filtered for the years 2018 through 2022 (using column “B” titled “year”). These data points were then filtered for the 20 percent most impaired days, indicated by “90” (in column “C” titled “impairment_Group”). The resulting data points for each Florida Class I area within the “haze_dv” column “AK”, corresponding to each of the five years, were averaged to determine the 20 percent most impaired days for the 2018-2022 five-year period. The 2018-2022 IMPROVE data for Florida's Class I areas are: 17.03 deciviews (Chassahowitzka), 14.37 deciviews (Everglades), and 16.02 deciviews (St. Marks).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>91</SU>
                         The 2014-2018 IMPROVE data was provided by Florida in table 2-6 of the 2021 Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>92</SU>
                         Percentage of progress toward natural conditions = [((2014-2018 IMPROVE data)−(2018-2022 IMPROVE data))/((2014-2018 IMPROVE data)−(Natural visibility conditions))] x100. Example calculation for Chassahowitzka: [(17.41−17.03)/(17.41−9.03)] × 100 = 4.5 percent.
                    </P>
                </FTNT>
                <P>
                    <E T="03">b. Consideration of the Four CAA Factors:</E>
                </P>
                <P>
                    i. FFAs: EPA proposes to find that FDEP's reasonable progress determinations and conclusions for the selected sources are reasonable and that Florida submissions satisfy the requirements of 40 CFR 51.308(f)(2)(i) as discussed below.
                    <SU>93</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>93</SU>
                         
                        <E T="03">See</E>
                         also section I.B of the TSD for additional details regarding Florida's FFAs.
                    </P>
                </FTNT>
                <P>
                    a. 
                    <E T="03">Foley:</E>
                     Regarding Foley, EPA proposes to find FDEP's determinations of measures that are necessary for reasonable progress are reasonable as described below.
                </P>
                <P>
                    The State evaluated available and technically feasible SO
                    <E T="52">2</E>
                     controls based on, where applicable, estimated values of capital costs, annualized costs, and cost per ton of emission reductions, consistent with recommendations in the Cost Manual.
                </P>
                <P>For the No. 1 Power Boiler, the State evaluated adding a wet scrubber with an estimated cost of $13,547/ton, and DSI with an estimated cost of $21,727/ton and determined that these controls are not cost effective.</P>
                <P>FDEP determined that existing measures are necessary for reasonable progress. Specifically, the No. 1 Power Boiler shall fire only natural gas except for periods of natural gas curtailment, pipeline disruptions, or physical mill problems that otherwise prevent the firing of natural gas in this unit. For future additions of No. 6 fuel oil to the common tank, the maximum sulfur content shall be 1.02 percent by weight with compliance determined by maintaining records of fuel deliveries, analytical methods, and results of analysis. Tall oil is no longer an authorized fuel.</P>
                <P>For the No. 1 Power Boiler, EPA proposes to find that FDEP's determination to impose limitations for existing measures is reasonable and necessary for reasonable progress.</P>
                <P>
                    For No. 1 Bark Boiler, as the unit was already equipped with a wet venturi scrubber, Florida considered operating scenarios to achieve additional SO
                    <E T="52">2</E>
                     emissions reductions, and determined that running the wet venturi scrubber with requirements on minimum pH and flow rate whenever a LVHC-NCG or oil is fired is cost-effective and necessary for reasonable progress, resulting in a 51 percent reduction in SO
                    <E T="52">2</E>
                     emissions annually. EPA proposes to find that FDEP's determination to require more frequent operation of the wet venturi scrubber for the No. 1 Bark Boiler is reasonable and that this measure is necessary for reasonable progress. Additionally, EPA proposes to find that FDEP's determination to impose the low-sulfur fuel restrictions for the No. 1 Bark Boiler that are similar to the restrictions proposed for No. 1 Power Boiler (except the No. 1 Bark Boiler is permitted to burn wood in addition to natural gas as the primary fuel type) is reasonable and that these measures are necessary for reasonable progress.
                </P>
                <P>
                    For the recovery boilers, the State evaluated wet scrubbers with estimated costs of $7,779/ton for Recovery Furnace No. 2; $5,197/ton for Recovery Furnace No. 3; and $6,587/ton for Recovery Furnace No. 4. Florida determined that these measures were not cost effective, but proposed existing measures as necessary for reasonable progress. EPA proposes to find that FDEP's determination to impose requirements for the following existing measures—black liquor as the primary fuel; natural gas and liquid fuels as supplements to recovery operations; a maximum sulfur content of 1.02 percent for purchased no. 6 fuel oil; and a SO
                    <E T="52">2</E>
                     emissions cap of 3,200 tons per consecutive 12 operating months as measured by CEMS—is reasonable and that these measures are necessary for reasonable progress.
                </P>
                <P>
                    Therefore, EPA proposes to incorporate into the Florida SIP the permit conditions from permit number 1230001-121-AC that are identified in the “Materials to be Incorporated into the SIP” section of the Second 2024 Supplement.
                    <SU>94</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>94</SU>
                         
                        <E T="03">See</E>
                         pp. 8-14 under “Appendix A” of “Materials to be Incorporated into the SIP” contained within filename “SIP 2024-01 Part II SIP Regional Haze Amendment Supplement October 28 2024.pdf” included with the Second 2024 Supplement which is in the docket for this proposed rulemaking.
                    </P>
                </FTNT>
                <P>
                    b. 
                    <E T="03">JEA Northside:</E>
                     Regarding JEA Northside Unit 3,
                    <SU>95</SU>
                    <FTREF/>
                     EPA proposes to find that FDEP's determinations regarding applicable controls for this source at JEA Northside are reasonable. The State evaluated available and technically feasible SO
                    <E T="52">2</E>
                     controls that were based on, where applicable, estimated values of capital costs, annualized costs, and cost per ton of emission reductions, consistent with recommendations in the Cost Manual. For NGS Unit 3, EPA proposes to find FDEP's determination that switching to lower sulfur No. 6 fuel oil at $3,053/ton of SO
                    <E T="52">2</E>
                     removed is necessary for reasonable progress is reasonable. Thus, EPA proposes to incorporate into the Florida SIP the permit conditions from 
                    <PRTPAGE P="105527"/>
                    permit number 0310045-057-AC that are listed under “Materials to be Incorporated into the SIP” section of the 2021 Plan.
                    <SU>96</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>95</SU>
                         The associated permits documenting proposed conditions and limits in the SIP may be found in appendix G-3 of the 2021 Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>96</SU>
                         
                        <E T="03">See</E>
                         p. 13 under “JEA Northside Unit 3 . . .” under “Materials to be Incorporated into the SIP” in filename “Final SIP 2021-01 Regional Haze.pdf” included with the 2021 Plan which is in the docket for this rulemaking. These permit conditions are also summarized in section 7.8.1.1.5 of the 2021 Plan.
                    </P>
                </FTNT>
                <P>
                    c. 
                    <E T="03">WestRock-Fernandina:</E>
                     EPA proposes to find FDEP's determinations regarding applicable controls for the sources at WestRock-Fernandina are reasonable. The State evaluated available and technically feasible SO
                    <E T="52">2</E>
                     controls based on, where applicable, estimated values of capital costs, annualized costs, and cost per ton of emission reductions, consistent with recommendations in the Cost Manual.
                </P>
                <P>
                    Regarding the No. 7 Power Boiler, FDEP evaluated removing coal as a fuel ($7,374/ton), reducing coal usage (cost savings $1,868/ton), FGD without and with a stack liner ($5,641/ton and $6,028/ton, respectively), DSI ($8,776/ton), and SDA ($16,398/ton). EPA proposes to find FDEP's determination for the No. 7 Power Boiler that reducing coal usage to 125 tpd is cost-effective is reasonable, and proposes to find that reducing coal usage is necessary for reasonable progress for the No. 7 Power Boiler.
                    <SU>97</SU>
                    <FTREF/>
                     Therefore, EPA proposes to incorporate into the Florida SIP the permit conditions from permit number 0890003-072-AC that are listed under the “Materials to be Incorporated into the SIP” section of the 2021 Plan; 
                    <SU>98</SU>
                    <FTREF/>
                     and the permit condition from permit number 0890003-074-AC and listed in appendix A-1 of the 2024 Supplement.
                </P>
                <FTNT>
                    <P>
                        <SU>97</SU>
                         Existing measures for the No. 7 Power Boiler can be found in section 7.8.2.1.5, 
                        <E T="03">Summary of Findings for WestRock-Fernandina Beach No.7 Power Boiler (EU15),</E>
                         of the 2021 Plan and section 7.8.2.5.5, 
                        <E T="03">Summary of Findings for No.7 Power Boiler,</E>
                         of the 2024 Supplement.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>98</SU>
                         
                        <E T="03">See</E>
                         pp. 15-16 under “WestRock Fernandina Beach Mill . . .” under “Materials to be Incorporated into the SIP” in filename “Final SIP 2021-01 Regional Haze.pdf” included with the 2021 Plan which is in the docket for this rulemaking. These permit conditions are also summarized in section 7.8.2.1.5 of the 2021 Plan.
                    </P>
                </FTNT>
                <P>
                    Regarding the No. 5 Power Boiler, FDEP evaluated a wet scrubber system without and with a stack liner ($285,615/ton and $298,499/ton, respectively) and DSI ($277,093/ton). For the Nos. 4 and 5 Recovery Boilers, FDEP evaluated a wet scrubber system at $282,375/ton and $169,425/ton, respectively. EPA proposes to find FDEP's determination that existing SO
                    <E T="52">2</E>
                     measures at the No. 5 Power Boiler and the Nos. 4 and 5 Recovery Boilers previously approved into the SIP 
                    <SU>99</SU>
                    <FTREF/>
                     are necessary for reasonable progress is reasonable.
                </P>
                <FTNT>
                    <P>
                        <SU>99</SU>
                         
                        <E T="03">See</E>
                         82 FR 30749 (July 3, 2017); 40 CFR 52.520(d).
                    </P>
                </FTNT>
                <P>
                    <E T="03">ii. Existing, Effective Control Demonstrations:</E>
                </P>
                <P>
                    EPA proposes to find that certain existing SO
                    <E T="52">2</E>
                     measures at the affected units of the eight facilities evaluated for existing, effective control demonstrations are necessary for reasonable progress, and thus, EPA proposes to include these measures in the SIP.
                </P>
                <P>
                    EPA proposes to find that FDEP's proposed adoption of the 0.20 lb/MMBtu MATS limit for the fossil fuel steam generating Unit 4 and Unit 5 at Duke-Crystal River and the permit requirements that allow the citrus combined cycle station Units 1A, 1B, 2A, and 2B to combust only pipeline natural gas is reasonable. The 2019 Guidance provides several scenarios in which EPA believes it may be reasonable for a state not to select a particular source for further analysis. One such scenario is applicable to Duke-Crystal River—a coal-fired EGU that has add-on FGD and meets the applicable alternative SO
                    <E T="52">2</E>
                     emission limit of 0.2 lb/MMBtu in the MATS rule. The 2019 Guidance states that it is unlikely that an analysis of control measures for a source already equipped with a scrubber and meeting a 0.20 lb/MMBtu limit or having fuel combustion units that is restricted to combust only pipeline natural gas per enforceable requirements would conclude that even more stringent control of SO
                    <E T="52">2</E>
                     is necessary to make reasonable progress. 
                    <E T="03">See</E>
                     2019 Guidance at 23.
                </P>
                <P>
                    EPA evaluated FGD control efficiency data at Units 4 and 5 at Duke-Crystal River and calculated that the existing FGD systems routinely achieve 96.2-98.9 percent yearly average SO
                    <E T="52">2</E>
                     removal efficiencies based on 2017-2023 data during periods when coal is one of the fuel sources consumed, with a seven-year average (2017-2023) SO
                    <E T="52">2</E>
                     removal efficiencies of 97.0 and 96.8 percent, respectively.
                    <SU>100</SU>
                    <FTREF/>
                     Therefore, for Duke-Crystal River's Units 4 and 5, EPA proposes to find it reasonable that an FFA would likely result in the conclusion that no further SO
                    <E T="52">2</E>
                     emissions controls (including FGD upgrades) are necessary for reasonable progress. Therefore, EPA proposes to find that FDEP's determination that these existing SO
                    <E T="52">2</E>
                     measures are necessary for reasonable progress and must be adopted into the SIP is reasonable.
                </P>
                <FTNT>
                    <P>
                        <SU>100</SU>
                         
                        <E T="03">See</E>
                         Florida EGU scrubber efficiency data file that is included in the docket for this proposed action.
                    </P>
                </FTNT>
                <P>
                    EPA proposes to find as reasonable FDEP's determination that an SO
                    <E T="52">2</E>
                     limit of 0.15 lb/MMBtu in combination with the MATS-based SO
                    <E T="52">2</E>
                     emission limit of 0.20 lb/MMBtu at CFB Boilers 1 and 2 at JEA Northside demonstrate existing, effective SO
                    <E T="52">2</E>
                     measures for these units. Regarding FGD control efficiencies at CFB Boilers 1 and 2 JEA Northside, EPA evaluated data from 2017-2023 and calculated that the existing FGD systems routinely achieve 94.8 to 96.6 percent yearly average SO
                    <E T="52">2</E>
                     removal efficiencies when consuming coal, having seven-year average (2017-2023) SO
                    <E T="52">2</E>
                     removal efficiencies of 95.8 percent.
                    <SU>101</SU>
                    <FTREF/>
                     Therefore, EPA proposes to find FDEP's determination that an FFA would likely result in the conclusion that no further SO
                    <E T="52">2</E>
                     emissions controls (including FGD upgrades) is reasonable and that these measures are necessary for reasonable progress. Therefore, EPA proposes to find that the proposed emissions limits are necessary for reasonable progress and must be adopted into the SIP.
                </P>
                <FTNT>
                    <P>
                        <SU>101</SU>
                         
                        <E T="03">See</E>
                         Florida EGU scrubber efficiency data file that is included in the docket for this proposed action.
                    </P>
                </FTNT>
                <P>
                    EPA proposes to find as reasonable FDEP's determination that Mosaic-Bartow's SAPs 4, 5, and 6 have existing, effective controls. Currently, these units use dual absorption process with cesium catalyst to control SO
                    <E T="52">2</E>
                     emissions and restrictions in the SIP to limit the three SAPs at the facility to four lbs/ton of 100 percent sulfuric acid produced, which is consistent with controls identified in EPA's RBLC. In addition, the facility has a three-unit cap at 1,100 lbs/hour on a 24-hour block average and had recent upgrades to reduce SO
                    <E T="52">2</E>
                     emissions. Thus, EPA proposes to find FDEP's determination that SAPs 4, 5, and 6 are effectively controlled reasonable, and that an FFA would likely result in the conclusion that no further SO
                    <E T="52">2</E>
                     emissions controls these measures are necessary for reasonable progress.
                </P>
                <P>
                    EPA proposes to find that FDEP's determination is reasonable that existing SO
                    <E T="52">2</E>
                     measures at Mosaic-New Wales' SAPs 1-5, which use dual absorption process with cesium-promoted catalyst, constitute existing, effective SO
                    <E T="52">2</E>
                     controls. The combination of the dual absorption design and the cesium-promoted catalysts represents BACT for sulfur-burning, non-single absorption column SAPs in accordance with the RBLC. Current restrictions in the SIP limit the Nos. 1-3 SAPs to 3.5 lbs/ton of 100 percent sulfuric acid produced on a 24-hr rolling average and four lbs/ton of sulfuric acid produced on a three-hour rolling average, while SAPs 4 and 
                    <PRTPAGE P="105528"/>
                    5 are each required to meet a limit of 4.0 lbs/ton of sulfuric acid produced. In addition, the facility has a five-unit cap at 1,090 lbs/hour on a 24-hour block average. Thus, EPA proposes to find FDEP's determination reasonable that SAPs 1-5 have effective SO
                    <E T="52">2</E>
                     control measures for Mosaic-New Wales, and that an FFA would likely result in the conclusion that no further SO
                    <E T="52">2</E>
                     emissions controls are necessary for reasonable progress.
                </P>
                <P>
                    EPA proposes to find that FDEP's determination is reasonable that existing SO
                    <E T="52">2</E>
                     measures at Mosaic-South Pierce's SAPs 10 and 11, which use dual absorption process with cesium-promoted catalyst, constitute existing effective SO
                    <E T="52">2</E>
                     controls. The combination of the dual absorption design and the cesium-promoted catalysts represents BACT for sulfur-burning, non-single absorption column SAPs in accordance with the RBLC. Current restrictions in the SIP impose a 750 lbs/hour SO
                    <E T="52">2</E>
                     limit on a 24-hour block average. Thus, EPA proposes to find FDEP's determination reasonable that Mosaic-South Pierce's SAPs 10 and 11 have effective SO
                    <E T="52">2</E>
                     control measures, and that an FFA would likely result in the conclusion that no further SO
                    <E T="52">2</E>
                     emissions controls these measures are necessary for reasonable progress.
                </P>
                <P>
                    EPA proposes to find that FDEP's determination that Nutrien's SAPs E and F have existing effective controls for SO
                    <E T="52">2</E>
                     is reasonable. Nutrien's SAPs E and F currently use dual absorption process with cesium catalyst. Current restrictions in the SIP impose SO
                    <E T="52">2</E>
                     emission limits at 2.6 lbs/ton, three-hour rolling average; 2.3 lbs/ton, 365-day rolling average, which applies during periods of shutdown and startup; and 840 lbs/hour on a 24-hour block averaging period. The facility elected to complete upgrades on SAP E and SAP F, which included changing out and augmenting the converter catalyst in the SAPs to meet the limits. EPA proposes to find that the State adequately demonstrates that Nutrien's SAPs E and F are effectively controlled, and that an FFA would likely result in the conclusion that no further SO
                    <E T="52">2</E>
                     emissions controls are necessary for reasonable.
                </P>
                <P>
                    EPA proposes to find that FDEP's determination that TECO-Big Bend has existing effective controls for SO
                    <E T="52">2</E>
                     for Unit 4 is reasonable. TECO-Big Bend's SO
                    <E T="52">2</E>
                     emissions are limited by the MATS limit of 0.20 lb/MMBtu which FDEP is proposing to incorporate into the SIP. Regarding FGD control efficiencies at Unit 4 at TECO-Big Bend, EPA evaluated data from 2017-2023 for Unit 4 and calculated that the existing FGD system routinely achieves 92.2-97.1 percent yearly average SO
                    <E T="52">2</E>
                     removal efficiencies during periods when coal is one of the fuel sources consumed, with a seven-year average (2017-2023) SO
                    <E T="52">2</E>
                     removal efficiency of 95.8 percent.
                    <SU>102</SU>
                    <FTREF/>
                     As mentioned above, Unit 3 at TECO-Big Bend was permanently retired from electric generation service on April 26, 2023, and therefore, Florida's demonstration of existing, effective controls is no longer relevant and no further action is required by EPA.
                    <SU>103</SU>
                    <FTREF/>
                     Therefore, EPA proposes to find FDEP's determination that TECO-Big Bend Unit 4 is effectively controlled is reasonable, and that an FFA would likely result in the conclusion that no further SO
                    <E T="52">2</E>
                     emissions controls (including FGD upgrades) are necessary.
                </P>
                <FTNT>
                    <P>
                        <SU>102</SU>
                         
                        <E T="03">See</E>
                         Florida EGU scrubber efficiency data file that is included in the docket for this proposed action.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>103</SU>
                         The Retired Unit Exemption Form for TECO Big Bend Unit 3 is included in the docket for this rulemaking.
                    </P>
                </FTNT>
                <P>
                    Lastly, EPA proposes to find that FDEP's determination that Seminole has existing effective controls for SO
                    <E T="52">2</E>
                     for steam electric generators Nos. 1 and 2 is reasonable. The MATS SO
                    <E T="52">2</E>
                     limit of 0.20 lb/MMBtu applies to the Seminole facility, and Florida identified this emission limit for incorporation into the SIP. Regarding FGD control efficiencies at Unit Nos. 1 and 2 at Seminole during periods when coal is one of the fuel sources consumed, EPA evaluated data from 2017-2023 and calculated that the existing FGD systems routinely achieve 96.5-97.3 percent yearly average SO
                    <E T="52">2</E>
                     removal efficiencies, with a seven-year average (2017-2023) SO
                    <E T="52">2</E>
                     removal efficiency of 96.8 percent.
                    <SU>104</SU>
                    <FTREF/>
                     Therefore, EPA proposes to find FDEP determination reasonable that Seminole Unit Nos. 1 and 2 are effectively controlled, and that an FFA would likely result in the conclusion that no further SO
                    <E T="52">2</E>
                     emissions controls (including FGD upgrades) are necessary.
                </P>
                <FTNT>
                    <P>
                        <SU>104</SU>
                         
                        <E T="03">See</E>
                         Florida EGU scrubber efficiency data file that is included in the docket for this proposed action.
                    </P>
                </FTNT>
                <P>
                    <E T="03">c. Documentation of Technical Basis:</E>
                     With respect to 40 CFR 51.308(f)(2)(iii), EPA proposes to find that Florida adequately documented cost, engineering, emissions, modeling, and monitoring information to determine the measures that are necessary to make reasonable progress for the following reasons. With regard to emissions information, as required by the RHR, the State included the required years of the most recent triennial emissions inventory (2017) and the most recent annual SO
                    <E T="52">2</E>
                     emissions data for specific sources (2019) available at the time of the development of the 2021 Plan. FDEP provided actual emissions inventory data for 2011, 2014, and 2017, and emissions projections for 2028 in its Haze Plan. Specifically, table 4-1 provides a 2011 emissions inventory for Florida which includes the visibility impairing pollutants and carbon monoxide. Emissions from the 2014 and 2017 NEIs are provided in tables 13-11, 13-12, and 13-13 for PM
                    <E T="52">2.5,</E>
                     NO
                    <E T="52">X</E>
                    , and SO
                    <E T="52">2</E>
                    , respectively. For all Florida facilities with emissions of either SO
                    <E T="52">2</E>
                     or NO
                    <E T="52">X</E>
                     greater than 100 tpy in 2017, table 7-28 (SO
                    <E T="52">2</E>
                    ) includes actual emissions for 2017, 2018, and 2019, and 2028 (remodeled) projected emissions. With regard to cost and engineering information, the State provided the underlying cost calculations associated with the cost summaries in section 7.8 of the Haze Plan for Foley, JEA Northside, and WestRock-Fernandina, and the proposed FFAs in appendix G provide engineering analyses evaluating potential new control measures. With regard to monitoring data, the State provided IMPROVE data for the modeling base period plus baseline, current (2014-2018), and natural conditions for all VISTAS Class I areas with more detailed data provided for the Florida Class I areas. With regard to modeling information, the State documented the modeling input and outputs and assumptions in the Haze Plan and the results of the modeling related to RPGs and PSAT source impacts at Class I areas.
                </P>
                <P>
                    <E T="03">d. Assessment of Five Additional Factors in 40 CFR 51.308(f)(2)(iv):</E>
                </P>
                <P>EPA proposes to find that Florida has satisfied the requirements of 40 CFR 51.308(f)(2)(iv) because FDEP considered each of the five additional factors, discussed the measures the State has in place to address each factor (or discussed why such measures are not needed), and where relevant, explained how each factor informed FDEP's and VISTAS' technical analyses for the second planning period.</P>
                <P>With respect to 40 CFR 51.308(f)(2)(iv)(A), EPA proposes to find that FDEP adequately addressed the requirement to assess emission reductions due to ongoing air pollution control programs, including measures to address RAVI, through the State's emissions inventory work for the base year of 2011 as projected out to 2028.</P>
                <P>
                    With respect to 40 CFR 51.308(f)(2)(iv)(B), EPA proposes to find that Florida adequately addressed this requirement to evaluate measures to mitigate the impacts of construction activities by describing a state regulation that addresses control of fugitive airborne dust and considering 
                    <PRTPAGE P="105529"/>
                    the minor impact fine soils have on visibility.
                </P>
                <P>With respect to 40 CFR 51.308(f)(2)(iv)(C), EPA proposes to find that Florida adequately addressed source retirement and replacement schedules by summarizing existing and planned source retirements in section 8.2.2 in the 2021 Plan.</P>
                <P>
                    With respect to 40 CFR 51.308(f)(2)(iv)(D), EPA proposes to find that Florida adequately addressed the requirement to consider the State's basic smoke management practices for prescribed fire used for agricultural and wildland vegetation management purposes and smoke management programs. The State describes its SMP to mitigate PM
                    <E T="52">2.5</E>
                     emissions associated with prescribed burning and highlights its burn authorization program, operated by Florida's Forest Service, that considers the potential impact of smoke at sensitive receptors.
                </P>
                <P>
                    With respect to 40 CFR 51.308(f)(2)(iv)(E), EPA proposes to find that Florida assessed the anticipated net effect on visibility due to projected changes in point, area, and mobile source emissions over the second planning period in development of the 2028 RPGs for the Florida Class I areas. FDEP also identifies control measures included in the VISTAS 2028 emissions inventory and source retirements and replacements. FDEP used the 2011 base year emissions inventory to project emissions from various source sectors to 2028, the end of the second planning period. FDEP, through VISTAS, completed CAMx modeling to estimate visibility impairment in 2028 based on projected 2028 emissions from the 2011 base year inventory and using IMPROVE monitoring data for 2009-2013. As mentioned previously, atmospheric ammonium sulfate is the largest contributor to visibility impairment in Class I areas in the Southeast. VISTAS emission sensitivity modeling determined that the most effective way to reduce ammonium sulfate is to reduce SO
                    <E T="52">2</E>
                     emissions from EGUs and non-utility industrial point sources.
                </P>
                <P>
                    <E T="03">e. Interstate Consultation:</E>
                     Based on the consultation documentation described in section III.C.2.e of this document and section I.F. of the TSD to this proposed rulemaking, EPA proposes to find that Florida has met the requirements under 40 CFR 51.308(f)(2)(ii) to consult with those states with Class I areas that Florida emissions impact for visibility and to consult with those states whose sources are impacting Florida's Class I areas.
                    <SU>105</SU>
                    <FTREF/>
                     Additionally, Florida appropriately responded to and documented requests from MANE-VU to address upwind emissions from sources in VISTAS states. Lastly, FDEP completed the requested emissions control analyses for the five facilities and provided the State's analyses and conclusions of these analyses in section 7.6 and 7.8 of the 2021 Plan and 2024 Supplement.
                </P>
                <FTNT>
                    <P>
                        <SU>105</SU>
                         Specifically, EPA proposes to find that FDEP appropriately responded to and documented requests from Georgia to complete FFAs or existing, effective control demonstrations for the SO
                        <E T="52">2</E>
                         emissions from Foley, JEA Northside, Nutrien, Seminole, and WestRock-Fernandina in Florida.
                    </P>
                </FTNT>
                <P>
                    EPA also proposes to find that FDEP appropriately consulted with other states, namely Kentucky, Georgia, and Alabama regarding specific sources that are reasonably anticipated to contribute to visibility impairment at Class I areas in Florida in accordance with 40 CFR 51.308(f)(2)(ii). EPA proposes to conclude that Florida appropriately documented its interstate consultations regarding Florida sources reasonably anticipated to contribute to visibility impairment at Class I areas outside of the State and sources in other states reasonably anticipated to contribute to visibility impairment at Florida's Class I areas.
                    <SU>106</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>106</SU>
                         EPA is proposing action on Florida's source selection and control analyses in this rulemaking on the State's Haze Plan. Thus, EPA is not proposing action regarding the adequacy of other states' responses to Florida's requests for consultation pursuant to 40 CFR 51.308(f)(2)(ii) in this proposed action.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">D. RPGs</HD>
                <P>
                    <E T="03">1. RHR Requirement:</E>
                     Section 51.308(f)(3) contains the requirements pertaining to RPGs for each Class I area. Section 51.308(f)(3)(i) requires a state in which a Class I area is located to establish RPGs—one each for the most impaired and clearest days—reflecting the visibility conditions that will be achieved at the end of the planning period as a result of the emission limitations, compliance schedules and other measures required under paragraph (f)(2) to be in states' LTS, as well as implementation of other CAA requirements. The LTS, as reflected by the RPGs, must provide for an improvement in visibility on the most impaired days relative to the baseline period and ensure no degradation on the clearest days relative to the baseline period. Section 51.308(f)(3)(ii) applies in circumstances in which a Class I area's RPG for the most impaired days represents a slower rate of visibility improvement than the URP calculated under 40 CFR 51.308(f)(1)(vi). Under 40 CFR 51.308(f)(3)(ii)(A), if the state in which a mandatory Class I area is located establishes an RPG for the most impaired days that provides for a slower rate of visibility improvement than the URP, the state must demonstrate that there are no additional emission reduction measures for anthropogenic sources or groups of sources in the state that would be reasonable to include in its LTS. Section 51.308(f)(3)(ii)(B) requires that if a state contains sources that are reasonably anticipated to contribute to visibility impairment in a Class I area in 
                    <E T="03">another</E>
                     state, and the RPG for the most impaired days in that Class I area is above the URP, the upwind state must provide the same demonstration.
                </P>
                <P>
                    <E T="03">2. State Assessment:</E>
                     Florida identified the 2028 RPGs for each of its Class I areas in deciviews. Florida's RPGs are listed in table 3.
                </P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,16,16,12">
                    <TTITLE>
                        Table 3—Florida Class I Areas' 2028 RPGs and URP in Deciviews (
                        <E T="01">dv</E>
                        )
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1">Class I area</CHED>
                        <CHED H="1">
                            2028 RPG clearest
                            <LI>20%</LI>
                        </CHED>
                        <CHED H="1">
                            2028 RPG most
                            <LI>impaired 20%</LI>
                        </CHED>
                        <CHED H="1">2028 URP</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Chassahowitzka</ENT>
                        <ENT>12.54</ENT>
                        <ENT>16.79</ENT>
                        <ENT>18.36</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">St. Marks</ENT>
                        <ENT>11.59</ENT>
                        <ENT>16.43</ENT>
                        <ENT>18.26</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Everglades</ENT>
                        <ENT>9.88</ENT>
                        <ENT>13.95</ENT>
                        <ENT>15.06</ENT>
                    </ROW>
                </GPOTABLE>
                <P>Florida's 2028 RPGs on the 20 percent most impaired days are below the URP for all Florida Class I areas. The 2028 RPGs on the 20 percent clearest days showed no degradation since the 2000-2004 baseline period.</P>
                <P>
                    <E T="03">3. EPA Evaluation:</E>
                     EPA proposes to determine that Florida has satisfied the applicable requirements of 40 CFR 51.308(f)(3) relating to RPGs. Florida provided 2028 RPGs for the most impaired and clearest days for the three 
                    <PRTPAGE P="105530"/>
                    Class I areas in the State subject to the RHR. Specifically, the State established 2028 RPGs expressed in deciviews that reflect the visibility conditions that are projected to be achieved by the end of the second planning period as a result of implementation of the LTS and other CAA requirements. Florida's 2028 RPGs show an improvement in visibility for the 20 percent most impaired days since the baseline period (2000-2004) and show no degradation in visibility for the 20 percent clearest days since the baseline period. The RPGs in the Haze Plan provide for a faster rate of visibility improvement than the URP, and thus, 40 CFR 51.308(f)(3)(ii)(A) does not apply to Florida. Additionally, 40 CFR 51.308(f)(3)(ii)(B), does not apply to Florida because the Class I areas impacted by emissions from Florida's sources are below their respective URPs.
                </P>
                <HD SOURCE="HD2">E. Monitoring Strategy and Other Regional Haze Plan Requirements</HD>
                <P>
                    <E T="03">1. RHR Requirement:</E>
                     Section 51.308(f)(6) specifies that each comprehensive revision of a state's regional haze SIP must contain or provide for certain elements, including monitoring strategies, emissions inventories, and any reporting, recordkeeping and other measures needed to assess and report on visibility. A main requirement of this subsection is for states with Class I areas to submit monitoring strategies for measuring, characterizing, and reporting on visibility impairment. Compliance with this requirement may be met through participation in the IMPROVE network.
                </P>
                <P>Section 51.308(f)(6)(i) requires SIPs to provide for the establishment of any additional monitoring sites or equipment needed to assess whether reasonable progress goals to address regional haze for all mandatory Class I areas within the state are being achieved.</P>
                <P>Section 51.308(f)(6)(ii) requires SIPs to provide for procedures by which monitoring data and other information are used in determining the contribution of emissions from within the state to regional haze visibility impairment at mandatory Class I areas both within and outside the state. Section 51.308(f)(6)(iii) does not apply to Florida, as it has Class I areas. Section 51.308(f)(6)(iv) requires the SIP to provide for the reporting of all visibility monitoring data to the Administrator at least annually for each Class I area in the state. Section 51.308(f)(6)(v) requires SIPs to provide for a statewide inventory of emissions of pollutants that are reasonably anticipated to cause or contribute to visibility impairment, including emissions for the most recent year for which data are available and estimates of future projected emissions. It also requires a commitment to update the inventory periodically. Under 40 CFR 51.308(f)(4), if EPA or the FLM of an affected Class I area has advised a State that additional monitoring is needed to assess RAVI, the State must include in its SIP revision for the second planning period an appropriate strategy for evaluating such impairment.</P>
                <P>
                    <E T="03">2. State Assessment:</E>
                </P>
                <P>
                    <E T="03">a. Section 51.308(f)(6)(i):</E>
                     Florida relies on the IMPROVE monitoring network to meet the monitoring strategy requirements and contends that the existing IMPROVE monitors for the State's Class I areas are adequate and no additional monitoring sites or equipment are needed to assess whether RPGs for all mandatory Class I areas within the State are being achieved.
                </P>
                <P>
                    <E T="03">b. Section 51.308(f)(6)(ii):</E>
                     Florida states that data produced by the IMPROVE monitoring network will be used for preparing the five-year progress reports and the 10-year comprehensive SIP revisions, each of which rely on analysis of the preceding five years of IMPROVE monitor data.
                </P>
                <P>
                    <E T="03">c. Section 51.308(f)(6)(iii):</E>
                     This provision applies to states with no mandatory Class I areas, and therefore, does not apply to Florida.
                </P>
                <P>
                    <E T="03">d. Section 51.308(f)(6)(iv):</E>
                     With respect to 40 CFR 51.308(f)(6)(iv), NPS manages and oversees the IMPROVE monitoring network and reviews, verifies, and validates IMPROVE data before its submission to EPA's Air Quality System. Florida believes the existing IMPROVE monitors for the State's Class I areas are sufficient for the purposes of this Haze Plan. Florida believes that participation of the state organizations, including FDEP, in the IMPROVE Steering Committee adequately represents the needs of the State.
                </P>
                <P>
                    <E T="03">e. Section 51.308(f)(6)(v):</E>
                     FDEP provided a statewide, baseline emissions inventory of pollutants for the year 2011 in table 4-1 of the 2021 Plan which includes the following pollutants: carbon monoxide, NH
                    <E T="52">3,</E>
                     NO
                    <E T="52">X</E>
                    , PM
                    <E T="52">10</E>
                    ,
                    <SU>107</SU>
                    <FTREF/>
                     PM
                    <E T="52">2.5</E>
                    , SO
                    <E T="52">2</E>
                    , and VOC. The 2011 base year modeling platform was the best platform available at the time the modeling work began in late 2017. Emissions and modeling work should begin three years before haze plans are due because of the significant amount of time required to complete the work one year in advance of preparing the haze plans. FDEP, through VISTAS, discussed the selection of modeling platforms with EPA and reliance on the 2011 base year.
                </P>
                <FTNT>
                    <P>
                        <SU>107</SU>
                         PM
                        <E T="52">10</E>
                         is particulate matter of greater than or equal to 10 micrometers (µm) in diameter.
                    </P>
                </FTNT>
                <P>
                    In addition, FDEP provided in tables 13-11, 13-12, 13-13 of the 2021 Plan statewide emissions data for 2014 (NEI), 2017 (NEI), and 2018 emissions projections developed in the first planning period for PM
                    <E T="52">2.5</E>
                    , NO
                    <E T="52">X</E>
                    , and SO
                    <E T="52">2</E>
                    , respectively, by source category in support of the progress report elements of its plan. Also, in table 7-1 of the 2021 Plan, FDEP includes both the 2011 actual and 2028 projected emissions for the criteria air pollutants, including SO
                    <E T="52">2</E>
                    , NO
                    <E T="52">X</E>
                    , PM
                    <E T="52">10</E>
                    , and PM
                    <E T="52">2.5</E>
                     for all VISTAS states including Florida. FDEP commits to periodically update its statewide emissions inventories under 40 CFR 51.308(f)(6)(v).
                </P>
                <P>
                    <E T="03">f. Section 51.308(f)(6)(vi):</E>
                     There are no elements, including reporting, recordkeeping, or other measures, necessary to address and report on visibility for Florida's Class I areas or Class I areas outside the State that are affected by sources in Florida.
                </P>
                <P>
                    <E T="03">g. Section 51.308(f)(4):</E>
                     With respect to 40 CFR 51.308(f)(4), the State did not include a strategy for evaluating RAVI for any Class I areas because no Federal agency requested additional monitoring to assess RAVI.
                </P>
                <P>
                    <E T="03">3. EPA Evaluation:</E>
                     EPA proposes to find that Florida has satisfied the applicable requirements of 40 CFR 51.308(f)(4) and (6) related to RAVI, visibility monitoring, and emissions inventories.
                </P>
                <P>With respect to 40 CFR 51.308(f)(4), EPA proposes to find that this requirement does not apply to Florida at this time because neither EPA nor the FLMs requested additional monitoring to assess RAVI.</P>
                <P>EPA proposes to find that Florida satisfied 40 CFR 51.308(f)(6), which is generally met by the State's continued participation in the IMPROVE monitoring network and the VISTAS RPO, for the following reasons.</P>
                <P>With respect to 40 CFR 51.308(f)(6)(i), EPA proposes to find that the existing IMPROVE monitors relied upon for the State's three Class I areas are adequate, and thus, additional monitoring sites or equipment are not needed to assess whether RPGs for all Class I areas within the State are being achieved.</P>
                <P>With respect to 40 CFR 51.308(f)(6)(ii), Florida has procedures by which monitoring data from the IMPROVE will be used to for preparing the five-year progress reports and the 10-year comprehensive SIP revisions.</P>
                <P>
                    With respect to 40 CFR 51.308(f)(6)(iii), this provision is applicable for states with no Class I areas and does not apply to Florida.
                    <PRTPAGE P="105531"/>
                </P>
                <P>With respect to 40 CFR 51.308(f)(6)(iv), EPA proposes to find that Florida's participation in the IMPROVE Steering Committee and the IMPROVE monitoring network addresses this requirement.</P>
                <P>With respect to 40 CFR 51.308(f)(6)(v), EPA proposes to find that Florida's continued participation in VISTAS' efforts for projecting future emissions and continued compliance with the requirements of the AERR to periodically update emissions inventories satisfies the requirement to provide for an emissions inventory for the most recent year for which data are available. EPA proposes to find that Florida adequately documented that no further elements are necessary at this time for the State to assess and report on visibility pursuant to 40 CFR 51.308(f)(6)(vi).</P>
                <HD SOURCE="HD2">F. Requirements for Periodic Reports Describing Progress Toward the RPGs</HD>
                <P>
                    <E T="03">1. RHR Requirement:</E>
                     Section 51.308(f)(5) requires that periodic comprehensive revisions of states' regional haze plans address the progress report requirements of 40 CFR 51.308(g)(1) through (5). The purpose of these requirements is to evaluate progress toward the applicable RPGs for each Class I area within the state and each Class I area outside the state that may be affected by emissions from within that state. Section 51.308(g)(1) and (2) apply to all states and require a description of the status of implementation of all measures included in a state's first planning period regional haze plan and a summary of the emission reductions achieved through implementation of those measures. Section 51.308(g)(3) applies only to states with Class I areas within their borders and requires such states to assess current visibility conditions, changes in visibility relative to baseline (2000-2004) visibility conditions, and changes in visibility conditions relative to the period addressed in the first planning period progress report. Section 51.308(g)(4) applies to all states and requires an analysis tracking changes in emissions of pollutants contributing to visibility impairment from all sources and sectors since the period addressed by the first planning period progress report. This provision further specifies the year or years through which the analysis must extend depending on the type of source and the platform through which its emission information is reported. Finally, 40 CFR 51.308(g)(5), which also applies to all states, requires an assessment of any significant changes in anthropogenic emissions within or outside the state have occurred since the period addressed by the first planning period progress report, including whether such changes were anticipated and whether they have limited or impeded expected progress toward reducing emissions and improving visibility.
                </P>
                <P>
                    <E T="03">2. State Assessment:</E>
                     With respect to the progress report elements pursuant to 40 CFR 51.308(f)(5), FDEP addressed these elements in section 13 of the 2021 Plan for the period 2014 to 2019.
                </P>
                <P>
                    Regarding 40 CFR 51.308(g)(1) and (2), FDEP describes the status of the implementation of the measures of the LTS from the first planning period in section 13.2 of the 2021 Plan and provides a summary of the emission reductions achieved by implementing those measures as such data is available in section 13.3 of the 2021 Plan. With respect to 40 CFR 51.308(g)(1), section 13.1.1 of the 2021 Plan lists key emissions control measures relied upon for Florida's first regional haze plan submitted March 19, 2010 (“2010 Haze Plan”).
                    <SU>108</SU>
                    <FTREF/>
                     Section 13.3.2 identifies key measures that contributed to emission reductions during the first planning period but were not a part of the LTS for the first period (
                    <E T="03">e.g.,</E>
                     2010 SO
                    <E T="52">2</E>
                     NAAQS).
                </P>
                <FTNT>
                    <P>
                        <SU>108</SU>
                         The 2010 Haze Plan was amended twice. 
                        <E T="03">See</E>
                         78 FR 53250 (August 29, 2013).
                    </P>
                </FTNT>
                <P>
                    With respect to 40 CFR 51.308(g)(2), Florida continued to focus on SO
                    <E T="52">2</E>
                     emissions reductions because the State determined that ammonium sulfate was the most important contributor to visibility impairment and fine particle mass on the 20 percent best and 20 percent worst days in the first planning period. Florida reported on emission reductions achieved by Federal and state measures relied upon to project the 2018 RPGs for the first period haze plan, including 2007 Heavy-Duty Highway Rule, Tier 2 Vehicle and Gasoline Sulfur Program, and the North Carolina Clean Smokestacks Act. In addition, the State provided emission reductions for sources evaluated for controls in the first period haze plan as follows. Table 13-4 of the 2021 Plan lists the 15 facilities that had units for which a reasonable progress determination was made and the current status. All facilities that were required to implement reasonable progress controls or measures have met their compliance dates. During the 2014-2019 period, SO
                    <E T="52">2</E>
                     emissions from the units listed in table 13-4 decreased by 60,752 tpy.
                </P>
                <P>
                    Table 13-5 lists the 12 sources for which a BART control determination was made. Sources that were exempt from BART analysis or shut down prior to submission of the first regional haze SIP are not listed. All BART controls have been implemented as of December 31, 2018. During the 2014-2019 period, SO
                    <E T="52">2</E>
                     emissions from these units decreased by 43,416 tons per year, NO
                    <E T="52">X</E>
                     emissions decreased by 10,073 tpy, and PM emissions decreased by 1,742 tpy.
                </P>
                <P>
                    Regarding 40 CFR 51.308(g)(3), FDEP calculated for Florida's three Class I areas: the current visibility conditions (2014-2018); the difference between current visibility conditions compared to the baseline; and the change in visibility impairment for the most and least impaired days over the past five years.
                    <SU>109</SU>
                    <FTREF/>
                     FDEP concluded that IMPROVE monitoring data for 2014-2018 show that all Florida Class I areas are well below the 2018 RPGs for the 20 percent most impaired days and there is no degradation on the 20 percent clearest days, which is illustrated in figures 13-4 through 13-9 of the 2021 Plan.
                    <SU>110</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>109</SU>
                         
                        <E T="03">See</E>
                         table 13-6 (20 percent most impaired days) and table 13-7 (20 percent clearest days) of the 2021 Plan.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>110</SU>
                         `Model Projection' = RPG and `Observation' = IMPROVE data in figures 13-4 through 13-9 of the 2021 Plan.
                    </P>
                </FTNT>
                <P>
                    Regarding 40 CFR 51.308(g)(4), in section 13.5 of the 2021 Plan, FDEP provided emissions trends from 2014 through 2019 for SO
                    <E T="52">2</E>
                     and NO
                    <E T="52">X</E>
                     which reflect the emissions reductions from the measures in the first planning period LTS. In summary, from 2014 to 2019, statewide EGU emissions of SO
                    <E T="52">2</E>
                     and NO
                    <E T="52">X</E>
                     have reduced (in percent) by 82.77 and 48.31, respectively. Statewide EGU SO
                    <E T="52">2</E>
                     emissions decreased from 99,074 tpy in 2014 to 17,075 tpy in 2019 as shown in table 13-14 of the 2021 Plan. Statewide EGU NO
                    <E T="52">X</E>
                     emissions decreased from 442,412 tpy in 2014 to 228,673 tpy in 2019. Additionally, in table 13-13, FDEP provides statewide SO
                    <E T="52">2</E>
                     emissions information for Florida from the 2014 NEI and 2017 NEI inventories. Again, total statewide SO
                    <E T="52">2</E>
                     emissions are shown to have decreased 47.53 percent from 164,468 tpy in 2014 to 78,173 tpy in 2017.
                </P>
                <P>
                    Regarding 40 CFR 51.308(g)(5), FDEP reviewed anthropogenic SO
                    <E T="52">2,</E>
                     and NO
                    <E T="52">X</E>
                     emissions trends based on emissions information included in the 2014 and 2017 NEIs for the VISTAS states and all of the RPOs. The data show a decline in PM
                    <E T="52">2.5</E>
                    , NO
                    <E T="52">X</E>
                    , and SO
                    <E T="52">2</E>
                     emissions from 2014 through 2017 NEI and these emissions are lower than the 2018 VISTAS RPG in most cases as shown in table 13-11, 13-12, and 13-13 of the 2021 Plan. Florida concluded that there does not appear to be any significant change in anthropogenic emissions within Florida that would limit or 
                    <PRTPAGE P="105532"/>
                    impede progress in reducing pollutant emissions or improving visibility.
                </P>
                <P>Section II of the TSD to this proposed rulemaking provides a more detailed summary of the State's assessment of how Florida addressed requirements for periodic reports describing progress toward the RPGs for the State's Class I areas pursuant to 40 CFR 51.308(f)(5).</P>
                <P>
                    <E T="03">3. EPA Evaluation:</E>
                     EPA proposes to find that FDEP has met the requirements of 40 CFR 51.308(g)(1) and (2) because its SIP submission describes the measures included in the LTS from the first planning period, as well as the status of their implementation and the emission reductions achieved through such implementation. EPA proposes to find that FDEP met the requirements of 40 CFR 51.308(g)(3) because the State reported on the visibility conditions and changes at Florida's Class I areas. EPA proposes to find that FDEP met the requirements of 40 CFR 51.308(g)(4) by providing an adequate analysis tracking the changes in emissions since the first period progress report using available emissions data since 2013 and appropriately included the 2017 NEI data, which is the most recent triennial emissions inventory submission from Florida prior to submission of the Haze Plan and included the annual 2019 emissions data. Regarding 40 CFR 51.308(g)(5), FDEP believes that there does not appear to be any significant change in anthropogenic emissions within Florida that have occurred since the period addressed in the most recent plan that would limit or impede progress in reducing pollutant emissions or improving visibility. For these reasons, EPA is proposing to find that Florida has met the requirements of 40 CFR 51.308(f)(5).
                </P>
                <HD SOURCE="HD2">G. Requirements for State and FLM Coordination</HD>
                <P>
                    <E T="03">1. CAA/RHR Requirement:</E>
                     Section 169A(d) of the Act requires states to consult with FLMs before holding the public hearing on a proposed regional haze SIP, and to include a summary of the FLMs' conclusions and recommendations in the notice to the public. In addition, § 51.308(i)(2)'s FLM consultation provision requires a state to provide FLMs with an opportunity for consultation that is early enough in the state's policy analyses of its emission reduction obligation so that information and recommendations provided by the FLMs' can meaningfully inform the state's decisions on its LTS. If the consultation has taken place at least 120 days before a public hearing or public comment period, the opportunity for consultation will be deemed early enough. Regardless, the opportunity for consultation must be provided at least 60 days before a public hearing or public comment period at the state level. Section 51.308(i)(2) also provides two substantive topics on which FLMs must be provided an opportunity to discuss with states: assessment of visibility impairment in any Class I area and recommendations on the development and implementation of strategies to address visibility impairment. Section 51.308(i)(3) requires states, in developing their implementation plans, to include a description of how they addressed FLMs' comments. Section 51.308(i)(4) requires that the regional haze SIP revision provide procedures for continuing consultation between the state and FLMs regarding the state's visibility protection program.
                </P>
                <P>
                    <E T="03">2. State Assessment:</E>
                </P>
                <P>
                    <E T="03">a. General:</E>
                     As required by CAA section 169A(d), Florida consulted with the FLMs prior to opening both State public comment periods 
                    <SU>111</SU>
                    <FTREF/>
                     and included summaries of the conclusions and recommendations of the FLMs in section 10.4.1 with copies of the FLMs' comments in appendices H-4 and H-5 of the proposed plan dated June 9, 2021, and in the public participation section of the proposed supplement dated January 19, 2024.
                </P>
                <FTNT>
                    <P>
                        <SU>111</SU>
                         FDEP provided draft plans to the FLMs on April 2, 2021, and June 8, 2023.
                    </P>
                </FTNT>
                <P>
                    With respect to 40 CFR 51.308(i)(2) FDEP offered the opportunity to consult on the May 18, 2021, draft Florida Haze Plan to the three FLM agencies. Additionally, FDEP shared with the FLMs the June 9, 2021, Prehearing Florida Haze Plan.
                    <SU>112</SU>
                    <FTREF/>
                     A summary of this consultation process is discussed and documented in section 10.4.1 of the 2021 Plan with supporting information in appendix H and appendix F. Regarding FLM consultation related to the 2024 Supplement development, FDEP offered the opportunity to consult on the 2024 Supplement to the three FLM agencies on June 8, 2023. The 2024 Supplement was issued for State public notice and comment on January 19, 2024, with a public hearing scheduled February 27, 2024, and a close of comment period February 19, 2024; however, FDEP received a request for an extension of the comment period and granted the request by extending the comment period to March 8, 2024. The public hearing, which was rescheduled for March 20, 2024, was cancelled because FDEP did not receive any requests for a hearing. A summary of this consultation process is discussed and documented in the public participation section of the 2024 Supplement.
                </P>
                <FTNT>
                    <P>
                        <SU>112</SU>
                         The June 9, 2021, Prehearing Florida Haze Plan was issued for a State public notice and had a comment period that closed on July 9, 2021. The public hearing was held on July 15, 2021.
                    </P>
                </FTNT>
                <P>To address 40 CFR 51.308(i)(3), FDEP provided responses to NPS comments in section 10.4.1 of the 2021 Plan and in the public participation section of the 2024 Supplement.</P>
                <P>With respect to 40 CFR 51.308(i)(4), Florida has established ongoing consultation procedures with the FLMs, which includes offering the FLMs an opportunity for consultation upon request and to comply with consultations requirements in accordance with 40 CFR 51.308(i)(3) for progress reports and plan revisions.</P>
                <P>
                    <E T="03">b. State Responses to FLM Comments:</E>
                     To address 40 CFR 51.308(i)(3), Florida provided responses to comments received from NPS in section 10.4.1 of the 2021 Plan, which are summarized in brief below. In the 2021 Plan, NPS comments received are located in appendices H-4 and H-5. AppendixH-4 contains documentation of a May 18, 2021, consultation call that NPS held with the FDEP. Representatives from FWS and USFS also attended. NPS requested clarification on why the Miami-Dade Water and Sewer Department facility was not selected for analysis. FDEP clarified that recent actual emissions are significantly lower due to the facility's use of lower sulfur content fuel, which the facility is expected to continue to use. Additionally, FDEP stated that the AoI analysis likely overpredicted this facility's impact at Everglades since this is a small source located very near the Class I area.
                    <SU>113</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>113</SU>
                         
                        <E T="03">See</E>
                         section 7.6.3 of the 2021 Plan.
                    </P>
                </FTNT>
                <P>Additionally, the 2021 Plan states that NPS made recommendations to update the interest rates in the FFA cost analyses. NPS also noted that the Florida Everglades have not observed increases in nitrate concentrations on the 20 percent most impaired days and that it is the least impaired NPS Class I areas in the VISTAS region, thus the VISTAS-wide methodologies used to select sources and pollutants for reasonable progress analyses were of no concern.</P>
                <P>
                    FDEP also addresses NPS comments in the public participation section of the 2024 Supplement. NPS acknowledges FDEP's inclusion of the Mosaic-South Pierce facility in the supplement and recommends that FDEP include the facility's emission history and consider the additional information for Mosaic-South Pierce that NPS provided concerning the evaluation of an Idaho 
                    <PRTPAGE P="105533"/>
                    facility with similar SAPs. In response, FDEP states that it determined that the use of post-process scrubbers for the dual adsorption process sulfuric acid plant at Mosaic-South Pierce was not considered to be cost-effective for the facility and that SO
                    <E T="52">2</E>
                     emission reductions were achieved through an SO
                    <E T="52">2</E>
                     emission limit in permit 1050055-037-AC, which was approved into Florida's SIP on August 4, 2023 (88 FR 51702).
                </P>
                <P>
                    <E T="03">3. EPA Evaluation:</E>
                     EPA proposes to find that Florida addressed all FLM consultation requirements in the CAA and RHR. With respect to CAA 169A(d), Florida consulted with the FLMs prior to the State's public comment periods 
                    <SU>114</SU>
                    <FTREF/>
                     and included a summary of the conclusions and recommendations of the FLMs in the proposed plans issued for public review.
                    <SU>115</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>114</SU>
                         The consultation did not occur in person as stated in the CAA due to the convenience and efficiency of using email, phone calls, and video meetings.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>115</SU>
                         A description of Florida's response to FLM comments can be found in section 10.4, and under the public participation section of the Haze Plan.
                    </P>
                </FTNT>
                <P>
                    FDEP fully addressed the requirement for FLM consultation under 40 CFR 51.308(i)(2) because FDEP offered the draft Florida Haze Plan on April 2, 2021, prior to the start of FDEP's public comment period which opened on June 9, 2021, and closed on July 9, 2021. Additionally, FDEP offered the FLMs a review of the draft 2024 Supplement on June 8, 2023, prior to the start of the comment period on January 19, 2024.
                    <SU>116</SU>
                    <FTREF/>
                     EPA proposes to find that Florida has met its requirements under 40 CFR 51.308(i)(2) to consult with the FLMs on its Haze Plan for the second planning period.
                </P>
                <FTNT>
                    <P>
                        <SU>116</SU>
                         
                        <E T="03">See</E>
                         the public participation section of the 2024 Supplement for details.
                    </P>
                </FTNT>
                <P>EPA proposes to find that Florida satisfied 40 CFR 51.308(i)(3) by providing responses to the FLM comments in section 10.4.1 of the 2021 Plan.</P>
                <P>EPA proposes to find that Florida satisfied 40 CFR 51.308(i)(4) by establishing in its 2021 Plan continuing consultation procedures as summarized above.</P>
                <HD SOURCE="HD1">V. Incorporation by Reference</HD>
                <P>
                    In this document, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, and as discussed above in this preamble, EPA is proposing to incorporate by reference into Florida's SIP the following conditions from the listed FDEP Air Construction Permits: Conditions 7 and 28 in Subsection A of Section 3 of the Duke Crystal River Citrus Co. Combined Cycle Permit No. 0170004-047-AC (State-effective December 16, 2014); Condition 1 of Section 3 of the Duke Crystal River Permit No. 0170004-059-AC (State-effective October 30, 2020); Conditions 8, 9, 11, 12, 13, 14, 15, 16, 18, 20, 21, 22, 23, 24 and 25 of Subsection A of Section 3 and Conditions 2, 3, 4, 5, 6, 7, 8 and 9 of Subsection B of Section 3 of the Georgia-Pacific Foley Mill Permit No. 1230001-121-AC (State-effective October 20, 2023); Conditions 9, 14(a), 31(a) of Section III of the JEA Northside Units 1 and 2 Permit No. 0310045-003-AC (State-effective July 14, 1999), and Condition 2 of Subsection A of Section 3 of Permit No. 0310045-059-AC (State-effective February 16, 2023); Conditions 2, 5, and 6 of Section 3 of the JEA Northside Unit 3 Permit Nos. 0310045-057-AC (State-effective June 17, 2021), and Condition 2 of Subsection A of Section 3 of Permit No. 0310045-062-AC (State-effective August 24, 2023); Condition 3 of Subsection A of Section 3 of the Seminole Generating Station Permit No. 1070025-037-AC (State-effective April 14, 2021); Conditions 12 and 13 of Subsection C of Section 3 of the TECO-Big Bend Permit No. 0570039-129-AC (State-effective August 11, 2020); and Conditions 2, 3, and 4 of Subsection A of Section 3 of the WestRock-Fernandina Beach Mill Permit No. 0890003-072-AC (State-effective June 24, 2021) and Condition 5 of Subsection A of Section 3 of Permit No. 0890003-074-AC (State-effective December 16, 2021). EPA has made, and will continue to make, the SIP available through 
                    <E T="03">www.regulations.gov</E>
                     and at the EPA Region 4 Office (please contact the person identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this preamble for more information).
                </P>
                <HD SOURCE="HD1">VI. Proposed Action</HD>
                <P>EPA is proposing to approve Florida's October 8, 2021, June 14, 2024, and October 28, 2024, SIP submissions, as satisfying the regional haze requirements for the second planning period contained in 40 CFR 51.308(f). Thus, EPA is proposing to incorporate by reference into Florida's SIP the permit conditions identified in section V above.</P>
                <HD SOURCE="HD1">VII. Statutory and Executive Order Reviews</HD>
                <P>
                    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 
                    <E T="03">See</E>
                     42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this proposed action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
                </P>
                <P>• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);</P>
                <P>
                    • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>
                    • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);</P>
                <P>• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);</P>
                <P>• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;</P>
                <P>• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and</P>
                <P>• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA.</P>
                <P>In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).</P>
                <P>
                    Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, Feb. 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on communities with environmental justice (EJ) concerns to the greatest extent practicable and permitted by law. Executive Order 14096 (Revitalizing Our Nation's 
                    <PRTPAGE P="105534"/>
                    Commitment to Environmental Justice for All, 88 FR 25251, April 26, 2023) builds on and supplements E.O. 12898 and defines EJ as, among other things, the just treatment and meaningful involvement of all people, regardless of income, race, color, national origin, or Tribal affiliation, or disability in agency decision-making and other Federal activities that affect human health and the environment.
                </P>
                <P>FDEP did not evaluate EJ considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. EPA did not perform an EJ analysis and did not consider EJ in this proposed action. Due to the nature of the action being proposed here, this proposed action is expected to have a neutral to positive impact on the air quality of the affected area. Consideration of EJ is not required as part of this proposed action, and there is no information in the record inconsistent with the stated goal of Executive Order 12898/14096 of achieving EJ for communities with EJ concerns.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 52</HD>
                    <P>Environmental protection, Air pollution control, Carbon moNOXide, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.</P>
                </LSTSUB>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>
                        42 U.S.C. 7401 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Jeaneanne Gettle,</NAME>
                    <TITLE>Acting Regional Administrator, Region 4.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30751 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </PRORULE>
    </PRORULES>
    <VOL>89</VOL>
    <NO>248</NO>
    <DATE>Friday, December 27, 2024</DATE>
    <UNITNAME>Notices</UNITNAME>
    <NOTICES>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="105535"/>
                <AGENCY TYPE="F">AGENCY FOR INTERNATIONAL DEVELOPMENT</AGENCY>
                <SUBJECT>Proposed Revision of AID 114-2 Anti-Harassment Intake Summary Sheet</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>United States Agency for International Development.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of information collection; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The United States Agency for International Development (USAID), in accordance with the Paperwork Reduction Act (PRA) of 1995, as amended, invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 30 days of public comment on the AID 114-2 Anti-Harassment Program Intake Summary Sheet, prior to the submission of the information collection request (ICR) to OMB for approval.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments should be submitted within 30 calendar days from the date of this publication.</P>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Interested persons are invited to submit written comments by email to 
                        <E T="03">OCRharassment@usaid.gov.</E>
                    </P>
                    <P>
                        Please reference the AID 114-2 Anti-Harassment Program Intake Summary Sheet in the subject line of your comments. All comments received are part of the public record. No comments will be posted to 
                        <E T="03">https://www.regulations.gov</E>
                         for public viewing until after the comment period has closed. Comments will generally be posted without change. All Personally Identifiable Information (for example, name and address) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information. You may submit attachments to electronic comments in Microsoft Word, Excel, or Adobe PDF file formats.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Tanya Shorter, Lead Anti-Harassment Program Specialist, USAID, Office of Civil Rights, telephone 771-202-3478 or email at 
                        <E T="03">OCRharassment@usaid.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The purpose of the AID 114-2 form is to document basic information regarding allegations of harassment to include the following: Information about involved individuals, including the individual alleged to be harassed, the alleged harasser, and witnesses or others with knowledge of the incident(s): (1) full name, (2) contact information, (3) position title, (4) hiring mechanism, and (5) office/work location; (6) Description of the alleged harassment, including the date(s) the alleged harassment occurred and whether the alleged harassment is alleged to be based on a protected EEO category (race, color, national origin, sex (including pregnancy, gender identity, sexual orientation, or transgender status), age (40 or older), religion, genetic information (including family medical history), physical or mental disability, or retaliation); (7) Whether the supervisor and/or other management official took any steps in response to the alleged harassment; and (8) Any other useful, preliminary information.</P>
                <P>
                    <E T="03">Type of Information Collection:</E>
                     AID 114-2 Anti-Harassment Program Intake Summary Sheet.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Notice for public comment.
                </P>
                <P>
                    <E T="03">Originating Office:</E>
                     USAID's Office of Civil Rights.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     General public and other Federal agencies.
                </P>
                <P>
                    <E T="03">Respondent's obligation to respond:</E>
                     Voluntary.
                </P>
                <P>
                    <E T="03">Estimated number of respondents:</E>
                     400.
                </P>
                <P>
                    <E T="03">Average time per response:</E>
                     15 minutes for respondents.
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     Once.
                </P>
                <P>
                    <E T="03">Total estimated burden:</E>
                     100.
                </P>
                <P>
                    <E T="03">Total estimated burden cost:</E>
                     None.
                </P>
                <P>We are soliciting general public and other federal agencies comments to permit USAID to:</P>
                <P>• Evaluate whether the proposed information collection is necessary for the proper functions of USAID.</P>
                <P>• Enhance the quality, utility, and clarity of the information to be collected.</P>
                <P>• Minimize the reporting burden on those who are to respond.</P>
                <SIG>
                    <NAME>Stephen Shih,</NAME>
                    <TITLE>Director, Office of Civil Rights, U.S. Agency for International Development.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30954 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6116-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Institute of Standards and Technology</SUBAGY>
                <SUBJECT>Dietary Supplement Laboratory Quality Assurance Program (DSQAP) Consortium</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Institute of Standards and Technology, Department of Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of research consortium.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The National Institute of Standards and Technology (NIST), an agency of the United States Department of Commerce, in support of efforts to develop and evaluate measurement methods and standards, including reference materials, to support quality and safety for the dietary supplement testing community, is establishing the Dietary Supplement Laboratory Quality Assurance Program (DSQAP) Consortium (“Consortium”). The Consortium will bring together stakeholders to identify and address measurement and standards needs related to analytical testing of dietary supplement ingredients and products. The Consortium efforts are intended to advance measurement capabilities, provide measurement quality assurance strategies, support the development of dietary supplement reference materials, and collect data to support the development of best practices and standard methods. Participants will be required to sign a Cooperative Research and Development Agreement (CRADA). At NIST's discretion, entities that are not permitted to enter into CRADAs pursuant to law or other governmental 
                        <PRTPAGE P="105536"/>
                        constraint may be allowed to participate in the Consortium pursuant to a separate non-CRADA agreement.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The Consortium's activities will commence on May 1, 2025 (“Commencement Date”). NIST will accept letters of interest to participate in this Consortium on an ongoing basis.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Completed letters of interest must be submitted via the letter of interest webform at 
                        <E T="03">https://forms.gle/bCMV9tmc9uRyZxmRA,</E>
                         by email to 
                        <E T="03">melissa.phillips@nist.gov,</E>
                         or via hardcopy to the Consortium Manager, Dr. Melissa Phillips, Chemical Sciences Division of NIST's Material Measurement Laboratory, 100 Bureau Drive, Mail Stop 8390, Gaithersburg, Maryland 20899. Organizations whose letters of interest are accepted in accordance with the process set forth in the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section of this notice will be asked to sign a consortium CRADA with NIST. A consortium CRADA template will be made available to qualifying applicants.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        J'aime Maynard, Consortia Agreements Officer, National Institute of Standards and Technology's Technology Partnerships Office, by mail to 100 Bureau Drive, Mail Stop 2200, Gaithersburg, Maryland 20899, by electronic mail 
                        <E T="03">agreements@nist.gov,</E>
                         or by phone (301) 975-8408.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The objective of the DSQAP is to develop and evaluate measurement methods and standards to support quality and safety for the dietary supplement testing community. Approximately 75% of the U.S. population takes dietary supplements, including vitamins and mineral supplements, representing an annual expenditure of more than $20 billion USD. Regulations, driven by reported cases of inaccurate labeling, adulteration, contamination (with pesticides, heavy metals, or toxic botanicals), and drug interactions, are now in place that require manufacturers to evaluate the identity, purity, and composition of their ingredients and finished products. The plethora of unique products on the market has led to an uptick in published methods but limited outlets for external method evaluation and validation.</P>
                <P>The focus of this Consortium is to evaluate and standardize methods to characterize and quantify nutrients, marker compounds, and/or contaminants in dietary supplement ingredients and finished products, improving overall comparability within the community and enabling organizations that join the Consortium (“Consortium Members”) to improve the accuracy and precision of their own, internal measurements. The Consortium will organize at least two interlaboratory exercises annually based on candidate reference materials and/or commercial products with the following goals:</P>
                <P>• Evaluate the suitability of current published methods, including standard methods, to measure nutrients, marker compounds, and/or contaminants in dietary supplement ingredients and finished products.</P>
                <P>• Utilize common materials to collect reproducibility data in support of measurement assurance and standards development.</P>
                <P>• Propose tests(s) that can be standardized through the AOAC International or similar consensus process, using outcomes from Consortium efforts as a foundation.</P>
                <P>• Evaluate the applicability of current reference materials for dietary supplement ingredient and finished product testing. If needed, develop new reference materials to support advancement of the dietary supplement testing industry.</P>
                <P>No proprietary information will be shared as part of the Consortium. Contributions of materials to be used as interlaboratory study samples, such as dietary supplement ingredients or products, are highly encouraged.</P>
                <HD SOURCE="HD1">Participation Process</HD>
                <P>
                    Eligibility to participate in the Consortium will be determined by NIST based on the information provided by prospective participants in response to this notice. Prospective participants can submit a letter of interest by completing the letter of interest webform at 
                    <E T="03">https://forms.gle/bCMV9tmc9uRyZxmRA;</E>
                     alternatively, parties can answer the questions detailed in LETTER OF INTEREST, below, and send via email or hardcopy (for reference, see 
                    <E T="02">ADDRESSES</E>
                     section above). NIST will contact interested parties if there are questions regarding the responsiveness of the letters of interest to the project objective or requirements identified below.
                </P>
                <P>Each responding organization's letter of interest should include the address, point of contact, and following information:</P>
                <P>(1) The contribution(s) the organization will make to the Consortium efforts. All Consortium members must contribute one or more of the following:</P>
                <P>
                    a. Analytical Testing: Narrative of interest and experience in analytical testing of dietary supplement ingredients and products and description of the services and/or technical capabilities (
                    <E T="03">e.g.,</E>
                     available instrumentation, relevant accreditations, published methods) they will contribute to Consortium activities.
                </P>
                <P>b. Materials: Narrative of interest and description of the dietary supplement ingredients and products they will contribute to Consortium activities.</P>
                <P>
                    c. Unique Industry or Community Perspective: Narrative of interest and description of other relevant expertise (
                    <E T="03">e.g.,</E>
                     trade associations, regulatory oversight, standards development) they will contribute to Consortium activities.
                </P>
                <P>(2) List of anticipated participating individuals.</P>
                <P>Letters of interest must not include proprietary information, including proprietary business information. NIST will not treat any information provided in response to this notice as proprietary information. NIST will notify each organization of its eligibility to join the Consortium. In order to participate in this Consortium, each eligible organization must sign a CRADA. Entities that are not permitted to enter into CRADAs pursuant to law or other governmental constraint may be allowed to participate in the Consortium, at NIST's discretion, pursuant to separate non-CRADA agreements with terms that may differ, as necessary from the Consortium CRADA terms. NIST does not guarantee participation in the Consortium to any organization submitting a letter of interest.</P>
                <P>
                    <E T="03">Authority:</E>
                     15 U.S.C. 3710a.
                </P>
                <SIG>
                    <NAME>Alicia Chambers,</NAME>
                    <TITLE>NIST Executive Secretariat.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30948 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-13-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XE504]</DEPDOC>
                <SUBJECT>Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Geophysical Surveys Related to Oil and Gas Activities in the Gulf of Mexico</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of issuance of letter of authorization.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In accordance with the Marine Mammal Protection Act (MMPA), as amended, its implementing regulations, and NMFS' MMPA Regulations for Taking Marine Mammals Incidental to Geophysical 
                        <PRTPAGE P="105537"/>
                        Surveys Related to Oil and Gas Activities in the Gulf of Mexico, notification is hereby given that NMFS has issued a Letter of Authorization (LOA) to TGS for the take of marine mammals incidental to geophysical survey activity in the Gulf of Mexico (GOM).
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The LOA is effective from December 20, 2024 through December 19, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The LOA, LOA request, and supporting documentation are available online at 
                        <E T="03">https://www.fisheries.noaa.gov/action/incidental-take-authorization-oil-and-gas-industry-geophysical-survey-activity-gulf-mexico.</E>
                         In case of problems accessing these documents, please call the contact listed below (see 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section).
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Rachel Wachtendonk, Office of Protected Resources, NMFS, (301) 427-8401.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 
                    <E T="03">et seq.</E>
                    ) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.
                </P>
                <P>An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.</P>
                <P>Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as any act of pursuit, torment, or annoyance, which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).</P>
                <P>On January 19, 2021, we issued a final rule with regulations to govern the unintentional taking of marine mammals incidental to geophysical survey activities conducted by oil and gas industry operators, and those persons authorized to conduct activities on their behalf (collectively “industry operators”), in U.S. waters of the GOM over the course of 5 years (86 FR 5322, January 19, 2021). The rule was based on our findings that the total taking from the specified activities over the 5-year period will have a negligible impact on the affected species or stock(s) of marine mammals and will not have an unmitigable adverse impact on the availability of those species or stocks for subsistence uses, and became effective on April 19, 2021.</P>
                <P>
                    The regulations at 50 CFR 217.180 
                    <E T="03">et seq.</E>
                     allow for the issuance of LOAs to industry operators for the incidental take of marine mammals during geophysical survey activities and prescribe the permissible methods of taking and other means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat (often referred to as mitigation), as well as requirements pertaining to the monitoring and reporting of such taking. Under 50 CFR 217.186(e), issuance of an LOA shall be based on a determination that the level of taking will be consistent with the findings made for the total taking allowable under these regulations and a determination that the amount of take authorized under the LOA is of no more than small numbers.
                </P>
                <P>NMFS subsequently discovered that the 2021 rule was based on erroneous take estimates. We conducted another rulemaking using correct take estimates and other newly available and pertinent information relevant to the analyses supporting some of the findings in the 2021 final rule and the taking allowable under the regulations. We issued a final rule in April 2024, effective May 24, 2024 (89 FR 31488, April 24, 2024).</P>
                <P>The 2024 final rule made no changes to the specified activities or the specified geographical region in which those activities would be conducted, nor to the original 5-year period of effectiveness. In consideration of the new information, the 2024 rule presented new analyses supporting affirmance of the negligible impact determinations for all species, and affirmed that the existing regulations, which contain mitigation, monitoring, and reporting requirements, are consistent with the “least practicable adverse impact” standard of the MMPA.</P>
                <HD SOURCE="HD1">Summary of Request and Analysis</HD>
                <P>TGS plans to conduct a three-dimensional (3D) ocean bottom node (OBN) survey over 453 lease blocks in the East Breaks area, with water depths ranging from approximately 1,200 to 2,000 m. See section F of the LOA application for a map of the area. TGS anticipates using two source vessels with a low-frequency airgun source known as Gemini (also referred to as a dual barbell source). Please see TGS's application for additional detail.</P>
                <P>
                    The Gemini source was not included in the acoustic exposure modeling developed in support of the rules. However, the Gemini was previously described and evaluated in support of a previous LOA and we rely on that analysis here (88 FR 72739, October 23, 2023). For additional detail regarding the source, see section C of the LOA application. Based on this information we have determined there will be no effects of a magnitude or intensity different from those evaluated in support of the rules. NMFS expects that use of modeling results supporting the final rule relating to use of the 4,130 cubic inch (in
                    <SU>3</SU>
                    ) airgun array are expected to be conservative as a proxy for use in evaluating potential impacts of use of the Gemini.
                </P>
                <P>
                    The survey effort proposed by TGS in its LOA request was used to develop LOA-specific take estimates based on the acoustic exposure modeling results described in our rule preamble (89 FR 31488, April 24, 2024). In order to generate the appropriate take number for authorization, the following information was considered: (1) survey type; (2) location (by modeling zone 
                    <SU>1</SU>
                    <FTREF/>
                    ); (3) number of days; (4) source; and (5) month.
                    <SU>2</SU>
                    <FTREF/>
                     In this case, the 4,130 in
                    <SU>3</SU>
                     airgun array was selected, as discussed above. The acoustic exposure modeling performed in support of the rule provides 24-hour exposure estimates for each species, specific to each modeled source and survey type in each zone and month.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         For purposes of acoustic exposure modeling, the GOM was divided into seven zones. Zone 1 is not included in the geographic scope of the rule.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Acoustic propagation modeling was performed for two seasons: winter (December-March) and summer (April-November). Marine mammal density data is generally available on a monthly basis, and therefore further refines take estimates temporally.
                    </P>
                </FTNT>
                <P>
                    No 3D OBN surveys were included in the modeled survey types, and use of existing proxies (
                    <E T="03">i.e.,</E>
                     two-dimensional (2D), 3D (narrow-azimuth) NAZ, 3D 
                    <PRTPAGE P="105538"/>
                    (wide-azimuth) WAZ, Coil) is generally conservative for use in evaluation of 3D OBN survey effort, largely due to the greater area covered by the modeled proxies. Summary descriptions of these modeled survey geometries are available in the preamble to the proposed rule (83 FR 29212, 29220, June 22, 2018). Coil was selected as the best available proxy survey type in this case because the spatial coverage of the planned survey is most similar to the coil survey pattern. The planned OBN survey will involve two source vessels sailing along closely spaced survey lines, with daily survey area coverage of approximately 172 kilometers squared per day, similar to that assumed for the coil survey proxy. Among the different parameters of the modeled survey patterns (
                    <E T="03">e.g.,</E>
                     area covered, line spacing, number of sources, shot interval, total simulated pulses), NMFS considers area covered per day to be most influential on daily modeled exposures exceeding Level B harassment criteria. Although TGS is not proposing to perform a survey using the coil geometry, the coil proxy is most representative of the effort planned by TGS in terms of predicted Level B harassment exposures.
                </P>
                <P>The survey will take place over approximately 150 days with 90 days of sound source operation in zone 6. The monthly distribution of survey days is not known in advance, so take estimates for each species are based on the time period that produces the greatest value.</P>
                <P>
                    For some species, take estimates based solely on the modeling yielded results that are not realistically likely to occur when considered in light of other relevant information available during the rulemaking process regarding marine mammal occurrence in the GOM. The approach used in the acoustic exposure modeling, in which seven modeling zones were defined over the U.S. GOM, necessarily averages fine-scale information about marine mammal distribution over the large area of each modeling zone. Thus, although the modeling conducted for the rule is a natural starting point for estimating take, the rule acknowledged that other information could be considered (see, 
                    <E T="03">e.g.,</E>
                     86 FR 5442, January 19, 2021), discussing the need to provide flexibility and make efficient use of previous public and agency review of other information and identifying that additional public review is not necessary unless the model or inputs used differ substantively from those that were previously reviewed by NMFS and the public. For this survey, NMFS has other relevant information reviewed during the rulemaking that indicates use of the acoustic exposure modeling to generate a take estimate for Rice's whale produces results inconsistent with what is known regarding their occurrence in the GOM. Accordingly, we have adjusted the calculated take estimates for Rice's whale as described below.
                </P>
                <P>
                    NMFS' final rule described a “core habitat area” for Rice's whales (formerly known as GOM Bryde's whales) 
                    <SU>3</SU>
                    <FTREF/>
                     located in the northeastern GOM in waters between 100 and 400 m depth along the continental shelf break (Rosel 
                    <E T="03">et al.,</E>
                     2016). However, whaling records suggest that Rice's whales historically had a broader distribution within similar habitat parameters throughout the GOM (Reeves 
                    <E T="03">et al.,</E>
                     2011; Rosel and Wilcox, 2014). In addition, habitat-based density modeling has identified similar habitat (
                    <E T="03">i.e.,</E>
                     approximately 100 to 400 m water depths along the continental shelf break) (Roberts 
                    <E T="03">et al.,</E>
                     2016; Garrison 
                    <E T="03">et al.,</E>
                     2023), and Rice's whales have been detected within this depth band throughout the GOM (Soldevilla 
                    <E T="03">et al.,</E>
                     2022, 2024). See discussion provided at, 
                    <E T="03">e.g.,</E>
                     83 FR 29228, June 22, 2018; 83 FR 29280, June 22, 2018; 86 FR 5418, January 19, 2021.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The final rule refers to the GOM Bryde's whale (
                        <E T="03">Balaenoptera edeni</E>
                        ). These whales were subsequently described as a new species, Rice's whale (
                        <E T="03">Balaenoptera ricei</E>
                        ) (Rosel 
                        <E T="03">et al.,</E>
                         2021).
                    </P>
                </FTNT>
                <P>
                    Although Rice's whales may occur outside of the core habitat area, we expect that any such occurrence would be limited to the narrow band of habitat described above (
                    <E T="03">i.e.,</E>
                     100-400 m) and that, based on the few available records, these occurrences would be rare. TGS's planned activities will occur in water depths of approximately 1,200 to 2,000 m in the central GOM. Thus, NMFS does not expect there to be the reasonable potential for take of Rice's whale in association with this survey and, accordingly, does not authorize take of Rice's whale through the LOA.
                </P>
                <P>Based on the results of our analysis, NMFS has determined that the level of taking expected for this survey and authorized through the LOA is consistent with the findings made for the total taking allowable under the regulations. See table 1 in this notice and table 6 of the rule (89 FR 31488, April 24, 2024).</P>
                <HD SOURCE="HD1">Small Numbers Determination</HD>
                <P>Under the GOM rule, NMFS may not authorize incidental take of marine mammals in an LOA if it will exceed “small numbers.” In short, when an acceptable estimate of the individual marine mammals taken is available, if the estimated number of individual animals taken is up to, but not greater than, one-third of the best available abundance estimate, NMFS will determine that the numbers of marine mammals taken of a species or stock are small (89 FR 31535, May 24, 2024). For more information please see NMFS' discussion of small numbers in the 2021 final rule (86 FR 5438, January 19, 2021).</P>
                <P>The take numbers for authorization are determined as described above in the Summary of Request and Analysis section. Subsequently, the total incidents of harassment for each species are multiplied by scalar ratios to produce a derived product that better reflects the number of individuals likely to be taken within a survey (as compared to the total number of instances of take), accounting for the likelihood that some individual marine mammals may be taken on more than 1 day (86 FR 5404, January 19, 2021; 89 FR 31535, May 24, 2024). The output of this scaling, where appropriate, is incorporated into adjusted total take estimates that are the basis for NMFS' small numbers determinations, as depicted in table 1.</P>
                <P>
                    This product is used by NMFS in making the necessary small numbers determinations through comparison with the best available abundance estimates (see discussion at 86 FR 5391, January 19, 2021). For this comparison, NMFS' approach is to use the maximum theoretical population, determined through review of current stock assessment reports (SAR; 
                    <E T="03">https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments</E>
                    ) and model-predicted abundance information (
                    <E T="03">https://seamap.env.duke.edu/models/Duke/GOM/</E>
                    ). Information supporting the small numbers determinations is provided in table 1.
                    <PRTPAGE P="105539"/>
                </P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,12,12,12,12">
                    <TTITLE>Table 1—Take Analysis</TTITLE>
                    <BOXHD>
                        <CHED H="1">Species</CHED>
                        <CHED H="1">Authorized take</CHED>
                        <CHED H="1">
                            Scaled take 
                            <SU>1</SU>
                        </CHED>
                        <CHED H="1">
                            Abundance 
                            <SU>2</SU>
                        </CHED>
                        <CHED H="1">
                            Percent 
                            <LI>abundance</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Rice's whale</ENT>
                        <ENT>0</ENT>
                        <ENT>n/a</ENT>
                        <ENT>51</ENT>
                        <ENT>n/a</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Sperm whale</ENT>
                        <ENT>674</ENT>
                        <ENT>284.9</ENT>
                        <ENT>3,007</ENT>
                        <ENT>9.5</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            <E T="03">Kogia</E>
                             spp.
                        </ENT>
                        <ENT>
                            <SU>3</SU>
                             259
                        </ENT>
                        <ENT>79.0</ENT>
                        <ENT>980</ENT>
                        <ENT>9.4</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Beaked whales</ENT>
                        <ENT>254</ENT>
                        <ENT>25.7</ENT>
                        <ENT>803</ENT>
                        <ENT>3.2</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Rough-toothed dolphin</ENT>
                        <ENT>1,862</ENT>
                        <ENT>534.5</ENT>
                        <ENT>4,853</ENT>
                        <ENT>11.0</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Bottlenose dolphin</ENT>
                        <ENT>2,581</ENT>
                        <ENT>740.8</ENT>
                        <ENT>165,125</ENT>
                        <ENT>0.4</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Clymene dolphin</ENT>
                        <ENT>3,209</ENT>
                        <ENT>921.1</ENT>
                        <ENT>4,619</ENT>
                        <ENT>19.9</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Atlantic spotted dolphin</ENT>
                        <ENT>4,349</ENT>
                        <ENT>1,248.2</ENT>
                        <ENT>21,506</ENT>
                        <ENT>5.8</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Pantropical spotted dolphin</ENT>
                        <ENT>11,870</ENT>
                        <ENT>3,406.7</ENT>
                        <ENT>67,225</ENT>
                        <ENT>5.1</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Spinner dolphin</ENT>
                        <ENT>
                            <SU>4</SU>
                             152
                        </ENT>
                        <ENT>43.6</ENT>
                        <ENT>5,548</ENT>
                        <ENT>0.8</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Striped dolphin</ENT>
                        <ENT>1,887</ENT>
                        <ENT>541.6</ENT>
                        <ENT>5,634</ENT>
                        <ENT>9.6</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Fraser's dolphin</ENT>
                        <ENT>742</ENT>
                        <ENT>213.0</ENT>
                        <ENT>1,665</ENT>
                        <ENT>12.8</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Risso's dolphin</ENT>
                        <ENT>482</ENT>
                        <ENT>142.1</ENT>
                        <ENT>1,974</ENT>
                        <ENT>7.2</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Blackfish 
                            <SU>5</SU>
                        </ENT>
                        <ENT>5,034</ENT>
                        <ENT>1,484.9</ENT>
                        <ENT>6,113</ENT>
                        <ENT>24.3</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Short-finned pilot whale</ENT>
                        <ENT>2,561</ENT>
                        <ENT>755.5</ENT>
                        <ENT>2,741</ENT>
                        <ENT>27.6</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         Scalar ratios were applied to “Authorized Take” values as described at 86 FR 5322, 5404 (January 19, 2021) to derive scaled take numbers shown here.
                    </TNOTE>
                    <TNOTE>
                        <SU>2</SU>
                         Best abundance estimate. For most taxa, the best abundance estimate for purposes of comparison with take estimates is considered here to be the model-predicted abundance (Garrison 
                        <E T="03">et al.,</E>
                         2023). For Rice's whale, Atlantic spotted dolphin, and Risso's dolphin, the larger estimated SAR abundance estimate is used.
                    </TNOTE>
                    <TNOTE>
                        <SU>3</SU>
                         Includes 13 takes by Level A harassment and 246 takes by Level B harassment. Scalar ratio is applied to takes by Level B harassment only; small numbers determination made on basis of scaled Level B harassment take plus authorized Level A harassment take.
                    </TNOTE>
                    <TNOTE>
                        <SU>4</SU>
                         Modeled take of 9 increased to account for potential encounter with a group of average size (Maze-Foley and Mullin, 2006).
                    </TNOTE>
                    <TNOTE>
                        <SU>5</SU>
                         The “blackfish” guild includes melon-headed whales, false killer whales, pygmy killer whales, and killer whales.
                    </TNOTE>
                </GPOTABLE>
                <P>
                    Based on the analysis contained herein of TGS's proposed survey activity described in its LOA application and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the affected species or stock sizes (
                    <E T="03">i.e.,</E>
                     less than one-third of the best available abundance estimate) and therefore the taking is of no more than small numbers.
                </P>
                <HD SOURCE="HD1">Authorization</HD>
                <P>NMFS has determined that the level of taking for this LOA request is consistent with the findings made for the total taking allowable under the incidental take regulations and that the amount of take authorized under the LOA is of no more than small numbers. Accordingly, we have issued an LOA to TGS authorizing the take of marine mammals incidental to its geophysical survey activity, as described above.</P>
                <SIG>
                    <DATED>Dated: December 20, 2024.</DATED>
                    <NAME>Kimberly Damon-Randall,</NAME>
                    <TITLE>Director, Office of Protected Resources, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31041 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XE526]</DEPDOC>
                <SUBJECT>Pacific Fishery Management Council; Public Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; public meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Pacific Fishery Management Council's (Pacific Council) Groundfish Management Team (GMT) will hold a hybrid in person/webinar work session that is open to the public.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The GMT meeting will be held Tuesday, February 4, 2025 from 12:30 p.m., Pacific standard time, until business for the day has been completed. The GMT will reconvene Wednesday, February 5 through Friday, February 7, 2025, from 8:30 a.m. until business for each day has been completed.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P/>
                    <P>
                        <E T="03">Meeting address:</E>
                         The meeting will be held at the Pacific Fishery Management Council Office, Large Conference Room, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384. This work session is being conducted in person with a web broadcast that provides the opportunity for remote public comment. Specific meeting information, including directions on how to join the meeting and system requirements will be provided in the meeting announcement on the Pacific Council's website (see 
                        <E T="03">www.pcouncil.org</E>
                        ). Please contact Mr. Kris Kleinschmidt (
                        <E T="03">kris.kleinschmidt@noaa.gov</E>
                        ) or (503) 820-2412 for technical assistance.
                    </P>
                    <P>
                        <E T="03">Council address:</E>
                         Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Mr. Todd Phillips, Pacific Council; telephone: (503) 820-2426.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The primary purpose of this work session is for the GMT to prepare for 2025 Pacific Council meetings. Specific agenda items will include: Phase 2 stock definitions, new management measure development and prioritization, 2027/2028 harvest specifications and management measure expectations, the expected humpback whale and leatherback sea turtle biological opinion, and GMT chair/vice chair elections. The GMT may also address groundfish management actions the Pacific Council has indicated on their Year-at-a-Glance calendar, such as the 2025 Pacific whiting fishery and limited entry fixed gear follow-on actions. A detailed agenda will be available on the Pacific Council's website prior to the meeting.</P>
                <P>
                    Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this document and any issues arising after 
                    <PRTPAGE P="105540"/>
                    publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
                </P>
                <HD SOURCE="HD1">Special Accommodations</HD>
                <P>
                    Requests for sign language interpretation or auxiliary aids should be directed to Mr. Kris Kleinschmidt (
                    <E T="03">kris.kleinschmidt@noaa.gov;</E>
                     (503) 820-2412) at least 10 business days prior to the meeting date.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     16 U.S.C. 1801 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: December 20, 2024.</DATED>
                    <NAME>Rey Israel Marquez,</NAME>
                    <TITLE>Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31039 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE:</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XE562]</DEPDOC>
                <SUBJECT>Gulf of Mexico Fishery Management Council; Public Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of hybrid meeting open to the public offering both in-person and virtual options for participation.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Gulf of Mexico Fishery Management Council (Council) will hold a four-day meeting to consider actions affecting the Gulf of Mexico fisheries in the exclusive economic zone (EEZ).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The meeting will convene Monday, January 27 through Thursday, January 30, 2025. Daily schedule will be 8:30 a.m.-5:30 p.m., CST Monday and Wednesday and 8:30 a.m. to 5 p.m., CST on Tuesday and Thursday.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The meeting will take place at the Renaissance New Orleans Pere Marquette French Quarter, located at 817 Common Street, New Orleans, LA 70112. If you prefer to “listen in”, you may access the log-in information by visiting our website at 
                        <E T="03">www.gulfcouncil.org.</E>
                    </P>
                    <P>
                        <E T="03">Council address:</E>
                         Gulf of Mexico Fishery Management Council, 4107 W. Spruce Street, Suite 200, Tampa, FL 33607; telephone: (813) 348-1630.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Dr. Carrie Simmons, Executive Director, Gulf of Mexico Fishery Management Council; telephone: (813) 348-1630.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Monday, January 27, 2025; 8:30 a.m.-5:30 p.m., CST</HD>
                <P>
                    Committee Sessions will begin with the Administrative/Budget Committee review and discussion of Proposed 2025 Activities and Budget and receive update on 2020-2024 Administrative Award No Cost Extension Request and Inflation Reduction Act Funding. The Committee will Review Advisory Panel appointments for Data Collection, 
                    <E T="03">Spiny Lobster,</E>
                     and Coral. The Habitat Protection &amp; Restoration Committee will receive updates on Essential Fish Habitat (EFH) Generic Amendment 5 and Programmatic Environmental Impact Statement of Proposed Aquaculture Opportunity areas in the Gulf of Mexico and Draft Comment Letter. The 
                    <E T="03">Shrimp</E>
                     Committee will review Draft 
                    <E T="03">Shrimp</E>
                     Framework Action: Modification of the Vessel Position Data Collection Program for the Gulf of Mexico 
                    <E T="03">Shrimp</E>
                     Fishery and 
                    <E T="03">Shrimp</E>
                     Advisory Panel (AP) Recommendations, and review remaining meeting summary items from the December 16, 2024 
                    <E T="03">Shrimp</E>
                     AP meeting.
                </P>
                <P>
                    Following lunch, the 
                    <E T="03">Mackerel</E>
                     Committee will receive a presentation on Gulf Stakeholder Coastal Migratory Pelagics (CMP) Engagement Meetings Summary Draft. The Committee will discuss 
                    <E T="03">Spanish Mackerel</E>
                     Framework Action and next steps and 
                    <E T="03">King Mackerel</E>
                     Document and next steps, including a presentation on 
                    <E T="03">King Mackerel</E>
                     Data Request Report, Framework Action and background of SEDAR 99 Draft Schedule. The Outreach and Education Technical Committee (OETC) will review 2024 Communications improvement Plan Progress and Analytics, Domestic 
                    <E T="03">Shrimp</E>
                     and Seafood Education and Ecosystem Based Fisheries Management Outreach Update on Red Tide Fishery Ecosystem Issues (FEI). The Committee will discuss Management Areas and Boundary Outreach, Public Comment Improvements, 2025 Communications Improvement Plan and remaining items from the O&amp;E Technical Committee meeting summary.
                </P>
                <HD SOURCE="HD1">Tuesday, January 28, 2025; 8:30 a.m.-5 p.m., CST</HD>
                <P>
                    The Council will receive a Litigation update. Following, the 
                    <E T="03">Reef Fish</E>
                     Committee will convene to review and discuss Draft: 
                    <E T="03">Reef Fish</E>
                     Amendment 58B:
                </P>
                <P>
                    Modifications to 
                    <E T="03">Deep-water Grouper</E>
                     Management Measures, receive a presentation on Modifications to 
                    <E T="03">Lane Snapper</E>
                     Minimum Size and Recreational Bag Limits and Draft 
                    <E T="03">Reef Fish Amendment 59:</E>
                     Requirements for Participation in Individual Fishing Quota Programs. 
                    <E T="03">The Committee will review Draft Framework:</E>
                     Other 
                    <E T="03">Shallow-water Grouper</E>
                     Catch Limits, receive a summary from the December 2024 Gulf SSC Webinar and remaining 
                    <E T="03">Reef Fish</E>
                     AP Discussions and Recommendations.
                </P>
                <HD SOURCE="HD1">Wednesday, January 29, 2025; 8:30 a.m.-5:30 p.m., CST</HD>
                <P>
                    The 
                    <E T="03">Reef Fish</E>
                     Committee will reconvene to review summary reports from Working Group 1 &amp; 2 for the Recreational Initiative and Public Engagement Sessions and receive a presentation on Recreational 
                    <E T="03">Red Snapper</E>
                     Accountability Measures. The Law Enforcement Technical Committee (LETC) will review the meeting summary from the January 2025 meeting.
                </P>
                <P>
                    Following lunch, the Council will convene at approximately 1:30 p.m., CST with a Call to Order, Announcements and Introductions, Adoption of Agenda and Approval of Minutes. The Council will receive a presentation on Stock Assessments 101: Spawning Potential Ratio and Maximum Sustainable Yield. The Council will hold public testimony beginning at 2 p.m. to 5 p.m.
                    <E T="02">, CST</E>
                     for comments for open testimony on other fishery issues or concerns. Public comment may begin earlier than 2 p.m. CST but will not conclude before that time. Persons wishing to give public testimony in-person must register at the registration kiosk in the meeting room. Persons wishing to give public testimony virtually must sign up on the Council website during the Council meeting. Registration for virtual testimony closes one hour (1 p.m. CST) before public testimony begins.
                </P>
                <HD SOURCE="HD1">Thursday, January 30, 2025; 8:30 a.m.-5 p.m., CST</HD>
                <P>
                    The Council will receive Committee reports from Administrative/Budget, Habitat Protection &amp; Restoration, 
                    <E T="03">Shrimp, Mackerel,</E>
                     Outreach and Education, 
                    <E T="03">Reef Fish,</E>
                     and Law Enforcement. The Council will receive updates from the following supporting agencies: South Atlantic Fishery Management Council Liaison; Louisiana Law Enforcement Efforts, NOAA Office of Law Enforcement (OLE); Gulf States Marine Fisheries Commission; U.S. Coast Guard; U.S. Fish and Wildlife Service; and Department of State.
                </P>
                <P>Lastly, the Council will hold a discussion on Council Planning and Primary Activities, and any Other Business items.</P>
                <P>
                    -Meeting Adjourns
                    <PRTPAGE P="105541"/>
                </P>
                <FP SOURCE="FP-1">
                    The meeting will be a hybrid meeting; both in-person and virtual participation available. You may register for the webinar to listen-in only by visiting 
                    <E T="03">www.gulfcouncil.org</E>
                     and click on the Council meeting on the calendar.
                </FP>
                <FP SOURCE="FP-1">The timing and order in which agenda items are addressed may change as required to effectively address the issue, and the latest version along with other meeting materials will be posted on the website as they become available.</FP>
                <FP SOURCE="FP-1">Although other non-emergency issues not contained in this agenda may come before this group for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), those issues may not be the subject of formal action during these meetings. Actions will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Act, provided that the public has been notified of the Council's intent to take final action to address the emergency.</FP>
                <HD SOURCE="HD1">Special Accommodations</HD>
                <P>These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid or accommodations should be directed to Kathy Pereira, (813) 348-1630, at least 15 days prior to the meeting date.</P>
                <P>
                    <E T="03">Authority:</E>
                     16 U.S.C. 1801 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: December 20, 2024.</DATED>
                    <NAME>Rey Israel Marquez,</NAME>
                    <TITLE>Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31036 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XE561]</DEPDOC>
                <SUBJECT>Pacific Fishery Management Council; Public Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of public online meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Pacific Fishery Management Council (Council) is hosting an informational session on Council practices and procedures for all Advisory Body members.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The online meeting will be held Wednesday, January 22, 2025, from 10 a.m. until 12 p.m., Pacific time or until business for the day concludes.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        This meeting will be held online. Specific meeting information, including directions on how to join and system requirements will be provided in the meeting announcement on the Council's website (see 
                        <E T="03">www.pcouncil.org</E>
                        ). You may send an email to Mr. Kris Kleinschmidt (
                        <E T="03">kris.kleinschmidt@noaa.gov</E>
                        ) or contact him at (503) 820-2280, extension 412 for technical assistance.
                    </P>
                    <P>
                        <E T="03">Council address:</E>
                         Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Kelly Ames, Deputy Director, Pacific Council; telephone: (503) 820-2417.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The primary purpose of the meeting is to provide an orientation for new and returning Advisory Body members, ensuring they have a clear understanding of the Council's processes, procedures, and expectations. The meeting is informational only and the Advisory Body members are not expected to develop recommendations or report to the Council.</P>
                <P>Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.</P>
                <HD SOURCE="HD1">Special Accommodations</HD>
                <P>
                    Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt (
                    <E T="03">kris.kleinschmidt@noaa.gov;</E>
                     (503) 820-2412) at least 10 days prior to the meeting date.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     16 U.S.C.1801 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Alyssa Weigers,</NAME>
                    <TITLE>Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30794 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XE553]</DEPDOC>
                <SUBJECT>Pacific Fishery Management Council; Public Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of a public online meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Pacific Fishery Management Council (Pacific Council) and the NMFS Northwest and Southwest Fisheries Science Centers will convene a virtual pre-assessment workshop to review proposed data and modeling approaches to inform groundfish stock assessments for chilipepper rockfish and California quillback rockfish scheduled for assessment during 2025. The workshop is open to the public.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The pre-assessment workshop will be held Thursday, January 23, 2025, from 9 a.m. until 4 p.m. (Pacific time) or until business for the day has been completed.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The pre-assessment workshop will be conducted as an online meeting. Specific meeting information, including the agenda and directions on how to join the meeting and system requirements, will be provided in the workshop announcement on the Pacific Council's website (see 
                        <E T="03">www.pcouncil.org</E>
                        ). You may send an email to Mr. Kris Kleinschmidt (
                        <E T="03">kris.kleinschmidt@noaa.gov</E>
                        ) or contact him at (503) 820-2412 for technical assistance.
                    </P>
                    <P>
                        <E T="03">Council address:</E>
                         Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Marlene A. Bellman, Staff Officer, Pacific Council; telephone: (503) 820-2414; email: 
                        <E T="03">marlene.bellman@noaa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The purpose of the pre-assessment workshop is to review proposed data inputs, modeling approaches, and any other pertinent information to inform 2025 stock assessments for chilipepper rockfish and California quillback rockfish. The goal of the pre-assessment workshop is to promote dialogue about and a common understanding between assessment teams and data providers of the best data and analytical and modeling approaches applicable to 
                    <PRTPAGE P="105542"/>
                    these assessments. Stock assessment teams will solicit advice from data stewards, stakeholders, and fishery managers knowledgeable about these species.
                </P>
                <P>No management actions will be decided by the workshop participants. The participants' role will be the development of recommendations for consideration by the stock assessment teams assigned to conduct these assessments. Assessments for these stocks are tentatively scheduled for peer review during a Stock Assessment Review (STAR) panel on June 23-27, 2025. The Pacific Council and the Pacific Council's Scientific and Statistical Committee are scheduled to consider these draft assessments for use in informing management decisions at their September 2025 meeting in Spokane, Washington.</P>
                <P>Although nonemergency issues not contained in the workshop's agenda may be discussed, those issues may not be the subject of formal action during this workshop. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent of the workshop participants to take final action to address the emergency.</P>
                <HD SOURCE="HD1">Special Accommodations</HD>
                <P>
                    Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt (
                    <E T="03">kris.kleinschmidt@noaa.gov;</E>
                     (503) 820-2412) at least 10 days prior to the meeting date.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     16 U.S.C 1801 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Alyssa Weigers,</NAME>
                    <TITLE>Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30786 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Telecommunications and Information Administration</SUBAGY>
                <DEPDOC>[NTIA-2024-0005]</DEPDOC>
                <RIN>RIN 0660-XC065</RIN>
                <SUBJECT>Impact of L-Band MSS ‘Direct-to-Device’ Operations on GPS</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Telecommunications and Information Administration, Department of Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The National Telecommunications and Information Administration (NTIA) is seeking information and public comment on the potential impact on the GPS L1 signal at 1575.42 MHz of the increasing deployment of mobile devices capable of operating on satellite systems in the L-band at 1610-1660.5 MHz. Under current FCC rules, these devices are permitted to operate subject to a substantially less restrictive out-of-band emission limit than similar devices transmitting on the same frequencies and connecting to terrestrial base station systems. NTIA is seeking public comment on the risk of interference posed by this increased deployment of mobile devices capable of operating on L-band satellite systems at 1610-1660.5 MHz, as well as potential mitigation options to safeguard GPS systems while facilitating the potential benefits of direct-to-device services (D2D services).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Written comments must be received on or before February 10, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        All electronic public comments on this action, identified by 
                        <E T="03">Regulations.gov</E>
                         docket number NTIA-2024-0005, may be submitted through the Federal e-Rulemaking Portal at 
                        <E T="03">https://www.regulations.gov.</E>
                         The docket established for this request for comment can be found at 
                        <E T="03">www.Regulations.gov,</E>
                         NTIA-2024-0005. To make a submission, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments. Additional instructions can be found in the “Instructions” section below, after 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                        .
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Please direct questions regarding this Request for Comment to Ashley Davenport at 
                        <E T="03">adavenport@ntia.gov</E>
                         with “Impact of L-band MSS D2D Operations on GPS” in the subject line. If submitting comments by U.S. mail, please address questions to Ashley Davenport, National Telecommunications and Information Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230. Questions submitted via telephone should be directed to (202) 482-0297. Please direct media inquiries to NTIA's Office of Public Affairs, telephone: (202) 482-7002; email: 
                        <E T="03">press@ntia.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>NTIA, located within the Department of Commerce, is the Executive Branch agency that is principally responsible by law for advising the President on telecommunications and information policy issues and managing the federal use of spectrum. The Global Positioning System (GPS) is one such federal system. NTIA is beginning to see increasing deployment of consumer equipment capable of operating on Mobile-Satellite Service (MSS) networks with operations in the L-band near the L1 signal of the Global Positioning System (GPS) at 1575.42 MHz. Some of these devices are traditional mobile phones or Internet of Things (IOT) devices that typically operate on terrestrial networks in mobile bands outside the L-band, while others are being designed as lower-cost IOT or other devices operating primarily, if not exclusively, with satellites (collectively, D2D devices). The services enabled by these devices (D2D services) could provide substantial benefits to the public, including during times of emergency, while also supporting important federal government missions. The purpose of this Request for Comment is to secure public input on the risk of interference into GPS posed by wider deployment of D2D services in the L-band and potential mitigation opportunities.</P>
                <P>When the FCC developed MSS rules for the L-band, there was an expectation that comparatively few user devices would be deployed relative to ubiquitous terrestrial mobile handsets. Therefore, the out-of-band emission (OOBE) limit for L-band devices operating in the MSS is substantially more relaxed (by more than 30 dB) than the requirement later developed for user devices that would communicate with terrestrial base stations in the L-band. The stricter OOBE limit for devices operating with terrestrial base stations was based in large part on the expectation that there would be a much larger number of such devices. The wide deployment of devices subject to the MSS limit thus presents an unexpected increase in the risk of interference to nearby GPS receivers. Attached hereto is a technical analysis conducted by the U.S. Department of Transportation, in conjunction with other U.S. Government departments and agencies, that more fully describes the basis for concern.</P>
                <P>
                    NTIA and other U.S. Government departments and agencies are cognizant that the initial business case for satellite operation of the new devices appears to focus on situations in which the user is outdoors and terrestrial wireless service is unavailable and that these situations will often arise in areas with less intensive GPS use for critical service. The extent to which this is the case and will continue to be the case in the future remains unclear, as is the extent to which the delivery of such a service 
                    <PRTPAGE P="105543"/>
                    might involve the devices transmitting in the L-band at other times. We seek to understand these issues and their connection to interference risks.
                </P>
                <P>One of the situations of greatest concern involves the use of such a device while on an airplane given the proximity of the device to GPS receivers and the importance of those receivers to aircraft navigation systems. We seek information on this scenario, in particular, and on the need for mitigation options that go beyond the existing regulatory prohibition against operating the device on an airplane and corresponding labeling requirements.</P>
                <HD SOURCE="HD1">Request for Comments</HD>
                <P>Through this Request for Comment, we hope to gather information on the following issues and questions. These questions are not exhaustive, and commenters are invited to provide input on relevant questions not asked below. Commenters are not required to respond to all questions. When responding to one or more of the questions below, please note in the text of your response the number of the question to which you are responding. Commenters should include a page number on each page of their submissions. Commenters are welcome to provide specific actionable proposals, rationales, and relevant facts.</P>
                <P>
                    All comments received are a part of the public record and will generally be posted to 
                    <E T="03">Regulations.gov</E>
                     without change. All personal identifying information (
                    <E T="03">e.g.,</E>
                     name, address) voluntarily submitted by the commenter may be publicly accessible. Anyone submitting business confidential information should clearly identify any business confidential portion of a comment at the time of submission, file a statement justifying nondisclosure and referring to the specific legal authority claimed, and provide a non-confidential version of the submission.
                </P>
                <P>
                    For comments submitted electronically containing business confidential information, the file name of the business confidential version should begin with the characters “BC.” Any page containing business confidential information must be clearly marked “BUSINESS CONFIDENTIAL” on the top of that page. The corresponding non-confidential version of those comments must be clearly marked “PUBLIC.” The file name of the non-confidential version should begin with the character “P.” Any submissions with file names that do not begin with either a “BC” or a “P” will be assumed to be public and will be made publicly available through 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <HD SOURCE="HD1">Questions</HD>
                <P>1. We seek further information from parties deploying or planning to deploy D2D service in the L-band regarding:</P>
                <P>a. the actual out-of-band emissions of the devices;</P>
                <P>b. the potential for limiting those emissions further;</P>
                <P>c. the typical duration and frequency of occurrence of L-band transmissions supporting D2D services (including any automatic transmissions);</P>
                <P>d. expected geographic deployment patterns based on initial offerings of D2D services, as well as planned and/or potential service expansions (for example, to what extent might they operate indoors as well as outdoors or in areas where terrestrial wireless service is also available);</P>
                <P>e. any other information relevant to an evaluation of the likelihood that an L-band device will cause harmful interference to a nearby GPS receiver;</P>
                <P>f. the ability to limit or preclude satellite operations to and from a device when terrestrial service is available, including incidental transmissions;</P>
                <P>g. the ability to limit L-band operations and attempted operations when on an airplane or near other critical GPS receivers (including information about the effectiveness of “airplane mode” or other similar settings);</P>
                <P>h. the options for educating users regarding the risks of operating near critical GPS receivers, including on-screen warnings and the likely effectiveness of these options; and</P>
                <P>i. any other mitigations that might reduce the risk of harmful interference to a nearby GPS receiver.</P>
                <P>2. We seek information from GPS manufacturers and users regarding:</P>
                <P>a. any documented instances of harmful interference from MSS L-band devices;</P>
                <P>b. their concerns regarding the increased probability of harmful interference; and</P>
                <P>c. any mitigations that might be effective in reducing the risk of harmful interference while minimizing impacts on MSS service delivery.</P>
                <P>3. We seek information on industry standards and performance improvements achieved by the GPS industry over the past ten years to self-protect the various categories of GPS receivers to minimize receiver blocking and overload.</P>
                <P>a. Information on separation distances due to receiver selectivity, compared with the separation distances shown in the DoT technical analysis due to MSS L-band mobile earth station out-of-band-emissions (OOBE).</P>
                <P>
                    b. GPS receiver overload limits (
                    <E T="03">i.e.,</E>
                     GPS receiver input power tolerance thresholds and separation distance(s)) from MSS mobile earth station operations from Globalstar, Inmarsat, etc., in the vicinity of different categories of GPS receivers.
                </P>
                <P>4. We seek comment on the Department of Transportation technical analysis. Parties should feel free to submit any alternative technical analysis.</P>
                <SIG>
                    <NAME>Sean Conway,</NAME>
                    <TITLE>Deputy Chief Counsel, National Telecommunications and Information Administration.</TITLE>
                </SIG>
                <HD SOURCE="HD1">Analysis of Potential Interference to GPS/GNSS From Emerging L-Band MSS D2D and IoT Services November 25, 2024</HD>
                <HD SOURCE="HD1">1 Overview</HD>
                <P>
                    This paper assesses the potential impact of emerging L-band mobile satellite service (MSS) direct-to-device (D2D) and Internet of Things (IoT) services on Global Positioning System (GPS)/Global Navigation Satellite System (GNSS) receivers that are to receive interference protection in the 1559-1610 MHz Radionavigation Satellite Service (RNSS) allocation. The analysis considers only the emissions from terrestrial devices (
                    <E T="03">e.g.,</E>
                     D2D handsets and IoT equipment) up to the L-band MSS satellites. The main finding of this initial analysis as detailed in this paper is that emissions from L-band MSS D2D and IoT user equipment operating at 1610-1660.5 MHz, operating in compliance with the Federal Communications Commission (FCC) rules can result in interference to GPS/GNSS receivers operating in the 1559-1610 MHz RNSS band. The risks of interference to GPS/GNSS from L-band MSS Mobile Earth Stations (MES) are growing rapidly as D2D and IoT services are increasingly included in high-volume, daily-use consumer and industrial products (
                    <E T="03">e.g.,</E>
                     Apple phones and tablets).
                </P>
                <P>
                    Within this paper, MSS emissions in the 1559-1610 MHz RNSS band are hereafter referred to as out-of-band emissions (OOBE). Both OOBE and the fundamental transmissions in the 1610-1660.5 MHz MSS band are considered. The OOBE results apply to all L-band MSS operators. The fundamental transmission analysis in this paper was performed using available data for Ligado's specific uplink frequency bands of 1627.5-1637.5 MHz and 1646.5-1656.5 MHz. Results for other operators are not provided in the paper but are expected to be worse for 
                    <PRTPAGE P="105544"/>
                    operators using frequencies closer to the RNSS band.
                </P>
                <P>FCC rules for L-band MSS mobile Earth stations that are applicable to emerging D2D and IoT services are summarized in Appendix A. A scenario in which MSS D2D equipment is operated onboard a commercial aircraft is presented in Appendix B.</P>
                <HD SOURCE="HD1">2 Impact Assessments</HD>
                <HD SOURCE="HD2">2.1 Emissions in the GNSS Band</HD>
                <HD SOURCE="HD2">2.1.1 D2D Handset and IoT Device Emissions</HD>
                <P>
                    D2D handset or IoT device emissions that fall within the 1559—1610 MHz RNSS allocation can cause degradation to GNSS receiver signal-to-noise-density (C/N0). The FCC rules for satellite services, contained within Part 25 of Title 47 of the Code of Federal Regulations (47 CFR part 25),
                    <SU>1</SU>
                    <FTREF/>
                     include requirements applicable to D2D handset or IoT device emissions. 47 CFR 25.216, in particular, requires that the effective isotropic radiated power (EIRP) levels of MES with assigned frequencies within 1610 and 1660.5 MHz “. . . shall not exceed−70 dBW/MHz, averaged over any 2 millisecond active transmission interval, in the band 1559-1605 MHz.”
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">https://www.ecfr.gov/current/title-47/chapter-I/subchapter-B/part-25.</E>
                    </P>
                </FTNT>
                <P>
                    Assuming a GNSS receiver noise floor of −201.5 dBW/Hz,
                    <SU>2</SU>
                    <FTREF/>
                     Table 1 provides the separation distances needed to limit GNSS receiver C/N0 degradation to 1, 3, 6, and 10 dB assuming an isotropic receive antenna, free space path loss, and assuming a 3 dB polarization loss for linearly polarized transmissions being received by a right-hand circularly polarized antenna.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         See, for example, ITU-R M.1903, 
                        <E T="03">https://www.itu.int/dms_pubrec/itu-r/rec/m/R-REC-M.1903-1-201909-I!!PDF-E.pdf.</E>
                         Five of 11 GNSS receiver types characterized in this recommendation have a system noise temperature of 513K, which equates to a −201.5 dBW/Hz noise floor. This level, −201.5 dBW/Hz, is also a standard noise floor assumption for certified GNSS equipment on aircraft; see, 
                        <E T="03">e.g.,</E>
                         RTCA DO-235C.
                    </P>
                </FTNT>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,20,20">
                    <TTITLE>Table 1—C/N0 Degradation vs Separation Distance—GNSS Receiver With Isotropic Receive Antenna</TTITLE>
                    <BOXHD>
                        <CHED H="1">Degradation to C/N0 (dB)</CHED>
                        <CHED H="1">
                            Received interference level 
                            <LI>(dBW/Hz)</LI>
                        </CHED>
                        <CHED H="1">
                            Required separation 
                            <LI>(m)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">1</ENT>
                        <ENT>−207.4</ENT>
                        <ENT>79.1</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">3</ENT>
                        <ENT>−201.5</ENT>
                        <ENT>40.3</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">6</ENT>
                        <ENT>−196.8</ENT>
                        <ENT>23.3</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">10</ENT>
                        <ENT>−192.0</ENT>
                        <ENT>13.4</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    Using a model for the relative antenna gain pattern of a GNSS high precision receiver (HPR) towards a vertically polarized source at 1575.42 MHz 
                    <SU>3</SU>
                    <FTREF/>
                     and assuming a maximum boresight gain of +3 dBic, Figure 1 shows the area around a single D2D device where the receiver could experience a 1, 3, or 10 dB C/N0 degradation. The plot assumes the D2D or IoT device is 2 m above the ground and that free space path loss conditions exist.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         See Section 4.1.3.1 of the Department of Transportation (DOT)'s Global Positioning System (GPS) Adjacent Band Compatibility Assessment Final Report, 
                        <E T="03">https://rosap.ntl.bts.gov/view/dot/35535.</E>
                         Vertically polarized emissions for the D2D or IoT device is assumed.
                    </P>
                </FTNT>
                <GPH SPAN="3" DEEP="198">
                    <GID>EN27DE24.241</GID>
                </GPH>
                <HD SOURCE="HD1">Figure 1. Impact on HPR Due to −70 dBW/MHz Emissions in 1559-1605 MHz</HD>
                <P>
                    The required lateral separations to keep a high precision GNSS receiver C/N0 degradation with the modeled antenna below 1, 3, or 10 dB shown in Figure 1 are slightly less than the results for a receiver with isotropic receive antenna in Table 1. This observation can be explained by the fact that a typical HPR antenna may have a gain towards a vertically polarized source at the horizon that is below 0 dBi. The results for other GPS/GNSS receiver classes are slightly worse (
                    <E T="03">i.e.,</E>
                     requiring additional separation for the same C/N0 degradation) since their noise floors are similar to HPR devices but they 
                    <PRTPAGE P="105545"/>
                    typically have higher antenna gain at low elevation angles (see Table 2). Sample calculations for the separation distances in Tables 1 and 2 are provided in Appendix C.
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">https://docs.fcc.gov/public/attachments/FCC-20-48A1.pdf.</E>
                    </P>
                </FTNT>
                <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="s100,r50,r60">
                    <TTITLE>Table 2—Separation Distances from D2D Handset or IoT Device Necessary To Limit C/N0 Degradation for Various GPS/GNSS Receiver Classes</TTITLE>
                    <BOXHD>
                        <CHED H="1">GPS/GNSS receiver class</CHED>
                        <CHED H="1">
                            Noise floor, N0 
                            <LI>(dBW/Hz) *</LI>
                        </CHED>
                        <CHED H="1">
                            Required separation to limit C/N0 
                            <LI>degradation to 1, 3, and 10 dB </LI>
                            <LI>(m) **</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">High precision (HPR)</ENT>
                        <ENT>−201.5</ENT>
                        <ENT>52.2 (1 dB), 27.5 (3 dB), 10.1 (10 dB)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">General Location/Navigation (GLN)</ENT>
                        <ENT>−200.5</ENT>
                        <ENT>59.6 (1 dB), 31.0 (3 dB), 10.9 (10 dB)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Cellular (CEL)</ENT>
                        <ENT>−200.5 to −201.5</ENT>
                        <ENT>99.8 to 112.0 (1 dB), 50.9 to 57.1 (3 dB), 16.9 to 19.0 (10 dB)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Certified Aviation *** or General Aviation (GAV)</ENT>
                        <ENT>−201.5</ENT>
                        <ENT>66.7 (1 dB), 34.6 (3 dB), 12.2 (10 dB)</ENT>
                    </ROW>
                    <TNOTE>* Based upon receiver system noise temperature values in ITU-R M.1903.</TNOTE>
                    <TNOTE>
                        ** Using representative antenna gain patterns for each receiver class from 
                        <E T="03">https://rosap.ntl.bts.gov/view/dot/35535,</E>
                         and assuming the transmit antenna is at 2 m height above ground.
                    </TNOTE>
                    <TNOTE>*** See Appendix B for an assessment of a scenario in which the D2D equipment is operated by a passenger on a commercial aircraft.</TNOTE>
                </GPOTABLE>
                <P>
                    A lower emission limit would reduce the impact area. For instance, Figure 2 shows the impacted area for HPR GNSS devices if the EIRP emissions in 1559-1605 MHz were reduced to −105 dBW/MHz (as required for Ligado ancillary terrestrial component [ATC] handset transmissions per the April 2020 FCC Order and Authorization 
                    <SU>4</SU>
                    ).
                </P>
                <GPH SPAN="3" DEEP="207">
                    <GID>EN27DE24.242</GID>
                </GPH>
                <HD SOURCE="HD1">Figure 2. Impact on HPR due to −105 dBW/MHz Emissions in 1559-1605 MHz</HD>
                <P>For a GNSS device with an isotropic receive antenna and -201.5 dBW/Hz noise floor, Figure 3 presents required separation distances for 1, 3, 6, and 10 dB C/N0 degradations as a function of D2D and IOT device emission levels in 1559-1605 MHz.</P>
                <GPH SPAN="3" DEEP="278">
                    <PRTPAGE P="105546"/>
                    <GID>EN27DE24.243</GID>
                </GPH>
                <HD SOURCE="HD1">Figure 3. Required Separation Distance vs D2D Emissions in 1559-1610 MHz To Limit GNSS Receiver C/N0 Degradation To 1, 3, 6, or 10 dB</HD>
                <P>
                    The above results are similar to those provided to DOT GPS ABC Workshops by Greenwood Telecommunications Consultants LLC 
                    <SU>5</SU>
                    <FTREF/>
                    . Greenwood additionally examined the impacts of multiple transmitters in the referenced presentations and recommended −105 dBW/MHz as a Ligado mobile device EIRP limit in 1559-1605 MHz.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         See 
                        <E T="03">https://rosap.ntl.bts.gov/view/dot/34708</E>
                         and 
                        <E T="03">https://rosap.ntl.bts.gov/view/dot/34710.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD2">2.2 Emissions in the Adjacent Band—Fundamental Emissions</HD>
                <HD SOURCE="HD2">2.2.1 D2D Handset and IoT Emissions</HD>
                <P>D2D handsets and IoT devices may operate with many center frequencies and at various power levels within the 1610-1660.5 MHz MSS band. In this section, one example is provided applicable to Ligado D2D operations. As noted earlier in Section 1, other L-band MSS operators are providing D2D/IoT services using frequencies closer to the 1559-1610 MHz RNSS band and may also utilize higher uplink transmit power levels. These services could therefore have a potentially greater impact on GPS/GNSS.</P>
                <P>Again, as just one example of D2D/IoT operations, Ligado D2D handsets are expected to have a maximum EIRP of 23 dBm, use vertical polarization, and only operate in the 1627.5-1637.5 MHz and 1646.5-1656.5 MHz bands. These are the same emission characteristics as Ligado ATC handsets.</P>
                <P>
                    Extensive results for the impact of vertically-polarized, 23 dBm handset emissions at 1630 MHz are presented in Appendix I of the DOT GPS ABC Assessment Final Report (see footnote 3 for a hyperlink to this report). Some of these results, for the most sensitive device within each receiver class, are reproduced below. In these figures “ITM” corresponds to a 1 dB CNR degradation, “LOL
                    <E T="52">L</E>
                    ” corresponds to loss of lock on low-elevation angle satellites, and “LOL
                    <E T="52">H</E>
                    ” corresponds to loss of lock on high elevation angle (
                    <E T="03">i.e.,</E>
                     all) satellites. GLN = “General Location/Navigation” and TIM = “Timing” GNSS devices. 
                </P>
                <GPH SPAN="3" DEEP="176">
                    <PRTPAGE P="105547"/>
                    <GID>EN27DE24.244</GID>
                </GPH>
                <GPH SPAN="3" DEEP="133">
                    <GID>EN27DE24.245</GID>
                </GPH>
                <GPH SPAN="3" DEEP="203">
                    <GID>EN27DE24.246</GID>
                </GPH>
                <P>
                    IoT devices may transmit significantly higher power levels. For instance, on April 5, 2023, the FCC granted a blanket license to Skylo Technologies for up to 1,000,000 IoT devices to communicate to the Ligado Skyterra-1 and Inmarsat satellites in the 1525-1559 MHz and 1626.5-1660.5 MHz MSS bands.
                    <SU>6</SU>
                    <FTREF/>
                     The license permits EIRPs of up to 10W for IoT transmissions to Skyterra-1 and the Inmarsat MSS satellites. This EIRP limit is 50 times greater than the Ligado ATC handset EIRP limit of 200 mW and could impact sensitive GNSS devices at distances of up to almost 1 km. Each of the impact contour plots shown above would have the impacted region expand by a factor of 7 (since free space path loss falls off with distance to the transmitter squared and the IoT devices are approximately a factor of 7 squared more powerful than 23 dBm).
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">https://docs.fcc.gov/public/attachments/DOC-392372A1.pdf.</E>
                    </P>
                </FTNT>
                <P>
                    Importantly, the impact of the fundamental D2D handset and IoT device transmissions on GPS/GNSS receivers varies significantly with receiver model. The results presented above apply to the most sensitive device of all of those tested within each receiver class by DOT. As detailed in 
                    <PRTPAGE P="105548"/>
                    Appendix B of the DOT GPS ABC Assessment Final Report (link in footnote 3), for the HPR tand GLN receiver classes approximately a 50 dB difference in interference levels resulting in a 1 dB C/N0 degradation at 1630 MHz was observed between the most and least sensitive receiver.
                </P>
                <HD SOURCE="HD1">3 Differences Between L-Band D2D and IoT Services and Historical Use of the Mobile Earth Stations</HD>
                <P>There have been MSS operations in the L band for over two decades now. Given that there have been no reports of interference from these operations to GNSS during this time, a reasonable question is: why should the GNSS community be concerned with interference at this point in time? There are several reasons for concern:</P>
                <P>• Legacy L-band mobile earth stations (MESs) are expensive and sparse in number compared to anticipated D2D and IoT devices</P>
                <P>
                    ○ We reviewed non-D2D/IoT products available from several prominent satellite equipment vendors,
                    <SU>7</SU>
                    <FTREF/>
                     and L-band MES equipment are on the order of several hundred dollars or more. The equipment cost, and the additional costs for the required satellite service plan and usage fees limits the number of devices in use and also limits their operation in highly populated areas (where cellular communications is an available and cheaper option).
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         See, 
                        <E T="03">e.g., https://www.remotesatellite.com/collections/msat-tracking/</E>
                         and 
                        <E T="03">https://satellitephonestore.com/catalog/search?q=msat.</E>
                    </P>
                </FTNT>
                <P>
                    ○ For comparison, D2D devices are anticipated to include millions of cellular phones that are owned and used on a daily basis by most U.S. citizens. Although D2D operations are expected to be mainly used when the users are out of cell coverage, with millions of devices in use it is likely that some transmissions will occur in populated areas (
                    <E T="03">e.g.,</E>
                     in cellular dead zones or when there is a radio propagation blockage in the direction of the cell tower). It is also possible that small D2D devices might be operated onboard aircraft (see Appendix B).
                </P>
                <P>
                    ○ In addition to legacy MES and cellular phones with D2D capabilities, there are also emerging standalone L-band MSS D2D/IoT devices. Just one company, Skylo, has alone already received a blanket license for up to 1M IoT devices capable of transmitting to Skyterra-1. The Motorola Defy satellite link is a new D2D product that became available for purchase in the United States in June 2023. This device is small (3.4 x 2.5 x 0.5 inches), battery-powered (with an advertised battery life of up to 4 days), and lightweight (2.5 ounces). It connects to iOS and Android smartphones through Bluetooth and enables smartphone users to send and receive text messages through MSS geostationary satellites, including those operated by Ligado and Viasat/Inmarsat. This device retails for $150 including a one-year service plan.
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         See, 
                        <E T="03">e.g., https://www.rei.com/product/227381/motorola-defy-satellite-link.</E>
                    </P>
                </FTNT>
                <P>• Most existing MES include a GPS tracking capability. The vendor would thus have a need to ensure that MES emissions in the 1559-1605 MHz band are far below the −70 dBW/MHz level permitted by 47 CFR 25.216 in order to protect their own equipment's GPS operation. It is not clear that IoT device manufacturers would have the same incentive to achieve far better OOBE performance than required by the FCC rules, especially considering the market motivation to make IoT devices extremely low-cost.</P>
                <P>
                    • The FCC rules (47 CFR 25.285) prohibit MES capable of transmitting in the 1610-1660.5 MHz band from operating on civil aircraft unless its use is approved by the FAA or pilot. Further 25.285 requires that such MES cannot be “. . . sold or distributed to users unless it conspicuously bears the following warning: `This device must be turned off at all times while on board aircraft.' ” Unfortunately, the E-LABEL Act permits such warnings to be made available to the users of electronic devices digitally through a screen on a device display.
                    <SU>9</SU>
                    <FTREF/>
                     This digital display can oftentimes be difficult for users to find. For instance, on the iPhone 14, users would have to navigate to a “Legal &amp; Regulatory” screen two levels deep under “Settings” to find the warning required per 47 CFR 25.285 against using on-board aircraft (see Figure 9).
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">https://www.govinfo.gov/content/pkg/COMPS-11324/pdf/COMPS-11324.pdf.</E>
                    </P>
                </FTNT>
                <GPH SPAN="3" DEEP="296">
                    <PRTPAGE P="105549"/>
                    <GID>EN27DE24.247</GID>
                </GPH>
                <HD SOURCE="HD1">Figure 9. The Warning Against Use of the iPhone 14 Satellite Feature on Aircraft is Compliant With the FCC Rules After the E-LABEL Act but Obscured Two Levels Deep in the Settings Menu (Settings/General/Legal&amp;Regulatory)</HD>
                <HD SOURCE="HD1">4 Summary</HD>
                <P>This paper assessed the potential impact of emerging L-band MSS D2D and IoT services on GPS/GNSS.</P>
                <P>If D2D or IoT devices are minimally compliant with 47 CFR 25.216, out-of-band emissions from single or multiple D2D devices could degrade GNSS receiver performance at distances up to 50 m or more. Additional filtering cannot mitigate the problem since the interference is overlapping with the GNSS signals in frequency.</P>
                <P>The fundamental emissions of L-band MSS terminals, including MES, D2D and IOT devices operating in the 1610-1660.5 MHz band can result in impact to GNSS devices at considerable distances. In this paper, as one example, 200 mW devices transmitting in 1627.5-1637.5 MHz were assessed to impact GPS/GNSS receivers at distances of up to 140 m. The FCC has authorized over 10 million mobile devices operate in L-band with EIRP of up to 10 W and at frequencies closer to the 1559-1610 MHz band. These devices could cause GNSS receiver degradation at distances exceeding 1 km. The impacted distances are highly variable across GNSS receivers, with the values cited above applying to the most sensitive receivers tested by DOT in 2016.</P>
                <P>
                    Finally, the paper identifies reasons why emerging L-band D2D and IoT operations may be problematic for GNSS even though reliant on existing MSS authorizations. Importantly, the primary concerns raised in this paper are applicable to MES, D2D and IoT devices with connectivity to any L-band MSS satellites with uplinks in the 1610-1660.5 MHz band. Thus, these issues are relevant to, 
                    <E T="03">e.g.,</E>
                     Inmarsat/Viasat, Iridium, Ligado, and Globalstar MSS operations.
                </P>
                <HD SOURCE="HD3">Appendix A. FCC L-Band MSS Mobile Earth Station Rules</HD>
                <HD SOURCE="HD3">The FCC Rules for satellite services (47 CFR part 25) include the following provisions related to L-band MSS operations:</HD>
                <P>• 25.216—provides limits on mobile earth station emissions in the 1559-1610 MHz ARNS band. Per 25.216(c), “The e.i.r.p. density of emissions from mobile earth stations placed in service after July 21, 2002 with assigned uplink frequencies between 1610 MHz and 1660.5 MHz shall not exceed −70 dBW/MHz, averaged over any 2 millisecond active transmission interval, in the band 1559-1605 MHz. The e.i.r.p. of discrete emissions of less than 700 Hz bandwidth from such stations shall not exceed −80 dBW, averaged over any 2 millisecond active transmission interval, in the 1559-1605 MHz band.”</P>
                <P>• 25.285—prohibits operation of Earth stations capable of transmitting in the 1.5/1.6 GHz MSS frequency bands on board civil aircraft “unless the device is installed in a manner approved by the Federal Aviation Administration or is used by the pilot or with the pilot's consent”. Further, portable Earth stations operating in these bands cannot be “. . . sold or distributed to users unless it conspicuously bears the following warning: `This device must be turned off at all times while on board aircraft.' ”</P>
                <P>• 25.287—provides requirements for mobile Earth stations operating in the 1530-1544 MHz and 1626.5-1645.5 MHz bands to ensure compliance with Footnote 5.353A in 47 CFR 2.106 and US315.</P>
                <HD SOURCE="HD3">Appendix B. MSS D2D Use on Commercial Aircraft</HD>
                <HD SOURCE="HD3">Overview</HD>
                <P>
                    One location that many people encounter that is often without cellular or WiFi service is when flying aboard a commercial aircraft. Low-cost D2D equipment may easily be taken aboard an aircraft and a passenger may operate this equipment (without knowing it is illegal to do so) in the United States 
                    <PRTPAGE P="105550"/>
                    from a window seat. They might do so for a variety of reasons, 
                    <E T="03">e.g.,</E>
                     to stay in touch with family and friends through text conversations while on the flight.
                </P>
                <HD SOURCE="HD3">Potential for Interference</HD>
                <P>
                    As noted in Section 2.1.1, MSS D2D devices are permitted to emit broadband noise in the GPS L1 band with an effective isotropic radiated power (EIRP) of up to −70 dBW/MHz from 1559-1605 MHz.
                    <SU>10</SU>
                    <FTREF/>
                     The path loss at the GPS L1 frequency from a vertically polarized antenna within a commercial aircraft to the right-hand circularly polarized GPS antenna on top of the aircraft fuselage can be as low as 54 dB.
                    <SU>11</SU>
                    <FTREF/>
                     This value was measured by Delta Airlines for a Boeing 737-800 aircraft. NASA, in cooperation with United Airlines, has measured values as low as 65 dB for Boeing 737 and 747 aircraft.
                    <SU>12</SU>
                    <FTREF/>
                     Figure 1 presents an example of these NASA path loss measurement results for a 737-200 aircraft measured from each window seat and also just inside each aircraft door.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         See 47 CFR 25.216.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         See, 
                        <E T="03">e.g.,</E>
                         Section E.5.2 of RTCA Document DO-235C, “Assessment of Radio Frequency Interference Relevant to the GNSS L1 Frequency Band,”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         See for instance 
                        <E T="03">https://ntrs.nasa.gov/api/citations/20030067884/downloads/20030067884.pdf</E>
                         and other NASA reports referenced within RTCA DO-235C.
                    </P>
                </FTNT>
                <GPH SPAN="3" DEEP="133">
                    <GID>EN27DE24.248</GID>
                </GPH>
                <HD SOURCE="HD1">Figure 1. Measured Path Loss at 1575 MHz From Vertically Polarized Antenna Inside a Boeing 737-200 Aircraft to the Top-Mounted GPS Antenna</HD>
                <P>
                    Commercial aircraft GPS avionics are typically certified to able to tolerate in-band interference with a maximum power spectral density of −140.5 dBW/MHz at the output of the passive antenna element while meeting all performance requirements after initial acquisition.
                    <SU>13</SU>
                    <FTREF/>
                     The interference from MSS D2D equipment could be much higher than this maximum tolerable level. For instance, for the worst-case location in a 737-800 aircraft measured by Delta Airlines, the −70 dBW/MHz permissible D2D equipment EIRP level within 1559-1605 MHz would result in −124 dBW/MHz received interference (16.5 dB higher than the required avionics tolerance). A more typical path loss from a window seat to the GPS antenna, based upon NASA's measurements (see Figure 2), is on the order of 70 dB. D2D equipment with a −70 dBW/MHz EIRP would still result in an excessive level of interference, −140 dBW/MHz, just above the maximum tested level for certified avionics.
                    <SU>14</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         See, 
                        <E T="03">e.g.,</E>
                         Federal Aviation Administration Technical Standard Orders (TSO)-C145, -C146, -C161, -C196, -C204, -C205 and also International Civil Aviation Organization (ICAO) GNSS Standards and Recommended Practices (SARPs). Certified GPS equipment are less tolerant of interference during initial acquisition and are only required to perform this function with in-band interference at a level of −146.5 dBW/MHz.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         Note that the International Telecommunication Union (ITU) recommends a 6 dB safety margin between permitted interference levels and maximum tolerable levels for safety applications of GNSS such as aircraft navigation. See, 
                        <E T="03">e.g.,</E>
                         ITU-R M.1903. Application of this safety margin would result in a much larger, 6.5 dB, excess of interference in this scenario.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Legality of Operating MSS D2D Equipment on Civil Aircraft</HD>
                <P>The FCC rules (47 CFR 25.285) prohibit operation of MSS equipment capable of transmitting in the 1.5/1.6 GHz MSS frequency bands on board civil aircraft “unless the device is installed in a manner approved by the Federal Aviation Administration or is used by the pilot or with the pilot's consent”. Further, portable Earth stations operating in these bands cannot be “. . . sold or distributed to users unless it conspicuously bears the following warning: `This device must be turned off at all times while on board aircraft.' ”</P>
                <P>Unfortunately, many consumers are not familiar with the FCC rules. Furthermore, the E-LABEL Act permits warnings such as that required in 47 CFR 25.285 to be made available to the users digitally through a screen on a device display. This E-LABEL provision makes it unlikely that the warning will be seen by most users. For instance, despite the Motorola Defy Satellite Link dongle being compliant with 47 CFR 25.285, nowhere in the user manual is it mentioned that the equipment should not be operated on an aircraft. The manual includes a cryptic section entitled “Viewing the E-label” that informs the user that an “E-label” can be found under a “Settings” menu within the Bullitt Satellite Messenger app used to send text messages on the users' smartphone. Only a user that bothers to look at this screen would find the warning shown towards the bottom of Figure 2.</P>
                <GPH SPAN="1" DEEP="181">
                    <GID>EN27DE24.249</GID>
                </GPH>
                <PRTPAGE P="105551"/>
                <HD SOURCE="HD1">Figure 2. The Warning Against Use of the Motorola Defy Satellite Link Aboard an Aircraft is Compliant With the FCC Rules, but Obscured in a Smartphone Application Settings Screen Unlikely To Be Noticed by Most Consumers</HD>
                <HD SOURCE="HD3">Potential Mitigations</HD>
                <HD SOURCE="HD3">Equipment Performing Better than FCC Rules</HD>
                <P>The −70 dBW/MHz EIRP emission limit for broadband noise in the 1559-1605 MHz band is required by the FCC rules (47 CFR 25.216) for all L-band MSS transmitters including D2D devices. It is possible that some devices may perform substantially better than this limit. One Motorola Defy device that was tested for FCC equipment authorization appears to have broadband emissions that are ~10 dB better than the −70 dBW/MHz limit (see Figure 3). Unfortunately, this is not sufficiently lower to preclude the concern of interference if operated aboard a civil aircraft described above. </P>
                <GPH SPAN="3" DEEP="189">
                    <GID>EN27DE24.250</GID>
                </GPH>
                <HD SOURCE="HD1">Figure 3. Measured Motorola Defy Satellite Link Broadband Emissions From 1559-1610 MHz From FCC Equipment Authorization Filing. Device Appears To Have Lower Emissions Than the FCC-70 dBW/MHz Limit in 1559-1605 MHz by ~10 dB.</HD>
                <HD SOURCE="HD3">Time Duration of Emissions</HD>
                <P>
                    Currently available MSS D2D devices only permit short messages to be sent (
                    <E T="03">e.g.,</E>
                     ~140 characters for the Motorola Defy Satellite Link). MITRE has obtained two Motorola devices to measure the time duration of emissions (both the fundamental within the MSS band and also the out-of-band emissions within the 1559-1610 MHz GPS/GNSS band).
                </P>
                <P>Noting that the use of GPS for aircraft navigation has some very strict continuity requirements, it is unlikely that even a short duration of emissions will be tolerable. For instance, for precision approach operations the International Civil Aviation Organization (ICAO) has adopted a continuity requirement that the probability that GPS is lost over an exposure period of 15 seconds must not exceed 8E-6. Furthermore, certified GPS avionics are not required to be able to continue to track GPS signals in the event that broadband interference exceeds −140.5 dBW/MHz, except if pulsed with pulse widths less than 125 microseconds and duty cycle less than 1%. Once tracking is disrupted, reacquisition within 20 seconds is only required if the receiver continues to track a set of satellites with good geometry and up to 5 minutes if not.</P>
                <HD SOURCE="HD3">Summary</HD>
                <P>This appendix has identified a concern of interference from MSS D2D devices to GPS avionics on commercial aircraft. Such devices have only very recently become available at very low cost in the United States. This concern is currently unmitigated from such devices that do not operate with significantly lower RNSS band emission limits than the FCC RNSS emission limit contained within 47 CFR 25.216 for L-band MSS transmitters, including D2D and IOT equipment.</P>
                <HD SOURCE="HD3">Appendix C. Separation Distances: Sample Calculations</HD>
                <P>Table 1 assumes a GNSS receiver with a right-hand circularly polarized isotropic receive antenna and a noise floor, N0, of −201.5 dBW/Hz referenced to the output port of the antenna. MSS MES emissions are assumed to be at the 47 CFR 25 limit of −70 dBW/MHz (= −130 dBW/Hz) and the MES is assumed to use a vertically polarized antenna. As an example of the calculations resulting in the separation distances within Table 1, consider the first row. A degradation of 1 dB in C/N0 results when the received interference power density, I0, at the output of the GNSS receiver antenna reaches a level of −207.4 dBW/Hz.</P>
                <GPH SPAN="3" DEEP="91">
                    <PRTPAGE P="105552"/>
                    <GID>EN27DE24.251</GID>
                </GPH>
                <P>This received interference power density occurs at a distance, d, of 79.1 m using free space propagation loss for the GNSS center frequency of 1575.42 MHz with corresponding wavelength, λ = 0.1903 meters:</P>
                <FP SOURCE="FP-1">
                    I0 = −130 dBW/Hz—20 log
                    <E T="52">10</E>
                    (4πd/λ)—3 = −207.4 dBW/Hz
                </FP>
                <P>The subtraction of 3 dB in the above equation is to account for polarization mismatch loss between an assumed vertically polarized MSS MES signal and the right-hand circularly polarized GNSS receive antenna.</P>
                <P>
                    Table 2 presents refined separation distance results using an average of representative measured GNSS receiver antenna gain patterns from Section 4.1.3.1 of the Department of Transportation (DOT)'s Global Positioning System (GPS) Adjacent Band Compatibility (ABC) Assessment Final Report, 
                    <E T="03">https://rosap.ntl.bts.gov/view/dot/35535.</E>
                     Vertically polarized emissions and a height of 2 meters for the MSS MES are assumed. As an example of the calculations, the first row in Table 2 assumes an HPR receiver with a -201.5 dBW/Hz noise floor. From the DOT's ABC report, and based upon measurements of multiple HPR antennas, Figure 1 below shows a modeled GNSS HPR receiver antenna gain pattern for a vertically polarized source. At a lateral distance of 52.2 meters the gain of this antenna on the ground towards a MSS MES at 2 m height is approximately -6.6 dBi. With this geometry, the slant range distance is ~52.2 meters and the received interference strength is:
                </P>
                <FP SOURCE="FP-1">
                    I0 = −130 dBW/Hz—20 log
                    <E T="52">10</E>
                    (4πd/λ)—6.6 = −207.4 dBW/Hz, resulting in a 1 dB increase over N0 (as explained in the footnote)
                </FP>
                <P>Note that since the GNSS antenna gain pattern that was used in this instance is based upon measurements with a vertically polarized source, no further polarization mismatch adjustment is required.</P>
                <GPH SPAN="3" DEEP="291">
                    <GID>EN27DE24.232</GID>
                </GPH>
                <HD SOURCE="HD1">
                    Figure 1. Representative HPR Antenna Gain Pattern Towards Vertically Polarized Source
                    <PRTPAGE P="105553"/>
                </HD>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30760 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-60-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF DEFENSE</AGENCY>
                <SUBAGY>Office of the Secretary</SUBAGY>
                <DEPDOC>[Docket ID: DoD-2024-HA-0037]</DEPDOC>
                <SUBJECT>Submission for OMB Review; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Assistant Secretary of Defense for Health Affairs (OASD(HA)), Department of Defense (DoD).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>30-Day information collection notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The DoD has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all comments received by January 27, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Reginald Lucas, (571) 372-7574, or 
                        <E T="03">whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Title; Associated Form; and OMB Number:</E>
                     TRICARE DoD/CHAMPUS Medical Claim Patient's Request for Medical Payment; DD Form 2642; OMB Control Number 0720-0006.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Extension.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     830,000.
                </P>
                <P>
                    <E T="03">Responses per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Annual Responses:</E>
                     830,000.
                </P>
                <P>
                    <E T="03">Average Burden per Response:</E>
                     15 minutes.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     207,500.
                </P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     The DD Form 2642, “TRICARE DoD/Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) Medical Claim Patient's Request for Medical Payment” is used by TRICARE beneficiaries to claim reimbursement for medical expenses under the TRICARE Program CHAMPUS. The information collected will be used by TRICARE to determine beneficiary eligibility, other health insurance liability, certification that the beneficiary has the received care, and reimbursement for medical services received.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or households.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Respondent's Obligation:</E>
                     Voluntary.
                </P>
                <P>
                    <E T="03">DOD Clearance Officer:</E>
                     Mr. Reginald Lucas.
                </P>
                <SIG>
                    <DATED>Dated: December 18, 2024.</DATED>
                    <NAME>Stephanie J. Bost,</NAME>
                    <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30889 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6001-FR-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
                <SUBAGY>Office of the Secretary</SUBAGY>
                <DEPDOC>[Docket ID: DoD-2024-OS-0139]</DEPDOC>
                <SUBJECT>Proposed Collection; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Washington Headquarters Services (WHS), Department of Defense (DoD).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>60-Day information collection notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In compliance with the 
                        <E T="03">Paperwork Reduction Act of 1995,</E>
                         the Washington Headquarters Services (WHS) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all comments received by February 25, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by docket number and title, by any of the following methods:</P>
                    <P>
                        <E T="03">Federal eRulemaking Portal:</E>
                          
                        <E T="03">http://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        <E T="03">Mail:</E>
                         Department of Defense, Office of the Assistant to the Secretary of Defense for Privacy, Civil Liberties, and Transparency, Regulatory Directorate, 4800 Mark Center Drive, Mailbox #24 Suite 05F16, Alexandria, VA 22350-1700.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the agency name, docket number and title for this 
                        <E T="04">Federal Register</E>
                         document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at 
                        <E T="03">http://www.regulations.gov</E>
                         as they are received without change, including any personal identifiers or contact information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to Office of the Secretary of Defense, 4800 Mark Center Drive Ste. 02F09-02 Alexandria, VA 22350-1700, Ronald McCully, 571-372-0473.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Title; Associated Form; and OMB Number</E>
                    : Separating Personnel Records Accountability Checklist—Transfer of Records Between DoD/OSD Components; SD Form 833; OMB Control Number 0704-SRAC.
                </P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     This form is needed to ensure records and information created and received by employees, Service members, and contract personnel departing or transferring from a WHS-serviced Component are preserved in appropriate locations or transferred to appropriate Record and Information Management personnel.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Contractors.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     250.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     50.
                </P>
                <P>
                    <E T="03">Responses per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Annual Responses:</E>
                     50.
                </P>
                <P>
                    <E T="03">Average Burden per Response:</E>
                     5 hours.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     As required.
                </P>
                <SIG>
                    <DATED>Dated: December 18, 2024.</DATED>
                    <NAME>Stephanie J. Bost,</NAME>
                    <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30893 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6001-FR-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF DEFENSE</AGENCY>
                <SUBAGY>Department of the Navy</SUBAGY>
                <DEPDOC>[Docket ID: USN-2024-HQ-0019]</DEPDOC>
                <SUBJECT>Proposed Collection; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of the Navy, Department of Defense (DoD).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>60-Day information collection notice.</P>
                </ACT>
                <SUM>
                    <PRTPAGE P="105554"/>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In compliance with the 
                        <E T="03">Paperwork Reduction Act of 1995,</E>
                         the United States Marine Corps announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all comments received by February 25, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by docket number and title, by any of the following methods:</P>
                    <P>
                        <E T="03">Federal eRulemaking Portal: http://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        <E T="03">Mail:</E>
                         Department of Defense, Office of the Assistant to the Secretary of Defense for Privacy, Civil Liberties, and Transparency, Regulatory Directorate, 4800 Mark Center Drive, Mailbox #24, Suite 05F16, Alexandria, VA 22350-1700.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the agency name, docket number and title for this 
                        <E T="04">Federal Register</E>
                         document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at 
                        <E T="03">http://www.regulations.gov</E>
                         as they are received without change, including any personal identifiers or contact information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to Headquarters Marine Corps Records, Reports, Directives, and Forms Management Section, 3000 Marine Corps, Pentagon Rm. 2B253, Mr. Mark Kazzi, (571) 256-8883.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Title; Associated Form; and OMB Number:</E>
                     Marine Corps Lodging Guest Registration and Feedback; OMB Control Number 0712-0001.
                </P>
                <P>
                    <E T="03">Needs and Uses:</E>
                     The information collection is necessary to keep a record of Marine Corps lodging reservations to ensure orderly room assignment and avoid improper booking; to record registration and payment of accounts; to verify proper usage by eligible patrons; for cash control; to gather occupancy data; to determine occupancy breakdown; to account for rentals and furnishings; and to collect data for customer satisfaction and marketing.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals or households.
                </P>
                <P>
                    <E T="03">Annual Burden Hours:</E>
                     1,887.
                </P>
                <P>
                    <E T="03">Number of Respondents:</E>
                     15,000.
                </P>
                <P>
                    <E T="03">Responses per Respondent:</E>
                     1.11.
                </P>
                <P>
                    <E T="03">Annual Responses:</E>
                     16,650.
                </P>
                <P>
                    <E T="03">Average Burden per Response:</E>
                     6.8 minutes.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     On occasion.
                </P>
                <SIG>
                    <DATED>Dated: December 18, 2024.</DATED>
                    <NAME>Stephanie J. Bost,</NAME>
                    <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30894 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6001-FR-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF EDUCATION</AGENCY>
                <DEPDOC>[Docket No.: ED-2024-SCC-0126]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Student Assistance General Provisions—Readmission for Servicemembers</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Student Aid (FSA), Department of Education (ED).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing an extension without change of a currently approved information collection request (ICR).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested persons are invited to submit comments on or before January 27, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for proposed information collection requests should be submitted within 30 days of publication of this notice. Click on this link 
                        <E T="03">www.reginfo.gov/public/do/PRAMain</E>
                         to access the site. Find this information collection request (ICR) by selecting “Department of Education” under “Currently Under Review,” then check the “Only Show ICR for Public Comment” checkbox. 
                        <E T="03">Reginfo.gov</E>
                         provides two links to view documents related to this information collection request. Information collection forms and instructions may be found by clicking on the “View Information Collection (IC) List” link. Supporting statements and other supporting documentation may be found by clicking on the “View Supporting Statement and Other Documents” link.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>For specific questions related to collection activities, please contact Beth Grebeldinger, 202-570-8414.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.</P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Student Assistance General Provisions—Readmission for Servicemembers.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1845-0095.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     An extension without change of a currently approved ICR.
                </P>
                <P>
                    <E T="03">Respondents/Affected Public:</E>
                     Individuals and Households; Private Sector; State, Local, and Tribal Governments.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Responses:</E>
                     4,570.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Burden Hours:</E>
                     1,531.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The Department of Education (the Department) is requesting an extension without change of the current record keeping information collection. There has been no change in either the statute as provided by the Higher Education Act of 1965, as amended (HEA) or in the regulations. The regulations identify the requirements under which an institution must readmit servicemembers with the same academic status they held at the institution when they last attended (or were accepted for attendance). The regulations require institutions to charge readmitted servicemembers, for the first academic year of their return, the same institutional charges they were charged for the academic year during which they left the institution (see section 484C of the HEA).
                </P>
                <SIG>
                    <PRTPAGE P="105555"/>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Kun Mullan,</NAME>
                    <TITLE>PRA Coordinator, Strategic Collections and Clearance, Governance and Strategy Division, Office of Chief Data Officer, Office of Planning, Evaluation and Policy Development.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30850 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4000-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF ENERGY</AGENCY>
                <SUBJECT>Notice of Intent To Prepare a Supplemental Environmental Impact Statement for Remediation of Area IV and the Northern Buffer Zone of the Santa Susana Field Laboratory and Conduct Public Scoping Meetings</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Environmental Management, Department of Energy.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of intent to prepare a supplemental environmental impact statement and conduct public scoping meetings.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Department of Energy (DOE) announces its intent to prepare a supplemental environmental impact statement (SEIS) under the National Environmental Policy Act (NEPA) to evaluate additional alternatives for cleanup of soils in Area IV, including the Energy Technology Engineering Center (ETEC), as well as the Northern Buffer Zone (NBZ) of the Santa Susana Field Laboratory (SSFL) (DOE/EIS-0402-S1) in eastern Ventura County, California, adjacent to Los Angeles County. DOE's operations bordered the NBZ. DOE is responsible for soil cleanup in Area IV and the portions of the NBZ where DOE's activities impacted the soils. This SEIS, prepared to supplement the “Final Environmental Impact Statement for Remediation of Area IV and the Northern Buffer Zone of the Santa Susana Field Laboratory and Conduct Public Scoping Meetings” (Final SSFL Area IV EIS) (DOE/EIS-0402; November 2018), will include additional soils remediation alternatives not previously evaluated. DOE is initiating a 60-day public scoping period. DOE plans to hold two public scoping meetings.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        DOE invites Federal and State agencies, State and local governments, Native American Tribes, industry and other organizations, and members of the public to submit comments to assist in determining the appropriate scope of this SEIS. The public scoping period will extend until February 25, 2025. DOE plans to hold two public scoping meetings. Dates, times, and locations will be announced in local media and posted on the ETEC EIS website at 
                        <E T="03">https://www.ssflareaiveis.com/</E>
                         at least 15 days before the date of the meetings.
                    </P>
                    <P>DOE will consider all comments received or postmarked by the end of the scoping period. Comments submitted after the close of the scoping period will be considered to the extent practicable.</P>
                    <P>
                        Additional information regarding scoping meetings is provided on the ETEC EIS website at 
                        <E T="03">https://www.ssflareaiveis.com/.</E>
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments on the scope of the SEIS, requests to speak at a public meeting, requests to be added to the SEIS mailing list, and comments or questions on the scoping process can be sent to: Dr. Joshua Mengers, NEPA Document Manager, Leidos 2109 Air Park Road SE, Ste 200 Albuquerque, NM 87106. Comments may also be submitted by email to 
                        <E T="03">SSFL_DOE_SEIS@emcbc.doe.gov</E>
                         (use “Scoping Comments” for the subject), or on the EIS website at 
                        <E T="03">https://www.ssflareaiveis.com</E>
                        /. Please submit comments in Microsoft
                        <SU>TM</SU>
                         Word or PDF file format and avoid the use of encryption.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For general information on the DOE Office of Environmental Management NEPA process, contact: Bill Ostrum, EM NEPA Compliance Officer, U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585; 202-5896-2513 or email: 
                        <E T="03">william.ostrum@hq.doe.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This NOI, the 2018 SSFL Area IV EIS, and related information are available online at 
                    <E T="03">https://www.energy.gov/nepa</E>
                     and at 
                    <E T="03">https://www.ssflareaiveis.com/.</E>
                </P>
                <P>Additional information about the SSFL Area IV is available in the following public reading rooms:</P>
                <P>• Simi Valley, California: Simi Valley Library, 2969 Tapo Canyon Road, (805) 526-1735;</P>
                <P>• Hidden Hills, California: Hidden Hills City Hall, 6165 Spring Valley Road, (818) 888-9281;</P>
                <P>• Northridge, California: California State University Northridge Oviatt Library, 2nd Floor, Room 265, (818) 677-3465; and</P>
                <P>• Chatsworth, California: State of California Department of Toxic Substances Control, 9211 Oakdale Avenue, (818) 717-6500.</P>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    DOE is preparing the “Supplemental Environmental Impact Statement for Remediation of Area IV and the Northern Buffer Zone of the Santa Susana Field Laboratory” (SEIS) (DOE/EIS-0402-S1) in accordance with the National Environmental Policy Act of 1969, as amended (Pub. L. 91-190,42 United States Code (U.S.C.) 4321 
                    <E T="03">et seq.</E>
                    ) (NEPA), the Council on Environmental Quality's (CEQ) NEPA regulations (40 CFR parts 1500-1508),
                    <SU>1</SU>
                    <FTREF/>
                     and DOE's NEPA Implementing Procedures (10 CFR part 1021).
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         The DOE is aware of the November 12, 2024, decision in 
                        <E T="03">Marin Audubon Society</E>
                         v. 
                        <E T="03">Federal Aviation Administration,</E>
                         No. 23-1067 (D.C. Cir. Nov. 12, 2024). To the extent that a court may conclude that the CEQ regulations implementing NEPA are not judicially enforceable or binding on this agency action, the DOE has nonetheless elected to follow those regulations at 40 CFR parts 1500-1508, in addition to the DOE's procedures/regulations implementing NEPA at 10 CFR part 1021, to meet the agency's obligations under NEPA, 42 U.S.C. 4321 
                        <E T="03">et seq.</E>
                    </P>
                </FTNT>
                <P>
                    <E T="03">Site History.</E>
                     Located on 2,850 acres in the hills between the San Fernando Valley and Simi Valley, CA, SSFL was established in 1947 by North American Aviation (NAA) for the development and testing of liquid propellant rocket engines, first for the U.S. Air Force and subsequently for the National Aeronautics and Space Administration (NASA). In 1955, NAA established the subdivision Atomics International for the purpose of conducting energy research and testing small nuclear reactors for the Atomic Energy Commission (AEC), a predecessor agency to DOE, and commercial clients in the western portion of SSFL, also known as Area IV. Atomics International merged into Rocketdyne in 1984. In 1996, the Boeing Company (Boeing) acquired part of Rocketdyne, and with it SSFL.
                </P>
                <P>
                    SSFL is divided into four administrative areas and two contiguous buffer zones north and south of the administrative areas. Area I consists of about 714 acres, including 672 acres that are owned and operated by Boeing and 42 acres that are owned by the Federal Government and administered by NASA. Area II consists of about 410 acres that are owned by the Federal Government and administered by NASA. Area III consists of about 120 acres that are owned and operated by Boeing. Area IV consists of about 290 acres that are owned by Boeing in which 90 acres have been leased by DOE and its predecessors for work described below. Boeing also owns contiguous buffer zone areas of 1,143 acres to the south (Southern Buffer Zone) and 182 acres to the north (NBZ). DOE has no responsibilities for the Southern Buffer Zone as it adjoins SSFL Areas I, II, and III. DOE does have responsibility for the cleanup of soils in the 290 acres of Area IV and in the 182-acre NBZ. Not all of the energy research conducted in Area IV was performed for DOE. Boeing has 
                    <PRTPAGE P="105556"/>
                    responsibility for the decontamination and demolition of the buildings it owns.
                </P>
                <P>Starting in the mid-1950s, the AEC funded nuclear energy research on a 90-acre parcel of SSFL Area IV leased from Atomics International. ETEC was established by the AEC on this parcel in the early 1960s as a “center of excellence” for liquid metals technology. Boeing and its predecessors operated ETEC on behalf of DOE. At ETEC, DOE also operated 10 small nuclear reactors built for various research activities. All SSFL reactor operations ended in 1980, and nuclear research work was completed in 1988.</P>
                <P>Cleanup of ETEC began in the 1960s and was undertaken continually and as unnecessary facilities were decommissioned. Operation of the research facilities and reactors resulted in localized radiological and chemical contamination of soil and groundwater, and the concrete containment that surrounded the reactors became radioactive. The major periods of building demolition were 1975 through 1977 and 1995 through 2005, and recently in 2020 through 2021. DOE has removed all nuclear materials from the site, as well as all above grade portions of its buildings (a few foundations remain). Prior building demolition and soil remediation efforts resulted in removal of much of the chemical and radioactive material from Area IV.</P>
                <P>
                    <E T="03">Prior NEPA Reviews:</E>
                     In March 2003, DOE issued an “Environmental Assessment for Cleanup and Closure of the Energy Technology Engineering Center
                    <E T="03">”</E>
                     (DOE/EA-1345). The purpose and need for agency action was based on a DOE determination in 1996 that ETEC was surplus to DOE's needs and that the site should be closed. Based on the results of the environmental assessment (EA), DOE determined that an EIS was not required and issued a finding of no significant impact (FONSI). DOE's FONSI was challenged, and the U.S. District Court for the Northern District of California's May 2, 2007, ruling in the case 
                    <E T="03">Natural Resources Defense Council</E>
                     v. 
                    <E T="03">Department of Energy</E>
                     (Slip Op. 2007 WL 2349288 (N.D. Cal. Aug. 15, 2007)) held that DOE's decision to issue a FONSI and conduct remediation on the basis of the final EA rather than prepare an EIS was in violation of NEPA. The court enjoined DOE from relinquishing control of any portion of SSFL Area IV until DOE completes an EIS and issues a Record of Decision pursuant to NEPA.
                </P>
                <P>In accordance with CEQ and DOE NEPA implementing regulations (40 CFR parts 1500-1508 and 10 CFR part 1021, respectively), DOE initiated an EIS in October 2007 by issuing an Advance NOI (72 FR 58834). Public comments received as a result of the publication of the Advance NOI aided in the preparation of the 2008 NOI announcing DOE's intent to prepare an EIS (73 FR 28437). DOE held scoping meetings in July 2008. DOE soon thereafter determined that additional site characterization data were needed before DOE could proceed with the EIS.</P>
                <P>
                    After the additional site characterization work was completed, DOE reinitiated the EIS process by issuing an Amended NOI and conduct additional scoping meetings to allow further public involvement. The Amended NOI to Prepare an “Environmental Impact Statement for Remediation of Area IV of the Santa Susana Field Laboratory” and Conduct Public Scoping Meetings (79 FR 7439) was published in the February 7, 2014, 
                    <E T="04">Federal Register</E>
                    . DOE held two scoping meetings in February and March.
                </P>
                <P>
                    The comments received during the 2008 and 2014 scoping periods were used in the development of the “Draft Environmental Impact Statement for Remediation of Area IV and the NBZ of the Santa Susana Field Laboratory
                    <E T="03">”</E>
                     (Draft SSFL Area IV EIS). On January 13, 2017, EPA published a notice in the 
                    <E T="04">Federal Register</E>
                     (82 FR 4336), announcing the availability of the Draft SSFL Area IV EIS and a public comment period. During the public comment period, DOE held two public hearings, as well as a hearing for Native Americans.
                </P>
                <P>
                    On December 28, 2018, EPA published a notice in the 
                    <E T="04">Federal Register</E>
                     (83 FR 67282), announcing the availability of the Final SSFL Area IV EIS. On September 27, 2019, DOE announced its decision to implement the preferred alternative for building demolition identified in the 2018 SSFL Area IV EIS to demolish the 18 buildings it owned in Area IV of SSFL and dispose of or recycle the materials off site (84 FR 51150). On November 10, 2020 (85 FR 71640), DOE announced its decision to implement the preferred alternatives for groundwater remediation identified in the 2018 SSFL Area IV EIS, with the exception of Building 4100/Building 56 Landfill TCE Plume, for which DOE would implement monitored natural attenuation. DOE has yet to issue a decision on soil remediation, the subject of this SEIS.
                </P>
                <P>
                    As required by CEQA and the California Health and Safety Code, in September 2017, California Department of Toxic Substances Control (DTSC) issued the “Draft Program Environmental Impact Report for the Santa Susana Field Laboratory, Ventura County, California” (Draft Program EIR) to evaluate proposed remedial actions at SSFL. On June 8, 2023, DTSC released the Final Program EIR for SSFL. According to DTSC's news release (
                    <E T="03">https://dtsc.ca.gov/2023/06/08/news-release_t-04-23/</E>
                    ), the Final Program EIR includes DTSC's analysis of the environmental impacts from cleanup work at the site, and mitigation measures to address those impacts, but the Final Program EIR itself does not select a cleanup standard. The Final Program EIR further provides that the responsible parties (Boeing, NASA, and DOE) will develop detailed work plans (characterized as “decision documents”) that outline the stages and methods of cleanup and will include cleanup standards. These documents will be made available for public review and comment prior to finalization and DTSC approval.
                </P>
                <P>
                    <E T="03">Regulations and Agreements:</E>
                     In 2007, DOE, NASA, Boeing, and DTSC entered into a Consent Order governing the remediation of soils and groundwater at SSFL.
                </P>
                <P>
                    In the Consolidated Appropriations Act, 2008 (Pub. L. 110-161), Congress, among other things, mandated that DOE use a portion of the funding for ETEC to enter into an interagency agreement with the EPA to conduct a joint comprehensive radioactive site characterization of Area IV and the NBZ. Additionally, in 2009, EPA received $38 million in American Recovery and Reinvestment Act funds from DOE to expand site characterization work. DOE continued to prepare the EIS while the site characterization was being completed, gathering information to support the EIS such as baseline data on traffic and noise. EPA conducted its background and on-site radionuclide investigation of Area IV and the NBZ from the summer of 2009 until the fall of 2012. EPA's final data report for the Area IV and NBZ radiological study was issued in December 2012. EPA's final data report for the radiological study is available on the ETEC website at 
                    <E T="03">www.energy.gov/etec/epa-characterization-1.</E>
                </P>
                <P>
                    In December 2010, DOE and DTSC entered into the Administrative Order on Consent (2010 AOC), which modifies DOE's obligations with respect to soil cleanup and provides the process for DOE to complete soil characterization within Area IV and the NBZ (
                    <E T="03">https://www.energy.gov/sites/default/files/2023-01/SSFL_DOE_AOC_Final.pdf</E>
                    ). The 2010 AOC also describes the process for establishing soil cleanup standards for Area IV. The 2010 AOC stipulates that the soils cleanup standard will be local background 
                    <PRTPAGE P="105557"/>
                    concentrations, subject to specified exceptions and conditions, including provisions addressing analytical detection limits, endangered species and habitat, cultural resources, and other unforeseen circumstances.
                    <SU>2</SU>
                    <FTREF/>
                     The AOC provides a preference for on-site treatment to minimize transportation of soils. DOE completed the AOC-required soil sampling and released its data report for the Area IV/NBZ chemical study in 2014. The most frequently observed chemicals in soils were polychlorinated biphenyls (from electrical components); polycyclic aromatic hydrocarbons (from fuels and burning of wastes); dioxins (from burning of wastes and brush fires); petroleum chemicals (mostly from diesel fuel and naturally occurring organic materials); mercury (from electrical components and as heat transfer medium); and metals (antimony, cadmium, chromium VI, mercury, selenium, and silver). The results of the EPA soil radiological characterization reports and the DOE chemical characterization were incorporated into the SSFL Area IV EIS analyses.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         The soil cleanup standards (action levels) are to be listed in a “Look-up Table” as not-to-exceed concentrations in the soil.
                    </P>
                </FTNT>
                <P>In December 2012, EPA provided to DTSC its cleanup value recommendations to be included in the Look-Up Table (LUT) for radionuclides, and DTSC released provisional radionuclide Look-Up Table values in January 2013. In June 2013, DTSC provided Look-Up Table values for 125 of the most frequently observed chemicals at the site.</P>
                <P>The provisional radionuclide LUT values and chemical LUT values are incorporated into appendix D of the 2018 SSFL Area IV EIS.</P>
                <P>Boeing is the landowner of Area IV and the NBZ. In April 2017, Boeing and North American Land Trust entered into a Grant Deed of Conservation Easement and Agreement (conservation easement) to permanently preserve nearly 2,400 acres of land at SSFL, including Area IV and the NBZ as open space. In November 2017, Boeing and North American Land Trust entered into a second Grant Deed of Conservation Easement and Agreement to protect approximately 53 additional acres along the Southern Buffer Zone of SSFL. The conservation easements are legally enforceable documents that, among other restrictions, forever prohibit residential, agricultural, or commercial development or uses of the site. They permanently bind the property, regardless of who owns the land.</P>
                <HD SOURCE="HD1">Purpose and Need for Agency Action</HD>
                <P>Similar to that described in the 2018 SSFL Area IV EIS DOE needs to complete remediation of SSFL Area IV and the NBZ to comply with applicable requirements for cleanup of radiological and hazardous substances. These requirements include laws, regulations, orders, and agreements. To this end, DOE proposes to clean up the affected environment in Area IV and the NBZ in a manner that is protective of the environment and the health and safety of the public and workers.</P>
                <HD SOURCE="HD1">Proposed Action</HD>
                <P>DOE proposes to remediate chemically and radiologically impacted soil in Area IV and the NBZ; dispose of resulting material; and restore the affected environment in accordance with applicable laws, orders, regulations, and agreements with the State of California.</P>
                <HD SOURCE="HD1">Preliminary Description of Alternatives</HD>
                <P>In the Final SSFL Area IV EIS, DOE evaluated the No Action Alternative and four different soil cleanup alternatives. The previously evaluated soil cleanup alternatives were: (1) Cleanup to the AOC LUT Values; (2) Cleanup to Revised LUT Values; (3) Conservation of Natural Resources—Residential Scenario; and (4) Conservation of Natural Resources Open Space Scenario.</P>
                <P>Various conditions warrant the consideration of additional options for soil cleanup actions. DOE's ongoing environmental review and assessment of the site identified numerous challenging issues for soil remediation. For example, the provisional LUT values developed to define background are not implementable. Backfill soils needed to restore the site are not available at the established cleanup standards. The provisional cleanup standards set for some contaminants are lower than laboratory detection capabilities. The pristine sites used to develop the provisional look-up-table values would not pass as clean. Therefore, DOE proposes to evaluate three new soil cleanup alternatives in the SEIS: (1) Updated LUT Values Alternative, (2) Multiple Lines of Evidence Alternative, and (3) Resident with Garden Risk-based Alternative.</P>
                <P>These alternatives are being evaluated in the SEIS because they are reasonable options for cleanup of soil contamination for DOE areas of responsibility at SSFL.</P>
                <P>
                    • 
                    <E T="03">Updated LUT Values Alternative</E>
                    —DOE, working with DTSC staff, identified issues with the AOC LUT background threshold values (BTVs) and method reporting limits (MRLs) and DOE developed proposed “Updated” LUT values that reduce the false positive decision error rate. The proposed Updated LUT Alternative would retain the other provisions of the AOC.
                </P>
                <P>
                    • 
                    <E T="03">Multiple Lines of Evidence Alternative</E>
                    —Looking at options for addressing issues with AOC soil cleanup implementation, DTSC developed a soil cleanup option termed the “Multiple-Lines of Evidence” (MLE) approach, which means using different types of proof to support an idea. The use of MLE makes the argument stronger and more reliable. US EPA identifies the use of MLE as a best practice in environmental cleanup. DTSC held public “Soil Smarts” workshops on November 20, 2024, and December 10, 2024, to explain the next phase of implementing the soil cleanup at SSFL and discuss the MLE approach. According to DTSC, “The MLE approach uses risk assessment to ensure the protection of human health while minimizing unnecessary removal of clean soil and destruction of critical habitats and cultural resources.” DTSC elaborated on the MLE approach: “[t]he evaluation is performed on a sample-by-sample basis and does not use any area averaging” and “[u]sing the MLE approach will allow for a cleanup to local background levels consistent with the AOCs.” A further description of DTSC's proposed MLE approach is available at 
                    <E T="03">https://dtsc.ca.gov/wp-content/uploads/sites/31/2024/11/SSFL-Fact-Sheet-5-Unearthing-a-Better-Approach-FINAL.pdf.</E>
                </P>
                <P>
                    • 
                    <E T="03">Resident with Garden Risk-based Alternative</E>
                    —The Boeing Company and DTSC entered into a settlement agreement (“Boeing Settlement Agreement”) providing a framework for the soil cleanup action for Boeing's cleanup at SSFL. According to the Boeing Settlement agreement, cleanup would be up to and including a resident with garden scenario. Standard risk assessment protocols would be followed in identifying locations for a soil cleanup action.
                </P>
                <P>
                    As part of this SEIS, DOE proposes to evaluate the resident with garden scenario based on the framework from the Boeing Settlement Agreement, which differs from the resident (without garden) and open space scenarios assessed in the 2018 SSFL Area IV EIS. In the interest of evaluating a consistent cleanup standard across the SSFL site and avoiding challenges associated with disparate standards, the resident with garden scenario is being addressed in this SEIS as an option for a soil cleanup 
                    <PRTPAGE P="105558"/>
                    action within DOE areas of responsibility at SSFL.
                </P>
                <P>A number of alternative concepts were proposed by the public during the 2018 SSFL Area IV EIS scoping period in 2008, the Community Alternatives Development Workshops in 2012, and the SSFL Area IV EIS scoping period in 2014. DOE incorporated most of these concepts into the alternatives described in the 2018 SSFL Area IV EIS. More detailed descriptions of these concepts, as well as a discussion of the analysis undertaken to evaluate each concept and inform DOE's dismissal of some concepts from detailed study, are provided in the 2018 SSFL Area IV EIS. DOE will reconsider these alternative concepts as part of the SEIS development process.</P>
                <P>In accordance with CEQ and DOE NEPA Regulations, DOE will also evaluate a “no action” alternative. Under the No Action Alternative, DOE would undertake no further soil cleanup at SSFL Area IV and the NBZ. Other DOE and Boeing activities would continue at SSFL Area IV and the NBZ. As required under NEPA, this alternative is to establish the baseline against which the environmental effects from other analyzed alternatives can be compared.</P>
                <P>This list of alternatives is preliminary. After public scoping, DOE will re-evaluate the reasonable alternatives to be analyzed in the SEIS.</P>
                <HD SOURCE="HD1">Preliminary Identification of Environmental Issues and Expected Effects</HD>
                <P>DOE has tentatively identified potential effects to the following resource areas for consideration in the SEIS. These are the same resource areas evaluated in the 2018 SSFL Area IV EIS. The following list is not intended to be all inclusive or to imply any predetermination of effects.</P>
                <FP SOURCE="FP-1">• Land Resources including land use, recreation, infrastructure, and aesthetics and visual quality</FP>
                <FP SOURCE="FP-1">• Geology and Soils including mineral and paleontological resources</FP>
                <FP SOURCE="FP-1">• Surface Water Resources including floodplains and wetlands</FP>
                <FP SOURCE="FP-1">• Groundwater Resources</FP>
                <FP SOURCE="FP-1">• Biological Resources including vegetation, wildlife, and threatened, endangered, and rare species</FP>
                <FP SOURCE="FP-1">• Air Quality, Climate Change, and Greenhouse Gas Emissions and Effects</FP>
                <FP SOURCE="FP-1">• Noise</FP>
                <FP SOURCE="FP-1">• Transportation including from radiological and non-radiological wastes to disposal sites and clean replacement soil to SSFL</FP>
                <FP SOURCE="FP-1">• Traffic</FP>
                <FP SOURCE="FP-1">• Human Health and Safety including occupational and public health and safety, and site accidents including from natural disasters (floods, hurricanes, tornadoes, and earthquakes) and intentional destructive acts (sabotage and terrorism)</FP>
                <FP SOURCE="FP-1">• Waste Management</FP>
                <FP SOURCE="FP-1">• Cultural Resources including archeological, paleontological, and Native American culturally important sites and Consultations</FP>
                <FP SOURCE="FP-1">• Socioeconomics</FP>
                <FP SOURCE="FP-1">• Environmental Justice (potential disproportionate and adverse effects on communities with environmental justice concerns)</FP>
                <FP SOURCE="FP-1">• Cumulative effects</FP>
                <P>This list will be re-evaluated following public scoping and, as directed by the CEQ's NEPA Regulations, DOE will analyze each potential environmental effect at a level of detail in proportion to its potential significance (40 CFR 1502.2(b)).</P>
                <HD SOURCE="HD1">Anticipated Permits, Authorizations, and Related Environmental Reviews</HD>
                <P>As described in the 2018 SSFL Area IV EIS, DOE areas of Area IV and the NBZ lie outside the floodplain. Because there are no floodplains, DOE's regulation 10 CFR part 1022 does not apply with respect to floodplain actions. Because the proposed project may involve actions in wetlands, the draft SEIS will include an updated wetland assessment.</P>
                <P>Section 106 of the National Historic Preservation Act (NHPA) requires Federal agencies to take into account the effects of their undertakings on historic properties. DOE will continue to coordinate compliance with section 106 during preparation of this SEIS.</P>
                <P>Also, DOE will continue formal consultations with the U.S. Fish and Wildlife Service as required under section 7 of the Endangered Species Act and begun during preparation of the 2018 SSFL Area IV EIS.</P>
                <HD SOURCE="HD1">Public Scoping Process</HD>
                <P>
                    DOE invites interested parties to comment on the scope of this SEIS, including the proposed action, alternatives, and effects, as well as on relevant information, studies, or analyses with respect to the proposed action. This may include environmental issues to be analyzed, and mitigation to reduce potential environmental effects. Written comments may be provided by any of the means described under 
                    <E T="02">ADDRESSES</E>
                     section. Oral comments may be provided at the public scoping meetings. DOE plans to hold two public scoping meetings. Dates, times, and locations will be announced in local media and posted on the ETEC EIS website at 
                    <E T="03">https://www.ssflareaiveis.com/</E>
                     at least 15 days before the date of the meetings.
                </P>
                <P>
                    Requests to speak at the public meeting should be made by sending an email to 
                    <E T="03">SSFL_DOE_SEIS@emcbc.doe.gov.</E>
                     Those who pre-register should indicate at which meeting they want to speak and their name. Speakers will be scheduled on a first-come, first-served basis. In addition, individuals may sign up at the meeting reception desk and will be accommodated as time permits.
                </P>
                <P>The scoping meetings will offer an opportunity for stakeholders to learn more about the proposed action from DOE officials and to provide comments on the proposed scope of the SEIS. DOE officials will provide a brief presentation explaining DOE's process for identifying reasonable alternatives and potential environmental effects to be analyzed in the SEIS. Following the presentation, the public will be given the opportunity to provide comments orally. A court reporter will be present to transcribe comments, but speakers are encouraged to provide written versions of their oral comments for the record. The presiding officer will establish the order of the speakers and will ensure that everyone who wishes to speak has a chance to do so. DOE may need to limit speakers to three minutes initially but will provide additional opportunities to speak if time allows. Comment cards will also be available for those who would prefer to submit written comments. DOE is especially interested in learning from the public any issues or alternatives that should be considered.</P>
                <P>
                    Persons needing reasonable accommodations in order to attend or participate in the public meeting should contact DOE using one of the methods listed in 
                    <E T="02">ADDRESSES</E>
                     section no later than one week before the relevant public meeting.
                </P>
                <P>
                    Because your comments will be made public, you are solely responsible for ensuring that your comments do not include any confidential information that you or a third party may not wish to be posted. Pursuant to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email, postal mail, or hand delivery/courier two well-marked copies: one copy of the document marked confidential including all the information believed to be confidential, and one copy of the document marked non-confidential with the information 
                    <PRTPAGE P="105559"/>
                    believed to be confidential deleted. Submit these documents via email. DOE will make its own determination about the confidential status of the information and treat it according to its determination.
                </P>
                <P>
                    Comments must be provided by the date provided in the 
                    <E T="02">DATES</E>
                     section of this notice to ensure consideration in preparation of the draft SEIS. DOE will consider late comments to the extent practicable.
                </P>
                <P>Please be advised that your entire comment—including your personal identifying information—may be made publicly available. It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure). If you wish for DOE to withhold your name and/or other personally identifiable information, please state this prominently at the beginning of your comment. You may also submit comments anonymously.</P>
                <HD SOURCE="HD1">Cooperating Agencies</HD>
                <P>Federal, State, local, and Tribal agencies with jurisdiction by law or special expertise, such as Indigenous Knowledge, are invited to participate in the preparation of the SEIS as cooperating agencies, as defined at 40 CFR 1501.8. Native American Tribes are invited to participate as consulting governments. For the 2018 SSFL Area IV EIS, there were three cooperating agencies: NASA, the U.S. Army Corps of Engineers, and the Santa Ynez Band of Chumash Indians (a federally recognized Native American Tribe with historical ties to the SSFL land). The EPA and DTSC were also invited to be cooperating agencies but declined. DOE is inviting these same agencies to participate in this SEIS as well.</P>
                <HD SOURCE="HD1">SEIS Process and Schedule</HD>
                <P>
                    DOE will consider all comments received during the public scoping period in preparing the draft SEIS. DOE anticipates issuing a draft SEIS in the winter of 2025-2026. The EPA will publish a notice of availability of the draft SEIS in the 
                    <E T="04">Federal Register</E>
                    , which will begin a minimum 45-day public comment period. DOE will hold at least one public hearing, no sooner than 30 days after the EPA notice of availability is published. DOE will consider comments submitted during the comment period on the draft SEIS when preparing the final SEIS. DOE anticipates issuing a final SEIS in the summer of 2026. EPA will issue a notice of availability of the final SEIS in the 
                    <E T="04">Federal Register</E>
                    . DOE anticipates issuing a record of decision in the fall of 2026 but will do so no sooner than 30 days from the EPA notice of availability of the final SEIS in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <HD SOURCE="HD1">Signing Authority</HD>
                <P>This document of the Department of Energy was signed on December 17, 2024, by Candice Trummell, Senior Advisor for Environmental Management, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy.</P>
                <P>
                    This administrative process in no way alters the legal effect of this document upon publication in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <DATED>Signed in Washington, DC, on December 19, 2024.</DATED>
                    <NAME>Jennifer Hartzell,</NAME>
                    <TITLE>Alternate Federal Register Liaison Officer, U.S. Department of Energy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30795 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6450-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Project No. 6689-000]</DEPDOC>
                <SUBJECT>Briar Hydro Associates; Notice of Authorization for Continued Project Operation</SUBJECT>
                <P>The license for the Penacook Upper Falls Hydroelectric Project No. 6689 was issued for a period ending November 30, 2024.</P>
                <P>Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee(s) under the terms and conditions of the prior license until a new license is issued, or the project is otherwise disposed of as provided in section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of section 15 of the FPA, then, based on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR 16.21(b), to continue project operations until the Commission issues someone else a license for the project or otherwise orders disposition of the project.</P>
                <P>If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 6689 is issued to Briar Hydro Associates for a period effective December 1, 2024, through November 30, 2025, or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first.</P>
                <P>If issuance of a new license (or other disposition) does not take place on or before November 30, 2025, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is renewed automatically without further order or notice by the Commission, unless the Commission orders otherwise.</P>
                <P>If the project is not subject to section 15 of the FPA, notice is hereby given that Briar Hydro Associates is authorized to continue operation of the Penacook Upper Falls Hydroelectric Project under the terms and conditions of the prior license until the issuance of a subsequent license for the project or other disposition under the FPA, whichever comes first.</P>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-31045 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Project No. 3342-000]</DEPDOC>
                <SUBJECT>Briar Hydro Associates; Notice of Authorization for Continued Project Operation</SUBJECT>
                <P>The license for the Penacook Lower Falls Hydroelectric Project No. 3342 was issued for a period ending November 30, 2024.</P>
                <P>
                    Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee(s) under the terms and conditions of the prior license until a 
                    <PRTPAGE P="105560"/>
                    new license is issued, or the project is otherwise disposed of as provided in section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of section 15 of the FPA, then, based on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR 16.21(b), to continue project operations until the Commission issues someone else a license for the project or otherwise orders disposition of the project.
                </P>
                <P>If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 3342 is issued to Briar Hydro Associates for a period effective December 1, 2024, through November 30, 2025, or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first.</P>
                <P>If issuance of a new license (or other disposition) does not take place on or before November 30, 2025, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is renewed automatically without further order or notice by the Commission, unless the Commission orders otherwise.</P>
                <P>If the project is not subject to section 15 of the FPA, notice is hereby given that Briar Hydro Associates is authorized to continue operation of the Penacook Lower Falls Hydroelectric Project under the terms and conditions of the prior license until the issuance of a subsequent license for the project or other disposition under the FPA, whichever comes first.</P>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-31047 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Project No. 15267-001]</DEPDOC>
                <SUBJECT>Allegheny Hydro Group Lock and Dam 4, Inc.; Notice of Intent To File License Application, Filing of Pre-Application Document, and Approving Use of the Traditional Licensing Process</SUBJECT>
                <P>
                    a. 
                    <E T="03">Type of Filing:</E>
                     Notice of Intent to File License Application and Request to Use the Traditional Licensing Process (TLP).
                </P>
                <P>
                    b. 
                    <E T="03">Project No.:</E>
                     15267-001.
                </P>
                <P>
                    c. 
                    <E T="03">Date Filed:</E>
                     October 30, 2024.
                </P>
                <P>
                    d. 
                    <E T="03">Submitted By:</E>
                     Allegheny Hydro Group Lock and Dam 4, Inc.
                    <SU>1</SU>
                    <FTREF/>
                     (Allegheny Hydro).
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Allegheny Hydro Group Lock and Dam 4, Inc. is a wholly owned subsidiary of Current Hydro LLC, which acts as agent for the applicant.
                    </P>
                </FTNT>
                <P>
                    e. 
                    <E T="03">Name of Project:</E>
                     Allegheny Lock and Dam 4 Hydropower Project.
                </P>
                <P>
                    f. 
                    <E T="03">Location:</E>
                     The project would be located on the Allegheny River, at the existing U.S. Army Corps of Engineers (Corps) Allegheny Lock and Dam 4, in Harrison Township, Allegheny County, and in the City of Lower Burrell, Westmoreland County, Pennsylvania. The project would partially occupy federal land administered by the Corps.
                </P>
                <P>
                    g. 
                    <E T="03">Filed Pursuant to:</E>
                     18 CFR 5.3 of the Commission's regulations.
                </P>
                <P>
                    h. 
                    <E T="03">Potential Applicant Contact:</E>
                     Jeremy King, CEO; Current Hydro LLC; 3120 Southwest Freeway; Suite 101, PMB 50808; Houston, TX 77098, . Email: 
                    <E T="03">jeremy@currenthydro.com;</E>
                     Phone: (706) 835-8516.
                </P>
                <P>
                    i. 
                    <E T="03">FERC Contact:</E>
                     Silvia Pineda-Munoz at (202) 502-8388; or email at 
                    <E T="03">silvia.pineda-munoz@ferc.gov.</E>
                </P>
                <P>j. Allegheny Hydro filed its request to use the Traditional Licensing Process on October 30, 2024, and provided public notice of its request on November 3, 2024, and November 4, 2024. In a letter dated December 18, 2024, the Director of the Division of Hydropower Licensing approved Allegheny Hydro's request to use the Traditional Licensing Process.</P>
                <P>k. With this notice, we are initiating informal consultation with the U.S. Fish and Wildlife Service under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 CFR part 402; and NOAA Fisheries under section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act and implementing regulations at 50 CFR 600.920. We are also initiating consultation with the Pennsylvania State Historic Preservation Officer, as required by section 106, National Historic Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.</P>
                <P>l. With this notice, we are designating Allegheny Hydro as the Commission's non-federal representative for carrying out informal consultation pursuant to section 7 of the Endangered Species Act and section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act; and consultation pursuant to section 106 of the National Historic Preservation Act.</P>
                <P>m. Allegheny Hydro filed a Pre-Application Document (PAD; including a proposed process plan and schedule) with the Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.</P>
                <P>
                    n. A copy of the PAD may be viewed on the Commission's website (
                    <E T="03">http://www.ferc.gov</E>
                    ), using the “eLibrary” link. Enter the docket number, excluding the last three digits in the docket number field, to access the document. For assistance, contact FERC Online Support at 
                    <E T="03">FERCOnlineSupport@ferc.gov,</E>
                     (866) 208-3676 (toll free), or (202) 502-8659 (TTY). You may register online at 
                    <E T="03">https://ferconline.ferc.gov/FERCOnline.aspx</E>
                     to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.
                </P>
                <P>o. The applicant states its unequivocal intent to submit an application for an original license for Project No. 15267.</P>
                <P>
                    p. The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: December 18, 2024.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30867 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="105561"/>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Docket Nos. RM19-15-002; AD16-16-002]</DEPDOC>
                <SUBJECT>Qualifying Facility Rates and Requirements; Implementation Issues Under the Public Utility Regulatory Policies Act of 1978; Notice of Revised Procedural Schedule for the Environmental Assessment for Qualifying Facility Rates and Requirements Implementation Issues Under the Public Utility Regulatory Policies Act of 1978</SUBJECT>
                <P>
                    On July 16, 2020, the Federal Energy Regulatory Commission (Commission) issued Order No. 872,
                    <SU>1</SU>
                    <FTREF/>
                     approving certain revisions to its regulations implementing sections 201 and 210 of the Public Utility Regulatory Policies Act of 1978 (PURPA).
                    <SU>2</SU>
                    <FTREF/>
                     On September 5, 2023, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) remanded Order No. 872, without vacatur, based on its finding that, pursuant to the National Environmental Policy Act (NEPA),
                    <SU>3</SU>
                    <FTREF/>
                     the Commission must prepare an environmental assessment (EA) analyzing the potential impacts of the rule on climate change and air quality.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">Qualifying Facility Rates &amp; Requirements; Implementation Issues Under the Pub. Util. Regul. Policies Act of 1978,</E>
                         Order No. 872, 172 FERC ¶ 61,041, 
                        <E T="03">order on reh'g,</E>
                         Order No. 872-A, 173 FERC ¶ 61,158 (2020), 
                        <E T="03">aff'd in part and remanded in part sub nom. Solar Energy Indus. Ass'n</E>
                         v. 
                        <E T="03">FERC,</E>
                         80 F.4th 956 (9th Cir. 2023) (
                        <E T="03">Solar Energy</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         16 U.S.C. 796(17)-(18), 824a-3.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         42 U.S.C. 4321 
                        <E T="03">et seq.; see also</E>
                         18 CFR pt. 380 (2024) (Commission's regulations implementing NEPA).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">Solar Energy,</E>
                         80 F.4th at 996-97.
                    </P>
                </FTNT>
                <P>On September 24, 2024, Commission staff issued a notice of intent to prepare an EA, which included an anticipated schedule for issuing the EA and a comment period.</P>
                <P>
                    By this notice, Commission staff is updating the procedural schedule 
                    <SU>5</SU>
                    <FTREF/>
                     and setting forth a revised schedule for completion of the EA. The revised schedule is shown below.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         The unique identification number for documents relating to this environmental review is EAXX-19-20-000-1726219809.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Schedule for Environmental Review</HD>
                <FP SOURCE="FP-2">Issuance of EA—June 30, 2025</FP>
                <FP SOURCE="FP-2">End of Public Comment Period—July 30, 2025</FP>
                <P>If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the progress.</P>
                <P>
                    The Commission strongly encourages electronic filing. Please file using the Commission's eFiling system at 
                    <E T="03">http://www.ferc.gov/docs-filing/efiling.asp.</E>
                     Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at 
                    <E T="03">http://www.ferc.gov/docs-filing/ecomment.asp.</E>
                     You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at 
                    <E T="03">FERCOnlineSupport@ferc.gov,</E>
                     (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, you may submit a paper copy. Submissions sent via the U.S. Postal Service must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. The first page of any filing should include the docket number RM19-15-002. Comments emailed to Commission staff are not considered part of the Commission record.
                </P>
                <P>
                    In order to receive notification of the issuance of the EA and to keep track of formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This service provides automatic notification of filings made to subscribed dockets, document summaries, and direct links to the documents. Go to 
                    <E T="03">https://www.ferc.gov/ferc-online/overview</E>
                     to register for eSubscription.
                </P>
                <P>
                    The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members, and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <P>
                    Additional information about the final rule is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC website (
                    <E T="03">www.ferc.gov</E>
                    ). Using the “eLibrary” link, select “General Search” from the eLibrary menu, enter the selected date range and “Docket Number” excluding the last three digits (
                    <E T="03">i.e.,</E>
                     RM19-15), and follow the instructions. For assistance with access to eLibrary, the helpline can be reached at (866) 208-3676, TTY (202) 502-8659, or at 
                    <E T="03">FERCOnlineSupport@ferc.gov.</E>
                     The eLibrary link on the FERC website also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rule makings.
                </P>
                <SIG>
                    <DATED>Dated: December 18, 2024.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30865 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Project No. 4108-000]</DEPDOC>
                <SUBJECT>City of St. Cloud, Minnesota; Notice of Authorization for Continued Project Operation</SUBJECT>
                <P>The license for the St. Cloud Hydroelectric Project No. 4108 was issued for a period ending November 30, 2024.</P>
                <P>Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee(s) under the terms and conditions of the prior license until a new license is issued, or the project is otherwise disposed of as provided in section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of section 15 of the FPA, then, based on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR 16.21(b), to continue project operations until the Commission issues someone else a license for the project or otherwise orders disposition of the project.</P>
                <P>If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 4108 is issued to the City of St. Cloud for a period effective December 1, 2024, through November 30, 2025, or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first.</P>
                <P>
                    If issuance of a new license (or other disposition) does not take place on or before November 30, 2025, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is renewed 
                    <PRTPAGE P="105562"/>
                    automatically without further order or notice by the Commission, unless the Commission orders otherwise.
                </P>
                <P>If the project is not subject to section 15 of the FPA, notice is hereby given that the City of St. Cloud is authorized to continue operation of the St. Cloud Hydroelectric Project under the terms and conditions of the prior license until the issuance of a subsequent license for the project or other disposition under the FPA, whichever comes first.</P>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-31046 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Docket No. CP24-494-000]</DEPDOC>
                <SUBJECT>Black Bayou Gas Storage, LLC; Notice of Revised Schedule for Environmental Review of the Black Bayou Gas Storage Project</SUBJECT>
                <P>
                    This notice identifies the Federal Energy Regulatory Commission staff's revised schedule for the completion of the environmental assessment (EA) for Black Bayou Gas Storage, LLC's Black Bayou Gas Storage Project.
                    <SU>1</SU>
                    <FTREF/>
                     The first notice of schedule, issued on October 2, 2024, identified February 14, 2025, as the EA issuance date. However, additional time is required for Black Bayou Gas Storage, LLC to file complete responses to staff's environmental information requests, and for staff to review those responses. As a result, staff has revised the schedule for issuance of the EA based on an expected receipt of all outstanding information by December 31, 2024.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         In accordance with the Council on Environmental Quality's regulations, the unique identification number for documents relating to this environmental review is EAXX-019-20-000-1726746869. 40 CFR 1502.4(e)(10)(2024).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Schedule for Environmental Review</HD>
                <FP SOURCE="FP-1">Issuance of the EA—April 18, 2025</FP>
                <FP SOURCE="FP-1">
                    90-day Federal Authorization Decision Deadline 
                    <SU>2</SU>
                    <FTREF/>
                    —July 17, 2025
                </FP>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         The Commission's deadline applies to the decisions of other federal agencies, and state agencies acting under federally delegated authority, that are responsible for federal authorizations, permits, and other approvals necessary for proposed projects under the Natural Gas Act. Per 18 CFR 157.22(a), the Commission's deadline for other agency's decisions applies unless a schedule is otherwise established by federal law.
                    </P>
                </FTNT>
                <P>If a schedule change becomes necessary, an additional notice will be provided so that the relevant agencies are kept informed of the project's progress.</P>
                <HD SOURCE="HD1">Additional Information</HD>
                <P>
                    In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to 
                    <E T="03">https://www.ferc.gov/ferc-online/overview</E>
                     to register for eSubscription.
                </P>
                <P>
                    The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <P>
                    Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC website (
                    <E T="03">www.ferc.gov</E>
                    ). Using the “eLibrary” link, select “General Search” from the eLibrary menu, enter the selected date range and “Docket Number” excluding the last three digits (
                    <E T="03">i.e.,</E>
                     CP24-494), and follow the instructions. For assistance with access to eLibrary, the helpline can be reached at (866) 208-3676, TTY (202) 502-8659, or at 
                    <E T="03">FERCOnlineSupport@ferc.gov.</E>
                     The eLibrary link on the FERC website also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rule makings.
                </P>
                <SIG>
                    <DATED>Dated: December 18, 2024.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30869 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <SUBJECT>Combined Notice of Filings #1</SUBJECT>
                <P>Take notice that the commission received the following accounting Request filings:</P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     AC25-39-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     San Diego Gas &amp; Electric Company.
                </P>
                <P>
                    <E T="03">Description:</E>
                     San Diego Gas &amp; Electric Company submits journal entries to clear Account 102 re the sale of certain electric distribution facilities to the Viejas Band of Kumeyaay Indians, effective July 5, 2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/19/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241219-5315.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/9/25.
                </P>
                <P>Take notice that the Commission received the following exempt wholesale generator filings:</P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     EG25-66-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Chillingham Storage LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Chillingham Storage LLC submits Notice of Self-Certification of Exempt Wholesale Generator Status.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/19/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241219-5143.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/9/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     EG25-67-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Padua Grid, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Padua Grid, LLC submits Notice of Self-Certification of Exempt Wholesale Generator Status.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/19/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241219-5266.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/9/25.
                </P>
                <P>Take notice that the Commission received the following electric rate filings:</P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER21-2460-009.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     New York Independent System Operator, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Compliance filing: NYISO Compliance Filing re: Apr 2023 Order on NYISO Order No. 2222 Compliance to be effective 12/31/9998.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/19/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241219-5247.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/9/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER24-627-004.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Mammoth North LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Compliance filing: Compliance to 2 with zero and new rate to be effective 6/30/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/19/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241219-5207.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/9/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-722-001.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Southwest Power Pool, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Tariff Amendment: 4346 WAPA/Black Hills Electric/Rushmore Electric Inter Agr—Amended Filing to be effective 12/16/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/19/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241219-5311.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/9/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-759-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Southwest Power Pool, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: 3125R17 Basin Electric Power Cooperative NITSA and NOA to be effective 12/1/2024.
                    <PRTPAGE P="105563"/>
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/19/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241219-5003.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/9/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-760-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     American Transmission Systems, Incorporated.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: ATSI submits Revised Interconnection Agreement (IA) SA No. 3994 to be effective 2/18/2025.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/19/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241219-5018.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/9/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-761-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Midcontinent Independent System Operator, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: 2024-12-19_SA 4415 Wolverine Power-Wolverine Power GIA (Burnips) to be effective 12/11/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/19/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241219-5053.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/9/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-762-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     PJM Interconnection, L.L.C.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: Amendment to ISA No. 6312; Queue No. AE2-297 to be effective 2/18/2025.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/19/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241219-5082.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/9/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-763-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Southwest Power Pool, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: 3552R6 TEA and MEAN Meter Agent Agreement to be effective 12/1/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/19/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241219-5092.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/9/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-764-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Southwest Power Pool, Inc.
                </P>
                <P>
                    <E T="03">Description:</E>
                     205(d) Rate Filing: 607R47 Evergy Kansas Central, Inc. NITSA NOA to be effective 12/1/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/19/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241219-5177.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/9/25.
                </P>
                <P>
                    <E T="03">Docket Numbers:</E>
                     ER25-765-000.
                </P>
                <P>
                    <E T="03">Applicants:</E>
                     Beowawe Power, LLC.
                </P>
                <P>
                    <E T="03">Description:</E>
                     Initial Rate Filing: Petition for Approval of Initial Market-Based Rate Tariff to be effective 12/20/2024.
                </P>
                <P>
                    <E T="03">Filed Date:</E>
                     12/19/24.
                </P>
                <P>
                    <E T="03">Accession Number:</E>
                     20241219-5218.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5 p.m. ET 1/9/25.
                </P>
                <P>
                    The filings are accessible in the Commission's eLibrary system (
                    <E T="03">https://elibrary.ferc.gov/idmws/search/fercgensearch.asp</E>
                    ) by querying the docket number.
                </P>
                <P>Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.</P>
                <P>
                    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: 
                    <E T="03">https://www.ferc.gov/docs-filing/efiling/filing-req.pdf.</E>
                     For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.
                </P>
                <P>
                    The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Carlos D. Clay,</NAME>
                    <TITLE>Acting Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-31069 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Project No. 15262-001]</DEPDOC>
                <SUBJECT>CW Bill Young Hydropower Group, Inc.; Notice of Intent To File License Application, Filing of Pre-Application Document, and Approving Use of the Traditional Licensing Process</SUBJECT>
                <P>
                    a. 
                    <E T="03">Type of Filing:</E>
                     Notice of Intent to File License Application and Request to Use the Traditional Licensing Process (TLP).
                </P>
                <P>
                    b. 
                    <E T="03">Project No.:</E>
                     15262-001.
                </P>
                <P>
                    c. 
                    <E T="03">Date Filed:</E>
                     October 31, 2024.
                </P>
                <P>
                    d. 
                    <E T="03">Submitted By:</E>
                     CW Bill Young Hydropower Group, Inc.
                    <SU>1</SU>
                    <FTREF/>
                     (CW Bill Young Hydropower).
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         CW Bill Young Hydropower Group, Inc. is a wholly owned subsidiary of Current Hydro LLC, which acts as agent for the applicant.
                    </P>
                </FTNT>
                <P>
                    e. 
                    <E T="03">Name of Project:</E>
                     CW Bill Young Lock and Dam Hydropower Project.
                </P>
                <P>
                    f. 
                    <E T="03">Location:</E>
                     The project would be located on the Allegheny River, at the existing U.S. Army Corps of Engineers (Corps) C.W. Bill Young Lock and Dam, in Harmar Township, Allegheny County, Pennsylvania. The project would partially occupy federal land administered by the Corps.
                </P>
                <P>
                    g. 
                    <E T="03">Filed Pursuant to:</E>
                     18 CFR 5.3 of the Commission's regulations.
                </P>
                <P>
                    h. 
                    <E T="03">Potential Applicant Contact:</E>
                     Jeremy King, CEO; Current Hydro LLC; 3120 Southwest Freeway; Suite 101, PMB 50808; Houston, TX 77098, Email: 
                    <E T="03">jeremy@currenthydro.com;</E>
                     Phone: (706) 835-8516.
                </P>
                <P>
                    i. 
                    <E T="03">FERC Contact:</E>
                     Silvia Pineda-Munoz at (202) 502-8388; or email at 
                    <E T="03">silvia.pineda-munoz@ferc.gov.</E>
                </P>
                <P>j. CW Bill Young Hydropower filed its request to use the Traditional Licensing Process on October 31, 2024, and provided public notice of its request on November 3, 2024. In a letter dated December 18, 2024, the Director of the Division of Hydropower Licensing approved CW Bill Young Hydropower's request to use the Traditional Licensing Process.</P>
                <P>k. With this notice, we are initiating informal consultation with the U.S. Fish and Wildlife Service under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 CFR, Part 402; and NOAA Fisheries under section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act and implementing regulations at 50 CFR 600.920. We are also initiating consultation with the Pennsylvania State Historic Preservation Officer, as required by section 106, National Historic Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.</P>
                <P>l. With this notice, we are designating CW Bill Young Hydropower as the Commission's non-federal representative for carrying out informal consultation pursuant to section 7 of the Endangered Species Act and section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act; and consultation pursuant to section 106 of the National Historic Preservation Act.</P>
                <P>m. CW Bill Young Hydropower filed a Pre-Application Document (PAD; including a proposed process plan and schedule) with the Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.</P>
                <P>
                    n. A copy of the PAD may be viewed on the Commission's website (
                    <E T="03">https://www.ferc.gov</E>
                    ), using the “eLibrary” link. Enter the docket number, excluding the last three digits in the docket number field, to access the document. For assistance, contact FERC Online Support at 
                    <E T="03">FERCOnlineSupport@ferc.gov,</E>
                     (866) 208-3676 (toll free), or (202) 502-8659 (TTY).
                    <PRTPAGE P="105564"/>
                </P>
                <P>
                    You may register online at 
                    <E T="03">https://ferconline.ferc.gov/FERCOnline.aspx</E>
                     to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.
                </P>
                <P>o. The applicant states its unequivocal intent to submit an application for an original license for Project No. 15262.</P>
                <P>
                    p. The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: December 18, 2024.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30868 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Project No. 2514-209]</DEPDOC>
                <SUBJECT>Appalachian Power Company; Notice of Availability of Environmental Assessment</SUBJECT>
                <P>In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380, the Office of Energy Projects has reviewed the application for a new license to continue to operate and maintain the Byllesby-Buck Hydroelectric Project (Byllesby-Buck Project). The Byllesby-Buck Project is located on the New River, in Carroll County, Virginia.</P>
                <P>The environmental assessment (EA) contains staff's analysis of the potential environmental impacts of the project and concludes that licensing the project, with appropriate environmental protective measures, would not constitute a major Federal action that would significantly affect the quality of the human environment.</P>
                <P>
                    The Commission provides all interested persons with an opportunity to view and/or print the EA via the internet through the Commission's Home Page (
                    <E T="03">https://www.ferc.gov/</E>
                    ), using the “eLibrary” link. Enter the docket number, excluding the last three digits in the docket number field, to access the document. For assistance, contact FERC Online Support at 
                    <E T="03">FERCOnlineSupport@ferc.gov,</E>
                     or toll-free at (866) 208-3676, or for TTY, (202) 502-8659.
                </P>
                <P>
                    You may also register online at 
                    <E T="03">https://ferconline.ferc.gov/FERCOnline.aspx</E>
                     to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.
                </P>
                <P>Any comments should be filed within 45 days from the date of this notice.</P>
                <P>
                    The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at 
                    <E T="03">https://ferconline.ferc.gov/FERCOnline.aspx.</E>
                     Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at 
                    <E T="03">https://ferconline.ferc.gov/QuickComment.aspx.</E>
                     For assistance, please contact FERC Online Support. In lieu of electronic filing, you may submit a paper copy. Submissions sent via the U.S. Postal Service must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Debbie-Anne A. Reese, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. The first page of any filing should include docket number P-2514-209.
                </P>
                <P>
                    The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or 
                    <E T="03">OPP@ferc.gov.</E>
                </P>
                <P>
                    For further information, contact Jody Callihan at (202) 502-8278 or by email at 
                    <E T="03">jody.callihan@ferc.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Debbie-Anne A. Reese,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-31048 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Western Area Power Administration</SUBAGY>
                <SUBJECT>Loveland Area Projects—Rate Order No. WAPA-219</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Western Area Power Administration, DOE.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed transmission and ancillary services formula rates.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Rocky Mountain (RM) region of the Western Area Power Administration (WAPA) proposes new formula rates for the Loveland Area Projects (LAP) transmission and ancillary services for RM's costs to be recovered under the Southwest Power Pool's (SPP) Open Access Transmission Tariff (Tariff) should RM decide to become a member of SPP. The proposed formula rates will become effective on the latter of RM's membership date or the go-live date of the expansion of the SPP Regional Transmission Organization (RTO) into the Western Interconnection (scheduled for April 1, 2026, as of the date of this notice) and will remain in effect for five years from the effective date, which with an effective date of April 1, 2026, will be March 31, 2031, or until superseded.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        A consultation and comment period will begin December 27, 2024 and end March 27, 2025. RM will present a detailed explanation of the proposed formula rates and other modifications at a public information forum that will be held on February 19, 2025, at 11 a.m. MST to no later than 12 noon MST. RM will also host a public comment forum on February 19, 2025, at 12:15 p.m. MST to no later than 1 p.m. MST. The public information forum and the public comment forum will be conducted virtually. Instructions for participating in the forums will be posted on RM's Rates website at least 14 days prior to the public information and comment forums at:
                        <E T="03">www.wapa.gov/about-wapa/regions/rm/rm-rates/2026-rate-adjustment-rto-trans-and-anc-svcs.</E>
                    </P>
                    <P>RM will accept comments any time during the consultation and comment period.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and requests to be informed of Federal Energy Regulatory Commission (FERC) actions concerning the proposed formula rates submitted by WAPA to FERC for approval should be sent to: Barton V. Barnhart, Regional Manager, Rocky Mountain Region, Western Area Power Administration, 5555 East Crossroads Boulevard, Loveland, CO 80538-8986, or email 
                        <E T="03">LAPTransAdj@wapa.gov.</E>
                         RM will post information about the proposed formula rates and 
                        <PRTPAGE P="105565"/>
                        written comments received to its Rates website at: 
                        <E T="03">www.wapa.gov/about-wapa/regions/rm/rm-rates/2026-rate-adjustment-rto-trans-and-anc-svcs</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Sheila D. Cook, Rates Manager, Rocky Mountain Region, Western Area Power Administration, (970) 685-9562 or email: 
                        <E T="03">scook@wapa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On April 28, 2023, WAPA published a 
                    <E T="04">Federal Register</E>
                     notice titled “Recommendation for the Western Area Power Administration's Rocky Mountain Region and Colorado River Storage Project Management Center to Pursue Final Negotiations Regarding Membership in the Southwest Power Pool Regional Transmission Organization, and for the Upper Great Plains Region to Expand its Participation” (88 FR 26298). On June 4, 2024, SPP submitted revisions to its Tariff, Bylaws, and Membership Agreement to expand the SPP RTO into the Western Interconnection to FERC.
                    <SU>1</SU>
                    <FTREF/>
                     If SPP succeeds in obtaining FERC's approval of its Tariff, Bylaws, and Membership Agreement revisions, and upon further approval by the Administrator, RM plans to become a member of SPP.
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Southwest Power Pool, Inc., Submission of Revisions to Tariff, Bylaws, and Membership Agreement to Expand the Regional Transmission Organization into the Western Interconnections (Part 1 of 2) and (Part 2 of 2), Docket Nos. ER24-2184, ER24-2185 (June 4, 2024).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         WAPA's Colorado River Storage Project Management Center also plans to become a member of the SPP RTO, and WAPA's Upper Great Plains region plans to expand membership participation in the SPP RTO. These regions are proposing new formula rate designs/rate schedules under separate Rate Order Nos. WAPA-220 and WAPA-218, respectively.
                    </P>
                </FTNT>
                <P>RM's membership will include RM becoming a Transmission Owner member of SPP and SPP assuming the balancing authority (BA) responsibilities for RM's Western Area Colorado Missouri (WACM) BA area. WAPA will transfer functional control of eligible LAP transmission facilities to SPP. At such time, LAP transmission and ancillary services and WACM BA ancillary services will no longer be available under WAPA's Tariff, and RM's BA contracts and the existing transmission and ancillary services rate schedules, specifically L-NT1, L-FPT1, L-NFPT1, L-UU1, L-AS1, L-AS2, L-AS3, L-AS4, L-AS5, L-AS6, L-AS7, and L-AS9, will no longer be applicable.</P>
                <P>LAP transmission service will be provided under the SPP Tariff by SPP as the transmission service provider. Accordingly, RM will need to have new rate designs/rate schedules and rate implementation protocols in place for specific costs to be recovered under the SPP Tariff.</P>
                <P>As of the date of this notice, SPP's anticipated deadline for filing certain SPP Tariff documents for RM (including annual revenue requirements (ARR), formula rate templates, and formula rate implementation protocols proposed in this rate filing, as well as other pertinent documents not included in this rate filing) with FERC is October 2025. RM is publishing this notice of proposed formula rates and initiating the rate consultation and comment period at this time in order for RM to obtain FERC-approved formula rates prior to this SPP deadline.</P>
                <P>
                    If RM does not become a member of SPP, further actions under this notice of proposed rates will be canceled, and existing formula rates will remain in effect. If canceled, RM will inform customers by letter and by posting notice of such on RM's Rates website (
                    <E T="03">www.wapa.gov/about-wapa/regions/rm/rm-rates/2026-rate-adjustment-rto-trans-and-anc-svcs</E>
                    ) and will withdraw the formula rates proposed in this notice.
                </P>
                <P>
                    RM is proposing a new formula rate to calculate the ARRs for its LAP transmission facilities located in both the Eastern and Western Interconnections and for its Virginia Smith Converter Station (Sidney DC Tie) that will be transferred to the functional control of SPP under the SPP Tariff. RM is also proposing a new formula rate to calculate the Sidney DC Tie Incremental Market Efficiency Use 
                    <SU>3</SU>
                    <FTREF/>
                     (Incremental MEU) share. RM is proposing a new formula rate to calculate the ARR for Scheduling, System Control, and Dispatch Service (SSCD Service) under the SPP Tariff. RM's revenue requirements will be added to the annual revenue requirements of other transmission owners in the SPP pricing Zone 104, also identified as the Loveland Area Projects Zone (LAPZ), for transmission service billed by SPP within the LAPZ. RM's revenue requirements under these proposed rates will also impact other costs for transmission service within the broader SPP footprint. For transmission and ancillary services provided under the SPP Tariff, RM also proposes to provide information related to RM's rate implementation and annual updates in “Formula Rate Implementation Protocols” (Protocols). Each of these topics is described in more detail below.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         “Incremental Market Efficiency Use (Incremental MEU) Charge: A market recovery mechanism to compensate West DC Tie Transmission Owners for the expected loss of life of certain West DC Tie facilities due to increased utilization of the West DC Ties by the Integrated Marketplace.” (SPP Proposed Tariff at Part I, Section 1, I Definitions.)
                    </P>
                </FTNT>
                <P>
                    The proposed formula rates will provide sufficient revenue to recover annual operation, maintenance, replacement, and interest expense while ensuring repayment of the project within the cost recovery criteria set forth in Department of Energy (DOE) Order RA6120.2. For more specific information on the proposed formula rates, please see the customer rate brochure located on RM's Rates website at: 
                    <E T="03">www.wapa.gov/about-wapa/regions/rm/rm-rates/2026-rate-adjustment-rto-trans-and-anc-svcs.</E>
                </P>
                <HD SOURCE="HD1">Proposed Transmission Formula Rate</HD>
                <P>
                    For transmission service provided by SPP under SPP's Tariff, under Rate Schedule LAPT-ATRR, RM proposes to provide its overall LAP annual transmission revenue requirement (ATRR) as separate subtotals to distinguish LAP transmission facilities separately between Western Interconnection, Eastern Interconnection, Sidney DC Tie (for use by SPP in assessing the DC Tie Access Charge 
                    <SU>4</SU>
                    <FTREF/>
                     to transmission service customers proposed in the SPP filing to FERC for the RTO expansion), and other SPP zones. SPP will utilize these LAP ATRR subtotals, along with zonal and regional load and other applicable information, to calculate the applicable charges and revenue distribution for SPP transmission service under the SPP Tariff.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         “DC Tie Access Charge: A charge on a transmission reservation utilizing a West DC Tie that sinks outside of the Zone where the West DC Tie is located. The Transmission Customer shall be responsible for DC Tie Access Charge determined in accordance with Schedule 14.” (SPP Proposed Tariff at Part I, Section 1, D Definitions.)
                    </P>
                </FTNT>
                <P>Consistent with RM's current transmission formula rates, RM proposes to continue recovering transmission-related expenses and investments on a forward-looking basis by using projections to estimate transmission costs for the upcoming year, with a true-up of incurred costs in a subsequent year. Transmission-related annual costs include operation and maintenance, administrative and general costs, interest, and depreciation. The annual costs will be reduced by applicable revenue credits received by RM under the SPP Tariff.</P>
                <P>
                    Revenue requirement data will be submitted to SPP in standard formula rate templates with costs classified as either “Zonal” or “Regional,” applying the definitions in the SPP Tariff. “Zonal” costs are those that meet certain criteria and are recovered within 
                    <PRTPAGE P="105566"/>
                    the local pricing zone, while “Regional” costs are those meeting certain criteria eligible to be recovered across SPP's applicable West or East BA area, dependent upon where the transmission upgrade is located. The Formula Rate Template for the LAP ATRR and related information will be posted on RM's LAPT Open Access Same-Time Information System (OASIS) website (
                    <E T="03">www.oasis.oati.com/LAPT/index.html</E>
                    ), on RM's Rates website (
                    <E T="03">www.wapa.gov/about-wapa/regions/rm/rm-rates/2026-rate-adjustment-rto-trans-and-anc-svcs</E>
                    ), and on SPP's Member Related Postings website(
                    <E T="03">opsportal.spp.org/OASIS/Directory/Member%20Related%20Postings</E>
                    ).
                </P>
                <HD SOURCE="HD1">Proposed Sidney DC Tie Incremental Market Efficiency Use Formula Rate</HD>
                <P>
                    In its FERC filing for the proposed expansion of the RTO into the Western Interconnection, SPP proposes to expand its Integrated Marketplace across the seam between the Eastern and Western Interconnections by including the West DC Ties 
                    <SU>5</SU>
                    <FTREF/>
                     into the Integrated Marketplace 5-minute market dispatch. To enable this market dispatch between the Eastern and Western Interconnections, SPP included a new Section 8.11 to Attachment AE of the SPP Tariff for the calculation of the Incremental MEU amounts. The Incremental MEU compensates each West DC Tie Transmission Owner for the expected loss of life of that owner's West DC Tie facility due to increased utilization of the West DC Ties by the Integrated Marketplace.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         “West DC Ties: A direct current interconnection between the Eastern Interconnection and Western Interconnection for which the DC Tie Access Charge and the Incremental Market Efficiency Use Charge may be applicable. In the Integrated Marketplace, the West DC Ties will be Non-Biddable Locations that will be used in the settlements in the TCR [Transmission Congestion Rights] Markets. The West DC Ties are Miles City, Stegall, or Sidney.” (SPP Proposed Tariff at Part I, Section W Definitions.)
                    </P>
                </FTNT>
                <P>For SPP to compensate RM as a West DC Tie Transmission Owner of the Sidney DC Tie for Incremental MEU under SPP's Tariff, RM proposes to provide its Sidney DC Tie Incremental MEU share under Rate Schedule LAPT-DCTIE-IMEU. SPP will utilize this Sidney DC Tie Incremental MEU share along with other applicable information to calculate the amount to be paid to RM for the expected loss of life of certain Sidney DC Tie facilities due to increased utilization of those West DC Tie facilities by SPP in the Integrated Marketplace.</P>
                <P>To simplify the calculation of the Incremental MEU and provide a consistent forward-looking known amount to be included in the market uplift, a loss-of-life will be estimated for each eligible group of West DC Tie equipment due to expected market operation impacts, and a levelized annual estimate will be provided to SPP. The loss-of-life calculations will be based upon pre-defined impact metrics directly related to the increased market use for each of the West DC Tie equipment groups eligible for cost recovery. Revenue received from SPP for RM's Sidney DC Tie Incremental MEU share will be credited against the Sidney DC Tie portion of the LAP ATRR described above.</P>
                <P>The Sidney DC Tie Incremental MEU share data will be submitted to SPP in a standard formula rate template in accordance with the SPP Tariff Attachment AE. The Formula Rate Template for the Sidney DC Tie Incremental MEU share will be posted on RM's LAPT OASIS website, on RM's Rates website, and on SPP's Member Related Postings website (see web addresses listed previously).</P>
                <HD SOURCE="HD1">Proposed Formula Rate for Scheduling, System Control, and Dispatch Service</HD>
                <P>SSCD Service is required to operate a Transmission Owner's SPP Tariff facilities and schedule movement of power through, out of, within, or into one or both of the SPP BA areas and certain parts of the transmission system not located within a SPP BA area. Under this proposal, RM's ARR for SSCD Service, under Rate Schedule LAPT-AS1, will be submitted to SPP in a standard formula rate template for inclusion in the SPP Tariff Schedule 1. The SSCD Service ARR will be used by SPP to determine the regional SPP Schedule 1 rate and revenue distribution for SPP through-and-out transactions and to determine the zonal SPP Schedule 1 rate and revenue distribution for the LAPZ under the SPP Tariff.</P>
                <P>For consistency with the LAP ATRR proposal, RM proposes a formula-based rate methodology to calculate its SSCD Service ARR on a forward-looking basis by using projections to estimate costs associated with SSCD Service for the upcoming year, with a true-up of incurred costs in a subsequent year. RM's SSCD Service ARR will be derived by calculating RM's applicable annual costs associated with the provision of SSCD Service, including operation and maintenance, administrative and general, interest, and depreciation. The annual costs will be reduced by any applicable revenue received by RM under the SPP Tariff. The Formula Rate Template for the SSCD Service and related information will be posted on RM's LAPT OASIS website, on RM's Rates website, and on SPP's Member Related Postings website (see web addresses listed previously).</P>
                <HD SOURCE="HD1">Formula Rate Implementation Protocols</HD>
                <P>For transmission service provided by SPP under SPP's Tariff, RM proposes to provide information relating to RM's rate implementation and annual update procedures and timelines in “Formula Rate Implementation Protocols” (Protocols). The Protocols, together with the above-mentioned formula rate templates, comprise the Formula Rates that will be submitted to SPP to be incorporated in the SPP Tariff. All relevant information pertaining to RM's annual updates, customer notifications and review periods, and meetings will be contained in the Protocols. The Protocols will be posted on RM's LAPT OASIS website, on RM's Rates website, and on SPP's Member Related Postings website (see web addresses listed previously).</P>
                <HD SOURCE="HD1">Legal Authority</HD>
                <P>DOE procedures for public participation in power and transmission rate adjustments are located at 10 CFR part 903. The proposed action is a major rate adjustment, as defined by 10 CFR 903.2(d). In accordance with 10 CFR 903.15(a) and 10 CFR 903.16(a), RM will hold public information and public comment forums for this rate adjustment. RM will review and consider all timely public comments at the conclusion of the consultation and comment period and adjust the proposal as appropriate. The rates will then be approved on an interim basis.</P>
                <P>
                    WAPA is establishing the formula rates for LAP in accordance with section 302 of the DOE Organization Act (42 U.S.C. 7152).
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         This Act transferred to, and vested in, the Secretary of Energy the power marketing functions of the Secretary of the Department of the Interior and the Bureau of Reclamation (Reclamation) under the Reclamation Act of 1902 (ch. 1093, 32 Stat. 388), as amended and supplemented by subsequent laws, particularly section 9(c) of the Reclamation Project Act of 1939 (43 U.S.C. 485h(c)) and section 5 of the Flood Control Act of 1944 (16 U.S.C. 825s); and other acts that specifically apply to the projects involved.
                    </P>
                </FTNT>
                <P>
                    By Delegation Order No. S1-DEL-RATES-2016, effective November 19, 2016, the Secretary of Energy delegated: (1) the authority to develop power and transmission rates to the WAPA Administrator; (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary of Energy; and (3) the authority to confirm, approve, and place into effect on a final basis, or to remand 
                    <PRTPAGE P="105567"/>
                    or disapprove such rates, to FERC. By Delegation Order No. S1-DEL-S3-2024, effective August 30, 2024, the Secretary of Energy also delegated the authority to confirm, approve, and place such rates into effect on an interim basis to the Under Secretary for Infrastructure. By Redelegation Order No. S3-DEL-WAPA1-2023, effective April 10, 2023, the Under Secretary for Infrastructure further redelegated the authority to confirm, approve, and place such rates into effect on an interim basis to WAPA's Administrator.
                </P>
                <HD SOURCE="HD1">Availability of Information</HD>
                <P>
                    All brochures, studies, comments, letters, memorandums, or other documents that RM initiates or uses to develop the proposed formula rates are available for inspection and copying at the Rocky Mountain Regional office located at 5555 East Crossroads Boulevard, Loveland, Colorado. Many of these documents and supporting information are also available on RM's Rates website at: 
                    <E T="03">www.wapa.gov/about-wapa/regions/rm/rm-rates/2026-rate-adjustment-rto-trans-and-anc-svcs.</E>
                </P>
                <HD SOURCE="HD1">Ratemaking Procedure Requirements</HD>
                <HD SOURCE="HD1">Environmental Compliance</HD>
                <P>
                    WAPA is in the process of determining whether an environmental assessment or an environmental impact statement should be prepared or if this action can be categorically excluded from those requirements.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         In compliance with the National Environmental Policy Act (NEPA) of 1969, as amended, 42 U.S.C. 4321-4347; the Council on Environmental Quality Regulations for implementing NEPA (40 CFR parts 1500-1508); and DOE NEPA Implementing Procedures and Guidelines (10 CFR part 1021).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Determination Under Executive Order 12866</HD>
                <P>WAPA has an exemption from centralized regulatory review under Executive Order 12866; accordingly, no clearance of this notice by the Office of Management and Budget is required.</P>
                <HD SOURCE="HD1">Signing Authority</HD>
                <P>
                    This document of the Department of Energy was signed on December 19, 2024, by Tracey A. LeBeau, Administrator, Western Area Power Administration, pursuant to delegated authority from the Secretary of Energy. That document, with the original signature and date, is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE 
                    <E T="04">Federal Register</E>
                     Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <DATED>Signed in Washington, DC, on December 19, 2024.</DATED>
                    <NAME>Jennifer Hartzell,</NAME>
                    <TITLE>Alternate Federal Register Liaison Officer, U.S. Department of Energy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30862 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6450-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OW-2023-0107; FRL 10680-01-OW]</DEPDOC>
                <SUBJECT>Comparison of Aquatic Life Protective Values Developed for Pesticides Under the FIFRA and the CWA</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The U.S. Environmental Protection Agency (EPA) is announcing the availability of draft analyses comparing aquatic life benchmarks developed by the EPA's Office of Pesticides Programs (OPP) in support of registration decisions for pesticides under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) to existing national recommended aquatic life Ambient Water Quality Criteria and criteria-related values developed under the Clean Water Act (CWA) for the protection of aquatic life from pesticides. The EPA's draft analyses show that the values developed under these statutes are similarly protective of aquatic life and that the most sensitive OPP aquatic life benchmarks, which are updated regularly to include the latest science, could also serve as CWA section 304(a)(1) recommended aquatic life criteria or 304(a)(2) informational benchmarks for pesticides. The EPA will accept public comments on the draft analyses and potential application of OPP aquatic life benchmarks for CWA 304(a) purposes for 30 days upon publication in the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before January 27, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may send comments, identified by Docket ID No. EPA-HQ-OW-2023-0107, by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov/</E>
                         (our preferred method). Follow the online instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Agency website: https://www.epa.gov/wqc/common-effects-methodology-pesticides.</E>
                         Follow the online instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         U.S. Environmental Protection Agency, EPA Docket Center, Office of Water Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery or Courier:</E>
                         EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket Center's hours of operations are 8:30 a.m.—4:30 p.m., Monday—Friday (except Federal Holidays).
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the Docket ID No. for this Notice of Availability. Comments received may be posted without change to 
                        <E T="03">https://www.regulations.gov/,</E>
                         including any personal information provided. For detailed instructions on sending comments and additional information on the public comment, see the “Public Participation” heading of the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section of this document.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Christine Bergeron, Health and Ecological Criteria Division, Office of Water (Mail Code 4304T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: (202) 566-0629; email: 
                        <E T="03">Bergeron.christine@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Public Participation</HD>
                <P>
                    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2023-0107, at 
                    <E T="03">https://www.regulations.gov</E>
                     (our preferred method)), or the other methods identified in the 
                    <E T="02">ADDRESSES</E>
                     section. Once submitted, comments cannot be edited or removed from the docket. The EPA may publish any comment received to its public docket. Do not submit to EPA's docket at 
                    <E T="03">https://www.regulations.gov</E>
                     any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (
                    <E T="03">i.e.,</E>
                     on the web, cloud, or other file sharing system). Please visit 
                    <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets</E>
                     for additional submission methods; the full EPA public comment policy; information 
                    <PRTPAGE P="105568"/>
                    about CBI or multimedia submissions; and general guidance on making effective comments.
                </P>
                <HD SOURCE="HD1">II. Purpose and Background</HD>
                <HD SOURCE="HD2">A. What is the purpose of this action?</HD>
                <P>
                    The purpose of this action is to request comment on: (1) the EPA's draft analyses comparing aquatic life benchmarks developed by the EPA's Office of Pesticides Programs (OPP) in support of registration decisions for pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to existing national recommended aquatic life Ambient Water Quality Criteria (AWQC) and criteria-related values (
                    <E T="03">e.g.,</E>
                     values developed using assessment or safety factors) developed under the Clean Water Act (CWA) for the protection of aquatic life from pesticides, and (2) the potential application of OPP aquatic life benchmarks for CWA 304(a) purposes, either as 304(a)(1) recommended criteria or 304(a)(2) informational benchmarks, and 3) whether the eight current pesticide criteria values that also have OPP benchmarks should be updated with the most sensitive OPP benchmark value and retained as CWA section 304(a)(1) aquatic life AWQC. The EPA prepared these draft analyses to support the agency's effort to harmonize aquatic life effects assessment methods for pesticides across statutes and to provide a common basis for achieving water quality protection under the FIFRA and the CWA by leveraging work across the agency. This collaborative effort promotes consistency and efficiency in the EPA's effects assessments for pesticides to protect aquatic life.
                </P>
                <HD SOURCE="HD2">B. Background</HD>
                <HD SOURCE="HD3">1. CWA section 304(a)(1) National Recommended Ambient Water Quality Criteria for Aquatic Life</HD>
                <P>
                    National recommended AWQC for the protection of aquatic life are numeric concentrations of pollutants in surface waters that are expected to protect against unacceptable adverse ecological effects to aquatic life resulting from exposure to pollutants found in water with specific recommendations on the duration and frequency of those concentrations (
                    <E T="03">https://www.epa.gov/wqc/national-recommended-water-quality-criteria-aquatic-life-criteria-table).</E>
                     CWA section 304(a)(1) directs the EPA to develop and publish AWQC recommendations that reflect the latest scientific knowledge. Generally, the EPA develops 304(a)(1) aquatic life AWQC recommendations following the 
                    <E T="03">“Guidelines for Deriving Numerical Water Quality Criteria for the Protection of Aquatic Organisms and Their Uses”</E>
                     (U.S. EPA 1985) (“Guidelines”), an approach that encourages collecting toxicity data for a broad range of aquatic organisms, specified by the recommended eight Minimum Data Requirements (MDRs), to ensure, with high confidence, that the AWQC will be protective of aquatic communities. AWQC are based solely on data and scientific judgments about the relationship between pollutant concentrations and the potential effects on aquatic organisms. The EPA's recommended AWQC are not regulatory, nor do they automatically become part of a State's water quality standards. States and authorized Tribes may adopt these criteria into their water quality standards (WQS) to protect the designated uses of water bodies. States and authorized Tribes may also modify these criteria to reflect site-specific conditions before adopting these into standards or use other scientifically defensible methods to develop criteria.
                </P>
                <HD SOURCE="HD3">2. CWA Section 304(a)(2) Aquatic Life Benchmarks</HD>
                <P>Aquatic life benchmarks, developed under CWA section 304(a)(2), are informational values that the EPA generates when there are limited high-quality data available to develop 304(a)(1) AWQC, because data gaps exist for several aquatic organism families. These data gaps can be addressed using new approach methods, such as mathematical extrapolation tools, read-across from other chemicals with similar structures, or other information. The EPA develops aquatic life benchmarks to provide information that States and Tribes may consider in their water quality protection programs including development of water quality criteria. Like AWQC, the EPA's CWA section 304(a)(2) aquatic life benchmark values are not regulatory, nor do they automatically become part of a State's or Tribe's water quality standards.</P>
                <HD SOURCE="HD3">3. OPP Aquatic Life Benchmarks</HD>
                <P>
                    Aquatic life benchmarks developed by OPP are based on the EPA's analysis of available high-quality data on the potential effects of pesticides on the aquatic community and support registration decisions for pesticides under the FIFRA. These benchmarks are estimates of the concentrations below which pesticides are not expected to present a risk of concern for aquatic organisms (
                    <E T="03">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/aquatic-life-benchmarks-and-ecological-risk</E>
                    ). EPA regularly updates the benchmarks to reflect the latest scientific information submitted under FIFRA. Federal, State, Tribal and local governments use these benchmarks in their interpretation of water monitoring data.
                </P>
                <HD SOURCE="HD1">III. Overview of Harmonized Approach and Draft Comparative Analysis</HD>
                <P>
                    The EPA has been working since 2009 to harmonize OPP's benchmarks and CWA section 304(a) aquatic life effects assessments in response to States and other stakeholders questioning the differences between these two approaches. In 2010, the EPA notified the public of multiple stakeholder meetings held when the agency first considered harmonizing aquatic effects assessments for pesticides under the FIFRA and the CWA. 
                    <E T="03">See https://www.regulations.gov/docket/EPA-HQ-OPP-2009-0773.</E>
                     In 2011, the agency solicited public comments as part of the 2012 FIFRA Scientific Advisory Panel (SAP) review of the EPA analyses regarding potential approaches. 
                    <E T="03">See https://www.regulations.gov/docket/EPA-HQ-OPP-2011-0898.</E>
                     The SAP made recommendations to develop an approach to harmonize OPP's benchmarks and CWA section 304(a) aquatic life criteria recommendations. The EPA focused on comparing the relative magnitude of the values derived using the respective FIFRA and CWA methods to examine whether the different effects assessment approaches yield similar results. This approach facilitates an efficient harmonization outcome of adopting the OPP benchmark values for the protection of aquatic life. For the draft comparative analyses, the EPA evaluated aquatic toxicity data for select insecticides and herbicides from different chemical classes and with different modes of action to compare the protective aquatic effect values developed by OPP and OW. These draft analyses are described in the “Comparison of Aquatic Life Protective Values Developed for Pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Clean Water Act (CWA)” (US EPA 2024, EPA-820-D-24-002), which is being made available for public comment in this notice of availability. The draft analyses demonstrate that the OPP benchmarks are similarly protective of aquatic life as the EPA's existing national recommended AWQC for pesticides, as well as criteria-related values developed for CWA purposes. For example, the most sensitive OPP benchmark for a given pesticide is generally lower than the corresponding current nationally recommended CWA 304(a)(1) criterion for that pesticide, with the OPP benchmarks being within a factor of two of the current 304(a)(1) 
                    <PRTPAGE P="105569"/>
                    criteria. The differences between the most sensitive OPP benchmarks and criteria-related values developed when toxicity data are limited are generally within the variability reported in the literature for toxicity tests repeated within a laboratory and tests conducted in different laboratories (5-10X).
                </P>
                <P>The OPP benchmarks reflect the latest scientific knowledge regarding the effects of a given pesticide on the aquatic environment, consistent with the requirement under CWA section 304(a) for establishing recommended AWQC. Most of the pesticides with OPP benchmarks do not have sufficient data available to meet the Guidelines' recommended eight MDRs for aquatic life AWQC development. Accordingly, strict adherence to the MDR recommendations in the Guidelines would result in far fewer AWQC for pesticides for which OPP has developed robust benchmarks. Thus, in this action, the EPA is proposing to rely on these available, science-based OPP values for pesticides to develop 304(a) values for pesticides for future consideration and potential use by States and Tribes in establishing water quality standards for their waters.</P>
                <HD SOURCE="HD1">IV. Development of CWA 304(a) Values for Pesticides</HD>
                <P>In light of these comparative analyses showing that OPP benchmarks are similarly protective of aquatic life as the EPA's existing CWA section 304(a) national recommended AWQC and criteria-related values, the EPA is considering recommending these OPP benchmarks as CWA section 304(a) aquatic life values. A list of the 757 anticipated CWA 304(a) aquatic life protective values based on the OPP pesticide benchmarks is presented in Table 1. Specifically, the EPA is requesting comment on whether to utilize the most sensitive OPP aquatic life benchmarks across all tested species for each pesticide as CWA 304(a)(1) recommended AWQC or 304(a)(2) informational aquatic life benchmarks, with the following exceptions:</P>
                <P>• When plants are the most sensitive taxonomic group overall for a given pesticide, the EPA would include protective values for both the plant and most sensitive animal (vertebrate or invertebrate). If the lowest OPP benchmark is a freshwater or estuarine/marine nonvascular plant, the CWA value will be identified accordingly.</P>
                <P>• CWA values for pesticide mixtures are not included.</P>
                <P>Consistent with the EPA's current approach for AWQC for the protection of aquatic life, the agency intends to recommend use of standard parameters for duration (one hour for acute effects, 4-day for chronic effects) and frequency (not to be exceeded more than once in three years) for the CWA 304(a) aquatic life value.</P>
                <HD SOURCE="HD1">V. The EPA's Request for Comments and Next Steps</HD>
                <P>The EPA will consider and evaluate all public comments and is most interested in receiving comments regarding the following three topics: 1) the comparison of approaches outlined in “Comparison of Aquatic Life Protective Values Developed for Pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Clean Water Act (CWA),” 2) whether the CWA values should be accepted as CWA section 304(a)(1) aquatic life AWQC or as CWA section 304(a)(2) informational aquatic life benchmarks for pesticides if the agency concludes it will use OPP benchmarks as CWA 304(a) values, and 3) whether the eight current pesticide criteria values that also have OPP benchmarks should be updated with the most sensitive OPP benchmark value and retained as CWA section 304(a)(1) aquatic life AWQC. Updating these eight data-rich pesticides with the OPP benchmark information would reflect the latest scientific knowledge.</P>
                <P>If the EPA pursues this approach, the agency would undertake subsequent efforts to publish CWA 304(a) aquatic life values for over 750 pesticides that States and Tribes may consider in their water quality protection programs. The CWA 304(a) values would be regularly updated to reflect the latest scientific information submitted under FIFRA and would represent the best available science regarding the aquatic life effects of pesticides.</P>
                <BILCOD>BILLING CODE 6560-50-P</BILCOD>
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                <GPH SPAN="3" DEEP="639">
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                <GPH SPAN="3" DEEP="639">
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                <GPH SPAN="3" DEEP="639">
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                <GPH SPAN="3" DEEP="639">
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                <GPH SPAN="3" DEEP="639">
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                <SIG>
                    <PRTPAGE P="105604"/>
                    <NAME>Bruno Pigott,</NAME>
                    <TITLE>Principal Deputy Assistant Administrator.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31086 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-C</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY </AGENCY>
                <DEPDOC>[FRL OP-OFA-158] </DEPDOC>
                <SUBJECT>Environmental Impact Statements; Notice of Availability</SUBJECT>
                <P>
                    <E T="03">Responsible Agency:</E>
                     Office of Federal Activities, General Information 202-564-5632 or 
                    <E T="03">https://www.epa.gov/nepa.</E>
                </P>
                <FP SOURCE="FP-1">Weekly Receipt of Environmental Impact Statements (EIS) </FP>
                <FP SOURCE="FP-1">Filed December 16, 2024 10 a.m. EST Through December 20, 2024 10 a.m. EST </FP>
                <FP SOURCE="FP-1">Pursuant to 40 CFR 1506.9.</FP>
                <P>
                    <E T="03">Notice:</E>
                     Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at: 
                    <E T="03">https://cdxapps.epa.gov/cdx-enepa-II/public/action/eis/search.</E>
                </P>
                <FP SOURCE="FP-1">
                    <E T="03">EIS No. 20240241, Final, FHWA, WI,</E>
                     Interstate 39/90/94 Corridor, Contact: Lisa Hemesath 608-829-7503.
                </FP>
                <P>Under 23 U.S.C. 139(n)(2), FHWA has issued a single document that consists of a final environmental impact statement and record of decision. Therefore, the 30-day wait/review period under NEPA does not apply to this action.</P>
                <FP SOURCE="FP-1">
                    <E T="03">EIS No. 20240242, Final, USAF, FL,</E>
                     Expansion of Childcare Services North of Eglin Test and Training Complex,  Review Period Ends: 01/27/2025, Contact: Nick Post 210-925-3516.
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">EIS No. 20240243, Final, FERC, TN,</E>
                     Ridgeline Expansion Project,  Review Period Ends: 01/27/2025, Contact: Office of External Affairs 866-208-3372.
                </FP>
                <P>
                    <E T="03">Amended Notice:</E>
                      
                </P>
                <FP SOURCE="FP-1">
                    <E T="03">EIS No. 20240214, Draft Supplement, USFWS, AK,</E>
                     Potential Land Exchange Involving Izembek National Wildlife Refuge Lands,  Comment Period Ends: 02/13/2025, Contact: Bobbie Jo Skibo 907-441-1539. 
                </FP>
                <P>Revision to FR Notice Published 11/15/2024; Extending the Comment Period from 12/30/2024 to 02/13/2025.</P>
                <SIG>
                    <DATED>Dated: December 20, 2024.</DATED>
                    <NAME>Mark Austin, </NAME>
                    <TITLE>Acting Director, NEPA Compliance Division, Office of Federal Activities.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30976 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL COMMUNICATIONS COMMISSION</AGENCY>
                <DEPDOC>[FR ID 270034]</DEPDOC>
                <SUBJECT>Disability Advisory Committee; Re-Establishment</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Communications Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of re-establishment of the Disability Advisory Committee.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Federal Communications Commission (Commission) hereby announces that the Disability Advisory Committee (hereinafter Committee) will be reestablished for a two-year period pursuant to the Federal Advisory Committee Act (FACA), following consultation with the Committee Management Secretariat, General Services Administration.</P>
                </SUM>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Federal Communications Commission, 45 L St. NE, Washington, DC 20554.</P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Joshua Mendelsohn, Designated Federal Officer, Federal Communications Commission, Consumer and Governmental Affairs Bureau, (202) 559-7304, or email: 
                        <E T="03">dac@fcc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>After consultation with the General Services Administration, the Commission intends to re-establish the charter, providing the Committee with authorization to operate for two years.</P>
                <P>The purpose of the Committee is to make recommendations to the Commission on the full range of disability access topics specified by the Commission and to facilitate the participation of consumers with disabilities in proceedings before the Commission. In addition, this Committee is intended to provide an effective means for stakeholders with interests in this area, including consumers with disabilities, to exchange ideas, which will in turn enhance the Commission's ability to effectively address disability access issues.</P>
                <HD SOURCE="HD1">Advisory Committee</HD>
                <P>
                    The Committee will be organized under, and will operate in accordance with, the provisions of the FACA (5 U.S.C. ch. 10). The Committee will be solely advisory in nature. Consistent with FACA and its requirements, each meeting of the Committee will be open to the public unless otherwise noticed. A notice of each meeting will be published in the 
                    <E T="04">Federal Register</E>
                     at least fifteen (15) days in advance of the meeting. Records will be maintained of each meeting and made available for public inspection. All activities of the Committee will be conducted in an open, transparent, and accessible manner. The Committee shall terminate two (2) years from the filing date of its charter, or earlier upon the completion of its work as determined by the Chair of the FCC, unless its charter is renewed prior to the termination date.
                </P>
                <P>
                    During the Committee's next term, it is anticipated that the Committee will meet in Washington, DC, or virtually, at the discretion of the Commission, approximately three (3) times a year. The first meeting date and agenda topics will be described in a Public Notice issued and published in the 
                    <E T="04">Federal Register</E>
                     at least fifteen (15) days prior to the first meeting date.
                </P>
                <P>In addition, as needed, subcommittees will be established to facilitate the Committee's work between meetings of the full Committee. All meetings of the Committee, including those of subcommittees, will be fully accessible to individuals with disabilities.</P>
                <SIG>
                    <FP>Federal Communications Commission.</FP>
                    <NAME>Michael Scott,</NAME>
                    <TITLE>Deputy Chief, Disability Rights Office, Consumer and Governmental Affairs Bureau.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30792 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6712-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL RESERVE SYSTEM</AGENCY>
                <SUBJECT>Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company</SUBJECT>
                <P>The notificants listed below have applied under the Change in Bank Control Act (Act) (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).</P>
                <P>
                    The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at 
                    <E T="03">https://www.federalreserve.gov/foia/request.htm.</E>
                     Interested persons may express their views in writing on the standards enumerated in paragraph 7 of the Act.
                </P>
                <P>
                    Comments received are subject to public disclosure. In general, comments received will be made available without 
                    <PRTPAGE P="105605"/>
                    change and will not be modified to remove personal or business information including confidential, contact, or other identifying information. Comments should not include any information such as confidential information that would not be appropriate for public disclosure.
                </P>
                <P>Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551-0001, not later than January 13, 2025.</P>
                <P>
                    <E T="03">A. Federal Reserve Bank of Chicago</E>
                     (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414. Comments can also be sent electronically to 
                    <E T="03">Comments.applications@chi.frb.org:</E>
                </P>
                <P>
                    1. 
                    <E T="03">Robert M. Kahn and Kristin Kahn, both of Newton, Iowa; Michael S. Albright and Mollie Albright, both of Sioux City, Iowa; and Megan Kahn, Basalt, Colorado;</E>
                     to join the Kahn Family Control Group, a group acting in concert, to retain voting shares of United Iowa Bancshares Inc., and thereby indirectly retain voting shares of FNNB Bank, both of Newton, Iowa.
                </P>
                <SIG>
                    <P>Board of Governors of the Federal Reserve System.</P>
                    <NAME>Michele Taylor Fennell,</NAME>
                    <TITLE>Associate Secretary of the Board.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-31073 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6210-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Agency for Healthcare Research and Quality</SUBAGY>
                <SUBJECT>Request for Information Regarding the Impact of Ageism in Healthcare</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Agency for Healthcare Research and Quality, Department of Health and Human Services.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of request for information about the impact of ageism in healthcare and methods and strategies to address ageism in healthcare delivery.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Agency for Healthcare Research and Quality (AHRQ) is seeking information from the public to understand the impacts of ageism on healthcare quality, including aspects related to safety, timeliness, patient-centeredness, equitable distribution, and care outcomes. How does the effect of ageism differ across different population groups? We are interested in identifying efforts and innovative strategies and programs that address and mitigate ageism to optimize older adults' health.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be submitted on or before March 15, 2025. AHRQ will not respond individually to responders but will consider all comments submitted by the deadline.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                         Submissions should follow the Submission Instructions below. We prefer that information be submitted electronically on the submission website. Email submissions may also be sent to 
                        <E T="03">ecareplan@ahrq.hhs.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jose Plascencia Jimenez, 
                        <E T="03">Jose.Plascenciajimenez@ahrq.hhs.gov.</E>
                         Telephone 301-427-1364.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Agency for Healthcare Research and Quality (AHRQ) is seeking information from the public to understand the effects of ageism on healthcare services and outcomes. Notably, the AHRQ seeks any evidence, insights, or perspectives on the impact of ageism on care delivery and quality to identify barriers and explore opportunities to address age-related biases. Responses will inform future research priorities and studies, policies, and initiatives to improve the quality and outcomes of care for older adults.</P>
                <P>
                    For this RFI, ageism is defined as stereotypes, prejudice, and discrimination directed towards other people or oneself based on age.
                    <SU>1</SU>
                     While ageism is often subtle, it is woven into our workforce, healthcare systems, and everyday interactions. Ageism undermines older adults and their contributions to our communities.
                </P>
                <P>
                    Research shows that 81 percent of adults aged 50-80 report experiencing internal ageism, 65 percent are exposed to ageist messages, and 45 percent face ageism in interpersonal interactions.
                    <SU>2</SU>
                </P>
                <P>
                    These statistics demonstrate how ingrained ageism is in our society. Ageism within healthcare leads to poorer health outcomes, avoidable morbidity, and costly preventable adverse events.
                    <SU>3</SU>
                </P>
                <P>
                    Ageism costs our nation an estimated $63 billion annually in healthcare expenditures.
                    <SU>4</SU>
                     In health care, ageism is expressed in our social and organizational policies, the practices of clinicians, and negative assumptions held by older adults themselves. At the macro level, ageism is complex and reflected in healthcare access issues, which result in older adults being less likely to receive care consistent with medical guidelines, payment policies that do not adequately reimburse for complex care needed for older adults, and exclusion or underrepresentation of older adults in clinical trials and other research. At the micro level, practices such as the use of ageist language and elder speak, exclusion of older patients from care plan conversations, and variations in treatment practices due to a patient's age all affect patients' quality of care. Self-directed ageism can also lead to adverse outcomes for a patient if their beliefs on aging lead them to believe that the symptoms they are experiencing should be considered a “normal” part of aging. For example, while some cognitive decline is expected as we age, memory loss, confusion, changes in behavior, and inability to complete activities of daily living are all signs of changes in cognitive ability that need to be evaluated by a medical professional. Moreover, people who internalize ageist societal messages tend to have poorer physical, cognitive, and mental health. The reverse is also true—individuals who internalize positive aging messages are likely to exhibit benefits in physical, cognitive, and mental health—highlighting the need to promote age inclusivity.
                </P>
                <P>AHRQ recognizes that due to population aging, the impact of ageism on the health and well-being of older Americans, their families, caregivers, and communities will continue to grow. Between 2009 and 2019, the number of people in the US aged 65 years and older increased 36%, from 39.6 to 54.1 million, and is projected to reach 94.7 million people in 2060. Addressing ageism is critical as the population ages, placing growing demands on healthcare systems and highlighting the need for policies that ensure compassionate and high-quality care for older adults.</P>
                <P>
                    Ageism does not affect all populations equally. Some groups of older adults may face additional barriers to care. Older adults living in rural or socioeconomically disadvantaged areas, those who have low incomes, or from certain racial or ethnic minority groups can face additional barriers to care, have limited access to resources, confront cultural biases, or encounter differential health services delivery. People living with disabilities may have specific needs often forgotten or neglected as they age. Women, with a higher life expectancy than men, have higher rates of chronic illnesses and functional impairments with fewer financial resources available. Understanding the compounded impact of ageism across different groups is critical to creating comprehensive strategies that ensure equitable and inclusive care that promotes healthy aging. Mitigating or eliminating the biases that encompass 
                    <PRTPAGE P="105606"/>
                    ageism can potentially improve health and functional status, reduce costs, and foster intergenerational collaboration among older adults. By eliminating age-related biases, older adults may be more likely to receive timely and effective care, improving health outcomes, including functional status, and physical and mental well-being, while increasing the value of healthcare.
                </P>
                <P>AHRQ encourages stakeholders to contribute their expertise and experiences to inform innovative approaches to reduce ageism in the healthcare system.</P>
                <HD SOURCE="HD1">Who Should Respond</HD>
                <P>• Clinicians and other health care personnel (including community health workers, peer support personnel, system navigators, and patient advocates) who provide services to older adults and others at risk for encountering ageism, including personnel from across all care settings (primary care, specialty care, mental and behavioral health, post-acute e care, rehabilitative care, and home and community-based services).</P>
                <P>• Researchers and implementers studying ageism or developing interventions to implement person-centered care planning in practice.</P>
                <P>• Clinical professional societies.</P>
                <P>• Payers.</P>
                <P>• Healthcare delivery organizations.</P>
                <P>• People who have experiences ageism in health care, their families, and caregivers.</P>
                <P>• Patient advocacy groups and organizations.</P>
                <P>• Clinical decision support developers.</P>
                <P>• Quality and other measure developers.</P>
                <P>• Representatives from human service agencies and/or community organizations with interest or experience in addressing ageism.</P>
                <P>• Higher education institutions that train clinicians and healthcare personnel and/or train those involved in community health and education.</P>
                <P>• Clinical and public health decision-makers.</P>
                <P>• Health technology developers focused on improving health outcomes among older adults.</P>
                <P>Specific questions of interest to the AHRQ include, but are not limited to, the following:</P>
                <P>1. What is the scope of ageism in health care and its impacts? Can you provide specific examples, especially those that are wide-spread and/or have large impact?</P>
                <P>2. How does ageism influence healthcare access, quality, safety, and outcomes of care?</P>
                <P>3. What is the impact of ageism on both the micro and macro levels of health care? How does this vary across diverse population groups, including older adults living in rural or socioeconomically disadvantaged areas, those with low incomes or from racial or ethnic minority groups, or those living with disabilities? Between women and men?</P>
                <P>4. What is the evidence for interventions to address ageism and promote age inclusivity in healthcare?</P>
                <P>5. How do age-related stereotypes affect clinical decision-making, and what steps can be taken to ensure that care plans align with older adults' individual needs, preferences, and goals?</P>
                <P>6. How does internalized and interpersonal ageism impact care seeking behavior and health outcomes? What strategies are there to address this?</P>
                <P>7. How can healthcare technology, such as electronic health records and decision-support tools, as well as artificial intelligence be designed to mitigate ageism rather than reinforce it?</P>
                <P>8. What role could Medicare, Medicaid, and private insurers play in incentivizing equitable, high-quality care for older adults and combating systemic ageism?</P>
                <P>9. What are the broader societal benefits of reducing ageism in healthcare, such as enhanced workforce participation of older adults, lower healthcare costs, and improved intergenerational health?</P>
                <P>10. What are the unique challenges and opportunities for addressing ageism in healthcare in an aging population and increasing healthcare demand?</P>
                <P>11. How can programs advance initiatives that reduce ageism in healthcare and promote older adults' dignity, autonomy, and well-being?</P>
                <P>12. How can intergenerational dialogue and collaboration be fostered to challenge stereotypes about aging and highlight the contributions of older adults to society?</P>
                <P>13. What are the social, cultural, and economic factors contributing to ageism in healthcare, and how can they be addressed through public awareness campaigns or policy reforms or other strategies?</P>
                <P>14. What roles do education and training for healthcare providers play in addressing implicit or explicit age-related biases, and what are the effective models for such education, both for those currently in training and those now in practice?</P>
                <P>AHRQ is interested in all the questions listed above. Still, respondents are welcome to address as many or as few as they choose and to address additional areas of interest regarding ageism not listed. It is helpful to identify the question to which a particular answer corresponds.</P>
                <P>This RFI is for planning purposes only and should not be construed as a policy, solicitation for applications, or as an obligation on the part of the Government to provide support for any ideas in response to it. AHRQ will use the information submitted in response to this RFI at its discretion and will not comment on any respondent's submission. However, responses to this RFI may be reflected in future solicitation(s) or policies. The information provided will be analyzed and may appear in reports. Respondents will not be identified in any published reports. Respondents are advised that the Government is not obligated to acknowledge receipt of the information received or provide feedback to respondents concerning any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The contents of all submissions will be made available to the public upon request. Submitted materials must be publicly available or able to be made public.</P>
                <EXTRACT>
                    <FP>(Authority: Section 902 of the Public Health Service Act, 42 U.S.C. 299a.)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: December 20, 2024.</DATED>
                    <NAME>Marquita Cullom,</NAME>
                    <TITLE>Associate Director.</TITLE>
                </SIG>
                <HD SOURCE="HD1">Footnotes</HD>
                <EXTRACT>
                    <P>1. World Health Organization. Global Report on Ageism. Geneva: World Health Organization; 2021. Global report on ageism (who.int). Accessed July 20, 2022.</P>
                    <P>2. Allen JO, Solway E, Kirch M, Singer D, Kullgren J, Moise V, Malani P. Experiences of Everyday Ageism and the Health of Older US Adults JAMA Open Network. 2022; 15 (5): e2217240.</P>
                    <P>3. Allen JO. Ageism as a risk factor for chronic disease. Gerontologist. 2016;56(4);610-614. Doi:10.1093/geront/gnw118.</P>
                    <P>4. Levy BR, Slade MD, Chang ES, Kannoth S, Wang SY. Ageism amplified cost and prevalence of health conditions. Gerontologist. 2020;60(1): 174-181. doi:10.1093/geront/gny131.</P>
                </EXTRACT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31074 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="105607"/>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Centers for Disease Control and Prevention</SUBAGY>
                <SUBJECT>Notice of Award of a Sole Source Cooperative Agreement To Fund World Health Organization (WHO)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $20,000,000, with an expected total funding of approximately $100,000,000 over a 5-year period, to World Health Organization (WHO). The award aims to support CDC and the WHO's continued collaboration to address global capacity to identify, respond, and prevent infectious diseases.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The period for this award will be September 30, 2025 through September 29, 2030.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Broderick Yoerg, Division of Global Health Protection, Global Health Center, Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA 30329, Telephone: (404) 234-0666, Email: 
                        <E T="03">DGHPNOFOs@cdc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The sole source award will ensure coordination between CDC and the WHO and contribute to the response to disease outbreaks and other health emergencies, both through capacity building and direct response to active emergencies.</P>
                <P>WHO is the only entity that can carry out this work, as it has a robust global infrastructure that gives it direct access to national ministries of health and other critical health institutions through its headquarters in Geneva and six regional offices. WHO will enhance global and regional preparedness, surveillance, and laboratory capacity to test for and respond to epidemic and pandemic-prone diseases.</P>
                <HD SOURCE="HD1">Summary of the Award</HD>
                <P>
                    <E T="03">Recipient:</E>
                     World Health Organization (WHO).
                </P>
                <P>
                    <E T="03">Purpose of the Award:</E>
                     The purpose of this award is to support implementation of infrastructure and collaborations between CDC and the WHO to build capacities needed to rapidly detect and contain disease outbreaks at the source and prevent their international spread. NOFO activities will ensure coordination between CDC and the WHO and contribute to the response to disease outbreaks and other health emergencies, both through capacity building and direct response to active emergencies.
                </P>
                <P>
                    <E T="03">Amount of Award:</E>
                     $20,000,000 in Federal Fiscal Year (FFY) 2025 funds, with a total estimated $100,000,000 for the 5-year period of performance, subject to availability of funds.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     This program is authorized under Section 307 of the Public Health Service Act [42 U.S.C. 24
                    <E T="03">l</E>
                    ) and Section 301(a)[42 U.S.C. 24
                    <E T="03">l</E>
                    (a) of the Public Health Service Act.
                </P>
                <P>
                    <E T="03">Period of Performance:</E>
                     September 30, 2025 through September 29, 2030.
                </P>
                <SIG>
                    <DATED>Dated: December 17, 2024.</DATED>
                    <NAME>Terrance Perry,</NAME>
                    <TITLE>Acting Director, Office of Grants Services, Centers for Disease Control and Prevention.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31197 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4163-18-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
                <DEPDOC>[Document Identifiers: CMS-359/CMS-360]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities: Proposed Collection; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Centers for Medicare &amp; Medicaid Services, Health and Human Services (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Centers for Medicare &amp; Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the 
                        <E T="04">Federal Register</E>
                         concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received by February 28, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:</P>
                    <P>
                        1. 
                        <E T="03">Electronically.</E>
                         You may send your comments electronically to 
                        <E T="03">http://www.regulations.gov.</E>
                         Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.
                    </P>
                    <P>
                        2. 
                        <E T="03">By regular mail.</E>
                         You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number:__, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
                    </P>
                    <P>
                        To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser: 
                        <E T="03">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>William N. Parham at (410) 786-4669.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Contents</HD>
                <P>
                    This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see 
                    <E T="02">ADDRESSES</E>
                    ).
                </P>
                <HD SOURCE="HD2">CMS-359/CMS-360 Comprehensive Outpatient Rehabilitation Facility (CORF) Certification and Survey Forms</HD>
                <P>
                    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires Federal agencies to publish a 60-day notice in the 
                    <E T="04">Federal Register</E>
                     concerning each proposed collection of information, including each proposed extension or reinstatement of an existing 
                    <PRTPAGE P="105608"/>
                    collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.
                </P>
                <HD SOURCE="HD1">Information Collections</HD>
                <P>
                    1. 
                    <E T="03">Type of Information Collection Request:</E>
                     Reinstatement with change of a previously approved information collection; 
                    <E T="03">Title of Information Collection:</E>
                     Comprehensive Outpatient Rehabilitation Facility (CORF) Certification and Survey Forms; 
                    <E T="03">Use:</E>
                     This information collection is for the reinstatement of the CMS-359 and CMS-360 forms. The purpose of these forms is described below. The form CMS-359 is an application for health care providers that seek to participate in the Medicare program as a Comprehensive Outpatient Rehabilitation Facility (CORF). The form initiates the process for facilities to become certified as a CORF and it provides the CMS Location and State Survey Agency (SA) staff identifying information regarding the applicant that is stored in the Automated Survey Processing Environment (ASPEN) system.
                </P>
                <P>
                    The form CMS-360 is a survey tool used by the SAs to record information in order to determine a provider's compliance with the CORF Conditions of Participation (COPs) and to report this information to the Federal Government. The form includes basic information on the COP requirements, check boxes to indicate the level of compliance, and a section for recording notes. CMS has the responsibility and authority for certification decisions which are based on provider compliance with the COPs and this form supports this process. 
                    <E T="03">Form Number:</E>
                     CMS-359/360 (OMB control number: 0938-0267); 
                    <E T="03">Frequency:</E>
                     Occasionally; 
                    <E T="03">Affected Public:</E>
                     Private Sector (Business or other for-profits); 
                    <E T="03">Number of Respondents:</E>
                     179; 
                    <E T="03">Number of Responses:</E>
                     31; 
                    <E T="03">Total Annual Hours:</E>
                     241. (For questions regarding this collection contact Caroline Gallaher (410)786-8705.)
                </P>
                <SIG>
                    <NAME>William N. Parham, III,</NAME>
                    <TITLE>Director, Division of Information Collections and Regulatory Impacts, Office of Strategic Operations and Regulatory Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30853 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4120-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Administration for Children and Families</SUBAGY>
                <SUBJECT>Proposed Information Collection Activity; Prevention Services Data Collection (Office of Management and Budget #0970-0529)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Children's Bureau, Administration for Children and Families, U.S. Department of Health and Human Services.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for public comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Administration for Children and Families (ACF), Children's Bureau is requesting a 3-year extension of the Prevention Services Data Collection (Office of Management and Budget #0970-0529, expiration May 31, 2025). There are no changes requested to the data collection.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Comments due</E>
                         February 25, 2025. In compliance with the requirements of the Paperwork Reduction Act of 1995, ACF is soliciting public comment on the specific aspects of the information collection described above.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You can obtain copies of the proposed collection of information and submit comments by emailing 
                        <E T="03">infocollection@acf.hhs.gov.</E>
                         Identify all requests by the title of the information collection.
                    </P>
                </ADD>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Description:</E>
                     Section 471(e)(4)(E) of the Social Security Act (the Act) (42 U.S.C. 671), as amended by Public Law 115-123, requires State and Tribal child welfare agencies to collect and report to ACF information on children receiving prevention and family services and programs. Title IV-E Agencies must report the following:
                </P>
                <P>• The specific services or programs provided</P>
                <P>• The total expenditures for each of the services or programs provided</P>
                <P>• The duration of the services or programs provided, and</P>
                <P>• If the child was identified in a prevention plan as a candidate for foster care:</P>
                <P>○ The child's placement status at the beginning, and at the end, of the 12-month period that begins on the date the child was identified as a candidate for foster care in a prevention plan; and</P>
                <P>○ Whether the child entered foster care during the initial 12-month period and during the subsequent 12-month period.</P>
                <P>To date, approximately 83 percent of the title IV-E Agencies have chosen to provide these prevention services. The data collected will continue to inform Federal policy decisions, program management, and responses to Congressional and Departmental inquiries. Specifically, the data will provide information about the use and availability of prevention services to children to prevent the need for foster care placement. The data contains personally identifiable information (date of birth and race/ethnicity).</P>
                <P>
                    <E T="03">Respondents:</E>
                     Title IV-E Agencies.
                </P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,10C,10C,10C,10C">
                    <TTITLE>Annual Burden Estimates</TTITLE>
                    <BOXHD>
                        <CHED H="1">Instrument</CHED>
                        <CHED H="1">Annual number of respondents</CHED>
                        <CHED H="1">
                            Annual number of responses per
                            <LI>respondent</LI>
                        </CHED>
                        <CHED H="1">Average burden hours per response</CHED>
                        <CHED H="1">Annual </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Prevention Services Data Collection</ENT>
                        <ENT>53</ENT>
                        <ENT>2</ENT>
                        <ENT>31</ENT>
                        <ENT>3,286</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    <E T="03">Comments:</E>
                     The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
                    <PRTPAGE P="105609"/>
                </P>
                <P>
                    <E T="03">Authority:</E>
                     Section 471(e)(4)(E) of the Act (42 U.S.C. 671), as amended by Public Law 115-123.
                </P>
                <SIG>
                    <NAME>Mary C. Jones,</NAME>
                    <TITLE>ACF/OPRE Certifying Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31075 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4184-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Administration for Children and Families</SUBAGY>
                <SUBJECT>Proposed Information Collection Activity; Refugee Assistance Program Estimates: Cash and Medical Assistance-ORR-1 (Office of Management and Budget #: 0970-0030)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Refugee Resettlement, Administration for Children and Families, U.S. Department of Health and Human Services.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for public comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services is requesting revisions to an existing data collection, ORR-1 Cash and Medical Assistance (CMA) Program Estimates (Office of Management and Budget #: 0970-0030, expiration June 30, 2025). The proposed revisions include minor revisions to the existing ORR-1 form and the addition of a template recipients must use in preparing their annual budget justification estimates in accordance with the refugee resettlement program regulations.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Comments due</E>
                         February 25, 2025. In compliance with the requirements of the Paperwork Reduction Act of 1995, ACF is soliciting public comment on the specific aspects of the information collection described above.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You can obtain copies of the proposed collection of information and submit comments by emailing 
                        <E T="03">infocollection@acf.hhs.gov.</E>
                         Identify all requests by the title of the information collection.
                    </P>
                </ADD>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Description:</E>
                     The ORR-1, CMA Program Estimates, is the application for grants under the CMA program. The application is required by ORR program regulations at 45 CFR 400.11(b). The regulation specifies that states must submit, as their application for this program, estimates of the projected costs they anticipate incurring in providing CMA for eligible recipients and the costs of administering the program. Under the CMA program, states are reimbursed for the costs of providing these services and benefits for 12 months after an eligible recipient arrives in this country. The eligible beneficiaries for these services and benefits are refugees, Amerasians, Cuban and Haitian Entrants, asylees, Afghans and Iraqi with Special Immigrant Visas, victims of a severe form of trafficking, and other populations. States that provide services for unaccompanied refugee minors also provide an estimate for the cost of these services for the year for which they are applying for grants.
                </P>
                <P>The proposed revisions include minor changes to the existing ORR-1 form and the addition of a template recipients must use in preparing their annual budget justification estimates in accordance with the refugee resettlement program regulations. Currently recipients must submit the ORR-1, CMA Program Estimates, as the application for grants under the CMA program. A budget justification must be submitted along with the ORR-1 form. However, ORR does not provide a standardized budget justification template, so submissions vary widely in format, content, and quality, making it challenging to extract and standardize information, increasing burden on both ORR reviewers and recipients. This revision to the information collection requires states to submit budget justifications in a standardized format via a Microsoft Excel workbook, with each tab of the justification in alignment with a specific line on the ORR-1. The ORR-1 form has minor revisions, including updating the titles of columns and lines to align with current terminology, and simplifying the form to require total cost estimates where unit costs were previously requested. These revisions are a result of the standardization of the budget justification.</P>
                <P>The revised instructions, which are now embedded within the standardized budget justification, provide guidance to recipients on how to fill out each section of the standardized budget justification. The recipients work through corresponding sections of the instructions and budget justification, and the standardized format makes clear what information is needed and at what level of detail. Upon completion of the budget justification, the values needed to populate the ORR-1 form are automatically calculated, and recipients are instructed to transfer specific data from the budget justification to the ORR-1 form in the system of record.</P>
                <P>ORR conducted a pilot of the standardized budget justification. Feedback was positive, with participating states citing time savings in development of their budget justification and more streamlined and consistent review and analysis by ORR reviewers. The annual burden estimate has been revised to reflect this.</P>
                <P>
                    <E T="03">Respondents:</E>
                     State Agencies, the District of Columbia, and Replacement Designees under 45 CFR 400.301(c) administering or supervising the administration of programs under Title IV of the Act.
                </P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s30,12C,12C,12C,12C">
                    <TTITLE>Annual Burden Estimates</TTITLE>
                    <BOXHD>
                        <CHED H="1">Information collection</CHED>
                        <CHED H="1">Total number of respondents</CHED>
                        <CHED H="1">
                            Annual 
                            <LI>number of </LI>
                            <LI>responses per respondent</LI>
                        </CHED>
                        <CHED H="1">
                            Average 
                            <LI>burden hours per response</LI>
                        </CHED>
                        <CHED H="1">Annual burden hours</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">ORR-1, CMA Program Estimates</ENT>
                        <ENT>57</ENT>
                        <ENT>1</ENT>
                        <ENT>0.5</ENT>
                        <ENT>28.5</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    <E T="03">Comments:</E>
                     The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
                    <PRTPAGE P="105610"/>
                </P>
                <P>
                    <E T="03">Authority:</E>
                     8 U.S.C. 412(a)(4).
                </P>
                <SIG>
                    <NAME>Mary C. Jones,</NAME>
                    <TITLE>ACF/OPRE Certifying Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31044 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4184-45-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Administration for Children and Families</SUBAGY>
                <SUBJECT>Proposed Information Collection Activity; Unaccompanied Children Bureau Incident Reporting (Office of Management and Budget #: 0970-NEW)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Refugee Resettlement, Administration for Children and Families, U.S. Department of Health and Human Services.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for public comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is inviting public comments on the proposed information collection, including proposed changes. The request consists of several forms that will allow the Unaccompanied Children Bureau (UCB) to ensure that serious issues are elevated to ORR and that all incidents and the response to such incidents are documented and resolved in a way that protects the interests of children.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Comments due</E>
                         February 25, 2025. In compliance with the requirements of the Paperwork Reduction Act of 1995, ACF is soliciting public comment on the specific aspects of the information collection described above.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You can obtain copies of the proposed collection of information and submit comments by emailing 
                        <E T="03">infocollection@acf.hhs.gov.</E>
                         Identify all requests by the title of the information collection.
                    </P>
                </ADD>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Description:</E>
                     ORR UCB is in the process of reorganizing its information collections to create more unique information collections that will contain fewer forms under each OMB control number. This will promote operational efficiency for UCB by decreasing the burden associated with renewing large collections and enabling UCB to create more purpose-specific information collections. In addition, this will facilitate OMB review by ensuring the scope of the collection is targeted and narrower than existing collections, resulting in clearer requests. As part of that reorganization effort, ORR plans to move the following forms into this new information collection:
                </P>
                <FP SOURCE="FP-1">• Child-Level Event (Form A-9A)</FP>
                <FP SOURCE="FP-1">• Emergency Significant Incident Report (eSIR) (Form A-9B)</FP>
                <FP SOURCE="FP-1">• Non-Emergency Significant Incident Report (non-eSIR)(Form A-9C)</FP>
                <FP SOURCE="FP-1">• Historical Disclosure (Form A-9D)</FP>
                <FP SOURCE="FP-1">• Behavioral Note (Form A-9E)</FP>
                <FP SOURCE="FP-1">• Program-Level Event (PLE) Report (Form A-10)</FP>
                <P>
                    In addition, ORR plans to revise the forms as follows to better align the forms with related reporting requirements and processes found in ORR agency guidance (
                    <E T="03">i.e.,</E>
                     regulations, policies, and procedures), as well as improve the forms' organization, clarity, and functionality:
                </P>
                <HD SOURCE="HD1">Child-Level Event (Form A-9A)</HD>
                <P>• Adjust the dropdown options for the “Location of Event” field to remove duplication and improve accuracy by:</P>
                <FP SOURCE="FP-2">○ Removing “Group Home” and “Foster Home”</FP>
                <FP SOURCE="FP-2">○ Rewording “Community (field trip or outside the foster home)” to “Community”</FP>
                <FP SOURCE="FP-2">○ Rewording “U.S. Interior, not DHS or ORR custody” to “U.S. Interior (before entering DHS or ORR custody)”</FP>
                <P>• Adjust the dropdown options for “Specify Location” for accuracy by:</P>
                <FP SOURCE="FP-2">○ Rewording options to clarify when they are referring to locations inside the care provider facility</FP>
                <FP SOURCE="FP-2">○ Adding an option for “Individual Foster Home”</FP>
                <FP SOURCE="FP-2">○ Adding the following options to select from if “Community” is selected in the “Location of Event” field</FP>
                <FP SOURCE="FP1-2"> Hospital or other healthcare facility</FP>
                <FP SOURCE="FP1-2"> School</FP>
                <FP SOURCE="FP1-2"> Field Trip</FP>
                <FP SOURCE="FP1-2"> Other</FP>
                <P>• Add the following fields:</P>
                <FP SOURCE="FP-2">○ Level of Care</FP>
                <FP SOURCE="FP-2">○ Specify Out-of-Network Facility</FP>
                <FP SOURCE="FP-2">○ Specify Out-of-Network Level of Care</FP>
                <P>• Reword the Date/Time Event Reported to Care Provider fields as follows since provider staff may have directly witnessed the event, as opposed to having it reported to them by a third-party:</P>
                <FP SOURCE="FP-2">○ Date Care Provider Became Aware of Event</FP>
                <FP SOURCE="FP-2">○ Time Care Provider Became Aware of Event</FP>
                <HD SOURCE="HD1">Emergency Significant Incident Report (Form A-9B)</HD>
                <P>• Reword the subcategory “Molestation (penetration or touching unrelated to official job duties of a child's buttocks, breasts, or anal, oral, or genital area by a body part or object” to “Molestation (intentional penetration or touching unrelated to official job duties of a child's genitalia, anus, groin, breast, inner thigh, buttocks, or mouth by a body part or object, including kissing, with intent to abuse, arouse, or gratify sexual desire)” for added clarity.</P>
                <P>• Remove the option of “UC and UC consensual” from the “Type of Allegation” dropdown field to align with the related regulation.</P>
                <HD SOURCE="HD1">Non-Emergency Significant Incident Report (Form A-9C)</HD>
                <P>• For the “Staff Code of Conduct &amp; Boundary Violation” category:</P>
                <FP SOURCE="FP-2">○ Reworded the subcategory “Failing to report any knowledge, suspicion, or information about sexual abuse, sexual harassment, or inappropriate sexual behavior” to “Failing to report any knowledge, suspicion, or information about sexual abuse, sexual harassment, inappropriate sexual behavior, or any other form of abuse/neglect” to clarify that other forms of abuse/neglect are also reportable</FP>
                <FP SOURCE="FP-2">○ Added the following subcategories to better align with ORR agency guidance:</FP>
                <FP SOURCE="FP1-2"> Failing to report a code of conduct violation</FP>
                <FP SOURCE="FP1-2"> Engaging in sexual contact with anyone while on duty or while acting in the official capacity of their position</FP>
                <FP SOURCE="FP1-2"> Threatening a child with incident reporting or behavioral notes to regulate their behavior or for any other reason</FP>
                <FP SOURCE="FP1-2"> Threatening a child with legal, immigration, sponsor unification, or asylum case consequences to regulate their behavior or for any other reason</FP>
                <HD SOURCE="HD1">Historical Disclosure (Form A-9D)</HD>
                <P>• Reword the “Abuse Neglect in DHS Custody” category to “Violation of Civil Rights/Liberties in DHS Custody” and replace the current subcategories with the following options to better reflect the types of reportable incidents:</P>
                <FP SOURCE="FP-2">○ Conditions of detention</FP>
                <FP SOURCE="FP-2">○ Disability accommodation</FP>
                <FP SOURCE="FP-2">○ Excessive force or inappropriate use of force</FP>
                <FP SOURCE="FP-2">○ Fourth Amendment (confiscation of documents/property)</FP>
                <FP SOURCE="FP-2">
                    ○ Intimidation, threat, or improper coercion
                    <PRTPAGE P="105611"/>
                </FP>
                <FP SOURCE="FP-2">○ Legal access/due process rights</FP>
                <FP SOURCE="FP-2">○ Undocumented separation from parent/legal guardian</FP>
                <FP SOURCE="FP-2">○ Undocumented separation from minor sibling</FP>
                <FP SOURCE="FP-2">○ Medical/mental health care</FP>
                <FP SOURCE="FP-2">○ Privacy Violation</FP>
                <FP SOURCE="FP-2">○ Religious Accommodation</FP>
                <FP SOURCE="FP-2">○ Retaliation</FP>
                <FP SOURCE="FP-2">○ Restraints or isolation</FP>
                <FP SOURCE="FP-2">○ Sexual abuse, sexual harassment, or inappropriate sexual behavior</FP>
                <FP SOURCE="FP-2">○ Previous enrollment in the U.S. Department of Homeland Security (DHS) Migrant Protection Protocols program</FP>
                <P>• Add a “Notifications” section to document notifications made to parties other than ORR.</P>
                <HD SOURCE="HD1">Behavioral Note (Form A-9E)</HD>
                <P>• Change the title of the “Incident Information” section to “Behavior Information” and added the following fields:</P>
                <P>○ Type of Behavior, with the following options:</P>
                <FP SOURCE="FP1-2"> Positive behavior, habit, resilience, personal growth, skill-building, or another meritorious action/trait</FP>
                <FP SOURCE="FP1-2"> Behavior that merits monitoring in the event a behavioral pattern emerges that requires intervention or support</FP>
                <P>○ Is the behavior part of an established behavioral pattern?</P>
                <P>○ Is intervention or support required?</P>
                <P>• In the Actions Taken section:</P>
                <FP SOURCE="FP-1">○ Reword “Staff Response and Intervention” to “Staff Response (if applicable)”</FP>
                <FP SOURCE="FP-1">○ Reword “Follow-up and/or Resolution” to “Potential Consequence(s) of Continued Behavior”</FP>
                <FP SOURCE="FP-1">○ Reword “Recommendations” to “Staff Intervention or Support”</FP>
                <HD SOURCE="HD1">Program-Level Event Report (Form A-10)</HD>
                <P>• Reword “Program/Facility” to “Specify Program”.</P>
                <P>• Add a field for “Level of Care”.</P>
                <P>• Reword “Synopsis of Event” to “Short Synopsis”.</P>
                <P>• Remove the category for “Other”.</P>
                <P>• Reword the category “Death (non-UC)” to “Death of an Adult or non-UC Child”.</P>
                <P>• Reword the category “Major Disturbance” to “Threats to Safety” and replace the current subcategories with:</P>
                <FP SOURCE="FP-1">○ Trespassing/Intruder</FP>
                <FP SOURCE="FP-1">○ Threats to Children or Staff</FP>
                <FP SOURCE="FP-1">○ Weapon Found</FP>
                <FP SOURCE="FP-1">○ Vehicle Accident</FP>
                <FP SOURCE="FP-1">○ Cyber Breech, Attack, or Threat</FP>
                <P>• Reword the category “Natural Disaster” to “Natural Disaster or Weather Event” and replace the “Other” subcategory with “Storm”.</P>
                <P>• Add the following categories and subcategories:</P>
                <FP SOURCE="FP-2">○ Facilities Issues, with subcategories for:</FP>
                <FP SOURCE="FP1-2"> Environmental</FP>
                <FP SOURCE="FP1-2"> Mechanical Malfunction</FP>
                <FP SOURCE="FP1-2"> Imminent Risk to Safety</FP>
                <FP SOURCE="FP1-2"> Maintenance</FP>
                <FP SOURCE="FP1-2"> Staffing Shortage</FP>
                <FP SOURCE="FP-2">○ Video Monitoring Disruption</FP>
                <FP SOURCE="FP-2">○ Infectious Disease/Health and Safety Incident</FP>
                <FP SOURCE="FP-2">○ Power Outage/Disruption of Utilities (External)</FP>
                <FP SOURCE="FP-2">○ Incident Involving Unidentified Child, with subcategories for:</FP>
                <FP SOURCE="FP1-2"> Code of Conduct Violation</FP>
                <FP SOURCE="FP1-2"> Safety or Abuse/Neglect Concern</FP>
                <FP SOURCE="FP-2">○ Code of Conduct Violation Not Involving a Child, with subcategories for:</FP>
                <FP SOURCE="FP1-2"> Failing to disclose staff misconduct witnessed on or off duty</FP>
                <FP SOURCE="FP1-2"> Failing to self-disclose misconduct occurring on or off duty</FP>
                <FP SOURCE="FP-2">○ Unauthorized Photography, Video, or Surveillance</FP>
                <FP SOURCE="FP-2">○ Media Requests/External Questions</FP>
                <FP SOURCE="FP-2">○ IT Disruption/internet Outage</FP>
                <FP SOURCE="FP-2">○ Records Issues, with subcategories for:</FP>
                <FP SOURCE="FP1-2"> Damaged Records</FP>
                <FP SOURCE="FP1-2"> Unauthorized Destruction of Records</FP>
                <FP SOURCE="FP1-2"> Lost Records</FP>
                <P>• Remove the following fields from the Incident Information section:</P>
                <FP SOURCE="FP-2">○ Location of Incident (and Specify)</FP>
                <FP SOURCE="FP-2">○ Was the UAC or Anyone Else Injured? (If Yes, SIR must be created) (and Specify)</FP>
                <FP SOURCE="FP-2">○ Internal Investigation?</FP>
                <FP SOURCE="FP-2">○ Results/Findings of Investigation</FP>
                <P>• Reword the following fields from the Incident Information section:</P>
                <FP SOURCE="FP-2">○ “Description of Incident” to “Describe the event and explain the effect on the program's operations.”</FP>
                <FP SOURCE="FP-2">○ “Was the UAC or Anyone Else Evacuated?” to “Were or are children being evacuated?”</FP>
                <FP SOURCE="FP-2">○ “Staff Response and Intervention” to “Describe actions taken to mitigate the impact on children in care”</FP>
                <P>• Reword the field “Follow-up and/or Resolution” to “Updates, Follow-up, and/or Resolution” and move it into a new “Addendum” section.</P>
                <P>• Add the following fields from the Incident Information section:</P>
                <FP SOURCE="FP-2">○ Does the program need immediate guidance or resources?</FP>
                <FP SOURCE="FP-2">○ Was or is the facility locked down or sheltered in place?</FP>
                <FP SOURCE="FP-2">○ Has or will the program's ability to provide healthcare services be affected?</FP>
                <FP SOURCE="FP-2">○ Does the program have adequate resources to provide care for children for duration of the event?</FP>
                <FP SOURCE="FP-2">○ Did or will the event affect the program's bed capacity?</FP>
                <FP SOURCE="FP-2">○ Specify Effect on Bed Capacity, with options for:</FP>
                <FP SOURCE="FP1-2"> Beds need to come offline</FP>
                <FP SOURCE="FP1-2"> Unable to receive additional children</FP>
                <FP SOURCE="FP1-2"> Children need to be transferred to another program</FP>
                <P>• Add new areas to document reporting to and the outcome of investigations conducted by the following parties:</P>
                <FP SOURCE="FP-2">○ Child Protective Services</FP>
                <FP SOURCE="FP-2">○ Office of the Inspector General (OIG)</FP>
                <FP SOURCE="FP-2">○ Department of Homeland Security (DHS)</FP>
                <FP SOURCE="FP-2">○ Office on Trafficking in Persons</FP>
                <HD SOURCE="HD1">Revisions Applied to Multiple Forms</HD>
                <P>• Change “UC” to “child” or “children” where possible [all forms].</P>
                <P>• Update the field in the “UC Basic Information” section as follows to align with how information is currently displayed [all forms]:</P>
                <FP SOURCE="FP-2">○ Remove the following fields:</FP>
                <FP SOURCE="FP1-2"> LOC</FP>
                <FP SOURCE="FP1-2"> Age</FP>
                <FP SOURCE="FP1-2"> Current Location</FP>
                <FP SOURCE="FP-2">○ Add system-generated “Portal ID” field</FP>
                <FP SOURCE="FP-2">○ Reword fields as follows:</FP>
                <FP SOURCE="FP1-2"> “A No.” to “A#”</FP>
                <FP SOURCE="FP1-2"> “Child's Country of Birth” to “Country of Birth”</FP>
                <FP SOURCE="FP1-2"> “LOS” to “Length of Stay”</FP>
                <FP SOURCE="FP-2">○ Reorganized the order in which the fields appear</FP>
                <P>• Add a field for “Physical Location of the Child” in the “UC Basic Information Section”.</P>
                <P>• For the “How was this child involved?” and “Were other unaccompanied children involved” fields [eSIR and non-eSIR]:</P>
                <FP SOURCE="FP-2">○ Use terms better aligned with child welfare best practices for incidents involving children by rewording “Victim” to “Impacted” and “Perpetrator” to “Exhibiting.”</FP>
                <FP SOURCE="FP-2">○ Allow users to select multiple options since a child may play multiple roles in an incident. This includes situations where the child is both exhibiting problematic behaviors and impacted due to past trauma or victimization.</FP>
                <P>• In the “Actions Taken” section [eSIR, non-eSIR, and Historical Disclosure]:</P>
                <FP SOURCE="FP-2">
                    ○ Add the following fields to better track compliance with requirements in ORR agency guidance:
                    <PRTPAGE P="105612"/>
                </FP>
                <FP SOURCE="FP1-2"> Was or will the child be referred to the local legal service provider for a follow-up legal consultation?</FP>
                <FP SOURCE="FP1-2"> Was or will the child be referred for appointment of a child advocate?</FP>
                <FP SOURCE="FP-2">○ Add the following fields to better track what healthcare services may be required because of the incident [eSIR, non-eSIR, and Historical Disclosure]:</FP>
                <FP SOURCE="FP1-2"> Was the child hospitalized and/or receive serious medical services? [eSIR only]</FP>
                <FP SOURCE="FP1-2"> Was or will the child be referred for healthcare services?</FP>
                <FP SOURCE="FP1-2"> Specify Type(s) of Healthcare Services (with options for Medical, Mental Health/Behavioral, and Dental)</FP>
                <FP SOURCE="FP1-2"> Describe the healthcare services that were or will be provided</FP>
                <FP SOURCE="FP-2">○ Replace the “Follow-up Regarding Individuals Involved” field, which is duplicative of other fields in the section, with “Actions Taken for Witnesses” [eSIR and non-eSIR]</FP>
                <P>• Add a new “Immediate Phone Call Notifications” section to better track compliance with policy requirements [eSIR and PLE Report].</P>
                <P>• In the Reporting section:</P>
                <FP SOURCE="FP-2">○ Replace the yes/no radio button options for fields that ask if the incident was investigated with a dropdown field that includes the following options: “Yes,” “No,” “To Be Determined,” “Unknown” [eSIR, non-eSIR, Historical Disclosure, and PLE Report]</FP>
                <FP SOURCE="FP-2">○ Add a “Disposition of Investigation” field for reports made to state licensing, child protective services, and local law enforcement to better track outcomes when the incident is investigated by those parties [eSIR, non-eSIR, Historical Disclosure, and PLE Report]</FP>
                <FP SOURCE="FP-2">○ Add a new area to document reports to and the outcome of investigations conducted by the ORR Division of Child Protection Investigations (DCPI) [eSIR, non-eSIR, Historical Disclosure, and PLE Report]</FP>
                <FP SOURCE="FP-2">○ Add a new area to document when an Incident Review form (currently approved under OMB# 0970-0564) must be completed and a place to upload the completed form [eSIR and non-eSIR]</FP>
                <P>• Update the auto-populated information in the “ORR Notifications” table to align with policy and replace the “Email” and “Phone” columns with columns for “Method of Notification” and “Specify” (for when “Other” is selected) [eSIR and PLE Report].</P>
                <P>• Remove the “ORR Notifications” table since notifications are made by ORR's SIR Triage Team, not the care provider [non-eSIR and Historical Disclosure].</P>
                <P>• Update the auto-populated information in the “Other Notifications” table to align with policy and add options for “Messaging app” and “Mail” for the “Method of Notification” field [eSIR and non-eSIR].</P>
                <HD SOURCE="HD1">Revisions to Burden Estimates</HD>
                <P>
                    • 
                    <E T="03">Child-Level Event (Form A-9A):</E>
                     Revise the burden estimate to account for an increase in the number of care provider facilities and to align with the actual number of forms submitted per year. The annual number of respondents increased from 216 to 300 and the annual number of responses per response increased from 160 to 262.
                </P>
                <P>
                    • 
                    <E T="03">Emergency Significant Incident Report (eSIR) (Form A-9B):</E>
                     Revise the burden estimate to account for an increase in the number of care provider facilities and to align with the actual number of forms submitted per year. The annual number of respondents increased from 216 to 300 and the annual number of responses per response decreased from 26 to 10.
                </P>
                <P>
                    • 
                    <E T="03">Non-Emergency Significant Incident Report (non-eSIR)(Form A-9C):</E>
                     Revise the burden estimate to account for an increase in the number of care provider facilities and to align with the actual number of forms submitted per year. The annual number of respondents increased from 216 to 300 and the annual number of responses per response decreased from 261 to 62.
                </P>
                <P>
                    • 
                    <E T="03">Historical Disclosure (Form A-9D):</E>
                     Revise the burden estimate to account for an increase in the number of care provider facilities and to align with the actual number of forms submitted per year. The annual number of respondents increased from 216 to 300 and the annual number of responses per response decreased from 163 to 139.
                </P>
                <P>
                    • 
                    <E T="03">Behavioral Note (Form A-9E):</E>
                     Revise the burden estimate to account for an increase in the number of care provider facilities and to align with the actual number of forms submitted per year. The annual number of respondents increased from 216 to 300 and the annual number of responses per response decreased from 137 to 90.
                </P>
                <P>
                    • 
                    <E T="03">Program-Level Event (PLE) Report (Form A-10):</E>
                     Revise the burden estimate to account for an increase in the number of care provider facilities and to align with the actual number of forms submitted per year. The annual number of respondents increased from 216 to 300 and the annual number of responses per response decreased from 7 to 6.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Care provider programs.
                </P>
                <HD SOURCE="HD2">Annual Burden Estimates</HD>
                <GPOTABLE COLS="5" OPTS="L2,nj,i1" CDEF="s100,12,12,12,10">
                    <TTITLE>Estimated Total Annual Burden Hours</TTITLE>
                    <BOXHD>
                        <CHED H="1">Form</CHED>
                        <CHED H="1">
                            Annual
                            <LI>number of</LI>
                            <LI>respondents</LI>
                        </CHED>
                        <CHED H="1">
                            Number of
                            <LI>responses per</LI>
                            <LI>respondent</LI>
                        </CHED>
                        <CHED H="1">
                            Average
                            <LI>burden</LI>
                            <LI>hours per</LI>
                            <LI>response</LI>
                        </CHED>
                        <CHED H="1">
                            Annual
                            <LI>total</LI>
                            <LI>burden</LI>
                            <LI>hours</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Child-Level Event (Form A-9A)</ENT>
                        <ENT>300</ENT>
                        <ENT>262.0</ENT>
                        <ENT>0.17</ENT>
                        <ENT>13,362</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Emergency Significant Incident Report (Form A-9B)</ENT>
                        <ENT>300</ENT>
                        <ENT>10.0</ENT>
                        <ENT>1.50</ENT>
                        <ENT>4,500</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Non-Emergency Significant Incident Report (Form A-9C)</ENT>
                        <ENT>300</ENT>
                        <ENT>62.0</ENT>
                        <ENT>1.50</ENT>
                        <ENT>27,900</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Historical Disclosure (Form A-9D)</ENT>
                        <ENT>300</ENT>
                        <ENT>139.0</ENT>
                        <ENT>1.50</ENT>
                        <ENT>62,550</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Behavioral Note (Form A-9E)</ENT>
                        <ENT>300</ENT>
                        <ENT>90.0</ENT>
                        <ENT>0.50</ENT>
                        <ENT>13,500</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">Program Level Event (Form A-10D)</ENT>
                        <ENT>300</ENT>
                        <ENT>6.0</ENT>
                        <ENT>1.00</ENT>
                        <ENT>1,800</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Estimated Annual Burden Hours Total</ENT>
                        <ENT/>
                        <ENT/>
                        <ENT/>
                        <ENT>123,612</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    <E T="03">Comments:</E>
                     The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques 
                    <PRTPAGE P="105613"/>
                    or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     6 U.S.C. 279; 8 U.S.C. 1232; 45 CFR 410; 45 CFR 411.
                </P>
                <SIG>
                    <NAME>Mary C. Jones,</NAME>
                    <TITLE>ACF/OPRE Certifying Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30851 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4184-45-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Food and Drug Administration</SUBAGY>
                <DEPDOC>[Docket No. FDA-2024-N-5381]</DEPDOC>
                <SUBJECT>Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Food and Drug Administration (FDA, Agency, or we) is announcing that we have concluded that certain statements set forth in the FDA-approved labeling for buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs) related to the recommended maintenance dosage and dosage adjustments during pregnancy can be modified. We believe that certain statements in BTOD labeling can be modified because the labeling for these products may be misinterpreted by some as establishing a maximum dosage when none exists. FDA is concerned that misinterpretation of these labeling statements may be adversely impacting patients' access to BTODs. We encourage sponsors of approved applications for BTODs to submit supplemental new drug applications (NDAs) (labeling supplements) to modify these labeling statements as described in this notice.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Kimberly Compton, Center for Drug Evaluation and Research (HFD-170), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3168, Silver Spring, MD 20993, 301-796-1191, 
                        <E T="03">kimberly.compton@fda.hhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <HD SOURCE="HD2">A. FDA-Approved BTODs</HD>
                <P>
                    Buprenorphine is a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist. BUPRENEX (buprenorphine hydrochloride (HCl)) injection (under NDA 018401) is a schedule III controlled substance under the Controlled Substances Act (CSA) and was the first buprenorphine product to be approved in the United States (approved in 1981) for management of moderate to severe pain. Other buprenorphine products were subsequently approved for the treatment of opioid use disorder (OUD) 
                    <SU>1</SU>
                    <FTREF/>
                     and are also controlled under schedule III of the CSA.
                    <SU>2</SU>
                    <FTREF/>
                     BTODs have been approved by FDA since 2002. BTODs are available both as products containing buprenorphine alone and as fixed combination drug products containing buprenorphine and naloxone. BTODs include ZUBSOLV (buprenorphine HCl and naloxone HCl) sublingual tablets; SUBOXONE (buprenorphine HCl and naloxone HCl) sublingual film (for sublingual or buccal use); Buprenorphine and Naloxone Sublingual Film; and Buprenorphine and Naloxone Sublingual Tablets.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         For the purposes of this notice, the terms 
                        <E T="03">opioid dependence</E>
                         and 
                        <E T="03">opioid use disorder</E>
                         are used interchangeably.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         21 CFR 1308.13(e).
                    </P>
                </FTNT>
                <P>
                    The first BTODs approved were SUBUTEX (buprenorphine HCl) sublingual tablets (NDA 020732)and SUBOXONE (buprenorphine HCl and naloxone HCl) sublingual tablets (NDA 020733).
                    <SU>3</SU>
                    <FTREF/>
                     Approval of these products was based, in part, on clinical studies of Buprenorphine Sublingual Tablets with and without Naloxone Sublingual Tablets, and on studies of sublingual administration of a more bioavailable ethanolic solution of buprenorphine (Ref. 1). Dosing recommendations were based on data from one trial of both buprenorphine products and two trials of the ethanolic solutions. In a double-blind, parallel-group, 16-week study, 731 subjects were randomized to receive 1 of 4 dosages of buprenorphine ethanolic solution: 1 milligram (mg), 4 mg, 8 mg, and 16 mg. For comparison purposes 1 mg of solution would be equivalent to less than 2 mg of buprenorphine in sublingual tablets; 4 mg, 8 mg, and 16 mg of buprenorphine in the solution would be roughly equivalent to 6 mg, 12 mg, and 24 mg of buprenorphine in sublingual tablets, respectively. Buprenorphine (administered once daily) was titrated to a maintenance dosage over 1 to 4 days and continued for 16 weeks. Based on retention in treatment and the percentage of thrice-weekly urine samples negative for non-study opioids, the three highest tested dosages of the ethanolic solution (
                    <E T="03">i.e.,</E>
                     4 mg, 8 mg, and 16 mg once daily dosages) were superior to the 1 mg once daily dosage. This study and the additional information submitted to support the approval of SUBUTEX and SUBOXONE demonstrated Buprenorphine Sublingual Tablets are effective from 4 mg to 24 mg once daily. The “Dosage and Administration” section of the original labeling for these products in describing the appropriate maintenance dosage read, in part:
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Approvals of Subutex and Suboxone sublingual tablets were withdrawn on September 15, 2022 (87 FR 50337, August 16, 2022).
                    </P>
                </FTNT>
                <P>The dosage of SUBOXONE should be progressively adjusted in increments/decrements of 2 mg or 4 mg to a level that holds the patient in treatment and suppresses opioid withdrawal effects. This is likely to be in the range of 4 mg to 24 mg per day depending on the individual [Ref. 1].</P>
                <P>
                    In 2011, the Agency took several actions including the approval of two additional strengths, updates to the labeling, and modifications to the risk evaluation and mitigation strategy (REMS) for SUBUTEX and SUBOXONE sublingual tablets (Refs. 2, 3, 4, 5). The goals of the REMS for SUBUTEX and SUBOXONE were to mitigate the risks of accidental overdose, particularly in the pediatric population, and to mitigate the risks of misuse and abuse, as well as to inform patients of the serious risks associated with use of these products (Refs. 2, 4
                    <E T="03">).</E>
                     It was at this time and within the context of addressing these concerns that the application holder for SUBUTEX and SUBOXONE proposed changes to the “Dosage and Administration” section of the approved labeling. For SUBOXONE, FDA approved the following language related to the maintenance dosage in the “Dosage and Administration” section of the labeling (SUBUTEX shares similar language in its labeling (Ref. 5)):
                </P>
                <P>• SUBOXONE sublingual tablet is indicated for maintenance treatment.</P>
                <P>• The recommended target dosage of SUBOXONE sublingual tablet is 16 mg/4 mg buprenorphine/naloxone/day as a single daily dose.</P>
                <P>• The dosage of SUBOXONE sublingual tablet should be progressively adjusted in increments/decrements of 2 mg/0.5 mg or 4 mg/1 mg buprenorphine/naloxone to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms.</P>
                <P>
                    • The maintenance dose of SUBOXONE sublingual tablet is generally in the range of 4 mg/1 mg buprenorphine/naloxone to 24 mg/6 mg buprenorphine/naloxone per day depending on the individual patient. Dosages higher than this have not been 
                    <PRTPAGE P="105614"/>
                    demonstrated to provide any clinical advantage.
                </P>
                <P>Relevant to this notice is the inclusion of the statement, “Dosages higher than [24 mg/6 mg buprenorphine/naloxone per day] have not been demonstrated to provide any clinical advantage” in the BTOD labeling (Ref. 5). This language is consistent with 21 CFR 201.57(c)(3)(i)(B) and conveys, in part, that clinical trial data support the safety and effectiveness of buprenorphine dosages up to 24 mg once daily. Although clinical trial data support the effectiveness of buprenorphine dosages ranging from 4 mg to 24 mg once daily for maintenance treatment, this statement may be misconstrued by some as imposing a maximum dosage beyond which buprenorphine may not be prescribed. Further, although the labeling for SUBUTEX and SUBOXONE has always referred to the 16 mg buprenorphine dosage and 16 mg/4 mg buprenorphine and naloxone dosage, respectively, as the “target” dosage, we understand that this too may be misinterpreted as a maximum dosage.</P>
                <P>The labeling for these products has changed since the inclusion of the 2011 statement, but the maintenance dosage recommendations in the “Dosage and Administration” section of the SUBUTEX and SUBOXONE labeling have largely remained the same (Refs. 6, 7). Additionally, labeling for other BTODs includes similar language as the labeling for SUBUTEX and SUBOXONE regarding maintenance dosage and treatment (Refs. 8, 9).</P>
                <HD SOURCE="HD2">B. Perceived Dosage Maximums for BTODs</HD>
                <P>
                    In recent years, a number of interested parties have raised concerns that the labeling for BTODs, in particular the maintenance dosage recommendations in the “Dosage and Administration” section, may be adversely impacting patient access to this OUD treatment. In August 2022, FDA received a citizen petition submitted by the Colorado Society of Addiction Medicine, in which the petitioner raised concerns that the current labeling for BTODs may be perceived as a barrier to prescribing buprenorphine dosages higher than 24 mg once daily 
                    <SU>4</SU>
                    <FTREF/>
                     for certain patients, and even dosages higher than 16 mg once daily, and that the language in the labeling may have other implications, such as being used to limit insurance coverage for higher dosages (Ref. 10).
                    <SU>5</SU>
                    <FTREF/>
                     The citizen petition specifically cited the maintenance dosage recommendations in the “Dosage and Administration” section of the SUBOXONE labeling and asserted that these recommendations do not recognize the needs of certain patients for buprenorphine dosages higher than 24 mg once daily (Ref. 10). In May 2023, the Reagan-Udall Foundation hosted a 2-day public meeting with FDA and the Substance Abuse and Mental Health Services Administration (SAMHSA), entitled “Considerations for Buprenorphine Initiation and Maintenance Care” (Ref. 11). Some interested parties attending the public meeting expressed concerns similar to those raised in the citizen petition about perceived buprenorphine maximum dosages (Refs. 12, 13). Additionally, on December 11, 2023, SAMHSA, FDA, and the National Institute on Drug Abuse, hosted a listening session to discuss the medical need, emerging data, and barriers to accessing higher doses of buprenorphine in the context of high potency synthetic opioid exposure and concerns were raised about a perceived dosage “cap at 24 mg/day” that is “set to the FDA label” for BTODs (Ref. 14).
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         The dosages of buprenorphine listed herein are based on the bioavailability of SUBUTEX and SUBOXONE sublingual tablets. Some fixed combination products containing buprenorphine and naloxone may provide equivalent buprenorphine exposure at alternate dosages due to differences in formulation. Refer to the product labeling for these products, as appropriate, for equivalent dosing to SUBOXONE.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Issues concerning insurance coverage and reimbursement are outside FDA's regulatory purview.
                    </P>
                </FTNT>
                <P>
                    The reported reluctance of some healthcare practitioners to prescribe buprenorphine daily dosages of 24 mg or higher, and even 16 mg in some instances, may be based on a misinterpretation of the labeling that 16 mg or 24 mg once daily dosages are a required “dosage limit.” Some publications have incorrectly interpreted BTOD labeling as imposing “dosage limits” or “dose limits” of 16 mg or 24 mg once daily (Ref. 15). Moreover, the Agency is aware that some States' Medicaid plans require prior authorization as a condition of reimbursement, to include such requirements as documentation of medical necessity for buprenorphine daily dosages of 16 mg or 24 mg and higher, before buprenorphine is dispensed to the patient (Ref. 16). Additionally, we understand that some States impose additional requirements on healthcare practitioners who prescribe buprenorphine dosages higher than 16 mg/day.
                    <SU>6</SU>
                    <FTREF/>
                     States have authority to regulate the activities of doctors and pharmacists within their jurisdictions. However, we want to minimize the possibility that the approved labeling for BTODs is misinterpreted in a way that results in stakeholders believing that such labeling recommendations reflect dosage limitations. The labeling, which states that dosages higher than 24 mg daily “have not been demonstrated to provide any clinical advantage,” or that 16 mg/day is the “recommended target dose,” are not buprenorphine dosage caps.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         See Tennessee Code Annotated section 53-11-311 (d) (requiring the healthcare provider to document rationale for prescribing higher than 16 mg/day); Ohio Administrative Code 4731-33-03 (same).
                    </P>
                </FTNT>
                <P>The inclusion of a buprenorphine “target” dosage in BTOD labeling reflects the need to move quickly from the very low dosages recommended for treatment initiation (to reduce the risk of precipitation of opioid withdrawal) to dosages that are effective for the treatment of opioid dependence. BTOD labeling recommends a “target” buprenorphine daily dosage of 16 mg, which is not a maximum dosage. The labeling for these products recommends that the buprenorphine dosage should be progressively adjusted in increments or decrements to a level that holds the patient in treatment and suppresses opioid withdrawal. The labeling further provides a general range of daily maintenance buprenorphine dosages of 4 mg to 24 mg per day, depending on the individual patient and clinical response.</P>
                <P>The labeling also includes the statement “Dosages higher than 24 mg/day have not been demonstrated to provide a clinical advantage.” This statement informs healthcare practitioners regarding the limitations of data available at the time of approval of the application from adequate and well-controlled studies evaluating safety and efficacy beyond a buprenorphine dosage of 24 mg/day. In other words, higher daily dosages have not been subjected to evaluation in randomized trials; it does not mean that daily dosages higher than 24 mg have been shown to be ineffective or that 24 mg/day is a maximum dosage. The labeling does not include any recommended maximum daily buprenorphine dosage.</P>
                <HD SOURCE="HD1">II. Proposed Revisions to the Labeling for BTODs</HD>
                <HD SOURCE="HD2">A. Ways in Which Labeling May Be Revised</HD>
                <P>
                    Labeling, including the Prescribing Information (PI), must be updated when new information becomes available that causes the labeling to become inaccurate, false, or misleading (21 CFR 201.56(a)(2)). An applicant may, on its own initiative, submit a supplemental NDA (labeling supplement) to propose 
                    <PRTPAGE P="105615"/>
                    changes to the PI based on new information to satisfy this requirement. FDA may also ask applicants to voluntarily update the PI with information, such as safety information or how to safely use the medication, by sending applicants a letter requesting them to submit a labeling supplement. FDA can also require applicants make safety labeling changes if FDA becomes aware of new safety information or information related to reduced effectiveness (pursuant to section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(4))) that it determines should be included in the labeling of the drug. Less commonly, FDA has encouraged application holders to submit labeling supplements to modify the approved labeling of drug products by announcing recommended changes to the labeling through a 
                    <E T="04">Federal Register</E>
                     notice.
                    <SU>7</SU>
                    <FTREF/>
                     We are issuing this notice today because we believe that the recommended clarifications to BTOD labeling would benefit the public health by providing clearer dosage and administration recommendations for these important OUD treatments.
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         See 78 FR 19718 (April 2, 2013), 66 FR 55679 (November 2, 2001).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Recommended Changes to the Maintenance Dosage Recommendations in the “Dosage and Administration” Section of the Labeling</HD>
                <P>The “Dosage and Administration” section of the most recently approved labeling for BTODs contains the following: (1) “Dosages higher than 24 mg daily have not been demonstrated to provide a clinical advantage;” and (2) reference to dosage of 16 mg as a “target” dosage.</P>
                <P>As stated previously, the statement “Dosages higher than 24 mg daily have not been demonstrated to provide a clinical advantage” was added to the labeling to convey, in part, that clinical trial data support the safety and effectiveness of buprenorphine daily dosages up to 24 mg. However, this statement should not be construed as a buprenorphine maximum dosage, and its inclusion is not a recommendation against healthcare practitioners prescribing buprenorphine daily dosages higher than 24 mg.</P>
                <P>Regarding the reference in the labeling to a buprenorphine daily dosage of 16 mg as a “target” dosage, the “target” dosage is to emphasize the need to move quickly from the very low dosages recommended for treatment initiation (to reduce the risk of precipitation of opioid withdrawal) to the dosages that are effective for the treatment of opioid dependence. For example, patients generally begin at a low buprenorphine dosage and titrate upward, which allows the healthcare practitioner to monitor for effectiveness and adverse reactions, such as precipitated opioid withdrawal. During this time of titration, the “target” buprenorphine dosage provides healthcare practitioners with a dosage to aim for because most patients can be stabilized at around 16 mg/day, while also recognizing that further upward titration may be necessary. Due to patient variability in response, daily dosages higher or lower than 16 mg/day may be needed, and each patient should be dosed to clinical effect. The “target” dosage is not a maximum daily maintenance dosage.</P>
                <P>
                    Accordingly, we are announcing that the statements in the labeling that dosages higher than 24 mg daily have not been demonstrated to provide a clinical advantage and the reference to the dosage of 16 mg as a “target” dosage can be modified. FDA recommends the following specific changes to the maintenance dosage recommendations in the “Dosage and Administration” section of the most recent approved BTOD labeling: 
                    <SU>8</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Some BTOD products contain buprenorphine only and others are fixed combination products containing buprenorphine and naloxone. Further, as discussed in footnote 2, some products containing buprenorphine may provide equivalent buprenorphine exposure at alternate doses (
                        <E T="03">e.g.,</E>
                         equivalent to 16 mg or equivalent to 24 mg buprenorphine in SUBUTEX and SUBOXONE) due to differences in formulation. Accordingly, where this notice recommends changes to the labeling, application holders of these BTOD products should update the labeling with appropriate product-specific information, including the appropriate dose(s) specific to their products.
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>After treatment induction to the recommended dose of [equivalent 16 mg buprenorphine OR equivalent 16 mg/4 mg buprenorphine/naloxone] per day, dosing should be further adjusted based on the individual patient and clinical response. The maintenance dose of [DRUG NAME] is generally in the range of [equivalent 4 mg buprenorphine OR equivalent 4 mg/1 mg buprenorphine/naloxone] to [equivalent 24 mg buprenorphine OR equivalent 24 mg/6 mg buprenorphine/naloxone] per day. Dosages higher than [equivalent 24 mg buprenorphine OR equivalent 24 mg/6 mg buprenorphine/naloxone] daily have not been investigated in randomized clinical trials but may be appropriate for some patients.</P>
                </EXTRACT>
                <HD SOURCE="HD2">C. Recommended Changes to the “Pregnancy” Subsection of the “Use in Specific Populations” Section of the Labeling</HD>
                <P>The “Pregnancy” subsection of the “Use in Specific Populations” section of the most recently approved BTOD labeling contains the statements “Dosage adjustments of buprenorphine may be required during pregnancy, even if the patient was maintained on a stable dose prior to pregnancy. Withdrawal signs and symptoms should be monitored closely, and the dose adjusted as necessary” (Refs. 6, 7). To better align with the changes that the Agency is recommending for the maintenance dosage recommendations in the “Dosage and Administration” section of BTOD labeling, the Agency further recommends that “dosage adjustments” be revised in the “Pregnancy” subsection of BTOD labeling to qualify that the adjustment is most often a dosage increase. For example, the labeling would read, “Dosage adjustments of buprenorphine, such as using higher doses, may be required . . . .”</P>
                <P>
                    FDA recommends these changes given the concerns raised regarding the maintenance dosage recommendations in the “Dosage and Administration” section of BTOD labeling. Specifically, it may not be clear from the most recent approved labeling that certain populations, including pregnant females,
                    <SU>9</SU>
                    <FTREF/>
                     may need a higher dosage of buprenorphine. For example, the “Pregnancy” subsection of the “Use in Specific Populations” section of the labeling discusses the possible need for “dosage adjustments” for pregnant females but does not specifically highlight the potential need for higher dosages (Refs. 17, 18, 19, 20). We believe it is important that the labeling clearly communicate that this population may require a higher dosage.
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         For purposes of this notice, “sex” is a biological construct based on anatomical, physiological, hormonal, and genetic (chromosomal) traits, and is generally assigned based on anatomy at birth typically categorized as male or female, but variations occur. Variations of sex refers to differences in sex development or intersex traits. See Measuring Sex, Gender Identity, and Sexual Orientation (2022). National Academies of Science, Engineering, and Medicine. Washington, DC: The National Academies Press. FDA recognizes that sex and gender are distinct terms, with sex defined as a biological construct and gender as a social construct. For more information, see the guidance for industry Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs (November 2020) available at: 
                        <E T="03">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial.</E>
                    </P>
                </FTNT>
                <P>
                    Further, these changes are consistent with the data submitted to support the initial inclusion of the “dosage adjustment” statement to the “Pregnancy” subsection of BTOD labeling (Ref. 21). When the statement on “dosage adjustments” for pregnant females was first added to BTOD labeling, FDA reviewed data showing that this population may need higher 
                    <PRTPAGE P="105616"/>
                    dosages. This labeling statement was supported, in part, by a retrospective case review of buprenorphine dosage adjustments for 45 adult females maintained on buprenorphine during pregnancy, in which 89 percent of all patients required an increase of buprenorphine dosage during pregnancy (Ref. 17). Pharmacokinetic data submitted at the time the “dosage adjustment” statement was added to the “Pregnancy” subsection is also consistent with the changes that are being proposed in this notice. A study of nine pregnant females, where pharmacokinetic data were collected on three subjects, reported a trend suggesting a lower buprenorphine and norbuprenorphine (major metabolite) maximum plasma concentration (C
                    <E T="52">max</E>
                    ) and area under the plasma concentration-time curve (AUC
                    <E T="52">0-24hrs</E>
                    ) over the last 24-hour dosing interval during the third trimester of pregnancy than after delivery (Ref. 22). The magnitude of this exposure reduction was highly variable; however, the study authors found that lower C
                    <E T="52">max</E>
                     and AUC
                    <E T="52">0-24hrs</E>
                     suggest “pregnant opioid-dependent women may require increased [buprenorphine] dose during gestation and decreased dose postpartum” (Ref. 22).
                </P>
                <P>Accordingly, we are announcing that the statement in BTOD labeling regarding the potential need for dosage adjustments during pregnancy can be modified as described below. FDA recommends the following specific change under the “Dose Adjustment during Pregnancy and the Postpartum Period” subheading under the “Clinical Considerations” heading in the “Pregnancy” subsection of the “Use in Specific Populations” section in BTOD labeling:</P>
                <EXTRACT>
                    <P>Dosage adjustments of buprenorphine, such as using higher doses, may be required during pregnancy, even if the patient was maintained on a stable dose prior to pregnancy. Dosing should be based on individual response, and withdrawal signs and symptoms should be monitored closely and the dose adjusted as necessary.</P>
                </EXTRACT>
                <HD SOURCE="HD2">D. Summary of Proposed Labeling Revisions</HD>
                <P>To clarify that the recommendations in the current BTOD labeling do not reflect a maximum buprenorphine dosage of 16 mg or 24 mg once daily, FDA recommends changes to the maintenance dosage recommendations in the “Dosage and Administration” section of BTOD labeling as noted in table 1.</P>
                <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s100,r100">
                    <TTITLE>Table 1—Recommended Changes to Maintenance Dosage Recommendations in the “Dosage and Administration” Section of BTOD Labeling</TTITLE>
                    <BOXHD>
                        <CHED H="1">Most recently approved labeling</CHED>
                        <CHED H="1">Proposed labeling</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="22">2 DOSAGE AND ADMINISTRATION</ENT>
                        <ENT>2 DOSAGE AND ADMINISTRATION</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">. . .</ENT>
                        <ENT>. . .</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03" O="xl">After treatment induction and stabilization, the maintenance dose of [DRUG NAME] is generally in the range of [equivalent 4 mg buprenorphine OR equivalent 4 mg/1 mg buprenorphine/naloxone] to [equivalent 24 mg buprenorphine OR equivalent 24 mg/6 mg buprenorphine/naloxone] per day depending on the individual patient. The recommended target dosage of [DRUG NAME] is [equivalent 16 mg buprenorphine OR equivalent 16 mg/4 mg buprenorphine/naloxone] as a single daily dose. Dosages higher than [equivalent 24 mg buprenorphine OR 24 mg/6 mg buprenorphine/naloxone] have not been demonstrated to provide any clinical advantage.</ENT>
                        <ENT O="oi3">After treatment induction to the recommended dose of [equivalent 16 mg buprenorphine OR equivalent 16 mg/4 mg buprenorphine/naloxone] per day, dosing should be further adjusted based on the individual patient and clinical response. The maintenance dose of [DRUG NAME] is generally in the range of [equivalent 4 mg buprenorphine OR 4 mg/1 mg buprenorphine/naloxone] to [equivalent 24 mg buprenorphine OR equivalent 24 mg/6 mg buprenorphine/naloxone] per day. Dosages higher than [equivalent 24 mg buprenorphine OR equivalent 24 mg/6 mg buprenorphine/naloxone] mg daily have not been investigated in randomized clinical trials but may be appropriate for some patients.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>Additionally, to align with the changes that the Agency is recommending for the maintenance information in the “Dosage and Administration” section of BTOD labeling, FDA recommends changes to the “Dose Adjustment during Pregnancy and the Postpartum Period” subheading under the “Clinical Considerations” heading in the “Pregnancy” subsection of the “Use in Specific Populations” section of BTOD labeling as noted in table 2.</P>
                <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s100,r100">
                    <TTITLE>Table 2—Recommended Changes to the “Pregnancy” Subsection of the “Use in Special Populations” Section of BTOD Labeling</TTITLE>
                    <BOXHD>
                        <CHED H="1">Most recently approved labeling</CHED>
                        <CHED H="1">Proposed labeling</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="22">8 USE IN SPECIFIC POPULATIONS</ENT>
                        <ENT>8 USE IN SPECIFIC POPULATIONS</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">8.1 Pregnancy</ENT>
                        <ENT>8.1 Pregnancy</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">Clinical Considerations</ENT>
                        <ENT>Clinical Considerations</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">. . .</ENT>
                        <ENT>. . .</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22">
                            <E T="03">Dose Adjustment during Pregnancy and the Postpartum Period.</E>
                        </ENT>
                        <ENT>
                            <E T="03">Dose Adjustment during Pregnancy and the Postpartum Period.</E>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03" O="xl">Dosage adjustments of buprenorphine may be required during pregnancy, even if the patient was maintained on a stable dose prior to pregnancy. Withdrawal signs and symptoms should be monitored closely and the dose adjusted as necessary.</ENT>
                        <ENT O="oi3">Dosage adjustments of buprenorphine, such as using higher doses, may be required during pregnancy, even if the patient was maintained on a stable dose prior to pregnancy. Dosing should be based on individual response, and withdrawal signs and symptoms should be monitored closely and the dose adjusted as necessary.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    We have determined that these labeling revisions may be addressed through a supplement submitted under 21 CFR 314.70(c)(6). Any labeling revisions submitted pursuant to this notice should reflect changes to all of 
                    <PRTPAGE P="105617"/>
                    the relevant sections of the labeling identified in this notice, which include the “Dosage and Administration” and “Use in Specific Populations” sections of BTOD labeling.
                </P>
                <HD SOURCE="HD1">III. Electronic Submissions</HD>
                <P>
                    Submit any draft labeling as a prior approval supplement to your NDA. Any labeling supplement must be submitted in the electronic common technical document (eCTD) standard format. The eCTD is the standard format for electronic regulatory submissions to FDA's Center for Drug Evaluation and Research. The FDA Electronic Submissions Gateway (available at: 
                    <E T="03">https://www.fda.gov/industry/electronic-submissions-gateway)</E>
                     is the central transmission point for sending information electronically to FDA and enables the secure submission of regulatory information for review
                    <E T="03">.</E>
                </P>
                <HD SOURCE="HD1">IV. References</HD>
                <P>
                    The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see 
                    <E T="02">ADDRESSES</E>
                    ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at 
                    <E T="03">https://www.regulations.gov.</E>
                     References without asterisks are not on public display at 
                    <E T="03">https://www.regulations.gov</E>
                     because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. Although FDA verified the website addresses in this document, please note that websites are subject to change over time.
                </P>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        1. * Labeling for SUBUTEX (buprenorphine HCl) (NDA 020732) and SUBOXONE (buprenorphine HCl and naloxone HCl) (NDA 020733) sublingual tablets, Oct. 8, 2002, available at: 
                        <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20732,20733lbl.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        2. * Supplement Approval for SUBUTEX (buprenorphine HCl) sublingual tablets (NDA 020732), Dec. 22, 2011, available at: 
                        <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020732s006,s007ltr.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        3. * Labeling for SUBUTEX (buprenorphine HCl) sublingual tablets (NDA 020732), Dec. 22, 2011, available at: 
                        <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020732s006s007lbl.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        4. * Supplement Approval for SUBOXONE (buprenorphine HCl and naloxone HCl) sublingual tablets (NDA 020733), Dec. 22, 2011, available at: 
                        <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020733s007,s008ltr.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        * 5. Labeling for SUBOXONE (buprenorphine HCl and naloxone HCl) sublingual tablets (NDA 020733), Dec. 22, 2011, available at: 
                        <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020733s007s008lbl.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        * 6. Labeling for SUBUTEX (buprenorphine HCl) sublingual tablets (NDA 020732), June 17, 2022, available at: 
                        <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020732s027s028lbl.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        * 7. Labeling for SUBOXONE (buprenorphine HCl and naloxone HCl) sublingual tablets (NDA 020733), June 17, 2022, available at: 
                        <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020733s031s032lbl.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        * 8. ZUBSOLV (buprenorphine HCl and naloxone HCl) sublingual tablets (NDA 204242), Dec. 15, 2023, available at: 
                        <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204242s027lbl.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        * 9. BUNAVAIL (buprenorphine HCl and naloxone HCl) buccal film (NDA 205637), June 17, 2022, available at: 
                        <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205637s023s024lbl.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        * 10. Citizen petition submitted by the Colorado Society of Addiction Medicine (FDA-2022-P-1863), posted Aug. 10, 2022, available at: 
                        <E T="03">https://www.regulations.gov/docket/FDA-2022-P-1863.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        11. Reagan-Udall Foundation, virtual public meeting entitled “Considerations for Buprenorphine Initiation and Maintenance Care,” May 10-11, 2023, meeting materials and transcripts available at: 
                        <E T="03">https://reaganudall.org/news-and-events/events/considerations-buprenorphine-initiation-and-maintenance-care.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        12. Reagan-Udall Foundation, Meeting Transcript, “Considerations for Buprenorphine Initiation and Maintenance Care—Day One,” May 10, 2023, available at: 
                        <E T="03">https://reaganudall.org/sites/default/files/2023-07/Transcript%20-%20Buprenorphine%20Initiation%20-%20Day%201%20-%20REVISED%20FINAL.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        13. Reagan-Udall Foundation, Meeting Transcript, “Considerations for Buprenorphine Initiation and Maintenance Care—Day Two,” May 11, 2023, available at: 
                        <E T="03">https://reaganudall.org/sites/default/files/2023-05/Transcript%20-%20Buprenorphine%20Initiation%20-%20Day%202%20-%20final.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        * 14. SAMHSA, Meeting Summary, “Listening Session: Use of High Dose Buprenorphine for the Treatment of Opioid Use Disorder,” December 11, 2023, available at: 
                        <E T="03">https://store.samhsa.gov/sites/default/files/high-dose-buprenorphine-report-pep24-02-013.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        15. Grande, LA, D Cundiff, MK Greenwald, et al., 2023, “Evidence on Buprenorphine Dose Limits: A Review,” 
                        <E T="03">J Addict Med,</E>
                         17(5): 509-516.
                    </FP>
                    <FP SOURCE="FP-2">
                        16. Tiako, MJN, A Dolan, M Abrams, et al., 2023, “Thematic Analysis of State Medicaid Buprenorphine Prior Authorization Requirements,” 
                        <E T="03">JAMA Netw Open,</E>
                         6(6):e2318487.
                    </FP>
                    <FP SOURCE="FP-2">
                        17. Bakaysa, S, S Heil, and M Meyer, 2009, “833: Buprenorphine Dose Changes During Gestation,” 
                        <E T="03">Am J Obstet Gynecol,</E>
                         201(6):S297-S298.
                    </FP>
                    <FP SOURCE="FP-2">
                        18. Martin, CE, C Shadowen, B Thakkar, et al., 2020, “Buprenorphine Dosing for the Treatment of Opioid Use Disorder Through Pregnancy and Postpartum,” 
                        <E T="03">Curr Treat Options Psychiatry,</E>
                         7(3): 375-399.
                    </FP>
                    <FP SOURCE="FP-2">
                        19. The American College of Obstetricians and Gynecologists, “Opioid Use and Opioid Use Disorder in Pregnancy,” Committee Opinion Number 711, August 2017, available at: 
                        <E T="03">https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/08/opioid-use-and-opioid-use-disorder-in-pregnancy.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        * 20. Substance Abuse and Mental Health Services Administration (SAMHSA) Advisory, “Evidence-Based, Whole-Person Care for Pregnant People Who Have Opioid Use Disorder,” March 2024, available at: 
                        <E T="03">https://store.samhsa.gov/sites/default/files/whole-person-care-pregnant-people-oud-pep23-02-01-002.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        * 21. Supplement Approval for SUBOXONE (buprenorphine HCl and naloxone HCl) sublingual film (NDA 022410), Feb. 13, 2017, available at: 
                        <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022410Orig1s023ltr.pdf.</E>
                    </FP>
                    <FP SOURCE="FP-2">
                        22. Concheiro, M, HE Jones, RE Johnson, et al., 2011, “Preliminary Buprenorphine Sublingual Tablet Pharmacokinetic Data in Plasma, Oral Fluid and Sweat During Treatment of Opioid-Dependent Pregnant Women,” 
                        <E T="03">The Drug Monit,</E>
                         33(5):619-626.
                    </FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: December 18, 2024.</DATED>
                    <NAME>P. Ritu Nalubola,</NAME>
                    <TITLE>Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30776 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4164-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Indian Health Service</SUBAGY>
                <SUBJECT>Request for Public Comment: 60-Day Notice for Extension of the Indian Health Service Loan Repayment Program</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Indian Health Service, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice and request for comments; request for extension of approval.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917-
                        <PRTPAGE P="105618"/>
                        0014, titled, “IHS Loan Repayment Program (LRP).” This notice announces our intent to submit this collection, which expires February 28, 2025, to the OMB for approval of an extension and solicit comments on specific aspects for the proposed information collection.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Consideration will be given to all comments received by February 25, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P/>
                    <P>
                        <E T="03">For Comments:</E>
                         Submit comments to Correy Ahhaitty by one of the following methods:
                    </P>
                    <P>
                        • 
                        <E T="03">Email:</E>
                          
                        <E T="03">Correy.Ahhaitty@ihs.gov.</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Phone:</E>
                         (301) 443-2544.
                    </P>
                    <P>
                        Comments submitted in response to this notice will be made available to the public by publishing them in the 30-day 
                        <E T="04">Federal Register</E>
                         Notice for this information collection. For this reason, please do not include information of a confidential nature, such as sensitive personal information or proprietary information. If comments are submitted via email, the email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. Please note that responses to this public comment request containing any routine notice about the confidentiality of the communication will be treated as public comments that may be made available to the public notwithstanding the inclusion of the routine notice.
                    </P>
                    <P>
                        A copy of the draft supporting statement is available at 
                        <E T="03">www.regulations.gov</E>
                         (see Docket ID (IHS_FRDOC_0001)).
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        To request additional information, please contact Patricia Lawton, Information Collection Clearance Officer at: 
                        <E T="03">Patricia.Lawton@ihs.gov</E>
                         or 240-381-9031.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This previously approved information collection project was last published in the 
                    <E T="04">Federal Register</E>
                     (86 FR 60055) on October 29, 2021, and allowed 30 days for public comment. No public comment was received in response to the notice.
                </P>
                <P>
                    The IHS is submitting the proposed information collection to the OMB for review, as required by the Paperwork Reduction Act of 1995, as amended, and its implementing regulations. This notice is soliciting comments from members of the public and affected agencies as required by 44 U.S.C. 3506(c)(2)(A) and 5 CFR 1320.8(d) concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques of other forms of information technology, 
                    <E T="03">e.g.,</E>
                     permitting electronic submission of responses.
                </P>
                <P>
                    <E T="03">Title:</E>
                     0917-0014, “Indian Health Service Loan Repayment Program.”
                </P>
                <P>
                    <E T="03">Type of Information Collection Request:</E>
                     3-year extension approval of this information collection.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     0917-0014.
                </P>
                <P>
                    <E T="03">Forms:</E>
                     Educational and Professional Background, Financial Information, and General Applicant Information (
                    <E T="03">i.e.,</E>
                     all forms are part of the LRP application). The LRP application is available in an electronically fillable and fileable format.
                </P>
                <P>
                    <E T="03">Need and Use of Information Collection:</E>
                     The IHS LRP identifies health professionals with pre-existing financial obligations for education expenses that meet program criteria and who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract through which the IHS agrees to repay part or all of their indebtedness in exchange for an initial 2-year service commitment to practice full-time at an eligible Indian health program. This program is necessary to augment the critically low health professional staff at IHS health care facilities.
                </P>
                <P>Eligible health professionals wishing to have their health education loans repaid may apply to the IHS LRP. A 2-year contract obligation is signed by both parties, and the individual agrees to work at an eligible Indian health program location and provide health services to American Indian and Alaska Native individuals.</P>
                <P>The information collected via the online application from individuals is analyzed and a score is given to each applicant. This score will determine which applicants will be awarded each fiscal year (FY). The administrative scoring system assigns a score to the geographic location according to vacancy rates for that FY and also considers whether the location is in an isolated area. When an applicant accepts employment at a location, the applicant in turn “picks-up” the score of that location.</P>
                <P>
                    <E T="03">Status of the Proposed Information Collection:</E>
                     Renewal of a current collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Individuals and households.
                </P>
                <P>
                    <E T="03">Type of Respondents:</E>
                     Individuals.
                </P>
                <P>The table below provides: Types of data collection instruments, estimated number of respondents, number of responses per respondent, average burden hour per response, and total annual burden hours.</P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s100,12C,12C,12C,12C">
                    <TTITLE>Estimated Burden Hours</TTITLE>
                    <BOXHD>
                        <CHED H="1">Data collection instrument(s)</CHED>
                        <CHED H="1">
                            Number of
                            <LI>respondents</LI>
                        </CHED>
                        <CHED H="1">
                            Number of
                            <LI>responses</LI>
                            <LI>per respondent</LI>
                        </CHED>
                        <CHED H="1">
                            Average
                            <LI>burden</LI>
                            <LI>per response</LI>
                            <LI>(in hours)</LI>
                        </CHED>
                        <CHED H="1">
                            Total
                            <LI>annual</LI>
                            <LI>burden</LI>
                            <LI>responses</LI>
                            <LI>(in hours)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">LRP Application (3 forms in total)</ENT>
                        <ENT>1999</ENT>
                        <ENT>1</ENT>
                        <ENT>1.5</ENT>
                        <ENT>2998.5</ENT>
                    </ROW>
                </GPOTABLE>
                <PRTPAGE P="105619"/>
                <P>There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.</P>
                <SIG>
                    <NAME>Roselyn Tso,</NAME>
                    <TITLE>Director, Indian Health Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31030 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4165-16-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute of Mental Health; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors, National Institute of Mental Health.</P>
                <P>The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Mental Health, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         Board of Scientific Counselors, National Institute of Mental Health.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 5-7, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         February 05, 2025, 9:30 a.m. to 6:15 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate personnel qualifications and performance, and competence of individual investigators.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         Porter Neuroscience Research Center, Building 35A, 35 Convent Drive, Bethesda, MD 20892 (In Person and Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         February 06, 2025, 10:00 a.m. to 5:15 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate personnel qualifications and performance, and competence of individual investigators.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         Porter Neuroscience Research Center, Building 35A, 35 Convent Drive, Bethesda, MD 20892 (In Person and Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         February 07, 2025, 10:00 a.m. to 3:15 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate personnel qualifications and performance, and competence of individual investigators.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         Porter Neuroscience Research Center, Building 35A, 35 Convent Drive, Bethesda, MD 20892 (In Person and Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Jennifer E Mehren, Ph.D., Scientific Advisor, Division of Intramural Research Programs, National Institute of Mental Health, National Institutes of Health, 35A Convent Drive, Bethesda, MD 20892-3747, 301-496-3501, email: 
                        <E T="03">mehrenj@mail.nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: December 20, 2024.</DATED>
                    <NAME>Bruce A. George, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30957 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute on Aging; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute on Aging Special Emphasis Panel; Aging and Spinal Cord Injury.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 12, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         1:30 p.m. to 6:30 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institute on Aging, 5601 Fishers Lane, Suite 8B, Rockville, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                        <E T="03">Contact Person:</E>
                         Michael James Butler, Ph.D., Scientific Review Officer National Institute on Aging, National Institutes of Health, 5601 Fishers Lane, Suite 8B, Rockville, MD 20852, (301) 496-9666, 
                        <E T="03">michael.butler@nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: December 19, 2024 </DATED>
                    <NAME>Miguelina Perez, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30879 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute on Aging; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute on Aging Special Emphasis Panel; Maternal Nutrition and Aging.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 4, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         11:00 a.m. to 5:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institute on Aging, 5601 Fishers Lane, Suite 8B, Rockville, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Kaitlyn Noel Lewis Hardell, Ph.D., MPH, Scientific Review Officer, National Institute on Aging, National Institutes of Health, 5601 Fishers Lane, Suite 8B, Rockville, MD 20892, (301) 594-7945, 
                        <E T="03">kaitlyn.hardell@nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: December 19, 2024. </DATED>
                    <NAME>Miguelina Perez, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30881 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute on Aging; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>
                    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial 
                    <PRTPAGE P="105620"/>
                    property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
                </P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute on Aging Special Emphasis Panel Biomarkers for AD &amp; ADRD.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 13, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 1:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institute on Aging, 5601 Fishers Lane, Suite 8B, Rockville, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Anita T Tandle, Ph.D., Scientific Review Officer, National Institute of Aging, National Institute of Health, 5601 Fishers Lane, Suite 8B, Rockville, MD 20852, (240) 276-5085, 
                        <E T="03">tandlea@mail.nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: December 19, 2024. </DATED>
                    <NAME>Miguelina Perez, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30874 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute on Aging; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute on Aging Special Emphasis Panel; Research Infrastructure Development for Interdisciplinary Aging Studies.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         March 6, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         9 a.m. to 5 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institute on Aging, 5601 Fishers Lane, Suite 8B, Rockville, MD 20852.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Thomas John O'Farrell, Ph.D., Scientific Review Officer National Institute of Aging, National Institute of Health, 5601 Fishers Lane, Suite 8B, Rockville, MD 20852, (301) 402-8559, 
                        <E T="03">tom.ofarrell@nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: December 19, 2024. </DATED>
                    <NAME>Miguelina Perez, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30876 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute on Aging; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. </P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute on Aging Special Emphasis Panel; Retromer Function and Alzheimer's Disease.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 19, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 3:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institute on Aging, 5601 Fishers Lane, Suite 8B, Rockville, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Michael James Butler, Ph.D., Scientific Review Officer, National Institute on Aging, National Institutes of Health, 5601 Fishers Lane, Suite 8B, Rockville, MD 20852, (301) 496-9666, 
                        <E T="03">michael.butler@nih.gov.</E>
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Miguelina Perez, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30878 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>National Institute on Aging; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.</P>
                <P>The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.</P>
                <EXTRACT>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Institute on Aging Special Emphasis Panel; Short Courses.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         February 7, 2025.
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         2:00 p.m. to 6:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Address:</E>
                         National Institute on Aging, 5601 Fishers Lane, Suite 8B, Rockville, MD 20892.
                    </P>
                    <P>
                        <E T="03">Meeting Format:</E>
                         Virtual Meeting.
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Kimberly Firth, Ph.D., Scientific Review Officer, National Institute of Aging, National Institute of Health, 5601 Fishers Lane, Suite 8B, Rockville, MD 20852, 301-402-7702, 
                        <E T="03">firthkm@mail.nih.gov</E>
                        .
                    </P>
                    <FP>(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: December 19, 2024. </DATED>
                    <NAME>Miguelina Perez, </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30875 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4140-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <SUBAGY>Transportation Security Administration</SUBAGY>
                <SUBJECT>Intent to Request Extension From OMB of One Current Public Collection of Information: Speaker Request Form</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Transportation Security Administration, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>60-Day notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Transportation Security Administration (TSA) invites public comment on one currently approved Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0075, abstracted below that we will submit to 
                        <PRTPAGE P="105621"/>
                        OMB for an extension in compliance with the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. The collection involves point of contact information for the person/organization requesting a TSA speaker; logistical information for that speaking engagement; and context for the request to determine the audience reach, any ethical concerns, and possible promotion of the speaking engagement.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Send your comments by February 25, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments may be emailed to 
                        <E T="03">TSAPRA@tsa.dhs.gov</E>
                         or delivered to the TSA PRA Officer, Information Technology, TSA-11, Transportation Security Administration, 6595 Springfield Center Drive, Springfield, VA 20598-6011.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Christina A. Walsh at the above address, or by telephone (571) 227-2062.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ), an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The ICR documentation will be available at 
                    <E T="03">https://www.reginfo.gov</E>
                     upon its submission to OMB. Therefore, in preparation for OMB review and approval of the following information collection, TSA is soliciting comments to—
                </P>
                <P>(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;</P>
                <P>(2) Evaluate the accuracy of the agency's estimate of the burden;</P>
                <P>(3) Enhance the quality, utility, and clarity of the information to be collected; and</P>
                <P>(4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.</P>
                <HD SOURCE="HD1">Information Collection Requirement</HD>
                <P>
                    <E T="03">OMB Control Number 1652-0075; Speaker Request Form.</E>
                     Under the Aviation and Transportation Security Act (ATSA) (Pub. L. 107-71; 115 Stat. 597; Nov. 19, 2001), TSA is responsible for security in all modes of transportation, including screening operations for passenger air transportation and for carrying out such other duties it considers appropriate relating to transportation security. 
                    <E T="03">See</E>
                     sec. 101(a) of ATSA, 115 Stat. 597-598, as codified at 49 U.S.C. 114(d) and (f). DHS Directive 110-02 established the Department of Homeland Security (DHS) policy with respect to the acceptance of public speaking invitations by DHS employees and formally implemented the Office of Public Affairs DHS Speakers Bureau as well as DHS Component speaker bureaus. Based on these requirements, TSA created its own Speaker Bureau and modeled it after the DHS Speakers Bureau process to allow for the acceptance of public speaking invitations.
                </P>
                <P>
                    To comply with the policy, TSA created the Speaker Request Form, which collects information on the requestor and the event a speaker would attend. The form requests the name of the organization; the event sponsor; whether it is a profit or nonprofit organization; the point of contact information for the person coordinating the event; the title, date, time, and location of the event; the type of event (
                    <E T="03">e.g.,</E>
                     keynote, dinner, panel, interview, etc.); the purpose of the event; the event website, the topics of discussion; the audience makeup; other notable guests; and if media will be attending.
                </P>
                <P>This basic contact information is needed to respond to the requestor, determine where to find a TSA speaker geographically, and determine what resources would be needed to send a speaker to the event. TSA uses this information to determine if it is consistent with federal ethics requirements to send a speaker to the speaking engagement and if it aligns with the agency's communication goals. If TSA determines it is in the best interests of the agency to participate, TSA will also use this information to select who should speak on behalf of the agency on the requested topics. The information is collected only once for any engagement and is completely voluntary on the part of the requestor. The form streamlines the TSA Speaker Request's coordination and reduces and confusion with the requestor.</P>
                <P>
                    TSA is submitting the form as a Common Form to permit Federal agency users beyond the agency that created the form (
                    <E T="03">e.g.,</E>
                     DHS or U.S. Office of Personnel Management) to streamline the information collection process in coordination with OMB.
                </P>
                <P>TSA expects to receive approximately 300 speaker requests per year. The agency estimates that each respondent will spend approximately 10 minutes to complete the Speaker Request Form, for a total annual burden of 3,000 minutes (50 hours).</P>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Christina A. Walsh,</NAME>
                    <TITLE>TSA Paperwork Reduction Act Officer, Information Technology.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30789 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-05-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT</AGENCY>
                <DEPDOC>[Docket No. FR-7080-N-62]</DEPDOC>
                <SUBJECT>30-Day Notice of Proposed Information Collection; OCHCO Personnel Security Integrated System for Tracking (PerSIST); OMB Control No.: 2501-0038</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Policy Development and Research, Chief Data Officer, HUD.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for an additional 30 days of public comment.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Comments Due Date:</E>
                         January 27, 2025.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Interested persons are invited to submit comments regarding this proposal. Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Interested persons are also invited to submit comments regarding this proposal by name and/or OMB Control Number and should be sent to: Anna Guido, Clearance Officer, REE, Department of Housing and Urban Development, 451 7th Street SW, Room 8210, Washington, DC 20410-5000; telephone 202-402-5534 (this is not a toll-free number).
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Anna Guido, Clearance Officer, REE, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410; email 
                        <E T="03">Anna.P.Guido@hud.gov,</E>
                         telephone 202-402-5534. This is not a toll-free number. HUD welcomes and is prepared to receive calls from individuals who are deaf or hard of hearing, as well as 
                        <PRTPAGE P="105622"/>
                        individuals with speech or communication disabilities. To learn more about how to make an accessible telephone call, please visit 
                        <E T="03">https://www.fcc.gov/consumers/guides/telecommunications-relay-service-trs.</E>
                        Copies of available documents submitted to OMB may be obtained from Ms. Guido.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.</P>
                <P>
                    The 
                    <E T="04">Federal Register</E>
                     notice that solicited public comment on the information collection for a period of 60 days was published on October 15, 2024 at 89 FR 83034.
                </P>
                <HD SOURCE="HD1">A. Overview of Information Collection</HD>
                <P>
                    <E T="03">Title of Information Collection:</E>
                     OCHCO Personnel Security Integrated System for Tracking (PerSIST); 22019 PIV Pre-Screen Application.
                </P>
                <P>
                    <E T="03">MB Approval Number:</E>
                     2501-0038.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     HUD 22019.
                </P>
                <P>
                    <E T="03">Description of the need for the information and proposed use:</E>
                     The PII collected and maintained in PerSIST is relevant and necessary to carrying out the investigatory process used to document and support decisions regarding the suitability, eligibility, and fitness for service of applicants for federal employment and contract positions, including long-term students, interns, or volunteers to the extent that their duties require access to federal facilities, information, systems, or applications.
                </P>
                <GPOTABLE COLS="8" OPTS="L2,tp0,p7,7/8,i1" CDEF="s50,10,10,10,10,10,10,10">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Information collection</CHED>
                        <CHED H="1">Number of respondents</CHED>
                        <CHED H="1">Frequency of response</CHED>
                        <CHED H="1">
                            Responses
                            <LI>per annum</LI>
                        </CHED>
                        <CHED H="1">
                            Burden hour per
                            <LI>response</LI>
                        </CHED>
                        <CHED H="1">
                            Annual
                            <LI>burden</LI>
                            <LI>hours</LI>
                        </CHED>
                        <CHED H="1">
                            Hourly cost per
                            <LI>response</LI>
                        </CHED>
                        <CHED H="1">Annual cost</CHED>
                    </BOXHD>
                    <ROW RUL="n,s">
                        <ENT I="01">22019 PIV Pre-Screen Application</ENT>
                        <ENT>1,625</ENT>
                        <ENT>1</ENT>
                        <ENT>1,625</ENT>
                        <ENT>.17</ENT>
                        <ENT>276.25</ENT>
                        <ENT>$43.77</ENT>
                        <ENT>$12,091.46</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total</ENT>
                        <ENT>1,625</ENT>
                        <ENT>1</ENT>
                        <ENT>1,625</ENT>
                        <ENT>.17</ENT>
                        <ENT>276.25</ENT>
                        <ENT>43.77</ENT>
                        <ENT>12,091.46</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">B. Solicitation of Public Comment</HD>
                <P>This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:</P>
                <P>(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;</P>
                <P>(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;</P>
                <P>(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and</P>
                <P>
                    (4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, 
                    <E T="03">e.g.,</E>
                     permitting electronic submission of responses.
                </P>
                <P>(5) Ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology. </P>
                <P>HUD encourages interested parties to submit comment in response to these questions.</P>
                <HD SOURCE="HD1">C. Authority</HD>
                <P>Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35.</P>
                <SIG>
                    <NAME>Colette Pollard,</NAME>
                    <TITLE>Department Reports Management Officer, Office of Policy Development and Research, Chief Data Officer. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31120 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4210-67-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT</AGENCY>
                <DEPDOC>[Docket No. FR-7086-N-34]</DEPDOC>
                <SUBJECT>60-Day Notice of Proposed Information Collection: Application for Roster Personnel (Appraisers) Designation and Appraisal Reports; OMB Control No.: 2502-0538</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Housing and Urban Development (HUD) is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Comments Due Date:</E>
                         February 25, 2025.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Interested persons are invited to submit comments regarding this proposal. Written comments and recommendations for the proposed information collection can be sent within 60 days of publication of this notice to 
                        <E T="03">www.regulations.gov.</E>
                         Interested persons are also invited to submit comments regarding this proposal by name and/or OMB Control Number and can be sent to: Anna Guido, Clearance Officer, REE, Department of Housing and Urban Development, 451 7th Street SW, Room 8210, Washington, DC 20410, telephone (202) 402-5535. (this is not a toll-free number) or email at 
                        <E T="03">Anna.P.Guido@hud.gov</E>
                         for a copy of the proposed forms or other available information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Anna Guido, Clearance Officer, REE, Department of Housing and Urban Development, 451 7th Street SW, Room 4176, Washington, DC 20410; telephone (202) 402-5535 (this is not a toll-free number) or email at 
                        <E T="03">Anna.P.Guido@hud.gov.</E>
                         HUD welcomes and is prepared to receive calls from individuals who are deaf or hard of hearing, as well as individuals with speech and communication disabilities. To learn more about how to make an accessible telephone call, please visit 
                        <E T="03">https://www.fcc.gov/consumers/guides/telecommunications-relay-service-trs.</E>
                    </P>
                    <P>Copies of available documents submitted to OMB may be obtained from Ms. Guido.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.</P>
                <HD SOURCE="HD1">A. Overview of Information Collection</HD>
                <P>
                    <E T="03">Title of Information Collection:</E>
                     Application for Fee or Roster Personnel (Appraisers). Designation and Appraisal Reports.
                </P>
                <P>
                    <E T="03">OMB Approval Number:</E>
                     2502-0538.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Extension.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     HUD 92563-A, HUD 92564-CN, Fannie Mae Forms: 1004, 1004C, 1004D, 1007, 1025, 1073, 1075, and 2055.
                </P>
                <P>
                    <E T="03">Description of the need for the information and proposed use:</E>
                     Accurate and thorough Appraisal reporting is critical to the accuracy of underwriting for the mortgage insurance process. The need for accuracy is increased for a Federal Housing Administration (FHA) 
                    <PRTPAGE P="105623"/>
                    insured mortgage since buyers tend to have more limited income and lower equity in the properties. This collection of information provides a more thorough and complete appraisal of prospective HUD-insured single-family properties ensuring that mortgages are acceptable for FHA insurance and thereby protect the interest of HUD, the taxpayers, and the FHA insurance fund. The collection allows HUD to maintain an effective appraisal program with the ability to discipline appraisers and inform potential homeowners of the benefits of purchasing an independent home inspection.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     Business or other for profit and potential home purchasers.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     22,973.
                </P>
                <P>
                    <E T="03">Estimated Number of Responses:</E>
                     657,287.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Average Hours per Response:</E>
                     0.02.
                </P>
                <P>
                    <E T="03">Total Estimated Burdens:</E>
                     $497,627.
                </P>
                <HD SOURCE="HD1">B. Solicitation of Public Comment</HD>
                <P>This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:</P>
                <P>
                    (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, 
                    <E T="03">e.g.,</E>
                     permitting electronic submission of responses.
                </P>
                <P>HUD encourages interested parties to submit comments in response to these questions.</P>
                <HD SOURCE="HD1">C. Authority</HD>
                <P>Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35.</P>
                <SIG>
                    <NAME>Jeffrey D. Little,</NAME>
                    <TITLE>General Deputy Assistant Secretary for Housing.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30796 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4210-67-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[PO #4820000251]</DEPDOC>
                <SUBJECT>Notice of Availability of the Approved Resource Management Plan Amendments and Record of Decision for Utility-Scale Solar Energy Development</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Bureau of Land Management (BLM) announces the availability of a Record of Decision (ROD) for Approved Resource Management Plan (RMP) Amendments that update the public lands management framework to support utility-scale solar energy development and improve protection of important and sensitive resources.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The BLM Principal Deputy Director and the Department of the Interior Principal Deputy Assistant Secretary for Land and Minerals Management signed the ROD on December 19, 2024, which constitutes the decision of the BLM, as approved by the Department of the Interior, and makes the Approved RMP Amendments effective immediately.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The ROD/Approved RMP Amendments are available online at 
                        <E T="03">https://eplanning.blm.gov/eplanning-ui/project/2022371/510.</E>
                    </P>
                    <P>
                        Printed copies of the ROD/Approved RMP Amendments are available for public inspection at the BLM State Offices in Arizona, California, Colorado, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, and Wyoming or can be provided upon request by contacting the BLM at 
                        <E T="03">solar@blm.gov.</E>
                    </P>
                    <P>
                        A copy of the Protest Resolution Report is available at: 
                        <E T="03">https://www.blm.gov/programs/planning-and-nepa/public-participation/protest-resolution-reports.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Scott Whitesides, Project Manager, National Renewable Energy Coordination Office, BLM Headquarters, email: 
                        <E T="03">solar@blm.gov</E>
                         or telephone: (801) 598-8669. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services for contacting Mr. Whitesides. Individuals outside the United States should use the relay services offered within their country to make international calls to the point of contact in the United States.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Approved RMP Amendments change the following existing plans:</P>
                <FP SOURCE="FP-1">• Agua Fria NM RMP (2010)</FP>
                <FP SOURCE="FP-1">• Arizona Strip RMP (2008)</FP>
                <FP SOURCE="FP-1">• Bradshaw Harquahala RMP (2010)</FP>
                <FP SOURCE="FP-1">• Grand Canyon-Parashant NM RMP (2008)</FP>
                <FP SOURCE="FP-1">• Ironwood Forest NM RMP (2013)</FP>
                <FP SOURCE="FP-1">• Kingman RMP (1995)</FP>
                <FP SOURCE="FP-1">• Lake Havasu RMP (2007)</FP>
                <FP SOURCE="FP-1">• Las Cienegas RMP (2003)</FP>
                <FP SOURCE="FP-1">• Lower Gila North MFP (1983)</FP>
                <FP SOURCE="FP-1">• Lower Sonoran RMP (2012)</FP>
                <FP SOURCE="FP-1">• Phoenix RMP (1989)</FP>
                <FP SOURCE="FP-1">• Safford RMP (1992/1994)</FP>
                <FP SOURCE="FP-1">• San Pedro Riparian NCA RMP (2019)</FP>
                <FP SOURCE="FP-1">• Sonoran Desert NM RMP (2012)</FP>
                <FP SOURCE="FP-1">• Vermilion Cliffs NM RMP (2008)</FP>
                <FP SOURCE="FP-1">• Yuma RMP (2010)</FP>
                <FP SOURCE="FP-1">• Alturas RMP (2008)</FP>
                <FP SOURCE="FP-1">• Bakersfield RMP (2014)</FP>
                <FP SOURCE="FP-1">• Bishop RMP (1993, 2016)</FP>
                <FP SOURCE="FP-1">• California Coastal NM RMP (2005)</FP>
                <FP SOURCE="FP-1">• California Desert Conservation Area Plan (2016)</FP>
                <FP SOURCE="FP-1">• Carrizo Plain NM RMP (2010)</FP>
                <FP SOURCE="FP-1">• Clear Creek RMP (2014)</FP>
                <FP SOURCE="FP-1">• Eagle Lake RMP (2008)</FP>
                <FP SOURCE="FP-1">• Eastern San Diego County RMP (2008)</FP>
                <FP SOURCE="FP-1">• Headwaters Forest Reserve RMP (2004)</FP>
                <FP SOURCE="FP-1">• King Range NCA RMP (2005)</FP>
                <FP SOURCE="FP-1">• Northwest California Integrated RMP (2024)</FP>
                <FP SOURCE="FP-1">• Santa Rosa and San Jacinto Mountains NM RMP (2004)</FP>
                <FP SOURCE="FP-1">• Sierra RMP (2007)</FP>
                <FP SOURCE="FP-1">• South Coast RMP (1994)</FP>
                <FP SOURCE="FP-1">• Southern Diablo Mountain Range and Central Coast of California RMP (2007)</FP>
                <FP SOURCE="FP-1">• Surprise RMP (2008)</FP>
                <FP SOURCE="FP-1">• Ukiah RMP (2006)</FP>
                <FP SOURCE="FP-1">• Cotoni-Coast Dairies RMP Amendment—Environmental Assessment (2021)</FP>
                <FP SOURCE="FP-1">• Browns Canyon NM RMP (2020)</FP>
                <FP SOURCE="FP-1">• Canyons of the Ancients NM RMP (2010)</FP>
                <FP SOURCE="FP-1">• Colorado River Valley RMP (2015)</FP>
                <FP SOURCE="FP-1">• Colorado River Valley Roan Plateau RMP (2016)</FP>
                <FP SOURCE="FP-1">• Dominguez-Escalante NCA RMP (2017)</FP>
                <FP SOURCE="FP-1">• Eastern Colorado RMP (2024)</FP>
                <FP SOURCE="FP-1">• Grand Junction RMP (2015</FP>
                <FP SOURCE="FP-1">• Gunnison Gorge NCA RMP (2004)</FP>
                <FP SOURCE="FP-1">• Gunnison RMP (1993)</FP>
                <FP SOURCE="FP-1">• Kremmling RMP (2015)</FP>
                <FP SOURCE="FP-1">• Little Snake RMP (2011)</FP>
                <FP SOURCE="FP-1">• McInnis Canyons NCA RMP (2004)</FP>
                <FP SOURCE="FP-1">• San Luis RMP (1991)</FP>
                <FP SOURCE="FP-1">• Tres Rios RMP (2015)</FP>
                <FP SOURCE="FP-1">• Uncompahgre RMP (2020)</FP>
                <FP SOURCE="FP-1">• White River RMP (1997)</FP>
                <FP SOURCE="FP-1">
                    • Gunnison Sage-Grouse Resource Management Plan Amendment (2024)
                    <PRTPAGE P="105624"/>
                </FP>
                <FP SOURCE="FP-1">• Bennett Hills Timmerman Hills MFP (1980)</FP>
                <FP SOURCE="FP-1">• Big Desert MFP (1981)</FP>
                <FP SOURCE="FP-1">• Big Lost MFP (1982)</FP>
                <FP SOURCE="FP-1">• Bruneau MFP (1983)</FP>
                <FP SOURCE="FP-1">• Cassia RMP (1985)</FP>
                <FP SOURCE="FP-1">• Challis RMP (1999)</FP>
                <FP SOURCE="FP-1">• Coeur d'Alene RMP (2007)</FP>
                <FP SOURCE="FP-1">• Cottonwood RMP (2009)</FP>
                <FP SOURCE="FP-1">• Craters of the Moon Monument RMP (2007)</FP>
                <FP SOURCE="FP-1">• Four Rivers RMP (2023)</FP>
                <FP SOURCE="FP-1">• Jarbidge RMP (2015)</FP>
                <FP SOURCE="FP-1">• Lemhi RMP (1987)</FP>
                <FP SOURCE="FP-1">• Little Lost and Birch Creek MFP (1985)</FP>
                <FP SOURCE="FP-1">• Magic MFP (1980)  </FP>
                <FP SOURCE="FP-1">• Medicine Lodge RMP (1985)</FP>
                <FP SOURCE="FP-1">• Monument RMP (1986)</FP>
                <FP SOURCE="FP-1">• Morley Nelson Snake River Birds of Prey NCA RMP (2008)</FP>
                <FP SOURCE="FP-1">• Owyhee RMP (1999)</FP>
                <FP SOURCE="FP-1">• Pocatello RMP (2012)</FP>
                <FP SOURCE="FP-1">• Sun Valley MFP (1981)</FP>
                <FP SOURCE="FP-1">• Twin Falls MFP (1982)</FP>
                <FP SOURCE="FP-1">• Billings RMP (2015)</FP>
                <FP SOURCE="FP-1">• Butte RMP (2009)</FP>
                <FP SOURCE="FP-1">• Dillon RMP (2006)</FP>
                <FP SOURCE="FP-1">• HiLine RMP (2015)</FP>
                <FP SOURCE="FP-1">• Lewistown RMP (2021)</FP>
                <FP SOURCE="FP-1">• Miles City RMP (2015)</FP>
                <FP SOURCE="FP-1">• Missoula RMP (2021)</FP>
                <FP SOURCE="FP-1">• Pompeys Pillar NM RMP (2015)</FP>
                <FP SOURCE="FP-1">• Upper Missouri River Breaks NM RMP (2008)</FP>
                <FP SOURCE="FP-1">• Black Rock Desert-High Rock Canyon NCA RMP (2004)</FP>
                <FP SOURCE="FP-1">• Carson City RMP (2001)</FP>
                <FP SOURCE="FP-1">• Elko RMP (1987)</FP>
                <FP SOURCE="FP-1">• Ely RMP (2008)</FP>
                <FP SOURCE="FP-1">• Las Vegas RMP (1998)</FP>
                <FP SOURCE="FP-1">• Nevada Test and Training Range RMP (2004)</FP>
                <FP SOURCE="FP-1">• Red Rock Canyon NCA RMP (2005)</FP>
                <FP SOURCE="FP-1">• Shoshone-Eureka RMP (1986)</FP>
                <FP SOURCE="FP-1">• Sloan Canyon NCA RMP (2006)</FP>
                <FP SOURCE="FP-1">• Tonopah RMP (1997)</FP>
                <FP SOURCE="FP-1">• Wells RMP (1985)</FP>
                <FP SOURCE="FP-1">• Winnemucca RMP (2015)</FP>
                <FP SOURCE="FP-1">• Carlsbad RMP (1988)</FP>
                <FP SOURCE="FP-1">• El Malpais NCA RMP (2001)</FP>
                <FP SOURCE="FP-1">• Farmington RMP (2003)</FP>
                <FP SOURCE="FP-1">• Kasha-Katuwe Tent Rocks NM RMP (2007)</FP>
                <FP SOURCE="FP-1">• Mimbres RMP (1993)</FP>
                <FP SOURCE="FP-1">• Prehistoric Trackways NM RMP (2015)</FP>
                <FP SOURCE="FP-1">• Rio Puerco RMP (1986)</FP>
                <FP SOURCE="FP-1">• Roswell RMP (1997)</FP>
                <FP SOURCE="FP-1">• Socorro RMP (2010)</FP>
                <FP SOURCE="FP-1">• Taos RMP (2012)</FP>
                <FP SOURCE="FP-1">• White Sands RMP (1986)</FP>
                <FP SOURCE="FP-1">• Andrews RMP (2005)</FP>
                <FP SOURCE="FP-1">• Baker RMP (1989)</FP>
                <FP SOURCE="FP-1">• Brothers La Pine RMP (1989)</FP>
                <FP SOURCE="FP-1">• Cascade-Siskiyou NM RMP (2008)</FP>
                <FP SOURCE="FP-1">• John Day Basin RMP (2015)</FP>
                <FP SOURCE="FP-1">• Lakeview RMP (2003)</FP>
                <FP SOURCE="FP-1">• Northwestern and Coastal Oregon RMP (2016)</FP>
                <FP SOURCE="FP-1">• San Juan Islands NM RMP (2023)</FP>
                <FP SOURCE="FP-1">• Southeastern Oregon RMP (2002)</FP>
                <FP SOURCE="FP-1">• Southwestern Oregon RMP (2016)</FP>
                <FP SOURCE="FP-1">• Spokane District RMP (1987)</FP>
                <FP SOURCE="FP-1">• Steens Mountain Cooperative Management and Protection Area RMP (2005)</FP>
                <FP SOURCE="FP-1">• Three Rivers RMP (1992)</FP>
                <FP SOURCE="FP-1">• Two Rivers RMP (1986)</FP>
                <FP SOURCE="FP-1">• Upper Deschutes RMP (2005)</FP>
                <FP SOURCE="FP-1">• Upper Klamath Basin and Wood River Wetland RMP (1996)</FP>
                <FP SOURCE="FP-1">• West Eugene Wetlands RMP (2015)</FP>
                <FP SOURCE="FP-1">• Bears Ears NM—RMPs for the Indian Creek and Shash Jaa Units (2020)</FP>
                <FP SOURCE="FP-1">• Beaver Dam Wash NCA RMP (2016)</FP>
                <FP SOURCE="FP-1">• Box Elder RMP (1986)</FP>
                <FP SOURCE="FP-1">• Cedar Beaver Garfield Antimony RMP (1986)</FP>
                <FP SOURCE="FP-1">• Grand Staircase-Escalante NM RMP (2020)</FP>
                <FP SOURCE="FP-1">• House Range RMP (1987)</FP>
                <FP SOURCE="FP-1">• Isolated Tract Planning Analysis (1985)</FP>
                <FP SOURCE="FP-1">• Kanab RMP (2008)</FP>
                <FP SOURCE="FP-1">• Kanab-Escalante RMP (2020)</FP>
                <FP SOURCE="FP-1">• Moab RMP (2008)</FP>
                <FP SOURCE="FP-1">• Monticello RMP (2008)</FP>
                <FP SOURCE="FP-1">• Park City MFP (1975)</FP>
                <FP SOURCE="FP-1">• Pinyon MFP (1983)</FP>
                <FP SOURCE="FP-1">• Pony Express RMP (1990)</FP>
                <FP SOURCE="FP-1">• Price RMP (2008)</FP>
                <FP SOURCE="FP-1">• Randolph MFP (1980)</FP>
                <FP SOURCE="FP-1">• Red Cliffs NCA RMP (2016)</FP>
                <FP SOURCE="FP-1">• Richfield RMP (2008)</FP>
                <FP SOURCE="FP-1">• St. George RMP (1999)</FP>
                <FP SOURCE="FP-1">• Vernal RMP (2008)</FP>
                <FP SOURCE="FP-1">• Warm Springs RMP (1987)</FP>
                <FP SOURCE="FP-1">• Buffalo RMP (2015)</FP>
                <FP SOURCE="FP-1">• Casper RMP (2007)</FP>
                <FP SOURCE="FP-1">• Cody RMP (2015)</FP>
                <FP SOURCE="FP-1">• Green River RMP (1997)</FP>
                <FP SOURCE="FP-1">• Kemmerer RMP (2010)</FP>
                <FP SOURCE="FP-1">• Lander RMP (2014)</FP>
                <FP SOURCE="FP-1">• Newcastle RMP (2000)</FP>
                <FP SOURCE="FP-1">• Pinedale RMP (2008)</FP>
                <FP SOURCE="FP-1">• Rawlins RMP (2008)</FP>
                <FP SOURCE="FP-1">• Snake River RMP (2004)</FP>
                <FP SOURCE="FP-1">• Worland RMP (2015)</FP>
                <P>The 11-state planning area for this effort includes approximately 162 million acres of public lands administered by the BLM.</P>
                <P>The Approved RMP Amendments improve the BLM's management consistency with respect to utility-scale solar energy development, address changes in solar energy technology that have occurred since the BLM's last solar energy planning effort in 2012 (2012 Western Solar Plan), support national renewable energy and climate goals, and incorporate updated information about important resource values. As the BLM seeks to advance its solar energy program, it does so while managing other important land uses. These include recreational use; agricultural use, such as grazing; other energy and mineral development; resource protection, including National Monuments, National Conservation Areas, wilderness areas, wilderness study areas, other specially designated areas, wildlife and big game, water resources, and cultural, historical, and paleontological resources; and the restoration of lands and resources, in all cases where appropriate and consistent with the principles of multiple use and sustained yield, as defined by the Federal Land Policy and Management Act.</P>
                <P>The Approved RMP Amendments describe the BLM's approach for implementing utility-scale photovoltaic solar energy development on BLM-administered land. The Approved RMP Amendments exclude approximately 131 million acres of public lands from solar development to protect sensitive resources as described in the exclusion criteria in the ROD. Approximately 31 million acres of public lands are available for solar projects under the Approved RMP Amendments, including approximately 3.8 million acres of designated avoidance lands. Public lands are available if, after accounting for the resource-based exclusions and the exclusion for slopes exceeding 10 percent, they are within 15 miles of an existing or planned transmission line with capacity of at least 69 kilovolts, or they are identified as “previously disturbed” based on criteria described in the ROD. The Approved RMP Amendments also update programmatic design features and environmental evaluation processes and incorporate new information and analysis. The Approved RMP Amendments will improve the solar energy project application process by excluding projects from areas where protection is warranted while maintaining sufficient siting flexibility to account for site-specific resource considerations on a case-by-case basis under subsequent project-specific decisions.</P>
                <P>
                    The BLM provided the Proposed RMP Amendments on August 30, 2024, for a 30-day protest period and received 35 valid protests. The BLM Director resolved all protests. Responses to protest issues have been compiled and documented in a Protest Resolution Report (see 
                    <E T="02">ADDRESSES</E>
                    ). The BLM incorporated minor clarifications in the Approved RMP Amendments in response to protests, but no substantive changes were necessary.
                </P>
                <P>
                    The BLM provided the Proposed RMP Amendments to the Governors of Arizona, California, Colorado, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, and Wyoming for a 
                    <PRTPAGE P="105625"/>
                    60-day Governor's consistency review. The Governors of California, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, and Wyoming raised concerns regarding the Proposed RMP Amendments, identified inconsistencies with State and local plans, and provided recommendations relating to the BLM's Proposed RMP Amendments. The BLM considered the information provided by the Governors but declined to revise the Approved RMP Amendments, finding that the Approved RMP Amendments appropriately integrate State and local plans to the maximum extent practical, consistent with Federal law. The Governors of California and Utah appealed the BLM's response to the Governors' consistency review to the BLM Director. The BLM Director determined that the Approved RMP Amendments provide for a reasonable balance between the national interest and the State's interest, and notified the Governors that no changes to the Approved RMP Amendments were necessary as a result of the Governor's consistency review.
                </P>
                <EXTRACT>
                    <FP>(Authority: 40 CFR 1506.6 (2022), 43 CFR subpart 1610.)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Nada Wolff Culver,</NAME>
                    <TITLE>Principal Deputy Director.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30953 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4331-27-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[SDMT 106276277; SDM 112598]</DEPDOC>
                <SUBJECT>Public Land Order No. 7956; Withdrawal of Pactola Reservoir—Rapid Creek Watershed; South Dakota</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Public land order.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This Public Land Order (PLO) withdraws 20,510 acres of National Forest System (NFS) lands in the Black Hills National Forest, Pennington County, South Dakota, from settlement, sale, location, or entry under the public land laws; location and entry under the United States mining laws; and leasing under the mineral and geothermal leasing laws for 20 years, subject to valid existing rights, to protect the cultural and natural resources of the Pactola Reservoir—Rapid Creek Watershed, including municipal water for Rapid City and Ellsworth Air Force Base.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This PLO takes effect on December 27, 2024.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Adam Carr, Branch Chief, Realty Lands and Renewable Energy, BLM Montana/Dakotas, 5001 Southgate Drive, Billings, Montana 59101, telephone: (406) 538-1957; email: 
                        <E T="03">acarr@blm.gov;</E>
                         or Shawn Cochran, Forest Supervisor, Black Hills National Forest, 1019 N. 5th Street, Custer, South Dakota 57730, telephone: (605) 673-9203, email: 
                        <E T="03">shawn.cochran@usda.gov.</E>
                         Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point-of-contact in the United States.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The purpose of this withdrawal is to protect and preserve cultural and natural resources of the Pactola Reservoir—Rapid Creek Watershed, including municipal water for Rapid City and Ellsworth Air Force Base, from the known and potential adverse environmental impacts that may arise from exploration and development of federally owned minerals. A Notice of Application for Withdrawal and Notification of Public Meeting was published in the 
                    <E T="04">Federal Register</E>
                     on March 21, 2023 (88 FR 17006).
                </P>
                <HD SOURCE="HD1">Order</HD>
                <P>By virtue of the authority vested in the Secretary of the Interior by Section 204 of the Federal Land Policy and Management Act of 1976 (FLPMA), 43 U.S.C. 1714, it is ordered as follows:</P>
                <P>1. Subject to valid existing rights, the following described lands are hereby withdrawn from settlement, sale, location, or entry under the public land laws; location and entry under the United States mining laws; and leasing under the mineral and geothermal leasing laws for 20 years.</P>
                <EXTRACT>
                    <HD SOURCE="HD1">Black Hills Meridian, South Dakota</HD>
                    <FP SOURCE="FP-2">T. 1 N., R. 4 E.,</FP>
                    <FP SOURCE="FP1-2">Sec. 1;</FP>
                    <FP SOURCE="FP1-2">Sec. 2, that part lying easterly of the Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">Sec. 11, that part lying easterly of the Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">Secs. 12 and 13;</FP>
                    <FP SOURCE="FP1-2">Sec. 14, that part lying easterly of the Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">Sec. 23, that part lying northeasterly of Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">Sec. 24, that part lying northeasterly of Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">Sec. 25, that part lying northeasterly of Pactola Reservoir—Rapid Creek subwatershed boundary.</FP>
                    <FP SOURCE="FP-2">T. 2 N., R. 4 E.,</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 13, lots 1 thru 5, SW
                        <FR>1/4</FR>
                        SW
                        <FR>1/4</FR>
                        , and SE
                        <FR>1/4</FR>
                        , except Tract A of H.E.S. No. 241, that part lying southerly of Pactola Reservoir—Rapid Creek subwatershed boundary;
                    </FP>
                    <FP SOURCE="FP1-2">
                        Sec. 14, lot 2, SW
                        <FR>1/4</FR>
                        , W
                        <FR>1/2</FR>
                        SE
                        <FR>1/4</FR>
                        , and SE
                        <FR>1/4</FR>
                        SE
                        <FR>1/4</FR>
                        , that part lying southeasterly of Pactola Reservoir—Rapid Creek subwatershed boundary;
                    </FP>
                    <FP SOURCE="FP1-2">
                        Sec. 22, SE
                        <FR>1/4</FR>
                        SE
                        <FR>1/4</FR>
                        , those portions lying southerly and easterly of Pactola Reservoir—Rapid Creek subwatershed boundary;
                    </FP>
                    <FP SOURCE="FP1-2">Sec. 23, that part lying easterly of Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">Sec. 24, except Tract A of H.E.S. No. 241;</FP>
                    <FP SOURCE="FP1-2">Sec. 25, except M.S. No. 1948 and M.S. No. 2016;</FP>
                    <FP SOURCE="FP1-2">Sec. 26, that part lying easterly of Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">Sec. 27, those portions lying easterly of Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 34, lots 1, 4, 6, and 9, E
                        <FR>1/2</FR>
                        NE
                        <FR>1/4</FR>
                        , NW
                        <FR>1/4</FR>
                        NE
                        <FR>1/4</FR>
                        , and S
                        <FR>1/2</FR>
                        SE
                        <FR>1/4</FR>
                        SE
                        <FR>1/4</FR>
                        , that part lying easterly of Pactola Reservoir—Rapid Creek subwatershed boundary;
                    </FP>
                    <FP SOURCE="FP1-2">Sec. 35, except M.S. No. 2047, that part lying northeasterly of Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">Sec. 36, except M.S. No. 1948;</FP>
                    <FP SOURCE="FP1-2">M.S. No. 1019, that part lying southerly of Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">M.S. No. 2047.</FP>
                    <FP SOURCE="FP-2">T. 1 N., R. 5 E.,</FP>
                    <FP SOURCE="FP1-2">Sec. 2, that part lying southwesterly of Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">Secs. 3 thru 7;</FP>
                    <FP SOURCE="FP1-2">Sec. 8, except M.S. No. 1918;</FP>
                    <FP SOURCE="FP1-2">Secs. 9 and 10;</FP>
                    <FP SOURCE="FP1-2">Sec. 11, that part lying northwesterly of the Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">Sec. 14, that part lying northwesterly of the Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 15, N
                        <FR>1/2</FR>
                        , N
                        <FR>1/2</FR>
                        SW
                        <FR>1/4</FR>
                        , N
                        <FR>1/2</FR>
                        SE
                        <FR>1/4</FR>
                        , and NE
                        <FR>1/4</FR>
                        NE
                        <FR>1/4</FR>
                        SW
                        <FR>1/4</FR>
                        SE
                        <FR>1/4</FR>
                        , that part lying northerly of the Pactola Reservoir—Rapid Creek subwatershed boundary;
                    </FP>
                    <FP SOURCE="FP1-2">Sec. 16, that part lying northwesterly of the Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">Sec. 17, except M.S. Nos. 1916 and 1918 and M.S. No. 2092, Peggy Lode, Merrit No. 1 Lode, and Luckly Boy Lode;</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 18, N
                        <FR>1/2</FR>
                        , NE
                        <FR>1/4</FR>
                        SW
                        <FR>1/4</FR>
                        , and SE
                        <FR>1/4</FR>
                        ;
                    </FP>
                    <FP SOURCE="FP1-2">
                        Sec. 19, NE
                        <FR>1/4</FR>
                        , NW
                        <FR>1/4</FR>
                        NW
                        <FR>1/4</FR>
                        , S
                        <FR>1/2</FR>
                        NW
                        <FR>1/4</FR>
                        , S
                        <FR>1/2</FR>
                        , that part lying northwesterly of the Pactola Reservoir—Rapid Creek subwatershed boundary;
                    </FP>
                    <FP SOURCE="FP1-2">Sec. 20, except M.S. No. 1916, that part lying northerly of the Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 21, NW
                        <FR>1/4</FR>
                        , that part lying northwesterly of the Pactola Reservoir—Rapid Creek subwatershed boundary;
                        <PRTPAGE P="105626"/>
                    </FP>
                    <FP SOURCE="FP1-2">
                        Sec. 30, W
                        <FR>1/2</FR>
                        , that part lying northwesterly of the Pactola Reservoir—Rapid Creek subwatershed boundary.
                    </FP>
                    <FP SOURCE="FP1-2">H.E.S. No. 106;</FP>
                    <FP SOURCE="FP1-2">H.E.S. No. 599;</FP>
                    <FP SOURCE="FP1-2">M.S. No. 891.</FP>
                    <FP SOURCE="FP-2">T. 2 N., R. 5 E.,</FP>
                    <FP SOURCE="FP1-2">Sec. 18, that part lying southerly of the Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">Sec. 19, that part lying southwesterly of the Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 20, SW
                        <FR>1/4</FR>
                        , that part lying southwesterly of the Pactola Reservoir—Rapid Creek subwatershed boundary;
                    </FP>
                    <FP SOURCE="FP1-2">
                        Sec. 28, SW
                        <FR>1/4</FR>
                        , that part lying southerly of the Pactola Reservoir—Rapid Creek subwatershed boundary;
                    </FP>
                    <FP SOURCE="FP1-2">Sec. 29, that part lying westerly of the Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">Sec. 30, except M.S. No. 1948 and M.S. No. 2016;</FP>
                    <FP SOURCE="FP1-2">
                        Sec. 31, lots 5 and 6, lots 10 thru 19, NE
                        <FR>1/4</FR>
                        , E
                        <FR>1/2</FR>
                        NW
                        <FR>1/4</FR>
                        , NW
                        <FR>1/4</FR>
                        NE
                        <FR>1/4</FR>
                        SE
                        <FR>1/4</FR>
                        , W
                        <FR>1/2</FR>
                        SE
                        <FR>1/4</FR>
                        SE
                        <FR>1/4</FR>
                        SE
                        <FR>1/4</FR>
                        , and those portions of M.S. No. 504 further described as Town of Silver City, Blocks A, B, C, D, and E, lots 3 thru 16 and lots 23 thru 32 of Block 9, lots 4 and 5, lots 12 thru 15, lots 27 thru 30 of Block 12, and Blocks 19 and 20;
                    </FP>
                    <FP SOURCE="FP1-2">Sec. 32, except M.S. No. 2040 and The Silver City Cemetery Tract, as shown on the survey plat of the Silver City Cemetery Tract recorded as Doc. # A201717833, in the Pennington County Register of Deeds, on 12/19/2017, at 2:15 p.m., that part lying southwesterly of the Pactola Reservoir—Rapid Creek subwatershed boundary; Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">Sec. 33, that part lying southerly of the Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">Sec. 34, that part lying southerly of the Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">Sec. 35, those portions lying westerly of the Pactola Reservoir—Rapid Creek subwatershed boundary;</FP>
                    <FP SOURCE="FP1-2">
                        M.S. No 2040, except W
                        <FR>1/2</FR>
                        SE
                        <FR>1/4</FR>
                        SE
                        <FR>1/4</FR>
                        SE
                        <FR>1/4</FR>
                         of Sec. 31 and The Silver City Cemetery Tract, as shown on the survey plat of the Silver City Cemetery Tract recorded as Doc. #A201717833, in the Pennington County Register of Deeds, on 12/19/2017, at 2:15 p.m.
                    </FP>
                </EXTRACT>
                <P>The Pactola Reservoir—Rapid Creek subwatershed boundary described within this land description was derived from Geographic Information Systems (GIS) and used for convenience in determining acreage. This subwatershed is also known as Hydrological Unit Code (HUC) 101201100110. This land description intends to include all Federal lands administered by the United States Department of Agriculture Forest Service within this subwatershed. The actual boundary is intended to be the location of said subwatershed as it exists on the ground.</P>
                <P>The areas described aggregate 20,510 acres, more or less, according to the official plats of surveys of the said lands, on file with the Bureau of Land Management, Conveyance Documents, and GIS.</P>
                <P>2. The withdrawal made by this order does not alter the applicability of laws governing the use of public lands or NFS lands other than the public land laws, the United States mining laws, mineral leasing, and geothermal leasing laws.</P>
                <P>3. The withdrawal will expire 20 years from the effective date of this Order, unless, as a result of a review conducted prior to the expiration date pursuant to Section 204(f) of FLPMA, 43 U.S.C. 1714(f), the Secretary determines the withdrawal should be extended.</P>
                <EXTRACT>
                    <FP>(Authority: 43 U.S.C. 1714)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Robert T. Anderson,</NAME>
                    <TITLE>Solicitor.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30790 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3411-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Ocean Energy Management</SUBAGY>
                <DEPDOC>[Docket No. BOEM-2024-0055]</DEPDOC>
                <SUBJECT>Notice of Availability of a Joint Record of Decision for the Proposed SouthCoast Wind Project</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Ocean Energy Management, Interior; National Marine Fisheries Service, National Oceanic and Atmospheric Administration, Commerce; U.S. Army Corps of Engineers, Department of the Army.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Record of decision; notice of availability.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Bureau of Ocean Energy Management (BOEM) announces the availability of the joint record of decision (ROD) on the final environmental impact statement (EIS) for the construction and operations plan (COP) submitted by SouthCoast Wind Energy LLC (SouthCoast Wind) for its proposed SouthCoast Wind Project (Project) offshore Massachusetts and Rhode Island. The joint ROD includes the Department of the Interior's (DOI) decision regarding the COP; National Marine Fisheries Service's (NMFS) decision, pending completion of all statutory processes, regarding SouthCoast Wind's requested Incidental Take Regulations (ITR) and an associated Letter of Authorization (LOA) under the Marine Mammal Protection Act (MMPA); and U.S. Army Corps of Engineers' (USACE) decision regarding authorizations under section 10 of the Rivers and Harbors Act of 1899 (RHA) and section 404 of the Clean Water Act (CWA). NMFS has adopted the final EIS to support its decision about whether or not to promulgate the requested ITR and issue an LOA to SouthCoast Wind under the MMPA. USACE has adopted the final EIS to support its decision to issue a Department of the Army (DA) permit under section 10 of the RHA and section 404 of the CWA. The joint ROD concludes the National Environmental Policy Act process for each agency.</P>
                </SUM>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The joint ROD and associated information are available on BOEM's website at 
                        <E T="03">https://www.boem.gov/renewable-energy/state-activities/southcoast-wind-formerly-mayflower-wind.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For information related to BOEM's action, please contact Genevieve Brune, BOEM Office of Renewable Energy Programs, 45600 Woodland Road, VAM-OREP, Sterling, Virginia 20166, (703) 787-1553, or 
                        <E T="03">genevieve.brune@boem.gov.</E>
                         For information related to NMFS' action, please contact Katherine Renshaw, National Oceanic Atmospheric Administration (NOAA) Office of General Counsel, (302) 515-0324, 
                        <E T="03">katherine.renshaw@noaa.gov.</E>
                         For information related to USACE's action, please contact Roberta Budnik, Regulatory Division, New England District, (978) 318-8766, 
                        <E T="03">roberta.K.Budnik@usace.army.mil.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>SouthCoast Wind seeks approval to construct, operate, and maintain the Project: a wind energy facility and the associated export cables on the Outer Continental Shelf (OCS) offshore Massachusetts and Rhode Island. The Project would be developed within the range of design parameters outlined in the COP, subject to applicable mitigation measures.</P>
                <P>
                    A notice of availability for the final EIS was published in the 
                    <E T="04">Federal Register</E>
                     on November 15, 2024 at 89 FR 90316. On December 16, 2024, BOEM published an errata on its website that included certain edits to the Executive Summary, Chapter 2, Chapter 3, Appendix F, Appendix G, Appendix I, Appendix N, and Appendix O. None of these edits are substantive or affect the analysis or conclusions in the final EIS.
                </P>
                <P>
                    The proposed Project would be located about 26 nautical miles (nm) (48 kilometers) south of Martha's Vineyard and 20 nm (37 kilometers) south of Nantucket in the area defined in BOEM's renewable energy lease number OCS-A 0521 (Lease Area). The Lease Area covers approximately 127,388 acres. The Project would consist of up 
                    <PRTPAGE P="105627"/>
                    to 149 positions in the Lease Area to be occupied by up to 147 wind turbine generators and up to five offshore substation platforms. The 149 positions will conform to a 1 nm x 1 nm grid layout with an east-west and north-south orientation, which lessees agreed would apply across all the Massachusetts and Rhode Island wind energy areas. The Project would include one preferred export cable corridor making landfall and interconnecting to the ISO New England Inc. (ISO-NE) grid at Brayton Point in Somerset, Massachusetts. The Project would be developed in two parts or projects: Project 1 refers to the development in the northern portion of the Lease Area and associated interconnection, and Project 2 refers to the development in the southern portion of the Lease Area and associated interconnection. The preferred export cable corridor to Brayton Point would be used for both Project 1 and Project 2 to be built out within the Lease Area. The Project would also include one variant export cable corridor that, if used, would make landfall and interconnect to the ISO-NE grid in the town of Falmouth, Massachusetts. In the event that technical, logistical, grid interconnection, or other unforeseen challenges arise during the design and engineering phase that prevent Project 2 from making interconnection at Brayton Point, Project 2 would use the Falmouth variant export cable corridor.
                </P>
                <P>
                    After carefully considering public comments on the draft EIS and the alternatives described and analyzed in the final EIS, DOI selected Alternative D, “Nantucket Shoals,” which eliminates six wind turbine generators from the Project as proposed in the COP. Alternative D is the Preferred Alternative identified in the final EIS. The anticipated mitigation, monitoring, and reporting requirements, which will be included in BOEM's COP approval as terms and conditions, are included in Appendix A of the ROD, which is available at: 
                    <E T="03">https://www.boem.gov/renewable-energy/state-activities/southcoast-wind-formerly-mayflower-wind.</E>
                </P>
                <P>
                    NMFS has adopted BOEM's final EIS to support its decision about whether or not to promulgate the requested ITR and issue the associated LOA to SouthCoast Wind. NMFS' final decision of whether or not to promulgate the requested ITR and issue the LOA will be documented in a separate Decision Memorandum prepared in accordance with internal NMFS policy and procedures. The final ITR and a notice of issuance of the LOA, if issued, would be published in the 
                    <E T="04">Federal Register</E>
                    . The LOA would authorize SouthCoast Wind to take small numbers of marine mammals incidental to Project construction and would set forth: permissible methods of incidental taking; means of effecting the least practicable adverse impact on the species and their habitat; and requirements for monitoring and reporting. Pursuant to Section 7 of the Endangered Species Act (ESA), NMFS issued a final Biological Opinion to BOEM on November 7, 2024, evaluating the effects of the proposed action on ESA-listed species. The proposed action in the Biological Opinion includes the associated permits, approvals, and authorizations that may be issued.
                </P>
                <P>USACE has decided to adopt BOEM's final EIS and issue a permit to SouthCoast Wind under section 10 of the RHA and section 404 of the CWA. The USACE permit will authorize SouthCoast Wind to discharge fill below the high tide line of waters of the United States. It will also authorize SouthCoast Wind to perform work and place structures below the mean high water mark of navigable waters of the United States and to affix structures to the seabed on the OCS.</P>
                <P>
                    <E T="03">Authority:</E>
                     National Environmental Policy Act of 1969, as amended, (42 U.S.C. 4321 
                    <E T="03">et seq.);</E>
                     40 CFR 1505.2
                </P>
                <SIG>
                    <NAME>Karen Baker,</NAME>
                    <TITLE>Associate Director, Renewable Energy Programs, Bureau of Ocean Energy Management.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31062 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4340-98-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">INTERNATIONAL TRADE COMMISSION</AGENCY>
                <DEPDOC>[Investigation Nos. 701-TA-452 and 731-TA-1129-1130 (Third Review)]</DEPDOC>
                <SUBJECT>Raw Flexible Magnets From China and Taiwan</SUBJECT>
                <HD SOURCE="HD1">Determinations</HD>
                <P>
                    On the basis of the record 
                    <SU>1</SU>
                    <FTREF/>
                     developed in the subject five-year reviews, the United States International Trade Commission (“Commission”) determines, pursuant to the Tariff Act of 1930 (“the Act”), that revocation of the countervailing duty order on raw flexible magnets from China and revocation of the antidumping duty orders on raw flexible magnets from China and Taiwan would be likely to lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time.
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         The record is defined in § 207.2(f) of the Commission's Rules of Practice and Procedure (19 CFR 207.2(f)).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Commissioner Jason E. Kearns did not participate.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Background</HD>
                <P>The Commission instituted these reviews on June 3, 2024 (89 FR 47607) and determined on September 6, 2024, that it would conduct expedited reviews (89 FR 81938, October 9, 2024).</P>
                <P>
                    The Commission made these determinations pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)). It completed and filed its determinations in these reviews on December 20, 2024. The views of the Commission are contained in USITC Publication 5574 (December 2024), entitled 
                    <E T="03">Raw Flexible Magnets from China and Taiwan: Investigation Nos. 701-TA-452 and 731-TA-1129-1130 (Third Review).</E>
                </P>
                <SIG>
                    <P>By order of the Commission.</P>
                    <DATED>Issued: December 20, 2024.</DATED>
                    <NAME>Lisa Barton,</NAME>
                    <TITLE>Secretary to the Commission.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-31085 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7020-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">INTERNATIONAL TRADE COMMISSION</AGENCY>
                <DEPDOC>[Investigation No. 337-TA-1429]</DEPDOC>
                <SUBJECT>Certain Wireless Communication Devices and Components Thereof; Notice of Institution of Investigation</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. International Trade Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on November 18, 2024, under section 337 of the Tariff Act of 1930, as amended, on behalf of International Semiconductor Group Co., Ltd. of Seoul, South Korea. A supplement was filed on December 6, 2024. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain wireless communication devices and components thereof by reason of the infringement of certain claims of U.S. Patent No. 10,575,262 (“the '262 patent”); U.S. Patent No. 9,271,308 (“the '308 patent”); U.S. Patent No. 10,111,227 (“the '227 patent”); and U.S. Patent No. 10,616,919 (“the '919 patent”). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant 
                        <PRTPAGE P="105628"/>
                        requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
                    </P>
                </SUM>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The complaint, except for any confidential information contained therein, may be viewed on the Commission's electronic docket (EDIS) at 
                        <E T="03">https://edis.usitc.gov.</E>
                         For help accessing EDIS, please email 
                        <E T="03">EDIS3Help@usitc.gov.</E>
                         Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at 
                        <E T="03">https://www.usitc.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Pathenia M. Proctor, The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Authority:</E>
                     The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2024).
                </P>
                <P>
                    <E T="03">Scope of Investigation:</E>
                     Having considered the complaint, the U.S. International Trade Commission, on December 19, 2024, 
                    <E T="03">ordered that</E>
                    —
                </P>
                <P>(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of claims 1-5 of the '262 patent; claims 11-20 of the '308 patent; claims 12-18 and 20 of the '227; and claims 11-19 of the '919 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;</P>
                <P>(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is “wireless laptop computers, notebook computers, tablets, desktop computers, and wireless chips”;</P>
                <P>(3) Pursuant to Commission Rule 210.50(b)(l), 19 CFR 210.50(b)(1), the presiding administrative law judge shall take evidence or other information and hear arguments from the parties or other interested persons with respect to the public interest in this investigation, as appropriate, and provide the Commission with findings of fact and a recommended determination on this issue, which shall be limited to the statutory public interest factors set forth in 19 U.S.C. l337(d)(l), (f)(1), (g)(1);</P>
                <P>(4) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:</P>
                <P>(a) The complainant is:</P>
                <FP SOURCE="FP-1">International Semiconductor Group Co., Ltd., 15 Teheran-ro, 82-gil, DI Tower, Suite 1231, Seoul, Republic of Korea 06178</FP>
                <P>(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:</P>
                <FP SOURCE="FP-1">Dell Technologies Inc., 1 Dell Way, Round Rock, TX 78682-7000</FP>
                <FP SOURCE="FP-1">Dell Products L.P., 1 Dell Way, Round Rock, TX, 78682-7000</FP>
                <FP SOURCE="FP-1">Dell (Chengdu) Co. Ltd., No. 800, Tianqin Road, High-tech Zone Chengdu, Sichuan, 610000 China</FP>
                <FP SOURCE="FP-1">HP, Inc., 1501 Page Mill Road, Palo Alto, CA 94304</FP>
                <FP SOURCE="FP-1">Lenovo Group Limited, 23rd Floor, Lincoln House, Taikoo Place, 979 King's Road, Quarry Bay, Hong Kong SAR</FP>
                <FP SOURCE="FP-1">Lenovo (United States) Inc., 8001 Development Drive, Morrisville, NC 27560</FP>
                <P>(c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and</P>
                <P>(4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.</P>
                <P>Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), as amended in 85 FR 15798 (March 19, 2020), such responses will be considered by the Commission if received not later than 20 days after the date of service by the complainant of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.</P>
                <P>Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.</P>
                <SIG>
                    <P>By order of the Commission.</P>
                    <DATED>Issued: December 19, 2024.</DATED>
                    <NAME>Lisa Barton,</NAME>
                    <TITLE>Secretary to the Commission.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30897 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7020-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF JUSTICE</AGENCY>
                <DEPDOC>[CPCLO Order No. 008/2024]</DEPDOC>
                <SUBJECT>Privacy Act of 1974; Matching Program </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Justice Management Division, United States Department of Justice.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of a new matching program.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Justice (DOJ) is issuing a public notice of its intent to conduct a computer matching program with the Internal Revenue Service (IRS), Department of the Treasury. Under this matching program, entitled Taxpayer Address Request (TAR), the IRS will provide information relating to taxpayers' mailing addresses to the DOJ for purposes of enabling DOJ to locate debtors to initiate litigation and/or enforce the collection of debts owed by the taxpayers to the United States.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This matching program will become effective on January 30, 2025. This matching program will continue for 18 months after the effective date. Please submit any comments by January 27, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Interested persons are invited to submit written comments regarding this notice by mail to Dennis Dauphin, Director, Debt Collection Management Staff, Justice Management Division, 145 N St. NE, Rm 6W.102, Washington, DC 20530, or by email at 
                        <E T="03">Dennis.E.Dauphin2@usdoj.gov</E>
                        .
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Dennis Dauphin, Director, Debt Collection Management Staff, Justice Management Division, 
                        <PRTPAGE P="105629"/>
                        <E T="03">Dennis.E.Dauphin2@usdoj.gov,</E>
                         145 N St. NE, Rm 6W.102, Washington, DC 20530.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    This agreement reestablishes a matching program between the IRS and the DOJ to provide DOJ with the mailing addresses of taxpayers to assist DOJ in its effort to collect or to compromise debts owed to the United States. DOJ will provide IRS with an electronic file containing the names and Social Security Numbers (SSN) of individuals who owe debts to the U.S. and whose debts have been referred to DOJ for litigation and/or enforced collection. The IRS provides direct notice to taxpayers in the instructions to Form 1040, and constructive notice in the 
                    <E T="04">Federal Register</E>
                     system of records notice. The notice informs taxpayers that information provided on the income tax returns may be given to other Federal agencies, as provided by law. For the records involved in this match, both IRS and DOJ have provided constructive notice to record subjects through the publication, in the 
                    <E T="04">Federal Register</E>
                    , of systems of records notices that contain routine uses permitting disclosures consistent with this matching program.
                </P>
                <FP>
                    <E T="03">PARTICIPATING AGENCIES:</E>
                     The participating agencies include:  DOJ and the IRS.
                </FP>
                <HD SOURCE="HD2">AUTHORITY FOR CONDUCTING THE MATCHING PROGRAM:</HD>
                <P>This matching agreement is executed pursuant to 5 U.S.C. 552a(o), the Privacy Act of 1974, as amended, and sets forth the terms under which the IRS agrees to disclose taxpayer mailing addresses to the DOJ. This matching program is being conducted under the authority of the Internal Revenue Code § 6103(m)(2), and the routine uses published in the agencies' Privacy Act systems of records notices for the systems of records used in this match. This provides for disclosure, upon written request, of a taxpayer's mailing address for use by officers, employees, or agents of a Federal agency for the purpose of locating such taxpayer to collect or compromise a Federal claim against the taxpayer in accordance with Title 31, §§ 3711, 3717, and 3718. These statutory provisions authorize DOJ to collect debts on behalf of the United States through litigation.</P>
                <HD SOURCE="HD2">PURPOSES:</HD>
                <P>The purpose of this program is to provide DOJ with the most current addresses of taxpayers, to notify debtors of legal actions that may be taken by DOJ and the rights afforded them in the litigation, and to enforce collection of debts owed to the United States.</P>
                <HD SOURCE="HD2">CATEGORIES OF INDIVIDUALS: </HD>
                <P>Individuals who owe debts to the United States and whose debts have been referred to the DOJ for litigation and/or enforced collection.</P>
                <HD SOURCE="HD2">CATEGORIES OF RECORDS:</HD>
                <P>DOJ will submit the nine-digit SSN and four-character Name Control (the first four letters of the surname) of each individual whose current address is requested. IRS will provide:</P>
                <P>a. Nine-digit SSN and four-character Name Control; and</P>
                <P>b. The latest street address, P.O. Box, or other address, city, State and ZIP Code, only if the input SSN and Name Control both match the Individual Master File (IMF); or</P>
                <P>c. A code explaining that no match was found on the IMF.</P>
                <HD SOURCE="HD2">SYSTEMS OF RECORDS: </HD>
                <P>DOJ will provide records from the Debt Collection Enforcement System, JUSTICE/DOJ-016, last published in its entirety at 77 FR 9965 (February 21, 2012). This system of records contains information on persons who owe debts to the United States and whose debts have been referred to the DOJ for litigation and/or enforced collection. DOJ records will be matched against records contained in Treasury's Privacy Act System of Records: Customer Account Data Engine (CADE) IMF, Treasury/IRS 24.030, last published at 80 FR 54082 (September 8, 2015). This system of records contains, among other information, the taxpayer's name, SSN, and most recent address known by IRS.</P>
                <P>In accordance with 5 U.S.C. 552a(o)(2)(A) and 5 U.S.C. 552a(r), the Department has provided a report to the Office of Management and Budget (OMB) and Congress on this new Computer Matching Program.</P>
                <SIG>
                    <DATED>Dated: December 17, 2024.</DATED>
                    <NAME>Peter A. Winn,</NAME>
                    <TITLE>Acting Chief Privacy and Civil Liberties Officer, United States Department of Justice.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30466 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-CN-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <SUBJECT>Petition for Modification of Application of Existing Mandatory Safety Standards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by Wolf Run Mining, LLC.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before January 27, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by Docket No. MSHA-2024-0113 by any of the following methods:</P>
                    <P>
                        1. 
                        <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments for MSHA-2024-0113.
                    </P>
                    <P>
                        2. 
                        <E T="03">Fax:</E>
                         202-693-9441.
                    </P>
                    <P>
                        3. 
                        <E T="03">Email: petitioncomments@dol.gov.</E>
                    </P>
                    <P>
                        4. 
                        <E T="03">Regular Mail or Hand Delivery:</E>
                         MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Suite 4E401, Arlington, Virginia 22202-5452.
                    </P>
                    <P>
                        <E T="03">Attention:</E>
                         S. Aromie Noe, Director, Office of Standards, Regulations, and Variances. Persons delivering documents are required to check in at the receptionist's desk, 4th Floor West. Individuals may inspect copies of the petition and comments during normal business hours at the address listed above. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Office of Standards, Regulations, and Variances at 202-693-9440 (voice), 
                        <E T="03">Petitionsformodification@dol.gov</E>
                         (email), or 202-693-9441 (fax). [These are not toll-free numbers.]
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations (CFR) part 44 govern the application, processing, and disposition of petitions for modification.</P>
                <HD SOURCE="HD1">I. Background</HD>
                <P>Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:</P>
                <P>1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or</P>
                <P>
                    2. The application of such standard to such mine will result in a diminution of safety to the miners in such mine.
                    <PRTPAGE P="105630"/>
                </P>
                <P>In addition, sections 44.10 and 44.11 of 30 CFR establish the requirements for filing petitions for modification.</P>
                <HD SOURCE="HD1">II. Petition for Modification</HD>
                <P>
                    <E T="03">Docket Number:</E>
                     M-2024-088-C.
                </P>
                <P>
                    <E T="03">Petitioner:</E>
                     Wolf Run Mining, LLC, 21550 Barbour County Highway, Philippi, WV 26416.
                </P>
                <P>
                    <E T="03">Mine:</E>
                     Leer South Mine, MSHA ID No. 46-04168, located in Barbour County, West Virginia.
                </P>
                <P>
                    <E T="03">Regulation Affected:</E>
                     30 CFR 75.507-1(a), Permissible electric equipment.
                </P>
                <P>
                    <E T="03">Modification Request:</E>
                     The petitioner requests a modification of 30 CFR 75.507-1(a) to allow the use of an alternative method of respirable dust protection. Specifically, the petitioner is requesting to use the 3M Versaflo TR-800 Intrinsically Safe Powered Air Purifying Respirator (PAPR) and the CleanSpace EX PAPR in return air outby the last open crosscut.
                </P>
                <P>The petitioner states that:</P>
                <P>(a) Leer South Mine has previously used the 3M Airstream Headgear-Mounted PAPR System to provide additional protection for its miners against exposure to respirable coal mine dust. There are clear long-term health benefits from using such technology. One of the benefits of PAPRs is that they provide a constant flow of air inside the headtop or helmet. This constant airflow helps to provide both respiratory protection and comfort in hot working environments.</P>
                <P>(b) 3M elected to discontinue the 3M Airstream helmet, replacing it with the 3M Versaflo TR-800, which benefits from additional features and reduced weight. Because of its reduced weight, it provides significant ergonomic benefits.</P>
                <P>(c) For more than 40 years the 3M Airstream has been used by many mine operators to help protect their workers. During those years there have been technological advancements in products and services for industrial applications. 3M indicated that they faced multiple key component supply disruptions for the Airstream product line that created issues with providing acceptable supply service levels. Because of those issues, 3M discontinued the Airstream in June 2020, and that discontinuation was global.</P>
                <P>(d) 3M announced that February 2020 was the final time to place an order for systems and components and that June 2020 was the final date to purchase Airstream components.</P>
                <P>(e) Currently there are no replacement 3M PAPRs that meet applicable MSHA standards for permissibility. Electronic equipment used in underground mines in potentially explosive atmospheres are required to be approved by MSHA in accordance with 30 CFR. 3M and other manufacturers offer alternative products for many other environments and applications.</P>
                <P>(f) Following the discontinuation, mines that currently use the Airstream do not have an MSHA-approved alternative PAPR to provide to miners.</P>
                <P>(g) Application of the standard results in a diminution of safety at the mine.</P>
                <P>(h) The 3M Versaflo TR-800 motor/blower and battery qualify as intrinsically safe in the U.S., Canada, and any other country accepting IECEx (International Electrotechnical Commission System for Certification to Standards Relating to Equipment for Use in Explosive Atmospheres) reports. The 3M Versaflo TR-800 has a blower that is UL-certified with an intrinsically safe (IS) rating of Division 1: IS Class I, II, III; Division 1 (includes Division 2) Groups C, D, E, F, G; T4, under the most current standard (UL 60079, 6th Edition, 2013). It is ATEX-certified with an IS rating of “ia.” (ATEX refers to European directives for controlling explosive 2 atmospheres.) It is rated and marked with Ex ia I Ma, Ex ia IIB T4 Ga, Ex ia IIIC 135 °C Da, -20 °C ≤ Ta ≤ +55 °C, under the current standard (IEC 60079).</P>
                <P>(i) Leer South Mine seeks modification to also permit the use of the CleanSpace EX powered respirator under the same conditions as it proposes with respect to the 3M Versaflo TR-800. It too has been determined to be intrinsically safe.</P>
                <P>(j) The 3M Versaflo TR-800 is not MSHA approved as permissible, and 3M is not pursuing approval.</P>
                <P>(k) The CleanSpace EX Power Unit is not MSHA approved as permissible, and CleanSpace is not pursuing approval.</P>
                <P>(l) The standards for approval of these respirators are an acceptable alternative to MSHA's standards and provide an equivalent level of protection.</P>
                <P>(m) The alternative method will guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <P>The petitioner proposes the following alternative method:</P>
                <P>(a) Affected mine employees shall be trained in the proper use and maintenance of the 3M Versaflo TR-800 and the CleanSpace EX in accordance with established manufacturer guidelines. This training shall alert the affected employee that neither the 3M Versaflo TR-800 nor the CleanSpace EX is approved under 30 CFR part 18 and shall be deenergized when 1.0 or more percent methane is detected. The training shall also include the proper method to deenergize these PAPRs. In addition to manufacturer guidelines, the petitioner shall require that mine employees be trained to inspect the units before use to determine if there is any damage to the units that would negatively impact intrinsic safety as well as all stipulations in the Proposed Decision and Order (PDO) granted by MSHA.</P>
                <P>(b) The PAPRs, battery packs, and all associated wiring and connections shall be inspected before use to determine if there is any damage to the units that would negatively impact intrinsic safety. If any defects are found, the PAPR shall be removed from service.</P>
                <P>(c) Leer South Mine shall maintain a separate logbook for the 3M Versaflo TR-800 and CleanSpace EX PAPRs that shall be kept with the equipment or in a location with other mine record books and shall be made available to MSHA upon request. The equipment shall be examined at least weekly by a qualified person as defined in 30 CFR 75.512-1 and the examination results recorded in the logbook. Since float coal dust is removed by the air filter prior to reaching the motor, the PAPR user shall conduct regular examinations of the filter and perform periodic testing for proper operation of the “high filter load alarm” on the 3M Versaflo TR-800 and the “blocked filter” alarm on the CleanSpace EX. Examination entries may be expunged after one year.</P>
                <P>(d) All 3M Versaflo TR-800 and CleanSpace EX PAPRs to be used in the return air outby the last open crosscut shall be physically examined prior to initial use, and each unit shall be assigned a unique identification number. Each unit shall be examined by the person who will be operating the equipment prior to taking the equipment underground to ensure the equipment is being used according to the original equipment manufacturer's recommendations and maintained in a safe operating condition.</P>
                <P>(e) The examination for the 3M Versaflo TR-800 shall include:</P>
                <P>(1) Check the equipment for any physical damage and the integrity of the case;</P>
                <P>(2) Remove the battery and inspect for corrosion;</P>
                <P>(3) Inspect the contact points to ensure a secure connection to the battery;</P>
                <P>(4) Reinsert the battery and power up and shut down to ensure proper connections;</P>
                <P>(5) Check the battery compartment cover or battery attachment to ensure that it is securely fastened.</P>
                <P>
                    (6) For equipment utilizing lithium type cells, ensure that lithium cells and/or packs are not damaged or swelled in size.
                    <PRTPAGE P="105631"/>
                </P>
                <P>(f) The CleanSpace EX does not have an accessible/removable battery. The battery and motor/blower assembly are both contained within the sealed four power pack assembly and cannot be removed, reinserted, or fastened. The pre-use examination is limited to inspecting the equipment for indications of physical damage.</P>
                <P>(g) Leer South Mine shall ensure that all 3M Versaflo TR-800 and CleanSpace EX PAPRs are serviced according to the manufacturer's recommendations. Dates of service shall be recorded in the equipment's logbook and shall include a description of the work performed.</P>
                <P>(h) The 3M Versaflo TR-800 and CleanSpace EX PAPRs that will be used in the return air outby the last open crosscut, or in areas where methane may enter the air current, shall not be put into service until MSHA has initially inspected the equipment and determined that it is following all the terms and conditions of the PDO granted by MSHA.</P>
                <P>(i) Prior to energizing the 3M Versaflo TR-800 or the CleanSpace EX in the return air outby the last open crosscut, methane tests shall be made in accordance with 30 CFR 75.323(a).</P>
                <P>(j) All hand-held methane detectors shall be MSHA-approved and maintained in permissible and proper operating condition as defined by 30 CFR 75.320. All methane detectors shall provide visual and audible warnings when methane is detected at or above 1.0 percent.</P>
                <P>(k) A qualified person as defined in 30 CFR 75.151 shall continuously monitor for methane immediately before and during the use of the 3M Versaflo TR-800 or CleanSpace EX in the return air outby the last open crosscut or in areas where methane may enter the air current.</P>
                <P>(l) Neither the 3M Versaflo TR-800 nor the CleanSpace EX shall be used if methane is detected in concentrations at or above 1.0 percent. When 1.0 percent or more of methane is detected while the 3M Versaflo TR-800 or CleanSpace EX is being used, the equipment shall be deenergized immediately and the equipment withdrawn outby the last open crosscut.</P>
                <P>(m) Leer South Mine shall use only the 3M TR-830 Battery Pack, which meets lithium battery safety standard UL 1642 or IEC 62133 in the 3M Versaflo TR-800. The petitioner shall use only the CleanSpace EX Power 5 Unit which meets lithium battery safety standard UL 1642 or IEC 62133 in the CleanSpace EX.</P>
                <P>(n) The battery packs shall be “changed out” in intake air outby the last open crosscut. Before each shift when the 3M Versaflo TR-800 or CleanSpace EX is to be used, all batteries and power units for the equipment shall be charged sufficiently so that they are not expected to be replaced on that shift.</P>
                <P>(o) The following maintenance and use conditions shall apply to equipment containing lithium-type batteries:</P>
                <P>(1) Always correctly use and maintain the lithium-ion battery packs. Neither the 3M TR-830 Battery Pack nor the CleanSpace EX Power Unit may be disassembled or modified by anyone other than persons permitted by the manufacturer of the equipment.</P>
                <P>(2) The 3M TR-830 Battery Pack shall only be charged in an area free of combustible material, readily monitored, and located on the surface of the mine. The 3M TR-830 Battery Pack is to be charged by either:</P>
                <P>(i) 3M Battery Charger Kit TR-641N, which includes one 3M Charger Cradle TR-640 and one 3M Power Supply TR-941N, or</P>
                <P>(ii) 3M 4-Station Battery Charger Kit TR-644N, which includes four 3M Charger Cradles TR-640 and one 3M 4-Station Battery Charger Base/Power Supply TR-944N.</P>
                <P>(iii) The CleanSpace EX Power Unit is to be charged only by the CleanSpace Battery Charger EX, Product Code PAF-0066.</P>
                <P>(iv) The batteries shall not be allowed to get wet. This does not preclude incidental exposure of sealed battery packs.</P>
                <P>(v) The batteries shall not be used, charged, or stored in locations where the manufacturer's recommended temperature limits are exceeded. The batteries shall not be placed in direct sunlight or used or stored near a source of heat.</P>
                <P>(p) Personnel engaged in the use of the 3M Versaflo TR-800 and CleanSpace EX PAPRs shall be properly trained to recognize the hazards and limitations associated with the use of the equipment in areas where methane could be present. Additionally, personnel shall be trained regarding proper procedures for donning Self-Contained Self Rescuers (SCSRs) during a mine emergency while wearing the 3M Versaflo TR-800 or CleanSpace EX. The mine operator shall submit proposed revisions to update the Mine Emergency Evacuation and Firefighting Program of Instruction under 30 CFR 75.1502 to address this issue.</P>
                <P>(q) Within 60 days after the PDO granted by MSHA becomes final, Leer South Mine shall submit proposed revisions for its approved 30 CFR part 48 training plans to the Mine Safety and Health Enforcement District Manager. These proposed revisions shall specify initial and refresher training regarding the terms and conditions stated in the PDO granted by MSHA. When training is conducted on the terms and conditions in the PDO granted by MSHA, an MSHA Certificate of Training (Form 5000-23) shall be completed. Comments shall be included on the Certificate of Training indicating that the training received was for use of the 3M Versaflo TR-800 or CleanSpace EX.</P>
                <P>(r) All personnel who will be involved with or affected by the use of the 3M Versaflo TR-800 or CleanSpace EX shall receive training in accordance with 30 CFR 48.7 on the requirements of the PDO granted by MSHA within 60 days of the date the PDO granted by MSHA becomes final. Such training shall be completed before any 3M Versaflo TR-800 or CleanSpace EX can be used in return air outby the last open crosscut. The operator shall keep a record of such training and provide such record to MSHA upon request.</P>
                <P>(s) Leer South Mine shall provide annual retraining to all personnel who will be involved with or affected by the use of the 3M Versaflo TR-800 or CleanSpace EX in accordance with 30 CFR 48.8. The operator shall train new miners on the requirements of the PDO granted by MSHA in accordance with 30 CFR 48.5 and shall train experienced miners on the requirements of the PDO granted by MSHA in accordance with 30 CFR 48.6. The operator shall keep a record of such training and provide such record to MSHA upon request.</P>
                <P>(t) Leer South Mine shall post the PDO granted by MSHA in unobstructed locations on the bulletin boards and/or in other conspicuous places where notices to miners are ordinarily posted for a period of not less than 60 consecutive days.</P>
                <P>(u) There are no representatives of miners at Wolf Run Mining, LLC, Leer South Mine. A copy of this petition has been posted on the bulletin board as of November 22, 2024.</P>
                <P>The petitioner asserts that the alternative method will guarantee no less than the same measure of protection afforded the miners under the mandatory standard.</P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Director, Office of Standards, Regulations, and Variances.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30944 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="105632"/>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <DEPDOC>[OMB Control No. 1219-0030]</DEPDOC>
                <SUBJECT>Proposed Extension of Information Collection; Main Fan Operation and Inspection (I-A, II-A, III, and V-A Mines)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for public comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information, in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection entitled Main Fan Operation and Inspection (I-A, II-A, III, and V-A Mines).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments must be received on or before February 25, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below. Please note that late comments received after the deadline will not be considered.</P>
                    <P>
                        • 
                        <E T="03">Federal E-Rulemaking Portal: https://www.regulations.gov.</E>
                         Follow the on-line instructions for submitting comments for docket number MSHA-2024-0068.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail/Hand Delivery:</E>
                         DOL-MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, 4th Floor West, Arlington, VA 22202-5452. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                    </P>
                    <P>
                        • MSHA will post all comments as well as any attachments, except for information submitted and marked as confidential, in the docket at 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Director, Office of Standards, Regulations, and Variances, MSHA, at 
                        <E T="03">MSHA.information.collections@dol.gov</E>
                         (email); (202) 693-9440 (voice); or (202) 693-9441 (facsimile). These are not toll-free numbers.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <HD SOURCE="HD2">A. Legal Authority</HD>
                <P>Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act) as amended, 30 U.S.C. 813(h), authorizes the Mine Safety and Health Administration (MSHA) to collect information necessary to carry out its duty in protecting the safety and health of miners. 30 U.S.C. 813(h). Further, section 101(a) of the Mine Act, 30 U.S.C. 811(a), authorizes the Secretary of Labor (Secretary) to develop, promulgate, and revise as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal, metal, and nonmetal mines.</P>
                <HD SOURCE="HD2">B. Information Collection</HD>
                <P>In order to fulfill the statutory mandates to promote miners' health and safety, MSHA requires the collection of information under the information request titled “Main Fan Operation and Inspection (I-A, II-A, III, and V-A Mines).” The information collection is intended to ensure that mine ventilation is constantly monitored and that unsafe conditions are identified early and corrected.</P>
                <HD SOURCE="HD3">1. Daily Main Fan Inspection and Certification (I-A, II-A, III, and V-A Mines)</HD>
                <P>Maintaining proper ventilation is critical to providing miners with a safe working environment. Potentially dangerous conditions in underground mines due to explosive gases are largely controlled by the main fans. When accumulations of explosive gases, such as methane, are not quickly removed from the mine by the main fans, they may reasonably be expected to come in contact with an ignition source and cause explosions. The results of such explosions are often severe and have previously included incidents with multiple fatalities.</P>
                <P>Under 30 CFR 57.22204, which applies to underground metal and nonmetal mines that are categorized as I-A, II-A, III or V-A mines, the main fans must have a pressure-recording system. This standard also requires main fans to be inspected daily while operating if persons are underground, and certification of inspections must be made by signature and date. Certifications and pressure recordings must be retained for at least one year and made available to an authorized representative of the Secretary.</P>
                <HD SOURCE="HD1">II. Desired Focus of Comments</HD>
                <P>MSHA is soliciting comments concerning the proposed information collection titled “Main Fan Operation and Inspection (I-A, II-A, III, and V-A Mines).” MSHA is particularly interested in comments that:</P>
                <P>• Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information has practical utility;</P>
                <P>• Evaluate the accuracy of MSHA's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;</P>
                <P>• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and</P>
                <P>
                    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, 
                    <E T="03">e.g.,</E>
                     permitting electronic submission of responses.
                </P>
                <P>
                    The information collection request will be available on 
                    <E T="03">https://www.regulations.gov.</E>
                     MSHA cautions the commenter against providing any information in the submission that should not be publicly disclosed. Full comments, including personal information provided, will be made available on 
                    <E T="03">https://www.regulations.gov</E>
                     and 
                    <E T="03">https://www.reginfo.gov.</E>
                </P>
                <P>The public may also examine publicly available documents at DOL-MSHA, Office of Standards, Regulations and Variances, 201 12th Street South, 4th Floor West, Arlington, VA 22202-5452. Sign in at the receptionist's desk on the 4th Floor via the West elevator. Before visiting MSHA in person, call 202-693-9455 to make an appointment.</P>
                <P>
                    Questions about the information collection requirements may be directed to the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this notice.
                </P>
                <HD SOURCE="HD1">III. Current Actions</HD>
                <P>This information collection request concerns provisions for Main Fan Operation and Inspection (I-A, II-A, III, and V-A Mines). MSHA has updated the data with respect to the number of respondents, responses, time burden, and burden costs supporting this information collection request from the previous information collection request.</P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension, without change, of a currently approved collection.
                </P>
                <P>
                    <E T="03">Agency:</E>
                     Mine Safety and Health Administration.
                    <PRTPAGE P="105633"/>
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1219-0030.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profit.
                </P>
                <P>
                    <E T="03">Number of Annual Respondents:</E>
                     6.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Number of Annual Responses:</E>
                     3,960.
                </P>
                <P>
                    <E T="03">Annual Time Burden:</E>
                     2,112 hours.
                </P>
                <P>
                    <E T="03">Annual Other Burden Costs</E>
                     $6,000.
                </P>
                <P>
                    Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the proposed information collection request; they will become a matter of public record and be available at 
                    <E T="03">https://www.reginfo.gov.</E>
                </P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Certifying Officer, Mine Safety and Health Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30942 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Mine Safety and Health Administration</SUBAGY>
                <DEPDOC>[OMB Control No. 1219-0026]</DEPDOC>
                <SUBJECT>Proposed Extension of Information Collection; Ground Control for Surface Coal Mines and Surface Work Areas of Underground Coal Mines</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Mine Safety and Health Administration, Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Request for public comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information, in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection entitled Ground Control for Surface Coal Mines and Surface Work Areas of Underground Coal Mines.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All comments must be received on or before February 25, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below. Please note that late comments received after the deadline will not be considered.</P>
                    <P>
                        • 
                        <E T="03">Federal E-Rulemaking Portal:</E>
                          
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the on-line instructions for submitting comments for docket number MSHA-2024-0067.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail/Hand Delivery:</E>
                         DOL-MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, 4th Floor West, Arlington, VA 22202-5452. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                    </P>
                    <P>
                        • MSHA will post all comments as well as any attachments, except for information submitted and marked as confidential, in the docket at 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        S. Aromie Noe, Director, Office of Standards, Regulations, and Variances, MSHA, at 
                        <E T="03">MSHA.information.collections@dol.gov</E>
                         (email); (202) 693-9440 (voice); or (202) 693-9441 (facsimile). These are not toll-free numbers.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <HD SOURCE="HD2">A. Legal Authority</HD>
                <P>Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act) as amended, 30 U.S.C. 813(h), authorizes the Mine Safety and Health Administration (MSHA) to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, section 101(a) of the Mine Act, 30 U.S.C. 811(a), authorizes the Secretary of Labor (Secretary) to develop, promulgate, and revise, as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal, metal and nonmetal mines.</P>
                <HD SOURCE="HD2">B. Information Collection</HD>
                <P>In order to fulfill the statutory mandates to promote miners' health and safety, MSHA requires the collection of information under the information collection request titled “Ground Control for Surface Coal Mines and Surface Work Areas of Underground Coal Mines.” The information collection is intended to ensure that mine operators are properly maintaining the highwalls, pits, and spoil banks of surface coal mines and underground coal mines with surface work areas so that a safe environment is provided for mine employees, management, and others who visit the mine property. Mine operators are required to (1) develop ground control plans for highwalls, pits, and spoil banks and (2) submit the ground control plans. Details on the two requirements are following:</P>
                <HD SOURCE="HD3">1. Development of Ground Control Plans of Highwalls, Pits and Spoil Banks</HD>
                <P>Under 30 CFR 77.1000, each operator must establish and follow a ground control plan for the safe control of all highwalls, pits and spoil banks, which must be consistent with prudent engineering design and will ensure safe working conditions. The mining methods employed by the operator must be selected to ensure highwall and spoil bank stability.</P>
                <HD SOURCE="HD3">2. Submission of Ground Control Plans</HD>
                <P>Under 30 CFR 77.1000-1, the mine operator must file a copy of the ground control plan, and revisions thereof, with the MSHA District Office in which the mine is located, and must identify: the name and location of the mine; the MSHA identification number if known; and the name and address of the mine operator.</P>
                <HD SOURCE="HD1">II. Desired Focus of Comments</HD>
                <P>MSHA is soliciting comments concerning the proposed information collection titled “Ground Control for Surface Coal Mines and Surface Work Areas of Underground Coal Mines.” MSHA is particularly interested in comments that:</P>
                <P>• Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information has practical utility;</P>
                <P>• Evaluate the accuracy of MSHA's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;</P>
                <P>• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and</P>
                <P>
                    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, 
                    <E T="03">e.g.,</E>
                     permitting electronic submission of responses.
                </P>
                <P>
                    The information collection request will be available on 
                    <E T="03">https://www.regulations.gov.</E>
                     MSHA cautions the commenter against providing any information in the submission that should not be publicly disclosed. Full comments, including personal information provided, will be made available on 
                    <E T="03">https://www.regulations.gov</E>
                     and 
                    <E T="03">https://www.reginfo.gov.</E>
                </P>
                <P>
                    The public may also examine publicly available documents at DOL-MSHA, Office of Standards, Regulations and Variances, 201 12th Street South, 4th 
                    <PRTPAGE P="105634"/>
                    Floor West, Arlington, VA 22202-5452. Sign in at the receptionist's desk on the 4th Floor via the West elevator. Before visiting MSHA in person, call 202-693-9455 to make an appointment.
                </P>
                <P>
                    Questions about the information collection requirements may be directed to the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this notice.
                </P>
                <HD SOURCE="HD1">III. Current Actions</HD>
                <P>This information collection request concerns provisions for Ground Control for Surface Coal Mines and Surface Work Areas of Underground Coal Mines. MSHA has updated the data with respect to the number of respondents, responses, time burden, and burden costs supporting this information collection request from the previous information collection request.</P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension, without change, of a currently approved collection.
                </P>
                <P>
                    <E T="03">Agency:</E>
                     Mine Safety and Health Administration.
                </P>
                <P>
                    <E T="03">OMB Number:</E>
                     1219-0026.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profit.
                </P>
                <P>
                    <E T="03">Number of Annual Respondents:</E>
                     349.
                </P>
                <P>
                    <E T="03">Frequency:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Number of Annual Responses:</E>
                     349.
                </P>
                <P>
                    <E T="03">Annual Time Burden:</E>
                     2,398 hours.
                </P>
                <P>
                    <E T="03">Annual Other Burden Costs:</E>
                     $663.
                </P>
                <P>
                    Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the proposed information collection request; they will become a matter of public record and be available at 
                    <E T="03">https://www.reginfo.gov.</E>
                </P>
                <SIG>
                    <NAME>Song-ae Aromie Noe,</NAME>
                    <TITLE>Certifying Officer, Mine Safety and Health Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30941 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4520-43-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF LABOR</AGENCY>
                <SUBAGY>Occupational Safety and Health Administration</SUBAGY>
                <DEPDOC>[Docket No. OSHA-2009-0025]</DEPDOC>
                <SUBJECT>UL LLC: Grant of Expansion of Recognition</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Occupational Safety and Health Administration (OSHA), Labor.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In this notice, OSHA announces the final decision to expand the scope of recognition for UL LLC as a Nationally Recognized Testing Laboratory (NRTL).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The expansion of the scope of recognition becomes effective on December 27, 2024.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Information regarding this notice is available from the following sources:</P>
                    <P>
                        <E T="03">Press inquiries:</E>
                         Contact Mr. Frank Meilinger, Director, OSHA Office of Communications, U.S. Department of Labor, telephone: (202) 693-1999; email: 
                        <E T="03">meilinger.francis@dol.gov.</E>
                    </P>
                    <P>
                        <E T="03">General and technical information:</E>
                         Contact Mr. Kevin Robinson, Director, Office of Technical Programs and Coordination Activities, Directorate of Technical Support and Emergency Management, Occupational Safety and Health Administration, U.S. Department of Labor, phone: (202) 693-2300 or email: 
                        <E T="03">robinson.kevin@dol.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Notice of Final Decision</HD>
                <P>OSHA hereby gives notice of the expansion of the scope of recognition of UL LLC (UL), as a NRTL. UL's expansion covers the addition of one test site to the NRTL scope of recognition.</P>
                <P>OSHA recognition of a NRTL signifies that the organization meets the requirements specified in 29 CFR 1910.7. Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within the scope of recognition. Each NRTL's scope of recognition includes (1) the type of products the NRTL may test, with each type specified by the applicable test standard and (2) the recognized site(s) that has/have the technical capability to perform the product-testing and product-certification activities for test standards within the NRTL's scope. Recognition is not a delegation or grant of government authority; however, recognition enables employers to use products approved by the NRTL to meet OSHA standards that require product testing and certification.</P>
                <P>
                    The agency processes applications by a NRTL for initial recognition, as well as for an expansion or renewal of recognition, following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the agency publish two notices in the 
                    <E T="04">Federal Register</E>
                     in processing an application. In the first notice, OSHA announces the application and provides the preliminary finding. In the second notice, the agency provides the final decision on the application. These notices set forth the NRTL's scope of recognition or modifications of that scope. OSHA maintains an informational web page for each NRTL, including UL, which details that NRTL's scope of recognition. These pages are available from the OSHA website at 
                    <E T="03">https://www.osha.gov/dts/otpca/nrtl/index.html.</E>
                </P>
                <P>UL submitted an application, dated November 29, 2022 (OSHA-2009-0025-0066), to expand recognition as a NRTL to include one additional test site located at: Uiwang (LAB), Obongsandan 1-Ro, 42, Uiwang-Si, Gyeonggi-Do Uiwang 16079, South Korea. OSHA staff performed an on-site review of UL's testing facilities at UL Uiwang on May 8-9, 2024, in which assessors found some nonconformances with the requirements of 29 CFR 1910.7. UL has addressed these issues sufficiently, and OSHA staff has preliminarily determined that OSHA should grant the application.</P>
                <P>
                    OSHA published the preliminary notice announcing UL's expansion application in the 
                    <E T="04">Federal Register</E>
                     on October 25, 2024 (89 FR 85249). The agency requested comments by November 12, 2024, but it received no comments in response to this notice. OSHA is now proceeding with this notice to grant expansion to UL's scope of recognition.
                </P>
                <P>
                    To obtain or review copies of all public documents pertaining to the UL expansion application, go to 
                    <E T="03">www.regulations.gov</E>
                     or contact the Docket Office (202) 693-2350 (TTY (877) 889-5627. Docket No. OSHA-2009-0025 contains all materials in the record containing UL's recognition.
                </P>
                <HD SOURCE="HD1">II. Final Decision and Order</HD>
                <P>OSHA staff examined UL's expansion application, conducted a detailed on-site assessment, and examined other pertinent information. Based on review of this evidence, OSHA finds that UL meets the requirements of 29 CFR 1910.7 for expansion of recognition, subject to the specified limitations and conditions. OSHA, therefore, is proceeding with this final notice to grant UL's scope of recognition. OSHA limits the expansion of UL's recognition to include the site at Uiwang, Korea as listed above. OSHA's recognition of the site limits UL to performing product testing and certifications only to the test standards for which the site has the proper capability and programs, and for test standards in UL's scope of recognition. This limitation is consistent with the recognition that OSHA grants to other NRTLs that operate multiple sites.</P>
                <HD SOURCE="HD2">A. Conditions</HD>
                <P>
                    In addition to those conditions already required by 29 CFR 1910.7, UL 
                    <PRTPAGE P="105635"/>
                    also must abide by the following conditions of the recognition:
                </P>
                <P>1. UL must inform OSHA as soon as possible, in writing, of any change of ownership, facilities, or key personnel, and of any major change in its operations as a NRTL, and provide details of the change(s);</P>
                <P>2. UL must meet all the terms of its recognition and comply with all OSHA policies pertaining to this recognition; and</P>
                <P>3. UL must continue to meet the requirements for recognition, including all previously published conditions on UL's scope of recognition, in all areas for which it has recognition.</P>
                <P>OSHA hereby expands the NRTL scope of recognition for UL to include one additional test site in Uiwang, Korea.</P>
                <HD SOURCE="HD1">III. Authority and Signature</HD>
                <P>James S. Frederick, Deputy Assistant Secretary of Labor for Occupational Safety and Health, 200 Constitution Avenue NW, Washington, DC 20210, authorized the preparation of this notice. Accordingly, the agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2), Secretary of Labor's Order No. 8-2020 (85 FR 58393; Sept. 18, 2020), and 29 CFR 1910.7.</P>
                <SIG>
                    <DATED>Signed at Washington, DC, on December 19, 2024.</DATED>
                    <NAME>James S. Frederick,</NAME>
                    <TITLE>Deputy Assistant Secretary of Labor for Occupational Safety and Health.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31020 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4510-26-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">LIBRARY OF CONGRESS</AGENCY>
                <SUBAGY>Copyright Royalty Board</SUBAGY>
                <DEPDOC>[Docket No. 24-CRB-0005-CRA (2025-2029)]</DEPDOC>
                <SUBJECT>Adjustment of Cable Statutory License Royalty Rates</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Copyright Royalty Board, Library of Congress.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice announcing commencement of proceeding with request for petitions to participate.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Copyright Royalty Judges (Judges) announce the commencement of a proceeding to adjust the rates for the cable statutory license described in section 111 of the Copyright Act. The Judges also announce the date by which a party who wishes to participate in the proceeding must file its Petition to Participate and pay the $150 filing fee.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Petitions to Participate and the filing fee are due no later than January 27, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The petition to participate form is available online in eCRB, the Copyright Royalty Board's online electronic filing application, at 
                        <E T="03">https://app.crb.gov/.</E>
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         The petition to participate process has been simplified. Interested parties file a petition to participate by filling out the petition to participate form in eCRB and paying the fee in eCRB. Do not upload a petition to participate document.
                    </P>
                    <P>
                        <E T="03">Docket:</E>
                         For access to the docket to read submitted documents, go to eCRB, the Copyright Royalty Board's electronic filing and case management system, at 
                        <E T="03">https://app.crb.gov/,</E>
                         and search for docket number 24-CRB-0005-CRA (2025-2029).
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Anita Brown, CRB Program Specialist, (202) 707-7658, 
                        <E T="03">crb@loc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>Section 111 of the Copyright Act grants a statutory copyright license to cable television systems for the retransmission of over-the-air television and radio broadcast stations to their subscribers. 17 U.S.C. 111(c). In exchange for the license, cable operators submit royalty payments and statements of account detailing their retransmissions semiannually to the Copyright Office. 17 U.S.C. 111(d)(1). The Copyright Office deposits the royalties into the United States Treasury for later distribution to copyright owners of the broadcast programming that the cable systems retransmit. 17 U.S.C. 111(d)(2).</P>
                <P>
                    A cable system calculates its royalty payments in accordance with the statutory formula described in 17 U.S.C. 111(d)(1). 
                    <E T="03">See</E>
                     37 CFR part 387. Royalty rates are based upon a cable system's gross receipts from subscribers who receive retransmitted broadcast signals. For rate calculation purposes, cable systems are divided into three tiers based on their gross receipts (small, medium, and large). 17 U.S.C. 111(d)(1)(B) through (F). Both the applicable rates and the tiers are subject to adjustment. 17 U.S.C. 801(b)(2).
                </P>
                <P>
                    Section 804 of the Copyright Act provides that the gross receipts and royalty rates may be adjusted every five years beginning with 2005, thus making 2025 a royalty adjustment year, upon the filing of a petition to initiate a proceeding. 17 U.S.C. 804(b)(1). However, since no petition has been filed pursuant to section 804(b)(1), section 803(b)(1)(A)(i)(V) requires the Judges to publish a 
                    <E T="04">Federal Register</E>
                     notice no later than January 5, 2025, commencing this proceeding.
                </P>
                <P>
                    No person with a significant interest has filed a petition to initiate a proceeding in 2024.
                    <SU>1</SU>
                    <FTREF/>
                     The Judges must, therefore, publish notice in the 
                    <E T="04">Federal Register</E>
                     announcing the commencement of a proceeding and calling for Petitions to Participate. 
                    <E T="03">See</E>
                     17 U.S.C. 803(b)(1).
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         With respect to the rates for the 2020-2024 period, the Judges adopted a settlement proposed by the participants to leave the then-current rates unchanged. 86 FR 72845, 72846 (Dec. 23, 2021).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Petitions to Participate</HD>
                <P>Parties filing Petitions to Participate should use the interactive form in eCRB, instead of uploading a document, and must comply with the requirements of § 351.1(b) of the Copyright Royalty Board's regulations.</P>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>David P. Shaw,</NAME>
                    <TITLE>Chief Copyright Royalty Judge.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30822 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 1410-72-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">MILLENNIUM CHALLENGE CORPORATION</AGENCY>
                <DEPDOC>[MCC FR 24-12]</DEPDOC>
                <SUBJECT>Report on the Selection of Eligible Countries for Fiscal Year 2025</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Millennium Challenge Corporation.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This report is provided in accordance with the Millennium Challenge Act of 2003, as amended. The report is set forth in full below.</P>
                </SUM>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Report on the Selection of Eligible Countries for Fiscal Year 2025.</P>
                <HD SOURCE="HD1">Summary</HD>
                <P>This report is provided in accordance with section 608(d)(1) of the Millennium Challenge Act of 2003, as amended (the Act) (22 U.S.C. 7707(d)(1)).</P>
                <P>
                    The Act authorizes the provision of assistance under section 605 of the Act (22 U.S.C. 7704) to countries that enter into compacts with the United States to support policies and programs that advance the progress of such countries in achieving lasting poverty reduction through economic growth and are in furtherance of the Act. The Act requires the Millennium Challenge Corporation (MCC) to determine the countries that will be eligible to receive assistance for the fiscal year, based on their demonstrated commitment to just and democratic governance, economic freedom, and investing in their people, 
                    <PRTPAGE P="105636"/>
                    as well as on the opportunity to reduce poverty through economic growth in the country. The Act also requires the submission of reports to appropriate congressional committees and the publication of notices in the 
                    <E T="04">Federal Register</E>
                     that identify, among other things:
                </P>
                <P>1. The countries that are “candidate countries” for assistance for fiscal year (FY) 2025 based on their per-capita income levels and their eligibility to receive assistance under U.S. law, and countries that would be candidate countries, but for specified legal prohibitions on assistance (section 608(a) of the Act (22 U.S.C. 7707(a)));</P>
                <P>2. The criteria and methodology that the Board of Directors of MCC (the Board) used to measure and evaluate the policy performance of the “candidate countries” consistent with the requirements of section 607 of the Act in order to determine “eligible countries” from among the “candidate countries” (section 608(b) of the Act (22 U.S.C. 7707(b))); and</P>
                <P>3. The list of countries determined by the Board to be “eligible countries” for FY 2025, with justification for eligibility determination and selection for compact negotiation, including with which of the eligible countries the Board will seek to enter into compacts (section 608(d) of the Act (22 U.S.C. 7707(d))).</P>
                <P>This is the third of the above-described reports by MCC for FY 2025. It identifies countries determined by the Board to be eligible under section 607 of the Act (22 U.S.C. 7706) for FY 2025 with which MCC seeks to enter into compacts under section 609 of the Act (22 U.S.C. 7708), as well as the justification for such decisions. The report also identifies countries selected by the Board to receive assistance under MCC's threshold program pursuant to section 616 of the Act (22 U.S.C. 7715).</P>
                <P>Following the passage of the MCC Candidate Country Reform Act, as part of the National Defense Authorization Act on December 18, 2024, MCC's Board of Directors is considering additional countries for MCC assistance for FY 2025. Should the Board select another eligible country, MCC will submit a report notifying Congress of such selection(s).</P>
                <HD SOURCE="HD1">Eligible Countries</HD>
                <P>The Board met on December 18, 2024, to select those eligible countries with which the United States, through MCC, will seek to enter into a Millennium Challenge Compact pursuant to section 607 of the Act (22 U.S.C. 7706). The Board selected the following eligible country for such assistance for FY 2025: Liberia. Liberia is invited by MCC to develop a compact. The Board also selected the following previously selected countries for compact assistance for FY 2025: Cabo Verde, Senegal, and The Gambia. The Board did not vote on the selection of Togo, a country previously selected for compact assistance.</P>
                <HD SOURCE="HD1">Criteria</HD>
                <P>
                    In accordance with the Act and with the “Selection Criteria and Methodology Report for Fiscal Year 2025” formally submitted to Congress on September 20, 2024, selection was based primarily on a country's overall performance in three broad policy categories: 
                    <E T="03">Ruling Justly, Encouraging Economic Freedom,</E>
                     and 
                    <E T="03">Investing in People.</E>
                     The Board relied, to the fullest extent possible, upon transparent and independent indicators to assess countries' policy performance and demonstrated commitment in these three broad policy areas. The Board compared countries' performance on the indicators relative to their income-level peers, evaluating them in comparison to either the group of countries with a GNI per capita equal to or less than $2,165, or the group with a GNI per capita between $2,166 and $4,515.
                </P>
                <P>
                    The criteria and methodology used to assess countries, including the methodology for the annual scorecards, are outlined in the “Selection Criteria and Methodology Report for Fiscal Year 2025 
                    <SU>1</SU>
                    <FTREF/>
                    .” Scorecards reflecting each country's performance on the indicators are available on MCC's website at 
                    <E T="03">https://www.mcc.gov/who-we-select/scorecards.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Available at 
                        <E T="03">https://www.mcc.gov/resources/doc/report-selection-criteria-methodology-fy25.</E>
                    </P>
                </FTNT>
                <P>
                    The Board also considered whether any adjustments should be made for data gaps, data lags, or recent events since the indicators were published, as well as strengths or weaknesses in particular indicators. Where appropriate, the Board considered additional quantitative and qualitative information, such as evidence of a country's commitment to fighting corruption, investments in human development outcomes, or poverty rates. MCC has a Guide to Supplemental Information 
                    <SU>2</SU>
                    <FTREF/>
                     available on its website to increase transparency about the type of supplemental information the Board uses to assess a country's policy performance. In keeping with statutory requirements, the Board also considered the opportunity to reduce poverty and promote economic growth in a country, as well as the availability of appropriated funds.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Available at 
                        <E T="03">https://www.mcc.gov/resources/doc/guide-to-supplemental-information.</E>
                    </P>
                </FTNT>
                <P>The Board sees the selection decision as an annual opportunity to determine where MCC funds can be most effectively used to support poverty reduction through economic growth in well-governed countries with demonstrated development need. The Board carefully considers the appropriate nature of each country partnership—on a case-by-case basis—based on factors related to poverty reduction through economic growth, the sustainability of MCC's investments, and the country's ability to attract and leverage public and private resources in support of development.</P>
                <P>This was the seventh year the Board considered the eligibility of countries for concurrent compacts, as permitted under section 609(k) of the Act. In addition to the considerations for compact eligibility detailed above, the Board considered whether a country being considered for a concurrent compact is making considerable and demonstrable progress in implementing the terms of its existing compact.</P>
                <P>
                    This was the sixteenth year the Board considered the eligibility of countries for subsequent compacts, as permitted under section 609(l) of the Act. MCC's engagement with partner countries is not open-ended, and the Board is deliberate when selecting countries for follow-on partnerships, particularly regarding the higher bar applicable to subsequent compact countries. The Board considered—in addition to the criteria outlined above—a country's performance implementing its prior compact, including the nature of the country's partnership with MCC, the degree to which the country has demonstrated a commitment and capacity to achieve program results, and the degree to which the country implemented the compact in accordance with MCC's core policies and standards. To the greatest extent possible, these factors are assessed using pre-existing monitoring and evaluation targets and regular quarterly reporting. This information is supplemented with direct surveys and consultation with MCC staff responsible for compact implementation, monitoring, and evaluation. MCC has a Guide to the Program Surveys 
                    <SU>3</SU>
                    <FTREF/>
                     available on its website regarding the information collected and assessed for any country with an existing or prior compact or threshold program to ensure transparency about the type of information the Board considers 
                    <PRTPAGE P="105637"/>
                    regarding a country's performance on MCC programs, as relevant. The Board also considered a country's commitment to further sector reform, as well as evidence of improved scorecard policy performance.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Available at 
                        <E T="03">https://www.mcc.gov/resources/doc/guide-to-the-program-surveys/.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD2">Countries Newly Selected for Compact Assistance</HD>
                <P>
                    Using the criteria described above, one candidate country under section 606(a) of the Act (22 U.S.C. 7705(a) was newly selected as eligible for assistance under section 607 of the Act (22 U.S.C. 7706): 
                    <E T="03">Liberia.</E>
                     Liberia is invited by MCC to develop a compact.
                </P>
                <P>
                    <E T="03">Liberia:</E>
                     A prior compact partner, Liberia passes the scorecard for the third consecutive year in FY 2025. One of the world's poorest countries, Liberia is a politically stable democracy that has seen two decades of peace since the second civil war ended in 2003. General elections held in late 2023 were free, fair, competitive, and peaceful, and the new government has committed to prioritize reforms to boost the economy, advance national reconciliation efforts, and strengthen the fight against corruption. MCC's Board selected Liberia as eligible to develop a subsequent compact in recognition of the progress the country has made to strengthen its scorecard performance and pursue economic and democratic governance reforms. The selection provides MCC the opportunity to develop a program that could significantly impact the lives of the Liberian people through a committed and engaged former MCC partner.
                </P>
                <HD SOURCE="HD2">Countries Selected To Continue Compact Development</HD>
                <P>
                    Three of the countries selected as eligible for compact assistance for FY 2025 were previously selected for FY 2024. 
                    <E T="03">Cabo Verde</E>
                     (regional), 
                    <E T="03">Senegal</E>
                     (regional), and 
                    <E T="03">The Gambia</E>
                     were selected to continue developing compacts. Selection of these countries for FY 2025 was based on an assessment of their policy performance since their prior selection and their progress in developing programs with MCC. The Board deferred a vote on the selection of 
                    <E T="03">Togo</E>
                     to continue developing a compact to provide the Government of Togo additional time to strengthen the protection of democratic rights and fundamental freedoms as it implements its new constitution and transitions to a new system of government next year. In making its decision to defer a vote, the Board discussed the importance of the Government of Togo taking meaningful action to address MCC's concerns regarding the country's constitutional change process and restrictions on fundamental freedoms. The Board may revisit its decision over the course of 2025 as more information becomes available.
                </P>
                <HD SOURCE="HD2">Country Selected To Receive Threshold Program Assistance</HD>
                <P>The Board did not newly select any countries to receive threshold program assistance for FY 2025.</P>
                <HD SOURCE="HD2">Countries Selected To Continue Developing Threshold Programs</HD>
                <P>
                    The Board selected 
                    <E T="03">Philippines</E>
                     and 
                    <E T="03">Tanzania</E>
                     to continue developing threshold programs.
                </P>
                <P>Selection of Philippines for FY 2025 was based on its commitment to strengthening its policy performance, protections for human rights and fundamental freedoms, and anti-corruption efforts since its prior selection and its progress developing its threshold program.</P>
                <P>Selection of Tanzania for FY 2025 recognized the progress that has been made in developing a threshold program. However, in making the selection the Board expressed concern that the November 27 local elections were a missed opportunity to open political space and advance democratic reforms. The Board also noted with concern reports of disappearances, political violence, and restrictions on peaceful assembly and press freedoms and urges the Government of Tanzania to protect democratic freedoms as the country prepares for national elections in 2025.</P>
                <HD SOURCE="HD2">Ongoing Review of Partner Countries' Policy Performance</HD>
                <P>
                    The Board emphasized the need for all partner countries to maintain or improve their policy performance. If it is determined during program implementation that a country has demonstrated a significant policy reversal, MCC can hold it accountable by applying MCC's Suspension and Termination Policy.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Available at 
                        <E T="03">https://www.mcc.gov/who-we-select/suspension-or-termination.</E>
                    </P>
                </FTNT>
                <EXTRACT>
                    <FP>(Authority: 22 U.S.C. 7707(d)(2))</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Peter E. Jaffe,</NAME>
                    <TITLE>Vice President, General Counsel, and Corporate Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30925 Filed 12-20-24; 11:15 am]</FRDOC>
            <BILCOD>BILLING CODE 9211-03-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NATIONAL CREDIT UNION ADMINISTRATION</AGENCY>
                <SUBJECT>Renewal of Agency Information Collection of a Previously Approved Collection; Request for Comments</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Credit Union Administration (NCUA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of submission to the Office of Management and Budget.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>As required by the Paperwork Reduction Act of 1995, The National Credit Union Administration (NCUA) is submitting the following extensions and revisions of currently approved collections to the Office of Management and Budget (OMB) for renewal.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Written comments should be received on or before January 27, 2025 to be assured consideration.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Copies of the submission may be obtained by contacting Madeleine Humm at (703) 518-6547, emailing 
                        <E T="03">PRAComments@ncua.gov,</E>
                         or viewing the entire information collection request at 
                        <E T="03">www.reginfo.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">OMB Number:</E>
                     3133-0169.
                </P>
                <P>
                    <E T="03">Title:</E>
                     Purchase of Assets and Assumptions of Liabilities, 12 CFR 741.8.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Revision of a currently approved collection.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     In accordance with § 741.8, federally insured credit unions (FICUs) must request approval from the NCUA prior to purchasing assets or assuming liabilities of a privately insured credit union, other financial institution, or their successor interest. A FICU seeking approval must submit a letter to the appropriate Regional Director stating the nature of the transaction, and include copies of relevant transaction documents. Relevant transactions documents may include, but are not limited to: the credit union's financial statements, strategic plan, and budget, inventory of the assets and liabilities to be transferred, and any relevant contracts or agreements regarding the transfer. NCUA will use the information to determine the safety and soundness of the transaction and risk to the National Credit Union Share Insurance Fund (NCUSIF).
                    <PRTPAGE P="105638"/>
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Private Sector: Not-for-profit institutions.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     18.
                </P>
                <P>
                    <E T="03">Estimated Number of Responses per Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Responses:</E>
                     18.
                </P>
                <P>
                    <E T="03">Estimated Hours per Response:</E>
                     120.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     2160.
                </P>
                <P>
                    <E T="03">Reason for Change:</E>
                     There are no changes to the information collection since the last OMB approval. The increase in total burden hours by 240 hours reflects an increase in the number of respondents, not a change in the burden per submission.
                </P>
                <P>
                    <E T="03">Request for Comments:</E>
                     Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will become a matter of public record. The public is invited to submit comments concerning: (a) whether the collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of the information on the respondents, including the use of automated collection techniques or other forms of information technology.
                </P>
                <SIG>
                    <P>By the National Credit Union Administration Board.</P>
                    <NAME>Melane Conyers-Ausbrooks,</NAME>
                    <TITLE>Secretary of the Board.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30989 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7535-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NUCLEAR REGULATORY COMMISSION</AGENCY>
                <DEPDOC>[NRC-2024-0033]</DEPDOC>
                <SUBJECT>Information Collection: Voluntary Reporting of Planned New Reactor Applications</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Nuclear Regulatory Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of submission to the Office of Management and Budget; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, “Voluntary Reporting of Planned New Reactor Applications.”</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments by January 27, 2025. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        David Cullison, NRC Clearance Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email: 
                        <E T="03">Infocollects.Resource@nrc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Obtaining Information and Submitting Comments</HD>
                <HD SOURCE="HD2">A. Obtaining Information</HD>
                <P>Please refer to Docket ID NRC-2024-0033 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:</P>
                <P>
                    • 
                    <E T="03">Federal Rulemaking Website:</E>
                     Go to 
                    <E T="03">https://www.regulations.gov</E>
                     and search for Docket ID NRC-2024-0033.
                </P>
                <P>
                    • 
                    <E T="03">NRC's Agencywide Documents Access and Management System (ADAMS):</E>
                     You may obtain publicly available documents online in the ADAMS Public Documents collection at 
                    <E T="03">https://www.nrc.gov/reading-rm/adams.html.</E>
                     To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by email to 
                    <E T="03">PDR.Resource@nrc.gov.</E>
                     A copy of the collection of information and related instructions may be obtained without charge by accessing ADAMS Accession No. ML24310A315. The supporting statement is available in ADAMS under Accession No. ML24262A165.
                </P>
                <P>
                    • 
                    <E T="03">NRC's PDR:</E>
                     The PDR, where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to 
                    <E T="03">PDR.Resource@nrc.gov</E>
                     or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time (ET), Monday through Friday, except Federal holidays.
                </P>
                <P>
                    • 
                    <E T="03">NRC's Clearance Officer:</E>
                     A copy of the collection of information and related instructions may be obtained without charge by contacting the NRC's Clearance Officer, David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email: 
                    <E T="03">Infocollects.Resource@nrc.gov.</E>
                </P>
                <HD SOURCE="HD2">B. Submitting Comments</HD>
                <P>
                    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                    <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E>
                     Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function.
                </P>
                <P>
                    The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at 
                    <E T="03">https://www.regulations.gov</E>
                     and entered into ADAMS. Comment submissions are not routinely edited to remove identifying or contact information.
                </P>
                <P>If you are requesting or aggregating comments from other persons for submission to the OMB, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.</P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the NRC recently submitted a request for renewal of an existing collection of information to OMB for review entitled, “Voluntary Reporting of Planned New Reactor Applications.” The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.</P>
                <P>
                    The NRC published a 
                    <E T="04">Federal Register</E>
                     notice with a 60-day comment period on this information collection on July 22, 2024, 89 FR 59171.
                    <PRTPAGE P="105639"/>
                </P>
                <P>
                    1. 
                    <E T="03">The title of the information collection:</E>
                     Voluntary Reporting of Planned New Reactor Applications.
                </P>
                <P>
                    2. 
                    <E T="03">OMB approval number:</E>
                     3150-0228.
                </P>
                <P>
                    3. 
                    <E T="03">Type of submission:</E>
                     Revision.
                </P>
                <P>
                    4. 
                    <E T="03">The form number, if applicable:</E>
                     Not applicable.
                </P>
                <P>
                    5. 
                    <E T="03">How often the collection is required or requested:</E>
                     Annually.
                </P>
                <P>
                    6. 
                    <E T="03">Who will be required or asked to respond:</E>
                     Applicants, licensees, and potential applicants report this information on a strictly voluntary basis.
                </P>
                <P>
                    7. 
                    <E T="03">The estimated number of annual responses:</E>
                     20.
                </P>
                <P>
                    8. 
                    <E T="03">The estimated number of annual respondents:</E>
                     20.
                </P>
                <P>
                    9. 
                    <E T="03">The estimated number of hours needed annually to comply with the information collection requirement or request:</E>
                     1,405.
                </P>
                <P>
                    10. 
                    <E T="03">Abstract:</E>
                     This voluntary information collection assists the NRC in determining resource and budget needs with respect to future construction-related activities, anticipated licensing and design certification rulemaking actions under part 50 of title 10 of the 
                    <E T="03">Code of Federal Regulations</E>
                     (10 CFR), “Domestic Licensing of Production and Utilization Facilities” and/or 10 CFR part 52 “Licenses, Certifications, and Approvals for Nuclear Power Plants” and other regulatory and preapplication activities for large light water reactors (LWRs), light water cooled small modular reactors, non-LWRs, and nonpower production and utilization facilities. In addition, information provided to the NRC staff is intended to promote early communications between the NRC and potential applicants about planned licensing and construction activities under 10 CFR part 50 and/or 10 CFR part 52. The overarching goal of this information collection is to assist the NRC staff more effectively and efficiently plan, schedule, and implement activities and reviews in a timely manner.
                </P>
                <SIG>
                    <DATED>Dated: December 20, 2024.</DATED>
                    <P>For the Nuclear Regulatory Commission.</P>
                    <NAME>David Cullison,</NAME>
                    <TITLE>NRC Clearance Officer, Office of the Chief Information Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31063 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7590-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 13, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1071 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-831, K2025-832.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30813 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 13, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1073 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-836, K2025-837.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30815 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 13, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail &amp; USPS Ground Advantage® Contract 539 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-840, K2025-841.
                </P>
                <SIG>
                    <NAME>Sean Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30804 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail and USPS Ground Advantage ® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service  
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service ® hereby gives notice that, pursuant to 39 U.S.C. 
                    <PRTPAGE P="105640"/>
                    3642 and 3632(b)(3), on December 13, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail &amp; USPS Ground Advantage ® Contract 536 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-833, K2025-834.
                </P>
                <SIG>
                    <NAME>Sean Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30801 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 13, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1066 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-826, K2025-827.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30808 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 16, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1090 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-858, K2025-859.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30839 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 17, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1118 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-897, K2025-898.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31001 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 16, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1088 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-856, K2025-857.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30837 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 13, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">
                        USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 
                        <PRTPAGE P="105641"/>
                        1072 to Competitive Product List.
                    </E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-832, K2025-833.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30814 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 13, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1070 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-830, K2025-831.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30812 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 13, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1078 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-842, K2025-843.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30820 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 17, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1121 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-901, K2025-902.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31004 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 17, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail &amp; USPS Ground Advantage® Contract 555 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-902, K2025-903.
                </P>
                <SIG>
                    <NAME>Sean Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31010 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 17, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1112 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-891 K2025-892.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30995 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="105642"/>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 13, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1065 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-825, K2025-826.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30807 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 17, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1119 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-898, K2025-899.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31002 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 13, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail &amp; USPS Ground Advantage® Contract 540 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-843, K2025-844.
                </P>
                <SIG>
                    <NAME>Sean Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30805 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 16, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1080 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-848, K2025-849.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30829 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 13, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail &amp; USPS Ground Advantage® Contract 538 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-835, K2025-836.
                </P>
                <SIG>
                    <NAME>Sean Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30803 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a 
                        <PRTPAGE P="105643"/>
                        domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 13, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1067 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-827, K2025-828.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30809 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 16, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1093 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-861, K2025-862.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30842 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 16, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail &amp; USPS Ground Advantage® Contract 544 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-863, K2025-864.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30847 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 16, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1091 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-859, K2025-860.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30840 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 16, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1087 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-855, K2025-856.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30836 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <PRTPAGE P="105644"/>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 13, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1077 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-841, K2025-842.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30819 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 17, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1122 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-904, K2025-904.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31005 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 16, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail &amp; USPS Ground Advantage® Contract 545 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-864, K2025-865.
                </P>
                <SIG>
                    <NAME>Sean Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30844 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 13, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail &amp; USPS Ground Advantage® Contract 537 to Competitive Product List</E>
                    . Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-834, K2025-835.
                </P>
                <SIG>
                    <NAME>Sean Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30802 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 17, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1117 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-896, K2025-897.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31000 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 17, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">
                        USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 
                        <PRTPAGE P="105645"/>
                        1124 to Competitive Product List.
                    </E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-905, K2025-906.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-31007 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage ® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service 
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 13, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1074 to Competitive Product List</E>
                    . Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-837, K2025-838.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30816 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 16, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1081 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-849, K2025-850.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30830 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">POSTAL SERVICE</AGENCY>
                <SUBJECT>Product Change—Priority Mail Express, Priority Mail, and USPS Ground Advantage® Negotiated Service Agreement</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>
                        Postal Service
                        <E T="51">TM</E>
                        .
                    </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Date of required notice:</E>
                         December 27, 2024.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Sean C. Robinson, 202-268-8405.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on December 16, 2024, it filed with the Postal Regulatory Commission a 
                    <E T="03">USPS Request to Add Priority Mail Express, Priority Mail &amp; USPS Ground Advantage® Contract 1084 to Competitive Product List.</E>
                     Documents are available at 
                    <E T="03">www.prc.gov,</E>
                     Docket Nos. MC2025-852, K2025-853.
                </P>
                <SIG>
                    <NAME>Sean C. Robinson,</NAME>
                    <TITLE>Attorney, Corporate and Postal Business Law.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30833 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-12-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-102013; File No. SR-OCC-2024-017]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Update the Options Clearing Corporation's Schedule of Fees</SUBJECT>
                <DATE>December 20, 2024.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act” or “Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on December 19, 2024, The Options Clearing Corporation (“OCC”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I, II, and III below, which Items have been prepared primarily by OCC. OCC filed the proposed rule change pursuant to Section 19(b)(3)(A)(ii) 
                    <SU>3</SU>
                    <FTREF/>
                     of the Act and Rule 19b-4(f)(2) 
                    <SU>4</SU>
                    <FTREF/>
                     thereunder so that the proposal was effective upon filing with the Commission. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         15 U.S.C. 78s(b)(3)(A)(ii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         17 CFR 240.19b-4(f)(2).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Clearing Agency's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    The proposed rule change would revise OCC's schedule of fees effective January 1, 2025, to implement an increase in clearing fees. Specifically, OCC proposes to increase the per contract clearing fee from $0.02 to $0.025 and to remove the flat per transaction fee (currently $55.00 for transactions of 2,751 or more contracts) entirely. The fee change is designed to address OCC's anticipated cash flow needs based on interest rate forecasts, projected operating expenses, projected volumes, and capital needs. Proposed changes to OCC's schedule of fees are included [sic] as Exhibit 5 to File Number SR-OCC-2024-017. Material proposed to be added to OCC's schedule of fees as currently in effect is italicized and material proposed to be deleted is marked in strikethrough text. All capitalized terms not defined herein have the same meaning as set forth in the OCC By-Laws and Rules.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         OCC's By-Laws and Rules can be found on OCC's public website: 
                        <E T="03">
                            https://www.theocc.com/
                            <PRTPAGE/>
                            Company-Information/Documents-and-Archives/By-Laws-and-Rules.
                        </E>
                    </P>
                </FTNT>
                <PRTPAGE P="105646"/>
                <HD SOURCE="HD1">II. Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, OCC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. OCC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.</P>
                <HD SOURCE="HD2">(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">(1) Purpose</HD>
                <P>
                    As the sole clearing agency for standardized equity options listed on national securities exchanges registered with the Commission, and with respect to OCC's clearance and settlement of futures and stock loan transactions, OCC maintains policies and procedures to manage the risks borne by OCC as a central counterparty. One such risk that OCC manages is general business risk—that is, the risk of potential impairment to OCC's financial position resulting from a decline in revenues or an increase in expenses. To manage this risk and help to ensure that OCC can continue operations and services as a going concern if general business losses materialize, OCC has filed, and the Commission has approved, OCC's Capital Management Policy,
                    <SU>6</SU>
                    <FTREF/>
                     which provides the framework by which OCC manages its capital. Amending OCC's schedule of fees is one action used by OCC to manage its capital.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         Notice of Filing and Immediate Effectiveness of Proposed Rule Change Concerning Updates to OCC's Capital Management Policy, Exchange Act Release No. 101151 (Sep. 24, 2024), 89 FR 79668 (Sep. 30, 2024) (SR-OCC-2024-012); Order Approving Proposed Rule Change to Establish OCC's Persistent Minimum Skin-In-The-Game, Exchange Act Release No. 92038 (May 27, 2021), 86 FR 29861 (June 3, 2021) (SR-OCC-2021-003); Order Approving Proposed Rule Change, as Modified by Partial Amendment No. 1, Concerning a Proposed Capital Management Policy That Would Support the Option Clearing Corporation's Function as a Systemically Important Financial Market Utility, Exchange Act Release No. 88029 (Jan. 24, 2020), 85 FR 5500 (Jan. 30, 2020) (SR-OCC-2019-007); see also Notice of Filing of Partial Amendment No. 1 and Notice of No Objection to Advance Notice, as Modified by Partial Amendment No. 1, Concerning a Proposed Capital Management Policy That Would Support the Option Clearing Corporation's Function as a Systemically Important Financial Market Utility, Exchange Act Release No. 87257 (Oct. 8, 2019), 84 FR 55194 (Oct. 15, 2019) (SR-OCC-2019-805).
                    </P>
                </FTNT>
                <P>In accordance with the Capital Management Policy, OCC management reviews the fee schedule at regularly scheduled meetings and, considering factors including, but not limited to, interest rate forecasts, anticipated cashflows, projected operating expenses, projected volumes, and capital needs, recommends to the Board (or a committee to which the Board has delegated authority) whether a fee change should be made. In accordance with such procedures, OCC management recommended, and the Compensation and Performance Committee of OCC's Board approved, the proposed fee change. The purpose of this proposed rule change is to revise OCC's schedule of fees, effective January 1, 2025, to implement an increase in clearing fees, as further described below.</P>
                <HD SOURCE="HD3">Proposed Fee Change</HD>
                <P>
                    OCC proposes to implement an increase in clearing fees, effective January 1, 2025, to better align its clearing fees with the costs of providing its clearing and settlement services to Clearing Members. OCC serves market participants as a financially responsible steward of clearing services while ensuring that it meets regulatory expectations and responsibly invests in its infrastructure. OCC has in place policies and procedures, including the Capital Management Policy, to control costs and regularly review fees and operating expenses, including during its annual budgeting process. Consistent with the Capital Management Policy, OCC's clearing fees are based on the sum of OCC's annual budgeted or forecasted operating expenses, a defined operating margin, cash flow needs and OCC's capital requirement. OCC currently has a two-tier clearing fee structure: OCC charges a $0.02 clearing fee per contract for transactions involving 2,750 or fewer contracts (the “Per Contract Clearing Fee”); and OCC charges a flat clearing fee of $55.00 per transaction for transactions of 2,751 or more contracts (the “Per Transaction Clearing Fee”). After an evaluation of OCC's financial position in consideration of such factors, including interest rate forecasts, anticipated cash flows, projected operating expenses, projected volumes, and capital needs, OCC determined that it should increase the Per Contract Clearing Fee from $0.02 to $0.025 and remove the Per Transaction Clearing Fee. Accordingly, going forward, OCC will have a single tier clearing fee structure, 
                    <E T="03">i.e.,</E>
                     OCC will charge one rate for clearing every contract, regardless of the size of the transaction.
                </P>
                <P>
                    OCC has not increased clearing fees since 2019. On April 1, 2019, OCC increased the Per Contract Clearing Fee from $0.05 to $0.055 and adjusted the quantity of contracts at which the Per Transaction Clearing Fee applied from greater than 1,100 contracts to greater than 999 contracts per transaction.
                    <SU>7</SU>
                    <FTREF/>
                     Since that time, OCC decreased clearing fees twice in accordance with the Capital Management Policy.
                    <SU>8</SU>
                    <FTREF/>
                     On September 1, 2020, OCC decreased the Per Contract Clearing Fee from $0.055 to $0.045 and adjusted the quantity of contracts at which the Per Transaction Clearing Fee applied from transactions with more than 999 contracts to transactions with more than 1,222 contracts per transaction.
                    <SU>9</SU>
                    <FTREF/>
                     On June 1, 2021, OCC decreased the Per Contract Clearing Fee from $0.045 to its current fee of $0.02 and adjusted the quantity of contracts at which the Per Transaction Clearing Fee applied from transactions with more than 1,222 contracts to transactions with more than 2,750 contracts.
                    <SU>10</SU>
                    <FTREF/>
                     OCC also implemented a fee holiday for the period of November 2021 to December 2021 to decrease all clearing fees to $0 for the last two months of 2021.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         Exchange Act Release No. 85322 (Mar. 14, 2019), 84 FR 10377 (Mar. 20, 2019) (File No. SR-OCC-2019-001) (modifying the schedule of fees to (i) increase the Per Contract Clearing Fee from $0.05 to $0.055 and (ii) adjust the quantity of contracts at which the Per Transaction Clearing Fee begins from greater than 1,100 contracts per transaction to greater than 999 contracts per transaction).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Under the Capital Management Policy as drafted at the time of the fee decreases, if OCC's Equity is above 110% of the Target Capital Requirement and other approved capital needs, OCC's Board may use tools to lower costs for Clearing Members, including lowering fees, declaring a fee holiday, or issuing refunds. 
                        <E T="03">See</E>
                         Exchange Act Release No. 88029 (Jan. 24, 2020), 85 FR 5500, 5502 (Jan. 30, 2020) (SR-OCC-2019-007). The Commission recently approved a change to OCC's Capital Management Policy, such that OCC's Board may use such tools to lower the costs for Clearing Members if liquid net assets funded by equity, rather than Equity, is above 110% of the Target Capital Requirement. 
                        <E T="03">See</E>
                         Exchange Act Release No. 101151 (Sept. 24, 2024), 89 FR 79668, 79670 (Sept. 30, 2024) (File No. SR-OCC-2024-12).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         Exchange Act Release No. 89534 (Aug. 12, 2020), 85 FR 50858 (Aug. 18, 2020) (File No. SR-OCC-2020-009) (modifying the schedule of fees to (i) decrease the Per Contract Clearing Fee from $0.055 to $0.045 and (ii) adjust the quantity of contracts at which the Per Transaction Clearing Fee begins from transactions with more than 999 contracts per transaction to transactions with more than 1,222 contracts per transaction).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See</E>
                         Exchange Act Release No. 91920 (May 18, 2021), 86 FR 27916 (May 24, 2021) (File No. SR-OCC-2021-006) (modifying the schedule of fees to (i) decrease the Per Contract Clearing Fee from $0.045 to $0.02 and (ii) adjust the quantity of contracts at which the Per Transaction Clearing Fee begins from transactions with more than 1,222 contracts per transaction to transactions with more than 2,750).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See</E>
                         Exchange Act Release Nos. 93195 (Sept. 29, 2021), 86 FR 55039 (Oct. 5, 2021) (File No. SR-OCC-2021-009) and 93612 (Nov. 18, 2021), 86 FR 67108 (Nov. 24, 2021) (File No. SR-OCC-2021-012).
                    </P>
                </FTNT>
                <PRTPAGE P="105647"/>
                <P>
                    Since the current clearing fees were set in 2021, the U.S. economy has experienced (i) notable inflation 
                    <SU>12</SU>
                    <FTREF/>
                     and (ii) a fluctuating interest rate environment. For instance, the dollar had an average inflation rate of 5.18% per year between 2021 and 2024, producing a cumulative price increase of approximately 16%.
                    <SU>13</SU>
                    <FTREF/>
                     While the proposed Per Contract Clearing Fee constitutes a 25% increase from the fee adopted in 2021, which is higher than the cumulative price increase, OCC believes the proposed fee increase is reasonable given the increased expenses associated with its technology infrastructure and the lower interest rate environment discussed below. Notably, the costs associated with OCC's technology hardware, including upfront and maintenance costs, have outpaced the rate of inflation. In addition to rising costs associated with inflation, decreasing interest rates will have a negative impact on what has been a reliable source of income for OCC. Moreover, inflation increases the price of goods and services over time, however, the price levels that result from those inflationary run-ups tend not to decrease even as inflation decreases, which results in OCC's costs remaining at those higher price levels.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Other self-regulatory organizations have referenced such inflation when filing fee increases. 
                        <E T="03">See, e.g.,</E>
                         Exchange Act Release Nos. 101017 (Sep. 12, 2024), 89 FR 76545 (Sep. 18, 2024) (File No. SR-CboeBYX-2024-032), 100882 (Aug. 30, 2024), 89 FR 72542 (Sep. 5, 2024) (File No. SR-BOX-2024-19).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See</E>
                         the inflation calculator, measuring inflation as of October 16, 2024, at 
                        <E T="03">https://www.officialdata.org/us/inflation/2021?amount=1.</E>
                    </P>
                </FTNT>
                  
                <P>During a review of OCC's fees in 2024, and in consideration of factors including, but not limited to, interest rate forecasts, anticipated cash flows, projected operating expenses, projected volumes, and capital needs, OCC management recommended, and the Compensation and Performance Committee of OCC's Board approved, to increase the Per Contract Clearing Fee by $0.005 to $0.025 and remove the Per Transaction Clearing Fee. The Per Transaction Clearing Fee currently limits the fee for clearing transactions with more than 2,750 contracts to $55.00 per transaction. Removal of the Per Transaction Clearing Fee would subject all transactions, regardless of contract size, to the same Per Contract Clearing Fee of $0.025. These changes are designed to address OCC's anticipated cash flow needs based on interest rate forecasts, projected operating expenses, projected volumes, and capital needs. In particular, as more fully described herein, OCC's anticipated cash flow needs have changed due to a decline in projected revenue from interest income; an increase in projected expenses associated with the development, maintenance, and modernization of OCC's technology infrastructure, including growing technology hardware costs and additional employee time; and an increase in capital needs, including due to inflation and increased investment in growing areas such as cybersecurity.</P>
                <P>
                    The proposed fee change is intended to better align OCC's clearing fees with the costs of providing its clearing and settlement services to Clearing Members. In determining the fee change, OCC considered analyses based on certain assumptions and projections, including declining interest rates contributing to a decrease in revenue. The effective federal funds rate increased significantly from near zero beginning in early 2022 to peaks over 5% in the fall of 2023, generating additional income for OCC.
                    <SU>14</SU>
                    <FTREF/>
                     Interest rates have recently decreased.
                    <SU>15</SU>
                    <FTREF/>
                     The general expectation in the marketplace is that rates will continue to decline into 2025, which will have a negative impact on interest and investment revenue from clearing margin cash balances, which has been a reliable source of income for OCC over the past three years.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         Effective Federal Funds Rate at 
                        <E T="03">https://www.newyorkfed.org/markets/reference-rates/effr.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">Id.</E>
                         As of October 7, 2024, the effective Federal funds rate was 4.83%.
                    </P>
                </FTNT>
                <P>Moreover, OCC has increased investments in various areas, such as compliance, regulatory, legal, and cybersecurity, and headcount, since the last time it increased clearing fees. In addition, the costs associated with providing OCC's clearing and settlement services, including the maintenance, development, and modernization of its technology infrastructure, are significant and have increased OCC's cash flow needs year-over-year. Investment in OCC's technology infrastructure will allow OCC to continue to deliver best-in-class service from a risk management and settlement perspective. However, such investment has also required OCC to make significant capital expenditures, including information technology, employee time, and other resources needed to maintain, develop, and modernize its infrastructure.</P>
                <P>The proposed fee change would better align OCC's clearing fees with the costs of providing its clearing and settlement services to Clearing Members. To implement the proposed changes, OCC would update its schedule of fees as set out below.</P>
                <GPH SPAN="3" DEEP="141">
                    <GID>EN27DE24.290</GID>
                </GPH>
                <P>
                    The proposed fee change is designed to promote cost management in compliance with Rule 17Ad-22(e)(15) under the Exchange Act that, among other things, requires OCC to establish, implement, maintain and enforce written policies and procedures reasonably designed to identify, monitor, and manage its general business risk,
                    <SU>16</SU>
                    <FTREF/>
                     which includes the risk of potential impairment to OCC's financial position resulting from a 
                    <PRTPAGE P="105648"/>
                    decline in revenues or an increase in expenses. As described above, the proposed fee change would better align OCC's clearing fees with the costs of providing its clearing and settlement services to Clearing Members. Despite increased expenses associated with its technology infrastructure and notable inflation, OCC has not increased clearing fees since 2019.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See</E>
                         17 CFR 240.17Ad-22(e)(15).
                    </P>
                </FTNT>
                <P>
                    The proposed Per Contract Clearing Fee of $0.025 continues to be in line with, or even lower than, the Per Contract Clearing Fees OCC assessed in the past five years, which ranged from $0.055 in 2019 to $0.02 today. The proposed Per Contract Clearing Fee of $0.025 represents a 54% decrease from the Per Contract Clearing Fee charged in 2019. Moreover, removal of the Per Transaction Clearing Fee ensures that Clearing Members are charged the same Per Contract Clearing Fee per transaction regardless of the size of such transaction. OCC believes that charging all Clearing Members the same fee, regardless of transaction size, equitably and reasonably allocates the cost of providing clearance and settlement services for a given transaction regardless of size.
                    <SU>17</SU>
                    <FTREF/>
                     In particular, OCC believes that removing the Per Transaction Clearing Fee is equitable because all transactions will be charged the same fee regardless of size. OCC also believes that removing the Per Transaction Clearing Fee is reasonable because all transactions will be charged the same fee of $0.025 per contract, which continues to be in line with, or even lower than, the Per Contract Clearing Fees OCC assessed in the past five years, as noted above.
                    <SU>18</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See</E>
                         confidential Exhibit 3 to SR-OCC-2024-017 for additional detail and analysis regarding the proposed fee change. Removing the Per Transaction Clearing Fee allows OCC to limit the Per Contract Clearing Fee increase to $0.005, which minimizes impact while equitably allocating the cost of providing clearance and settlement services for a given transaction regardless of size.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         Other self-regulatory organizations have filed to remove fee caps from their fee schedules. 
                        <E T="03">See, e.g.,</E>
                         Exchange Act Release Nos. 93873 (Dec. 29, 2021), 87 FR 508 (Jan. 5, 2022) (File No. SR-NSCC-2021-017), 93562 (Nov. 12, 2021), 86 FR 64554 (Nov. 18, 2021) (File No. SR-BOX-2021-026).
                    </P>
                </FTNT>
                <P>
                    OCC reviewed volume and clearing fees OCC assessed from June 2021 
                    <SU>19</SU>
                    <FTREF/>
                     through November 2024 to determine the impact of the proposed change. OCC determined that the average clearing fee per contract per year, including fees generated by the Per Transaction Clearing Fee, was approximately $0.019 per contract, which represents only a 5% decrease from the lowest per contract clearing fee charged during this time frame, 
                    <E T="03">i.e.,</E>
                     $0.02. Most recently, from January through November 2024, the average clearing fee per contract was $0.019, including the Per Transaction Clearing Fee, and would have been $0.020 without the Per Transaction Clearing Fee, which represents a 5% difference and shows a limited impact to Clearing Members from the removal of the Per Transaction Clearing Fee.
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         Due to the fee holiday in November and December 2021, the average clearing fee per contract for 2021 was calculated using data through October 31, 2021.
                    </P>
                </FTNT>
                <P>
                    Furthermore, OCC did not intend the Per Transaction Clearing Fee to incentivize transactions over a certain size, nor does OCC believe it is necessary for OCC to provide an incentive for such transactions. The Per Transaction Clearing Fee is based on the longstanding structure of OCC's schedule of fees, which has historically included various tiers and caps.
                    <SU>20</SU>
                    <FTREF/>
                     In 2016, OCC filed to modify the schedule of fees to adopt a flat, per contract, clearing fee subject to a fixed dollar cap, which would promote simplicity and transparency and allow users to execute trades without regard to size.
                    <SU>21</SU>
                    <FTREF/>
                     The proposed changes would allow OCC to continue to promote simplicity and transparency in its schedule of fees by moving to a single tier clearing fee structure, which removes the Per Transaction Clearing Fee. As discussed, such changes limit the Per Contract Clearing Fee increase to $0.005 while equitably allocating the cost of providing clearance and settlement services for a given transaction regardless of size.
                    <SU>22</SU>
                    <FTREF/>
                     As described above, OCC believes that the Per Contract Clearing Fee is reasonable and that it would not be discriminatory or prohibitive to remove the Per Transaction Clearing Fee for those Clearing Members that currently submit transactions with more than 2,750 contracts such that Clearing Members would continue to execute transactions without regard to size.
                    <SU>23</SU>
                    <FTREF/>
                     At this time, OCC believes the proposed fee change is appropriate in order to raise fees to more closely align with its cash flow needs. Such change would ensure that OCC continues to serve market participants as a financially responsible steward of clearing services while ensuring that it meets regulatory expectations and responsibly invests in its infrastructure.
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">See</E>
                         Exchange Act Release No. 55709 (May 4, 2007), 72 FR 26669 (May 10, 2007) (File No. SR-OCC-2007-05).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See</E>
                         Exchange Act Release No. 77336 (Mar. 10, 2016), 81 FR 14153 (Mar. 16, 2016) (File No. SR-OCC-2016-005).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         
                        <E T="03">See supra</E>
                         note 17.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         OCC believes that removing the Per Transaction Clearing Fee would not unfairly disadvantage or burden smaller market participants, as larger market participants tend to benefit more from the Per Transaction Clearing Fee due to their trading activity.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Implementation Timeframe</HD>
                <P>
                    OCC proposes to make the fee change effective January 1, 2025. To provide Clearing Members with adequate time to make any necessary adjustments, OCC has provided notice of such changes by Information Memorandum at least 30 calendar days in advance of the effective date.
                    <SU>24</SU>
                    <FTREF/>
                     This ensures that the industry is prepared to process the new fee without disruption. Additionally, OCC would not make the fee change operative until after the time required to self-certify the proposed change with the Commodity Futures Trading Commission (“CFTC”).
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         The Information Memorandum can be found on OCC's public website: 
                        <E T="03">https://infomemo.theocc.com/infomemos?number=55624.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD3">(2) Statutory Basis</HD>
                <P>
                    OCC believes the proposed rule change is consistent with the Act 
                    <SU>25</SU>
                    <FTREF/>
                     and the rules and regulations thereunder. In particular, OCC believes that the proposed fee change is consistent with Section 17A(b)(3)(D) of the Act,
                    <SU>26</SU>
                    <FTREF/>
                     which requires that the rules of a clearing agency provide for the equitable allocation of reasonable dues, fees, and other charges among its participants.
                </P>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         15 U.S.C. 78a, 
                        <E T="03">et seq.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         15 U.S.C. 78q-1(b)(3)(D).
                    </P>
                </FTNT>
                <P>
                    OCC believes that the proposed fee change is reasonable. The proposed fee change is intended to better align OCC's clearing fees with the costs of providing its clearing and settlement services to Clearing Members by ensuring that OCC continues to maintain sufficient reserves to cover OCC's cash flows and address potential business or operational losses so that OCC can continue to meet its obligations as a systemically important financial market utility to Clearing Members and the general public if such losses were to materialize. OCC believes the proposed fee change is reasonable given increased expenses associated with its technology infrastructure, notable inflation, and the fluctuating interest rate environment, as discussed above. With respect to the removal of the Per Transaction Clearing Fee, OCC believes that charging all Clearing Members a flat fee per contract is reasonable as it equitably allocates the cost of providing clearance and settlement services for a given transaction regardless of size. Further, OCC does not believe the proposed Per Contract Clearing Fee would create a financial burden as it continues to be in line with, or even lower than, the clearing fees assessed by OCC over the past five years. OCC also does not believe that removal of the Per 
                    <PRTPAGE P="105649"/>
                    Transaction Clearing Fee would create a financial burden as it ensures that Clearing Members are charged the same Per Contract Clearing Fee per transaction regardless of the size of such transaction.
                </P>
                <P>
                    As discussed above, OCC determined that the average clearing fee per contract per year from June 2021 
                    <SU>27</SU>
                    <FTREF/>
                     through November 2024, including fees generated by the Per Transaction Clearing Fee, represented only a 5% decrease from the lowest Per Contract Clearing Fee charged during this time frame. From January through November 2024, the average clearing fee per contract was $0.019, including the Per Transaction Clearing Fee, and would have been $0.020 without the Per Transaction Clearing Fee, which represents a 5% difference and shows a limited impact to Clearing Members from the removal of the Per Transaction Clearing Fee. OCC believes that the Per Contract Clearing Fee is reasonable and would not be discriminatory without the Per Transaction Clearing Fee for those Clearing Members that currently submit transactions with more than 2,750 contracts. OCC thus believes that it does not constitute an inequitable allocation of fees and is not unfairly discriminatory to remove the Per Transaction Clearing Fee. In accordance with its current policies and procedures, OCC will continue to evaluate the fee schedule at regularly scheduled meetings to determine if additional changes, including fee decreases, are necessary or appropriate at such time, including once OCC's technology infrastructure modernization initiative is complete.
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         
                        <E T="03">See supra</E>
                         note 19.
                    </P>
                </FTNT>
                <P>
                    OCC also believes that the proposed fee change would result in an equitable allocation of fees among its participants because it would be equally applicable to all Clearing Members transacting at any given level of contract volume. As a result, OCC believes that the proposed change to OCC's fee schedule provides for the equitable allocation of reasonable fees in accordance with Section 17A(b)(3)(D) of the Act.
                    <SU>28</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         15 U.S.C. 78q-1(b)(3)(D).
                    </P>
                </FTNT>
                <P>
                    In addition, OCC believes that the proposed rule change is consistent with Rule 17Ad-22(e)(15), which requires that OCC establish, implement, maintain and enforce written policies and procedures reasonably designed to identify, monitor, and manage OCC's general business risk and hold sufficient liquid net assets funded by equity to cover potential general business losses so that OCC can continue operations and services as a going concern if those losses materialize.
                    <SU>29</SU>
                    <FTREF/>
                     The proposed changes are designed to promote cost management in compliance with this Rule. As described above, the proposed fee change would better align OCC's clearing fees with the costs of providing its clearing and settlement services to Clearing Members to ensure that OCC continues to maintains sufficient reserves to cover OCC's cash flow needs and address potential business or operational losses so that OCC can continue to meet its obligations as a systemically important financial market utility to Clearing Members and the general public if such losses were to materialize. Therefore, OCC believes that the proposed changes to OCC's schedule of fees are consistent with Rule 17Ad-22(e)(15).
                    <SU>30</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         17 CFR 240.17Ad-22(e)(15).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <HD SOURCE="HD2">(B) Clearing Agency's Statement on Burden on Competition</HD>
                <P>
                    Section 17A(b)(3)(I) of the Act 
                    <SU>31</SU>
                    <FTREF/>
                     requires that the rules of a clearing agency not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. OCC does not believe that the proposed rule change would have any impact or impose a burden on competition. OCC believes that the proposed rule change would not disadvantage or favor any particular user of OCC's services in relationship to another user because the proposed fee change would apply equally to all Clearing Members. In addition, OCC does not believe that the proposed Per Contract Clearing Fee imposes a significant burden as the proposed fee continues to be in line with, or even lower than, the clearing fees assessed by OCC over the past five years. OCC also does not believe that the removal of the Per Transaction Clearing Fee imposes a significant burden as it ensures that Clearing Members are charged the same Per Contract Clearing Fee per transaction regardless of the size of such transaction. Accordingly, OCC does not believe that the proposed rule change would have any impact or impose a burden on competition.
                </P>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         15 U.S.C. 78q-1(b)(3)(I).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">(C) Clearing Agency's Statement on Comments on the Proposed Rule Change Received From Members, Participants or Others</HD>
                <P>Written comments were not and are not intended to be solicited with respect to the proposed rule change and none have been received.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>32</SU>
                    <FTREF/>
                     and paragraph (f) of Rule 19b-4 
                    <SU>33</SU>
                    <FTREF/>
                     thereunder. At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. The proposal shall not take effect until all regulatory actions required with respect to the proposal are completed.
                    <SU>34</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>32</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>33</SU>
                         17 CFR 240.19b-4(f).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>34</SU>
                         Notwithstanding its immediate effectiveness, implementation of this rule change will be delayed until this change is deemed certified under CFTC Regulation 40.6.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Solicitation of Comments</HD>
                <P>Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:</P>
                <HD SOURCE="HD2">Electronic Comments</HD>
                <P>
                    • Use the Commission's internet comment form (
                    <E T="03">https://www.sec.gov/rules/sro.shtml</E>
                    ); or
                </P>
                <P>
                    • Send an email to 
                    <E T="03">rule-comments@sec.gov.</E>
                     Please include file number SR-OCC-2024-017 on the subject line.
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.</P>
                <FP>
                    All submissions should refer to file number SR-OCC-2024-017. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (
                    <E T="03">https://www.sec.gov/rules/sro.shtml</E>
                    ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be 
                    <PRTPAGE P="105650"/>
                    available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Copies of such filing also will be available for inspection and copying at the principal office of OCC and on OCC's website at 
                    <E T="03">https://www.theocc.com/Company-Information/Documents-and-Archives/By-Laws-and-Rules.</E>
                     Do not include personal identifiable information in submissions; you should submit only information that you wish to make available publicly. We may redact in part or withhold entirely from publication submitted material that is obscene or subject to copyright protection.
                </FP>
                <P>
                    All submissions should refer to File Number SR-OCC-2024-017 and should be submitted on or before January 17, 2025.
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>35</SU>
                         17 CFR 200.30-3(a)(12).
                    </P>
                </FTNT>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>35</SU>
                    </P>
                    <NAME>J. Matthew DeLesDernier, </NAME>
                    <TITLE>Deputy Secretary. </TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-31089 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-102002; File No. SR-NYSEARCA-2024-89]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To Adopt Temporary Rule 7.34-E(T) and revise Rules 1.1 and 7.34-E to Lengthen the Current Extended Trading Sessions</SUBJECT>
                <DATE>December 19, 2024.</DATE>
                <P>
                    On October 25, 2024, NYSE Arca, Inc. (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) 
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     a proposed rule change to lengthen the hours of the extended trading sessions. The proposed rule change was published for comment in the 
                    <E T="04">Federal Register</E>
                     on November 14, 2024.
                    <SU>3</SU>
                    <FTREF/>
                     The Commission has received comments on the proposed rule change.
                    <SU>4</SU>
                    <FTREF/>
                     On December 13, 2024, the Exchange filed an amendment to the proposed rule change, which was published for comment.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 101559 (November 7, 2024), 89 FR 90143 (“Initial Proposal”).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Comments on the proposed rule change are available at 
                        <E T="03">https://www.sec.gov/comments/sr-nysearca-2024-89/srnysearca202489.htm</E>
                        .
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 101985 (December 19, 2024). Amendment No. 1 superceded and replaced the Initial Proposal.
                    </P>
                </FTNT>
                <P>
                    Section 19(b)(2) of the Act 
                    <SU>6</SU>
                    <FTREF/>
                     provides that within 45 days of the publication of notice of the filing of a proposed rule change, or within such longer period up to 90 days as the Commission may designate if it finds such longer period to be appropriate and publishes its reasons for so finding, or as to which the self-regulatory organization consents, the Commission shall either approve the proposed rule change, disapprove the proposed rule change, or institute proceedings to determine whether the proposed rule change should be disapproved. The 45th day after publication of the notice for this proposed rule change is December 29, 2024. The Commission is extending this 45-day time period.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         15 U.S.C. 78s(b)(2).
                    </P>
                </FTNT>
                <P>
                    The Commission finds it appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change, as amended by Amendment No. 1 and the comments received. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
                    <SU>7</SU>
                    <FTREF/>
                     designates February 12, 2025 as the date by which the Commission shall either approve or disapprove, or institute proceedings to determine whether to disapprove, the proposed rule change (File No. SR-NYSEARCA-2024-89).
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>8</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             17 CFR 200.30-3(a)(31).
                        </P>
                    </FTNT>
                    <NAME>Vanessa A. Countryman,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30914 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-102016; File No. SR-CboeBZX-2024-128]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Its Fees Schedule Related to Physical Port Fees</SUBJECT>
                <DATE>December 20, 2024.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on December 18, 2024, Cboe BZX Exchange, Inc. (the “Exchange” or “BZX”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I, II, and III below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>Cboe BZX Exchange, Inc. (the “Exchange” or “BZX Options”) proposes to amend its Fees Schedule. The text of the proposed rule change is provided in Exhibit 5.</P>
                <P>
                    The text of the proposed rule change is also available on the Exchange's website (
                    <E T="03">https://markets.cboe.com/us/equities/regulation/rule_filings/BZX/</E>
                    ), at the Exchange's Office of the Secretary, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>
                    In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
                    <PRTPAGE P="105651"/>
                </P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    The Exchange proposes to amend its fee schedule relating to physical connectivity fees.
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The Exchange initially filed the proposed fee changes on July 3, 2023 (SR-CboeBZX-2023-047). On September 1, 2023, the Exchange withdrew that filing and submitted SR-CboeBZX-2023-068. On September 29, 2023, the Securities and Exchange Commission issued a Suspension of and Order Instituting Proceedings to Determine whether to Approve or Disapprove a Proposed Rule Change to Amend its Fees Schedule Related to Physical Port Fees (the “OIP”) in anticipation of a possible U.S. government shutdown. On September 29, 2023, the Exchange filed the proposed fee change (SR-CboeBZX-2023-79). On October 13, 2023, the Exchange withdrew that filing and submitted SR-CboeBZX-2023-083. On December 12, 2023 the Exchange withdrew that filing and submitted SR-CboeBZX-2023-104. On February 9, 2024, the Exchange withdrew that filing and submitted SR-CboeBZX-2024-017. On April 9, 2024, the Exchange withdrew that filing and submitted this SR-CboeBZX-2024-028. On April 18, 2024, the Exchange withdrew that filing and submitted SR-CboeBZX-2024-030. On June 7, 2024, the Exchange withdrew that filing and submitted SR-CboeBZX-2024-052. On August 29, 2024, the Exchange withdrew that filing and submitted SR-CboeBZX-2024-080. On October 25, 2024, the Exchange withdrew that filing and submitted SR-CboeBZX-2024-107. On October 28, 2024, the Exchange withdrew that filing and submitted SR-CboeBZX-2024-109. On December 18, 2024 the Exchange withdrew that filing and submitted this filing.
                    </P>
                </FTNT>
                <P>
                    By way of background, a physical port is utilized by a Member or non-Member to connect to the Exchange at the data centers where the Exchange's servers are located. The Exchange currently assesses the following physical connectivity fees for Members and non-Members on a monthly basis: $2,500 per physical port for a 1 gigabit (“Gb”) circuit and $7,500 per physical port for a 10 Gb circuit. The Exchange proposes to increase the monthly fee for 10 Gb physical ports from $7,500 to $8,500 per port. The Exchange notes the proposed fee change better enables it to continue to maintain and improve its market technology and services and also notes that the proposed fee amount, even as amended, continues to be in line with, or even lower than, amounts assessed by other exchanges for similar connections.
                    <SU>4</SU>
                    <FTREF/>
                     The Exchange also notes that a single 10 Gb physical port can be used to access the Systems of the following affiliate exchanges: the Cboe BYX Exchange, Inc., Cboe EDGX Exchange, Inc. (options and equities platforms), Cboe EDGA Exchange, Inc., and Cboe C2 Exchange, Inc., (“Affiliate Exchanges”).
                    <SU>5</SU>
                    <FTREF/>
                     Notably, only one monthly fee currently (and will continue) to apply per 10 Gb physical port regardless of how many affiliated exchanges are accessed through that one port.
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See e.g.,</E>
                         The Nasdaq Stock Market LLC (“Nasdaq”), General 8, Connectivity to the Exchange. Nasdaq and its affiliated exchanges charge a monthly fee of $15,000 for each 10Gb Ultra fiber connection to the respective exchange, which is analogous to the Exchange's 10Gb physical port. 
                        <E T="03">See also</E>
                         New York Stock Exchange LLC, NYSE American LLC, NYSE Arca, Inc., NYSE Chicago Inc., NYSE National, Inc. Connectivity Fee Schedule, which provides that 10 Gb LX LCN Circuits (which are analogous to the Exchange's 10 Gb physical port) are assessed $22,000 per month, per port.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         The Affiliate Exchanges are also submitting contemporaneous identical rule filings.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         The Exchange notes that conversely, other exchange groups charge separate port fees for access to separate, but affiliated, exchanges. 
                        <E T="03">See e.g.,</E>
                         Securities and Exchange Release No. 99822 (March 21, 2024), 89 FR 21337 (March 27, 2024) (SR-MIAX-2024-016).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
                    <SU>7</SU>
                    <FTREF/>
                     Specifically, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 
                    <SU>8</SU>
                    <FTREF/>
                     requirements that the rules of an exchange be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Additionally, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 
                    <SU>9</SU>
                    <FTREF/>
                     requirement that the rules of an exchange not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers. The Exchange also believes the proposed rule change is consistent with Section 6(b)(4) 
                    <SU>10</SU>
                    <FTREF/>
                     of the Act, which requires that Exchange rules provide for the equitable allocation of reasonable dues, fees, and other charges among its Members and other persons using its facilities. This belief is based on various factors as described below.
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         15 U.S.C. 78f(b)(4).
                    </P>
                </FTNT>
                <P>
                    First, the Exchange believes its proposal is reasonable as it reflects a moderate increase in physical connectivity fees for 10 Gb physical ports and its offering, even as amended, continues to be more affordable as compared to analogous physical connectivity offerings at competitor exchanges.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See e.g.,</E>
                         The Nasdaq Stock Market LLC (“Nasdaq”), General 8, Connectivity to the Exchange. Nasdaq and its affiliated exchanges charge a monthly fee of $15,000 for each 10Gbps Ultra fiber connection to the respective exchange, which is analogous to the Exchange's 10Gbps physical port. 
                        <E T="03">See also</E>
                         New York Stock Exchange LLC, NYSE American LLC, NYSE Arca, Inc., NYSE Chicago Inc., NYSE National, Inc. Connectivity Fee Schedule, which provides that 10 Gbps LX LCN Circuits (which are analogous to the Exchange's 10 Gbps physical port) are assessed $22,000 per month, per port.
                    </P>
                </FTNT>
                <P>
                    The Exchange also believes the current fee does not properly reflect the quality of the service and product, as fees for 10 Gb physical ports have been static in nominal terms since 2018, and therefore falling in real terms due to inflation. As a general matter, the Producer Price Index (“PPI”) is a family of indexes that measures the average change over time in selling prices received by domestic producers of goods and services. PPI measures price change from the perspective of the seller. This contrasts with other metrics, such as the Consumer Price Index (CPI), that measure price change from the purchaser's perspective.
                    <SU>12</SU>
                    <FTREF/>
                     About 10,000 PPIs for individual products and groups of products are tracked and released each month.
                    <SU>13</SU>
                    <FTREF/>
                     PPIs are available for the output of nearly all industries in the goods-producing sectors of the U.S. economy—mining, manufacturing, agriculture, fishing, and forestry—as well as natural gas, electricity, and construction, among others. The PPI program covers approximately 69 percent of the service sector's output, as measured by revenue reported in the 2017 Economic Census.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See https://www.bls.gov/ppi/overview.htm.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                  
                <P>
                    For purposes of this proposal, the relevant industry-specific PPI is the Data Processing, hosting and related services (“Data PPI”) and more particularly the more granular service line Data Processing, Hosting and Related Services: Hosting, Active Server Pages (ASP), and Other Information Technology (IT) Infrastructure Provisioning Services.
                    <SU>14</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         Provisioning is the process of preparing, assigning, and activating IT infrastructure components, such as servers, storage, and network connectivity, according to user requirements. It is a critical part of IT operations, as it ensures that computing resources are available when needed and that they are set up and connected to work correctly.
                    </P>
                </FTNT>
                <P>
                    The Data PPI was introduced in January 2002 by the Bureau of Labor Statistics (“BLS”) as part of an ongoing effort to expand Producer Price Index coverage of the services sector of the U.S. economy and is identified as 
                    <PRTPAGE P="105652"/>
                    NAICS—518210 in the North American Industry Classification System (“NAICS”).
                    <SU>15</SU>
                    <FTREF/>
                     According to the BLS “[t]he primary output of NAICS 518210 is the provision of electronic data processing services. In the broadest sense, computer services companies help their customers efficiently use technology. The processing services market consists of vendors who use their own computer systems—often utilizing proprietary software—to process customers' transactions and data. Price movements for the NAICS 518210 index are based on changes in the revenue received by companies that provide data processing services and price movements for the service line NAICS 518210 index are based on changes in the revenue received by companies that provide, among other things, IT infrastructure provisioning services. Each month, companies provide net transaction prices for a specified service. The transaction is an actual contract selected by probability, where the price-determining characteristics are held constant while the service is repriced. The prices used in index calculation are the actual prices billed for the selected service contract.” 
                    <SU>16</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See https://www.bls.gov/ppi/overview.htm.</E>
                         Among the industry-specific PPIs is for North American Industry Classification System (“NAICS”) Code 518210: “Data Processing and Related Services,” NAICS index codes categorize products and services that are common to particular industries. According to BLS, these codes “provide comparability with a wide assortment of industry-based data for other economic programs, including productivity, production, employment, wages, and earnings.”
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See https://www.bls.gov/ppi/factsheets/producer-price-index-for-the-data-processing-and-related-services-industry-naics-518210.htm.</E>
                    </P>
                </FTNT>
                <P>
                    The service (product) lines for which price indexes are available under the Data PPI are: (1) business process management services (2) data management and storage information transformation and other services and (3) hosting ASP and other IT infrastructure provisioning services. The most apt of these industry and product specific categorizations for purposes of this present proposal to modify fees for the 10 Gb physical port fee measures inflation for the provision of data processing, hosting and related services as well as other information technology infrastructure provisioning services which BLS identifies as identified as NAICS—5182105.
                    <SU>17</SU>
                    <FTREF/>
                     The Exchange believes that this measure of inflation is particularly appropriate because the Exchange's connectivity services involve hosting and providing connections to its customers' telecommunications and information technology equipment, as well as preparing, assigning, and activating IT infrastructure components, such as servers, storage, and network connectivity. The Exchange also uses its “proprietary software,” 
                    <E T="03">i.e.,</E>
                     its own proprietary matching engine software, to receive orders on the Exchange's proprietary trading platform as well as to collect, organize, store and report customers' transactions. In other words, the Exchange is in the business of data processing, hosting, ASP, and providing other IT infrastructure provisioning services.
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See https://data.bls.gov/timeseries/PCU5182105182105.</E>
                    </P>
                </FTNT>
                <P>
                    The Exchange further believes the Data PPI is an appropriate measure for purposes of the proposed rule change on the basis that it is a stable metric with limited volatility, unlike other consumer-side inflation metrics. In fact, the Data PPI has not experienced a greater than 2.16% increase for any one calendar year period since Data PPI was introduced into the PPI in January 2002. For example, the average calendar year change from January 2002 to December 2023 was .62%, with a cumulative increase of 15.67% over this 21-year period. The Exchange believes the Data PPI is considerably less volatile than other inflation metrics such as CPI, which has had individual calendar-year increases of more than 6.5%, and a cumulative increase of over 73% over the same period.
                    <SU>18</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See https://www.usinflationcalculator.com/inflation/consumer-price-index-and-annual-percent-changes-from-1913-to-2008/.</E>
                    </P>
                </FTNT>
                <P>
                    As noted above, the current 10 Gb physical port fee remained unchanged for six years, particularly since June 2018.
                    <SU>19</SU>
                    <FTREF/>
                     Since its last increase over 6 years ago however, there has been notable inflation, including under the industry- and product-specific PPI, which as described above is a tailored measure of inflation. Particularly, the Hosting, ASP and other IT Infrastructure Provisioning Services inflation measure had a starting value of 102.2 in June 2018 (the month the Exchange started assessing the current fee) and an ending value of 115.66 in November 2024, representing an 13% increase.
                    <SU>20</SU>
                    <FTREF/>
                     This indicates that companies who are also in the hosting ASP and other IT infrastructure provisioning services have generally increased prices for a specified service covered under NAICS 5182105 by an average of 13% during this period.
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         
                        <E T="03">See</E>
                         Securities and Exchange Release No. 83429 (June 14, 2018), 83 FR 28685 (June 20, 2018) (SR-CboeBZX-2018-038).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">See https://data.bls.gov/timeseries/PCU5182105182105.</E>
                    </P>
                </FTNT>
                <P>
                    The Exchange also believes that it is reasonable to increase its fees to compensate for inflation because, over time, inflation has degraded the value of each dollar that the Exchange collects in fees, such that the real revenue collected today is considerably less than that same revenue collected in 2018. The impact of this inflationary effect is also independent of any change in the Exchange's costs in providing its goods and services. The Exchange therefore believes that it is reasonable for it to offset, in part, this erosion in the value of the revenues it collects. Additionally, the Exchange historically does not increase fees every year notwithstanding inflation. Other exchanges have also filed for increases in certain fees, based in part on comparisons to inflation.
                    <SU>21</SU>
                    <FTREF/>
                     Accordingly, based on the above-described percentage change based on an industry- and product-specific inflationary measure, and in conjunction with the rationale further described above and below, the Exchange believes the proposed fee increase is reasonable.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See, e.g.,</E>
                         Securities Exchange Act Release Nos. 34-100994 (September 10, 2024), 89 FR 75612 (September 16, 2024) (SR-NYSEARCA-2024-79).
                    </P>
                </FTNT>
                <P>Next, the Exchange believes significant investments into, and enhanced performance of, the Exchange, in the years following the last 10 Gb physical port fee increase support the reasonableness of the proposed fee increase. These investments enhanced the quality of its services, as measured by, among other things, increased throughput and faster processing speeds. Customers have therefore greatly benefitted from these investments, while the Exchange's ability to recoup its investments has been hampered.</P>
                <P>
                    For example, the Exchange and its affiliated exchanges recently launched a multi-year initiative to improve Cboe Exchange Platform performance and capacity requirements to increase competitiveness, support growth and advance a consistent world class platform. The goal of the project, among other things, is to provide faster and more consistent order handling and matching performance for options, while ensuring quicker processing time and supporting increasing volumes and capacity needs. For example, the Exchange recently performed switch hardware upgrades. Particularly, the Exchange replaced existing customer access switches with newer models, which the Exchange believes resulted in increased determinism. The recent switch upgrades also increased the Exchange's capacity to accommodate 
                    <PRTPAGE P="105653"/>
                    more physical ports by nearly 50%. Network bandwidth was also increased nearly two-fold as a result of the upgrades, which among other things, can lead to reduce message queuing. The Exchange also believes these newer models result in less natural variance in the processing of messages. The Exchange notes that it incurred costs associated with purchasing and upgrading to these newer models, of which the Exchange has not otherwise passed through or offset.
                </P>
                <P>
                    As of April 1, 2024, market participants also having the option of connecting to a new data center (
                    <E T="03">i.e.,</E>
                     Secaucus NY6 Data Center (“NY6”)), in addition to the current data centers at NY4 and NY5. The Exchange made NY6 available in response to customer requests in connection with their need for additional space and capacity. In order to make this space available, the Exchange expended significant resources to prepare this space, and will also incur ongoing costs with respect to maintaining this offering, including costs related to power, space, fiber, cabinets, panels, labor and maintenance of racks. The Exchange also incurred a large cost with respect to ensuring NY6 would be latency equalized, as it is for NY4 and NY5.
                </P>
                <P>The Exchange also has made various other improvements since the current physical port rates were adopted in 2018. For example, the Exchange has updated its customer portal to provide more transparency with respect to firms' respective connectivity subscriptions, enabling them to better monitor, evaluate and adjust their connections based on their evolving business needs. The Exchange also performs proactive audits on a weekly basis to ensure that all customer cross connects continue to fall within allowable tolerances for Latency Equalized connections. Accordingly, the Exchange expended, and will continue to expend, resources to innovate and modernize technology so that it may benefit its Members and continue to compete among other options markets. The ability to continue to innovate with technology and offer new products to market participants allows the Exchange to remain competitive in the options space which currently has 18 registered options markets and potential new entrants. If the Exchange were not able to assess incrementally higher fees for its connectivity, it would effectively impact how the Exchange manages its technology and hamper the Exchange's ability to continue to invest in and fund access services in a manner that allows it to meet existing and anticipated access demands of market participants. Disapproval of fee changes such as the proposal herein, could also have the adverse effect of discouraging an exchange from improving its operations and implementing innovative technology to the benefit of market participants if it believes the Commission would later prevent that exchange from recouping costs and monetizing its operational enhancements, thus adversely impacting competition as well as the interests of market participants and investors.  </P>
                <P>
                    Finally, the proposed fee is also the same as is concurrently being proposed for its Affiliate Exchanges. Further, Members are able to utilize a single port to connect to all of its Affiliate Exchanges and will only be charged one single fee (
                    <E T="03">i.e.,</E>
                     a market participant will only be assessed the proposed $8,500 even if it uses that physical port to connect to the Exchange and another (or even all 6) of its Affiliate Exchanges. Particularly, the Exchange believes the proposed monthly per port fee is reasonable, equitable and not unfairly discriminatory since as the Exchange has determined to not charge multiple fees for the same port. Indeed, the Exchange notes that several ports are in fact purchased and utilized across one or more of the Exchange's affiliated Exchanges (and charged only once).
                </P>
                <P>
                    The Exchange also believes that the proposed fee change is not unfairly discriminatory because it would be assessed uniformly across all market participants that purchase the physical ports. The Exchange believes increasing the fee for 10 Gb physical ports and charging a higher fee as compared to the 1 Gb physical port is equitable as the 1 Gb physical port is 1/10th the size of the 10 Gb physical port and therefore does not offer access to many of the products and services offered by the Exchange (
                    <E T="03">e.g.,</E>
                     ability to receive certain market data products). Thus, the value of the 1 Gb alternative is lower than the value of the 10 Gb alternative, when measured based on the type of Exchange access it offers. Moreover, market participants that purchase 10 Gb physical ports utilize the most bandwidth and therefore consume the most resources from the network. The Exchange also anticipates that firms that utilize 10 Gb ports will benefit the most from the Exchange's investment in offering NY6 as the Exchange anticipates there will be much higher quantities of 10 Gb physical ports connecting from NY6 as compared to 1 Gb ports. Indeed, the Exchange notes that 10 Gb physical ports account for approximately 90% of physical ports across the NY4, NY5, and NY6 data centers, and to date, 80% of new port connections in NY6 are 10 Gb ports. As such, the Exchange believes the proposed fee change for 10 Gb physical ports is reasonably and appropriately allocated.
                </P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>
                    The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed fee change will not impact intramarket competition because it will apply to all similarly situated Members equally (
                    <E T="03">i.e.,</E>
                     all market participants that choose to purchase the 10 Gb physical port). Additionally, the Exchange does not believe its proposed pricing will impose a barrier to entry to smaller participants and notes that its proposed connectivity pricing is associated with relative usage of the various market participants. For example, market participants with modest capacity needs can continue to buy the less expensive 1 Gb physical port (which cost is not changing) or may choose to obtain access via a third-party re-seller. While pricing may be increased for the larger capacity physical ports, such options provide far more capacity and are purchased by those that consume more resources from the network. Accordingly, the proposed connectivity fees do not favor certain categories of market participants in a manner that would impose a burden on competition; rather, the allocation reflects the network resources consumed by the various size of market participants—lowest bandwidth consuming members pay the least, and highest bandwidth consuming members pays the most.
                </P>
                <P>
                    The proposed fee change also does not impose a burden on competition or on other Self-Regulatory Organizations that is not necessary or appropriate. As described above, the Exchange evaluated its proposed fee change using objective and stable metric with limited volatility. Utilizing Data Processing PPI over a specified period of time is a reasonable means of recouping a portion of the Exchange's investment in maintaining and enhancing the connectivity service identified above. The Exchange believes utilizing Data Processing PPI, a tailored measure of inflation, to increase certain connectivity fees to recoup the Exchange's investment in maintaining and enhancing its services and products would not impose a burden on competition.
                    <PRTPAGE P="105654"/>
                </P>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>The Exchange neither solicited nor received comments on the proposed rule change.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>22</SU>
                    <FTREF/>
                     and paragraph (f) of Rule 19b-4 
                    <SU>23</SU>
                    <FTREF/>
                     thereunder. At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         17 CFR 240.19b-4(f).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Solicitation of Comments</HD>
                <P>Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:</P>
                <HD SOURCE="HD2">Electronic Comments</HD>
                <P>
                    • Use the Commission's internet comment form (
                    <E T="03">https://www.sec.gov/rules/sro.shtml</E>
                    ); or
                </P>
                <P>
                    • Send an email to 
                    <E T="03">rule-comments@sec.gov.</E>
                     Please include file number SR-CboeBZX-2024-128 on the subject line.
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.</P>
                <FP>
                    All submissions should refer to file number SR-CboeBZX-2024-128. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (
                    <E T="03">https://www.sec.gov/rules/sro.shtml</E>
                    ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. Do not include personal identifiable information in submissions; you should submit only information that you wish to make available publicly. We may redact in part or withhold entirely from publication submitted material that is obscene or subject to copyright protection. All submissions should refer to file number SR-CboeBZX-2024-128 and should be submitted on or before January 17, 2025.
                    <FTREF/>
                </FP>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         17 CFR 200.30-3(a)(12).
                    </P>
                </FTNT>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>24</SU>
                    </P>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-31092 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-101970; File No. SR-ICC-2024-012]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change Relating to the ICC End-of-Day Price Discovery Policies and Procedures</SUBJECT>
                <DATE>December 19, 2024.</DATE>
                <HD SOURCE="HD1">I. Introduction</HD>
                <P>
                    On October 21, 2024, ICE Clear Credit LLC (“ICC”) filed with the Securities and Exchange Commission (the “Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”) 
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     a proposed rule change to revise ICC's End-of-Day Price Discovery Policies and Procedures.
                    <SU>3</SU>
                    <FTREF/>
                     The proposed rule change was published for comment in the 
                    <E T="04">Federal Register</E>
                     on November 6, 2024.
                    <SU>4</SU>
                    <FTREF/>
                     The Commission did not receive comments regarding the proposed rule change. For the reasons discussed below, the Commission is approving the proposed rule change.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Capitalized terms used but not defined herein have the meanings specified in the End-of-Day Price Discovery Policies and Procedures (“EOD Procedures”) as applicable.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Securities Exchange Act Release No. 101489 (Oct. 31, 2024), 89 FR 88094 (Nov. 6, 2024) (File No. SR-ICC-2024-012) (“Notice”).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">II. Description of the Proposed Rule Change</HD>
                <HD SOURCE="HD2">A. Background</HD>
                <P>
                    ICC is registered with the Commission as a clearing agency for the purpose of clearing Credit Default Swap (“CDS”) contracts.
                    <SU>5</SU>
                    <FTREF/>
                     ICC's EOD Procedures set out ICC's end-of-day (“EOD”) price discovery process, which provides prices for cleared contracts using submissions made by Clearing Participants. ICC uses its EOD price discovery process to provide market-driven prices for cleared CDS instruments and cleared derivatives of CDS instruments. ICC uses the resulting EOD prices for risk management purposes and distributes them to Clearing Participants and their clients. ICC also publishes a subset of EOD prices on its public website.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Capitalized terms not otherwise defined herein have the meanings assigned to them in EOD Procedures, as applicable.
                    </P>
                </FTNT>
                <P>
                    ICC proposes to revise the EOD Procedures. The primary purpose of the proposed revisions is to address Commodity Futures Trading Commission (“CFTC”) exam findings.
                    <SU>6</SU>
                    <FTREF/>
                     The proposed revisions clarify the meanings of certain terms used in the EOD Procedures, specifically Most-Actively-Traded-Instrument; Most-Actively-Traded-Coupon; and bid-offer widths. The proposed changes also make other miscellaneous updates to the EOD Procedures.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Notice, 89 FR 88095.
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Most-Actively-Traded-Instrument</HD>
                <P>
                    The term Most-Actively-Traded-Instrument (“MATI”) is used by ICC throughout the EOD Procedures to refer to the most-liquid instrument in a specified group of instruments. Because the most-liquid instrument in a given group of instruments will depend on the specific group of instruments at issue, the MATI varies. Currently, Section 1.2.3 of the EOD Procedures, titled Most-Actively-Traded Instrument, defines the term MATI as “the most-liquid instrument in the group of instruments” and specifies the typical MATI for index risk sub factors and corporate single name risk sub factors. To highlight the context-dependent nature of the term MATI, the proposed rule change would modify the definition 
                    <PRTPAGE P="105655"/>
                    of MATI and provide examples of a typical MATI for a given risk factor rather than identifying a specific MATI. The proposed examples would illustrate the specific contexts in which the term MATI is most commonly used.
                </P>
                <P>Specifically, ICC would strike a statement that the term MATI is “defined” as “the most-liquid instrument in the group of instruments” and replace it with a statement that ICC uses the term MATI “to refer to the most-liquid instrument in a specified group of instruments.”</P>
                <P>
                    Similarly, with regard to the specific contexts in which the term MATI is most commonly used, the proposed rule change would strike two statements describing the “typical” MATI for “index risk sub factors” and “investment grade North American and European corporate [single name] risk sub factors.” The statement regarding index risk sub factors would be replaced with an example of the MATI for “an index risk factor,” which typically is the contract with a scheduled termination date corresponding to the 5-year “tenor” and being the most recent series and version of the applicable cleared CDS index instrument. The current statement regarding single name risk factors would be replaced with an example of the MATI for a single name risk factor “for investment grade North American corporate SN risk factors,” which typically is the contract with a scheduled termination date corresponding to the 5-year “tenor,” having U.S. Dollar as the currency of denomination, having a coupon of 100 basis points, referencing deliverable obligations having a senior debt tier, and having an “XR14” restructuring clause.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Under applicable ISDA Credit Derivatives Definitions, ‘XR14’ references no restructuring under the 2014 ISDA Definitions.
                    </P>
                </FTNT>
                <P>
                    The examples in subsection 1.2.3 would further be expanded to include examples of the MATI for “a SN risk sub-factor and the MATI for “a specific coupon within a SN risk sub-factor,” which typically would be the most actively traded coupon and scheduled termination date in the group of single name instruments sharing the same reference entity, currency of denomination, reference entity debt tier, and restructuring clause, and the most actively traded schedule termination date (
                    <E T="03">i.e.,</E>
                     tenor) in the group of single name instruments sharing the same reference entity, currency of denomination, reference entity debt tier, restructuring clause, and coupon, respectively.
                </P>
                <HD SOURCE="HD2">C. Most Actively Traded Coupon</HD>
                <P>Subsection 1.2.3 also currently defines the term Most-Actively-Traded Coupon (“MATC”) as the coupon associated with a single name risk sub factor's MATI. ICC proposes additional clarifying revisions to this provision of subsection 1.2.3. Specifically, the current statement that “ICC further defines the coupon associated with a SN risk sub-factor's MATI as the most-actively traded coupon (“MATC”) for that risk sub-factor” would be replaced with a statement that “ICC uses the term” MATC to refer to the coupon of the MATI for a SN risk factor, or SN risk sub-factor, depending on the stated context.</P>
                <HD SOURCE="HD2">D. Bid-Offer Widths</HD>
                <P>Section 2 of the EOD Procedures addresses ICC's methodology for producing EOD prices. ICC is proposing to make changes to clarify the use of bid-offer widths (“BOW”) in Section 2 of the EOD Procedures.</P>
                <P>ICC proposes revisions to subsection 2.1.2, which addresses consensus BOWs, to clarify the definition and use of consensus BOWs. BOWs are estimates of the bid-offer widths for the two-way market available for each clearing-eligible instrument at a specific time on each business day. ICC proposes to amend subsection 2.1.2 to describe a consensus BOW as the estimate of the prevailing market BOW during a given period. The revisions would further clarify that ICC determines a consensus BOW for each on-the-run index and for all single name benchmark-instruments at the appropriate EOD BOW execution time. ICC also proposes to add further detail to subsection 2.1.2 with respect to ICC's estimates of consensus BOWs to add that such estimations are performed with respect to each index risk factor MATI. With respect to consensus BOWs for single name instruments, ICC proposes to add additional detail to subsection 2.1.2 to clarify that ICC estimates a consensus BOW from Clearing Participant-submitted mid-prices for all single name benchmark-instruments.</P>
                <P>ICC proposes to revise subsection 2.1.4, which covers EOD BOWs, to describe the calculation of EOD BOWs more accurately. The EOD BOW is the BOW calculated for each clearing-eligible instrument at the applicable end of the clearing day. ICC calculates the EOD BOW by first determining a consensus BOW for an instrument.</P>
                <P>Subsection 2.1.4.a describes how ICC determines EOD BOWs for index instruments. Section 2.1.4.a currently includes a statement that “ICC compares the consensus BOW to the three predefined BOWs.” The proposed rule change would revise that statement to clarify that “ICC compares the consensus BOW established for that instrument to the three predefined BOWS.”</P>
                <P>ICC also proposes to revise subsection 2.1.4.b, which describes the process for calculating EOD BOWs for single name instruments. In the description of the factors ICC applies to each consensus BOW, the proposed revisions clarify that such list of factors includes observed intraday price variability. The proposed revisions also add a statement that the benchmark-instrument BOW resulting after applying the listed factors to the benchmark-instrument consensus BOW is referred to in the EOD Procedures as the benchmark-instrument “systematic” BOW. Finally, ICC proposes to add to subsection 2.1.4.b details related to ICC's determination of the systematic BOW for each benchmark instrument for non-MATC coupons. These proposed changes clarify that ICC's calculation involves use of the benchmark-instrument consensus BOW established for non-MATC benchmark instruments belonging to the given single name risk sub-factor.</P>
                <HD SOURCE="HD2">E. Other Updates</HD>
                <P>Within Section 2, ICC proposes to amend subsection 2.1.3 and 2.1.4, which covers variability bands and EOD BOWs respectively. The proposed amendments modify the titles of Table 2, Table 4, and Table 6, and clarify the uses of the tables. The titles of Table 2 and Table 4 are currently “Assignment of Index Risk Factors to Market Proxy Groups.” ICC proposes to expand the title of Table 2 to include a statement that the table is used for the purpose of determining the variability band for each market proxy group. ICC proposes to add language to the caption for Table 4 to clarify that the table is used for the purpose of selecting which market proxy groups variability band to apply to each index risk factor. ICC also proposes to revise the content of Table 4 to remove obsolete references to the CDX-NAIGHVOL and iTraxx HiVol index risk factors, as those index types are no longer clearing eligible at ICC.</P>
                <P>
                    The title of Table 6 is currently “Assignment of SN Risk Factors to Market Proxy Groups.” ICC proposes to expand the title of Table 6 to include a statement that the table is used for the purpose of selecting which market-proxy groups variability band to apply to the benchmark instruments associated with each given risk factor. ICC also proposes to update the content 
                    <PRTPAGE P="105656"/>
                    of Table 6 to clarify that both the Standard Latin American and Standard Australian single name risk factors include not only sovereign single instruments, but also corporate instruments, to more accurately reflect the single name risk factors currently cleared at ICC. Specifically, ICC proposes to append the phrase “&amp; Corporates” to the current bullets for “Standard Australia Sovereign” and “Standard Asia Sovereign.”
                </P>
                <P>
                    ICC proposes to revise subsection 2.5, which addresses distribution of EOD prices, to revise the instruments for which ICC publishes daily EOD prices on the Intercontinental Exchange, Inc. (“ICE, Inc.”) website. With respect to index instruments, ICC currently publishes EOD prices for a subset of cleared index instruments to the website. The proposed rule change would modify this practice such that ICC would instead publish EOD prices for every clearing eligible index instrument as required by the CFTC.
                    <SU>8</SU>
                    <FTREF/>
                     With respect to single name instruments, the proposed rule change would not substantively modify the EOD prices that ICC publishes on the ICE, Inc. Website, but rather would revise subsection 2.5 to clarify the description of the single name instruments for which it publishes daily EOD prices on the website. Specifically, subsection 2.5 currently states that ICC publishes prices for every listed risk sub-factor. The proposed rule change would clarify this description to state that, for every single name risk sub-factor, ICC publishes the price of all MATI for each clearable coupon. In ICC's view, this is a more accurate description of the daily single name settlement prices ICC publishes on the ICE, Inc. Website.
                    <SU>9</SU>
                    <FTREF/>
                     ICC believes the proposed daily publication of settlement prices for all clearing eligible index instruments will improve pricing transparency to market participants and the public.
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         Notice, 89 FR 88096.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         Id.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         Id.
                    </P>
                </FTNT>
                <P>Finally, ICC proposes other drafting clarifications and conforming changes to the EOD Procedures, such as updating the use of relevant defined terms, section cross-references, and other non-substantive drafting improvements. The amendments would also update the revision history section of the EOD Procedures.</P>
                <HD SOURCE="HD1">III. Discussion and Commission Findings</HD>
                <P>
                    Section 19(b)(2)(C) of the Act requires the Commission to approve a proposed rule change of a self-regulatory organization if it finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to the organization.
                    <SU>11</SU>
                    <FTREF/>
                     Under the Commission's Rules of Practice, the “burden to demonstrate that a proposed rule change is consistent with the Exchange Act and the rules and regulations issued thereunder . . . is on the self-regulatory organization [`SRO'] that proposed the rule change.” 
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         15 U.S.C. 78s(b)(2)(C).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         Rule 700(b)(3), Commission Rules of Practice, 17 CFR 201.700(b)(3).
                    </P>
                </FTNT>
                <P>
                    The description of a proposed rule change, its purpose and operation, its effect, and a legal analysis of its consistency with applicable requirements must all be sufficiently detailed and specific to support an affirmative Commission finding,
                    <SU>13</SU>
                    <FTREF/>
                     and any failure of an SRO to provide this information may result in the Commission not having a sufficient basis to make an affirmative finding that a proposed rule change is consistent with the Exchange Act and the applicable rules and regulations.
                    <SU>14</SU>
                    <FTREF/>
                     Moreover, “unquestioning reliance” on an SRO's representations in a proposed rule change is not sufficient to justify Commission approval of a proposed rule change.
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">Susquehanna Int'l Group, LLP</E>
                         v. 
                        <E T="03">Securities and Exchange Commission,</E>
                         866 F.3d 442, 447 (D.C. Cir. 2017).
                    </P>
                </FTNT>
                <P>
                    After carefully considering the proposed rule change, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to ICC. More specifically, for the reasons given below, the Commission finds that the proposed rule change is consistent with Section 17A(b)(3)(F) of the Act 
                    <SU>16</SU>
                    <FTREF/>
                     and Rule 17Ad-22(e)(6)(iv).
                    <SU>17</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         15 U.S.C. 78q-1(b)(3)(F).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         17 CFR 240.17Ad-22(e)(6)(iv) and (e)(18).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">A. Consistency With Section 17A(b)(3)(F) of the Act</HD>
                <P>
                    Section 17A(b)(3)(F) of the Act requires, among other things, that the rules of ICC be designed to promote the prompt and accurate clearance and settlement of securities transactions.
                    <SU>18</SU>
                    <FTREF/>
                     As discussed above, the proposed rule change would clarify ICC's EOD pricing methodology, including that ICC determines a consensus BOW for each on-the-run index and for all single name benchmark instruments at the appropriate EOD BOW execution time. The proposed rule change would also more accurately describe the calculation of EOD BOW and require that ICC publish EOD prices for every clearing eligible index instrument instead of just a subset of them. These changes would clarify ICC's methodology for EOD and BOW calculations, thereby enhancing ICC's ability to calculate accurate EOD prices. Further, EOD prices are distributed to Clearing Participants and their clients. Enhancing ICC's ability to calculate accurate EOD prices is critical to ICC's ability to manage the risks of clearing and settling CDS given that ICC bases margin and guaranty fund requirements on these prices. Moreover, ensuring that ICC's Clearing Participants, their clients, and other market participants have correct pricing information for the instruments that ICC clears would promote the prompt and accurate clearance and settlement of CDS transactions by reducing the chance there are inaccuracies in the settlement of such transactions. Accordingly, the proposed rule change would promote the prompt and accurate clearance and settlement of transactions at ICC, consistent with Section 17A(b)(3)(F) of the Act.
                    <SU>19</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         15 U.S.C. 78q-1(b)(3)(F).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         15 U.S.C. 78q-1(b)(3)(F).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Consistency With Rule 17Ad-22(e)(6)(iv)</HD>
                <P>
                    Rule 17Ad-22(e)(6)(iv) requires that ICC establish, implement, maintain, and enforce written policies and procedures reasonably designed to cover its credit exposures to its participants by establishing a risk-based margin system that, among other things, uses reliable sources of timely price data and uses procedures and sound valuation models for addressing circumstances in which pricing data are not readily available or reliable.
                    <SU>20</SU>
                    <FTREF/>
                     As discussed above, the proposed rule change would clarify how ICC's price data—EOD BOWs—are calculated, and how consensus BOWs are defined and calculated. The proposed rule change also would require that ICC publish EOD prices for every clearing eligible index instrument rather than just a subset of them, as is ICC's current practice. Clarifying ICC's EOD pricing methodology and ensuring that EOD prices for all clearing eligible index instruments are published will help ICC ensure that the sources for its price data are both timely and reliable, which in turn will support and enhance ICC's risk-based margin system. Accordingly, the proposed rule change is consistent with Rule 17Ad-22(e)(6)(iv).
                    <SU>21</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         17 CFR 240.17Ad-22(e)(6)(iv).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         17 CFR 240.17Ad-22(e)(2)(v).
                    </P>
                </FTNT>
                <PRTPAGE P="105657"/>
                <HD SOURCE="HD1">IV. Conclusion</HD>
                <P>
                    On the basis of the foregoing, the Commission finds that the proposed rule change is consistent with the requirements of the Act, and in particular, with the requirements of Section 17A(b)(3)(F) of the Act 
                    <SU>22</SU>
                    <FTREF/>
                     and Rule 17Ad-22(e)(6)(iv) 
                    <SU>23</SU>
                    <FTREF/>
                     thereunder.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         15 U.S.C. 78q-1(b)(3)(F).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         17 CFR 240.17Ad-22(e)(2)(v).
                    </P>
                </FTNT>
                <P>
                    It is therefore ordered pursuant to Section 19(b)(2) of the Act 
                    <SU>24</SU>
                    <FTREF/>
                     that the proposed rule change (SR-ICC-2024-012) be, and hereby is, approved.
                    <SU>25</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         15 U.S.C. 78s(b)(2).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         In approving the proposed rule change, the Commission considered the proposal's impact on efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
                    </P>
                </FTNT>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>26</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30778 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-101979; File No. SR-BOX-2024-30]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; BOX Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fee Schedule relating to BOX Connectivity Fees and Port Fees for Trading on the BOX Options Market LLC Facility</SUBJECT>
                <DATE>December 19, 2024</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on December 17, 2024, BOX Exchange LLC (the “Exchange”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I, II, and III, below, which Items have been prepared by the Exchange. The Exchange filed the proposed rule change pursuant to Section 19(b)(3)(A)(ii) of the Act,
                    <SU>3</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(2) thereunder,
                    <SU>4</SU>
                    <FTREF/>
                     which renders the proposal effective upon filing with the Commission. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         15 U.S.C. 78s(b)(3)(A)(ii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         17 CFR 240.19b-4(f)(2).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of the Substance of the Proposed Rule Change</HD>
                <P>
                    The Exchange is filing with the Securities and Exchange Commission (“Commission”) a proposed rule change to amend the Fee Schedule relating to BOX Connectivity Fees and Port Fees on the BOX Options Market LLC (“BOX”) options facility. The text of the proposed rule change is available from the principal office of the Exchange, at the Commission's Public Reference Room and also on the Exchange's internet website at 
                    <E T="03">https://rules.boxexchange.com/rulefilings.</E>
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.</P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    The Exchange proposes to amend the Fee Schedule to increase Connectivity Fees for 10 gigabit (“Gb”) Connections, Non-10 Gb Connections, Financial Information Exchange (“FIX”) Ports, SOLA® Access Information Language (“SAIL”) Ports, Drop Copy Ports, and High Speed Vendor Feed (“HSVF”) Ports (collectively “Connectivity and Ports”).
                    <SU>5</SU>
                    <FTREF/>
                     Specifically, the Exchange proposes a one-time 
                    <SU>6</SU>
                    <FTREF/>
                     increase to its fees for Connectivity and Ports in Sections III.A.2 and III.B of the Fee Schedule.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         The Exchange initially filed the proposed pricing change on June 3, 2024 (SR-BOX-2024-13). On June 18, 2024, the Exchange withdrew that filing and submitted SR-BOX-2024-16. On August 16, 2024, the Exchange withdrew SR-BOX-2024-16 and submitted SR-BOX-2024-19. On October 10, 2024, the Exchange withdrew SR-BOX-2024-19 and submitted SR-BOX-2024-24. On October 24, 2024, the Exchange withdrew SR-BOX-2024-24 and submitted SR-BOX-2024-26. The instant filing replaces SR-BOX-2024-26, which was withdrawn on December 17, 2024.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         If the Exchange intends to increase or decrease fees for Connectivity and Ports in the future, the Exchange would be required to file a proposed rule change with the Commission under Section 19(b) of the Act to amend its Fee Schedule.
                    </P>
                </FTNT>
                <P>By way of background, a physical connection is utilized by a Participant or non-Participant to connect to BOX at the datacenters where BOX's servers are located. BOX currently assesses the following physical connectivity fees for Participants and non-Participants on a monthly basis: $1,000 per connection for a Non-10 Gb Connection and $5,000 per connection for a 10 Gb Connection. The Exchange proposes to increase, on a one-time basis, the monthly fee for Non-10 Gb Connections from $1,000 to $1,080 per connection and from $5,000 to $5,400 monthly fee for each 10 Gb Connection. The Exchange notes the proposed fee changes better enable BOX to continue to maintain and improve its market technology and services.</P>
                <P>Further, BOX currently provides four types of ports, including: (i) the FIX Port, which allows Participants to electronically send orders in all products traded on BOX; (ii) the SAIL Port, which allows Market Makers to submit electronic quotes and orders and other Participants to submit orders to BOX; (iii) the Drop Copy Port, which provides a real-time feed containing trade execution, trade correction, trade cancellation and trade allocation for regular and complex orders on BOX for Participants; and (iv) the HSVF Port, which provides a BOX market data feed for both Participants and non-Participants. The Exchange notes that Participants must connect to a minimum of one port via FIX or SAIL and that there is no minimum or maximum number of ports required for the Drop Copy Port or the HSVF Port.</P>
                <P>Current FIX Port fees are as follows:</P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,p7,7/8,i1" CDEF="s50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">FIX ports</CHED>
                        <CHED H="1">BOX monthly port fees</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">1st FIX Port</ENT>
                        <ENT>$500 per port per month.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FIX Ports 2 through 5</ENT>
                        <ENT>$250 per port per month.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Additional FIX Ports over 5</ENT>
                        <ENT>$150 per port per month.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>Current SAIL Port fees are as follows:</P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,p7,7/8,i1" CDEF="s50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">SAIL ports</CHED>
                        <CHED H="1">BOX monthly port fees</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Market Making</ENT>
                        <ENT>$1,000 per month for all Ports.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Order Entry</ENT>
                        <ENT>
                            $500 per month per port (1-5 Ports).
                            <LI>$150 per month for each additional Port.</LI>
                        </ENT>
                    </ROW>
                </GPOTABLE>
                <P>The Exchange proposes to increase FIX Port fees on a one-time basis as follows:</P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,p7,7/8,i1" CDEF="s50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">FIX ports</CHED>
                        <CHED H="1">BOX monthly port fees</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">1st FIX Port</ENT>
                        <ENT>$540 per port per month.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">FIX Ports 2 through 5</ENT>
                        <ENT>$270 per port per month.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Additional FIX Ports over 5</ENT>
                        <ENT>$162 per port per month.</ENT>
                    </ROW>
                </GPOTABLE>
                <PRTPAGE P="105658"/>
                <P>The Exchange proposes to increase SAIL Port fees on a one-time basis as follows:</P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,p7,7/8,i1" CDEF="s50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">SAIL ports</CHED>
                        <CHED H="1">BOX monthly port fees</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Market Making</ENT>
                        <ENT>$1,080 per month for all Ports.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Order Entry</ENT>
                        <ENT>
                            $540 per month per port (1-5 Ports).
                            <LI>$162 per month for each additional Port.</LI>
                        </ENT>
                    </ROW>
                </GPOTABLE>
                <P>The Exchange also proposes to increase Drop Copy Ports on a one-time basis, currently $500 per port per month, to $540 per port per month for each month a Participant is credentialed to use a Drop Copy Port. Drop Copy Port fees will remain capped at $2,000 per month.</P>
                <P>The Exchange proposes lastly to increase HSVF Port fees on a one-time basis, currently $1,500 per month, to $1,620 per month for each month a Participant or non-Participant is credentialed to use the HSVF Port.</P>
                <P>
                    The Exchange notes that BOX continuously invests in improvements that enhance the value of its Connectivity and Ports services. BOX has expended, and will continue to expend, resources to innovate and modernize technology so that it may benefit its Participants and continue to compete among other options markets. BOX regularly invests in efforts to support and optimize its systems to support system capacity, reliability, and performance. Yet the Exchange has not adjusted any of the fees included in this proposal since 2018, to even partially offset the costs of maintaining and enhancing its Connectivity and Ports services.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         The 10 Gb and Non-10 Gb Connection fees were initially effective on July 19, 2018. 
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 83728 (July 27, 2018), 83 FR 37853 (August 2, 2018) (Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fee Schedule on BOX Market LLC (“BOX”) Options Facility To Establish BOX Connectivity Fees for Participants and Non-Participants Who Connect to the BOX Network). These fees were suspended on September 17, 2018 and became effective again on October 31, 2019. HSVF port fees were increased on January 31, 2018. 
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 82654 (February 7, 2018), 83 FR 6284 (February 13, 2018) (SR-BOX-2018-04) (Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Section VI. (Technology Fees) of the BOX Fee Schedule). SAIL, FIX, and Drop Copy port fees were established on April 27, 2018. 
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 83197 (May 9, 2018), 83 FR 22567 (May 15, 2018) (SR-BOX-2018-15) (Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fee Schedule on the BOX Market LLC (“BOX”) Options Facility To Amend Connectivity Fees and Establish Port Fees).
                    </P>
                </FTNT>
                <P>
                    As discussed below, the Exchange proposes to adjust Connectivity and Ports fees by an industry- and product-specific inflationary measure. It is reasonable and consistent with the Securities and Exchange Act of 1934 (the “Act”) for BOX to recoup its investments, at least in part, by adjusting its fees. Continuing to operate at fees frozen at 2018 levels impacts BOX's ability to enhance its services and the interests of market participants. The proposed fee increases are based on an industry-specific Producer Price Index (PPI), which is a tailored measure of inflation.
                    <SU>8</SU>
                    <FTREF/>
                     As a general matter, the Producer Price Index is a family of indexes that measures the average change over time in selling prices received by domestic producers of goods and services. PPI measures price change from the perspective of the seller. This contrasts with other metrics, such as the Consumer Price Index (CPI), that measure price change from the purchaser's perspective.
                    <SU>9</SU>
                    <FTREF/>
                     About 10,000 PPIs for individual products and groups of products are tracked and released each month.
                    <SU>10</SU>
                    <FTREF/>
                     PPIs are available for the output of nearly all industries in the goods-producing sectors of the U.S. economy—mining, manufacturing, agriculture, fishing, and forestry—as well as natural gas, electricity, and construction, among others. The PPI program covers approximately 69 percent of the service sector's output, as measured by revenue reported in the 2017 Economic Census. For purposes of this proposal, the relevant industry-specific PPI is the Data Processing and Related Services PPI (“Data PPI”), which is an industry net-output PPI that measures the average change in selling prices received by companies that provide data processing services. The Data PPI was introduced in January 2002 by the Bureau of Labor Statistics (BLS) as part of an ongoing effort to expand Producer Price Index coverage of the services sector of the U.S. economy and is identified as NAICS—518210 in the North American Industry Classification System.
                    <SU>11</SU>
                    <FTREF/>
                     According to the BLS “[t]he primary output of NAICS 518210 is the provision of electronic data processing services. In the broadest sense, computer services companies help their customers efficiently use technology. The processing services market consists of vendors who use their own computer systems—often utilizing proprietary software—to process customers' transactions and data. Companies that offer processing services collect, organize, and store a customer's transactions and other data for record-keeping purposes. Price movements for the NAICS 518210 index are based on changes in the revenue received by companies that provide data processing services. Each month, companies provide net transaction prices for a specified service. The transaction is an actual contract selected by probability, where the price-determining characteristics are held constant while the service is repriced. The prices used in index calculation are the actual prices billed for the selected service contract.” 
                    <SU>12</SU>
                    <FTREF/>
                     The Exchange believes the Data PPI is an appropriate measure to be considered in the context of the proposed rule change to increase the fees for BOX Connectivity and Ports because BOX uses its “own computer systems” and “proprietary software,” 
                    <E T="03">i.e.,</E>
                     its own servers and proprietary matching engine software, respectively, to collect, organize, store and report customers' transactions on BOX's proprietary trading platform. In other words, BOX is in the business of data processing and related services.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See https://fred.stlouisfed.org/series/PCU51825182.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See https://www.bls.gov/ppi/overview.htm.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         NAICS appears in the PPI Detailed Report and is available at 
                        <E T="03">https://data.bls.gov/dataViewer/view/timeseries/PCU5182-5182-.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See https://www.bls.gov/ppi/factsheets/producer-price-index-for-the-data-processing-and-related-services-industry-naics-518210.htm.</E>
                    </P>
                </FTNT>
                <P>
                    For the period from July 2018 to August 2024, the Data PPI had a starting value of 107 in July 2018 and an ending value of 116.022 in August 2024, an 8.43% increase.
                    <SU>13</SU>
                    <FTREF/>
                     This indicates that companies who are also in the data storage and processing business have generally increased prices for a specified service covered under NAICS 518210 by an average of 8.43% during this period. Based on that percentage change, the Exchange proposes to make a one-time fee increase of 8% for BOX Connectivity and Ports, which reflects an increase covering approximately the period since the last adjustment was made. The Exchange further believes the Data PPI is an appropriate measure for purposes of the proposed change on the basis that it is a stable metric with limited volatility, unlike other consumer-side inflation metrics. In fact, the Data PPI has not experienced a greater than 2.16% increase for any one calendar year period since Data PPI was introduced into the PPI in January 2002. The average calendar year change from January 2002 to December 2023 was .62%, with a cumulative increase of 15.67% over this 21-year period. The 
                    <PRTPAGE P="105659"/>
                    Exchange believes the Data PPI is considerably less volatile than other inflation metrics such as CPI, which has had individual calendar-year increases of more than 6.5%, and a cumulative increase of over 73% over the same period.
                    <SU>14</SU>
                    <FTREF/>
                     The Exchange believes the Data PPI, and significant investments into and enhanced performance of BOX, support the reasonableness of the proposed fee increases.
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         The Exchange used July 2018 as a starting point for measuring Data PPI because that is when the last of the Connectivity and Ports fees were established. 
                        <E T="03">See supra</E>
                         note 7. The Exchange notes that starting from January 2018 results in an 8.74% Data PPI increase and starting from April 2018 results in the same Data PPI increase as starting from July 2018.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See https://www.usinflationcalculator.com/inflation/consumer-price-index-and-annual-percent-changes-from-1913-to-2008/.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See infra</E>
                         discussion of system performance advancements. Additionally, other exchanges have filed for increases in certain fees, based in part on comparisons to inflation. 
                        <E T="03">See, e.g.,</E>
                         Securities Exchange Act Release Nos. 101519 (November 5, 2024), 89 FR 89071 (November 12, 2024) (SR-CboeBYX-2024-039); 101691 (November 21, 2024), 89 FR 93697 (November 27, 2024) (SR-Phlx-2024-57).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the “Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
                    <SU>16</SU>
                    <FTREF/>
                     Specifically, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 
                    <SU>17</SU>
                    <FTREF/>
                     requirements that the rules of an exchange be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Additionally, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 
                    <SU>18</SU>
                    <FTREF/>
                     requirement that the rules of an exchange not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers. The Exchange also believes the proposed rule change is consistent with Section 6(b)(4) 
                    <SU>19</SU>
                    <FTREF/>
                     of the Act, which requires that Exchange rules provide for the equitable allocation of reasonable dues, fees, and other charges among its Participants and other persons using its facilities.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         15 U.S.C. 78f(b)(4).
                    </P>
                </FTNT>
                <P>This belief is based on two factors. First, the current fees do not properly reflect the quality of the services and products, as the fees for the services and products in question have been static in nominal terms, and therefore falling in real terms due to inflation. Second, the Exchange believes that investments made in enhancing the capacity and speed of BOX systems increase the performance of the services and products.</P>
                <P>
                    As noted above, the Exchange has not increased any of the fees included in the proposal since 2018. However, in the years following the last fee increase BOX has made significant investments in upgrades to BOX systems, enhancing the quality of its services, as measured by, among other things, increased throughput and faster processing speeds. In other words, BOX customers have greatly benefitted, while BOX's ability to recoup its investments has been hampered. Between 2018 and 2024, the inflation rate is 3.86% per year, on average, producing a cumulative inflation rate of 25.50%.
                    <SU>20</SU>
                    <FTREF/>
                     Using the more targeted inflation number of Data PPI, the cumulative inflation rate was 8.43% during an approximately similar time period.
                    <SU>21</SU>
                    <FTREF/>
                     The Exchange believes the Data PPI is a reasonable metric to base this fee increase on because it is targeted to producer-side increases in the data processing industry. Notwithstanding inflation, as noted above, the Exchange has not increased its fees at all for over six years for the subject services. The proposed fee changes represent a modest increase from the current fees.
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">See https://www.officialdata.org/us/inflation/2018?amount=1.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         The general CPI inflation rate was measured from the beginning of 2018 through October 24, 2024, while the Data PPI was measured from July 2018 through August 2024.
                    </P>
                </FTNT>
                <P>The Exchange believes the proposed fee increase is reasonable in light of BOX's continued expenditure in maintaining a robust technology ecosystem. Furthermore, BOX continues to invest in maintaining and enhancing its Connectivity and Ports services—for the benefit and often at the behest of its Participants. For example, BOX recently performed a redesign of its customer access network. Particularly, BOX replaced existing customer access switches with newer models, increased the number of switches, and implemented an equalized cabling system, which the Exchange believes resulted in increased determinism. Network bandwidth was also increased as a result of the upgrades, which among other things, can lead to reduced message queuing. The Exchange believes these network changes result in less natural variance in the processing of messages for our market participants. In addition, BOX has upgraded and increased the servers supporting its trading platform to enable it to support increased levels of incoming participant traffic while offering faster message processing. The Exchange believes that these enhancements increase the value of its connectivity and port services.</P>
                <P>The goal of the initiatives discussed above, among other things, is to provide faster and more consistent order handling and matching performance for options, while ensuring quicker processing time and supporting increasing volumes. Accordingly, BOX continuously invests in improvements that enhance the value of its Connectivity and Ports services. As discussed above, BOX expended, and will continue to expend, resources to innovate and modernize technology so that it may benefit its Participants and continue to compete among other options markets. BOX regularly invests in efforts to support and optimize its systems to support system capacity, reliability, and performance.</P>
                <P>The Exchange believes that the proposed fee increases are equitably allocated and not unfairly discriminatory because they would apply to all market participants that choose to purchase connectivity products and services from BOX. Any participant that chooses to purchase BOX's connectivity products and services would be subject to the same Fee Schedule, regardless of what type of business they operate or the use they plan to make use of the products and services. Additionally, the fee increase would be applied uniformly to market participants without regard to Exchange membership status or the extent of any other business with BOX. The Exchange also believes that the proposal represents an equitable allocation of reasonable dues, fees and other charges because Exchange fees have fallen in real terms during the relevant period. Finally, the Exchange believes that the proposed fee changes are not unfairly discriminatory because the fees would be assessed uniformly across all market participants, in the same manner they are today, that voluntarily purchase BOX's connectivity products and services, which would remain available for purchase by all market participants.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>
                    The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The proposed fee changes will not impact intramarket competition because it will apply to all similarly situated Participants and non-Participants 
                    <PRTPAGE P="105660"/>
                    equally (
                    <E T="03">i.e.,</E>
                     all market participants that choose to purchase connectivity or ports).
                    <SU>22</SU>
                    <FTREF/>
                     As such, the Exchange believes that the proposed fees do not put any market participants at a relative disadvantage compared to other market participants. As noted above, the fee schedule would continue to apply to all market participants that choose to connect to BOX in the same manner as it does today albeit at inflation-adjusted rates for certain fees, and market participants may choose whether to connect directly to BOX at all. The Exchange also believes that the level of the proposed fees neither favor nor penalize one or more categories of market participants in a manner that would impose an undue burden on competition.
                </P>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         The Exchange notes that only Participants may purchase FIX Ports, SAIL Ports, and Drop Copy Ports.
                    </P>
                </FTNT>
                <P>The Exchange believes that the proposed fees do not impose a burden on intermarket competition that is not necessary or appropriate. In determining the proposed fees, the Exchange utilized an objective and stable metric with limited volatility. Utilizing Data PPI over a specified period of time is a reasonable means of recouping BOX's investment in maintaining and enhancing its Connectivity and Ports services. The Exchange believes utilizing Data PPI, a tailored measure of inflation, to increase certain fees for BOX connectivity to recoup BOX's investment in maintaining and enhancing its Connectivity and Ports services would not impose a burden on intermarket competition.</P>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>No written comments were either solicited or received.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action Effectiveness</HD>
                <P>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Exchange Act 
                    <SU>23</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(2) thereunder,
                    <SU>24</SU>
                    <FTREF/>
                     because it establishes or changes a due, or fee.
                </P>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         15 U.S.C. 78s(b)(3)(A)(ii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         17 CFR 240.19b-4(f)(2).
                    </P>
                </FTNT>
                <P>At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend the rule change if it appears to the Commission that the action is necessary or appropriate in the public interest, for the protection of investors, or would otherwise further the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.</P>
                <HD SOURCE="HD1">IV. Solicitation of Comments</HD>
                <P>Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:</P>
                <HD SOURCE="HD2">Electronic Comments</HD>
                <P>
                    • Use the Commission's internet comment form (
                    <E T="03">https://www.sec.gov/rules/sro.shtml</E>
                    ); or
                </P>
                <P>
                    • Send an email to 
                    <E T="03">rule-comments@sec.gov.</E>
                     Please include file number SR-BOX-2024-30 on the subject line.
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.</P>
                <FP>
                    All submissions should refer to file number SR-BOX-2024-30. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (
                    <E T="03">https://www.sec.gov/rules/sro.shtml</E>
                    ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. Do not include personal identifiable information in submissions; you should submit only information that you wish to make available publicly. We may redact in part or withhold entirely from publication submitted material that is obscene or subject to copyright protection. All submissions should refer to file number SR-BOX-2024-30 and should be submitted on or before January 17, 2025.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>25</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>Vanessa A. Countryman,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30899 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-101982; File No. SR-CboeEDGX-2024-083]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Update Its Fee Schedule Regarding Uncontrolled External Distributors</SUBJECT>
                <DATE>December 19, 2024.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on December 16, 2024, Cboe EDGX Exchange, Inc. (the “Exchange” or “EDGX”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I, II, and III below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>Cboe EDGX Exchange, Inc. (the “Exchange” or “EDGX”) proposes to update its Fee Schedule. The text of the proposed rule change is provided in Exhibit 5.</P>
                <P>
                    The text of the proposed rule change is also available on the Exchange's website (
                    <E T="03">http://markets.cboe.com/us/options/regulation/rule_filings/edgx/</E>
                    ), at the Exchange's Office of the Secretary, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>
                    In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the 
                    <PRTPAGE P="105661"/>
                    places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
                </P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    The Exchange proposes to amend the Market Data section of its Fee Schedule to adopt a new fee waiver for Uncontrolled External Distributors.
                    <SU>3</SU>
                    <FTREF/>
                     Particularly, the Exchange proposes to: (i) adopt a waiver of External Distribution fees for Uncontrolled External Distributors of the Summary Depth Feed and Top Feed, and (ii) adopt fee waiver of External Distribution fees and Data Consolidation fees for Uncontrolled External Distributors of the Cboe One Summary Feed and Cboe One Premium Feed.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The Exchange initially adopted this fee waiver on December 2, 2024 (SR-CboeEDGX-2024-081). On December 16, 2024, the Exchange withdrew that filing and submitted this filing.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         For clarity, the Exchange also proposes to modify the applicable sections of its Fee Schedule for these data feeds to use numbered footnotes in lieu of asterisks.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">EDGX Top and Summary Depth Data</HD>
                <P>
                    By way of background, the Exchange offers the EDGX Top Data Feed, which is a data feed that offers top-of-book quotations and last sale information based on orders entered into the Exchange's System. The EDGX Top Data Feed benefits investors by facilitating their prompt access to real-time top-of-book information contained in EDGX Top Data. The Exchange's affiliated equities exchanges (
                    <E T="03">i.e.,</E>
                     Cboe EDGA, Inc. (“EDGA”), Cboe BZX Exchange, Inc. (“BZX”), and Cboe BYX Exchange, Inc. (“BYX”) (collectively, “Affiliates” and together with the Exchange, “Cboe Equities Exchanges”) also offer similar top-of-book data feeds. Particularly, each of the Exchange's Affiliates offer top-of-book quotation and last sale information based on their own quotation and trading activity that is substantially similar to the information provided by the Exchange through the EDGX Top Data Feed.
                </P>
                <P>
                    In addition to EDGX Top Data Feed, the Exchange offers EDGX Summary Depth Data Feed, which is a data feed that offers aggregated two-sided quotations for all displayed orders entered into the System for up to five (5) price levels. The EDGX Summary Depth Data Feed also contains the individual last sale information, Market Status, Trading Status, and Trade Break messages.
                    <SU>5</SU>
                    <FTREF/>
                     The EDGX Summary Depth Data Feed benefits investors by facilitating their prompt access to real-time market depth information contained in EDGX Summary Depth Data. The Exchange's Affiliates also offer similar depth-of-book data feeds. Particularly, each of the Exchange's Affiliates offer depth-of-book quotations up to five (5) price levels based on their own quotation and trading activity that is substantially similar to the information provided by the Exchange through the EDGX Summary Depth.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Exchange Rule 13.8(f)
                    </P>
                </FTNT>
                <P>The Exchange proposes to make the following fee changes relating to both EDGX Top and EDGX Summary Depth.</P>
                <HD SOURCE="HD3">EDGX Top Data Feed and EDGX Summary Depth Data Feed New Uncontrolled External Distributor External Distribution Fee Waiver</HD>
                <P>
                    Currently, the Exchange assesses all External Distributors of EDGX Top Data Feed an External Distribution fee of $2,250 per month and External Distributors of EDGX Summary Depth Data Feed an External Distribution fee of $2,500 per month.
                    <SU>6</SU>
                    <FTREF/>
                     The Exchange proposes to adopt a fee waiver which will provide that new Uncontrolled External Distributors of the EDGX Top and/or Summary Depth feeds will not be charged the External Distributor fees until such time they enlist one or more Users 
                    <SU>7</SU>
                    <FTREF/>
                     to receive the EDGX Top Feed or Summary Depth Feed (the “New Uncontrolled External Distributor EDGX Top and Depth Fee Waiver”).
                    <SU>8</SU>
                    <FTREF/>
                     “Uncontrolled External Distributors” distribute data externally to a User that is not an affiliate of the Uncontrolled Distributor and is unable to control the entitlements of and display of information to such User (
                    <E T="03">i.e.,</E>
                     a data feed subscriber).
                    <SU>9</SU>
                    <FTREF/>
                     To be eligible for the New Uncontrolled External Distributor EDGX Top and Depth Fee Waiver, a new Uncontrolled External Distributor must not have received the data feed(s) for which it seeks a waiver (EDGX Top and/or Depth) within the last 18 months.
                    <SU>10</SU>
                    <FTREF/>
                     As discussed further below, the Exchange seeks to adopt the proposed New Uncontrolled External Distributor EDGX Top and Depth Fee Waiver to incentivize vendors to adopt the EDGX Top and Summary Depth feeds proactively without having to wait for customer demand to start development and integration of data feeds. The Exchange notes that both the Exchange and its Affiliates currently offer similar credits to External Distributors (which both Uncontrolled and Controlled External Distributors are eligible for) for the purposes of allowing them time to enlist new users to receive certain data feeds. For example, the Exchange and its Affiliates currently offer a one (1) month New External Distributor Credit applicable to External Distributors of top-of-book data feeds.
                    <SU>11</SU>
                    <FTREF/>
                     They also offer a three (3) month new External Credit applicable to External Distributors of summary depth-of-book feeds.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         External Distribution Fees for both EDGX Top and Summary Depth are subject to the New External Distributor Credit and eligible for a free trial. 
                        <E T="03">See</E>
                         EDGX Equities Exchange Fees Schedule, Market Data Fees.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         The Exchange defines a “User” of an Exchange Market Data Product as a natural person, a proprietorship, corporation, partnership or entity, or device (computer or other automated service), that is entitled to receive Exchange data. 
                        <E T="03">See</E>
                         EDGX Equities Exchange Fees Schedule, Market Data Fees.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         The proposed waivers of the External Distribution fees for each of EDGX Top and EDGX Summary Depth will be applied separately. For example, when an Uncontrolled External Distributor that is receiving a fee waiver for both EDGX Top and EDGX Summary Depth enlists a first User for EDGX Top, the Uncontrolled External Distributor will no longer eligible to receive the waiver for EDGX Top, but will still receive the waiver for EDGX Summary Depth until and unless it enlists a new subscriber for EDGX Summary Depth. Additionally Uncontrolled External Distributors will receive at least the one month New External Distributor Credit for EDGX Top and the New External Distributor credit of at least three months for EDGX Summary Depth. For example, if an Uncontrolled Distributor enlists a new subscriber of EDGX Summary Depth during its second month taking EDGX Summary Depth, the Uncontrolled External Distributor will still receive a credit for the remainder of the second month, as well as the third month under the existing New External Distributor Credit program.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         Cboe Global Markets North American Data Policies. The Exchange proposes to codify the definition of an “Uncontrolled External Distributor” in the Definitions section of the Market Data Fees schedule in the Exchange's Fees Schedule for transparency and clarity.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         The Exchange notes that its affiliate exchange, EDGA, has a similar 18 moth requirement for participants to be considered eligible for the New Member Program. 
                        <E T="03">See</E>
                         EDGA Equities Exchange Fees Schedule, New Member Program.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         With the exception that EDGA does not offer this credit as the monthly cost is $0. 
                        <E T="03">See e.g.</E>
                        , BZX Equities Exchange Fees Schedule, Market Data Fees and EDGX Equities Exchange Fees Schedule, Market Data Fees.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See e.g.</E>
                        , BZX Equities Exchange Fees Schedule, Market Data Fees.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Cboe One Summary and Premium</HD>
                <P>
                    By way of background, Cboe One Premium is a data feed that disseminates, on a real-time basis, the aggregate best bid and offer (“BBO”) of all displayed orders for securities traded on EDGX and its Affiliates and contains optional functionality which enables recipients to receive aggregated two-sided quotations from EDGX and its Affiliates for up to five (5) price levels.
                    <FTREF/>
                    <SU>13</SU>
                      
                    <PRTPAGE P="105662"/>
                    The Cboe One Premium Data Feed is created using the data from the Exchange and its Affiliates' Summary Depth data feeds. In contract, Cboe One Summary is a data feed that disseminates, on a real-time basis, the aggregate BBO of all displayed orders for securities traded on EDGX and its affiliated equities exchanges and also contains individual last sale information for the EDGX and its affiliated equities exchanges.
                    <SU>14</SU>
                    <FTREF/>
                     The Cboe One Summary Data Feed is created using the data from the Exchange and its Affiliates' Top data feeds. Currently, the Exchange offers the New External Distributor Credit which provide that new External Distributors of the Cboe One Premium Feed and Cboe One Summary Feed will not be charged an External Distributor Fee for their first three (3) months and one (1) month, respectively, in order to allow them to enlist new Users to receive the respective feed.
                    <SU>15</SU>
                    <FTREF/>
                     The Exchange proposes to make the following fee change relating to both the Cboe One Summary Data Feed and the Cboe One Premium Data Feed.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         The Cboe Aggregated Market (“Cboe One”) Feed is a data feed that contains the aggregate best bid and offer of all displayed orders for securities traded on the Exchange and its affiliated exchanges 
                        <PRTPAGE/>
                        (
                        <E T="03">i.e.,</E>
                         EDGX, EDGA, and BZX). 
                        <E T="03">See</E>
                         Exchange Rule 13.8(b). The Cboe One Feed contains optional functionality which enables recipients to receive aggregated two-sided quotations from the Cboe Equities Exchanges for up to five (5) price levels (“Cboe One Premium Feed”). The Cboe One Premium external distribution fee is equal to the aggregate EDGX Summary Depth, BYX Summary Depth, EDGA Summary Depth, and BZX Summary Depth external distribution fees.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         The Exchange notes that when it first adopted the New External Distributor Credit for Cboe One Summary, it similarly applied for a new External Distributor's first three (3) months. 
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 74282 (February 17, 2015), 80 FR 9487 (February 23, 2015) (SR-EDGX-2015-09).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See</E>
                         EDGX Fee Schedule.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Cboe One Summary and Premium New Uncontrolled External Distributor External Distribution and Data Consolidation Fee Waivers</HD>
                <P>
                    Currently, the Exchange assesses all External Distributors of Cboe One Summary an External Distribution fee of $5,000 per month and External Distributors of Cboe One Premium an External Distribution fee of $12,500 per month.
                    <SU>16</SU>
                    <FTREF/>
                     The Exchange proposes to adopt fee waivers which will provide that new Uncontrolled External Distributors of the Cboe One Summary and Cboe One Premium feeds will not be charged either the (i) External Distribution fees nor (ii) Data Consolidation fee until such time they enlist one or more Users to receive the Cboe One Summary or Cboe One Premium Feeds (the “New Uncontrolled External Distributor Cboe One Summary and Cboe One Premium Fee Waiver”).
                    <SU>17</SU>
                    <FTREF/>
                     To be eligible for either fee waiver for the applicable feed(s) (Cboe One Summary and/or Cboe One Premium), the new Uncontrolled Data Distributor must not have received the applicable data feed(s) for which it seeks a waiver in the last 18 months.
                    <SU>18</SU>
                    <FTREF/>
                     For clarity, similar to the New Uncontrolled External Distributor EDGX Top and Depth Fee Waiver, while the Uncontrolled External Distributor receives the New Uncontrolled External Distributor Cboe One Summary and Cboe One Premium Fee Waiver, the Uncontrolled External Distributor will not have any customers receiving this data. As described herein, once the New Uncontrolled External Distributor enlists its first User, it is no longer eligible to receive the New Uncontrolled External Distributor Cboe One Summary and Cboe One Premium Fee Waiver.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         External Distribution Fees for both Cboe One Summary and Cboe One Premium are subject to the New External Distribution Credit and eligible for a free trial. 
                        <E T="03">See</E>
                         EDGX Equities Exchange Fees Schedule.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         The proposed waivers of the External Distribution fees for each of Cboe One Summary and Cboe One Premium will be applied separately. For example, when an Uncontrolled External Distributor that is receiving a fee waiver for both Cboe One Summary and Cboe One Premium enlists a first User for Cboe One Summary, the Uncontrolled External Distributor will no longer eligible to receive the waiver for Cboe One Summary, but will still receive the waiver for Cboe One Premium until and unless it enlists a new subscriber for Cboe One Premium. Additionally Uncontrolled External Distributors will receive at least the one month New External Distributor Credit for Cboe One Summary and the New External Distributor credit of at least three months for Cboe One Premium. For example, if an Uncontrolled Distributor enlists a new subscriber of Cboe One Premium during its second month taking Cboe One Premium, the Uncontrolled External Distributor will still receive a credit for the remainder of the second month, as well as the third month under the existing New External Distributor Credit program.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See supra</E>
                         note 8.
                    </P>
                </FTNT>
                <P>To start, the Exchange's proposal to waive the External Distributor fee for New Uncontrolled External Distributors until a User is enlisted, will prevent the combined cost of subscribing to BYX, EDGA, EDGX, and BZX Summary Depth feeds for new Uncontrolled External Distributors to be greater than those currently charged to subscribe to the Cboe One Premium feed. Similarly, the proposed External Distributor fee waiver for Cboe One Summary will prevent the combined cost of subscribing to BYX, EDGA, EDGX, and BZX Top feeds for new Uncontrolled External Distributors to be greater than those currently charged to subscribe to the Cboe One Summary feed.</P>
                <P>
                    Next, the Exchange proposes to waive the Data Consolidation fee for New Uncontrolled External Distributors until its first User enlists for the Cboe One feeds. The Exchange currently charges Distributors of the Cboe One Feeds a separate Data Consolidation Fee of $1,000 per month, which reflects the value of the aggregation and consolidation function the Exchange performs in creating the Cboe One Options Feed.
                    <SU>19</SU>
                    <FTREF/>
                     As stated above, the Exchange creates the Cboe One feeds from data derived from the Cboe Equities Exchanges. Distributors (including vendors) could similarly create a competing product to the Cboe One feeds based on these individual data feeds offered by the Exchanges and could charge its clients a fee that it believes reflects the value of the aggregation and consolidation function.
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         
                        <E T="03">See</E>
                         Cboe EDGX Fee Schedule. If a vendor distributes the Cboe One Options Feed to another firm, who then re-distributes the Cboe One Options Feed, both entities would be subject to the Data Consolidation Fee. A vendor will only be assessed a single Data Consolidated Fee, even if it distributes Cboe One Options Feed to more than one entity.
                    </P>
                </FTNT>
                <P>The Exchange proposes to adopt this fee waiver to similarly prevent new Uncontrolled External Distributors of the Cboe One Summary or Cboe One Premium feeds from being charged a Data Consolidation Fee until such time they enlist one or more Users to receive the Cboe One Premium or Cboe One Summary feeds.</P>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
                    <SU>20</SU>
                    <FTREF/>
                     Specifically, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 
                    <SU>21</SU>
                    <FTREF/>
                     requirements that the rules of an exchange be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Additionally, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) requirement that the rules of an exchange not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers. The Exchange also believes this proposal is consistent with Section 6(b)(8) of the Act, which requires that 
                    <PRTPAGE P="105663"/>
                    the rules of an exchange not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
                    <SU>22</SU>
                    <FTREF/>
                     In addition, the Exchange believes that the proposed rule change is consistent with Section 11(A) of the Act as it supports (i) fair competition among brokers and dealers, among exchange markets, and between exchange markets and markets other than exchange markets, and (ii) the availability to brokers, dealers, and investors of information with respect to quotations for and transactions in securities.
                    <SU>23</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         15 U.S.C. 78k-1.
                    </P>
                </FTNT>
                <P>First, the Exchange notes that EDGX Top Feed, EDGX Summary Depth Feed, Cboe One Summary Data Feed and Cboe One Premium Data Feed (together, the “Applicable Feeds”) are distributed and purchased on a voluntary basis, in that neither the Exchange nor market data distributors are required by any rule or regulation to make these data products available. Distributors (including vendors) and Users can therefore discontinue use at any time and for any reason, including due to an assessment of the reasonableness of fees charged. Further, the Exchange is not required to make any proprietary data products available or to offer any specific pricing alternatives to any customers.</P>
                <P>
                    The Exchange proposes that the proposed waivers applicable to EDGX Top &amp; Depth and Cboe One Feeds (together, the “New Uncontrolled External Distributor Fee Waivers”) only apply to Uncontrolled External Distributors for two reasons. The first is to account for Uncontrolled External Distributors needing to develop to the data feed itself. By way of background, the other category of External Data Distributors are Controlled Distributors.
                    <SU>24</SU>
                    <FTREF/>
                     Controlled Distributors both (i) provides data to a User and (ii) controls the entitlements of and display of information to such User.
                    <SU>25</SU>
                    <FTREF/>
                     Therefore, the key distinction between Uncontrolled Distributors and Controlled Distributors is that Uncontrolled Distributors distribute a data feed and Controlled Distributors enable visible data for one of its Users. The proposed fee waivers will allow Uncontrolled External Distributors the necessary time to develop to the data feed itself and program all of the different messages, fields and flags and not subject them to any fees until such time they are able to recoup their costs from end-users. Additionally, once the data feed is setup on the Uncontrolled External Distributors end, there are typically long lead times for Uncontrolled External Distributors to onboard new downstream data feed customers. The lead times, or sales cycles, are vastly different for Uncontrolled versus Controlled Distributors, as Uncontrolled Distributors are attempting to locate Users who need to receive a real-time market data feed for downstream ingestion on their side (whether this be for trading, analysis, or application development). In contrast, Controlled Distributors are only entitling individual Users to view the data on a pre-existing Display application. For an Uncontrolled Distributor to both set up and find its first User as a data feed subscriber, it can easily take several months. As there is more uncertainty with the viability of both developing a data feed and finding Users for this data feed after the Uncontrolled External Distributor develops it, the Exchange believes it is therefore reasonable, equitable and not unfairly discriminatory for this discount to only apply to Uncontrolled External Distributors to encourage development of their data offerings.
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         Controlled Distributors may be Internal or External Distributors. 
                        <E T="03">See supra</E>
                         note 7. “Controlled External Distributors” provide data to an unaffiliated User (
                        <E T="03">i.e.,</E>
                         externally distribute) and unlike Uncontrolled External Distributors, they control the entitlement of and display of info to such User.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    The Exchange has also taken into consideration its affiliated relationship with its Affiliates in its design of the proposed waivers 
                    <SU>26</SU>
                    <FTREF/>
                     to ensure that vendors would be able to offer similar products to its Cboe One Summary and Cboe One Premium Feeds on the same terms as the Exchange from a cost perspective. While the Cboe Equities Exchanges are the exclusive distributors of the individual data feeds from which certain data elements may be taken to create the Cboe One feeds, they are not the exclusive distributors of the aggregated and consolidated information that comprises the Cboe One feeds. Any entity that receives, or elects to receive, the individual data feeds would be able to, if it so chooses, to create a data feed with the same information included in either of the Cboe One feeds and sell and distribute it to its clients so that it could be received by those clients. Such entities would also not be assessed any greater fees by the Exchange than the Exchange assess for the Cboe One feeds (
                    <E T="03">i.e.,</E>
                     those who elect to distribute and consolidate the individual data fees and those who elect to distribute the Cboe One feeds will all be eligible for the proposed fee waivers offered by the Exchange).
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         The Exchange notes that its Affiliates will also be proposing to adopt these same credits with the exception of the EDGA Top Data Feed as the External Distribution monthly cost is $0 for that particular data feed. 
                        <E T="03">See</E>
                         EDGA Equities Exchange Fees Schedule, Market Data Fees.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">New External Distributor Credit</HD>
                <P>
                    The Exchange believes it is reasonable to not charge Uncontrolled External Distributors of an Applicable Feed(s) until such time they enlist one or more Users to receive the applicable feed as such Distributors will not be subject to the External Distribution Fees for the applicable product(s) during this period.
                    <SU>27</SU>
                    <FTREF/>
                     Additionally, the Exchange and its Affiliates offer a similar credit now that all External Distributors, including Controlled External Distributors, may receive.
                    <SU>28</SU>
                    <FTREF/>
                     The proposed credit is intended to incentivize new Uncontrolled External Distributors to enlist Users to subscribe to the Applicable Feeds in an effort to broaden the products' distribution to data feed Users. While this incentive is not available to Internal Distributors of these products, the Exchange believes it is appropriate as Internal Distributors have no Users outside of their own firm. Furthermore, External Distributors are subject to higher risks of launch as the data is provided outside their own firm. In contrast, Internal Distributors who only subscribe to a specific Exchange offered market data product when there is a need as they themselves are using the information, External Distributors do not use the data themselves, but as noted, take the risk of onboarding the data to sell as a service to downstream customers.
                    <SU>29</SU>
                    <FTREF/>
                     For these reasons, the Exchange believes it is appropriate, equitable and not unfairly discriminatory to provide additional incentives to External Distributors so they have sufficient time to test the data within their own systems prior to going live externally. As discussed above, the Exchange also believes it is appropriate to limit this specific credit to Uncontrolled External Distributors given the longer development times associated with both the integration of the data feed and onboarding Users.
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         As noted above, Distributors may still receive this credit for any of the applicable feeds of which there are no Users (
                        <E T="03">i.e.,</E>
                         the Uncontrolled Distributor may still receive this credit for Cboe One Summary if there is a User subscribed for EDGX Top).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         
                        <E T="03">See e.g.</E>
                        <E T="03">,</E>
                         EDGX Equities Exchange Fees Schedule, Market Data Fees.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         The Exchange notes that in addition to the existing New External Distributor Credit offered by it and its affiliates, other exchanges have offered similar waivers for external redistribution. 
                        <E T="03">See</E>
                         EDGX Equities Exchange Fees Schedule, Market Data Fees and Securities Exchange Act Release No. 90407 (November 12, 2020), 85 FR 73570 (November 18, 2020 (SR-NYSE-2020-91).
                    </P>
                </FTNT>
                <PRTPAGE P="105664"/>
                <HD SOURCE="HD3">Data Consolidation Fee</HD>
                <P>The Exchange believes it is reasonable to not charge Uncontrolled External Distributors of Cboe One Summary and Cboe One Premium a Data Consolidation Fee until such time they enlist one or more Users to receive the applicable feed as such Distributors will not be subject to the Data Consolidation Fee for the applicable product(s) during this period. For the avoidance of doubt, once an Uncontrolled External Distributor enlists its first User, this waiver will no longer be applicable—at no time will an Uncontrolled External Distributor receive this waiver while it has customers receiving the applicable data feed. As previously discussed, the Exchange believes the proposed Data Consolidation Fee Waiver for Uncontrolled External Distributors is not designed to permit unfair discrimination against Controlled External Distributors because of the longer lead times in the development Uncontrolled External Distributors experience. Further, as previously discussed, the Exchange believes only applying this to a subset of External Distributors and not any Internal Distributors is equitable and not unfairly discriminatory given the additional risk External Distributors assume when building out a product for which they have no existing use cases. Therefore, the Exchange believes the proposed application of the Data Consolidation Fee Waiver is reasonable and would not permit unfair discrimination.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.</P>
                <P>
                    The proposed rule changes are grounded in the Exchange's efforts to compete more effectively and to assist in mitigating business costs (
                    <E T="03">i.e.,</E>
                     the costs associated with the development of data feeds and seeking Users to onboard for such data feeds) for Uncontrolled External Distributors. Further, as previously discussed, the Exchange believes the proposed Data Consolidation Fee Waiver for Uncontrolled External Distributors is not designed to permit unfair discrimination against Controlled External Distributors because of the longer lead times in the development Uncontrolled External Distributors experience. As a result, the Exchange believes this proposed rule change permits fair competition among national securities exchanges. Further, the Exchange believes that these changes will not cause any unnecessary or inappropriate burden on intermarket competition, as the proposed incentive program applies uniformly to all Uncontrolled External Distributors.
                </P>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>The Exchange neither solicited nor received comments on the proposed rule change.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>30</SU>
                    <FTREF/>
                     and paragraph (f) of Rule 19b-4 
                    <SU>31</SU>
                    <FTREF/>
                     thereunder. At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         17 CFR 240.19b-4(f).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Solicitation of Comments</HD>
                <P>Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:</P>
                <HD SOURCE="HD2">Electronic Comments</HD>
                <P>
                    • Use the Commission's internet comment form (
                    <E T="03">https://www.sec.gov/rules/sro.shtml</E>
                    ); or
                </P>
                <P>
                    • Send an email to 
                    <E T="03">rule-comments@sec.gov.</E>
                     Please include file number SR-CboeEDGX-2024-083 on the subject line.
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.</P>
                <FP>
                    All submissions should refer to file number SR-CboeEDGX-2024-083. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (
                    <E T="03">https://www.sec.gov/rules/sro.shtml</E>
                    ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. Do not include personal identifiable information in submissions; you should submit only information that you wish to make available publicly. We may redact in part or withhold entirely from publication submitted material that is obscene or subject to copyright protection. All submissions should refer to file number SR-CboeEDGX-2024-083 and should be submitted on or before January 17, 2025.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>32</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>Vanessa A. Countryman,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30901 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[SEC File No. 270-521, OMB Control No. 3235-0579]</DEPDOC>
                <SUBJECT>Submission for OMB Review; Comment Request; Extension: Regulation BTR</SUBJECT>
                <FP SOURCE="FP-1">
                    <E T="03">Upon Written Request Copies Available From:</E>
                     Securities and Exchange Commission, Office of FOIA Services, 100 F Street NE, Washington, DC 20549-2736
                </FP>
                <P>
                    Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ), the Securities and Exchange Commission (“Commission”) has submitted to the Office of Management and Budget this request for extension of the previously approved collection of information discussed below.
                    <PRTPAGE P="105665"/>
                </P>
                <P>Regulation Blackout Trade Restriction (“Regulation BTR”) (17 CFR 245.100—245.104) clarifies the scope and application of Section 306(a) of the Sarbanes-Oxley Act of 2002 (“Act”) (15 U.S.C. 7244(a)). Section 306(a)(6) [15 U.S.C.7244(a)(6)] of the Act requires an issuer to provide timely notice to its directors and executive officers and to the Commission of the imposition of a blackout period that would trigger the statutory trading prohibition of section 306(a)(1) [15 U.S.C. 7244(a)(1)]. Section 306(a) of the Act prohibits any director or executive officer of an issuer of any equity security, directly or indirectly, from purchasing, selling or otherwise acquiring or transferring any equity security of that issuer during any blackout period with respect to such equity security if the director or executive officer acquired the equity security in connection with his or her service or employment. Approximately 1,230 issuers file Regulation BTR notices approximately 5 times a year for a total of 6,150 responses. We estimate that it takes approximately 2 hours to prepare the blackout notice for a total annual burden of 2,460 hours. The issuer prepares 75% of the 2,460 annual burden hours for a total reporting burden of (1,230 issuers × 2 hours per issuer × 0.75) 1,845 hours. In addition, we estimate that an issuer distributes a notice to five directors and executive officers at an estimated 5 minutes per notice (1,230 blackout period × 5 notices × 5 minutes) for a total reporting burden of 512 hours. The combined annual reporting burden is (1,845 hours + 512 hours) 2,357 hours.</P>
                <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.</P>
                <P>
                    <E T="03">Public Comment Instructions:</E>
                     The public may view and comment on this information collection request at: 
                    <E T="03">https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202412-3235-022</E>
                     or send an email comment to 
                    <E T="03">MBX.OMB.OIRA.SEC_desk_officer@omb.eop.gov</E>
                     within 30 days of the day after publication of this notice by January 27, 2025.
                </P>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30768 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-101990; File No. SR-CboeBZX-2024-125]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Update Its Fee Schedule Regarding Uncontrolled External Distributors</SUBJECT>
                <DATE>December 19, 2024.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on December 16, 2024, Cboe BZX Exchange, Inc. (the “Exchange” or “BZX”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I, II, and III below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>Cboe BZX Exchange, Inc. (the “Exchange” or “BZX”) proposes to update its Fee Schedule. The text of the proposed rule change is provided in Exhibit 5.</P>
                <P>
                    The text of the proposed rule change is also available on the Exchange's website (
                    <E T="03">http://markets.cboe.com/us/equities/regulation/rule_filings/BZX/</E>
                    ), at the Exchange's Office of the Secretary, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.</P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    The Exchange proposes to amend the Market Data section of its Fee Schedule to adopt a new fee waiver for Uncontrolled External Distributors.
                    <SU>3</SU>
                    <FTREF/>
                     Particularly, the Exchange proposes to: (i) adopt a waiver of External Distribution fees for Uncontrolled External Distributors of the Summary Depth Feed and Top Feed, and (ii) adopt fee waiver of External Distribution fees and Data Consolidation fees for Uncontrolled External Distributors of the Cboe One Summary Feed and Cboe One Premium Feed.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The Exchange initially adopted this fee waiver on December 2, 2024 (SR-CboeBZX-2024-123). On December 16, 2024, the Exchange withdrew that filing and submitted this filing.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         For clarity, the Exchange also proposes to modify the applicable sections of its Fee Schedule for these data feeds to use numbered footnotes in lieu of asterisks.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">BZX Top and Summary Depth Data</HD>
                <P>
                    By way of background, the Exchange offers the BZX Top Data Feed, which is a data feed that offers top-of-book quotations and last sale information based on orders entered into the Exchange's System. The BZX Top Data Feed benefits investors by facilitating their prompt access to real-time top-of-book information contained in BZX Top Data. The Exchange's affiliated equities exchanges (
                    <E T="03">i.e.,</E>
                     Cboe EDGA, Inc. (“EDGA”), Cboe BYX Exchange, Inc. (“BYX”), and Cboe EDGX Exchange, Inc. (“EDGX”) (collectively, “Affiliates” and together with the Exchange, “Cboe Equities Exchanges”) also offer similar top-of-book data feeds. Particularly, each of the Exchange's Affiliates offer top-of-book quotation and last sale information based on their own quotation and trading activity that is substantially similar to the information provided by the Exchange through the BZX Top Data Feed.
                </P>
                <P>
                    In addition to BZX Top Data Feed, the Exchange offers BZX Summary Depth Data Feed, which is a data feed that offers aggregated two-sided quotations for all displayed orders entered into the System for up to five (5) price levels. The BZX Summary Depth Data Feed also contains the individual last sale information, Market Status, Trading Status, and Trade Break messages.
                    <SU>5</SU>
                    <FTREF/>
                     The BZX Summary Depth Data Feed benefits investors by facilitating their prompt access to real-time market depth information contained in BZX Summary 
                    <PRTPAGE P="105666"/>
                    Depth Data. The Exchange's Affiliates also offer similar depth-of-book data feeds. Particularly, each of the Exchange's Affiliates offer depth-of-book quotations up to five (5) price levels based on their own quotation and trading activity that is substantially similar to the information provided by the Exchange through the BZX Summary Depth.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         Exchange Rule 11.22(m)
                    </P>
                </FTNT>
                <P>The Exchange proposes to make the following fee changes relating to both BZX Top and BZX Summary Depth.</P>
                <HD SOURCE="HD3">BZX Top Data Feed and BZX Summary Depth Data Feed New Uncontrolled External Distributor External Distribution Fee Waiver</HD>
                <P>
                    Currently, the Exchange assesses all External Distributors of BZX Top Data Feed an External Distribution fee of $2,500 per month and External Distributors of BZX Summary Depth Data Feed an External Distribution fee of $5,000 per month.
                    <SU>6</SU>
                    <FTREF/>
                     The Exchange proposes to adopt a fee waiver which will provide that new Uncontrolled External Distributors of the BZX Top and/or Summary Depth feeds will not be charged the External Distributor fees until such time they enlist one or more Users 
                    <SU>7</SU>
                    <FTREF/>
                     to receive the BZX Top Feed or Summary Depth Feed (the “New Uncontrolled External Distributor BZX Top and Depth Fee Waiver”).
                    <SU>8</SU>
                    <FTREF/>
                     “Uncontrolled External Distributors” distribute data externally to a User that is not an affiliate of the Uncontrolled Distributor and is unable to control the entitlements of and display of information to such User (
                    <E T="03">i.e.,</E>
                     a data feed subscriber).
                    <SU>9</SU>
                    <FTREF/>
                     To be eligible for the New Uncontrolled External Distributor BZX Top and Depth Fee Waiver, a new Uncontrolled External Distributor must not have received the data feed(s) for which it seeks a waiver (BZX Top and/or Depth) within the last 18 months.
                    <SU>10</SU>
                    <FTREF/>
                     As discussed further below, the Exchange seeks to adopt the proposed New Uncontrolled External Distributor BZX Top and Depth Fee Waiver to incentivize vendors to adopt the BZX Top and Summary Depth feeds proactively without having to wait for customer demand to start development and integration of data feeds. The Exchange notes that both the Exchange and its Affiliates currently offer similar credits to External Distributors (which both Uncontrolled and Controlled External Distributors are eligible for) for the purposes of allowing them time to enlist new users to receive certain data feeds. For example, the Exchange and its Affiliates currently offer a one (1) month New External Distributor Credit applicable to External Distributors of top-of-book data feeds.
                    <SU>11</SU>
                    <FTREF/>
                     They also offer a three (3) month new External Credit applicable to External Distributors of summary depth-of-book feeds.
                    <SU>12</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         External Distribution Fees for both BZX Top and Summary Depth are subject to the New External Distributor Credit and eligible for a free trial. 
                        <E T="03">See</E>
                         BZX Equities Exchange Fees Schedule, Market Data Fees.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         The Exchange defines a “User” of an Exchange Market Data Product as a natural person, a proprietorship, corporation, partnership or entity, or device (computer or other automated service), that is entitled to receive Exchange data. 
                        <E T="03">See</E>
                         BZX Equities Exchange Fees Schedule, Market Data Fees.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         The proposed waivers of the External Distribution fees for each of BZX Top and BZX Summary Depth will be applied separately. For example, when an Uncontrolled External Distributor that is receiving a fee waiver for both BZX Top and BZX Summary Depth enlists a first User for BZX Top, the Uncontrolled External Distributor will no longer eligible to receive the waiver for BZX Top, but will still receive the waiver for BZX Summary Depth until and unless it enlists a new subscriber for BZX Summary Depth. Additionally Uncontrolled External Distributors will receive at least the one month New External Distributor Credit for BZX Top and the New External Distributor credit of at least three months for BZX Summary Depth. For example, if an Uncontrolled Distributor enlists a new subscriber of BZX Summary Depth during its second month taking BZX Summary Depth, the Uncontrolled External Distributor will still receive a credit for the remainder of the second month, as well as the third month under the existing New External Distributor Credit program.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         Cboe Global Markets North American Data Policies. The Exchange proposes to codify the definition of an “Uncontrolled External Distributor” in the Definitions section of the Market Data Fees schedule in the Exchange's Fees Schedule for transparency and clarity.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         The Exchange notes that its affiliate exchange, EDGA, has a similar 18 moth requirement for participants to be considered eligible for the New Member Program. 
                        <E T="03">See</E>
                         EDGA Equities Exchange Fees Schedule, New Member Program.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         With the exception that EDGA does not offer this credit as the monthly cost is $0. 
                        <E T="03">See e.g.,</E>
                         EDGA Equities Exchange Fees Schedule, Market Data Fees and EDGX Equities Exchange Fees Schedule, Market Data Fees.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See e.g.,</E>
                         EDGX Equities Exchange Fees Schedule, Market Data Fees.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Cboe One Summary and Premium</HD>
                <P>
                    By way of background, Cboe One Premium is a data feed that disseminates, on a real-time basis, the aggregate best bid and offer (“BBO”) of all displayed orders for securities traded on BZX and its Affiliates and contains optional functionality which enables recipients to receive aggregated two-sided quotations from BZX and its Affiliates for up to five (5) price levels.
                    <SU>13</SU>
                    <FTREF/>
                     The Cboe One Premium Data Feed is created using the data from the Exchange and its Affiliates' Summary Depth data feeds. In contract, Cboe One Summary is a data feed that disseminates, on a real-time basis, the aggregate BBO of all displayed orders for securities traded on BZX and its affiliated equities exchanges and also contains individual last sale information for the BZX and its affiliated equities exchanges.
                    <SU>14</SU>
                    <FTREF/>
                     The Cboe One Summary Data Feed is created using the data from the Exchange and its Affiliates' Top data feeds. Currently, the Exchange offers the New External Distributor Credit which provide that new External Distributors of the Cboe One Premium Feed and Cboe One Summary Feed will not be charged an External Distributor Fee for their first three (3) months and one (1) month, respectively, in order to allow them to enlist new Users to receive the respective feed.
                    <SU>15</SU>
                    <FTREF/>
                     The Exchange proposes to make the following fee change relating to both the Cboe One Summary Data Feed and the Cboe One Premium Data Feed.
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         The Cboe Aggregated Market (“Cboe One”) Feed is a data feed that contains the aggregate best bid and offer of all displayed orders for securities traded on the Exchange and its affiliated exchanges (
                        <E T="03">i.e.,</E>
                         EDGX, EDGA, and BZX). 
                        <E T="03">See</E>
                         Exchange Rule 11.22(j). The Cboe One Feed contains optional functionality which enables recipients to receive aggregated two-sided quotations from the Cboe Equities Exchanges for up to five (5) price levels (“Cboe One Premium Feed”). The Cboe One Premium external distribution fee is equal to the aggregate EDGX Summary Depth, BYX Summary Depth, EDGA Summary Depth, and BZX Summary Depth external distribution fees.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         The Exchange notes that when it first adopted the New External Distributor Credit for Cboe One Summary, it similarly applied for a new External Distributor's first three (3) months. 
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 74285 (February 18, 2015), 80 FR 9828 (February 24, 2015) (SR-BATS-2015-11).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See</E>
                         BZX Fee Schedule.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Cboe One Summary and Premium New Uncontrolled External Distributor External Distribution and Data Consolidation Fee Waivers</HD>
                <P>
                    Currently, the Exchange assesses all External Distributors of Cboe One Summary an External Distribution fee of $5,000 per month and External Distributors of Cboe One Premium an External Distribution fee of $12,500 per month.
                    <SU>16</SU>
                    <FTREF/>
                     The Exchange proposes to adopt fee waivers which will provide that new Uncontrolled External Distributors of the Cboe One Summary and Cboe One Premium feeds will not be charged either the (i) External Distribution fees nor (ii) Data Consolidation fee until such time they enlist one or more Users to receive the Cboe One Summary or Cboe One Premium Feeds (the “New Uncontrolled External Distributor Cboe One Summary and Cboe One Premium Fee Waiver”).
                    <FTREF/>
                    <SU>17</SU>
                      
                    <PRTPAGE P="105667"/>
                    To be eligible for either fee waiver for the applicable feed(s) (Cboe One Summary and/or Cboe One Premium), the new Uncontrolled Data Distributor must not have received the applicable data feed(s) for which it seeks a waiver in the last 18 months.
                    <SU>18</SU>
                    <FTREF/>
                     For clarity, similar to the New Uncontrolled External Distributor BZX Top and Depth Fee Waiver, while the Uncontrolled External Distributor receives the New Uncontrolled External Distributor Cboe One Summary and Cboe One Premium Fee Waiver, the Uncontrolled External Distributor will not have any customers receiving this data. As described herein, once the New Uncontrolled External Distributor enlists its first User, it is no longer eligible to receive the New Uncontrolled External Distributor Cboe One Summary and Cboe One Premium Fee Waiver.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         External Distribution Fees for both Cboe One Summary and Cboe One Premium are subject to the New External Distribution Credit and eligible for a free trial. 
                        <E T="03">See</E>
                         BZX Equities Exchange Fees Schedule.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         The proposed waivers of the External Distribution fees for each of Cboe One Summary and Cboe One Premium will be applied separately. 
                        <PRTPAGE/>
                        For example, when an Uncontrolled External Distributor that is receiving a fee waiver for both Cboe One Summary and Cboe One Premium enlists a first User for Cboe One Summary, the Uncontrolled External Distributor will no longer eligible to receive the waiver for Cboe One Summary, but will still receive the waiver for Cboe One Premium until and unless it enlists a new subscriber for Cboe One Premium. Additionally Uncontrolled External Distributors will receive at least the one month New External Distributor Credit for Cboe One Summary and the New External Distributor credit of at least three months for Cboe One Premium. For example, if an Uncontrolled Distributor enlists a new subscriber of Cboe One Premium during its second month taking Cboe One Premium, the Uncontrolled External Distributor will still receive a credit for the remainder of the second month, as well as the third month under the existing New External Distributor Credit program.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See supra</E>
                         note 8.
                    </P>
                </FTNT>
                <P>To start, the Exchange's proposal to waive the External Distributor fee for New Uncontrolled External Distributors until a User is enlisted, will prevent the combined cost of subscribing to BYX, EDGA, EDGX, and BZX Summary Depth feeds for new Uncontrolled External Distributors to be greater than those currently charged to subscribe to the Cboe One Premium feed. Similarly, the proposed External Distributor fee waiver for Cboe One Summary will prevent the combined cost of subscribing to BYX, EDGA, EDGX, and BZX Top feeds for new Uncontrolled External Distributors to be greater than those currently charged to subscribe to the Cboe One Summary feed.</P>
                <P>
                    Next, the Exchange proposes to waive the Data Consolidation fee for New Uncontrolled External Distributors its first User enlists for the Cboe One feeds. The Exchange currently charges Distributors of the Cboe One Feeds a separate Data Consolidation Fee of $1,000 per month, which reflects the value of the aggregation and consolidation function the Exchange performs in creating the Cboe One Options Feed.
                    <SU>19</SU>
                    <FTREF/>
                     As stated above, the Exchange creates the Cboe One feeds from data derived from the Cboe Equities Exchanges. Distributors (including vendors) could similarly create a competing product to the Cboe One feeds based on these individual data feeds offered by the Exchanges and could charge its clients a fee that it believes reflects the value of the aggregation and consolidation function.
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         
                        <E T="03">See</E>
                         Cboe BZX Fee Schedule. If a vendor distributes the Cboe One Options Feed to another firm, who then re-distributes the Cboe One Options Feed, both entities would be subject to the Data Consolidation Fee. A vendor will only be assessed a single Data Consolidated Fee, even if it distributes Cboe One Options Feed to more than one entity.
                    </P>
                </FTNT>
                <P>The Exchange proposes to adopt this fee waiver to similarly prevent new Uncontrolled External Distributors of the Cboe One Summary or Cboe One Premium feeds from being charged a Data Consolidation Fee until such time they enlist one or more Users to receive the Cboe One Premium or Cboe One Summary feeds.</P>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
                    <SU>20</SU>
                    <FTREF/>
                     Specifically, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) 
                    <SU>21</SU>
                    <FTREF/>
                     requirements that the rules of an exchange be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Additionally, the Exchange believes the proposed rule change is consistent with the Section 6(b)(5) requirement that the rules of an exchange not be designed to permit unfair discrimination between customers, issuers, brokers, or dealers. The Exchange also believes this proposal is consistent with Section 6(b)(8) of the Act, which requires that the rules of an exchange not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
                    <SU>22</SU>
                    <FTREF/>
                     In addition, the Exchange believes that the proposed rule change is consistent with Section 11(A) of the Act as it supports (i) fair competition among brokers and dealers, among exchange markets, and between exchange markets and markets other than exchange markets, and (ii) the availability to brokers, dealers, and investors of information with respect to quotations for and transactions in securities.
                    <SU>23</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>22</SU>
                         15 U.S.C. 78f(b)(8).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>23</SU>
                         15 U.S.C. 78k-1.
                    </P>
                </FTNT>
                <P>First, the Exchange notes that BZX Top Feed, BZX Summary Depth Feed, Cboe One Summary Data Feed and Cboe One Premium Data Feed (together, the “Applicable Feeds”) are distributed and purchased on a voluntary basis, in that neither the Exchange nor market data distributors are required by any rule or regulation to make these data products available. Distributors (including vendors) and Users can therefore discontinue use at any time and for any reason, including due to an assessment of the reasonableness of fees charged. Further, the Exchange is not required to make any proprietary data products available or to offer any specific pricing alternatives to any customers.</P>
                <P>
                    The Exchange proposes that the proposed waivers applicable to BZX Top &amp; Depth and Cboe One Feeds (together, the “New Uncontrolled External Distributor Fee Waivers”) only apply to Uncontrolled External Distributors for two reasons. The first is to account for Uncontrolled External Distributors needing to develop to the data feed itself. By way of background, the other category of External Data Distributors are Controlled Distributors.
                    <SU>24</SU>
                    <FTREF/>
                     Controlled Distributors both (i) provides data to a User and (ii) controls the entitlements of and display of information to such User.
                    <SU>25</SU>
                    <FTREF/>
                     Therefore, the key distinction between Uncontrolled Distributors and Controlled Distributors is that Uncontrolled Distributors distribute a data feed and Controlled Distributors enable visible data for one of its Users. The proposed fee waivers will allow Uncontrolled External Distributors the necessary time to develop to the data feed itself and program all of the different messages, fields and flags and not subject them to any fees until such time they are able to recoup their costs from end-users. Additionally, once the data feed is setup on the Uncontrolled External Distributors end, there are 
                    <PRTPAGE P="105668"/>
                    typically long lead times for Uncontrolled External Distributors to onboard new downstream data feed customers. The lead times, or sales cycles, are vastly different for Uncontrolled versus Controlled Distributors, as Uncontrolled Distributors are attempting to locate Users who need to receive a real-time market data feed for downstream ingestion on their side (whether this be for trading, analysis, or application development). In contrast, Controlled Distributors are only entitling individual Users to view the data on a pre-existing Display application. For an Uncontrolled Distributor to both set up and find its first User as a data feed subscriber, it can easily take several months. As there is more uncertainty with the viability of both developing a data feed and finding Users for this data feed after the Uncontrolled External Distributor develops it, the Exchange believes it is therefore reasonable, equitable and not unfairly discriminatory for this discount to only apply to Uncontrolled External Distributors to encourage development of their data offerings.
                </P>
                <FTNT>
                    <P>
                        <SU>24</SU>
                         Controlled Distributors may be Internal or External Distributors. 
                        <E T="03">See supra</E>
                         note 7. “Controlled External Distributors” provide data to an unaffiliated User (
                        <E T="03">i.e.,</E>
                         externally distribute) and unlike Uncontrolled External Distributors, they control the entitlement of and display of info to such User.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>25</SU>
                         
                        <E T="03">Id.</E>
                    </P>
                </FTNT>
                <P>
                    The Exchange has also taken into consideration its affiliated relationship with its Affiliates in its design of the proposed waivers 
                    <SU>26</SU>
                    <FTREF/>
                     to ensure that vendors would be able to offer similar products to its Cboe One Summary and Cboe One Premium Feeds on the same terms as the Exchange from a cost perspective. While the Cboe Equities Exchanges are the exclusive distributors of the individual data feeds from which certain data elements may be taken to create the Cboe One feeds, they are not the exclusive distributors of the aggregated and consolidated information that comprises the Cboe One feeds. Any entity that receives, or elects to receive, the individual data feeds would be able to, if it so chooses, to create a data feed with the same information included in either of the Cboe One feeds and sell and distribute it to its clients so that it could be received by those clients as quickly as the Cboe One feeds would be received by those same clients. Such entities would also not be assessed any greater fees by the Exchange than the Exchange assess for the Cboe One feeds (
                    <E T="03">i.e.,</E>
                     those who elect to distribute and consolidate the individual data fees and those who elect to distribute the Cboe One feeds will all be eligible for the proposed fee waivers offered by the Exchange).
                </P>
                <FTNT>
                    <P>
                        <SU>26</SU>
                         The Exchange notes that its Affiliates will also be proposing to adopt these same credits with the exception of the EDGA Top Data Feed as the External Distribution monthly cost is $0 for that particular data feed. 
                        <E T="03">See</E>
                         EDGA Equities Fees Schedule, Market Data Fees.
                    </P>
                </FTNT>
                <HD SOURCE="HD3">New External Distributor Credit</HD>
                <P>
                    The Exchange believes it is reasonable to not charge Uncontrolled External Distributors of an Applicable Feed(s) until such time they enlist one or more Users to receive the applicable feed as such Distributors will not be subject to the External Distribution Fees for the applicable product(s) during this period.
                    <SU>27</SU>
                    <FTREF/>
                     Additionally, the Exchange and its Affiliates offer a similar credit now that all External Distributors, including Controlled External Distributors, may receive.
                    <SU>28</SU>
                    <FTREF/>
                     The proposed credit is intended to incentivize new Uncontrolled External Distributors to enlist Users to subscribe to the Applicable Feeds in an effort to broaden the products' distribution to data feed Users. While this incentive is not available to Internal Distributors of these products, the Exchange believes it is appropriate as Internal Distributors have no Users outside of their own firm. Furthermore, External Distributors are subject to higher risks of launch as the data is provided outside their own firm. In contrast, Internal Distributors who only subscribe to a specific Exchange offered market data product when there is a need as they themselves are using the information, External Distributors do not use the data themselves, but as noted, take the risk of onboarding the data to sell as a service to downstream customers.
                    <SU>29</SU>
                    <FTREF/>
                     For these reasons, the Exchange believes it is appropriate, equitable and not unfairly discriminatory to provide additional incentives to External Distributors so they have sufficient time to test the data within their own systems prior to going live externally. As discussed above, the Exchange also believes it is appropriate to limit this specific credit to Uncontrolled External Distributors given the longer development times associated with both the integration of the data feed and onboarding Users.
                </P>
                <FTNT>
                    <P>
                        <SU>27</SU>
                         As noted above, Distributors may still receive this credit for any of the applicable feeds of which there are no Users (
                        <E T="03">i.e.,</E>
                         the Uncontrolled Distributor may still receive this credit for Cboe One Summary if there is a User subscribed for BZX Top).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>28</SU>
                         
                        <E T="03">See e.g.,</E>
                         EDGX Equities Exchange Fees Schedule, Market Data Fees.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>29</SU>
                         The Exchange notes that in addition to the existing New External Distributor Credit offered by it and its affiliates, other exchanges have offered similar waivers for external redistribution. 
                        <E T="03">See</E>
                         BZX Equities Exchange Fees Schedule, Market Data Fees and Securities Exchange Act Release No. 90407 (November 12, 2020), 85 FR 73570 (November 18, 2020 (SR-NYSE-2020-91).
                    </P>
                </FTNT>
                <HD SOURCE="HD3">Data Consolidation Fee</HD>
                <P>The Exchange believes it is reasonable to not charge Uncontrolled External Distributors of Cboe One Summary and Cboe One Premium a Data Consolidation Fee until such time they enlist one or more Users to receive the applicable feed as such Distributors will not be subject to the Data Consolidation Fee for the applicable product(s) during this period. For the avoidance of doubt, once an Uncontrolled External Distributor enlists its first User, this waiver will no longer be applicable—at no time will an Uncontrolled External Distributor receive this waiver while it has customers receiving the applicable data feed. As previously discussed, the Exchange believes the proposed Data Consolidation Fee Waiver for Uncontrolled External Distributors is not designed to permit unfair discrimination against Controlled External Distributors because of the longer lead times in the development Uncontrolled External Distributors experience. Further, as previously discussed, the Exchange believes only applying this to a subset of External Distributors and not any Internal Distributors is equitable and not unfairly discriminatory given the additional risk External Distributors assume when building out a product for which they have no existing use cases. Therefore, the Exchange believes the proposed application of the Data Consolidation Fee Waiver is reasonable and would not permit unfair discrimination.</P>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.</P>
                <P>
                    The proposed rule changes are grounded in the Exchange's efforts to compete more effectively and to assist in mitigating business costs (
                    <E T="03">i.e.,</E>
                     the costs associated with the development of data feeds and seeking Users to onboard for such data feeds) for Uncontrolled External Distributors. Further, as previously discussed, the Exchange believes the proposed Data Consolidation Fee Waiver for Uncontrolled External Distributors is not designed to permit unfair discrimination against Controlled External Distributors because of the longer lead times in the development Uncontrolled External Distributors experience. As a result, the Exchange believes this proposed rule change permits fair competition among national securities exchanges. Further, the Exchange believes that these changes will not cause any unnecessary or inappropriate burden on intermarket 
                    <PRTPAGE P="105669"/>
                    competition, as the proposed incentive program applies uniformly to all Uncontrolled External Distributors.
                </P>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>The Exchange neither solicited nor received comments on the proposed rule change.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>30</SU>
                    <FTREF/>
                     and paragraph (f) of Rule 19b-4 
                    <SU>31</SU>
                    <FTREF/>
                     thereunder. At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
                </P>
                <FTNT>
                    <P>
                        <SU>30</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>31</SU>
                         17 CFR 240.19b-4(f).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Solicitation of Comments</HD>
                <P>Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:</P>
                <HD SOURCE="HD2">Electronic Comments</HD>
                <P>
                    • Use the Commission's internet comment form (
                    <E T="03">https://www.sec.gov/rules/sro.shtml</E>
                    ); or
                </P>
                <P>
                    • Send an email to 
                    <E T="03">rule-comments@sec.gov.</E>
                     Please include file number SR-CboeBZX-2024-125 on the subject line.
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.</P>
                <FP>
                    All submissions should refer to file number SR-CboeBZX-2024-125. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (
                    <E T="03">https://www.sec.gov/rules/sro.shtml</E>
                    ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. Do not include personal identifiable information in submissions; you should submit only information that you wish to make available publicly. We may redact in part or withhold entirely from publication submitted material that is obscene or subject to copyright protection. All submissions should refer to file number SR-CboeBZX-2024-125 and should be submitted on or before January 17, 2025.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>32</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>Vanessa A. Countryman,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30905 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-102014; File No. SR-NYSEAMER-2024-78]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; NYSE American LLC; Notice of Filing of Proposed Change To Amend Certain Rules Related to Flexible Exchange Options</SUBJECT>
                <DATE>December 20, 2024.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) 
                    <SU>1</SU>
                    <FTREF/>
                     of the Securities Exchange Act of 1934 (“Act”) 
                    <SU>2</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>3</SU>
                    <FTREF/>
                     notice is hereby given that, on December 13, 2024, NYSE American LLC (“Exchange”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I, II, and III below, which Items have been prepared by the self-regulatory organization. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         15 U.S.C. 78s(b)(1).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         15 U.S.C. 78a.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         17 CFR 240.19b-4.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    The Exchange proposes to amend certain rules related to Flexible Exchange (“FLEX”) Options to permit FLEX Options on the Grayscale Bitcoin Trust (BTC) (“GBTC”). The proposed rule change is available on the Exchange's website at 
                    <E T="03">www.nyse.com,</E>
                     at the principal office of the Exchange, and at the Commission's Public Reference Room.
                </P>
                <HD SOURCE="HD1">II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change</HD>
                <P>In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.</P>
                <HD SOURCE="HD2">A. Self-Regulatory Organization's Statement of the Purpose of, and the Statutory Basis for, the Proposed Rule Change</HD>
                <HD SOURCE="HD3">1. Purpose</HD>
                <P>
                    FLEX Options are customized equity or index contracts that allow investors to tailor contract terms for exchange-listed equity and index options.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         A “FLEX Equity Option” is an option on a specified underlying equity security that is subject to the rules of Section 15. 
                        <E T="03">See</E>
                         Rule 900G(b)(10).
                    </P>
                </FTNT>
                <P>
                    GBTC is an Exchange-Traded Fund (or ETF) that holds bitcoin and is listed on NYSE Arca, Inc., the Exchange's affiliated equities exchange.
                    <SU>5</SU>
                    <FTREF/>
                     Recently, the Commission approved options trading on GBTC and, on November 22, 2024, the Exchange began trading GBTC options.
                    <SU>6</SU>
                    <FTREF/>
                     The position and exercise 
                    <PRTPAGE P="105670"/>
                    limits established for GBTC options is 25,000 contracts, the lowest limit available in options.
                    <SU>7</SU>
                    <FTREF/>
                     Additionally, GBTC options are currently not approved for FLEX trading.
                    <SU>8</SU>
                    <FTREF/>
                     Except for a few enumerated exceptions, FLEX Options are not subject to position limits.
                    <SU>9</SU>
                    <FTREF/>
                     The Exchange proposes to permit FLEX Equity Options on GBTC (“FLEX GBTC”) and to impose position limits on FLEX GBTC. As proposed, FLEX GBTC options would have the same 25,000-contract position limit as Non-FLEX Options on GBTC, and positions in FLEX GBTC will be aggregated with positions in Non-FLEX GBTC. In other words, the position limit for options on GBTC—both FLEX GBTX and non-FLEX GBTC—will be 25,000 contracts.
                    <SU>10</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         On January 11, 2024, GBTC began trading on NYSE Arca after the Commission approved rule changes to list and trade shares of “Bitcoin-Based Commodity-Based Trust Shares” pursuant to NYSE Arca Rule 8.201-E(c)(1) (Commodity-Based Trust Shares), including GBTC. 
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 99306 (January 10, 2024) (Order Granting Accelerated Approval of Proposed Rule Changes, as Modified by Amendments Thereto, to List and Trade Bitcoin-Based Commodity-Based Trust Shares and Trust Units), 89 FR 3008 (January 17, 2024) (SR-NYSEARCA-2021-90).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 101386 (October 18, 2024), 89 FR 84960 (October 24, 2024) (SR-NYSEAMER-2024-49) (Order approving the listing and trading of options on GBTC, among 
                        <PRTPAGE/>
                        other funds that hold bitcoin, pursuant to Rule 915, Commentary .10(a) (the “GBTC Options Approval Order”). 
                        <E T="03">See also</E>
                         Trader Update, November 21, 2024 (announcing that on November 22, 2024, the Exchange would begin listing and trading options on GBTC, among other funds that hold bitcoin), 
                        <E T="03">available here, https://www.nyse.com/trader-update/history#110000945911.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         Rule 904, Commentary .07(f). The Exchange notes that this 25,000-contract exercise and position limit applies to all options on ETFs the hold bitcoin. 
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">See</E>
                         Rule 903G(a)(1) (excluding GBTC from the general principle that the Exchange may approve and open for trading any FLEX Equity Options series on any equity security that is eligible for Non-FLEX Options trading, “except those set forth in Commentary .10(a) to Rule 915”, which includes GBTC).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         Rule 906G(b) (subject to the exceptions enumerated in the rule “there shall be no position limits for FLEX Equity options.”)
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See</E>
                         proposed Rules 903G(a)(1) (excepting GBTC from the prohibition of FLEX trading) and 906G(b)(iv) (providing that position limits for FLEX GBTC “will be the same as Non-FLEX Options on GBTC, as set forth in Rule 906G, Commentary .07(f), except that positions in FLEX GBTC shall be aggregated with positions in Non-FLEX GBTC for the purpose of calculating position limits.”). The Exchange notes there is precedent for aggregating position limits of FLEX options with non-FLEX options for purposes of calculating position limits. 
                        <E T="03">See</E>
                         Rule 906G(b)(iii) (proving that “FLEX ByRDs [Binary Return Derivatives] shall be the same as Non-FLEX ByRDs, as set forth in Rule 904ByRDs(a), except that positions in FLEX ByRDs shall be aggregated with positions in Non-FLEX ByRDs on the same or similar underlying (`comparable Non-FLEX ByRDs') for the purpose of calculating position limits.”).
                    </P>
                </FTNT>
                <P>
                    Per the Commission “rules regarding position and exercise limits are intended to prevent the establishment of options positions that can be used or might create incentives to manipulate or disrupt the underlying market so as to benefit the options positions.” 
                    <SU>11</SU>
                    <FTREF/>
                     For this reason, the Commission requires that “position and exercise limits must be sufficient to prevent investors from disrupting the market for the underlying security by acquiring and exercising a number of options contracts disproportionate to the deliverable supply and average trading volume of the underlying security.” 
                    <SU>12</SU>
                    <FTREF/>
                     Based on its review of the data and analysis provided by the Exchange, the Commission concluded that the 25,000-contract position limit for non-FLEX GBTC options satisfied these objectives.
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See supra</E>
                         note 6, GBTC Options Approval Order, 89 FR 84971.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See id.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See id.</E>
                         (noting that the Commission considered and reviewed the Exchange's analysis that, based on the number of GBTC shares outstanding as of August 30th, “if 114 market participants had 25,000 same side positions in options on GBTC, each of them would have to simultaneously exercise all of those options to create a scenario that may put the underlying security under stress.”).
                    </P>
                </FTNT>
                <P>As proposed, the Exchange will aggregate position (and exercise) limits for all GBTC options, thus limiting positions for options on all GBTC options—FLEX and non-FLEX—to 25,000 contracts. This proposed aggregated limit effectively restricts a market participant from holding positions that could result in the receipt of more than 2,500,000 shares, aggregated for FLEX GBTC and non-FLEX GBTC (if that market participant exercised all its GBTC options). The Exchange believes that capping the aggregated position limit at 25,000 contracts, the lowest limit available in options, would be sufficient to address concerns related to manipulation and the protection of investors. The Exchange notes that this number is conservative for GBTC and therefore appropriate given its liquidity.</P>
                <P>
                    While the Exchange proposes an aggregated 25,000-contract position limit for all GBTC options, it nonetheless believes that, for the reasons set forth below, evidence exists to support a much higher position limit.
                    <SU>14</SU>
                    <FTREF/>
                     For example, GBTC currently qualifies for the 250,000-contract position limit available to other ETFs pursuant to the criteria in Rule 904, Commentary .07(a)(i), which requires that, for the most recent six-month period, trading volume for the underlying security be at least 100,000,000 shares.
                    <SU>15</SU>
                    <FTREF/>
                     As of September 30, 2024, GBTC had traded 723,758,100 shares during the six-month period from March 30, 2024 to September 30, 2024, well above the requisite minimum of 100,000,000 shares necessary to qualify for the 250,000-contract position limit. By comparison, other options symbols with six-month trading volume less than GBTC are currently eligible and do in fact have position and exercise limits of at least 250,000 contracts.
                    <SU>16</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         The Exchange may file a subsequent rule change to increase the position and exercise limit for options on GBTC based on additional data regarding trading activity, to continue to balance any concerns regarding manipulation. A higher position limit would allow institutional investors to utilize GBTC options for prudent risk management purposes. In this regard, the Exchange would address the impact of higher position (and exercise) limits on the proposed FLEX GBTC options.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         Per Commentary .07(a) to Rule 904, to qualify for the 250,000-contract position limit for options, the underlying security must (i) have trading volume of at least 100,000,000 shares during the most recent six-month trading period; or (ii) have trading volume of at least 75,000,000 shares during the most recent six-month trading period 
                        <E T="03">and</E>
                         have at least 300,000,000 shares currently outstanding.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See https://www.theocc.com/Market-Data/Market-Data-Reports/Series-and-Trading-Data/Series-Search</E>
                         (including the following symbols that have a position limit of 250,000: GLD, IAU, SLV, SIVR, SGOL).
                    </P>
                </FTNT>
                <P>Further, the Exchange believes that the share creation and redemption process unique to ETFs would mitigate any potential risk of manipulation in FLEX trading in GBTC options. The creation and redemption process is designed to ensure that an ETF's price closely tracks the value of its underlying asset(s). For example, if a market participant exercised a long call position for 25,000 contracts and purchased 2,500,000 shares of GBTC and this purchase resulted in the value of GBTC shares to trade at a premium to the value of the (underlying) bitcoin held by GBTC, the Exchange believes that other market participants would attempt to arbitrage this price difference by selling short GBTC shares while concurrently purchasing bitcoin. Those market participants (arbitrageurs) would then deliver cash to GBTC and receive shares of GBTC, which would be used to close out any previously established short position in GBTC. Thus, this creation and redemptions process would significantly reduce the potential risk of price dislocation between the value of GBTC shares and the value of bitcoin holdings.</P>
                <P>
                    The Exchange understands that FLEX Options on ETFs are currently traded in the over-the-counter (“OTC”) market by a variety of market participants, 
                    <E T="03">e.g.,</E>
                     hedge funds, proprietary trading firms, and pension funds, to name a few. The Exchange believes there is room for significant growth if a comparable product were introduced for trading on a regulated market. The Exchange expects that users of these OTC products would be among the primary users of FLEX GBTC options. The Exchange also believes that the trading of FLEX GBTC options would allow these same market participants to better manage the risk associated with the volatility of GBTC (the underlying ETF) positions given the enhanced liquidity that an exchange-traded product would bring.
                </P>
                <P>
                    Additionally, the Exchange believes that FLEX GBTC options traded on the Exchange would have three important 
                    <PRTPAGE P="105671"/>
                    advantages over the contracts that are traded in the OTC market. First, as a result of greater standardization of contract terms, exchange-traded contracts should develop more liquidity. Second, counter-party credit risk would be mitigated by the fact that the contracts are issued and guaranteed by The Options Clearing Corporation (“OCC”). Finally, the price discovery and dissemination provided by the Exchange and its members would lead to more transparent markets. The Exchange believes that its ability to offer FLEX GBTC options would aid it in competing with the OTC market and at the same time expand the universe of products available to interested market participants. The Exchange believes that an exchange-traded alternative may provide a useful risk management and trading vehicle for market participants and their customers.
                </P>
                <P>The Exchange has analyzed its capacity and represents that it and The Options Price Reporting Authority (“OPRA”) have the necessary systems capacity to handle the additional traffic associated with the listing of FLEX GBTC options. The Exchange believes any additional traffic that would be generated from the trading of FLEX GBTC options would be manageable. The Exchange believes ATP Holders will not have a capacity issue as a result of this proposed rule change. The Exchange also represents that it does not believe this proposed rule change will cause fragmentation of liquidity. The Exchange will monitor the trading volume associated with the additional options series listed as a result of this proposed rule change and the effect (if any) of these additional series on market fragmentation and on the capacity of the Exchange's automated systems.  </P>
                <P>
                    The Exchange represents that the same surveillance procedures applicable to the Exchange's other options products listed and traded on the Exchange, including non-FLEX GBTC options, will apply to FLEX GBTC options, and that it has the necessary systems capacity to support such options. FLEX options products (and their respective symbols) are integrated into the Exchange's existing surveillance system architecture and are thus subject to the relevant surveillance processes. The Exchange's market surveillance staff (including staff of the Financial Industry Regulatory Authority (“FINRA”) who perform surveillance and investigative work on behalf of the Exchange pursuant a regulatory services agreement) conducts surveillances with respect to GBTC (the underlying ETF) and, as appropriate, would review activity in GBTC when conducting surveillances for market abuse or manipulation in the FLEX GBTC options.
                    <SU>17</SU>
                    <FTREF/>
                     The Exchange does not believe that allowing FLEX GBTC options would render the marketplace for non-FLEX GBTC options, or equity options in general, more susceptible to manipulative practices.
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See supra</E>
                         note 6, GBTC Options Approval Order, 89 FR at 84966-68 (regarding surveillance procedures applicable to GBTC and other funds that hold bitcoin).
                    </P>
                </FTNT>
                <P>
                    The Exchange represents that its existing trading surveillances are adequate to monitor the trading in GBTC and subsequent trading of FLEX GBTC options on the Exchange. Additionally, the Exchange is a member of the Intermarket Surveillance Group (“ISG”) under the Intermarket Surveillance Group Agreement. ISG members work together to coordinate surveillance and investigative information sharing in the stock, options, and futures markets. For surveillance purposes, the Exchange would therefore have access to information regarding trading activity in the pertinent underlying securities. In addition, and as referenced above, the Exchange has a regulatory services agreement with FINRA, pursuant to which FINRA conducts certain surveillances on behalf of the Exchange. Further, pursuant to a multi-party 17d-2 joint plan, all options exchanges allocate regulatory responsibilities to FINRA to conduct certain options-related market surveillances.
                    <SU>18</SU>
                    <FTREF/>
                     The Exchange will implement any additional surveillance procedures it deems necessary to effectively monitor the trading of GBTC options.
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         Section 19(g)(1) of the Act, among other things, requires every SRO registered as a national securities exchange or national securities association to comply with the Act, the rules and regulations thereunder, and the SRO's own rules, and, absent reasonable justification or excuse, enforce compliance by its members and persons associated with its members. 
                        <E T="03">See</E>
                         15 U.S.C. 78q(d)(1) and 17 CFR 240.17d-2. Section 17(d)(1) of the Act allows the Commission to relieve an SRO of certain responsibilities with respect to members of the SRO who are also members of another SRO. Specifically, Section 17(d)(1) allows the Commission to relieve an SRO of its responsibilities to: (i) receive regulatory reports from such members; (ii) examine such members for compliance with the Act and the rules and regulations thereunder, and the rules of the SRO; or (iii) carry out other specified regulatory responsibilities with respect to such members.
                    </P>
                </FTNT>
                <P>The proposed rule change is designed to allow investors seeking to trade options on GBTC to utilize FLEX GBTC options. The Exchange believes that offering innovative products flows to the benefit of the investing public. A robust and competitive market requires that exchanges respond to member's evolving needs by constantly improving their offerings. Such efforts would be stymied if exchanges were prohibited from offering innovative products such as the proposed FLEX GBTC options. The Exchange believes that introducing FLEX GBTC options would further broaden the base of investors that use FLEX Options (and options on GBTC in general) to manage their trading and investment risk, including investors that currently trade in the OTC market for customized options. The proposed rule change is also designed to encourage market makers to shift liquidity from the OTC market on the Exchange, which, it believes, will enhance the process of price discovery conducted on the Exchange through increased order flow.</P>
                <P>Finally, as discussed herein, the Exchange does not believe that this proposed rule change raises any unique regulatory concerns because the proposal to aggregate FLEX and non-FLEX GBTC options at the (most conservative) 25,000-contract limit, which currently applies solely to non-FLEX GBTC options, should provide an adequate safeguard.</P>
                <HD SOURCE="HD3">Implementation</HD>
                <P>The Exchange will announce the implementation date by Trader Update within sixty (60) days of the rule approval.</P>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes that its proposal is consistent with Section 6(b) of the Securities Exchange Act of 1934 (the “Act”),
                    <SU>19</SU>
                    <FTREF/>
                     in general, and furthers the objectives of Section 6(b)(5) of the Act,
                    <SU>20</SU>
                    <FTREF/>
                     in particular, in that it is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Specifically, the Exchange believes that introducing FLEX GBTC options will increase order flow to the Exchange, increase the variety of options products available for trading, and provide a valuable tool for investors to manage risk. The proposed rule change is designed to allow investors seeking to trade options on GBTC to utilize FLEX GBTC options.
                </P>
                <FTNT>
                    <P>
                        <SU>19</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>20</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <P>
                    The Exchange believes that the proposal to permit FLEX GBTC options would remove impediments to and perfect the mechanism of a free and open market. The Exchange believes that offering FLEX GBTC options will benefit investors by providing them 
                    <PRTPAGE P="105672"/>
                    with an additional, relatively lower cost investing tool to gain exposure to the price of bitcoin and provide a hedging vehicle to meet their investment needs in connection with a bitcoin-related product. Moreover, the proposal would broaden the base of investors that use FLEX Options to manage their trading and investment risk, including investors that currently trade in the OTC market for customized options. By trading a product in an exchange-traded environment (that is currently being used in the OTC market), the Exchange would be able to compete more effectively with the OTC market. The Exchange believes the proposed rule change is designed to prevent fraudulent and manipulative acts and practices in that it would lead to the migration of options currently trading in the OTC market to trading to the Exchange. Also, any migration to the Exchange from the OTC market would result in increased market transparency and enhance the process of price discovery conducted on the Exchange through increased order flow. The Exchange also believes that offering FLEX GBTC options may open up the market for options on GBTC to more retail investors.
                </P>
                <P>Additionally, the Exchange believes the proposed rule change is designed to remove impediments to and to perfect the mechanism for a free and open market and a national market system, and, in general, to protect investors and the public interest in that it should create greater trading and hedging opportunities and flexibility. The proposed rule change should also result in enhanced efficiency in initiating and closing out positions and heightened contra-party creditworthiness due to the role of OCC as issuer and guarantor of FLEX GBTC options. Further, the proposed rule change would result in increased competition by permitting the Exchange to offer products that are currently used in the OTC market.</P>
                <P>The Exchange does not believe that this proposed rule change raises any unique regulatory concerns because the proposal to aggregate FLEX and non-FLEX GBTC options at the (most conservative) 25,000-contract limit should provide an adequate safeguard. The purpose of position limits is to address potential manipulative schemes and adverse market impacts surrounding the use of options, such as disrupting the market in the security underlying the options. The Exchange believes the proposal will benefit investors and public interest because the aggregated position limit for all options on GBTC (FLEX and non-FLEX) at 25,000 contracts, the lowest limit available in options, would address concerns related to manipulation and protection of investors as this number is conservative for GBTC and therefore appropriate given its liquidity.</P>
                <P>The Exchange believes that offering innovative products flows to the benefit of the investing public. A robust and competitive market requires that exchanges respond to member's evolving needs by constantly improving their offerings. Such efforts would be stymied if exchanges were prohibited from offering innovative products such as the proposed FLEX GBTC options. The Exchange does not believe that allowing FLEX GBTC options would render the marketplace for equity options more susceptible to manipulative practices.</P>
                <P>
                    Finally, the Exchange represents that it has an adequate surveillance program in place to detect manipulative trading in FLEX GBTC options. Regarding the proposed FLEX GBTC options, the Exchange would use the same surveillance procedures currently utilized for FLEX Options listed on the Exchange (as well as for non-FLEX GBTC options). For surveillance purposes, the Exchange would have access to information regarding trading activity in GBTC (the underlying ETF).
                    <SU>21</SU>
                    <FTREF/>
                     In light of surveillance measures related to both options and GBTC (the underlying ETF), the Exchange believes that existing surveillance procedures are designed to deter and detect possible manipulative behavior which might potentially arise from listing and trading the proposed FLEX GBTC options.
                </P>
                <FTNT>
                    <P>
                        <SU>21</SU>
                         
                        <E T="03">See supra</E>
                         note 6, GBTC Options Approval Order, 89 FR at 84966-68 (regarding surveillance procedures applicable to GBTC and other funds that hold bitcoin).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">B. Self-Regulatory Organization's Statement on Burden on Competition</HD>
                <P>The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.</P>
                <P>
                    <E T="03">Intra-market competition.</E>
                     The Exchange does not believe that its proposed rule change will impose any burden on intra-market competition as all market participants would have the option of utilizing the FLEX GBTC options. The proposed rule change is designed to allow investors seeking option exposure to bitcoin to trade FLEX GBTC options. Moreover, the Exchange believes that the proposal to permit FLEX GBTC options would broaden the base of investors that use FLEX Options to manage their trading and investment risk, including investors that currently trade in the OTC market for customized options.
                </P>
                <P>
                    <E T="03">Inter-market competition.</E>
                     The Exchange does not believe that its proposed rule change will impose any burden on inter-market competition as all market participants would have the option of utilizing the FLEX GBTC options. The Exchange notes that it operates in a highly competitive market in which market participants can readily direct order flow to competing venues. The proposed rule change would support that intermarket competition by allowing the Exchange to offer additional functionality to ATP Holders. The Exchange believes that the proposed FLEX GBTC options will increase the variety of options products available for trading in general and bitcoin-related products in particular and, as such, will provide a valuable tool for investors to manage risk.
                </P>
                <P>As such, the Exchange believes that this proposal does not create an undue burden on intermarket competition. Rather, the Exchange believes that the proposed rule would bolster intermarket competition by promoting fair competition among individual markets. The Exchange notes that, upon approval of this proposal, competing options exchanges will be free to offer products like the proposed FLEX GBTC options.</P>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>No written comments were solicited or received with respect to the proposed rule change.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    Within 45 days of the date of publication of this notice in the 
                    <E T="04">Federal Register</E>
                     or within such longer period up to 90 days (i) as the Commission may designate if it finds such longer period to be appropriate and publishes its reasons for so finding or (ii) as to which the self-regulatory organization consents, the Commission will:
                </P>
                <P>(A) by order approve or disapprove the proposed rule change, or</P>
                <P>(B) institute proceedings to determine whether the proposed rule change should be disapproved.</P>
                <HD SOURCE="HD1">IV. Solicitation of Comments</HD>
                <P>
                    Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
                    <PRTPAGE P="105673"/>
                </P>
                <HD SOURCE="HD2">Electronic Comments</HD>
                <P>
                    • Use the Commission's internet comment form (
                    <E T="03">https://www.sec.gov/rules/sro.shtml</E>
                    ); or
                </P>
                <P>
                    • Send an email to 
                    <E T="03">rule-comments@sec.gov.</E>
                     Please include file number SR-NYSEAMER-2024-78 on the subject line.
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.</P>
                <FP>
                    All submissions should refer to file number SR-NYSEAMER-2024-78. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (
                    <E T="03">https://www.sec.gov/rules/sro.shtml</E>
                    ). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. Do not include personal identifiable information in submissions; you should submit only information that you wish to make available publicly. We may redact in part or withhold entirely from publication submitted material that is obscene or subject to copyright protection. All submissions should refer to file number SR-NYSEAMER-2024-78 and should be submitted on or before January 17, 2025.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>22</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-31090 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[SEC File No. 270-789, OMB Control No. 3235-0731]</DEPDOC>
                <SUBJECT>Proposed Collection; Comment Request; Extension for Generic ICR: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery</SUBJECT>
                <FP SOURCE="FP-1">
                    <E T="03">Upon Written Request Copies Available From:</E>
                     Securities and Exchange Commission, Office of FOIA Services, 100 F Street NE, Washington, DC 20549-2736.
                </FP>
                <P>
                    Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ), the Securities and Exchange Commission (“Commission”) is soliciting comments on the collection of information summarized below. The Commission plans to submit this existing collection of information to the Office of Management and Budget for extension and approval.
                </P>
                <P>The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Commission's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the SEC and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.</P>
                <P>Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.</P>
                <P>Below is the projected average annual estimates each year for the next three years:</P>
                <P>
                    <E T="03">Expected Annual Number of activities:</E>
                     20.
                </P>
                <P>
                    <E T="03">Respondents:</E>
                     30,000.
                </P>
                <P>
                    <E T="03">Annual responses:</E>
                     30,000.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     Once per request.
                </P>
                <P>
                    <E T="03">Average minutes per response:</E>
                     10.
                </P>
                <P>
                    <E T="03">Annual burden hours:</E>
                     5,000.
                </P>
                <P>Written comments are invited on: (a) whether this proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden imposed by the collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication by February 25, 2025.</P>
                <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.</P>
                <P>
                    Please direct your written comment to Austin Gerig, Director/Chief Data Officer, Securities and Exchange Commission, c/o Tanya Ruttenberg, 100 F Street NE, Washington, DC 20549 or send an email to: 
                    <E T="03">PRA_Mailbox@sec.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: December 20, 2024.</DATED>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Deputy Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-30986 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SMALL BUSINESS ADMINISTRATION</AGENCY>
                <DEPDOC>[Disaster Declaration #20720 and #20721; NORTH CAROLINA Disaster Number NC-20009]</DEPDOC>
                <SUBJECT>Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of North Carolina</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Small Business Administration.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Amendment 2.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of North Carolina (FEMA-4827-DR), dated October 2, 2024.
                        <PRTPAGE P="105674"/>
                    </P>
                    <P>
                        <E T="03">Incident:</E>
                         Tropical Storm Helene.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Issued on December 18, 2024.</P>
                    <P>
                        <E T="03">Incident Period:</E>
                         September 25, 2024 and continuing.
                    </P>
                    <P>
                        <E T="03">Physical Loan Application Deadline Date:</E>
                         January 20, 2025.
                    </P>
                    <P>
                        <E T="03">Economic Injury (EIDL) Loan Application Deadline Date:</E>
                         July 2, 2025.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        <E T="03">Visit the MySBA Loan Portal at https://lending.sba.gov</E>
                         to apply for a disaster assistance loan.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Alan Escobar, Office of Disaster Recovery &amp; Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of North Carolina, dated October 2, 2024, is hereby amended to extend the deadline for filing applications for physical damages as a result of this disaster to January 20, 2025. This notice is further amended to include the following areas as adversely affected by the disaster.</P>
                <FP SOURCE="FP-2">
                    <E T="03">Primary Counties:</E>
                </FP>
                <FP SOURCE="FP1-2">Surry, Yadkin.</FP>
                <P>All other information in the original declaration remains unchanged. </P>
                <EXTRACT>
                    <FP>(Catalog of Federal Domestic Assistance Number 59008)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Alejandro Contreras,</NAME>
                    <TITLE>Acting Deputy Associate Administrator, Office of Disaster Recovery &amp; Resilience.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30922 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8026-09-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SOCIAL SECURITY ADMINISTRATION</AGENCY>
                <DEPDOC>[Docket No. SSA-2024-0047]</DEPDOC>
                <SUBJECT>Notice on Penalty Inflation Adjustments for Civil Monetary Penalties</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Social Security Administration.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice announcing updated penalty inflation adjustments for civil monetary penalties for 2025.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Social Security Administration is giving notice of its updated maximum civil monetary penalties. These amounts are effective from January 15, 2025, through January 14, 2026. These figures represent an annual adjustment for inflation. The updated figures and notification are required by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jessica Stubbs Platt, Deputy Counsel to the Inspector General, Room 3-ME-1, 6401 Security Boulevard, Baltimore, MD 21235-6401, (410) 816-4054. For information on eligibility or filing for benefits, call the Social Security Administration's national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or visit the Social Security Administration's internet site, Social Security Online, at 
                        <E T="03">http://www.socialsecurity.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On June 27, 2016, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act),
                    <SU>1</SU>
                    <FTREF/>
                     we published an interim final rule to adjust the level of civil monetary penalties (CMPs) under sections 1129 and 1140 of the Social Security Act, 42 U.S.C. 1320a-8 and 1320b-10, respectively, with an initial “catch-up” adjustment effective August 1, 2016.
                    <SU>2</SU>
                    <FTREF/>
                     We announced in the interim final rule that for any future adjustments, we would publish a notice in the 
                    <E T="04">Federal Register</E>
                     to announce the new amounts. The annual inflation adjustment in subsequent years must be a cost-of-living adjustment based on any increases in the October Consumer Price Index for All Urban Consumers (CPI-U) (not seasonally adjusted) each year.
                    <SU>3</SU>
                    <FTREF/>
                     Inflation adjustment increases must be rounded to the nearest multiple of $1.
                    <SU>4</SU>
                    <FTREF/>
                     We last updated the maximum penalty amounts effective January 15, 2024.
                    <SU>5</SU>
                    <FTREF/>
                     Based on Office of Management and Budget (OMB) guidance,
                    <SU>6</SU>
                    <FTREF/>
                     the information below serves as public notice of the new maximum penalty amounts for 2025. The adjustment results in the following new maximum penalties, which will be effective as of January 15, 2025.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See https://www.congress.gov/bill/114th-congress/house-bill/1314/text.</E>
                          
                        <E T="03">See also</E>
                         81 FR 41438, 
                        <E T="03">https://www.federalregister.gov/documents/2016/06/27/2016-13241/penalty-inflation-adjustments-for-civil-money-penalties.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See</E>
                         81 FR 41438, 
                        <E T="03">https://www.federalregister.gov/documents/2016/06/27/2016-13241/penalty-inflation-adjustments-for-civil-money-penalties.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">See</E>
                         OMB Memorandum, Implementation of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, M-16-06, p. 1 (February 24, 2016), 
                        <E T="03">https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/memoranda/2016/m-16-06.pdf.</E>
                          
                        <E T="03">See also</E>
                         81 FR 41438, 
                        <E T="03">https://www.federalregister.gov/documents/2016/06/27/2016-13241/penalty-inflation-adjustments-for-civil-money-penalties.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         OMB Memorandum, Implementation of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, M-16-06, p. 3 (February 24, 2016), 
                        <E T="03">https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/memoranda/2016/m-16-06.pdf. See also</E>
                         81 FR 41438, 
                        <E T="03">https://www.federalregister.gov/documents/2016/06/27/2016-13241/penalty-inflation-adjustments-for-civil-money-penalties.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See</E>
                         89 FR 1973, 
                        <E T="03">https://www.federalregister.gov/documents/2024/01/11/2024-00408/notice-on-penalty-inflation-adjustments-for-civil-monetary-penalties.</E>
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         OMB Memorandum, Implementation of Penalty Inflation Adjustments for 2025, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, M-25-02, p. 2 (December 17, 2024), 
                        <E T="03">https://www.whitehouse.gov/wp-content/uploads/2024/12/M-25-02.pdf.</E>
                    </P>
                </FTNT>
                <P>Section 1129 CMPs (42 U.S.C. 1320a-8):</P>
                <EXTRACT>
                    <P>$9,704.00 (current maximum per violation for fraud facilitators in a position of trust) x 1.02598 (OMB-issued inflationary adjustment multiplier) = $9,956.11. When rounded to the nearest dollar, the new maximum penalty is $9,956.</P>
                    <P>$10,289.00 (current maximum per violation for all other violators) × 1.02598 (OMB-issued inflationary adjustment multiplier) = $10,556.31. When rounded to the nearest dollar, the new maximum penalty is $10,556.</P>
                </EXTRACT>
                <P>Section 1140 CMPs (42 U.S.C. 1320b-10):</P>
                <EXTRACT>
                    <P>$12,799.00 (current maximum per violation for all violations other than broadcast or telecasts) × 1.02598 (OMB-issued inflationary adjustment multiplier) = $13,131.52. When rounded to the nearest dollar, the new maximum penalty is $13,132.</P>
                    <P>$63,991.00 (current maximum per violative broadcast or telecast) × 1.02598 (OMB-issued inflationary adjustment multiplier) = $65,653.49. When rounded to the nearest dollar, the new maximum penalty is $65,653.</P>
                </EXTRACT>
                <SIG>
                    <NAME>Michelle Murray,</NAME>
                    <TITLE>Chief Counsel, Office of the Inspector General, Social Security Administration.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30791 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4191-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF STATE</AGENCY>
                <DEPDOC>[Public Notice: 12617]</DEPDOC>
                <SUBJECT>Notice of Determinations; Culturally Significant Objects Being Imported for Exhibition—Determinations: “Edvard Munch: Technically Speaking” Exhibition</SUBJECT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to an agreement with their foreign owner or custodian for temporary display in the exhibition “Edvard Munch: Technically Speaking” at the Harvard Art Museums, Cambridge, Massachusetts, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                </SUM>
                <FURINF>
                    <PRTPAGE P="105675"/>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Reed Liriano, Program Coordinator, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email: 
                        <E T="03">section2459@state.gov</E>
                        ). The mailing address is U.S. Department of State, L/PD, 2200 C Street NW (SA-5), Suite 5H03, Washington, DC 20522-0505.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, 
                    <E T="03">et seq.;</E>
                     22 U.S.C. 6501 note, 
                    <E T="03">et seq.</E>
                    ), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000, and Delegation of Authority No. 523 of December 22, 2021.
                </P>
                <SIG>
                    <NAME>Nicole L. Elkon,</NAME>
                    <TITLE>Deputy Assistant Secretary for Professional and Cultural Exchanges, Bureau of Educational and Cultural Affairs, Department of State.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30946 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4710-05-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Motor Carrier Safety Administration</SUBAGY>
                <DEPDOC>[Docket No. FMCSA-2023-0071]</DEPDOC>
                <SUBJECT>Parts and Accessories Necessary for Safe Operation; Application for an Exemption From Waymo LLC (USDOT #3000336) and Aurora Operations, Inc. (USDOT #3441156)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of final disposition; denial of exemption.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Federal Motor Carrier Safety Administration (FMCSA or the Agency) publishes its decision to deny an application from Waymo LLC (Waymo, USDOT #3000336) and Aurora Operations, Inc. (Aurora, USDOT #3441156) (together, Applicants), requesting an exemption from certain Federal Motor Carrier Safety Regulations (FMCSRs) related to requirements to place specific types of warning devices at prescribed locations around commercial motor vehicles (CMVs) stopped on the traveled portion or shoulder of a highway for any cause other than necessary traffic stops and requirements that lamps on CMVs be steady burning. Applicants requested that they and “other similarly situated companies” be permitted to instead use “Cab-Mounted Warning Beacons” (including “variants” and “any configuration of similar effectiveness”) when the CMV is operated by a Level 4 Automated Driving System (ADS) either without a human on board or with a human on board when testing the warning beacons. Safety is FMCSA's highest priority. The Agency embraces USDOT's Innovation Principles, including adapting as technology changes and supporting technologies that further our policy goals. While the application and the public comments show promise for alternative warning devices to provide safety benefits for warning motorists of a stopped CMV under certain conditions, the present application does not demonstrate how Applicants or other proposed exempted parties would ensure an equivalent or greater level of safety than would be achieved absent the exemption. The application does not provide sufficient details about proposed alternative devices, and the limited data presented does not support a likely equivalent level of safety for a national, industry-wide exemption for all companies operating autonomous CMVs. If Applicants can reasonably address the reasons for the denial, Applicants may resubmit an exemption application.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Mr. David Sutula, Vehicle and Roadside Operations Division, Office of Carrier, Driver, and Vehicle Safety, FMCSA; 1200 New Jersey Avenue SE, Washington, DC 20590-0001; (202) 366-9209; 
                        <E T="03">MCPSV@dot.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Viewing Comments and Documents</HD>
                <P>
                    To view comments, go to 
                    <E T="03">www.regulations.gov,</E>
                     insert the docket number “FMCSA-2023-0071” in the keyword box, and click “Search.” Next, sort the results by “Posted (Newer-Older),” choose the first notice listed, click “Browse Comments.”
                </P>
                <P>
                    To view documents mentioned in this notice as being available in the docket, go to 
                    <E T="03">www.regulations.gov,</E>
                     insert the docket number “FMCSA-2023-0071” in the keyword box, click “Search,” and choose the document to review.
                </P>
                <P>If you do not have access to the internet, you may view the docket online by visiting Dockets Operations on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m. ET, Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.</P>
                <HD SOURCE="HD1">II. Legal Basis</HD>
                <P>FMCSA has authority to grant exemptions from FMCSRs where the Agency finds that “such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption.” 49 U.S.C. 31136(e); 49 U.S.C. 31315(b)(1).</P>
                <P>An exemption application must provide specific information relevant to the scope of the exemption sought including, but not limited to, the provisions from which the person requests exemption, the reason the exemption is needed, the time period during which the requested exemption would apply, an analysis of the safety impacts the requested exemption may cause, and the specific countermeasures the person would undertake to ensure an equivalent or greater measure of safety than would be achieved absent the requested exemption. 49 U.S.C. 31315(b)(5); 49 CFR 381.310.</P>
                <P>
                    Upon receipt of an exemption request, FMCSA must publish a notice of the request in the 
                    <E T="04">Federal Register</E>
                     and provide the public an opportunity to inspect the applicant's safety analysis and any other relevant information known to the Agency, and to comment on the request. See 49 U.S.C. 31315(b)(6)(A); 49 CFR 381.315(a). The Agency reviews the application and any public comments submitted and determines whether to grant or deny the request. 49 CFR 381.315(b). The Agency must publish its decision in the 
                    <E T="04">Federal Register</E>
                    . Id. If the request is granted, the decision will identify the name of the person or class of persons granted the exemption, the provisions from which the person is exempt, the effective period, and the terms and conditions of the exemption. 49 U.S.C. 31315(b)(6)(B); 49 CFR 381.315(c)(1). If the request is denied, the Agency will publish the name of the person denied the exemption and the reasons for such denial. 49 U.S.C. 31315(b)(6)(C); 49 CFR 381.315(c)(2). A granted exemption may be renewed, upon request, for subsequent 5-year periods. 49 U.S.C. 31315(b)(2); 49 CFR 381.300(b). If an exemption request is denied, and the applicant can reasonably address the reason for the denial, the Agency may allow the applicant to resubmit the application. 49 U.S.C. 31315(b)(3); 49 CFR 381.317.
                    <PRTPAGE P="105676"/>
                </P>
                <HD SOURCE="HD1">III. Background</HD>
                <HD SOURCE="HD2">A. Current Regulatory Requirements Under the FMCSRs</HD>
                <P>Applicants request an exemption from certain FMCSRs related to requirements for placing warning devices around a stopped CMV, requirements that exterior lamps be steady burning, and requirements that specific types of warning devices be used.</P>
                <P>
                    The applicable FMCSRs require the driver of a CMV stopped on the traveled portion or the shoulder of a road for any cause other than a necessary traffic stop to activate hazard warning signal flashers and place required warning devices as soon as possible but within ten minutes, at specified locations behind and in front of the stopped CMV. 49 CFR 392.22(b). They also specify placement of warning devices in certain circumstances, such as during daylight hours, or where devices may be obstructed from view (
                    <E T="03">e.g.,</E>
                     when stopped within 500 feet of a curve or the crest of a hill). Id.
                </P>
                <P>The FMCSRs also require that all exterior lamps be steady burning, with exceptions not relevant here. 49 CFR 393.25(e).</P>
                <P>Finally, the FMCSRs specify the types and number of warning devices to be used for stopped vehicles, namely 3 bidirectional emergency reflective triangles, or at least 6 fusees or 3 liquid-burning flares. Other warning devices may be used in addition to required devices, as long as they do not reduce the effectiveness of required devices. 49 CFR 393.95(f).  </P>
                <HD SOURCE="HD2">B. Applicants' Requested Exemption</HD>
                <P>Applicants request an exemption on behalf of themselves and “similarly situated companies” from requirements of 49 CFR 392.22(b), 393.25(e), and 393.95(f). Application (App.) at 1. They request that CMVs operated by a Level 4 ADS be permitted to use “Cab-Mounted Warning Beacons” instead of FMCSR-specified warning devices when the vehicles are operating either without a human on board, or with a human on board when testing the warning beacons. Id.</P>
                <P>Applicants define Cab-Mounted Warning Beacons as “cab-mounted warning devices, consisting of both forward- and rearward-facing amber flashing lights mounted at a height above the upper edge of the sideview mirrors.” App. at 2. The proposed warning beacons are amber colored and meet certain Society of Automotive Engineers (SAE) requirements. Id. at 7-8. These warning beacons would “flash at a different rate than the required hazard warning signal flashers to increase conspicuity of the stopped CMV,” which Applicants contend would not interfere with or impair the effectiveness of hazard warning signal flashers. Id. at 11. Applicants propose that at least one rearward-facing light be mounted on each side of the cab “at some point on or above the upper edge of the sideview mirrors and below the top edge of the cab,” and that at least one forward-facing light be mounted “similarly high” on the front of the cab. Id. at 9-10. Applicants provide a diagram illustrating areas where the beacons “could be mounted,” noting that the description “purposely allows for flexibility with regard to the mounting location of the beacons so long as the beacons are positioned at a sufficiently high point on the cab.” Id. at 10 n.19. Applicants propose that “[t]he exemption, if granted, should permit any configuration of similar effectiveness.” Id. at 10.</P>
                <P>Applicants state that the exemption is needed because compliance with 49 CFR 392.22(b) is “not feasible for autonomous CMVs without a human on board,” and because proposed Cab-Mounted Warning Beacons are not steady burning (as required under 49 CFR 393.25(e)) and are not among the approved warning devices under 49 CFR 393.95(f). Applicants posit that if the exemption is not granted, the deployment of autonomous CMVs without a human driver on board will be “sufficiently impeded,” and that alternatives to the exemption would be unnecessarily costly. App. at 14-15.</P>
                <HD SOURCE="HD2">C. Research Submitted by Applicants in Support of Proposed Beacons</HD>
                <P>To support the asserted equivalent level of safety of Cab-Mounted Warning Beacons, Applicants submitted two reports on testing certain beacon “variants.” App. at 9. Waymo sponsored a study by the Virginia Tech Transportation Institute (VTTI) (“Stopped Automated Commercial Motor Vehicle Warning Device Surrogates,” prepared for Waymo, LLC, by Erin Mabry, Susan Soccolich, Kary Meissner, Josh Radlbeck, and Andy Schaudt, VTTI, August 1, 2022 (the Waymo study)). Aurora conducted what it calls a “naturalistic study” (“Naturalistic Study for Warning Device Equivalency,” prepared by Aurora Operations, Inc., October 2022 (the Aurora study)). Id. at 11, apps. B-C.</P>
                <P>The Waymo study evaluated whether drivers detected, recognized, and responded appropriately to certain beacons while traveling on a closed-circuit test track in daylight and nighttime conditions and encountering a stopped CMV at three different locations (on the shoulder, in the lane ahead, and on the right shoulder after a curve). App. at 12. The study compared driver reactions to Cab-Mounted Warning Beacons with driver reactions to warning triangles and concluded that study participants subjectively preferred beacons over triangles for communicating the presence of a stopped CMV. Waymo study at 20. The study was conducted in Virginia with 48 participants (24 daylight, 24 nighttime). Id. at 7-8. The report does not describe the weather conditions.</P>
                <P>The Aurora study observed the reactions of over 7,000 passing vehicles to the presence of certain beacons versus warning triangles. App. at 13. The study was conducted on public roads with passing motorists who were unaware of the study and traveling at highway speeds when they encountered a stopped CMV on the right shoulder. Id., Aurora study at 3. Aurora used sensors mounted on the stopped CMV to collect data about motorist responses. Aurora study at 8. Aurora reports that similar proportions of motorists responded to the presence of beacons as they did to warning triangles, and that among those responding, responses occurred at similar distances and motorists increased lateral separation in similar proportions. App. at 13-14. The Aurora study was conducted in Texas on Interstate 45 between Exits 258 and 249. Aurora study at 5. The report does not describe the weather conditions.</P>
                <P>Applicants posit that the two reports confirm that the proposed beacons achieve a level of safety equivalent to or greater than the level achieved with FMCSR-specified warning triangles placed at prescribed distances. App. at 14.</P>
                <HD SOURCE="HD1">IV. Overview of Public Notice and Comments</HD>
                <P>
                    FMCSA published in the 
                    <E T="04">Federal Register</E>
                     on March 9, 2023, notice of the exemption application and the opportunity for public comment. 88 FR 14665. In response, the Agency received 51 public comments.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         FMCSA considered all comments in the docket received through October 31, 2024. FMCSA notes that it received two comments from the Association for Uncrewed Vehicle Systems International but is treating those submissions as one comment because they are substantively identical. See 
                        <E T="03">https://www.regulations.gov/comment/FMCSA-2023-0071-0020</E>
                         and 
                        <E T="03">https://www.regulations.gov/comment/FMCSA-2023-0071-0037.</E>
                    </P>
                </FTNT>
                <P>
                    Twenty-five comments generally supported granting the application, including comments submitted by the Association for Uncrewed Vehicle Systems International (AUVSI); the American Trucking Associations (ATA); 
                    <PRTPAGE P="105677"/>
                    the Autonomous Vehicle Industry Association (AVIA); the Consumer Technology Association (CTA); Continental Automotive Systems, Inc.; Daimler Trucks of North America (Daimler); Hirschbach Motor Lines, Inc. (Hirschbach); Kodiak Robotics (Kodiak); the Motor and Equipment Manufacturers Association (MEMA); PACCAR Inc.; Stack AV Co. (Stack); TechNet; Uber Freight US, LLC (Uber Freight); the U.S. Chamber of Commerce; Volvo Autonomous Solutions NA, Inc. (VAS); Waabi Innovation US, Inc. (Waabi); Werner Enterprises (Werner); CWK Consulting, LLC; the Texas Trucking Association (TXTA); the Institute for Safer Trucking (IST); Isuzu Motors Limited, Isuzu Technical Center of America, Inc. (Isuzu); the Montana Trucking Association (MTA); the Allegheny Conference on Community Development (Allegheny Conference); the National Fraternal Order of Police (NFOP); and an individual commenter.
                </P>
                <P>One commenter, HAAS Alert, was neutral on the proposal, although it supported updating current standards for hazard warnings and notifications.</P>
                <P>Twenty-five comments generally expressed concerns with granting the exemption, including comments submitted by the Amalgamated Transit Union, AFL-CIO (ATU); AWM Associates, LLC; the Motor Vehicle Lighting Supplier Safety Institute (MVLSSI); the Owner Operator Independent Drivers Association (OOIDA); the Towing and Recovery Association of America, Inc. (TRA); the Transportation Trades Department, AFL-CIO (TTD); the Transport Workers Union of America, AFL-CIO (TWU); the Truck Safety Coalition (TSC)/Citizens for Reliable and Safe Highways (CRASH)/Parents Against Tired Truckers (PATT) (joint comment); eleven individual commenters; and six anonymous commenters.</P>
                <P>Generally, commenters supporting the exemption cited the need for a warning system that does not require human intervention to place warning devices for ADS-operated CMVs and the need for continued development of automated technologies. AVIA, for example, argued that the exemption application proposes a new safety solution that would avoid the need for human intervention when a Level 4 or 5 ADS-equipped CMV is stopped on the highway. This position was echoed by comments from ATA; AUVSI; CTA; CWK Consulting, LLC; Daimler; Hirschbach; Kodiak; PACCAR Inc.; Stack; TechNet; Uber Freight; the U.S. Chamber of Commerce; VAS; Waabi; and Werner. These commenters stated that the exemption would help address regulatory burdens that they believe are hindering the deployment of ADS-equipped CMVs. AVIA also commented that it believes the proposed beacons not only address needs of ADS-equipped vehicles but also could enhance safety if applied to traditional CMVs by reducing risks to drivers who would otherwise be required to exit their vehicles to place warning devices. IST expressed concern over the “significant risk” to truck drivers placing warning triangles (particularly in conditions of poor visibility or adverse weather). Waabi also emphasized that it is “extremely dangerous” to require human drivers to “get out of a CMV, walk into or next to oncoming traffic (including at night and during severe weather events), and proceed 100 feet beyond the vehicle, and then physically deploy a warning triangle or flare.” ATA and Kodiak commented that the exemption would be a positive step toward improving overall roadway safety. Similar comments from TXTA, Isuzu, MTA, IST, and Allegheny Conference noted that this would be a step toward enhancing or improving “roadway safety” for “autonomous trucks and other road users.” NFOP stated that granting the exemption would be “a step toward collecting data that can support a broader rulemaking effort to update FMCSA's current regulation on warning devices for all CMVs.”  </P>
                <P>
                    Commenters generally opposed to granting the exemption cited concerns about the effectiveness of the proposed beacons and the lack of evidence in Applicants' studies to address certain safety concerns. ATU, for example, commented that there was no data demonstrating how the beacons would perform where there are blind corners blocking the sight lines of oncoming vehicles, where a vehicle is turned on its side, or if there is a fire or electrical problems. Other efficacy concerns included visibility of the beacons due to a single location, or based on roadway topography or alignment of the truck tractor and trailer; electrical failure causing failure of the beacons; and desensitization of the public to flashing beacons or confusion about what beacons mean (ATU, OOIDA, four individual commenters, one anonymous commenter, MVLSSI, and TRA). MVLSSI, OOIDA, TSC/CRASH/PATT, and trade unions (TWU, ATU, and TTD) also commented that Applicants presented insufficient evidence to demonstrate an equivalent level of safety, noting that more testing would be needed, with TSC/CRASH/PATT emphasizing the lack of performance standards for ADS-equipped CMVs.
                    <SU>2</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Among other FMCSA efforts to promote the safe testing and deployment of ADS-equipped CMVs, a proposed rulemaking, “Motor Carrier Operation of Automated Driving Systems (ADS)-Equipped Commercial Motor Vehicles” (RIN 2126-AC17), is currently underway.
                    </P>
                </FTNT>
                <P>
                    Two individuals commented that the exemption, if granted, should apply to all CMVs, not just ADS-equipped CMVs. TWU and others called for FMCSA or DOT to consider larger studies on alternative warning devices to potentially update existing standards rather than granting an exemption from the current safety standards, and TTD similarly noted that the Applicants' request would have been more appropriate as a petition for rulemaking. Some commenters believed that the exemption request was too broad, seeking an exemption that would apply to an entire class of CMVs, rather than limited to those CMVs under the control of the applicants (see, 
                    <E T="03">e.g.,</E>
                     ATU, TWU, and TSC/CRASH/PATT), with some noting that many of these operators currently use different systems and processes. Commenters also noted that the cited testing does not account for the safety case for a broader spectrum of autonomous and non-autonomous CMVs operated by different entities.
                </P>
                <P>Applicants submitted a 2.5-page response to public comments, dated April 19, 2023 (Applicant's Response). They responded to certain commenter concerns regarding curves and hills by stating that the Waymo and Aurora studies evaluated beacons on or after curves, and that Aurora's study assessed beacons beyond the crest of a hill. They argue that warning beacons' positioning high on the cab made them effective. Regarding commenters' concerns about electrical failure, Applicants responded that beacons “can and should be designed and installed to avoid a single-point power failure” (such as by establishing two power domains to draw from, although they encouraged FMCSA to remain technology neutral as to how they are designed). They also noted that existing warning devices are not immune from failure. They further contended that the proposed beacons would activate immediately and thereby provide an immediate warning, unlike specified warning devices, which may take up to ten minutes to be placed. Applicants did not submit additional evidence to support these positions.</P>
                <HD SOURCE="HD1">V. Exemption Decision</HD>
                <P>
                    Safety is the Agency's highest priority. The Agency embraces the United States Department of Transportation's Innovation Principles, 
                    <PRTPAGE P="105678"/>
                    including adapting as technology changes and supporting technologies that further our policy goals. Having carefully evaluated Applicants' exemption application, supporting documentation, the public comments, and the safety implications of Applicants' request, the Agency denies the application. While the application and public comments suggest promise for alternative warning devices in some circumstances—and the Agency encourages continued innovation and analyses in this area—given the scope of the exemption sought, including the proposed flexible standard for Cab-Mounted Warning Beacons and the proposed national and industry-wide exemption for all companies operating autonomous CMVs, FMCSA finds that the application does not demonstrate that granting the exemption will likely achieve a level of safety that is equivalent to, or greater than, the level of safety that would be achieved absent the exemption. As discussed below, the broad exemption is not supported by the data presented and lacks necessary monitoring controls to ensure highway safety. FMCSA notes that this decision does not preclude Applicants or others from seeking an exemption to use better defined warning beacons for specified companies in particular locations, as one of the bases of the Agency's decision here is the broad reach of Applicants' request.
                </P>
                <HD SOURCE="HD2">A. Applicants Do Not Provide Sufficient Details About the Proposed Alternative Devices and Do Not Demonstrate an Equivalent or Greater Level of Safety for Those Devices, Particularly for a Nationwide and Industry-Wide Exemption</HD>
                <P>To obtain an exemption from the FMCSRs, an applicant must provide evidence allowing the Agency to conclude that the exemption would “likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption.” 49 U.S.C. 31315(b)(1). An applicant likewise must include sufficient details about the specific countermeasures they would take to ensure an equivalent or greater measure of safety. 49 U.S.C. 31315(b)(5); 49 CFR 381.310(c)(5). The present application fails to do so.</P>
                <HD SOURCE="HD3">1. Applicants Do Not Provide Sufficient Details About the Proposed Alternative Warning Devices</HD>
                <P>
                    Applicants propose Cab-Mounted Warning Beacons consisting of “at least one” rearward-facing light mounted “at some point on 
                    <E T="03">or</E>
                     above the upper edge of the sideview mirrors” and “at least one” forward-facing light. App. at 9-10. Applicants provide a diagram of where beacons “could be mounted,” proposing that the description “purposely allows for flexibility with regard to the mounting location.” Id. at 10 n.19. Applicants further propose that the exemption should “permit any configuration of similar effectiveness.” Id. at 10. As several commenters noted, the proposed devices are not specific enough to ensure an equivalent level of safety. The variability of the description also does not readily enable the Agency to monitor the exemption terms and conditions. See 49 U.S.C. 31315(b)(8).
                </P>
                <HD SOURCE="HD3">2. Applicants Do Not Demonstrate an Equivalent Level of Safety Supporting the Full Scope of the Exemption Sought</HD>
                <P>Applicants' submitted studies do not support an equivalent level of safety for Cab-Mounted Warning Beacons for the full scope of the exemption sought.  </P>
                <P>
                    First, the studies at best address beacons mounted at 110 inches from the ground (Waymo study at 6) and at an undetermined height (Aurora study),
                    <SU>3</SU>
                    <FTREF/>
                     and with the particular placement and operational constraints described in the studies. They do not address the visibility of beacons for the full range of the “flexible” standard that Applicants propose, or “any configuration of similar effectiveness.”
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The Aurora study indicates that one light is temporarily mounted on each side of the cab at “approximately one foot behind the sideview mirror” and “approximately four inches above the top of the sideview mirror.” Aurora study at 3 n.3.
                    </P>
                </FTNT>
                <P>Second, while Applicants contend that both studies demonstrated similar overall reactions from highway users driving by a stopped CMV for the proposed Cab-Mounted Warning Beacons compared to warning triangles, the studies provided insufficient data to demonstrate an equivalency in driver responses. For example, as the Waymo study acknowledged, unfamiliarity of the warning beacons may have contributed to motorist behavior. Waymo study at 20. And while Applicants rely on the study to demonstrate that warning beacons were “easier to see” or “preferred” by drivers, the study also showed that for respondents who answered which device was better for signaling a stopped truck, 8 out of 10 selected warning triangles over beacons. Waymo study at 55. Aurora's study notes that some motorist responses may have occurred wholly outside the sensor range (Aurora study at 8)—an indication that the study may not have captured enough data points to compare whether drivers responded earlier to one warning device over the other.</P>
                <P>The studies also failed to fully support whether motorist behavior was causally based on seeing warning beacons rather than a stopped CMV. One distinction between FMCSR-specified warning triangles and the proposed beacons is that warning triangles are placed at the rear of a stopped CMV (in addition to the front), while the proposed beacons are located only at the front of the cab—raising the possibility that drivers see the rear of a stopped CMV before they see the beacons. While Applicants contend that the beacons are visible from behind the vehicle, the evidence was inconclusive. For example, the studies failed to demonstrate through photos or videos the point at which a beacon or warning triangle was visible or recognized by a motorist, or the point at which a stopped CMV came into view. Changes in driver behavior were observed in 11 out of 12 observations with warning beacons (as opposed to 12 out of 12 for triangles) (Waymo study at 16, Table 3); still, the evidence does not clearly demonstrate whether drivers reacted to the CMV or the warning device. For example, neither study establishes a baseline condition that measured driver reaction to a stopped CMV with no warning device deployed, a concern raised by MVLSSI in its comments.</P>
                <P>Applicants' contentions of equal or higher overall responses to warning beacons, moreover, fail to acknowledge circumstances where beacons performed worse than triangles. Aurora's study, for example, concluded that a warning beacon elicited a 2.75% higher percentage of responses than warning triangles overall. Aurora study at 24, Table 3.2.1-1. The same table, however, shows a lower percentage responded overall to warning beacons than to warning triangles in five of eight (62.5%) scenarios in the table, including daytime tests at left curve and straight locations, and nighttime tests at crest, right curve, and straight locations. Id. Although the differences in percentage responding were small, the overall worse performance for beacons in the majority of categories does not support Applicants' conclusion that the proposed beacons performed at a level equal to or better than warning triangles.</P>
                <P>
                    Another limitation of the studies was the limited data. The Aurora study tested for 8 minutes with warning beacons, replaced the warning beacons with warning triangles, and then tested the next 8 minutes with warning triangles. Aurora study at 5-6. This leads to 16 minutes of total testing time for both warning devices for each roadway geometry (straight, curve left, curve right, and beyond the crest of a 
                    <PRTPAGE P="105679"/>
                    hill), with the tests repeated in daytime and nighttime lighting conditions. The total test time is just over 2 hours for all devices across all scenarios, with only around 64 minutes of total testing time for the proposed beacons across 8 scenarios. The Waymo study was limited to 48 participants. Waymo study at 7. This limited amount of data does not support an equivalent level of safety, particularly considering the scope of the exemption requested, which is nationwide for all current and future autonomous CMV operators during the exemption period.
                </P>
                <P>
                    Third, the studies do not demonstrate an equivalent level of safety across sufficiently varied circumstances. Many commenters expressed particular concern with the visibility of proposed warning beacons when a CMV is stopped along a curve. For example, TTD stated that the requirement in 49 CFR 392.22(2)(iv) is in place “to account for the simple geometry of curves, hills, and other obstructions that can make cab lights invisible to oncoming traffic.” 
                    <SU>4</SU>
                    <FTREF/>
                     FMCSA agrees that road curvatures or elevations may affect visibility of a beacon located in a fixed position on the cab of a CMV, and that placement of warning devices at FMCSR-prescribed distances away from the CMV allows for improved visibility in such situations. FMCSA notes that, due to the different placement of the devices, the range of the warning provided by a cab-mounted beacon to an approaching motorist would need to be longer than the range of the warning provided by an appropriately placed warning triangle because the source of the warning (the location at which the warning originates) would be farther from the approaching motorist for a cab-mounted beacon than for a warning triangle placed behind a vehicle. FMCSA also expects the radius of the curve could affect the range of the warning beacon in a similar fashion to how curves affect the range of adaptive driving beams, as described in 49 CFR 571.108 (FMVSS No. 108) under Table XXII—Adaptive Driving Beam System Test Matrix.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         See 
                        <E T="03">https://www.regulations.gov/comment/FMCSA-2023-0071-0036.</E>
                         See also 
                        <E T="03">https://www.regulations.gov/comment/FMCSA-2023-0071-0038</E>
                         (comment from HAAS Alert noting that “all line-of-sight alerting solutions are inherently limited by their relative visibility,” which can be significantly reduced by weather conditions, road curvature, hills, and other factors).
                    </P>
                </FTNT>
                  
                <P>
                    The studies also gave insufficient information about the nature of the curves in the studies,
                    <SU>5</SU>
                    <FTREF/>
                     making it difficult to understand whether the curves were sufficiently representative of the types of curves (
                    <E T="03">e.g.,</E>
                     slight vs. truly blind, sharp curves) the beacon-equipped autonomous CMVs would encounter across the United States, and therefore difficult to conclude that there is an equivalent level of safety on curves. Neither study presented photos or videos demonstrating the point of view of an approaching motorist entering or exiting the curve. Moreover, the Waymo study supports that the beacons performed significantly worse than warning triangles at a curve during daytime runs. Specifically, at truck exposure location III (shoulder after curve), 9 out of 12 drivers detected and recognized the truck with the beacon,
                    <SU>6</SU>
                    <FTREF/>
                     while 12 out of 12 did so with the warning triangles. This finding is salient to examine, considering that locations with curves would logically present a challenging scenario for fixed beacons versus triangles whose placement can be adjusted based on curves.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Appendix C of the Waymo study (Waymo study at 25) includes a map with a star at the curve location that did not appear from the map to be a very sharp curve. In Aurora's study, it was also difficult to determine whether the curves were sharp from the maps. For example, when examining the left curve shown in Appendix A (at coordinates 32.3089, -96.593) in Google maps, it appears this location has a posted speed limit of 75 mph. FMCSA notes a sharp curve would have a lower posted speed limit, depending on the curve's radius.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         Table 3 (Waymo study at 16), clearly shows that only 9 out of 12 drivers detected the scenario with the beacon at location III for daytime runs. The driver detection data for nighttime runs at that same location is unclear, however, since Table 17 (Id. at 41) shows non-response for the button press for 2 beacons and 1 triangle, with 2 non-response observations occurring at location III and 1 occurring at location II, making it difficult to determine whether the beacons were missed 16.67% of the time (2 out of 12) or 8.33% of the time (1 out of 12) at the curve.
                    </P>
                </FTNT>
                <P>Fourth, while Applicants seek an exemption for CMVs operating in a Level 4 autonomous mode (App. at 9), Applicants did not support that vehicles operating in an autonomous mode will stop and engage flashers and beacons similar to the CMVs in the studies. For example, in the Waymo study, it appears that CMVs began in a stopped position, while in the Aurora study, a human driver apparently stopped the vehicle, and in both studies, a human apparently activated both the hazard warning flashers and the beacon devices. Waymo study at 7, 9; Aurora study at 5-6; App. at 11 n.21. Thus, neither study demonstrated that CMVs operating in Level 4 autonomous mode will effectively engage hazard lamps and/or proposed beacons, or the timing with which they would do so, and how that timing compares to timing required under the FMCSRs. And while Applicants contend that they will be able to address electrical failure, Applicants did not provide evidence regarding how they will do so. Applicants' request to exempt a class of unspecified carriers using unspecified equipment on unspecified vehicles only further undermines the claimed likely equivalent level of safety.</P>
                <P>Applicants and some commenters noted potential safety benefits to human drivers. Indeed, in their “safety impact” analysis, Applicants state that the exemption would increase safety “most notably by eliminating the need for a human to enter the roadway to place traditional warning devices” and that while the application applies to CMVs without a human driver, the safety rationale could apply to conventional CMVs. App. at 9. The exemption request, however, is not directed at such circumstances—Applicants request that the exemption be permitted where there is no human driver or where drivers are used only for testing. App. at 4. Indeed, Applicants contend that no human drivers will be affected. App. at 9. While FMCSA agrees that there is promise for improving safety for CMV drivers if they do not need to leave a vehicle to place warning devices, neither Applicants nor the public comments presented data to allow FMCSA to find an equivalent or higher level of safety when using the proposed beacons for carriers operating CMVs with human drivers, and Applicants did not request an exemption to cover such operations.</P>
                <P>Fifth, there are other limitations of the application to support the scope sought. For example, the studies do not address visibility of proposed beacons for vehicle orientations with varying trailer heights, such as (for example) a truck tractor pulling a flatbed trailer versus a van type trailer that is taller than the truck tractor. As certain commenters observed, Applicants did not address how proposed beacons might perform in scenarios such as a CMV on its side. Applicants likewise seek a nationwide exemption based only on limited data from a test track in Virginia and a portion of Interstate 45 in Texas between Exits 258 and 249, and without establishing how warning beacons might perform in different geographical or weather conditions across the country.</P>
                <P>
                    Sixth, should Applicants (or future applicants) provide sufficient details about proposed alternative warning devices, FMCSA notes that industry-wide exemptions are not the norm and FMCSA grants them only on a very limited basis. Applicants present little data on the effect such a broad exemption would have on overall safety, particularly considering the unknown group of autonomous CMV operators at 
                    <PRTPAGE P="105680"/>
                    issue, the unknown fleet sizes, and potential differences among them in implementation and operations.
                    <SU>7</SU>
                    <FTREF/>
                     FMCSA also is concerned that operators will assume that their own similar but varying versions of Cab-Mounted Warning Beacons are a “configuration of similar effectiveness” (App. at 10) and therefore are exempted, without such operators applying for and supporting the safety of an exemption. Thus, at this stage, the record before the Agency does not show that Applicants' petition for an industry-wide exemption adequately demonstrates the required threshold, of likely to achieve an equivalent level of safety.
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         Applicants do not provide the names of motor carriers that would be responsible under the exemptions or the estimates—even for their own operations—of the number of drivers and CMVs that would be operated under the exemption. See 49 CFR 381.310(b) and (c). Such information would assist the Agency in assessing the equivalent level of safety for operations with the proposed alternative devices.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">VI. Conclusion</HD>
                <P>For the reasons given above, the Agency denies the application for an exemption.</P>
                <P>FMCSA notes that the Agency may accept a resubmission of an exemption application that has been denied, provided that the applicant can reasonably address the reason for the denial. 49 U.S.C. 31315(b)(3); 49 CFR 381.317.</P>
                <SIG>
                    <NAME>Vincent G. White,</NAME>
                    <TITLE>Deputy Administrator.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30860 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-EX-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Motor Carrier Safety Administration</SUBAGY>
                <DEPDOC>[Docket No. FMCSA-2024-0029]</DEPDOC>
                <SUBJECT>Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of applications for exemption; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>FMCSA announces receipt of applications from 12 individuals for an exemption from the prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs) against persons with a clinical diagnosis of epilepsy or any other condition that is likely to cause a loss of consciousness or any loss of ability to control a commercial motor vehicle (CMV) to drive in interstate commerce. If granted, the exemptions would enable these individuals who have had one or more seizures and are taking anti-seizure medication to operate CMVs in interstate commerce.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before January 27, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by the Federal Docket Management System Docket No. FMCSA-2024-0029 using any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">www.regulations.gov/,</E>
                         insert the docket number (FMCSA-2024-0029) in the keyword box and click “Search.” Next, choose the only notice listed, and click on the “Comment” button. Follow the online instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Dockets Operations; U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor, Washington, DC 20590-0001.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         West Building Ground Floor, 1200 New Jersey Avenue SE, Washington, DC 20590-0001 between 9 a.m. and 5 p.m. ET Monday through Friday, except Federal Holidays.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         (202) 493-2251.
                    </P>
                    <P>
                        To avoid duplication, please use only one of these four methods. See the “Public Participation” portion of the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section for instructions on submitting comments.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, (202) 366-4001, 
                        <E T="03">fmcsamedical@dot.gov.</E>
                         Office hours are 8:30 a.m. to 5 p.m. ET Monday through Friday, except Federal holidays. If you have questions regarding viewing or submitting material to the docket, contact Dockets Operations, (202) 366-9826.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Public Participation</HD>
                <HD SOURCE="HD2">A. Submitting Comments</HD>
                <P>If you submit a comment, please include the docket number for this notice (Docket No. FMCSA-2024-0029), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.</P>
                <P>To submit your comment online, go to</P>
                <P>
                    <E T="03">https://www.regulations.gov/docket/FMCSA-2024-0029</E>
                    .  Next, choose the only notice listed, click the “Comment” button, and type your comment into the text box on the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit.
                </P>
                <P>
                    If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
                    <FR>1/2</FR>
                     by 11 inches, suitable for copying and electronic filing. FMCSA will consider all comments and material received during the comment period.
                </P>
                <HD SOURCE="HD2">B. Viewing Comments</HD>
                <P>
                    To view comments go to 
                    <E T="03">www.regulations.gov.</E>
                     Insert the docket number (FMCSA-2024-0029) in the keyword box and click “Search.” Next, choose the only notice listed, and click “Browse Comments.” If you do not have access to the internet, you may view the docket online by visiting Dockets Operations on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
                </P>
                <HD SOURCE="HD2">C. Privacy Act</HD>
                <P>
                    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption request. DOT posts these comments, without edit, including any personal information the commenter provides, to 
                    <E T="03">www.regulations.gov.</E>
                     As described in the system of records notice DOT/ALL 14 (Federal Docket Management System), which can be reviewed at 
                    <E T="03">https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices,</E>
                     the comments are searchable by the name of the submitter.  
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>
                    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. The statutes also allow the Agency to renew exemptions at the end of the 5-year period. FMCSA grants medical exemptions from the FMCSRs for a 2-
                    <PRTPAGE P="105681"/>
                    year period to align with the maximum duration of a driver's medical certification.
                </P>
                <P>The 12 individuals listed in this notice have requested an exemption from the epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8). Accordingly, the Agency will evaluate the qualifications of each applicant to determine whether granting the exemption will achieve the required level of safety mandated by statute.</P>
                <P>The physical qualification standard for drivers regarding epilepsy found in § 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.</P>
                <P>
                    In addition to the regulations, FMCSA has published advisory criteria 
                    <SU>1</SU>
                    <FTREF/>
                     to assist medical examiners (MEs) in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         These criteria may be found in APPENDIX A TO PART 391—MEDICAL ADVISORY CRITERIA, section H. 
                        <E T="03">Epilepsy:</E>
                         § 391.41(b)(8), paragraphs 3, 4, and 5, which is available on the internet at 
                        <E T="03">https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.</E>
                    </P>
                </FTNT>
                <P>The criteria states that if an individual has had a sudden episode of a non-epileptic seizure or loss of consciousness of unknown cause that did not require anti-seizure medication, the decision whether that person's condition is likely to cause the loss of consciousness or loss of ability to control a CMV should be made on an individual basis by the ME in consultation with the treating physician. Before certification is considered, it is suggested that a 6-month waiting period elapse from the time of the episode. Following the waiting period, it is suggested that the individual have a complete neurological examination. If the results of the examination are negative and anti-seizure medication is not required, then the driver may be qualified.</P>
                <P>
                    In those individual cases where a driver has had a seizure or an episode of loss of consciousness that resulted from a known medical condition (
                    <E T="03">e.g.,</E>
                     drug reaction, high temperature, acute infectious disease, dehydration, or acute metabolic disturbance), certification should be deferred until the driver has recovered fully from that condition, has no existing residual complications, and is not taking anti-seizure medication.
                </P>
                <P>Drivers who have a history of epilepsy/seizures, off anti-seizure medication, and seizure-free for 10 years, may be qualified to operate a CMV in interstate commerce. Interstate drivers with a history of a single unprovoked seizure may be qualified to drive a CMV in interstate commerce if seizure-free and off anti-seizure medication for a 5-year period or more.</P>
                <P>As a result of MEs misinterpreting advisory criteria as regulation, numerous drivers have been prohibited from operating a CMV in interstate commerce based on the fact that they have had one or more seizures and are taking anti-seizure medication, rather than an individual analysis of their circumstances by a qualified ME based on the physical qualification standards and medical best practices.</P>
                <P>On January 15, 2013, FMCSA announced in a notice of final disposition titled, “Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders,” (78 FR 3069), its decision to grant requests from 22 individuals for exemptions from the regulatory requirement that interstate CMV drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” Since that time, the Agency has published additional notices granting requests from individuals for exemptions from the regulatory requirement regarding epilepsy found in § 391.41(b)(8).</P>
                <P>To be considered for an exemption from the epilepsy and seizure disorders prohibition in § 391.41(b)(8), applicants must meet the criteria in the 2007 recommendations of the Agency's Medical Expert Panel (78 FR 3069).</P>
                <HD SOURCE="HD1">III. Qualifications of Applicants</HD>
                <HD SOURCE="HD2">Ronald Buccheri</HD>
                <P>Ronald Buccheri is a 43-year-old class A commercial driver's license (CDL) holder in New Jersey. They have a history of a single unprovoked seizure and have been seizure free since September 7, 2020. They take anti-seizure medication with the dosage and frequency remaining the same since 2020. Their physician states that they are supportive of Ronald Buccheri receiving an exemption.</P>
                <HD SOURCE="HD2">Brian Daniels</HD>
                <P>Brian Daniels is a 68-year-old class A CDL holder in New Jersey. They have a history of seizure disorder and have been seizure free since April 1, 1999. They take anti-seizure medication with the dosage and frequency remaining the same since 1998. Their physician states that they are supportive of Brian Daniels receiving an exemption.</P>
                <HD SOURCE="HD2">Christopher Dowdy</HD>
                <P>Christopher Dowdy is a 48-year-old class C license holder in Kansas. They have a history of unprovoked seizure and have been seizure free since September 11, 2020. They take anti-seizure medication with the dosage and frequency remaining the same since May 17, 2021. Their physician states that they are supportive of Christopher Dowdy receiving an exemption.</P>
                <HD SOURCE="HD2">Dale Folsom</HD>
                <P>Dale Folsom is a 57-year-old class E license holder in Florida. They have a history of partial seizures and have been seizure free since April 2003. They take anti-seizure medication with the dosage and frequency remaining the same since April 2003. Their physician states that they are supportive of Dale Folsom receiving an exemption.</P>
                <HD SOURCE="HD2">Kenneth Horten</HD>
                <P>Kenneth Horten is a 55-year-old class D license holder in Arizona. They have a history of a single unprovoked seizure and have been seizure free since November 4, 2009. They take anti-seizure medication with the dosage and frequency remaining the same since November 4, 2009. Their physician states that they are supportive of Kenneth Horten receiving an exemption.</P>
                <HD SOURCE="HD2">Jacob Johnstone</HD>
                <P>Jacob Johnstone is a 25-year-old class D regular license holder in Wisconsin. They have a history of seizure disorder and have been seizure free since 2016. They take anti-seizure medication with the dosage and frequency remaining the same since 2020. Their physician states that they are supportive of Jacob Johnstone receiving an exemption.</P>
                <HD SOURCE="HD2">Steven Nelson</HD>
                <P>Steven Nelson is a 53-year-old class D license holder in Iowa. They have a history of epilepsy and have been seizure free since July 28, 2015. They take anti-seizure medication with the dosage and frequency remaining the same since June 2015. Their physician states that they are supportive of Steven Nelson receiving an exemption.</P>
                <HD SOURCE="HD2">Hunter Raso</HD>
                <P>
                    Hunter Raso is a 24-year-old class D license holder in Virginia. They have a history of partial seizures with loss of consciousness and have been seizure free since 2010. They take anti-seizure medication with the dosage and frequency remaining the same since 2016. Their physician states that they are supportive of Hunter Raso receiving an exemption.
                    <PRTPAGE P="105682"/>
                </P>
                <HD SOURCE="HD2">Andrew Speights</HD>
                <P>Andrew Speights is a 25-year-old class R license holder in Mississippi. They have a history of seizure disorder and have been seizure free since October 2016. They take anti-seizure medication with the dosage and frequency remaining the same since October 2016. Their physician states that they are supportive of Andrew Speights receiving an exemption.</P>
                <HD SOURCE="HD2">Vic Sprenkle</HD>
                <P>Vic Sprenkle is a 59-year-old class AM CDL holder in Pennsylvania. They have a history of single partial complex seizure and have been seizure free since August 3, 2009. They take anti-seizure medication with the dosage and frequency remaining the same since 2009. Their physician states that they are supportive of Vic Sprenkle receiving an exemption.</P>
                <HD SOURCE="HD2">Todd Weston</HD>
                <P>Todd Weston is a 48-year-old class AM1 CDL holder in California. They have a history of seizure disorder and have been seizure free since 2010. They take anti-seizure medication with the dosage and frequency remaining the same since October 2017. Their physician states that they are supportive of Todd Weston receiving an exemption.</P>
                <HD SOURCE="HD2">Vernon Wingate</HD>
                <P>Vernon Wingate is a 34-year-old class C license holder in Maryland. They have a history of seizure disorder and have been seizure free since June 2016. They take anti-seizure medication with the dosage and frequency remaining the same since March 4, 2020. Their physician states that they are supportive of Vernon Wingate receiving an exemption.</P>
                <HD SOURCE="HD1">IV. Request for Comments</HD>
                <P>
                    In accordance with 49 U.S.C. 31136(e) and 31315(b), FMCSA requests public comment from all interested persons on the exemption petitions described in this notice. We will consider all comments received before the close of business on the closing date indicated under the 
                    <E T="02">DATES</E>
                     section of the notice.
                </P>
                <SIG>
                    <NAME>Larry W. Minor,</NAME>
                    <TITLE>Associate Administrator for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30884 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-EX-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Motor Carrier Safety Administration</SUBAGY>
                <DEPDOC>[Docket No. FMCSA-2024-0277]</DEPDOC>
                <SUBJECT>Qualification of Drivers; Exemption Applications; Hearing</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of applications for exemption; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>FMCSA announces receipt of applications from 10 individuals for an exemption from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. If granted, the exemptions would enable these hard of hearing and deaf individuals to operate CMVs in interstate commerce.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before January 27, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by the Federal Docket Management System Docket No. FMCSA-2024-0277 using any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">www.regulations.gov/,</E>
                         insert the docket number (FMCSA-2024-0277) in the keyword box and click “Search.” Next, choose the only notice listed, and click on the “Comment” button. Follow the online instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Dockets Operations; U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor, Washington, DC 20590-0001.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         West Building Ground Floor, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET Monday through Friday, except Federal Holidays.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         (202) 493-2251.
                    </P>
                    <P>
                        To avoid duplication, please use only one of these four methods. See the “Public Participation” portion of the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section for instructions on submitting comments.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-0001, (202) 366-4001, 
                        <E T="03">fmcsamedical@dot.gov.</E>
                         Office hours are 8:30 a.m. to 5 p.m. ET Monday through Friday, except Federal holidays. If you have questions regarding viewing or submitting material to the docket, contact Dockets Operations, (202) 366-9826.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Public Participation</HD>
                <HD SOURCE="HD2">A. Submitting Comments</HD>
                <P>If you submit a comment, please include the docket number for this notice (Docket No. FMCSA-2024-0277), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.</P>
                <P>
                    To submit your comment online, go to 
                    <E T="03">https://www.regulations.gov/docket/FMCSA-2024-0277.</E>
                     Next, sort the results by “Posted (Newer-Older),” choose the only notice listed, click the “Comment” button, and type your comment into the text box on the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit.
                </P>
                <P>
                    If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
                    <FR>1/2</FR>
                     by 11 inches, suitable for copying and electronic filing. FMCSA will consider all comments and material received during the comment period.
                </P>
                <HD SOURCE="HD2">B. Viewing Comments</HD>
                <P>
                    To view comments go to 
                    <E T="03">www.regulations.gov.</E>
                     Insert the docket number (FMCSA-2024-0277) in the keyword box and click “Search.” Next, choose the only notice listed, and click “Browse Comments.” If you do not have access to the internet, you may view the docket online by visiting Dockets Operations on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Dockets Operations.
                </P>
                <HD SOURCE="HD2">C. Privacy Act</HD>
                <P>
                    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments from the public on the exemption requests. DOT posts these comments, without edit, including any personal information the commenter provides, to 
                    <E T="03">www.regulations.gov.</E>
                     As described in the system of records notice DOT/ALL 14 (Federal Docket Management 
                    <PRTPAGE P="105683"/>
                    System), which can be reviewed at 
                    <E T="03">https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices,</E>
                     the comments are searchable by the name of the submitter.
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. The statutes also allow the Agency to renew exemptions at the end of the 5-year period. FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.</P>
                <P>The 10 individuals listed in this notice have requested an exemption from the hearing requirement in 49 CFR 391.41(b)(11). Accordingly, the Agency will evaluate the qualifications of each applicant to determine whether granting the exemption will achieve the required level of safety mandated by statute.</P>
                <P>The physical qualification standard for drivers regarding hearing found in § 391.41(b)(11) states that a person is physically qualified to drive a CMV if that person first perceives a forced whispered voice in the better ear at not less than 5 feet with or without the use of a hearing aid or, if tested by use of an audiometric device, does not have an average hearing loss in the better ear greater than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a hearing aid when the audiometric device is calibrated to American National Standard (formerly ASA Standard) Z24.5—1951.</P>
                <P>This standard was adopted in 1970 and was revised in 1971 to allow drivers to be qualified under this standard while wearing a hearing aid, (35 FR 6458, 6463 (Apr. 22, 1970) and 36 FR 12857 (July 8, 1971), respectively).</P>
                <P>On February 1, 2013, FMCSA announced in a Notice of Final Disposition titled, “Qualification of Drivers; Application for Exemptions; National Association of the Deaf,” (78 FR 7479), its decision to grant requests from 40 individuals for exemptions from the Agency's physical qualification standard concerning hearing for interstate CMV drivers. Since that time the Agency has published additional notices granting requests from hard of hearing and deaf individuals for exemptions from the Agency's physical qualification standard concerning hearing for interstate CMV drivers.</P>
                <HD SOURCE="HD1">III. Qualifications of Applicants</HD>
                <HD SOURCE="HD2">James Armstrong</HD>
                <P>James Armstrong, 37, holds a class D driver's license in Tennessee.</P>
                <HD SOURCE="HD2">Bethany Barrett</HD>
                <P>Bethany Barrett, 32, holds a class D driver's license in Wisconsin.</P>
                <HD SOURCE="HD2">Kevin Lopez Morales</HD>
                <P>Kevin Lopez Morales, 29, holds a class D driver's license in North Dakota.</P>
                <HD SOURCE="HD2">Socorro Melendez</HD>
                <P>Socorro Melendez, 32, holds a class C driver's license in Texas.</P>
                <HD SOURCE="HD2">Robert Piacente</HD>
                <P>Robert Piacente, 69, holds a class A commercial driver's license (CDL) in Louisiana.</P>
                <HD SOURCE="HD2">Dalton Rosch</HD>
                <P>Dalton Rosch, 27, holds a class C driver's license in Iowa.</P>
                <HD SOURCE="HD2">Ferfran Sanchez Molina</HD>
                <P>Ferfran Sanchez Molina, 30, holds a class D driver's license in New Jersey.</P>
                <HD SOURCE="HD2">Jonathan Santiago</HD>
                <P>Jonathan Santiago, 40, holds a class E driver's license in Florida.</P>
                <HD SOURCE="HD2">John Shepard</HD>
                <P>John Shepard, 76, holds a class B CDL in Connecticut.</P>
                <HD SOURCE="HD2">Andrew Weaver</HD>
                <P>Andrew Weaver, 32, holds a class D driver's license in Virginia.</P>
                <HD SOURCE="HD1">IV. Request for Comments</HD>
                <P>
                    In accordance with 49 U.S.C. 31136(e) and 31315(b), FMCSA requests public comment from all interested persons on the exemption petitions described in this notice. We will consider all comments received before the close of business on the closing date indicated under the 
                    <E T="02">DATES</E>
                     section of the notice.
                </P>
                <SIG>
                    <NAME>Larry W. Minor,</NAME>
                    <TITLE>Associate Administrator for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30896 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-EX-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Railroad Administration</SUBAGY>
                <DEPDOC>[Docket Number FRA-2014-0048]</DEPDOC>
                <SUBJECT>Petition for Extension of Waiver of Compliance</SUBJECT>
                <P>Under part 211 of title 49 Code of Federal Regulations (CFR), this document provides the public notice that on October 14, 2024, and December 13, 2024, Union Pacific Railroad Company (UP) petitioned the Federal Railroad Administration (FRA) for an extension of a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR parts 215 (Railroad Freight Car Safety Standards), 229 (Railroad Locomotive Safety Standards), and 232 (Brake System Safety Standards for Freight and Other Non-Passenger Trains and Equipment; End-of-Train Devices). The relevant Docket Number is FRA-2014-0048.</P>
                <P>
                    Specifically, UP seeks an extension of relief from part 215, § 229.21, 
                    <E T="03">Daily inspection,</E>
                     and § 232.205(a)(1), 
                    <E T="03">Class I brake test—initial terminal inspection,</E>
                     to move freight cars received in interchange from Ferrocarriles Nacionales de Mexico at the International Yard on the Lordsburg Subdivision in El Paso, Texas, to Dallas Street Yard (for westbound traffic) or Alfalfa Yard (for eastbound traffic). The required inspections are conducted at these yards, which are 2.8 and 7 miles from the International Yard, respectively. In its petition, UP notes that the territory between International Yard and Dallas Street and Alfalfa Yards “traverses through a residential area with multiple public grade crossings[,] which also handle heavy pedestrian traffic.” Additionally, UP requests to expand the relief in this docket to permit it to move trains to Santa Teresa, New Mexico, a distance of 20.5 miles.
                </P>
                <P>In support of its petition, UP states that the movement “expedit[es] any delays caused by port of entry inspections and allow[s] a more efficient use of the bridge window.” UP adds that completing inspections and testing of equipment at the Dallas and Alfalfa Yards is “safer/more secure than attempting it on the bridge precisely at the US border line,” as the infrastructure of the Dallas and Alfalfa facilities “supports inspections, and repair associated activities, including switching out bad orders, safer and better than other upstream properties.” Finally, UP notes that the relief avoids “unnecessary public disruptions within the city of El Paso, [Texas], including, but not limited to, excessively blocked crossings” as well as “alleviates undue additional locomotive emissions from excessive idling times.”</P>
                <P>
                    A copy of the petition, as well as any written communications concerning the petition, is available for review online at 
                    <E T="03">www.regulations.gov.</E>
                </P>
                <P>
                    Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate 
                    <PRTPAGE P="105684"/>
                    scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested parties desire an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
                </P>
                <P>
                    All communications concerning these proceedings should identify the appropriate docket number and may be submitted at 
                    <E T="03">www.regulations.gov.</E>
                     Follow the online instructions for submitting comments.
                </P>
                <P>Communications received by February 25, 2025 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.</P>
                <P>
                    Anyone can search the electronic form of any written communications and comments received into any of the U.S. Department of Transportation's (DOT) dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to 
                    <E T="03">www.regulations.gov,</E>
                     as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                     See also 
                    <E T="03">https://www.regulations.gov/privacy-notice</E>
                     for the privacy notice of 
                    <E T="03">regulations.gov.</E>
                </P>
                <SIG>
                    <P>Issued in Washington, DC.</P>
                    <NAME>John Karl Alexy,</NAME>
                    <TITLE>Associate Administrator for Railroad Safety, Chief Safety Officer.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-31061 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-06-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Railroad Administration</SUBAGY>
                <DEPDOC>[Docket Number FRA-2020-0009]</DEPDOC>
                <SUBJECT>Petition for Extension of Waiver of Compliance</SUBJECT>
                <P>Under part 211 of title 49 Code of Federal Regulations (CFR), this document provides the public notice that on October 24, 2024, the Metropolitan Council's Metro Transit Division (Metro Transit) petitioned the Federal Railroad Administration (FRA) for an extension of a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR parts 219 (Control of Alcohol and Drug Use), 220 (Railroad Communications), and 234 (Grade Crossing Safety). The relevant Docket Number is FRA-2020-0009.</P>
                <P>Specifically, Metro Transit seeks an extension of relief for its METRO Green Line Light Rail Transit Extension Project, which is partly adjacent to freight rail service operated by Twin Cities &amp; Western Railroad (TCWR), with which it will share five highway-rail grade crossings. Metro Transit seeks extended relief from part 219 (excepting subpart C), as it has “adopted an alcohol and drug use policy (“FTA Safety Sensitive Drug and Alcohol Program”) that complies with applicable Federal Transit Administration regulations, meeting the requirements of part 655 (Prevention of Alcohol Misuse and Prohibited Drug Use in Transit Operations).</P>
                <P>Further, Metro Transit seeks an extension of relief from the entirety of part 220, noting that transit operations “will be signaled and dispatched separately from the adjacent TCWR freight railroad” at the shared five crossings. Metro Transit states that it “recognizes the importance of maintaining clear, effective and prompt communications between Metro Transit and the freight operator, particularly related to planned maintenance of way activities and emergencies.”</P>
                <P>
                    Metro Transit also requests relief from § 234.105(c), 
                    <E T="03">Activation failure,</E>
                     which gives requirements for protection of grade crossings in case of a train warning system activation failure. Because transit trains are operated by single-person crews, the train operator cannot simultaneously flag a crossing and move the train through the crossing. Metro Transit provides two alternative safety procedures involving sounding the horn followed by moving at restricted speed and indication using a lunar aspect signal.
                </P>
                <P>
                    A copy of the petition, as well as any written communications concerning the petition, is available for review online at 
                    <E T="03">www.regulations.gov.</E>
                </P>
                <P>Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested parties desire an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.</P>
                <P>
                    All communications concerning these proceedings should identify the appropriate docket number and may be submitted at 
                    <E T="03">www.regulations.gov.</E>
                     Follow the online instructions for submitting comments.
                </P>
                <P>Communications received by February 25, 2025 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.</P>
                <P>
                    Anyone can search the electronic form of any written communications and comments received into any of the U.S. Department of Transportation's (DOT) dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to 
                    <E T="03">www.regulations.gov,</E>
                     as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at 
                    <E T="03">https://www.transportation.gov/privacy.</E>
                     See also 
                    <E T="03">https://www.regulations.gov/privacy-notice</E>
                     for the privacy notice of 
                    <E T="03">regulations.gov.</E>
                </P>
                <SIG>
                    <P>Issued in Washington, DC.</P>
                    <NAME>John Karl Alexy,</NAME>
                    <TITLE>Associate Administrator for Railroad Safety, Chief Safety Officer.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2024-31054 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-06-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <DEPDOC>[Docket No: PHMSA-2024-0137]</DEPDOC>
                <SUBJECT>Pipeline Safety: Information Collection Activities</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice and request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In compliance with the Paperwork Reduction Act of 1995, this notice announces that the eight information collection requests abstracted below are being forwarded to the Office of Management and Budget (OMB) for review and comment. A 
                        <E T="04">Federal Register</E>
                         notice with a 60-day comment period soliciting comments on the information collections was published on October 10, 2024.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested persons are invited to submit comments on or before January 27, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The public is invited to submit comments regarding these information collection requests, including suggestions for reducing the burden, to Office of Management and 
                        <PRTPAGE P="105685"/>
                        Budget (OMB), Attention: Desk Officer for the Office of the Secretary of Transportation, 725 17th Street NW, Washington, DC 20503. Comments can also be submitted electronically at 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                         Angela Hill by telephone at 202-680-2034 or by email at 
                        <E T="03">angela.hill@dot.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    Title 5, Code of Federal Regulations section 1320.8(d), requires the Pipeline and Hazardous Materials Safety Administration (PHMSA) to provide interested members of the public and affected agencies the opportunity to comment on information collection and recordkeeping requests before they are submitted to OMB for approval. In accordance with this regulation, on October 10, 2024, PHMSA published a 
                    <E T="04">Federal Register</E>
                     notice (89 FR 82294) with a 60-day comment period soliciting comments on its intent to request OMB's renewed approval of several information collection requests that are due to expire in 2025.
                </P>
                <P>During the 60-day comment period, PHMSA received one comment from an anonymous source on a matter not pertaining to the proposed renewal of the impacted information collections.</P>
                <HD SOURCE="HD1">II. Summary of Impacted Collections</HD>
                <P>Section 1320.8(d), title 5, Code of Federal Regulations, requires PHMSA to provide interested members of the public and affected entities an opportunity to comment on information collection and recordkeeping requests. PHMSA will request a three-year term of approval for each of the following information collection activities.</P>
                <P>The following information is provided for each information collection: (1) Title of the information collection; (2) OMB control number; (3) Current expiration date; (4) Type of request; (5) Abstract of the information collection activity; (6) Description of affected public; (7) Estimate of total annual reporting and recordkeeping burden; and (8) Frequency of collection.</P>
                <P>
                    <E T="03">PHMSA requests comments on the following:</E>
                </P>
                <P>
                    1. 
                    <E T="03">Title:</E>
                     OPID Assignment Request and Registry Notifications.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     2137-0627.
                </P>
                <P>
                    <E T="03">Current Expiration Date:</E>
                     3/31/2025.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Renewal with no change of a currently approved collection.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The National Registry of Pipeline and LNG Operators serves as the storehouse for the reporting requirements for an operator regulated or subject to reporting requirements under 49 CFR parts 192, 193, or 195. This mandatory information collection would require jurisdictional pipeline operators to submit the required data to register with the National Registry of Pipeline and LNG Operators and notify PHMSA when they experience significant asset changes, including new construction, that affect PHMSA's ability to accurately monitor and assess pipeline safety performance. Certain types of changes to, or within, an operator's facilities or pipeline network represent potential safety-altering activities for which PHMSA may need to inspect, investigate, or otherwise oversee to ensure that any public safety concerns are adequately and proactively addressed. The forms for assigning and maintaining Operator Identification (OPID) information are the Operator Assignment Request Form (PHMSA F 1000.1) and Operator Registry Notification Form (PHMSA F 1000.2). The purpose of this information collection is to maintain an accurate assessment of the nation's pipeline infrastructure and to be kept abreast of conditions that could potentially compromise the safety and economic viability of the U.S. pipeline system. Due to the provisions contained within the Safety of Gas Gathering Pipelines: Extension of Reporting Requirements, Regulation of Large, High-Pressure Lines, and Other Related Amendments final rule, gas gathering pipeline operators must now request OPIDs due to the repeal of the reporting exception for gathering pipelines other than regulated gathering lines as determined in § 192.8. PHMSA plans to adjust the burden for this information collection to account for this addition to the reporting community.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Operators of natural gas and hazardous liquid pipeline systems and operators of liquefied natural gas facilities.
                </P>
                <P>
                    <E T="03">Annual Reporting and Recordkeeping Burden:</E>
                </P>
                <P>
                    <E T="03">Estimated number of responses:</E>
                     744.
                </P>
                <P>
                    <E T="03">Estimated annual burden hours:</E>
                     744.
                </P>
                <P>
                    <E T="03">Frequency of collection:</E>
                     On occasion
                </P>
                <P>
                    2. 
                    <E T="03">Title:</E>
                     Qualification of Pipeline Safety Training.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     2137-0600.
                </P>
                <P>
                    <E T="03">Current Expiration Date:</E>
                     04/30/2025.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Renewal with no change of a currently approved information collection.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     49 CFR part 192 subpart N and part 195 subpart G require all individuals who operate and maintain pipeline facilities to be qualified and keep records of qualification. The purpose of this mandatory information collection request is to ensure compliance with the record keeping requirements prescribed in the federal pipeline safety regulations. Pipeline operators must make and maintain the records as described and have those records available for compliance inspection by PHMSA staff upon request. Examples of such records include the identification of qualified individuals; identification of covered tasks; dates of current qualification; and qualification methods. Records supporting an individual's current qualification shall be maintained while the individual is performing the covered task. Records of prior qualification and records of individuals no longer performing covered tasks shall be retained for a period of five years.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Operators of PHMSA-regulated pipelines.
                </P>
                <P>
                    <E T="03">Annual Reporting and Recordkeeping Burden:</E>
                </P>
                <P>
                    <E T="03">Total Annual Responses:</E>
                     29,172.
                </P>
                <P>
                    <E T="03">Total Annual Burden Hours:</E>
                     7,293.
                </P>
                <P>
                    <E T="03">Frequency of Collection:</E>
                     On occasion.
                </P>
                <P>
                    3. 
                    <E T="03">Title:</E>
                     Hazardous Liquid Integrity Management.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     2137-0605.
                </P>
                <P>
                    <E T="03">Current Expiration Date:</E>
                     04/30/2025.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Renewal with no change of a currently approved information collection.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Operators of Hazardous Liquid Pipelines are required to document the continual assessment and evaluation of their pipelines' integrity through inspection or testing, as well as remedial preventive, and mitigative actions. In cases where a determination about pipeline threats has not been obtained within 180 days following the date of inspection, pipeline operators must notify PHMSA in writing and provide an expected date when adequate information will become available. Operators must also notify PHMSA if they are unable to assess their pipeline via an in-line inspection. Operators who choose to use an alternate assessment method must demonstrate that their pipeline is not capable of accommodating an in-line inspection tool and that the use of an alternative assessment method will provide a substantially equivalent understanding of the condition of the pipeline. This mandatory record keeping requirement supports the U.S. Department of Transportation's “SAFETY STRATEGIC GOAL” which targets three main strategic initiatives: managing risk and integrity, sharing responsibility, and providing effective stewardship. This goal enhances public health and safety by working toward the elimination of transportation-related deaths and injuries. This information is used by PHMSA to determine 
                    <PRTPAGE P="105686"/>
                    compliance with federal pipeline safety regulations and is also used by Agency and State Officials to assist federal and state pipeline safety inspectors who audit this information when they conduct compliance inspections and to provide background for failure investigations.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Operators of hazardous liquid pipeline systems.
                </P>
                <P>
                    <E T="03">Annual Reporting and Recordkeeping Burden:</E>
                </P>
                <P>
                    <E T="03">Estimated number of responses:</E>
                     10,515.
                </P>
                <P>
                    <E T="03">Estimated annual burden hours:</E>
                     344,807.
                </P>
                <P>
                    <E T="03">Frequency of Collection:</E>
                     On occasion.
                </P>
                <P>
                    4. 
                    <E T="03">Title:</E>
                     Public Awareness Program.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     2137-0622.
                </P>
                <P>
                    <E T="03">Current Expiration Date:</E>
                     04/30/2025.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Renewal with no change of a currently approved information collection.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     This information collection request would require pipeline operators to develop and implement public awareness programs. The public awareness programs should establish communications and provide information necessary to enhance public understanding of how pipelines function and the public's role in promoting pipeline safety. This mandatory information collection requires operators to submit their completed programs to PHMSA or, in the case of an intrastate pipeline facility operator, the appropriate State agency. The operator's program documentation and evaluation results must also be available for periodic review by appropriate regulatory agencies. This information will be used by PHMSA to evaluate compliance with pipeline safety regulations. The purpose of the collection is to prevent the risks caused by unintentional pipeline releases and their impact on the public and the environment.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Operators of natural gas and hazardous liquid pipelines.
                </P>
                <P>
                    <E T="03">Annual Reporting and Recordkeeping Burden:</E>
                </P>
                <P>
                    <E T="03">Estimated number of responses:</E>
                     45,004.
                </P>
                <P>
                    <E T="03">Estimated annual burden hours:</E>
                     517,546.
                </P>
                <P>
                    <E T="03">Frequency of Collection:</E>
                     On occasion.
                </P>
                <P>
                    5. 
                    <E T="03">Title:</E>
                     Gas and Liquid Pipeline Safety Program Certification.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     2137-0584.
                </P>
                <P>
                    <E T="03">Current Expiration Date:</E>
                     05/31/2025.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Renewal with no change of a currently approved information collection.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Section 60105 of 49 U.S.C. sets forth specific requirements a state must meet to qualify for certification status to assume regulatory and enforcement responsibility for intrastate pipelines, 
                    <E T="03">i.e.,</E>
                     state adoption of minimum federal safety standards, state inspection of pipeline operators to determine compliance with the standards, and state provision for enforcement sanctions substantially the same as those authorized by chapter 601, 49 U.S.C. A state must submit an annual certification to assume responsibility for regulating intrastate pipelines, and states who receive Federal grant funding must have adequate damage prevention plans and associated records in place. PHMSA uses this information to evaluate a state's eligibility for Federal grants and to enforce regulatory compliance. This information collection request requires a participating state to annually submit a Gas Pipeline Safety Program Certification and/or a Hazardous Liquid Pipeline Safety Program Certification to PHMSA's Office of Pipeline Safety (OPS) signifying compliance with the terms of the certification and to maintain records detailing a damage prevention plan for PHMSA inspectors whenever requested. The purpose of the collection is to exercise oversight of the grant program and to ensure that states are compliant with federal pipeline safety regulations.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Operators of pipeline facilities.
                </P>
                <P>
                    <E T="03">Annual Reporting and Recordkeeping Burden:</E>
                </P>
                <P>
                    <E T="03">Estimated number of responses:</E>
                     117.
                </P>
                <P>
                    <E T="03">Estimated annual burden hours:</E>
                     4,473.
                </P>
                <P>
                    <E T="03">Frequency of collection:</E>
                     On occasion
                </P>
                <P>
                    6. 
                    <E T="03">Title:</E>
                     Response Plans for Onshore Oil Pipelines.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     2137-0589.
                </P>
                <P>
                    <E T="03">Current Expiration Date:</E>
                     09/30/2025.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Renewal with no change of a currently approved information collection.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Title 49 CFR part 194 requires an operator of an onshore oil pipeline facility to prepare and submit an oil spill response plan to PHMSA for review and approval. This mandatory recordkeeping requirement details operators' plans to prepare for emergency situations involving oil spills. This mandatory information collection is used by PHMSA to determine if an operator is compliant with the requirements in part 194. Plans are submitted and/or updated annually. This information collection covers operators' submission of facility response plans for onshore hazardous liquid pipeline facilities.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Operators of onshore oil pipeline facilities.
                </P>
                <P>
                    <E T="03">Annual Reporting and Recordkeeping Burden:</E>
                </P>
                <P>
                    <E T="03">Estimated number of responses:</E>
                     540.
                </P>
                <P>
                    <E T="03">Estimated annual burden hours:</E>
                     73,980.
                </P>
                <P>
                    <E T="03">Frequency of Collection:</E>
                     On occasion.
                </P>
                <P>
                    7. 
                    <E T="03">Title:</E>
                     Gas Transmission Integrity Management in High Consequence Areas.
                </P>
                <P>
                    <E T="03">OMB Control Number: 2</E>
                    137-0610.
                </P>
                <P>
                    <E T="03">Current Expiration Date:</E>
                     09/30/2025.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Renewal with no change of a currently approved information collection.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     This mandatory information collection request pertains to gas transmission operators jurisdictional to 49 CFR part 192 subpart O Gas Transmission Integrity Management Program. The information collection requires gas transmission operators in high consequence areas to maintain a written integrity management program and keep records that demonstrate compliance with 49 CFR part 192 subpart O. Operators must maintain their integrity management records for the life of the pipeline, and PHMSA or State regulators may review it as a part of inspections. Gas transmission operators are also required to report to PHMSA certain actions related to their integrity management program. This information collection supports the DOT strategic goal of safety by reducing the number of incidents in natural gas transmission pipelines.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Operators of gas transmission pipeline systems.
                </P>
                <P>
                    <E T="03">Annual Reporting and Recordkeeping Burden:</E>
                </P>
                <P>
                    <E T="03">Estimated number of responses:</E>
                     733.
                </P>
                <P>
                    <E T="03">Estimated annual burden hours:</E>
                     1,018,807.
                </P>
                <P>
                    <E T="03">Frequency of Collection:</E>
                     On occasion.
                </P>
                <P>
                    8. 
                    <E T="03">Title:</E>
                     Control Room Management/Human Factors.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     2137-0624.
                </P>
                <P>
                    <E T="03">Current Expiration Date:</E>
                     09/30/2025.
                </P>
                <P>
                    <E T="03">Type of Request:</E>
                     Renewal with no change of a currently approved information collection.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Operators of gas and hazardous liquid pipelines must develop, implement, and submit human factors management plans designed to reduce risk associated with human factors in each control room. This mandatory record keeping requirement supports the U.S. Department of Transportation's “SAFETY STRATEGIC GOAL” which targets three main strategic initiatives: managing risk and integrity, sharing responsibility, and providing effective stewardship. This goal enhances public health and safety by working toward the elimination of transportation-related deaths and injuries. The information is used by PHMSA to determine compliance with federal pipeline safety regulations and is 
                    <PRTPAGE P="105687"/>
                    also used by Agency and State Officials to assist federal and state pipeline safety inspectors who audit this information when they conduct compliance inspections and to provide background for failure investigations.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Operators of natural gas and hazardous liquid pipeline systems.
                </P>
                <P>
                    <E T="03">Annual Reporting and Recordkeeping Burden:</E>
                </P>
                <P>
                    <E T="03">Estimated number of responses:</E>
                     11,656.
                </P>
                <P>
                    <E T="03">Estimated annual burden hours:</E>
                     127,328.
                </P>
                <P>
                    <E T="03">Frequency of Collection:</E>
                     On occasion.
                </P>
                <P>Comments are invited on:</P>
                <P>(a) The need for this information collections for the proper performance of the functions of the Agency, including whether the information will have practical utility;</P>
                <P>(b) The accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;</P>
                <P>(c) Ways to enhance the quality, utility, and clarity of the information to be collected; and</P>
                <P>(d) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques.</P>
                <P>
                    <E T="03">Authority:</E>
                     The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended, and 49 CFR 1.48.
                </P>
                <SIG>
                    <DATED>Issued in Washington, DC, on December 20, 2024, under authority delegated in 49 CFR 1.97.</DATED>
                    <NAME>John A. Gale,</NAME>
                    <TITLE>Director, Standards and Rulemaking Division.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30990 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-60-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE TREASURY</AGENCY>
                <SUBAGY>Office of Foreign Assets Control</SUBAGY>
                <SUBJECT>Notice of OFAC Sanctions Actions</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Foreign Assets Control, Treasury.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        This action was issued on December 2, 2024. See 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         for relevant dates.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        OFAC: Associate Director for Global Targeting, 202-622-2420; or the Assistant Director for Sanctions Compliance, 202-622-2490 or 
                        <E T="03">https://ofac.treasury.gov/contact-ofac.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Electronic Availability</HD>
                <P>
                    The SDN List and additional information concerning OFAC sanctions programs are available on OFAC's website: 
                    <E T="03">https://ofac.treasury.gov.</E>
                </P>
                <HD SOURCE="HD1">Notice of OFAC Actions</HD>
                <P>On December 2, 2024, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authority listed below.</P>
                <HD SOURCE="HD1">Individuals:</HD>
                <EXTRACT>
                    <P>1. KHUDAIBERGANOVA, Yulduz, Uzbekistan; DOB 1979; POB Urgench, Uzbekistan; nationality Uzbekistan; Gender Female (individual) [GLOMAG].</P>
                    <P>Designated pursuant to section 1(a)(ii)(A) of Executive Order 13818 of December 20, 2017, “Blocking the Property of Persons Involved in Serious Human Rights Abuse or Corruption,” 82 FR 60839, 3 CFR, 2017 Comp., p. 399 (E.O. 13818) for being a foreign person who is responsible for or complicit in, or has directly or indirectly engaged in, serious human rights abuse.</P>
                    <P>2. KURYAZOV, Anvar, Uzbekistan; DOB 1984; POB Yangiaryk District, Uzbekistan; nationality Uzbekistan; Gender Male (individual) [GLOMAG].</P>
                    <P>Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being a foreign person who is responsible for or complicit in, or has directly or indirectly engaged in, serious human rights abuse.</P>
                    <P>3. MASHARIPOV, Aybek, Uzbekistan; DOB 1979; POB Nukus, Uzbekistan; nationality Uzbekistan; Gender Male (individual) [GLOMAG].</P>
                    <P>Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being a foreign person who is responsible for or complicit in, or has directly or indirectly engaged in, serious human rights abuse.</P>
                </EXTRACT>
                <SIG>
                    <NAME>Lisa M. Palluconi,</NAME>
                    <TITLE>Acting Director, Office of Foreign Assets Control.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30821 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4810-AL-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE TREASURY</AGENCY>
                <SUBJECT>Agency Information Collection Activities; Submission for OMB Review; Comment Request; Reporting, Procedures and Penalties Regulations</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Departmental Offices, U.S. Department of the Treasury.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of information collection; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments should be received on or before January 27, 2025 to be assured of consideration.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Copies of the submissions may be obtained from Spencer W. Clark by emailing 
                        <E T="03">PRA@treasury.gov,</E>
                         calling (202) 927-5331, or viewing the entire information collection request at 
                        <E T="03">www.reginfo.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Office of Foreign Assets Control (OFAC)</HD>
                <P>
                    <E T="03">Title:</E>
                     Reporting, Procedures and Penalties Regulations and Other Information Collections Maintained by the Office of Foreign Assets Control.
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1505-0164.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Revision of a currently approved collection.
                </P>
                <P>
                    <E T="03">Description:</E>
                     This information collection request is submitted to renew and revise the information collection authority in the Office of Foreign Assets Control's (OFAC) Reporting, Procedures and Penalties Regulations (31 CFR part 501) (“the Regulations”), and certain other parts of 31 CFR chapter V.
                </P>
                <P>
                    The Regulations and other parts of 31 CFR chapter V are implemented pursuant to the Trading With the Enemy Act (50 U.S.C. 4301 
                    <E T="03">et seq.</E>
                    ), the International Emergency Economic Powers Act (50 U.S.C. 1701 
                    <E T="03">et seq.</E>
                    ), the United Nations Participation Act of 1945 (22 U.S.C. 287c), and other laws. 
                    <PRTPAGE P="105688"/>
                    The collections of information relevant to this request are contained in §§ 501.601 through 501.605, 501.801, and 501.804 through 501.807, and certain other parts of 31 CFR chapter V, and pertain to the operation of various economic sanctions programs administered by OFAC under 31 CFR chapter V.
                </P>
                <P>In addition, OFAC seeks to consolidate within this information collection request five existing information collection requests, which are relevant to 31 CFR 501.801, 515.572, 561.504, and 566.504.</P>
                <P>
                    <E T="03">Forms:</E>
                     For filers who have been granted an exception from electronic reporting using the OFAC Reporting System (ORS), OFAC allows the submission of the following, through the following approved forms: the Annual Report of Blocked Property (ARBP), TD-F 90-22.50; Report on Blocked Property—Financial, TD-F 93.02; Report on Blocked Property—Tangible/Real/Other Non-Financial Property, TD-F 93.08; Report on Rejected Transaction, TD-F 93.07. OFAC also maintains the following forms related to licensing: TSRA License Application, TD-F 93.04; Licensing Cover Sheet, TD-F 98-22.61; and Application for the Release of Blocked Funds TD-F 90-22.54. In addition, OFAC issued a new form, REPO for Ukrainians Act Report Form, TD-F 93.09, to implement a new reporting requirement pursuant to the Rebuilding Economic Prosperity and Opportunity for Ukrainians Act for financial institutions holding Russian sovereign assets, if not previously reported to OFAC. The other information collections covered by this notice do not have mandatory or voluntary forms.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Financial institutions, business organizations, nonprofit organizations, individuals, households, nongovernmental organizations, and legal representatives.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     10,900.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     The estimated annual frequency of responses is between 1 and 17,800, varying greatly by entity depending on the size, nature, and scope of business activities of each respondent, with the majority of filers providing a small number of responses and a small number of filers submitting a higher number of responses.
                </P>
                <P>
                    <E T="03">Estimated Total Number of Annual Responses:</E>
                     2,502,086.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     OFAC assesses that there is an average time estimate for reports associated with forms ranging from 15 minutes to 2 hours and for reports associated with general licenses, Cuba remittances, Cuba travel, closure of correspondent or payable-through accounts, and other miscellaneous reports ranging from 1 minute to 5 hours.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     86,223.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <NAME>Spencer W. Clark,</NAME>
                    <TITLE>Treasury PRA Clearance Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30825 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4810-AK-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE TREASURY</AGENCY>
                <RIN>RIN 1505-AC62</RIN>
                <SUBJECT>IMARA Calculation for Calendar Year 2025 Under the Terrorism Risk Insurance Program</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Departmental Offices, Department of the Treasury.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of the Treasury (Treasury) is providing notice to the public of the insurance marketplace aggregate retention amount (IMARA) for calendar year 2025 for purposes of the Terrorism Risk Insurance Program (TRIP or the Program) under the Terrorism Risk Insurance Act, as amended (TRIA or the Act). As explained below, Treasury has determined that the IMARA for calendar year 2025 is $53,366,227,478.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The IMARA for calendar year 2025 is effective January 1, 2025 through December 31, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Richard Ifft, Lead Management and Senior Regulatory Policy Analyst, Terrorism Risk Insurance Program, Federal Insurance Office, 202-622-2922 or Theodore Newman, Senior Insurance Regulatory Policy Analyst, Federal Insurance Office, 202-622-7009.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    TRIA—which established TRIP—was signed into law on November 26, 2002, following the attacks of September 11, 2001, to address disruptions in the market for terrorism risk insurance, to help ensure the continued availability and affordability of commercial property and casualty insurance for terrorism risk, and to allow for the private markets to stabilize and build insurance capacity to absorb any future losses for terrorism events.
                    <SU>1</SU>
                    <FTREF/>
                     TRIA requires insurers to “make available” terrorism risk insurance for commercial property and casualty losses resulting from certified acts of terrorism, and provides for shared public and private compensation for such insured losses. The Program has been reauthorized four times, most recently by the Terrorism Risk Insurance Program Reauthorization Act of 2019.
                    <SU>2</SU>
                    <FTREF/>
                     The Secretary of the Treasury (Secretary) administers the Program, with assistance from the Federal Insurance Office (FIO).
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         Public Law 107-297, sec. 101(b), 116 Stat. 2322, codified at 15 U.S.C. 6701 note. Because the provisions of TRIA (as amended) appear in a note instead of particular sections of the U.S. Code, the provisions of TRIA are identified by the sections of the law.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         See Terrorism Risk Insurance Extension Act of 2005, Public Law 109-144, 119 Stat. 2660; Terrorism Risk Insurance Program Reauthorization Act of 2007, Public Law 110-160, 121 Stat. 1839; Terrorism Risk Insurance Program Reauthorization Act of 2015, Public Law 114-1, 129 Stat. 3 (2015 Reauthorization Act); Terrorism Risk Insurance Program Reauthorization Act of 2019, Public Law 116-94, 133 Stat. 2534.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         31 U.S.C. 313(c)(1)(D).
                    </P>
                </FTNT>
                <P>
                    TRIA provides for an “industry marketplace aggregate retention amount” or “IMARA” to be used for determining whether Treasury must recoup any payments it makes under the Program. Under the Act, if total annual payments by all participating insurers are below the IMARA, then Treasury must recoup all amounts expended by it up to the IMARA threshold. If total annual payments by all participating insurers are above the IMARA, then Treasury has the discretionary authority (but not the obligation) to recoup all of the expended amounts that are above the IMARA threshold.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         TRIA, sec. 103(e)(7); see also 31 CFR part 50 subpart J (Recoupment and Surcharge Procedures).
                    </P>
                </FTNT>
                <P>
                    TRIA provides for a schedule of defined IMARA values from calendar year 2015 through calendar year 2019.
                    <SU>5</SU>
                    <FTREF/>
                     For calendar year 2020 and beyond, TRIA states that the IMARA “shall be revised to be the amount equal to the annual average of the sum of insurer deductibles for all insurers participating in the Program for the prior 3 calendar years,” as such sum is determined pursuant to final rules issued by the Secretary.
                    <SU>6</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         In 2015, the IMARA was $29.5 billion; it increased to $31.5 billion in 2016, $33.5 billion in 2017, $35.5 billion in 2018, and $37.5 billion in 2019. 
                        <E T="03">See</E>
                         TRIA, sec. 103(e)(6)(B).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         TRIA, sec. 103(e)(6)(B)(ii) and (e)(6)(C). An insurer's deductible under the Program for any particular year is 20 percent of its direct earned premium subject to the Program during the preceding year. TRIA, sec. 102(7). For example, an insurer's calendar year 2024 Program deductible is 20 percent of its calendar year 2023 direct earned premium.
                    </P>
                </FTNT>
                <P>
                    On November 15, 2019, Treasury issued a final rule for calculation of the IMARA.
                    <SU>7</SU>
                    <FTREF/>
                     This rule, which is codified at 31 CFR 50.4(m)(2), provides that the 
                    <PRTPAGE P="105689"/>
                    IMARA will be calculated by averaging the annual industry aggregate deductibles over the prior three calendar years, based upon the direct earned premiums (DEP) reported to Treasury by insurers in Treasury's annual data calls. Insurer deductibles under the Program are based upon the DEP of individual insurers reported to Treasury in the prior year (
                    <E T="03">e.g.,</E>
                     2023 DEP for 2024 calendar year program deductibles).
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">See</E>
                         84 FR 62450 (November 15, 2019) (Final Rule).
                    </P>
                </FTNT>
                <P>Accordingly, for purposes of determining the IMARA for calendar 2025, Treasury has averaged the aggregate insurer deductibles for calendar years 2024, 2023, and 2022 (as reported to Treasury in each of these years), which are based on the reported DEP for calendar years 2023, 2022, and 2021, respectively.</P>
                <P>
                    For purposes of the 2025 IMARA calculation, those figures are as follows:
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         The figures from the 2022 and 2021 TRIP data calls were previously reported in the IMARA calculation for calendar year 2024. 
                        <E T="03">See</E>
                         88 FR 87843 (December 19, 2023). The figures from the 2024 TRIP data call were previously reported in FIO's June 2024 Report on the Effectiveness of the Terrorism Risk Insurance Program (June 2024), 10 (Figure 1), 
                        <E T="03">https://home.treasury.gov/system/files/311/2024ProgramEffectivenessReportFINAL6.28.2024508.pdf,</E>
                         and have been updated to include data received by FIO after the reporting deadline. Some figures may not add up on account of rounding.
                    </P>
                </FTNT>
                <GPOTABLE COLS="7" OPTS="L2,p7,7/8,i1" CDEF="s50,16,10p,16,10p,16,10">
                    <TTITLE>
                        TRIP-Eligible DEP by Insurer Category 
                        <SU>8</SU>
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1"> </CHED>
                        <CHED H="1">2022 TRIP data call</CHED>
                        <CHED H="2">
                            2021 DEP in 
                            <LI>TRIP-</LI>
                            <LI>eligible lines</LI>
                        </CHED>
                        <CHED H="2">% of total</CHED>
                        <CHED H="1">2023 TRIP data call</CHED>
                        <CHED H="2">
                            2021 DEP in 
                            <LI>TRIP-</LI>
                            <LI>eligible lines</LI>
                        </CHED>
                        <CHED H="2">% of total</CHED>
                        <CHED H="1">2024 TRIP data call</CHED>
                        <CHED H="2">
                            2021 DEP in 
                            <LI>TRIP-</LI>
                            <LI>eligible lines</LI>
                        </CHED>
                        <CHED H="2">% of total</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Alien Surplus Lines Ins</ENT>
                        <ENT>$12,107,214,064</ENT>
                        <ENT>5</ENT>
                        <ENT>$16,954,356,655</ENT>
                        <ENT>6</ENT>
                        <ENT>$16,431,481,136</ENT>
                        <ENT>6</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Captive Insurers</ENT>
                        <ENT>14,359,289,661</ENT>
                        <ENT>6</ENT>
                        <ENT>11,992,422,807</ENT>
                        <ENT>4</ENT>
                        <ENT>13,952,931,340</ENT>
                        <ENT>5</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Non-Small Insurers</ENT>
                        <ENT>186,901,545,992</ENT>
                        <ENT>78</ENT>
                        <ENT>209,307,242,717</ENT>
                        <ENT>78</ENT>
                        <ENT>227,192,745,100</ENT>
                        <ENT>78</ENT>
                    </ROW>
                    <ROW RUL="n,s">
                        <ENT I="01">Small Insurers</ENT>
                        <ENT>26,226,080,899</ENT>
                        <ENT>11</ENT>
                        <ENT>31,206,381,036</ENT>
                        <ENT>12</ENT>
                        <ENT>33,861,720,766</ENT>
                        <ENT>12</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="03">Total</ENT>
                        <ENT>239,594,130,617</ENT>
                        <ENT>100</ENT>
                        <ENT>269,460,403,215</ENT>
                        <ENT>100</ENT>
                        <ENT>291,438,878,341</ENT>
                        <ENT>100</ENT>
                    </ROW>
                    <TNOTE>Source: 2022-2024 TRIP Data Calls.</TNOTE>
                </GPOTABLE>
                <P>
                    Treasury has used these reported premiums to calculate the IMARA for calendar year 2025. The average annual DEP figure for the combined period of 2021, 2022, and 2023 is $266,831,137,391 [($239,594,130,617 + $269,460,403,215 + $291,438,878,341)/3 = $266,831,137,391]. The average aggregate deductible for the prior three years is 20 percent of $266,831,137,391, which equals $53,366,227,478.
                    <SU>9</SU>
                    <FTREF/>
                     Accordingly, the IMARA for purposes of calendar year 2025 is $53,366,227,478.
                </P>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">See</E>
                         note 7.
                    </P>
                </FTNT>
                <SIG>
                    <DATED>Dated: December 19, 2024.</DATED>
                    <NAME>Steven E. Seitz,</NAME>
                    <TITLE>Director, Federal Insurance Office.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30885 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4810-AK-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF VETERANS AFFAIRS</AGENCY>
                <DEPDOC>[OMB Control No. 2900-XXXX]</DEPDOC>
                <SUBJECT>Agency Information Collection Activity: Veterans Legacy Memorial (VLM)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Cemetery Administration, Department of Veterans Affairs.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        National Cemetery Administration (NCA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the 
                        <E T="04">Federal Register</E>
                         concerning each proposed collection of information, including each proposed extension of a currently approved collection, and allow 60 days for public comment in response to the notice. 
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P> Comments must be received on or before February 25, 2025.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Comments must be submitted through 
                        <E T="03">www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P/>
                    <P>
                        <E T="03">Program-Specific information:</E>
                         Brian Hurley, 202-957-2093, 
                        <E T="03">Brian.Hurley1@va.gov.</E>
                    </P>
                    <P>
                        <E T="03">VA PRA information:</E>
                         Maribel Aponte, 202-461-8900, 
                        <E T="03">vacopaperworkreduact@va.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P> Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to section 3506(c)(2)(A) of the PRA.</P>
                <P>With respect to the following collection of information, NCA invites comments on: (1) whether the proposed collection of information is necessary for the proper performance of NCA's functions, including whether the information will have practical utility; (2) the accuracy of NCA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.</P>
                <P>
                    <E T="03">Title:</E>
                     Veterans Legacy Memorial (VLM).
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     2900-XXXX. 
                    <E T="03">https://www.reginfo.gov/public/do/PRASearch</E>
                     (Once at this link, you can enter the OMB Control Number to find the historical versions of this Information Collection).
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Existing collection in use without an OMB Control Number.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     NCA owns and manages the Veterans Legacy Memorial (VLM)—the largest Veteran memorialize site in the nation. VLM provides eligible Veterans with enhanced memorialization services by honoring their military service through online, web-based memorial pages. Users such as Next of Kin, friends, researchers, servicemembers, and the public are permitted to submit a variety of content to a Veterans VLM page including tributes, images, biographies, career and life milestones, documents, and more. Living Veterans who have requested and received an eligibility determination for burial in a VA national cemetery in advance of need may also submit biographical content to the VA so that after they die, if a VLM page is created for them by the VA, the content they submitted will appear on their VLM page. Next of Kin and Living Veterans are sent a general solicitation for this voluntary information, and all submitted content is moderated by the VA to ensure it complies with the VLM User Policy, 
                    <PRTPAGE P="105690"/>
                    available here: 
                    <E T="03">https://www.cem.va.gov/VLM/userpolicy.asp.</E>
                     The information obtained through this collection is used solely to provide enhanced memorialization services that honor eligible deceased Veterans.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Veterans who have been determined to be eligible for VA burial in advance of their time of need, their Next of Kin, and the public.
                </P>
                <P>
                    <E T="03">Estimated Annual Burden:</E>
                     22,500 hours.
                </P>
                <P>
                    <E T="03">Estimated Average Burden per Respondent:</E>
                     18 minutes.
                </P>
                <P>
                    <E T="03">Frequency of Response:</E>
                     One-time.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     75,000.
                </P>
                <P>
                    <E T="03">Authority:</E>
                     44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                </P>
                <SIG>
                    <NAME>Maribel Aponte,</NAME>
                    <TITLE>VA PRA Clearance Officer, Office of Enterprise and Integration/Data Governance Analytics, Department of Veterans Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2024-30949 Filed 12-26-24; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8320-01-P</BILCOD>
        </NOTICE>
    </NOTICES>
    <VOL>89</VOL>
    <NO>248</NO>
    <DATE>Friday, December 27, 2024</DATE>
    <UNITNAME>Presidential Documents</UNITNAME>
    <PRESDOCS>
        <PRESDOCU>
            <PROCLA>
                <TITLE3>Title 3—</TITLE3>
                <PRES>
                    The President
                    <PRTPAGE P="105333"/>
                </PRES>
                <PROC>Proclamation 10875 of December 20, 2024</PROC>
                <HD SOURCE="HED">To Implement the United States-Israel Agreement on Trade in Agricultural Products and for Other Purposes</HD>
                <PRES>By the President of the United States of America</PRES>
                <PROC>A Proclamation</PROC>
                <FP>1. On April 22, 1985, the United States and Israel entered into the Agreement on the Establishment of a Free Trade Area between the Government of the United States of America and the Government of Israel (USIFTA), which the Congress approved in section 3 of the United States-Israel Free Trade Area Implementation Act of 1985 (the “USIFTA Implementation Act”) (Public Law 99-47, 99 Stat. 82 (19 U.S.C. 2112 note)). Section 4(b) of the USIFTA Implementation Act provides that, whenever the President determines that it is necessary to maintain the general level of reciprocal and mutually advantageous concessions with respect to Israel provided for by the USIFTA, the President may proclaim such withdrawal, suspension, modification, or continuance of any duty, or such continuance of existing duty-free or excise treatment, or such additional duties, as the President determines to be required or appropriate to carry out the USIFTA. In order to maintain the general level of reciprocal and mutually advantageous concessions with respect to agricultural trade with Israel, on July 27, 2004, the United States entered into an agreement with Israel concerning certain aspects of trade in agricultural products during the period January 1, 2004, through December 31, 2008 (United States-Israel Agreement Concerning Certain Aspects of Trade in Agricultural Products (the “2004 Agreement”)). </FP>
                <FP>
                    2. In Proclamation 7826 of October 4, 2004, the President determined, pursuant to section 4(b) of the USIFTA Implementation Act and consistent with the 2004 Agreement, that, in order to maintain the general level of reciprocal and mutually advantageous concessions with respect to Israel provided for by the USIFTA, it was necessary to provide duty-free access into the United States through December 31, 2008, for specified quantities of certain agricultural products of Israel. Each year from 2008 through 2023, the United States and Israel entered into agreements to extend the period that the 2004 Agreement was in force for 1-year periods to allow additional time for the two governments to conclude an agreement to replace the 2004 Agreement. To carry out the extension agreements, the President in Proclamations 8334 of December 31, 2008; 8467 of December 23, 2009; 8618 of December 21, 2010; 8770 of December 29, 2011; 8921 of December 20, 2012; 9072 of December 23, 2013; 9223 of December 23, 2014; 9383 of December 21, 2015; 9555 of December 15, 2016; 9687 of December 22, 2017; 9834 of December 21, 2018; 9974 of December 26, 2019; 10128 of December 22, 2020; 10326 of December 23, 2021; 10509 of December 23, 2022; and 10692 of December 29, 2023, modified the Harmonized Tariff Schedule of the United States (HTS) to provide duty-free access into the United States for specified quantities of certain agricultural products of Israel, each time for an additional 1-year period. On October 31, 2024, the United States entered into an agreement with Israel to extend the period that the 2004 Agreement is in force through December 31, 2025, and to allow for further negotiations on an agreement to replace the 2004 Agreement. Pursuant to section 4(b) of the USIFTA Implementation Act, I have determined that it is necessary, in order to maintain the general level of reciprocal and mutually advantageous concessions with respect to Israel provided for 
                    <PRTPAGE P="105334"/>
                    by the USIFTA, to provide duty-free access into the United States through the close of December 31, 2025, for specified quantities of certain agricultural products of Israel, as provided in Annex I of this proclamation.
                </FP>
                <FP>3. Proclamation 10053 of June 29, 2020, implemented the Agreement between the United States of America, the United Mexican States, and Canada (USMCA) with respect to the United States and, pursuant to section 103 of the United States-Mexico-Canada Agreement Implementation Act (the “USMCA Implementation Act”) (Public Law 116-113, 134 Stat. 11, 15-17 (19 U.S.C. 4513)), incorporated in the HTS the tariff modifications and rules of origin necessary or appropriate to carry out the USMCA.</FP>
                <FP>4. In order to provide generally for the preferential tariff treatment being accorded under the USMCA, to set forth rules for determining whether goods imported into the customs territory of the United States are eligible for preferential tariff treatment under the USMCA, to provide tariff-rate quotas with respect to certain originating goods of Canada, and to provide certain other treatment to originating goods for purposes of the USMCA, Proclamation 10053 modified the HTS as set forth in Annex I of Publication 5060 of the United States International Trade Commission (the “Commission”), entitled “Modifications to the Harmonized Tariff Schedule of the United States to Implement the United States-Mexico-Canada Agreement” (Publication 5060), including by adding general note 11. Proclamation 10053 further modified the HTS to reflect the termination of tariff treatment under the North American Free Trade Agreement (NAFTA), as set forth in Annex III of Publication 5060, including by deleting general note 12. </FP>
                <FP>5. In order to implement the initial stage of duty reduction provided for in the USMCA, to provide for future staged reductions in duties for originating goods provided for in the USMCA, and to provide tariff-rate quotas with respect to certain goods provided for in the USMCA, Proclamation 10053 modified the HTS as set forth in Annex II of Publication 5060. </FP>
                <FP>6. A technical error was made in the modifications to U.S. note 3(d) to subchapter II of chapter 98 of the HTS, and certain references to general note 12 were inadvertently not modified. I have determined that additional modifications to the HTS are necessary or appropriate to provide for the intended tariff treatment under the USMCA, including certain technical or conforming changes within the tariff schedule. </FP>
                <FP>7. Proclamation 7987 of February 28, 2006, implemented the Dominican Republic-Central America-United States Free Trade Agreement (DR-CAFTA) with respect to the United States and, pursuant to section 201 of the Dominican Republic-Central America-United States Free Trade Agreement Implementation Act (the “DR-CAFTA Act”) (Public Law 109-53, 119 Stat. 462, 467 (19 U.S.C. 4001 note)), incorporated in the HTS the tariff modifications and rules of origin necessary or appropriate to carry out certain provisions of the DR-CAFTA. </FP>
                <FP>8. A rule of origin under the DR-CAFTA, found in general note 29 to the HTS, contains a reference to general note 12. Proclamation 10053 deleted general note 12 but omitted a conforming change to the reference in general note 29. I have determined that an additional modification to the HTS is necessary or appropriate to reflect this conforming change. </FP>
                <FP>
                    9. Section 602 of the Consolidated Appropriations Act, 2021 (Public Law 116-260, 134 Stat. 1182, 2152-54), made technical corrections to other laws, including replacing certain references to the NAFTA with references to the USMCA in sections 112 and 113(b) of the African Growth and Opportunity Act (the “AGOA”) (title I of Public Law 106-200, 114 Stat. 251, 258-265 (19 U.S.C. 3721, 3722(b))), as amended by the Africa Investment Incentive Act of 2006 (title VI of Public Law 109-432, 120 Stat. 2922, 3190-94), and in sections 212(a), 213(b), and 213A(b) of the Caribbean Basin Economic Recovery Act (the “CBERA”) (title II of Public Law 98-67, 97 Stat. 369, 384-85, 388 (19 U.S.C. 2702(a)(1), 2703(b), 2703a(b))), as amended by the United States-Caribbean Basin Trade Partnership Act 
                    <PRTPAGE P="105335"/>
                    (title II of Public Law 106-200, 114 Stat. 251, 275-288), the Haitian Hemispheric Opportunity through Partnership Encouragement Act of 2006 (title V of Public Law 109-432, 109 Stat. 2922, 3181-87), and the Haitian Hemispheric Opportunity through Partnership Encouragement Act of 2008 (subtitle D of Public Law 110-234, 122 Stat. 923, 1527-47).
                </FP>
                <FP>10. I have determined that additional modifications to the HTS are necessary or appropriate to provide for the intended tariff treatment under the AGOA and the CBERA, including certain technical or conforming changes within the tariff schedule.</FP>
                <FP>11. Section 104(c) of the Trade Preferences Extension Act of 2015 (the “TPEA”) (Public Law 114-27, 129 Stat. 362, 365 (19 U.S.C. 2466a note)) authorizes the President to proclaim modifications that may be necessary to add the special tariff treatment symbol “D” in the “Special” subcolumn of the HTS for each article classified under a heading or subheading with the special tariff treatment symbol “A” or “A*” in the “Special” subcolumn of the HTS. Pursuant to section 104(c) of the TPEA, Proclamation 9466 of June 30, 2016, modified the HTS to add the special tariff treatment symbol “D” in the HTS as set forth in Annex III of that proclamation.</FP>
                <FP>12. The modifications to the HTS authorized in Proclamation 9466 included certain technical errors. I have determined that additional modifications to the HTS are necessary or appropriate to provide for the intended tariff treatment under the AGOA, as authorized by section 104(c) of the TPEA, including certain technical or conforming changes within the tariff schedule.</FP>
                <FP>13. Proclamation 6763 of December 23, 1994, implemented, with respect to the United States, the trade agreements resulting from the Uruguay Round of multilateral trade negotiations, including Schedule XX-United States of America, annexed to the Marrakesh Protocol to the General Agreement on Tariffs and Trade 1994 (Schedule XX), that were entered into pursuant to sections 1102(a) and (e) of the Omnibus Trade and Competitiveness Act of 1988 (the “1988 Act”) (Public Law 100-418, 102 Stat. 1107, 1126 (19 U.S.C. 2902(a) and (e))), as amended by Public Law 103-49, 107 Stat. 239, and approved in section 101(a) of the Uruguay Round Agreements Act (the “URAA”) (Public Law 103-465, 108 Stat. 4809, 4814-15 (19 U.S.C. 3511(a))). </FP>
                <FP>14. Pursuant to the authority provided in section 111 of the URAA (19 U.S.C. 3521) and sections 1102(a) and (e) of the 1988 Act (19 U.S.C. 2902(a) and (e)), Proclamation 6763 included the staged reductions in rates of duty that the President determined to be necessary or appropriate to carry out the terms of Schedule XX.</FP>
                <FP>15. Section 1205(a) of the 1988 Act (102 Stat. 1150 (19 U.S.C. 3005(a))) directs the Commission to keep the HTS under continuous review and to periodically recommend to the President such modifications to the HTS as the Commission considers necessary or appropriate to accomplish the purposes set forth in that subsection.</FP>
                <FP>16. Pursuant to sections 1205(c) and (d) of the 1988 Act (102 Stat. 1150-51 (19 U.S.C. 3005(c) and (d))), in 2010, 2015, and 2021, the Commission recommended modifications to the HTS to conform the HTS to amendments made to the International Convention on the Harmonized Commodity Description and Coding System and the Protocol thereto (the “Convention”).</FP>
                <FP>17. Section 1206(a) of the 1988 Act (102 Stat. 1151 (19 U.S.C. 3006(a))) authorizes the President to proclaim modifications to the HTS based on the recommendations of the Commission under section 1205 of the 1988 Act if the President determines that the modifications are in conformity with United States obligations under the Convention and do not run counter to the national economic interest of the United States.</FP>
                <FP>
                    18. Proclamation 8771 of December 29, 2011, Proclamation 9549 of December 1, 2016, and Proclamation 10326 of December 23, 2021, modified the HTS pursuant to section 1206 of the 1988 Act to conform the HTS to the amendments to the Convention. However, the HTS modifications authorized in 
                    <PRTPAGE P="105336"/>
                    Proclamation 8771, Proclamation 9549, and Proclamation 10326 each included certain technical errors.
                </FP>
                <FP>19. Proclamation 8771 incorrectly modified the column 2 rate of duty for subheadings 0401.40.25 and 0401.50.25, and the “General” subcolumn rate of duty for column 1 and the column 2 rate of duty for subheading 6505.00.01. I have determined that additional modifications to the HTS are necessary or appropriate to provide for the intended tariff treatment.</FP>
                <FP>20. Proclamation 9549 and Proclamation 10326 each created certain new subheadings with the special tariff treatment symbol “A” or “A*” in the “Special” subcolumn of the HTS, but omitted the special tariff treatment symbol “D”. I have determined that additional modifications to the HTS are necessary or appropriate to provide for the intended tariff treatment under the AGOA, including certain technical or conforming changes within the tariff schedule.</FP>
                <FP>21. Proclamation 10326 also included technical errors with respect to other subheadings. I have determined that additional modifications to the HTS are necessary or appropriate to provide for the intended tariff treatment, including the tariff treatment previously proclaimed in Proclamation 6763.</FP>
                <FP>22. In Proclamation 9705 of March 8, 2018, pursuant to section 232 of the Trade Expansion Act of 1962, as amended (the “Trade Expansion Act”) (Public Law 87-794, 76 Stat. 872, 877 (19 U.S.C. 1862)), the President concurred with the finding of the Secretary of Commerce that steel articles, as defined in clause 1 of Proclamation 9705 (as amended by clause 8 of Proclamation 9711 of March 22, 2018), are being imported into the United States in such quantities and under such circumstances as to threaten to impair the national security of the United States, and decided to adjust the imports of steel articles by imposing a 25 percent ad valorem tariff on such articles imported from all countries except Canada and Mexico. Proclamation 9740 of April 30, 2018, and Proclamation 9759 of May 31, 2018, modified the HTS to provide quotas with respect to steel articles imported from certain countries. Proclamation 10328 of December 27, 2021, Proclamation 10356 of March 31, 2022, Proclamation 10406 of May 31, 2022, and Proclamation 10691 of December 28, 2023, modified the HTS to provide tariff-rate quotas with respect to steel articles imported from certain countries. </FP>
                <FP>23. On July 1, 2024, the Commission, in cooperation with the interagency Committee for Statistical Annotation of Tariff Schedules, implemented certain changes in 10-digit statistical reporting categories of the HTS under section 484(f) of the Tariff Act of 1930 (ch. 497, 46 Stat. 590, 723 (19 U.S.C. 1484(f))), as amended by section 637 of the North American Free Trade Agreement Implementation Act (Public Law 103-182, 107 Stat. 2057, 2202). I have determined that certain conforming amendments to the HTS are necessary in order to ensure the maintenance of duty rates, quotas, and tariff-rate quotas for steel articles under tariff categories that were modified.</FP>
                <FP>24. Section 604 of the Trade Act of 1974, as amended (the “Trade Act”) (Public Law 93-618, 88 Stat. 1978, 2073 (19 U.S.C. 2483)), authorizes the President to embody in the HTS the substance of the relevant provisions of that Act, and of other acts affecting import treatment, and actions taken thereunder, including the removal, modification, continuance, or imposition of any rate of duty or other import restriction. </FP>
                <FP>NOW, THEREFORE, I, JOSEPH R. BIDEN JR., President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States of America, including but not limited to section 4(b) of the USIFTA Implementation Act, section 104(c) of the TPEA, section 1206(a) of the 1988 Act, section 232 of the Trade Expansion Act, and section 604 of the Trade Act, do proclaim that: </FP>
                <FP SOURCE="FP1">
                    (1) In order to implement tariff commitments under the 2004 Agreement through December 31, 2025, the HTS is modified as set forth in Annex I of this proclamation.
                    <PRTPAGE P="105337"/>
                </FP>
                <FP SOURCE="FP1">(2) The modifications and technical rectifications to the HTS made by Annex I of this proclamation shall enter into effect on the applicable dates set forth in Annex I of this proclamation.</FP>
                <FP SOURCE="FP1">(3) In order to make the modifications and technical rectifications to the HTS described in paragraphs 3 through 24 of this proclamation, the HTS is modified as set forth in Annex II of this proclamation. These modifications and technical rectifications shall enter into effect on the applicable dates set forth in Annex II of this proclamation.</FP>
                <FP SOURCE="FP1">(4) Any provisions of previous proclamations and Executive Orders that are inconsistent with the actions taken in this proclamation are superseded to the extent of such inconsistency.</FP>
                <FP>IN WITNESS WHEREOF, I have hereunto set my hand this twentieth day of December, in the year of our Lord two thousand twenty-four, and of the Independence of the United States of America the two hundred and forty-ninth.</FP>
                <GPH SPAN="1" DEEP="80" HTYPE="RIGHT">
                    <GID>BIDEN.EPS</GID>
                </GPH>
                <PSIG> </PSIG>
                <BILCOD>Billing code 3395-F4-P</BILCOD>
                <GPH SPAN="1" DEEP="438">
                    <PRTPAGE P="105338"/>
                    <GID>ED27DE24.253</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105339"/>
                    <GID>ED27DE24.254</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105340"/>
                    <GID>ED27DE24.255</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105341"/>
                    <GID>ED27DE24.256</GID>
                </GPH>
                <GPH SPAN="1" DEEP="424">
                    <PRTPAGE P="105342"/>
                    <GID>ED27DE24.257</GID>
                </GPH>
                <FRDOC>[FR Doc. 2024-31353 </FRDOC>
                <FILED>Filed 12-26-24; 8:45 am] </FILED>
                <BILCOD>Billing code 7020-02-C</BILCOD>
            </PROCLA>
        </PRESDOCU>
    </PRESDOCS>
    <VOL>89</VOL>
    <NO>248</NO>
    <DATE>Friday, December 27, 2024</DATE>
    <UNITNAME>Presidential Documents</UNITNAME>
    <PRESDOC>
        <PRESDOCU>
            <EXECORD>
                <PRTPAGE P="105343"/>
                <EXECORDR>Executive Order 14130 of December 20, 2024</EXECORDR>
                <HD SOURCE="HED">2024 Amendments to the Manual for Courts Martial, United States</HD>
                <FP>By the authority vested in me as President by the Constitution and the laws of the United States of America, including chapter 47 of title 10, United States Code (Uniform Code of Military Justice, 10 U.S.C. 801-946a), and in order to prescribe additions and amendments to the Manual for Courts-Martial, United States, prescribed by Executive Order 12473 of April 13, 1984, as amended, it is hereby ordered as follows: </FP>
                <FP>
                    <E T="04">Section 1</E>
                    . Part II, Part III, Part IV, and Part V of the Manual for Courts-Martial, United States, are amended as described in the Annex attached to and made a part of this order.
                </FP>
                <FP>
                    <E T="04">Sec. 2</E>
                    . With this order, I hereby prescribe regulations for the randomized selection of qualified personnel as members of a court-martial to the maximum extent practicable, pursuant to section 543 of the James M. Inhofe National Defense Authorization Act for Fiscal Year 2023, Public Law 117-263 (10 U.S.C. 825(e)(4)).
                </FP>
                <FP>
                    <E T="04">Sec. 3</E>
                    . Except as provided in sections 4 and 5 of this order, these amendments shall take effect on the date of this order, subject to the following:
                </FP>
                <P>(a) Nothing in these amendments shall be construed to make punishable any act committed or omitted prior to the date of this order that was not punishable when committed or omitted. </P>
                <P>(b) Nothing in these amendments shall be construed to invalidate any nonjudicial punishment proceeding, restraint, preliminary hearing, referral of charges, trial in which arraignment occurred, or other action begun prior to the date of this order, and any such nonjudicial punishment proceeding, restraint, preliminary hearing, referral of charges, trial in which arraignment occurred, or other action may proceed in the same manner and with the same effect as if these amendments had not been prescribed. </P>
                <FP>
                    <E T="04">Sec. 4</E>
                    . The amendments to Rule for Courts-Martial (R.C.M.) 908(c)(3), R.C.M. 1205(a), and R.C.M. 1209(a)(1) shall take effect on December 22, 2024, subject to the following: 
                </FP>
                <P>(a) Nothing in these amendments shall be construed to make punishable any act committed or omitted prior to the effective date that was not punishable when committed or omitted. </P>
                <P>(b) Nothing in these amendments shall be construed to invalidate any nonjudicial punishment proceeding, restraint, preliminary hearing, referral of charges, trial in which arraignment occurred, or other action begun prior to the  effective date, and any such nonjudicial punishment proceeding, restraint, preliminary hearing, referral of charges, trial in which arraignment occurred, or other action may proceed in the same manner and with the same effect as if these amendments had not been prescribed. </P>
                <FP>
                    <E T="04">Sec. 5</E>
                    . The amendment to R.C.M. 503(a)(1) shall take effect on December 23, 2024, subject to the following: 
                </FP>
                <P>(a) Nothing in this amendment shall be construed to make punishable any act committed or omitted prior to the effective date that was not punishable when committed or omitted. </P>
                <P>
                    (b) Nothing in this amendment shall be construed to invalidate any nonjudicial punishment proceeding, restraint, preliminary hearing, referral of 
                    <PRTPAGE P="105344"/>
                    charges, trial in which arraignment occurred, or other action begun prior to the effective date, and any such nonjudicial punishment proceeding, restraint, preliminary hearing, referral of charges, trial in which arraignment occurred, or other action may proceed in the same manner and with the same effect as if this amendment had not been prescribed. 
                </P>
                <GPH SPAN="1" DEEP="80" HTYPE="RIGHT">
                    <GID>BIDEN.EPS</GID>
                </GPH>
                <PSIG> </PSIG>
                <PLACE>THE WHITE HOUSE,</PLACE>
                <DATE>December 20, 2024.</DATE>
                <BILCOD>Billing code 3395-F4-P</BILCOD>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105345"/>
                    <GID>ED27DE24.258</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105346"/>
                    <GID>ED27DE24.259</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105347"/>
                    <GID>ED27DE24.260</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105348"/>
                    <GID>ED27DE24.261</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105349"/>
                    <GID>ED27DE24.262</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105350"/>
                    <GID>ED27DE24.263</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105351"/>
                    <GID>ED27DE24.264</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105352"/>
                    <GID>ED27DE24.265</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105353"/>
                    <GID>ED27DE24.266</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105354"/>
                    <GID>ED27DE24.267</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105355"/>
                    <GID>ED27DE24.268</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105356"/>
                    <GID>ED27DE24.269</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105357"/>
                    <GID>ED27DE24.270</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105358"/>
                    <GID>ED27DE24.271</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105359"/>
                    <GID>ED27DE24.272</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105360"/>
                    <GID>ED27DE24.273</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105361"/>
                    <GID>ED27DE24.274</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105362"/>
                    <GID>ED27DE24.275</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105363"/>
                    <GID>ED27DE24.276</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105364"/>
                    <GID>ED27DE24.277</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105365"/>
                    <GID>ED27DE24.278</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105366"/>
                    <GID>ED27DE24.279</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105367"/>
                    <GID>ED27DE24.280</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105368"/>
                    <GID>ED27DE24.281</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105369"/>
                    <GID>ED27DE24.282</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105370"/>
                    <GID>ED27DE24.283</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105371"/>
                    <GID>ED27DE24.284</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105372"/>
                    <GID>ED27DE24.285</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105373"/>
                    <GID>ED27DE24.286</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105374"/>
                    <GID>ED27DE24.287</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105375"/>
                    <GID>ED27DE24.288</GID>
                </GPH>
                <GPH SPAN="1" DEEP="600">
                    <PRTPAGE P="105376"/>
                    <GID>ED27DE24.289</GID>
                </GPH>
                <FRDOC>[FR Doc. 2024-31354 </FRDOC>
                <FILED>Filed 12-26-24; 8:45 am] </FILED>
                <BILCOD>Billing code 6001-FR-C</BILCOD>
            </EXECORD>
        </PRESDOCU>
    </PRESDOC>
    <VOL>89</VOL>
    <NO>248</NO>
    <DATE>Friday, December 27, 2024</DATE>
    <UNITNAME>Presidential Documents</UNITNAME>
    <PRESDOC>
        <PRESDOCU>
            <EXECORD>
                <PRTPAGE P="105377"/>
                <EXECORDR>Executive Order 14131 of December 20, 2024</EXECORDR>
                <HD SOURCE="HED">Amendments to Executive Orders Relating to Certain Certificates and Badges</HD>
                <FP>By the authority vested in me as President by the Constitution and the laws of the United States of America, and as Commander in Chief of the Armed Forces of the United States, it is hereby ordered as follows:</FP>
                <FP>
                    <E T="04">Section 1</E>
                    . 
                    <E T="03">Amendments to Executive Order 12793, as Amended</E>
                    . Executive Order 12793 of March 20, 1992 (Continuing the Presidential Service Certificate and the Presidential Service Badge), as amended by Executive Order 13286 of February 28, 2003 (Amendment of Executive Orders, and Other Actions, in Connection With the Transfer of Certain Functions to the Secretary of Homeland Security), is further amended by:
                </FP>
                <P>(a) Amending section 1 to read as follows:</P>
                <FP SOURCE="FP1">
                    “
                    <E T="04">Section 1</E>
                    . 
                    <E T="03">Presidential Service Certificate</E>
                    . The Presidential Service Certificate (Certificate) is hereby continued, the design of which accompanies and is hereby made a part of this order. The Certificate shall be awarded in the name of the President of the United States to members of the United States Uniformed Services who have been assigned to the White House Office; to military units and support facilities under the administration of the White House Military Office; or to other direct support positions within the Executive Office of the President (EOP). The Certificate shall be awarded by the Secretary of the military department concerned, or, when the Coast Guard is not operating as a service in the Navy, by the Secretary of Homeland Security, and, in the case of members of the Commissioned Corps of the National Oceanic and Atmospheric Administration or the Commissioned Corps of the Public Health Service, by the Secretary of Commerce or the Secretary of Health and Human Services, respectively. The Certificate shall not be issued to any member who is issued a Vice Presidential Certificate, or similar EOP Certificate, for the same period of service. Such assignment must be for a period of at least 1 year, subsequent to January 21, 1989.”; and
                </FP>
                <P>(b) Amending section 2 to read as follows:</P>
                <FP SOURCE="FP1">
                    “
                    <E T="04">Sec. 2</E>
                    . 
                    <E T="03">Presidential Service Badge</E>
                    . The Presidential Service Badge (Badge) is hereby continued, the design of which accompanies and is hereby made a part of this order. The Badge shall be awarded to those members of the United States Uniformed Services who have been granted the Certificate and shall be awarded in the same manner in which the Certificate has been given. The Badge shall be worn as a part of the uniform of those individuals under such regulations as their respective Secretaries may severally prescribe.”.
                </FP>
                <FP>
                    <E T="04">Sec. 2</E>
                    . 
                    <E T="03">Amendments to Executive Order 11926, as Amended</E>
                    . Executive Order 11926 of July 19, 1976 (The Vice Presidential Service Badge), as amended by Executive Order 13286 and by Executive Order 13373 of March 10, 2005 (Amendments to Executive Order 11926 Relating to the Vice Presidential Service Badge), is further amended by:
                </FP>
                <P>(a) Amending section 1 to read as follows:</P>
                <FP SOURCE="FP1">
                    “
                    <E T="04">Section 1</E>
                    . There is established a Vice Presidential Service Badge to be awarded in the name of the Vice President of the United States of America to members of the United States Uniformed Services who have been assigned to duty in the Office of the Vice President for a period of at least 1 year subsequent to December 19, 1974, or who have been 
                    <PRTPAGE P="105378"/>
                    assigned to perform duties predominantly for the Vice President for a period of at least 1 year subsequent to January 20, 2001, in the implementation of Public Law 93-346, as amended, or in military units and support facilities to which section 1 of Executive Order 12793 of March 20, 1992, as amended, refers.”;
                </FP>
                <P>(b) Amending section 2 to read as follows:</P>
                <FP SOURCE="FP1">
                    “
                    <E T="04">Sec. 2</E>
                    . The Vice Presidential Service Badge may be awarded, upon recommendation of the Vice President's designee (with the concurrence of the Director of the White House Military Office in the case of personnel in military units or support facilities to which section 1 of Executive Order 12793, as amended, refers), by the Secretary of the military department concerned, or, when the Coast Guard is not operating as a service in the Navy, by the Secretary of Homeland Security, to military personnel of their respective services who have been assigned to duty in the Office of the Vice President and, in the case of members of the Commissioned Corps of the National Oceanic and Atmospheric Administration or the Commissioned Corps of the Public Health Service so assigned, by the Secretary of Commerce or the Secretary of Health and Human Services, respectively.”;
                </FP>
                <P>(c) Amending section 4 to read as follows:</P>
                <FP SOURCE="FP1">
                    “
                    <E T="04">Sec. 4</E>
                    . Upon award, the Vice Presidential Service Badge may be worn as a part of the uniform of an individual both during and after their assignment to duty in the Office of the Vice President.”; and
                </FP>
                <P>(d) Amending section 6 to read as follows:</P>
                <FP SOURCE="FP1">
                    “
                    <E T="04">Sec. 6</E>
                    . Notwithstanding the provisions of sections 1 and 2 of this order, any member of the United States Uniformed Services, who has been assigned to duty in the Office of the Vice President, or who has been assigned to perform duties predominantly for the Vice President, in the implementation of Public Law 93-346, as amended, or in military units and support facilities to which section 1 of Executive Order 12793, as amended, refers, is authorized, unless otherwise directed by the Director of the White House Military Office in the case of personnel in military units and support facilities to which section 1 of Executive Order 12793, as amended, refers, to wear the Vice Presidential Service Badge on their uniform commencing on the first day of such duty and thereafter while assigned to such duty.”.
                </FP>
                <FP>
                    <E T="04">Sec. 3</E>
                    . 
                    <E T="03">General Provisions</E>
                    . (a) Nothing in this order shall be construed to impair or otherwise affect: 
                </FP>
                <FP SOURCE="FP1">(i) the authority granted by law to an executive department or agency, or the head thereof; or </FP>
                <FP SOURCE="FP1">(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.</FP>
                <P>(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.</P>
                <PRTPAGE P="105379"/>
                <P>(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.</P>
                <GPH SPAN="1" DEEP="80" HTYPE="RIGHT">
                    <GID>BIDEN.EPS</GID>
                </GPH>
                <PSIG> </PSIG>
                <PLACE>THE WHITE HOUSE,</PLACE>
                <DATE>December 20, 2024.</DATE>
                <FRDOC>[FR Doc. 2024-31355 </FRDOC>
                <FILED>Filed 12-26-24; 8:45 am] </FILED>
                <BILCOD>Billing code 3395-F4-P</BILCOD>
            </EXECORD>
        </PRESDOCU>
    </PRESDOC>
    <VOL>89</VOL>
    <NO>248</NO>
    <DATE>Friday, December 27, 2024</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="105691"/>
            <PARTNO>Part II</PARTNO>
            <AGENCY TYPE="P">Environmental Protection Agency</AGENCY>
            <CFR>40 CFR Part 50</CFR>
            <TITLE>Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen, Oxides of Sulfur, and Particulate Matter; Final Rule</TITLE>
        </PTITLE>
        <RULES>
            <RULE>
                <PREAMB>
                    <PRTPAGE P="105692"/>
                    <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                    <CFR>40 CFR Part 50</CFR>
                    <DEPDOC>[EPA-HQ-OAR-2014-0128; FRL-5788-05-OAR]</DEPDOC>
                    <RIN>RIN 2060-AS35</RIN>
                    <SUBJECT>Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen, Oxides of Sulfur, and Particulate Matter</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Environmental Protection Agency (EPA).</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Final rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>
                            Based on the Environmental Protection Agency's (EPA's) review of the air quality criteria for ecological effects and secondary national ambient air quality standards (NAAQS) for oxides of nitrogen (N oxides), oxides of sulfur (SO
                            <E T="52">X</E>
                            ), and particulate matter (PM), the EPA is revising the existing secondary sulfur dioxide (SO
                            <E T="52">2</E>
                            ) standard to an annual average, averaged over three consecutive years, with a level of 10 parts per billion (ppb). Additionally, the Agency is retaining the existing secondary standards for N oxides and PM, without revision. The EPA is also finalizing revisions to the data handling requirements for the secondary SO
                            <E T="52">2</E>
                             NAAQS.
                        </P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>This final rule is effective on January 27, 2025.</P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>
                            The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2014-0128. All documents in the docket are listed on the 
                            <E T="03">https://www.regulations.gov</E>
                             website. Although listed in the index, some information is not publicly available, 
                            <E T="03">e.g.,</E>
                             CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available electronically through 
                            <E T="03">https://www.regulations.gov.</E>
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>
                            Ms. Ginger Tennant, Environmental Protection Agency, Health and Environmental Impacts Division, Office of Air Quality Planning and Standards (mail code C539-04), Research Triangle Park, NC 27711; telephone number: (919) 541-4072; email address: 
                            <E T="03">tennant.ginger@epa.gov.</E>
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <HD SOURCE="HD1">Table of Contents</HD>
                    <EXTRACT>
                        <FP SOURCE="FP-2">Executive Summary</FP>
                        <FP SOURCE="FP-2">I. Background</FP>
                        <FP SOURCE="FP1-2">A. Legislative Requirements</FP>
                        <FP SOURCE="FP1-2">B. Related Control Programs</FP>
                        <FP SOURCE="FP1-2">
                            C. History of the Secondary Standards for N Oxides, SO
                            <E T="52">X</E>
                             and PM
                        </FP>
                        <FP SOURCE="FP1-2">1. N Oxides</FP>
                        <FP SOURCE="FP1-2">
                            2. SO
                            <E T="52">X</E>
                        </FP>
                        <FP SOURCE="FP1-2">3. Related Actions Addressing Acid Deposition</FP>
                        <FP SOURCE="FP1-2">
                            4. Most Recent Review of the Secondary Standards for N Oxides and SO
                            <E T="52">X</E>
                        </FP>
                        <FP SOURCE="FP1-2">5. PM</FP>
                        <FP SOURCE="FP1-2">D. Current Review</FP>
                        <FP SOURCE="FP-2">II. Rationale for Decisions</FP>
                        <FP SOURCE="FP1-2">A. Introduction</FP>
                        <FP SOURCE="FP1-2">1. Background</FP>
                        <FP SOURCE="FP1-2">a. Basis for Existing Secondary Standards</FP>
                        <FP SOURCE="FP1-2">b. Prior Review of Deposition-Related Effects</FP>
                        <FP SOURCE="FP1-2">c. General Approach for This Review</FP>
                        <FP SOURCE="FP1-2">2. Overview of Air Quality and Deposition</FP>
                        <FP SOURCE="FP1-2">
                            a. Sources, Emissions and Atmospheric Processes Affecting SO
                            <E T="52">X</E>
                            , N Oxides and PM
                        </FP>
                        <FP SOURCE="FP1-2">b. Recent Trends in Emissions, Concentrations, and Deposition</FP>
                        <FP SOURCE="FP1-2">c. Relationships Between Concentrations and Deposition</FP>
                        <FP SOURCE="FP1-2">3. Overview of Welfare Effects Evidence</FP>
                        <FP SOURCE="FP1-2">a. Nature of Effects</FP>
                        <FP SOURCE="FP1-2">
                            (1) Direct Effects of SO
                            <E T="52">X</E>
                             and N Oxides in Ambient Air
                        </FP>
                        <FP SOURCE="FP1-2">(2) Acid Deposition-Related Ecological Effects</FP>
                        <FP SOURCE="FP1-2">(3) Nitrogen Enrichment and Associated Ecological Effects</FP>
                        <FP SOURCE="FP1-2">(4) Other Deposition-Related Effects</FP>
                        <FP SOURCE="FP1-2">b. Public Welfare Implications</FP>
                        <FP SOURCE="FP1-2">c. Exposure Conditions and Deposition-Related Metrics</FP>
                        <FP SOURCE="FP1-2">(1) Acidification and Nitrogen Enrichment in Aquatic Ecosystems</FP>
                        <FP SOURCE="FP1-2">(2) Deposition-Related Effects in Terrestrial Ecosystems</FP>
                        <FP SOURCE="FP1-2">
                            (3) Other Effects of N Oxides, SO
                            <E T="52">X</E>
                             and PM in Ambient Air
                        </FP>
                        <FP SOURCE="FP1-2">4. Overview of Exposure and Risk Assessment for Aquatic Acidification</FP>
                        <FP SOURCE="FP1-2">a. Key Design Aspects</FP>
                        <FP SOURCE="FP1-2">b. Key Limitations and Uncertainties</FP>
                        <FP SOURCE="FP1-2">c. Summary of Results</FP>
                        <FP SOURCE="FP1-2">B. Conclusions</FP>
                        <FP SOURCE="FP1-2">1. Basis for Proposed Decision</FP>
                        <FP SOURCE="FP1-2">a. Policy-Relevant Evaluations in the Policy Assessment</FP>
                        <FP SOURCE="FP1-2">(1) Effects Not Related to S and N Deposition</FP>
                        <FP SOURCE="FP1-2">(2) Evidence of Ecosystem Effects of S and N Deposition</FP>
                        <FP SOURCE="FP1-2">
                            (3) Sulfur Deposition and SO
                            <E T="52">X</E>
                        </FP>
                        <FP SOURCE="FP1-2">(4) Nitrogen Deposition and N Oxides and PM</FP>
                        <FP SOURCE="FP1-2">b. CASAC Advice</FP>
                        <FP SOURCE="FP1-2">c. Administrator's Proposed Conclusions</FP>
                        <FP SOURCE="FP1-2">2. Comments on the Proposed Decision</FP>
                        <FP SOURCE="FP1-2">a. Sulfur Oxides</FP>
                        <FP SOURCE="FP1-2">(1) Comments Regarding Adequacy of the Existing Standard</FP>
                        <FP SOURCE="FP1-2">(2) Comments in Support of Proposed Adoption of a New Annual Standard</FP>
                        <FP SOURCE="FP1-2">(3) Comments in Disagreement With Proposed Adoption of a New Annual Standard</FP>
                        <FP SOURCE="FP1-2">(4) Comments Regarding Retaining the Existing Secondary Standard</FP>
                        <FP SOURCE="FP1-2">b. Nitrogen Oxides and Particulate Matter</FP>
                        <FP SOURCE="FP1-2">(1) Comments in Support of Proposed Decisions</FP>
                        <FP SOURCE="FP1-2">(2) Comments in Disagreement With Proposed Decisions</FP>
                        <FP SOURCE="FP1-2">3. Administrator's Conclusions</FP>
                        <FP SOURCE="FP1-2">C. Decision on the Secondary Standards</FP>
                        <FP SOURCE="FP-2">
                            III. Interpretation of the Secondary SO
                            <E T="52">2</E>
                             NAAQS
                        </FP>
                        <FP SOURCE="FP1-2">A. Background</FP>
                        <FP SOURCE="FP1-2">
                            B. Interpretation of the Secondary SO
                            <E T="52">2</E>
                             Standard
                        </FP>
                        <FP SOURCE="FP-2">
                            IV. Ambient Air Monitoring Network for SO
                            <E T="52">2</E>
                        </FP>
                        <FP SOURCE="FP1-2">A. Public Comments</FP>
                        <FP SOURCE="FP1-2">B. Conclusion on the Monitoring Network</FP>
                        <FP SOURCE="FP-2">
                            V. Clean Air Act Implementation Considerations for the Revised Secondary SO
                            <E T="52">2</E>
                             Standard
                        </FP>
                        <FP SOURCE="FP1-2">A. Designation of Areas</FP>
                        <FP SOURCE="FP1-2">B. Section 110(a)(1) and (2) Infrastructure SIP Requirements</FP>
                        <FP SOURCE="FP1-2">
                            C. Prevention of Significant Deterioration and Nonattainment New Source Review Programs for the Revised Secondary SO
                            <E T="52">2</E>
                             Standard
                        </FP>
                        <FP SOURCE="FP1-2">D. Transportation Conformity Program</FP>
                        <FP SOURCE="FP1-2">E. General Conformity Program</FP>
                        <FP SOURCE="FP-2">VI. Statutory and Executive Order Reviews</FP>
                        <FP SOURCE="FP1-2">A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094: Modernizing Regulatory Review</FP>
                        <FP SOURCE="FP1-2">B. Paperwork Reduction Act (PRA)</FP>
                        <FP SOURCE="FP1-2">C. Regulatory Flexibility Act (RFA)</FP>
                        <FP SOURCE="FP1-2">D. Unfunded Mandates Reform Act (UMRA)</FP>
                        <FP SOURCE="FP1-2">E. Executive Order 13132: Federalism</FP>
                        <FP SOURCE="FP1-2">F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments</FP>
                        <FP SOURCE="FP1-2">G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks</FP>
                        <FP SOURCE="FP1-2">H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use</FP>
                        <FP SOURCE="FP1-2">I. National Technology Transfer and Advancement Act (NTTAA)</FP>
                        <FP SOURCE="FP1-2">J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations and Executive Order 14096: Revitalizing Our Nation's Commitment to Environmental Justice for All</FP>
                        <FP SOURCE="FP1-2">K. Congressional Review Act (CRA)</FP>
                        <FP SOURCE="FP1-2">L. Judicial Review</FP>
                        <FP SOURCE="FP-2">VII. References</FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">Executive Summary</HD>
                    <P>
                        This document presents the Administrator's final decisions in the current review of the secondary NAAQS for SO
                        <E T="52">X</E>
                        , N oxides, and PM. Specifically, this document summarizes the background and rationale for the Administrator's final decisions to revise the secondary SO
                        <E T="52">2</E>
                         standard to an annual average, averaged over three consecutive years, with a level of 10 ppb, and to retain the existing standards for N oxides and PM. In conducting this review of the secondary SO
                        <E T="52">X</E>
                        , N oxides, and PM NAAQS, the EPA has carefully evaluated the currently available scientific literature on the ecological 
                        <PRTPAGE P="105693"/>
                        effects of SO
                        <E T="52">X</E>
                        , N oxides, and PM 
                        <SU>1</SU>
                        <FTREF/>
                         as described in the Integrated Science Assessment (ISA) and conducted quantitative air quality, deposition, and risk analyses. The Administrator's final decisions are based on his consideration of the characterization of the available scientific evidence in the ISA; quantitative and policy analyses presented in the Policy Assessment (PA), and related analyses; advice from the Clean Air Scientific Advisory Committee (CASAC); and public comments on the proposed decision.
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             Welfare effects of PM considered in the review of the PM secondary standards completed in 2020, and reconsidered more recently, include effects on visibility and climate and materials damage (88 FR 5558, January 27, 2023).
                        </P>
                    </FTNT>
                    <P>
                        Sections 108 and 109 of the Clean Air Act (CAA) require the EPA to periodically review the air quality criteria—the science upon which the standards are based—and the standards themselves. Under section 109(b)(2) of the Act, a secondary standard must “specify a level of air quality the attainment and maintenance of which, in the judgment of the Administrator, based on such criteria, is requisite to protect the public welfare from any known or anticipated adverse effects associated with the presence of [the] pollutant in the ambient air.” As a result of the current review, the Administrator concluded that the current 3-hour secondary SO
                        <E T="52">2</E>
                         standard is not requisite to protect the public welfare from any known or anticipated adverse effects associated with the presence of SO
                        <E T="52">X</E>
                         in ambient air, and that it should be revised to an annual average SO
                        <E T="52">2</E>
                         standard, averaged over three years, with a level of 10 ppb to provide the requisite protection for the effects of SO
                        <E T="52">X</E>
                        , including those related to atmospheric deposition of sulfur (S) compounds in sensitive ecosystems. The Administrator also decided to retain the secondary nitrogen dioxide (NO
                        <E T="52">2</E>
                        ) and PM standards, without revision. With regard to the secondary NO
                        <E T="52">2</E>
                         standard, the Administrator finds that the evidence related to N oxides does not call into question the adequacy of protection provided by the existing standard. Additionally, the Administrator concludes that no change to the annual secondary PM
                        <E T="52">2.5</E>
                         standard is warranted and that the existing PM
                        <E T="52">2.5</E>
                         secondary standard should be retained without revision.
                    </P>
                    <P>
                        This document additionally includes revisions related to implementation of the proposed secondary SO
                        <E T="52">2</E>
                         annual standard. Specifically, the EPA is enacting revisions to the data handling requirements in appendix T of part 50 to include specifications needed for the new annual average standard. This document also describes the SO
                        <E T="52">2</E>
                         monitoring network and its adequacy for surveillance for the revised annual standard. Lastly, the document discusses implementation processes pertinent to implementation of the new standard.
                    </P>
                    <HD SOURCE="HD1">I. Background</HD>
                    <HD SOURCE="HD2">A. Legislative Requirements</HD>
                    <P>Two sections of the CAA govern the establishment and revision of the NAAQS. Section 108 (42 U.S.C. 7408) directs the Administrator to identify and list certain air pollutants and then to issue air quality criteria for those pollutants. The Administrator is to list those pollutants “emissions of which, in his judgment, cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare”; “the presence of which in the ambient air results from numerous or diverse mobile or stationary sources”; and for which he “plans to issue air quality criteria . . . .” (42 U.S.C. 7408(a)(1)). Air quality criteria are intended to “accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of [a] pollutant in the ambient air . . . .” 42 U.S.C. 7408(a)(2).</P>
                    <P>
                        Section 109 of the Act (42 U.S.C. 7409) directs the Administrator to propose and promulgate “primary” and “secondary” NAAQS for pollutants for which air quality criteria are issued [42 U.S.C. 7409(a)]. Under section 109(b)(2), a secondary standard must “specify a level of air quality the attainment and maintenance of which in the judgment of the Administrator, based on such criteria, is requisite to protect the public welfare from any known or anticipated adverse effects associated with the presence of [the] pollutant in the ambient air.” 
                        <SU>2</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             Under CAA section 302(h) (42 U.S.C. 7602(h)), effects on welfare include, but are not limited to, “effects on soils, water, crops, vegetation, manmade materials, animals, wildlife, weather, visibility, and climate, damage to and deterioration of property, and hazards to transportation, as well as effects on economic values and on personal comfort and well-being.”
                        </P>
                    </FTNT>
                    <P>
                        In setting primary and secondary standards that are “requisite” to protect public health and welfare, respectively, as provided in section 109(b), the EPA's task is to establish standards that are neither more nor less stringent than necessary. In so doing, the EPA may not consider the costs of implementing the standards. See generally, 
                        <E T="03">Whitman</E>
                         v. 
                        <E T="03">American Trucking Ass'ns,</E>
                         531 U.S. 457, 465-472, 475-76 (2001). Likewise, “[a]ttainability and technological feasibility are not relevant considerations in the promulgation of national ambient air quality standards” (
                        <E T="03">American Petroleum Institute</E>
                         v. 
                        <E T="03">Costle,</E>
                         665 F.2d 1176, 1185 [D.C. Cir. 1981]). However, courts have clarified that in deciding how to revise the NAAQS in the context of considering standard levels within the range of reasonable values supported by the air quality criteria and judgments of the Administrator, EPA may consider “relative proximity to peak background . . . concentrations” as a factor (
                        <E T="03">American Trucking Ass'ns,</E>
                         v. 
                        <E T="03">EPA,</E>
                         283 F.3d 355, 379 [D.C. Cir. 2002]).
                    </P>
                    <P>
                        Section 109(d)(1) of the Act requires periodic review and, if appropriate, revision of existing air quality criteria to reflect advances in scientific knowledge on the effects of the pollutant on public health and welfare. Under the same provision, the EPA is also to periodically review and, if appropriate, revise the NAAQS, based on the revised air quality criteria.
                        <SU>3</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             This section of the Act requires the Administrator to complete these reviews and make any revisions that may be appropriate “at five-year intervals.”
                        </P>
                    </FTNT>
                    <P>Section 109(d)(2) addresses the appointment and advisory functions of an independent scientific review committee. Section 109(d)(2)(A) requires the Administrator to appoint this committee, which is to be composed of “seven members including at least one member of the National Academy of Sciences, one physician, and one person representing State air pollution control agencies.” Section 109(d)(2)(B) provides that the independent scientific review committee “shall complete a review of the criteria . . . and the national primary and secondary ambient air quality standards . . . and shall recommend to the Administrator any new . . . standards and revisions of existing criteria and standards as may be appropriate. . . .” Since the early 1980s, this independent review function has been performed by the CASAC of the EPA's Science Advisory Board.</P>
                    <P>
                        Section 109(b)(2) specifies that “[a]ny national secondary ambient air quality standard prescribed under subsection (a) shall specify a level of air quality the attainment and maintenance of which in the judgment of the Administrator, based on such criteria, is requisite to protect the public welfare from any known or anticipated adverse effects associated with the presence of such air pollutant in the ambient air.” Consistent with this statutory direction, EPA has always understood the goal of the 
                        <PRTPAGE P="105694"/>
                        NAAQS is to identify a requisite level of air quality, and the means of achieving a specific level of air quality is to set a standard expressed as a concentration of a pollutant in the air, such as in terms of parts per million (ppm), ppb, or micrograms per cubic meter (μg/m
                        <SU>3</SU>
                        ). Thus, while deposition-related effects are included within the “adverse effects associated with the presence of such air pollutant in the ambient air,” EPA has never found a standard that quantifies atmospheric deposition onto surfaces to constitute a national secondary ambient air quality standard. Rather, EPA has established ambient air quality standards that specify air quality by quantifying pollution in the ambient air to address effects of such pollution, whether from ambient concentrations or deposition.
                    </P>
                    <HD SOURCE="HD2">B. Related Control Programs</HD>
                    <P>
                        States are primarily responsible for ensuring attainment and maintenance of ambient air quality standards once the EPA has established them. Under CAA sections 110 and part D, subparts 1, 5, and 6 for nitrogen and sulfur oxides, and subparts 1, 4, and 6 for PM, and related provisions and regulations, States are to submit, for the EPA's approval, State implementation plans (SIPs) that provide for the attainment and maintenance of such standards through control programs directed to sources of the pollutants involved. The States, in conjunction with the EPA, also administer the prevention of significant deterioration of air quality program that covers these pollutants. See 42 U.S.C. 7470-7479. In addition, Federal programs provide for or result in nationwide reductions in emissions of N oxides, SO
                        <E T="52">X</E>
                        , PM and other air pollutants under title II of the Act, 42 U.S.C. 7521-7574, which involves controls for motor vehicles, nonroad engines and equipment, and under the new source performance standards in section 111 of the Act, 42 U.S.C. 7411.
                    </P>
                    <HD SOURCE="HD2">
                        C. History of the Secondary Standards for N Oxides, SO
                        <E T="54">X</E>
                         and PM
                    </HD>
                    <P>
                        Secondary NAAQS were first established for N oxides, SO
                        <E T="52">X</E>
                         and PM in 1971 (36 FR 8186, April 30, 1971). Since that time, the EPA has periodically reviewed the air quality criteria and secondary standards for these pollutants, with the most recent reviews that considered the evidence for ecological effects of these pollutants being completed in 2012 and 2013 (77 FR 20218, April 3, 2012; 78 FR 3086, January 15, 2013). The subsections below summarize key proceedings from the initial standard setting in 1971 to the last reviews in 2012-2013.
                        <SU>4</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             Since the late 1970s, each review of the air quality criteria and standards has generally involved the development of an Air Quality Criteria Document or ISA and a Staff Paper or staff Policy Assessment, which is often accompanied by or includes a quantitative exposure or risk assessment, prior to the regulatory decision-making phase.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. N Oxides</HD>
                    <P>
                        The EPA first promulgated NAAQS for N oxides in April 1971 after reviewing the relevant science on the public health and welfare effects in the 1971 Air Quality Criteria for Nitrogen Oxides (air quality criteria document or AQCD).
                        <SU>5</SU>
                        <FTREF/>
                         With regard to welfare effects, the 1971 AQCD described effects of NO
                        <E T="52">2</E>
                         on vegetation and corrosion of electrical components linked to particulate nitrate (U.S. EPA, 1971). The primary and secondary standards were both set at 0.053 ppm NO
                        <E T="52">2</E>
                         as an annual average (36 FR 8186, April 30, 1971). In 1982, the EPA published an updated AQCD (U.S. EPA, 1982a). Based on the 1982 AQCD, the EPA proposed to retain the existing standards in February 1984 (49 FR 6866, February 23, 1984). After considering public comments, the EPA published the final decision to retain these standards in June 1985 (50 FR 25532, June 19, 1985).
                    </P>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             In reviews initiated prior to 2007, the AQCD provided the scientific foundation (
                            <E T="03">i.e.,</E>
                             the air quality criteria) for the NAAQS. Since that time, the ISA has replaced the AQCD.
                        </P>
                    </FTNT>
                    <P>
                        The EPA began a second review of the primary and secondary standards for oxides of nitrogen in 1987 (52 FR 27580, July 22, 1987). In November 1991, the EPA released an updated draft AQCD for CASAC and public review and comment (56 FR 59285, November 25, 1991). The CASAC reviewed the draft document at a meeting held on July 1, 1993, and concluded in a closure letter to the Administrator that the document provided “an adequate basis” for EPA's decision-making in the review (Wolff, 1993). The final AQCD was released later in 1993 (U.S. EPA, 1993). Based on the 1993 AQCD, the EPA's Office of Air Quality Planning and Standards (OAQPS) prepared a Staff Paper,
                        <SU>6</SU>
                        <FTREF/>
                         drafts of which were reviewed by the CASAC (Wolff, 1995; U.S. EPA, 1995a). In October 1995, the EPA proposed not to revise the secondary NO
                        <E T="52">2</E>
                         NAAQS (60 FR 52874; October 11, 1995). After consideration of the comments received on the proposal, the Administrator finalized the decision not to revise the NO
                        <E T="52">2</E>
                         NAAQS (61 FR 52852; October 8, 1996). The subsequent (and most recent) review of the N oxides secondary standard was a joint review with the secondary standard for SO
                        <E T="52">X</E>
                        , which was completed in 2012 (see subsection 4 below).
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             Prior to reviews initiated in 2007, the Staff Paper summarized and integrated key studies and the scientific evidence, and from the 1990s onward, it also assessed potential exposures and associated risk. The Staff Paper also presented the EPA staff's considerations and conclusions regarding the adequacy of existing NAAQS and, when appropriate, the potential alternative standards that could be supported by the evidence and information. More recent reviews present this information in the Policy Assessment.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">
                        2. SO
                        <E T="52">X</E>
                    </HD>
                    <P>
                        The EPA first promulgated secondary NAAQS for SO
                        <E T="52">X</E>
                         in April 1971 based on the scientific evidence evaluated in the 1969 AQCD (U.S. DHEW, 1969a [1969 AQCD]; 36 FR 8186, April 30, 1971). These standards, which were established on the basis of evidence of adverse effects on vegetation, included an annual arithmetic mean standard, set at 0.02 ppm SO
                        <E T="52">2</E>
                        ,
                        <SU>7</SU>
                        <FTREF/>
                         and a 3-hour average standard set at 0.5 ppm SO
                        <E T="52">2</E>
                        , not to be exceeded more than once per year. In 1973, based on information indicating there to be insufficient data to support the finding of a study in the 1969 AQCD concerning vegetation injury associated with SO
                        <E T="52">2</E>
                         exposure over the growing season, rather than from short-term peak concentrations, the EPA proposed to revoke the annual mean secondary standard (38 FR 11355, May 7, 1973). Based on consideration of public comments and external scientific review, the EPA released a revised chapter of the AQCD and published its final decision to revoke the annual mean secondary standard (U.S. EPA, 1973; 38 FR 25678, September 14, 1973). At that time, the EPA additionally noted that injury to vegetation was the only type of SO
                        <E T="52">2</E>
                         welfare effect for which the evidence base supported a quantitative relationship, stating that although data were not available at that time to establish a quantitative relationship between SO
                        <E T="52">2</E>
                         concentrations and other public welfare effects, including effects on materials, visibility, soils, and water, the SO
                        <E T="52">2</E>
                         primary standards and the 3-hour secondary standard may to some extent mitigate such effects. The EPA also stated it was not clear that any such effects, if occurring below the current standards, were adverse to the public welfare (38 FR 25679, September 14, 1973).
                    </P>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             Established with the annual standard as a guide to be used in assessing implementation plans to achieve the annual standard was a maximum 24-hour average concentration not to be exceeded more than once per year (36 FR 8187, April 30, 1971).
                        </P>
                    </FTNT>
                    <P>
                        In 1979, the EPA announced initiation of a concurrent review of the air quality criteria for SO
                        <E T="52">X</E>
                         and PM and plans for development of a combined AQCD for these pollutants (44 FR 56730, October 
                        <PRTPAGE P="105695"/>
                        2, 1979). The EPA subsequently released three drafts of a combined AQCD for CASAC review and public comment. In these reviews, and in guidance provided at the August 20-22, 1980, public meeting of the CASAC on the first draft AQCD, the CASAC concluded that acidic deposition was a topic of extreme scientific complexity because of the difficulty in establishing firm quantitative relationships among emissions of relevant pollutants, formation of acidic wet and dry deposition products, and effects on terrestrial and aquatic ecosystems (53 FR 14935, April 26, 1988). The CASAC also noted that a fundamental problem of addressing acid deposition in a criteria document is that acid deposition is produced by several different criteria pollutants: SO
                        <E T="52">X</E>
                        , N oxides, and the fine particulate fraction of suspended particles (U.S. EPA, 1982b, pp. 125-126). The CASAC also felt that any document on this subject should address both wet and dry deposition, since dry deposition was believed to account for a substantial portion of the total acid deposition problem (53 FR 14936, April 26, 1988; Lippman, 1987). For these reasons, CASAC recommended that, in addition to including a summary discussion of acid deposition in the final AQCD, a separate, comprehensive document on acid deposition be prepared prior to any consideration of using the NAAQS as a regulatory mechanism for the control of acid deposition.
                    </P>
                    <P>
                        Following CASAC closure on the AQCD for SO
                        <E T="52">X</E>
                         in December 1981, the EPA released a final AQCD (U.S. EPA, 1982b), and the EPA's OAQPS prepared a Staff Paper that was released in November 1982 (U.S. EPA, 1982c). The issue of acidic deposition was not, however, assessed directly in the OAQPS Staff Paper because the EPA followed the guidance given by the CASAC, subsequently preparing the following documents to address acid deposition: 
                        <E T="03">The Acidic Deposition Phenomenon and Its Effects: Critical Assessment Review Papers, Volumes I and II</E>
                         (U.S. EPA, 1984a, b) and 
                        <E T="03">The Acidic Deposition Phenomenon and Its Effects: Critical Assessment Document</E>
                         (U.S. EPA, 1985) (53 FR 14935-36, April 26, 1988). Although these documents were not considered criteria documents and had not undergone CASAC review, they represented the most comprehensive summary of scientific information relevant to acid deposition completed by the EPA at that point.
                    </P>
                    <P>
                        In April 1988, the EPA proposed not to revise the existing secondary standards for SO
                        <E T="52">X</E>
                         (53 FR 14926, April 26, 1988). The proposed decision reflected the Administrator's conclusions that: (1) based upon the then-current scientific understanding of the acid deposition problem, it would be premature and unwise to prescribe any regulatory control program at that time; and (2) when the fundamental scientific uncertainties had been decreased through ongoing research efforts, the EPA would draft and support an appropriate set of control measures (53 FR 14926, April 26, 1988). This review of the secondary standard for SO
                        <E T="52">X</E>
                         was concluded in 1993, subsequent to the CAA Amendments of 1990 (see section I.C.3.) with the decision not to revise the secondary standard. The EPA concluded that revisions to the standard to address acidic deposition and related SO
                        <E T="52">X</E>
                         welfare effects were not appropriate at that time (58 FR 21351, April 21, 1993). In describing the decision, the EPA recognized the significant reductions in SO
                        <E T="52">2</E>
                         emissions, ambient air SO
                        <E T="52">2</E>
                         concentrations, and ultimately deposition expected to result from implementation of the title IV program, which was expected to significantly decrease the acidification of water bodies and damage to forest ecosystems and to permit much of the existing damage to be reversed with time (58 FR 21357, April 21, 1993). While recognizing that further action might be needed to address acidic deposition in the longer term, the EPA judged it prudent to await the results of the studies and research programs then underway, including those assessing the comparative merits of secondary standards, acidic deposition standards and other approaches to controlling acidic deposition and related effects, and then to determine whether additional control measures should be adopted or recommended to Congress (58 FR 21358, April 21, 1993).
                    </P>
                    <HD SOURCE="HD3">3. Related Actions Addressing Acid Deposition</HD>
                    <P>In 1980, Congress created the National Acid Precipitation Assessment Program. During the 10-year course of this program, the program issued a series of reports, including a final report in 1990 (NAPAP, 1991). On November 15, 1990, Amendments to the CAA were passed by Congress and signed into law by the President. In title IV of these Amendments, Congress included a statement of findings including the following:</P>
                    <EXTRACT>
                        <FP>(1) the presence of acidic compounds and their precursors in the atmosphere and in deposition from the atmosphere represents a threat to natural resources, ecosystems, materials, visibility, and public health; . . . (3) the problem of acid deposition is of national and international significance; . . . (5) current and future generations of Americans will be adversely affected by delaying measures to remedy the problem[.]</FP>
                    </EXTRACT>
                    <P>
                        The goal of title IV was to reduce emissions of SO
                        <E T="52">2</E>
                         by 10 million tons and N oxides emissions by 2 million tons from 1980 emission levels in order to achieve reductions over broad geographic regions/areas. In envisioning that further action might be necessary in the long term, Congress included section 404 of the 1990 Amendments. This section requires the EPA to conduct a study on the feasibility and effectiveness of an acid deposition standard or standards to protect “sensitive and critically sensitive aquatic and terrestrial resources” and at the conclusion of the study, submit a report to Congress. Five years later, the EPA submitted to Congress its report titled Acid Deposition Standard Feasibility Study: Report to Congress (U.S. EPA, 1995b) in fulfillment of this requirement. The Report to Congress concluded that establishing acid deposition standards for S and N deposition might at some point in the future be technically feasible although appropriate deposition loads for these acidifying chemicals could not be defined with reasonable certainty at that time.
                    </P>
                    <P>
                        The 1990 Amendments also added new language to sections of the CAA pertaining to ecosystem effects of criteria pollutants, such as acid deposition. For example, a new section 108(g) was inserted, stating that “[t]he Administrator may assess the risks to ecosystems from exposure to criteria air pollutants (as identified by the Administrator in the Administrator's sole discretion).” The definition of welfare in CAA section 302(h) was expanded to indicate that welfare effects include those listed therein, “whether caused by transformation, conversion, or combination with other air pollutants.” Additionally, in response to legislative initiatives such as the 1990 Amendments, the EPA and other Federal agencies continued research on the causes and effects of acidic deposition and related welfare effects of SO
                        <E T="52">2</E>
                         and implemented an enhanced monitoring program to track progress (58 FR 21357, April 21, 1993).
                    </P>
                    <HD SOURCE="HD3">
                        4. Most Recent Review of the Secondary Standards for N Oxides and SO
                        <E T="52">X</E>
                    </HD>
                    <P>
                        In December 2005, the EPA initiated a joint review 
                        <SU>8</SU>
                        <FTREF/>
                         of the air quality criteria 
                        <PRTPAGE P="105696"/>
                        and secondary NAAQS for oxides of nitrogen and sulfur (70 FR 73236, December 9, 2005). The review focused on the evaluation of the protection provided by the standards for two general types of effects: (1) direct effects on vegetation of exposure to gaseous oxides of nitrogen and sulfur, which are the type of effects that the existing standards were developed to protect against, and (2) effects associated with the deposition of N oxides and SO
                        <E T="52">X</E>
                         to sensitive aquatic and terrestrial ecosystems (77 FR 20218, April 3, 2012).
                    </P>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             Although the EPA has historically reviewed separately the secondary standards for oxides of nitrogen and oxides of sulfur, the EPA conducted a joint review of these standards in recognition of the chemical interactions in the atmosphere and 
                            <PRTPAGE/>
                            associated contributions to acid deposition and related environmental effects. The joint review was also responsive to a National Research Council recommendation that the EPA consider pollutants in combination, as appropriate, in considering the NAAQS (NRC, 2004).
                        </P>
                    </FTNT>
                    <P>
                        The Integrated Review Plan (IRP) for the review was released in December 2007, after review of a draft IRP by the public and CASAC (72 FR 57570, October 10, 2007; Russell, 2007; U.S. EPA, 2007). The first and second drafts of the ISA were released in December 2007 and August 2008, respectively, for the CASAC and public review (72 FR 72719, December 21, 2007; 73 FR 10243, February 26, 2008; Russell and Henderson, 2008; 73 FR 46908, August 12, 2008; 73 FR 53242, September 15, 2008; Russell and Samet, 2008a). The EPA released a final ISA (referred to as 2008 ISA below) in December 2008 (73 FR 75716, December 12, 2008; U.S. EPA, 2008a). Based on the scientific information in the ISA, the EPA planned and developed a quantitative Risk and Exposure Assessment (REA),
                        <SU>9</SU>
                        <FTREF/>
                         two drafts of which were made available for public comment and reviewed by the CASAC (73 FR 10243, February 26, 2008; 73 FR 50965, August 29, 2008; Russell and Samet, 2008b; 73 FR 53242, September 15, 2008; 74 FR 28698, June 17, 2009; Russell and Samet, 2009). The final REA was released in September 2009 (U.S. EPA, 2009a; 74 FR 48543; September 23, 2009).
                    </P>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             The REAs for NAAQS reviews may be presented in appendices to the PA or in stand-alone documents (
                            <E T="03">e.g.,</E>
                             U.S. EPA 2020b, 2020c, and PA for current review [U.S. EPA, 2024]).
                        </P>
                    </FTNT>
                    <P>Drawing on the information in the REA and ISA, the EPA OAQPS prepared a PA, two drafts of which were made available for public comment and review by the CASAC (75 FR 10479, March 8, 2010; 75 FR 11877, March 12, 2010; Russell and Samet, 2010b; 75 FR 57463, September 21, 2010; 75 FR 65480, October 25, 2010; Russell and Samet, 2010a). The final PA was released in January 2011 (U.S. EPA, 2011). For the purpose of protection against the direct effects on vegetation of exposure to gaseous oxides of nitrogen and sulfur, the final PA concluded that consideration should be given to retaining the current standards. With respect to the effects associated with the deposition of oxides of nitrogen and oxides of sulfur to sensitive aquatic and terrestrial ecosystems, the 2011 PA focused on the acidifying effects of nitrogen and sulfur deposition on sensitive aquatic ecosystems. Based on the information in the ISA, the assessments in the REA, and the CASAC advice, the 2011 PA concluded that consideration should be given to a new multipollutant standard intended to address deposition-related effects (details provided in section II.A.1.b. below). Based on consideration of the final PA, the CASAC provided additional advice and recommendations on the multipollutant, deposition-based standard described in the 2011 PA (76 FR 4109, January 24, 2011; 76 FR 16768, March 25, 2011; Russell and Samet, 2011).</P>
                    <P>
                        On August 1, 2011, the EPA published a proposed decision to retain the existing annual average NO
                        <E T="52">2</E>
                         and 3-hour average SO
                        <E T="52">2</E>
                         secondary standards, recognizing the protection they provided from direct effects on vegetation (76 FR 46084, August 1, 2011). Further, after considering the multipollutant approach to establishing secondary standards that was described in the 2011 PA, the Administrator proposed not to set such a new multipollutant secondary standard in light of a number of uncertainties. Alternatively, the Administrator proposed to revise the secondary standards by adopting secondary NO
                        <E T="52">2</E>
                         and SO
                        <E T="52">2</E>
                         standards identical to the 1-hour primary NO
                        <E T="52">2</E>
                         and SO
                        <E T="52">2</E>
                         standards, both of which were set in 2010, noting that these new primary standards, while not set based on consideration of atmospheric deposition,
                        <SU>10</SU>
                        <FTREF/>
                         were likely to reduce oxides of nitrogen and sulfur emissions and associated nitrogen and sulfur deposition in sensitive ecosystems (76 FR 46084, August 1, 2011). After consideration of public comments, the EPA decided to retain the existing standards (without revision) to address the direct effects on vegetation of exposure to gaseous oxides of nitrogen and sulfur. At that time, the EPA also described its decision that it was not appropriate to set new secondary standards at that time to address deposition-related effects associated with oxides of nitrogen and sulfur (77 FR 20218, April 3, 2012).
                    </P>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             The 1-hour primary standards set in 2010 were a NO
                            <E T="52">2</E>
                             standard of 100 ppb, as the 98th percentile of 1-hour daily maximum concentrations, averaged over three years, and a SO
                            <E T="52">2</E>
                             standard of 75 ppb, as the 99th percentile of daily maximum 1-hour concentrations, averaged over three years (75 FR 6474, February 9, 2010; 75 FR 35520, June 22, 2010).
                        </P>
                    </FTNT>
                    <P>
                        The EPA's 2012 decision was challenged by the Center for Biological Diversity and other environmental groups, who argued that the EPA, having decided that the existing standards were not adequate to protect against adverse public welfare effects such as damage to sensitive ecosystems, was required to identify the requisite level of protection for the public welfare and to issue NAAQS to achieve and maintain that level of protection. The District of Columbia Circuit (D.C. Circuit) disagreed, finding that the EPA acted appropriately in not setting a secondary standard given EPA's conclusions that “the available information was insufficient to permit a reasoned judgment about whether any proposed standard would be `requisite to protect the public welfare . . . '.” 
                        <SU>11</SU>
                        <FTREF/>
                         In reaching this decision, the court noted that the EPA had “explained in great detail” the profound uncertainties associated with setting a secondary NAAQS to protect against aquatic acidification.
                        <SU>12</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             
                            <E T="03">Center for Biological Diversity, et al.</E>
                             v.
                            <E T="03"> EPA,</E>
                             749 F.3d 1079, 1087 (2014).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             
                            <E T="03">Id.</E>
                             at 1088.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">5. PM</HD>
                    <P>
                        The EPA first established a secondary standard for PM in 1971 (36 FR 8186, April 30, 1971), based on the original AQCD, which described the evidence as to effects of PM on visibility, materials, light absorption, and vegetation (U.S. DHEW, 1969b). To provide protection generally from visibility effects and materials damage, the secondary standard was set at 150 µg/m
                        <SU>3</SU>
                        , as a 24-hour average, from total suspended particles (TSP), not to be exceeded more than once per year (36 FR 8187; April 30, 1971).
                        <SU>13</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             Additionally, a guide to be used in assessing implementation plans to achieve the 24-hour standard was set at 60 µg/m
                            <SU>3</SU>
                            , as an annual geometric mean (36 FR 8187; April 30, 1971).
                        </P>
                    </FTNT>
                    <P>
                        In October 1979, the EPA announced the first review of the air quality criteria and NAAQS for PM (44 FR 56730, October 2, 1979). A combined AQCD for PM and SO
                        <E T="52">X</E>
                         was released in 1982, after CASAC and public review of drafts (U.S. EPA, 1982b). Soon after, the OAQPS released a Staff Paper (U.S. EPA, 1982d), two drafts of which had received public and CASAC review (Friedlander, 1982). In 1984, the EPA proposed replacing the secondary standard with an annual TSP standard with a level within the range of 70-90 μg/m
                        <SU>3</SU>
                        , as an expected annual arithmetic 
                        <PRTPAGE P="105697"/>
                        mean (49 FR 10408, March 20, 1984). After consideration of public comment and review by the CASAC and the public, the OAQPS released an Addendum to the Staff Paper in 1986 (Lippman, 1986; U.S. EPA, 1986). In 1987, the EPA completed the review by adopting two new primary PM NAAQS and setting the secondary standards identical to the primary standards in all respects, all with a new indicator for PM (particles with a nominal mass median diameter of 10 microns, PM
                        <E T="52">10</E>
                        ). The new primary and secondary standards included (1) a 24-hour standard of 150 μg/m
                        <SU>3</SU>
                        , in terms of one expected exceedance per year, on average over three years and (2) an annual secondary standard of 50 μg/m
                        <SU>3</SU>
                        , as an annual arithmetic mean, averaged over three years (52 FR 24634, July 1, 1987).
                    </P>
                    <P>
                        In April 1994, the EPA initiated the second periodic review of the air quality criteria and NAAQS for PM. In developing the AQCD, the Agency made available three external review drafts for public and CASAC review; the final AQCD was released in 1996 (U.S. EPA, 1996). The OAQPS released a Staff Paper in November 1997, after CASAC and public review of two drafts (U.S. EPA, 1996; Wolff, 1996). The EPA proposed revisions to the PM standards in 1996 and promulgated final standards in 1997 (61 FR 65738; December 13, 1996; 62 FR 38652, July 18, 1997). With the 1997 decision, the EPA added new standards, using particles with a nominal mean aerodynamic diameter less than or equal to 2.5 μm (PM
                        <E T="52">2.5</E>
                        ) as the indicator for fine particles. The new secondary PM
                        <E T="52">2.5</E>
                         standards were set equal to the primary PM
                        <E T="52">2.5</E>
                         standards, in all respects, as follows: (1) an annual standard with a level of 15.0 μg/m
                        <SU>3</SU>
                        , based on the 3-year average of annual arithmetic mean PM
                        <E T="52">2.5</E>
                         concentrations from single or multiple community-oriented monitors,
                        <SU>14</SU>
                        <FTREF/>
                         and (2) a 24-hour standard with a level of 65 μg/m
                        <SU>3</SU>
                        , based on the 3-year average of the 98th percentile of 24-hour PM
                        <E T="52">2.5</E>
                         concentrations at each monitor within an area. The EPA also retained the primary and secondary annual PM
                        <E T="52">10</E>
                         standards, without revision, and revised the form of the 24-hour primary and secondary PM
                        <E T="52">10</E>
                         standards to be based on the 99th percentile of 24-hour PM
                        <E T="52">10</E>
                         concentrations at each monitor in an area.
                    </P>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             The 1997 annual PM
                            <E T="52">2.5</E>
                             standard was compared with measurements made at the community-oriented monitoring site recording the highest concentration or, if specific constraints were met, measurements from multiple community-oriented monitoring sites could be averaged (
                            <E T="03">i.e.,</E>
                             “spatial averaging”). In the last review (completed in 2012) the EPA replaced the term “community-oriented” monitor with the term “area-wide” monitor. Area-wide monitors are those sited at the neighborhood scale or larger, as well as those monitors sited at micro- or middle-scales that are representative of many such locations in the same core-based statistical area (CBSA) (78 FR 3236, January 15, 2013).
                        </P>
                    </FTNT>
                    <P>
                        Following promulgation of the 1997 PM NAAQS, several parties filed petitions for review, raising a broad range of issues. In May 1999, the U.S. Court of Appeals for the D.C. Circuit upheld the EPA's decision to establish fine particle (PM
                        <E T="52">2.5</E>
                        ) standards, (
                        <E T="03">American Trucking Ass'ns, Inc.</E>
                         v. 
                        <E T="03">EPA,</E>
                         175 F. 3d 1027, 1055-56 [D.C. Cir. 1999]). The D.C. Circuit also found “ample support” for the EPA's decision to regulate coarse particle (PM
                        <E T="52">10</E>
                        ) pollution but vacated the 1997 PM
                        <E T="52">10</E>
                         standards, concluding that the EPA had not provided a reasonable explanation justifying use of PM
                        <E T="52">10</E>
                         as an indicator for coarse particles (
                        <E T="03">id.</E>
                         at 1054-55). Pursuant to the D.C. Circuit's decision, the EPA removed the vacated the 1997 PM
                        <E T="52">10</E>
                         standards, leaving the pre-existing 1987 PM
                        <E T="52">10</E>
                         standards in place (65 FR 80776, December 22, 2000). The D.C. Circuit also upheld the EPA's determination not to establish more stringent secondary standards for fine particles to address effects on visibility (
                        <E T="03">id.</E>
                         at 1027). The D.C. Circuit also addressed more general issues related to the NAAQS, including issues related to the consideration of costs in setting NAAQS and the EPA's approach to establishing the levels of NAAQS.
                    </P>
                    <P>
                        In October 1997, the EPA initiated the third periodic review of the air quality criteria and NAAQS for PM (62 FR 55201, October 23, 1997). The EPA released the final AQCD in October 2004, after the CASAC and public review of several drafts (U.S. EPA, 2004a, b). The OAQPS released a Staff Paper in December 2005 (U.S. EPA, 2005). Also in December 2005, the EPA proposed to revise the PM NAAQS and solicited public comment on a broad range of options (71 FR 2620, January 17, 2006). In September 2006, after consideration of public comment, the EPA revised the PM NAAQS, making revisions to the secondary standards identical to those for the primary standards, with the decision describing the protection provided specifically for visibility and non-visibility related welfare effects (71 FR 61144, 61203-61210, October 17, 2006). The EPA revised the level of the 24-hour PM
                        <E T="52">2.5</E>
                         standards to 35 μg/m
                        <SU>3</SU>
                        , retained the level of the annual PM
                        <E T="52">2.5</E>
                         standards at 15.0 μg/m
                        <SU>3</SU>
                        , and revised the form of the annual PM
                        <E T="52">2.5</E>
                         standards by narrowing the constraints on the optional use of spatial averaging. For PM
                        <E T="52">10</E>
                        , the EPA revoked the annual standards and retained the 24-hour standards, both with a level of 150 μg/m
                        <SU>3</SU>
                        .
                    </P>
                    <P>
                        Several parties filed petitions for review of the 2006 p.m. NAAQS decision, with one raising the issue of the secondary PM
                        <E T="52">2.5</E>
                         standards being identical to the primary standards. On February 24, 2009, the D.C. Circuit issued its opinion in 
                        <E T="03">American Farm Bureau Federation</E>
                         v. 
                        <E T="03">EPA,</E>
                         559 F. 3d 512 (D.C. Cir. 2009), remanding the standards to the EPA stating the Agency had failed to adequately explain how setting the secondary standards identical to the primary standards provided the required public welfare protection, including for visibility impairment (
                        <E T="03">Id.</E>
                         at 528-32). The EPA responded to the court's remands as part of the subsequent PM NAAQS review.
                    </P>
                    <P>
                        In June 2007, the EPA initiated the fourth periodic review of the air quality criteria and the PM NAAQS (72 FR 35462, June 28, 2007). To inform planning for the review, the EPA held science/policy issue workshops later that year (72 FR 34003, June 20, 2007; 72 FR 34005, June 20, 2007). Plans for the review and for welfare assessments were developed in 2008 and 2009; the ISA was completed in 2009, an urban-focused visibility assessment was completed in 2010 and the PA was released in 2011 (U.S. EPA, 2008b; U.S. EPA, 2009b; U.S. EPA, 2009c; U.S. EPA, 2010; U.S. EPA, 2011). In June 2012, the EPA proposed revisions to the PM NAAQS and in December 2012 announced its final decisions to revise the primary and secondary PM
                        <E T="52">2.5</E>
                         annual standards (77 FR 38890, June 29, 2012; 78 FR 3086, January 15, 2013). With regard to the secondary standards, the EPA retained the 24-hour PM
                        <E T="52">2.5</E>
                         and PM
                        <E T="52">10</E>
                         standards, with a revision to the form of the 24-hour PM
                        <E T="52">2.5</E>
                        , to eliminate the option for spatial averaging (78 FR 3086, January 15, 2013). Petitioners challenged the EPA's final rule. On judicial review, the revised standards and monitoring requirements were upheld in all respects (
                        <E T="03">National Association of Manufacturers</E>
                         v. 
                        <E T="03">EPA,</E>
                         750 F.3d 921, [D.C. Cir. 2014]).
                    </P>
                    <P>
                        The subsequent review of the PM secondary standards, completed in 2020, and its subsequent reconsideration focused on consideration of protection provided from visibility effects, materials damage, and climate effects (85 FR 82684, December 18, 2020; 89 FR 16202, March 6, 2024). Those effects—visibility effects, materials damage and climate effects—are not addressed in this review. The evidence for ecological effects of PM is addressed in the review of the air quality criteria and standards described in the PA for this review.
                        <PRTPAGE P="105698"/>
                    </P>
                    <HD SOURCE="HD2">D. Current Review</HD>
                    <P>
                        In August 2013, the EPA issued a call for information in the 
                        <E T="04">Federal Register</E>
                         for information related to the current review of the air quality criteria for SO
                        <E T="52">X</E>
                         and N oxides and announced a public workshop to discuss policy-relevant scientific information to inform the review (78 FR 53452, August 29, 2013). Based in part on the information received in response to the call for information, the EPA developed a draft IRP, which was made available for consultation with the CASAC and for public comment (80 FR 69220, November 9, 2015). Comments from the CASAC and the public on the draft IRP were considered in preparing the final IRP (Diez Roux and Fernandez, 2016; U.S. EPA, 2017). In developing the final IRP, the EPA expanded the review to also include review of the criteria and standards related to ecological effects of PM in recognition of atmospheric transformations and deposition involving the three pollutants (N oxides, SO
                        <E T="52">X</E>
                         and PM) and associated ecological effects (U.S. EPA, 2017). In so doing, the EPA clarified that other effects of PM, including materials damage, climate effects and visibility effects are beyond the scope of this review (IRP, p. 1-2 and section 2.1).
                    </P>
                    <P>
                        In March 2017, the EPA released the first external review draft of the 
                        <E T="03">Integrated Science Assessment (ISA) for Oxides of Nitrogen, Oxides of Sulfur, and Particulate Matter Ecological Criteria</E>
                         (82 FR 15702, March 30, 2017), which was then reviewed by the CASAC at public meetings in May and August 2017 (82 FR 15701, March 30, 2017; 82 FR 35200, July 28, 2017; Diez Roux and Fernandez, 2017). A second external review draft ISA was released in 2018 and reviewed by the CASAC at public meetings in September 2018 and April 2020 (83 FR 2018; July 9, 2018; 85 FR 16093, March 30, 2020; Cox, Kendall, and Fernandez, 2020a).
                        <SU>15</SU>
                        <FTREF/>
                         The EPA released the final ISA in October 2020 (85 FR 66327, October 19, 2020; U.S. EPA, 2020a).
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             A change in CASAC membership contributed to an extended time period between the two public meetings.
                        </P>
                    </FTNT>
                    <P>
                        In 2023, the draft PA, including the REA for aquatic acidification as an appendix,
                        <SU>16</SU>
                        <FTREF/>
                         was released for review by the CASAC and for public comment (88 FR 34852, May 31, 2023). The CASAC conducted its review at public meetings in June and September 2023 and conveyed its advice to the Administrator on the standards and comments on the draft PA in late September 2023 (88 FR 17572, March 23, 2023; 88 FR 45414, July 17, 2023; Sheppard, 2023). In January 2024, the EPA released the final PA (89 FR 2223, January 12, 2024; U.S. EPA, 2024). In April 2024, the EPA proposed to revise the secondary SO
                        <E T="52">2</E>
                         standard and retain the secondary standards for N oxides and PM (89 FR 26620, April 15, 2024). During the subsequent public comment period, public comments were received both orally during a virtual public hearing on May 8, 2024 (89 FR 26114, April 15, 2024) and in writing to the docket (as discussed in section II.B.2. below).
                        <SU>17</SU>
                        <FTREF/>
                         Significant comments received are addressed in this preamble to this final action and in the accompanying Response to Comments document, which can be found in the docket for this review. The schedule for completion of this review has been governed by a consent decree that requires the EPA to sign for publication a notice of final rulemaking concerning review of the NAAQS for N oxides, SO
                        <E T="52">X</E>
                         and PM no later than December 10, 2024 (
                        <E T="03">Center for Biological Diversity</E>
                         v. 
                        <E T="03">Regan</E>
                         [No. 4:22-cv-02285-HSG (N.D. Cal.)]).
                    </P>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             The planning document for quantitative aquatic acidification exposure/risk analyses was also made available for public comment and consultation with the CASAC (83 FR 31755, July 9, 2018; Cox, Kendall, and Fernandez, 2020b; U.S. EPA, 2018; 83 FR 42497, August 22, 2018).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             The public hearing transcript and any written testimony provided are also in the docket.
                        </P>
                    </FTNT>
                    <P>
                        Materials upon which the decision in this review is based, including the documents described above, are available to the public in the docket for this review.
                        <SU>18</SU>
                        <FTREF/>
                         The EPA is basing its decision in this review on studies and related information included in the air quality criteria, which have undergone CASAC and public review. The studies assessed in the ISA and PA, and the integration of the scientific evidence presented in them, have undergone extensive critical review by the EPA, the CASAC, and the public. The rigor of that review makes these studies, and their integrative assessment, the most reliable source of scientific information on which to base decisions on the NAAQS, decisions that all recognize to be of great import. Decisions on the NAAQS can have profound impacts on public health and welfare, and NAAQS decisions should be based on studies that have been rigorously assessed in an integrated manner not only by the EPA but also by the statutorily mandated independent scientific advisory committee, as well as the public review that accompanies this process.
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             The docket for this review, Docket ID No. EPA-HQ-OAR-2014-0128, has incorporated the ISA docket (Docket ID No. EPA-HQ-ORD-2013-0620) by reference. Both are publicly accessible at 
                            <E T="03">https://www.regulations.gov.</E>
                        </P>
                    </FTNT>
                    <P>
                        Some commenters have referred to and discussed individual scientific studies on the welfare effects of SO
                        <E T="52">X</E>
                        , N oxides, and PM that were not included in the ISA (“new” studies) and that have not gone through this comprehensive review process. In considering and responding to comments for which such “new” studies were cited in support, the EPA has provisionally considered the cited studies in the context of the findings of the ISA (Weaver, 2024). The EPA's provisional consideration of these studies did not and could not provide the kind of in-depth critical review described above, but rather was focused on determining whether they warranted reopening the review of the air quality criteria to enable the EPA, the CASAC and the public to consider them further as part of this review. This approach, and the decision to rely on studies and related information included in the air quality criteria, which have undergone CASAC and public review, is consistent with the EPA's practice in prior NAAQS reviews and its interpretation of the requirements of the CAA. Since the 1970 amendments, the EPA has taken the view that NAAQS decisions are to be based on scientific studies and related information that have been assessed as a part of the pertinent air quality criteria, and the EPA has consistently followed this approach. This longstanding interpretation was strengthened by new legislative requirements enacted in 1977, which added section 109(d)(2) of the Act concerning CASAC review of air quality criteria. See 71 FR 61144, 61148 (October 17, 2006, final decision on review of NAAQS for particulate matter) for a detailed discussion of this issue and the EPA's past practice.
                    </P>
                    <P>
                        As discussed in the EPA's 1993 decision not to revise the ozone (O
                        <E T="52">3</E>
                        ) NAAQS, “new” studies may sometimes be of such significance that it is appropriate to delay a decision in a NAAQS review and to supplement the pertinent air quality criteria so the studies can be taken into account (58 FR at 13013-13014, March 9, 1993). In the present case, the EPA's consideration of “new” studies concludes that, taken in context, the “new” information and findings do not materially change any of the broad scientific conclusions made in the air quality criteria regarding the health and welfare effects of the subject pollutants in ambient air. For this reason, reopening the air quality criteria review is not warranted. Accordingly, the EPA is basing the final decisions in this review on the studies and related information included in the air quality 
                        <PRTPAGE P="105699"/>
                        criteria that have undergone rigorous review by the EPA, the CASAC, and the public. The EPA will consider these “new” studies for inclusion in the air quality criteria for the next review, which will provide the opportunity to fully assess these studies through a more rigorous review process involving the EPA, the CASAC, and the public.
                    </P>
                    <HD SOURCE="HD1">II. Rationale for Decisions</HD>
                    <P>
                        This section presents the rationale for the Administrator's decisions in the review of the secondary NAAQS for the ecological effects of SO
                        <E T="52">X</E>
                        , N oxides and PM. This rationale is based on a thorough review of the full evidence base, including the scientific information available since the last reviews of the secondary standards for N oxides, SO
                        <E T="52">X</E>
                         and PM. This information on ecological effects associated with SO
                        <E T="52">X</E>
                        , N oxides and PM and pertaining to their presence in ambient air, which includes studies generally published between January 2008 and May 2017 (and considered in the ISA), is integrated with the information and conclusions from previous assessments and presented in the ISA (ISA, section IS.1.2).
                        <SU>19</SU>
                        <FTREF/>
                         The Administrator's rationale also takes into account: (1) the PA evaluation of the policy-relevant information in the ISA and presentation of quantitative analyses of air quality, exposure and aquatic acidification risks; (2) CASAC advice and recommendations, as reflected in discussions of drafts of the ISA and PA at public meetings and in the CASAC's letters to the Administrator; (3) public comments received during the development of these documents; and (4) public comments received on the proposed decisions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             In addition to the review's opening “Call for Information” (78 FR 53452, August 29, 2013), multiple search methodologies were applied to identify relevant scientific findings that have emerged since the 2008 ISA. Search techniques for the current ISA identified and evaluated studies and reports that have undergone scientific peer review and were published or accepted for publication between January 2008 (providing some overlap with the cutoff date for the 2008 ISA) and May 2017. Studies published after the literature cutoff date for this ISA were also considered in the ISA if they were submitted in response to the Call for Information or identified in subsequent phases of ISA development, particularly to the extent that they provide new information that affects key scientific conclusions. References that are cited in the ISA, the references that were considered for inclusion but not cited, and electronic links to bibliographic information and abstracts can be found at: 
                            <E T="03">https://hero.epa.gov/hero/index.cfm/project/page/project_id/2965</E>
                             (ISA, section IS.1.2).
                        </P>
                    </FTNT>
                    <P>
                        Before presenting the rationale for the Administrator's final decisions and their foundations, section II.A.1. provides an introduction that also summarizes the basis for the existing standards (section II.A.1.a.), provides background on the prior review of deposition-related effects of N oxides and SO
                        <E T="52">X</E>
                         (section II.A.1.b.), and summarizes the general approach in this review (section II.A.1.c.). Section II.A.2. provides an overview of the air quality information and analyses relating S and N deposition to concentrations of SO
                        <E T="52">X</E>
                        , N oxides and PM. Section II.A.3. provides an overview of the currently available ecological effects evidence as summarized in the ISA, focusing on consideration of key policy-relevant aspects, and section II.A.4. provides an overview of the exposure and risk information for this review, drawing on the quantitative analyses of aquatic acidification risk, presented in the PA. Section II.B.1. provides a summary of the Administrator's proposed decisions (section II.B.1.c.), which drew on both evidence-based and exposure/risk-based considerations from the PA (section II.B.1.a.) and advice from the CASAC (section II.B.1.b.). Section II.B.2. discusses comments received on the proposed decision, and section II.B.3. presents the Administrator's conclusions and associated rationale. The final decisions are summarized in section II.C.
                    </P>
                    <HD SOURCE="HD2">A. Introduction</HD>
                    <P>
                        The Agency's approach in its review of secondary standards is consistent with the requirements of the provisions of the CAA related to the review of NAAQS and with how the EPA and the courts have historically interpreted the CAA. These provisions require the Administrator to establish secondary standards that, in the Administrator's judgment, are requisite (
                        <E T="03">i.e.,</E>
                         neither more nor less stringent than necessary) to protect the public welfare from known or anticipated adverse effects associated with the presence of the pollutant in the ambient air. In so doing, the Administrator considers advice from the CASAC and public comment. This approach is based on a recognition that the available welfare effects evidence generally reflects a range of effects that include ambient air-related exposure circumstances for which scientists generally agree that effects are likely to occur as well as lower levels at which the likelihood and magnitude of response become increasingly uncertain. The CAA does not require that standards be set at a zero-risk level, but rather at a level that reduces risk sufficiently to protect the public welfare from known or anticipated adverse effects.
                    </P>
                    <P>
                        The Agency's decisions on the adequacy of the current secondary standards and, as appropriate, on any potential alternative standards considered in a review, are largely public welfare policy judgments made by the Administrator based on the Administrator's informed assessment of what constitutes requisite protection against adverse effects to the public welfare. A public welfare policy decision draws upon scientific information and analyses about welfare effects, exposures and risks, as well as judgments about the appropriate response to the range of uncertainties that are inherent in the scientific evidence and analyses. The ultimate determination as to what level of damage to ecosystems and the services provided by those ecosystems is adverse to public welfare is not wholly a scientific question, although it may be informed by scientific studies linking ecosystem damage to losses in ecosystem services and information on the value of those losses of ecosystem services. In reaching decisions on secondary standards, the Administrator seeks to establish standards that are neither more nor less stringent than necessary for this purpose. In evaluating the public welfare protection afforded by the standards, the four basic elements of the NAAQS (indicator, averaging time, level, and form) are considered collectively.
                        <SU>20</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             The indicator defines the chemical species or mixture to be measured in the ambient air for the purpose of determining whether an area attains the standard. The averaging time defines the period over which air quality measurements are to be averaged or otherwise analyzed. The form of a standard defines the air quality statistic that is to be compared to the level of the standard in determining whether an area attains the standard. For example, the form of the annual NAAQS for fine particulate matter (PM
                            <E T="52">2.5</E>
                            ) is the average of annual mean concentrations for three consecutive years, while the form of the 3-hour secondary NAAQS for SO
                            <E T="52">2</E>
                             is the second highest 3-hour average in a year. The level of the standard defines the air quality concentration used for that purpose.
                        </P>
                    </FTNT>
                    <P>
                        Generally, conclusions reached by the Administrator in secondary NAAQS reviews on the amount of public welfare protection from the presence of the pollutant(s) in ambient air that is appropriate to be afforded by a secondary standard take into account a number of considerations. Among these considerations are the nature and degree of effects of the pollutant, including the Administrator's judgments on what constitutes an adverse effect to the public welfare, as well as the strengths and limitations of the available and relevant information, with its associated uncertainties. Across reviews, it is generally recognized that such judgments should neither overstate nor understate the strengths and limitations of the evidence and information nor the 
                        <PRTPAGE P="105700"/>
                        appropriate inferences to be drawn as to risks to public welfare, and that the choice of the appropriate level of protection is a public welfare policy judgment entrusted to the Administrator under the CAA taking into account both the available evidence and associated uncertainties (80 FR 65404-05, October 26, 2015). Thus, the Administrator's final decisions in such reviews draw upon the scientific information and analyses about welfare effects, environmental exposures and risks, and associated public welfare significance, as well as judgments about how to consider the range and magnitude of uncertainties that are inherent in the scientific evidence and quantitative analyses.
                    </P>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>
                        Ecological effects of N oxides, SO
                        <E T="52">X</E>
                         and PM include those related to direct contact of the airborne pollutants with plants and those related to atmospheric deposition of N- and S-containing compounds into sensitive ecosystems. As summarized in section II.A.1.a. below, it is the former category of effects (from direct contact) that were considered in establishing the existing standards, with those effects as the basis for the secondary standards for N oxides and SO
                        <E T="52">X</E>
                        . In the last review of those standards, deposition-related effects were also considered. However, as summarized in section II.A.1.b. below, the extent of the uncertainties associated with the complex methodology investigated for defining a deposition-based standard in that review were found to be so significant that the Administrator concluded that the limitations and uncertainties in the available information were too great to support establishment of a new standard using this methodology that could be concluded to provide the requisite protection for such effects under the Act (77 FR 20218, April 3, 2012). As described in the proposal for the current action, and generally summarized in section II.A.1.c. below, in the current review we have taken a different approach to considering standards that might be expected to provide the appropriate level of protection from deposition-related effects.
                    </P>
                    <HD SOURCE="HD3">a. Basis for Existing Secondary Standards</HD>
                    <P>
                        The existing 3-hour secondary SO
                        <E T="52">2</E>
                         standard, with its level of 0.5 ppm, and the annual secondary NO
                        <E T="52">2</E>
                         standard, with its level of 0.053 ppm were established in 1971 (36 FR 8186, April 30, 1971). The basis for both the existing SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">2</E>
                         secondary standards is to provide protection to the public welfare related to direct effects on vegetation (U.S. DHEW, 1969a; U.S. EPA, 1971). There are three secondary PM standards—established in 1997 (annual PM
                        <E T="52">2.5</E>
                         standard) and 2006 (24-hour PM
                        <E T="52">2.5</E>
                         and PM
                        <E T="52">10</E>
                         standards)—variously based on consideration of materials damage, visibility impacts, climate effects and ecological effects.
                        <SU>21</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             As noted in section I.D. above, the 2020 review of the PM secondary NAAQS and its reconsideration focused on visibility effects, materials damage and climate effects, while the ecological effects of PM are being addressed in this combined review (89 FR 16205, March 6, 2024).
                        </P>
                    </FTNT>
                    <P>
                        The welfare effects evidence for SO
                        <E T="52">X</E>
                         in previous reviews indicates a relationship between short- and long-term SO
                        <E T="52">2</E>
                         exposures and foliar damage to cultivated plants, as well as reductions in productivity, species richness, and diversity (U.S. DHEW, 1969a; U.S. EPA, 1982c; U.S. EPA, 2008a). At the time the standard was set, concentrations of SO
                        <E T="52">2</E>
                         in the ambient air were also associated with other welfare effects, including effects on materials and visibility related to sulfate, a particulate transformation product of SO
                        <E T="52">2</E>
                         (U.S. DHEW, 1969a). However, the available data were not sufficient to establish a quantitative relationship between specific SO
                        <E T="52">2</E>
                         concentrations and such effects (38 FR 25679, September 14, 1973). Accordingly, direct effects of SO
                        <E T="52">X</E>
                         in ambient air on vegetation are the basis for the existing secondary standard for SO
                        <E T="52">X</E>
                        .
                    </P>
                    <P>
                        The welfare effects evidence for N oxides in previous reviews includes foliar injury, leaf drop, and reduced yield of some crops (U.S. EPA, 1971; U.S. EPA, 1982c; U.S. EPA, 1993; U.S. EPA, 2008a). Since it was established in 1971, the secondary standard for N oxides has been reviewed three times, in 1985, 1996, and 2012 (50 FR 25532, June 19, 1985; 61 FR 52852; October 8, 1996; 77 FR 20218, April 3, 2012). Although those reviews identified additional effects related to N deposition, they all have concluded that the existing NO
                        <E T="52">2</E>
                         secondary standard provided adequate protection related to the effects of direct contact of airborne N oxides with vegetation on which the standard is based.
                    </P>
                    <P>
                        In the last review of the secondary PM standards with regard to protection from ecological effects, completed in 2013, the EPA retained the 24-hour PM
                        <E T="52">2.5</E>
                         standard, with its level of 35 µg/m
                        <SU>3</SU>
                        , and the 24-hour PM
                        <E T="52">10</E>
                         standard, with its level of 150 µg/m
                        <SU>3</SU>
                         (78 FR 3228, January 15, 2013). With regard to the annual PM
                        <E T="52">2.5</E>
                         standard, the EPA retained the averaging time and level, set at 15 µg/m
                        <SU>3</SU>
                        , while revising the form to remove the option for spatial averaging consistent with this change to the primary annual PM
                        <E T="52">2.5</E>
                         standard (78 FR 3225, January 15, 2013). The effects considered in that review of the secondary PM standards include effects on visibility, materials damage, and climate effects, as well as ecological effects; the EPA concluded that those standards provided protection for ecological effects (
                        <E T="03">e.g.,</E>
                         78 FR 3225-3226, 3228, January 15, 2013). In reaching this conclusion, it was noted that the PA for the review explicitly excluded discussion of the effects associated with deposited PM components of N oxides and SO
                        <E T="52">X</E>
                         and their transformation products, which were being addressed in the joint review of the secondary NO
                        <E T="52">2</E>
                         and SO
                        <E T="52">2</E>
                         NAAQS (78 FR 3202, January 15, 2013). The ecological effects of PM considered in the 2013 review included direct effects on plant foliage as well as effects of the ecosystem loading of PM constituents such as metals or organic compounds (2009 ISA, section 2.5.3). For all of these effects, the 2013 decision recognized an absence of information that would support any different standards and concluded the existing standards, with the revision to the form of the annual PM
                        <E T="52">2.5</E>
                         standard, provided the requisite protection (78 FR 3086, January 15, 2013).
                    </P>
                    <HD SOURCE="HD3">b. Prior Review of Deposition-Related Effects</HD>
                    <P>
                        In the 2012 review of the NO
                        <E T="52">2</E>
                         and SO
                        <E T="52">2</E>
                         secondary standards, the EPA recognized that a significant increase in understanding of the effects of N oxides and SO
                        <E T="52">X</E>
                         had occurred since the preceding secondary standards reviews for those pollutants (77 FR 20236, April 3, 2012). Considering the extensive evidence available in the 2012 review, the Agency concluded that the most significant risks of adverse effects of N oxides and SO
                        <E T="52">X</E>
                         to the public welfare were those related to deposition of N and S compounds in both terrestrial and aquatic ecosystems (77 FR 20236, April 3, 2012). Accordingly, in addition to evaluating the protection provided by the secondary standards for N oxides and SO
                        <E T="52">X</E>
                         from effects associated with the airborne pollutants, the 2012 review also included extensive analyses of the welfare effects associated with atmospheric deposition of N and S compounds in sensitive aquatic and terrestrial ecosystems, described in the 2009 REA and 2011 PA (77 FR 20218, April 3, 2012).
                    </P>
                    <P>
                        The 2009 REA assessed atmospheric deposition of N and S compounds and the risks it posed of two categories of ecosystem effects: acidification and nutrient enrichment in both terrestrial 
                        <PRTPAGE P="105701"/>
                        and aquatic ecosystems (U.S. EPA, 2009a). In so doing, however, the 2009 REA and 2011 PA recognized that the different types of effects varied in the strength of the evidence and of the information characterizing quantitative linkages between pollutants in ambient air and ecosystem responses, and in associated potential public welfare implications. The support in the evidence for quantitative assessment of aquatic acidification-related effects was strongest and the least uncertain.
                    </P>
                    <P>
                        With regard to nutrient enrichment-related effects, despite the extensive evidence of deleterious effects of excessive ecosystem loading of nitrogen, the identification of options to provide protection from deposition-related effects was limited by several factors. These included the influence in terrestrial ecosystems of other air pollutants such as O
                        <E T="52">3</E>
                        , and limiting factors such as moisture and other nutrients, and their potential to confound the characterization of the effects of changes in any one stressor, such as N deposition, in those systems (2011 PA, section 6.3.2). Forest management practices were also recognized to have the ability to significantly affect nitrogen cycling within a given forest ecosystem (2008 ISA section 3.3.2.1 and Annex C, section C.6.3). In aquatic systems, appreciable contributions of non-atmospheric sources to nutrient loading in most large waterbodies, and limitations in data and tools, contributed uncertainties to characterizations of incremental adverse impacts of atmospheric N deposition (2011 PA, section 6.3.2). With regard to terrestrial acidification effects, data limitations contributed uncertainty to identification of appropriate indicator reference levels, and the potential for other stressors to confound relationships between deposition and terrestrial acidification effects was recognized with regard to empirical case studies described in the 2008 ISA.
                    </P>
                    <P>
                        Based on the strong support in the evidence for the relationship between atmospheric deposition of acidifying N and S compounds and loss of acid neutralizing capacity (ANC) in sensitive ecosystems, with associated aquatic acidification effects, the REA analyses for this endpoint (aquatic acidification) received greatest emphasis in the review relative to other deposition-related effects. This emphasis on aquatic acidification-related effects of N oxides and SO
                        <E T="52">X</E>
                         also reflected the advice from the CASAC. Accordingly, the 2011 PA focused on aquatic acidification effects in identifying policy options for providing public welfare protection from deposition-related effects of N oxides and SO
                        <E T="52">X</E>
                        , concluding that the available information and assessments were only sufficient at that time to support development of a standard to address aquatic acidification. Consistent with this, the PA concluded it was appropriate to consider a secondary standard in the form of an aquatic acidification index (AAI) and identified a range of AAI values (which correspond to ANC levels) for consideration in establishing such a standard (2011 PA, section 7.6.2). Conceptually, the AAI is an index that uses the results of ecosystem and air quality modeling to estimate waterbody ANC. The standard level for an AAI-based standard was conceptually envisioned to be a national minimum target ANC for waterbodies in the ecoregions of the U.S. for which data were considered adequate for these purposes (2011 PA, section 7.6.2).
                    </P>
                    <P>
                        While the NAAQS have historically been set in terms of an ambient air concentration, an AAI-based standard was envisioned to have a single value established for the AAI, but the concentrations of SO
                        <E T="52">X</E>
                         and N oxides would be specific to each ecoregion, taking into account variation in several factors that influence waterbody ANC, and consequently could vary across the U.S. The factors, specific to each ecoregion (“F factors”), which it was envisioned would be established as part of the standard, include surface water runoff rates and “transference ratios.” The latter is the term assigned to factors applied to deposition values (estimated to achieve the minimum specified ANC) to back-calculate or estimate the highest ambient air concentrations of SO
                        <E T="52">X</E>
                         and N oxides that would meet the AAI-based standard level (2011 PA, Chapter 7).
                        <SU>22</SU>
                        <FTREF/>
                         The ecoregion-specific values for these factors would be specified based on then-available data and simulations of the Community Multiscale Air Quality (CMAQ) model and codified as part of such a standard. As part of the standard, these factors would be reviewed in the context of each periodic review of the NAAQS.
                    </P>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             These were among the ecoregion-specific factors that comprised the parameters F1 through F4 in the AAI equation (2011 PA, p. 7-37). The parameter F2 represented the ecoregion-specific estimate of acidifying deposition associated with reduced forms of nitrogen, NH
                            <E T="52">X</E>
                             (2011 PA, p. 7-28 and ES-8 to ES-9). The 2011 PA suggested that this factor could be specified based on a 2005 CMAQ model simulation over 12-km grid cells or might involve the use of monitoring data for NH
                            <E T="52">X</E>
                             applied in dry deposition modeling. It was recognized that appreciable spatial variability, as well as overall uncertainty, were associated with this factor.
                        </P>
                    </FTNT>
                    <P>
                        After consideration of the PA conclusions, the Administrator concluded that while the conceptual basis for the AAI was supported by the available scientific information, there were limitations in the available relevant data and uncertainties associated with specifying the elements of the AAI, specifically those based on modeled factors, that posed obstacles to establishing such a standard under the CAA. It was recognized that the general structure of an AAI-based standard addressed the potential for contributions to acid deposition from both N oxides and SO
                        <E T="52">X</E>
                         and quantitatively described linkages between ambient air concentrations, deposition, and aquatic acidification, considering variations in factors affecting these linkages across the country. However, the Administrator judged that the limitations and uncertainties in the available information were too great to support establishment of a new standard that could be concluded to provide the requisite protection for such effects under the Act (77 FR 20218, April 3, 2012). These uncertainties generally related to the quantification of the various elements of the standard (the “F factors”) and their representativeness at an ecoregion scale. These uncertainties and the complexities in this approach were recognized to be unique to the 2012 review of the NAAQS for N and S oxides and were concluded to preclude the characterization and degree of protectiveness that would be afforded by an AAI-based standard, within the ranges of levels and forms identified in the PA, and the representativeness of F factors in the AAI equation described in the 2011 PA (77 FR 20261, April 3, 2012). As the EPA said:
                    </P>
                    <EXTRACT>
                        <FP>“[T]he Administrator recognizes that characterization of the uncertainties in the AAI equation as a whole represents a unique challenge in this review primarily as a result of the complexity in the structure of an AAI based standard. In this case, the very nature of some of the uncertainties is fundamentally different than uncertainties that have been relevant in other NAAQS reviews. She notes, for example, some of the uncertainties uniquely associated with the quantification of various elements of the AAI result from limitations in the extent to which ecological and atmospheric models, which have not been used to define other NAAQS, have been evaluated. Another important type of uncertainty relates to limitations in the extent to which the representativeness of various factors can be determined at an ecoregion scale, which has not been a consideration in other NAAQS.” [77 FR 20261, April 3, 2012]</FP>
                    </EXTRACT>
                    <P>
                        The Administrator concluded that while the existing secondary standards were not adequate to provide protection against potentially adverse deposition-
                        <PRTPAGE P="105702"/>
                        related effects associated with N oxides and SO
                        <E T="52">X</E>
                        , it was not appropriate under section 109 of the CAA (given the uncertainties summarized immediately above) to set any new or additional standards at that time to address effects associated with deposition of N and S compounds on sensitive aquatic and terrestrial ecosystems (77 FR 20262-20263, April 3, 2012). This decision was upheld upon judicial review.
                    </P>
                    <HD SOURCE="HD3">c. General Approach for This Review</HD>
                    <P>
                        As is the case for all NAAQS reviews, this secondary standards review uses the Agency's assessment of the current scientific evidence and associated quantitative analyses as a foundation to inform the Administrator's judgments regarding secondary standards for SO
                        <E T="52">X</E>
                        , N oxides and PM that are requisite to protect the public welfare from known or anticipated adverse effects associated with that pollutant's presence in the ambient air. The approach for this review of the secondary SO
                        <E T="52">X</E>
                        , N oxides, and PM standards builds on the last reviews of those pollutants, including the substantial assessments and evaluations performed over the course of those reviews, and considering the more recent scientific information and air quality data now available to inform understanding of the key policy-relevant issues in the current review. The EPA's assessments are primarily documented in the ISA and PA, both of which received CASAC review and public comment, as summarized in section I.D. above.
                    </P>
                    <P>
                        This review of the secondary standards for SO
                        <E T="52">X</E>
                        , N oxides, and PM assesses the protection provided by the standards from two categories of effects: direct contact effects of the airborne pollutants and also the effects of the associated S- and N-containing compounds (in gaseous and particulate form) deposited in ecosystems. In so doing, the review draws on the currently available evidence as assessed in the ISA (and prior assessments) and quantitative exposure, risk, and air quality information in the PA, including the REA for aquatic acidification.
                    </P>
                    <P>
                        With regard to direct contact effects, we draw on the currently available evidence as assessed in the ISA, including the determinations regarding the causal nature of relationships between the airborne pollutants and ecological effects, which focus most prominently on vegetation, and quantitative exposure and air quality information. Based on this information, we consider the policy implications, most specifically whether the evidence supports the retention or revision of the current NO
                        <E T="52">2</E>
                         and SO
                        <E T="52">2</E>
                         secondary standards. With regard to the effects of PM, we take a similar approach, based on the evidence presented in the current ISA and conclusions from the review of the PM NAAQS concluded in 2013 (in which ecological effects were last considered) to assess the effectiveness of the current PM standard to protect against these types of impacts.
                    </P>
                    <P>
                        With regard to deposition-related effects, we consider the evidence for the array of effects identified in the ISA (and summarized in section II.A.3. below), including both terrestrial and aquatic effects; and the limitations in the evidence and associated uncertainties as well as the public welfare implications of such effects. The overall approach takes into account the nature of the welfare effects and the exposure conditions associated with effects in identifying S and N deposition levels appropriate to consider in the context of public welfare protection. To identify and evaluate metrics relevant to air quality standards (and their elements), we have assessed relationships developed from air quality measurements near pollutant sources and deposition estimates nearby and in downwind ecoregions. In so doing, the available quantitative information both on deposition and effects, and on ambient air concentrations and deposition, has been assessed with regard to the existence of linkages between SO
                        <E T="52">X</E>
                        , N oxides, and PM in ambient air and deposition-related effects. These assessments, summarized briefly in the sections below (and in detail in the PA), inform judgments on the likelihood of occurrence of deposition-related effects under air quality that meets the existing standards for these pollutants or potential alternatives.
                    </P>
                    <P>In considering the information on atmospheric deposition and ecological effects, we recognize that the impacts from the dramatically higher deposition rates of the past century can affect how ecosystems and biota respond to more recent, lower deposition rates, complicating interpretation of impacts related to more recent, lower deposition levels. This complexity is illustrated by findings of studies that compared soil chemistry across intervals of 15 to 30 years (1984-2001 and 1967-1997). These studies reported that although atmospheric deposition in the Northeast declined across those intervals, soil acidity increased (ISA, Appendix4, section 4.6.1). As noted in the ISA, “[i]n areas where N and S deposition has decreased, chemical recovery must first create physical and chemical conditions favorable for growth, survival, and reproduction” (ISA, Appendix 4, section 4.6.1). Thus, the extent to which S and N compounds (once deposited) are retained in soil matrices (with potential effects on soil chemistry) influences the dynamics of the response of the various environmental pathways to changes in air quality, including changes in emissions, ambient air concentrations and associated deposition.</P>
                    <P>The two-pronged approach applied in the PA for deposition-related effects includes the consideration of deposition levels that may be associated with ecological effects of potential concern and consideration of relationships between ambient air concentrations and levels of deposition. In considering the ecological effects evidence, the focus is on effects for which the evidence is most robust with regard to established quantitative relationships between deposition and ecosystem effects. Such quantitative information for terrestrial ecosystems is derived primarily from analysis of the evidence presented in the ISA. For aquatic ecosystems, the primary focus has been given to effects related to aquatic acidification, for which we have conducted quantitative risk and exposure analyses based on available modeling applications that relate acid deposition and acid buffering capability in U.S. waterbodies, as summarized in section II.A.4. below (PA, section 5.1 and Appendix 5A). Regarding the second prong of the approach, we employed several different types of analyses to inform an understanding of relationships between ambient air concentrations near pollutant sources in terms of metrics relevant to air quality standards (and their elements) and ecosystem deposition estimates (as described in section II.A.2. below). Interpretation of findings from these analyses, in combination with the identified deposition levels of interest, and related policy judgments regarding limitations and associated uncertainties of the underlying information, informed the Administrator's proposed conclusions on the extent to which existing standards, or potential alternative standards, might be expected to provide protection from these levels and inform the Administrator's final decisions in this review, as discussed in section II.B.3. below.</P>
                    <P>
                        In summary, the approach to evaluating the standards with regard to protection from ecological effects related to ecosystem deposition of N and S compounds in this review involves multiple components: (1) review of the scientific evidence to identify the ecological effects associated with the three pollutants, those related 
                        <PRTPAGE P="105703"/>
                        both to direct pollutant contact and to ecosystem deposition; (2) assessment of the evidence and characterization of the REA results to identify deposition levels related to categories of ecosystem effects; and (3) analysis of relationships between ambient air concentrations of the pollutants and deposition of N and S compounds to understand aspects of these relationships that can inform judgments on ambient air standards that protect against air concentrations associated with direct effects and against deposition associated with deposition-related effects that are judged adverse to the public welfare. As discussed in the PA and the proposal, however, relating ambient air concentrations of N oxides and PM to deposition of N compounds is particularly complex because N deposition also results from an additional air pollutant that is not controlled by NAAQS for N oxides and PM. Thus, separate from the evaluation of secondary standards for SO
                        <E T="52">X</E>
                        , the evaluation for N oxides and PM also considers current information (
                        <E T="03">e.g.,</E>
                         spatial and temporal trends) related to the additional air pollutant, ammonia (NH
                        <E T="52">3</E>
                        ), that contributes to N deposition and also related to PM components that do not contribute to N deposition. Evaluation of all of this information, together, is considered by the Administrator in reaching his decision, as summarized in section II.B.3. below.
                    </P>
                    <HD SOURCE="HD3">2. Overview of Air Quality and Deposition</HD>
                    <P>
                        The three criteria pollutants that are the focus of this review (SO
                        <E T="52">X</E>
                        , N oxides, and PM) include both gases and particles. Both their physical state and chemical properties, as well as other factors, influence their deposition as N- or S-containing compounds. The complex pathway from pollutant and precursor emissions (section II.A.2.a.) to ambient air concentrations (section II.A.2.b.) and to eventual deposition (section II.A.2.c.) varies by pollutant and is influenced by a series of atmospheric processes and chemical transformations that occur at multiple spatial and temporal scales (ISA, Appendix 2; PA, Chapters 2 and 6).
                    </P>
                    <P>
                        A complication in the consideration of the influence of these criteria pollutants on N deposition and associated ecological effects is posed by the contribution of other, non-criteria, pollutants in ambient air, specifically NH
                        <E T="52">3</E>
                        . Although emissions of N oxides have appreciably declined, NH
                        <E T="52">3</E>
                         emissions have risen. Together, these co-occurring trends have reduced the influence of N oxides on total N deposition (PA, sections 6.2.1, 6.4.2 and 7.2.3.3). Geographic variability and temporal changes in the percentage of PM composed of N- (and S-) containing compounds, are other factors affecting decisions in this review.
                    </P>
                    <HD SOURCE="HD3">
                        a. Sources, Emissions and Atmospheric Processes Affecting SO
                        <E T="52">X</E>
                        , N Oxides and PM
                    </HD>
                    <P>
                        Sulfur dioxide is generally present at higher concentrations in the ambient air than the other gaseous and highly reactive SO
                        <E T="52">X</E>
                         (ISA, Appendix 2, section 2.1) and, as a result, SO
                        <E T="52">2</E>
                         is the indicator for the existing NAAQS for SO
                        <E T="52">X</E>
                        . The main anthropogenic source of SO
                        <E T="52">2</E>
                         emissions is fossil fuel combustion (PA, section 2.2.2). Based on the 2020 National Emissions Inventory (NEI), the top three emission sources of SO
                        <E T="52">2</E>
                         in the U.S. are coal-fired electricity generating units (48% of total), industrial processes (27%), and other stationary source fuel combustion (9%).
                    </P>
                    <P>
                        Once emitted to the atmosphere, SO
                        <E T="52">2</E>
                         can either remain as SO
                        <E T="52">2</E>
                         in the gas phase and be transported and/or be dry deposited, or it can be oxidized to form sulfate particles (SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                        ), with modeling studies suggesting that oxidation accounts for more than half of SO
                        <E T="52">2</E>
                         removal nationally (PA, section 2.1.1). The rate of SO
                        <E T="52">2</E>
                         oxidation accelerates with greater availability of oxidants, which are generally depleted near source stacks. Consequently, oxidization to SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         generally occurs in cleaner air downwind of SO
                        <E T="52">X</E>
                         sources (2008 ISA, section 2.6.3.1). As SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         particles are generally within the fine particle size range, they are a component of PM
                        <E T="52">2.5</E>
                         and have an atmospheric lifetime ranging from 2 to 10 days (PA, section 2.1.1). The areas of highest SO
                        <E T="52">2</E>
                         and SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         deposition are generally near or downwind of SO
                        <E T="52">X</E>
                         emissions sources, with most S deposition occurring in the eastern U.S. (PA, section 2.5.3). Geographic variation in precipitation also influences the spatial distribution of S wet deposition. In sum, both SO
                        <E T="52">2</E>
                        , and the SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         particles converted from SO
                        <E T="52">2</E>
                        , contribute to S deposition, and do so over different time and geographic scales, with dry deposition of SO
                        <E T="52">2</E>
                         typically occurring near the source, and wet deposition of sulfate particles distributing more regionally.
                    </P>
                    <P>
                        The term N oxides refers to all forms of oxidized nitrogen compounds, including NO, NO
                        <E T="52">2</E>
                        , nitric acid (HNO
                        <E T="52">3</E>
                        ), and particulate nitrate (NO
                        <E T="52">3</E>
                        <E T="51">−</E>
                        ). Most N oxides enter the atmosphere as either NO or NO
                        <E T="52">2</E>
                        , which are collectively referred to as NO
                        <E T="52">X</E>
                         (PA, section 2.1.2). Anthropogenic sources account for the majority of NO
                        <E T="52">X</E>
                         emissions in the U.S., per 2020 NEI estimates, with highway vehicles (26% of total), stationary fuel combustion including electric generating units (25%), and non-road mobile sources (19%) identified as the largest contributors to total emissions (PA, section 2.2.1). Once emitted into the atmosphere, NO
                        <E T="52">X</E>
                         can deposit to the surface or be chemically converted to other gaseous N oxides, including HNO
                        <E T="52">3</E>
                        , as well as to particulate NO
                        <E T="52">3</E>
                        <E T="51">−</E>
                        , which may occur in either the fine or coarse particle size range, such that not all particulate NO
                        <E T="52">3</E>
                        <E T="51">−</E>
                         is a component of PM
                        <E T="52">2.5</E>
                        . In general, gas phase N oxides tend to have shorter atmospheric lifetimes, either dry depositing (
                        <E T="03">e.g.,</E>
                         as HNO
                        <E T="52">3</E>
                        ) or quickly converting to particulate NO
                        <E T="52">3</E>
                        <E T="51">−</E>
                        , which has a similar atmospheric lifetime as particulate SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         and is generally removed by precipitation in wet deposition.
                    </P>
                    <P>
                        In addition to N oxides, there is another category of nitrogen pollutants, referred to as reduced nitrogen, which also contributes to nitrogen deposition. The most common form of reduced N emitted into the air is NH
                        <E T="52">3</E>
                         gas (PA, sections 2.1.3 and 2.2.3), which is not a criteria pollutant. The main sources of NH
                        <E T="52">3</E>
                         emissions include livestock waste (49% of total in 2020 NEI), fertilizer application (33%) and aggregate fires (11%). Ammonia tends to dry deposit near sources, with a fraction of what is emitted being converted to particle form, as ammonium (NH
                        <E T="52">4</E>
                        <SU>+</SU>
                        ), which can be transported away from sources and is most efficiently removed by precipitation (PA, section 2.1.3).
                    </P>
                    <P>
                        Particulate matter is both emitted to the atmosphere and formed in the atmosphere from precursor chemical gases, such as N Oxides, SO
                        <E T="52">X</E>
                         and NH
                        <E T="52">3</E>
                        . Accordingly, PM
                        <E T="52">2.5</E>
                         contributing to S and N deposition generally results from chemicals formed in the atmosphere after being emitted (
                        <E T="03">e.g.,</E>
                         particulate SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                        , particulate NO
                        <E T="52">3</E>
                        <E T="51">−</E>
                        , NH
                        <E T="52">4</E>
                        <E T="51">+</E>
                        ). The majority of PM
                        <E T="52">2.5</E>
                         mass in recent periods (
                        <E T="03">e.g.,</E>
                         2019-2021) is composed of materials that do not contribute to S and N deposition (PA, section 2.4.3 and 6.4.2). For example, at PM
                        <E T="52">2.5</E>
                         monitoring sites across the U.S., SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         generally comprises no more than about a third of PM
                        <E T="52">2.5</E>
                         mass (in eastern sites), with much lower percentages at monitoring sites in much of the West and South (PA Figure 2-30 and section 2.4.3). Similarly, nitrogen-containing species are also a minority of PM
                        <E T="52">2.5</E>
                         mass, representing less than about 30% and down to about 5% or lower in some areas of South (PA, sections 2.4.3 and 6.4.2).
                    </P>
                    <HD SOURCE="HD3">b. Recent Trends in Emissions, Concentrations, and Deposition</HD>
                    <P>
                        Emissions of SO
                        <E T="52">X</E>
                        , oxides of N, and PM have declined dramatically over the past two decades, continuing a longer-
                        <PRTPAGE P="105704"/>
                        term trend (PA, section 2.2). Total SO
                        <E T="52">2</E>
                         emissions nationwide declined by 87% between 2002 and 2022, including reductions of 91% in emissions from electricity generating units and 96% in emissions from mobile sources. Total anthropogenic NO
                        <E T="52">X</E>
                         emissions also trended downward from 2002 to 2022 by 70% nationwide, driven in part by large reductions in emissions from highway vehicles (84%) and stationary fuel combustion (68%) (PA, section 2.2.1). In contrast with these declining 20-year trends in NO
                        <E T="52">X</E>
                         and SO
                        <E T="52">X</E>
                         emissions, the annual rate of NH
                        <E T="52">3</E>
                         emissions increased by over 20 percent nationwide between 2002 and 2022 (PA, section 2.2.3). The two largest contributors are emissions from livestock waste and fertilizer application, which have increased by 11% and 44%, respectively. These trends in NO
                        <E T="52">X</E>
                         and NH
                        <E T="52">3</E>
                         emissions have had ramifications for N deposition patterns across the U.S., as described further below.
                    </P>
                    <P>
                        The large reductions in SO
                        <E T="52">X</E>
                         and NO
                        <E T="52">X</E>
                         emissions have resulted in substantially lower ambient air concentrations in recent years relative to the past. This is true for both 3-hour and 1-hour average concentrations. With regard to 3-hour SO
                        <E T="52">2</E>
                         concentrations, 2021 design values for the existing 3-hour standard at all State and Local Air Monitoring Stations (SLAMS) with valid design values (n= 333) 
                        <SU>23</SU>
                        <FTREF/>
                         are less than the level of the existing secondary standard (500 ppb) 
                        <SU>24</SU>
                        <FTREF/>
                         and more than 75 percent of the sites have design values below 20 ppb (PA, section 2.4.2). This reflects a downward trend since 2000, with the median design value declining from about 50 ppb to less than 10 ppb in 2021 (PA, Figure 2-27).
                    </P>
                    <FTNT>
                        <P>
                            <SU>23</SU>
                             A design value is a statistic that summarizes the air quality data for a given area in terms of the indicator, averaging time, and form of the standard. Design values can be compared to the level of the standard and are typically used to designate areas as meeting or not meeting the standard and assess progress towards meeting the NAAQS. Design values are computed and published annually by EPA (
                            <E T="03">https://www.epa.gov/air-trends/air-quality-designvalues</E>
                            ).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             The existing secondary standard for SO
                            <E T="52">2</E>
                             is 0.5 ppm (500 ppb), as a 3-hour average, not to be exceeded more than once per year.
                        </P>
                    </FTNT>
                    <P>
                        Similarly, design values for the primary SO
                        <E T="52">2</E>
                         standard (annual 99th percentile of daily maximum 1-hour average concentrations, averaged over 3 years) have also declined. In the mid-1990s, the median value of all sites with valid 1-hour design values often exceeded 75 ppb (PA, Figure 2-26). Since then, the entire distribution of design values (including source-oriented sites) has continued to decline such that the median design value for the 1-hour primary standard across the network of sites is now between 5 and 10 ppb (PA, Figure 2-26). Annual average SO
                        <E T="52">2</E>
                         concentrations have also declined over this period. Additionally, both peak and mean SO
                        <E T="52">2</E>
                         concentrations are higher at source-oriented sites than monitoring locations that are not source-oriented.
                        <SU>25</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             In the 2019-2021 period, the maximum design value for the primary SO
                            <E T="52">2</E>
                             standard was 376 ppb at a monitoring site near an industrial park in southeast Missouri. It is important to note that peak and mean SO
                            <E T="52">2</E>
                             concentrations are higher at source-oriented sites than monitoring locations that are not source-oriented. Additionally, it is not uncommon for there to be high SO
                            <E T="52">2</E>
                             values in areas with recurring volcanic eruptions, such as in Hawaii (PA, section 2.4.2).
                        </P>
                    </FTNT>
                    <P>
                        Regarding NO
                        <E T="52">2</E>
                        , design values for the secondary standard (annual averages) at all 399 sites with valid design values in 2021 are below the 53 ppb level of the existing standard,
                        <SU>26</SU>
                        <FTREF/>
                         and 98% of sites have design values below 20 ppb. In 2021, the maximum design value was 30 ppb,
                        <SU>27</SU>
                        <FTREF/>
                         and the median was 7 ppb, reflecting a downward trend since 2000 when the median annual design value was 15 ppb.
                    </P>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             Sites in the contiguous U.S. have met the existing NO
                            <E T="52">2</E>
                             secondary standard since around 1991 (PA, Figure 2-22).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             The maximum annual average NO
                            <E T="52">2</E>
                             concentrations has been at, slightly above, or slightly below 30 ppb since about 2008, with the highest 3-year average value just above 30 ppb (PA, Figures 2-22 and 7-9).
                        </P>
                    </FTNT>
                    <P>
                        Likewise, the median of the annual average PM
                        <E T="52">2.5</E>
                         concentrations also decreased substantially from 2000 to 2021, from 12.8 μg/m
                        <SU>3</SU>
                         to 8 μg/m
                        <SU>3</SU>
                        . The median of the annual 98th percentile 24-hour PM
                        <E T="52">2.5</E>
                         concentrations at the more than 1000 sites monitored also decreased, from 32 μg/m
                        <SU>3</SU>
                         in 2000 to 21 μg/m
                        <SU>3</SU>
                         in 2021. Although both the annual average and 98th percentile 24-hour PM
                        <E T="52">2.5</E>
                         concentrations decreased steadily from the early 2000s until 2016, these values have fluctuated in recent years due to large-scale wildfire events (PA, section 2.4.3; U.S. EPA, 2023, Figures 23 and 24).
                    </P>
                    <P>
                        The changes in emissions and associated concentrations since 2000 have also contributed to appreciable changes in N and S deposition nationwide (PA, sections 2.5.3 and 6.2.1). For S compounds, the dramatic reduction in SO
                        <E T="52">X</E>
                         emissions (87% nationwide) resulted in concordant reductions in S deposition, 68% on average across U.S. (PA, section 6.2.1). This decline is observed across the contiguous U.S. (CONUS), with the largest reductions in regions downwind of large sources such as electricity generating units. For N deposition, the impact of the appreciable reduction in N oxides emissions has been offset by deposition arising from increasing emissions of reduced forms of nitrogen over the same timeframe.
                    </P>
                    <HD SOURCE="HD3">c. Relationships Between Concentrations and Deposition</HD>
                    <P>
                        As the NAAQS are set in terms of pollutant concentrations, analyses in the PA evaluated relationships between criteria pollutant concentrations in ambient air and ecosystem deposition across the U.S. These relationships were evaluated over a range of conditions (
                        <E T="03">e.g.,</E>
                         pollutant, region, time period), and with consideration of deposition both near sources and at distance (allowing for pollutant transport and associated transformation) using five different approaches (PA, Chapter 6 and Appendix 6A).
                    </P>
                    <P>
                        First, as part of a “real-world experiment,” the PA analyses leveraged the recent downward trends in NO
                        <E T="52">X</E>
                         and SO
                        <E T="52">X</E>
                         emissions and corresponding air quality concentrations as well as the trends in deposition to examine the correlation between observed decreases in emissions and concentration and observed changes in deposition over the past two decades (PA, section 6.2.1). The deposition estimates used in these analyses (termed TDep) 
                        <SU>28</SU>
                        <FTREF/>
                         are based on a hybrid approach that involves a fusion of measured and modeled values, where measured values are given more weight at the monitoring locations and modeled data are used to fill in spatial gaps and provide information on chemical species that are not measured by routine monitoring networks (Schwede and Lear, 2014). For the second approach, we assessed how ambient air concentrations and associated deposition levels are related within the CMAQ 
                        <SU>29</SU>
                        <FTREF/>
                         both across the U.S. and then at certain Class I areas 
                        <SU>30</SU>
                        <FTREF/>
                         (PA, section 
                        <PRTPAGE P="105705"/>
                        6.2.2.1) where additional monitoring data are collected as part of the Clean Air Status and Trends Network (CASTNET) and the Interagency Monitoring of Protected Visual Environments (IMPROVE) networks. As a third approach, we analyzed the relationships across a limited number of monitoring locations (in Class I areas) where both air quality data (CASTNET and IMPROVE) and wet deposition of S and N was measured to evaluate the associations between concentrations and deposition at a local scale (PA, section 6.2.2.2 and 6.2.2.3). The fourth approach also considered the associations between the two terms, at the local scale, but did so using a broader set of ambient air concentration measurements (
                        <E T="03">i.e.,</E>
                         all valid SO
                        <E T="52">2</E>
                        , NO
                        <E T="52">2</E>
                        , and PM
                        <E T="52">2.5</E>
                         measurements at SLAMS across the U.S.) and the hybrid set of TDep estimates (PA, section 6.2.3).
                    </P>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             Other than the estimates associated with the CMAQ analysis (second approach referenced above), the deposition estimates used in these analyses are those provided by the National Atmospheric Deposition Program, TDep Science Committee. One of the outputs of this effort are annual datasets of total deposition estimates in the contiguous U.S. (CONUS), which are referred to as the TDep datasets (technical updates available from NADP, 2021; ISA, Appendix 2, section 2.6). TDep datasets do not currently exist for areas outside of the CONUS.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             The CMAQ is a state of the science photochemical air quality model that relies on scientific first principles to simulate the concentration of airborne gases and particles and the deposition of these pollutants back to Earth's surface under user-prescribed scenarios. See 
                            <E T="03">https://www.epa.gov/cmaq</E>
                             for more detail.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>30</SU>
                             Areas designated as Class I include all international parks, national wilderness areas which exceed 5,000 acres in size, national memorial parks which exceed 5,000 acres in size, and national parks which exceed 6,000 acres in size, provided the park or wilderness area was in existence on August 7, 1977. Other areas may also 
                            <PRTPAGE/>
                            be Class I if designated as Class I consistent with the CAA.
                        </P>
                    </FTNT>
                    <P>
                        Finally, in recognition of the fact that air quality at upwind locations can also influence downwind deposition, the fifth approach used a trajectory model (HYSPLIT—The Hybrid Single-Particle Lagrangian Integrated Trajectory model) to identify upwind areas where emissions might be expected to influence deposition at downwind ecoregions (PA, section 6.2.4 and Appendix 6A).
                        <SU>31</SU>
                        <FTREF/>
                         Once those potential zones of influence were established, we evaluated the relationships between air quality metrics for the three pollutants 
                        <SU>32</SU>
                        <FTREF/>
                         at sites within those zones (sites of influence) and deposition estimates in the downwind ecoregion, as 3-year averages for five periods: 2001-2003, 2006-2008, 2010-2012, 2014-2016 and 2018-2020. The metrics, Ecoregion Air Quality Metrics (EAQMs), include a weighted-average (EAQM-weighted) and a maximum metric (EAQM-max). The EAQM-max is the maximum concentration among the upwind monitoring sites identified for each downwind ecoregion. For the EAQM-weighted, the value of each site linked to the downwind ecoregion was weighted by how often the forward HYSPLIT trajectory crossed into the ecoregion, 
                        <E T="03">i.e.,</E>
                         sites with more frequent trajectory intersections with the ecoregion were weighted higher (PA, section 6.2.4.1).
                    </P>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             Upwind sites of influence were identified for all 84 ecoregions (level III categorization) in the contiguous U.S. Identification of monitoring sites linked to each downwind ecoregion was based on HYSPLIT modeling for a 120-hour period and focusing on monitoring site locations estimated to contribute at least 0.5% of hits to the downwind ecoregion in the trajectory modeling (PA, Appendix 6, section 6A.2).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             For SO
                            <E T="52">2</E>
                            , there were two sets of metrics: one based on an annual average and one based on the 2nd highest 3-hour maximum concentration in the year. Both the NO
                            <E T="52">2</E>
                             and PM
                            <E T="52">2.5</E>
                             metrics are annual averages. For relating to 3-year average deposition, all are averaged across three years.
                        </P>
                    </FTNT>
                    <P>
                        The full set of quantitative results of the characterization of air quality and deposition relationships is discussed more thoroughly in Chapter 6 and Appendix 6A of the PA. The evaluation of measured air quality concentrations (SO
                        <E T="52">2</E>
                        , NO
                        <E T="52">2</E>
                        , and PM
                        <E T="52">2.5</E>
                        ) and TDep estimates of deposition at all SLAMS (generally composed of sites that use either a Federal Reference Method [FRM] or a Federal Equivalence Method [FEM]) is a robust analysis (
                        <E T="03">i.e.,</E>
                         large number of monitors distributed across the U.S.) and relevant given that compliance with the current standards (both primary and secondary) is judged using design value metrics based on measurements at the current SO
                        <E T="52">2</E>
                        , NO
                        <E T="52">2</E>
                         and PM
                        <E T="52">2.5</E>
                         monitors. As with any assessment, there are uncertainties and limitations, as discussed in the PA (PA, sections 6.3 and 6.4). For example, the SLAMS analyses are site-based comparisons that do not account for deposition associated with the transport of pollutants emitted some distance upwind. Similarly, the other analyses have their own limitations ranging from model uncertainty to limitations in geographical scope. In combination, these analyses supported the PA conclusion of a strong association between SO
                        <E T="52">2</E>
                         and S deposition. The results and associated information for N oxides and PM, however, indicate more variable relationships, both between NO
                        <E T="52">2</E>
                         concentrations and N deposition, and between PM
                        <E T="52">2.5</E>
                         concentrations with either S or N deposition.
                    </P>
                    <P>
                        For SO
                        <E T="52">2</E>
                        , annual monitored SO
                        <E T="52">2</E>
                         concentrations, at existing monitors within the SLAMS network, averaged over 3 years at the national scale were highly correlated with S deposition estimates in the TDep dataset at the local scale (correlation coefficient of 0.70),
                        <SU>33</SU>
                        <FTREF/>
                         especially in the earlier periods of the record and across the eastern U.S. (PA, section 6.2.3). This association is also seen in the relationships between SO
                        <E T="52">2</E>
                         annual values at the identified upwind sites of influence and S deposition estimates from TDep in downwind ecoregions, especially in those locations where the annual average SO
                        <E T="52">2</E>
                         concentrations are greater than 5 ppb (PA, section 6.2.4.2). Finally, we note that the observed declines in national levels of S deposition over the past two decades have occurred during a period in which emissions of SO
                        <E T="52">2</E>
                         have also declined sharply (PA, sections 6.2.1 and 6.4.1).
                    </P>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             The correlation coefficients reported here, from the PA, are based on Spearman's rank correlation coefficient. These nonparametric coefficients are generally used with data that are not normally distributed to assess how well the relationship between two variables can be described via a monotonic function. The term “r value” is sometimes used as shorthand for this correlation coefficient. Higher values indicate that the two variables are highly associated with one another (can range from 1.0 to −1.0).
                        </P>
                    </FTNT>
                    <P>
                        Analyses in the PA also investigated relationships between S deposition and air quality metrics other than the current indicator species (SO
                        <E T="52">2</E>
                        ) in a limited number of circumstances at relatively remote sites, generally distant from emissions sources. For example, an evaluation of the associations of total S TDep estimates with SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         concentrations and of wet S deposition with the sum of SO
                        <E T="52">2</E>
                         + SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         at 27 sites in 27 Class I areas concluded that the correlations for S deposition with particulate SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         and total S (
                        <E T="03">i.e.,</E>
                         SO
                        <E T="52">2</E>
                         + SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                        ) were lower than what was exhibited for S deposition and SO
                        <E T="52">2</E>
                         concentrations at the SLAMS (PA, section 6.2.2). The analyses also found poor correlation (correlation coefficient of 0.33) between total S deposition estimates (TDep) and PM
                        <E T="52">2.5</E>
                         mass at IMPROVE sites in the 27 Class I areas (PA, sections 2.3.3 and 6.2.2.3). While this set of analyses is based on data at a relatively limited number of sites (
                        <E T="03">e.g.,</E>
                         compared to the SLAMS network), the results do not indicate advantages to PM
                        <E T="52">2.5</E>
                         mass, particulate SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                        , or total S (SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         plus SO
                        <E T="52">2</E>
                        ) over SO
                        <E T="52">2</E>
                         (alone) as an indicator for a secondary NAAQS to address S deposition-related effects.
                    </P>
                    <P>
                        Both NO
                        <E T="52">2</E>
                         and certain components of PM
                        <E T="52">2.5</E>
                         (NO
                        <E T="52">3</E>
                        <E T="51">−</E>
                         and NH
                        <E T="52">4</E>
                        <E T="51">+</E>
                        ) contribute to N deposition. As is the case for SO
                        <E T="52">2</E>
                         and S deposition, there are multiple pathways for N deposition (dry and wet) and multiple scales of N deposition (local and regional). However, there are some additional complications to relating ambient air concentrations of NO
                        <E T="52">2</E>
                         and PM
                        <E T="52">2.5</E>
                         mass to N deposition. First, not all N deposition is caused by these pollutants (PA, Chapter 2 and section 6.1.1). Ammonia, which is not a criteria pollutant, also contributes to N deposition, especially through dry deposition at local scales. Second, only certain components of PM
                        <E T="52">2.5</E>
                         mass contribute to N deposition (
                        <E T="03">i.e.,</E>
                         NO
                        <E T="52">3</E>
                        <E T="51">−</E>
                         and NH
                        <E T="52">4</E>
                        <SU>+</SU>
                        ) and these comprise less than about 30% of PM
                        <E T="52">2.5</E>
                         mass across the U.S., below 5% in some regions (PA, Figure 6-56). As a result of these two factors, the associations between NO
                        <E T="52">2</E>
                         concentrations and N deposition, and between PM
                        <E T="52">2.5</E>
                         concentrations and N deposition are less robust than what is observed for SO
                        <E T="52">2</E>
                         and S deposition. The multi-faceted approach to evaluating these relationships confirmed this expectation. For example, there are 
                        <PRTPAGE P="105706"/>
                        weaker associations of N deposition with NO
                        <E T="52">2</E>
                         observations at SLAMS across the U.S. than what is observed in the similar S deposition and SO
                        <E T="52">2</E>
                         analysis (PA, section 6.4.2). There is little correlation for N deposition with NO
                        <E T="52">2</E>
                         concentrations, as evidenced by a Spearman's correlation coefficient of 0.38, compared to 0.70 for SO
                        <E T="52">2</E>
                         and S deposition (PA, Table 6-6 and Table 6-4). Further, the trajectory-based analyses of the relationships between NO
                        <E T="52">2</E>
                         annual values at the identified upwind sites of influence and N deposition estimates from TDep in downwind ecoregions indicate negative correlations (PA, Table 6-10). These negative correlations are observed for both the EAQM-weighed and EAQM-max values. This relative lack of association for NO
                        <E T="52">2</E>
                         concentrations with N deposition was confirmed by national trends over the past 20 years, where sharp declines in NO
                        <E T="52">2</E>
                         emissions and concentrations are linked in time with sharp declines in oxidized N deposition (PA, Table 6-2), but not with trends in total or reduced atmospheric N deposition. Since 2010, NO
                        <E T="52">2</E>
                         concentrations have continued to drop while N deposition nationally has remained steady (PA, section 6.2.1). As for S deposition and S compound metrics, the PA also investigated relationships between N deposition and air quality metrics other than the current indicator species (NO
                        <E T="52">2</E>
                        ) in the 27 Class I areas where collocated data were available. Recognizing that such information was not available in other, less remote areas of the U.S., including areas where contributing emissions are highest or at the regulatory SLAMS monitors, no clear advantages of these other parameters (
                        <E T="03">e.g.,</E>
                         nitric acid, particulate NO
                        <E T="52">3</E>
                        <E T="51">−</E>
                        , and NH
                        <E T="52">4</E>
                        <SU>+</SU>
                        ) over NO
                        <E T="52">2</E>
                         or PM
                        <E T="52">2.5</E>
                         mass were indicated. Across all analyses, the evidence indicates NO
                        <E T="52">2</E>
                         to be a weak indicator of total atmospheric N deposition, especially in areas where NH
                        <E T="52">3</E>
                         is prevalent and where PM
                        <E T="52">2.5</E>
                         mass is dominated by species other than NO
                        <E T="52">3</E>
                        <E T="51">−</E>
                         or NH
                        <E T="52">4</E>
                        <E T="51">+</E>
                         (PA, section 6.4.2).
                    </P>
                    <HD SOURCE="HD3">3. Overview of Welfare Effects Evidence</HD>
                    <P>
                        More than 3,000 welfare effects studies, including approximately 2,000 studies newly available since the last review, have been considered in the ISA.
                        <E T="51">34 35</E>
                        <FTREF/>
                         While expanding the evidence for some effect categories, the studies on acid deposition, an important category of effects in the last review, are largely consistent with the evidence that was previously available. The subsections below briefly summarize the nature of welfare effects of S oxides, N oxides and PM (section II.A.3.a.), the potential public welfare implications of these effects (section II.A.3.b.), and exposure concentrations and deposition-related metrics (section II.A.3.c.).
                    </P>
                    <FTNT>
                        <P>
                            <SU>34</SU>
                             The ISA builds on evidence and conclusions from previous assessments, focusing on synthesizing and integrating the newly available evidence (ISA, section IS.1.1). Past assessments are cited when providing further details not repeated in newer assessments.
                        </P>
                        <P>
                            <SU>35</SU>
                             The study count and citations are available on the project page for the ISA on the Health &amp; Environmental Research Online (HERO) website (
                            <E T="03">https://heronet.epa.gov/heronet/index.cfm/project/page/project_id/2965</E>
                            ).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">a. Nature of Effects</HD>
                    <P>
                        The welfare effects evidence base evaluated in the current review includes decades of extensive research on the ecological effects of N oxides, SO
                        <E T="52">X</E>
                         and PM. The sections below provide an overview of the nature of the direct effects of gas-phase exposure to oxides of nitrogen and sulfur (section II.A.3.a.(1)), acid deposition-related ecological effects (section II.A.3.a.(2)), N enrichment and associated effects (section II.A.3.a.(3)), and other effects (section II.A.3.a.(4)).
                    </P>
                    <HD SOURCE="HD3">
                        (1) Direct Effects of SO
                        <E T="52">X</E>
                         and N Oxides in Ambient Air
                    </HD>
                    <P>
                        A well-established body of scientific evidence has shown that acute and chronic exposures to oxides of N and S, such as SO
                        <E T="52">2</E>
                        , NO
                        <E T="52">2</E>
                        , NO, HNO
                        <E T="52">3</E>
                         and peroxyacetyl nitrate (PAN) in the air, are associated with negative effects on vegetation. The scientific evidence available for these effects in 1971 is the basis for the current secondary NAAQS for SO
                        <E T="52">X</E>
                         and N oxides.
                    </P>
                    <P>
                        The current scientific evidence continues to be sufficient to infer a causal relationship between gas-phase SO
                        <E T="52">2</E>
                         and injury to vegetation (ISA, Appendix 3, section 3.6.1). High concentrations have been associated with damage to plant foliage (ISA, Appendix 3, section 3.2). In addition to foliar injury, which is usually a rapid response, and which can vary significantly among species and growth conditions (which affect stomatal conductance), SO
                        <E T="52">2</E>
                         exposures have also been documented to reduce plant photosynthesis and growth. As exposures have declined in the U.S., some studies in the eastern U.S. have reported increased growth in some SO
                        <E T="52">2</E>
                        -sensitive tree species (
                        <E T="03">e.g.,</E>
                         Thomas et al., 2013). Multiple factors, including reduced deposition, buffering and other environmental variables, may play a role in such species recovery. (ISA, Appendix 3, section 3.2, Schaberg et al., 2014). Some of this evidence seems to suggest a somewhat faster recovery than might be expected from deposition-related soil acidification alone, which may indicate a relatively greater role for changes in ambient air concentrations of SO
                        <E T="52">2</E>
                        , in combination with changes in other gases, than was previously understood (ISA, Appendix 3, section 3.2 and Appendix 5, section 5.2.1.3). For lichens, damage from SO
                        <E T="52">2</E>
                         exposure has been observed to include reduction in metabolic functions that are vital for growth and survival (
                        <E T="03">e.g.,</E>
                         decreases in photosynthesis and respiration), damage to cellular integrity (
                        <E T="03">e.g.,</E>
                         leakage of electrolytes), and structural changes (ISA, Appendix 3, section 3.2).
                    </P>
                    <P>
                        The current scientific evidence also continues to be sufficient to infer a causal relationship between gas-phase NO, NO
                        <E T="52">2</E>
                         and PAN and injury to vegetation (ISA, Appendix 3, section 3.6.2). The evidence base evaluated in the 1993 
                        <E T="03">Air Quality Criteria Document for Oxides of N</E>
                         included evidence of phytotoxic effects of NO, NO
                        <E T="52">2,</E>
                         and PAN on plants through decreasing photosynthesis and induction of visible foliar injury (U.S. EPA, 1993 [1993 AQCD]). The 1993 AQCD additionally concluded that concentrations of NO, NO
                        <E T="52">2</E>
                        , and PAN in the atmosphere were rarely high enough to have phytotoxic effects on vegetation. Little new information is available since that time on these phytotoxic effects at concentrations currently observed in the U.S. (ISA, Appendix 3, section 3.3).
                    </P>
                    <P>
                        With regard to HNO
                        <E T="52">3</E>
                        , the evidence is sufficient to infer a causal relationship between exposure to HNO
                        <E T="52">3</E>
                         and changes to vegetation (ISA, Appendix 3, section 3.6.3). The evidence suggests a role in observed declines in lichen species in the 1970s in the Los Angeles basin (ISA, Appendix 3, section 3.3). A 2008 resampling of areas shown to be impacted in the past by HNO
                        <E T="52">3</E>
                         found community shifts, declines in the most pollutant-sensitive lichen species, and increases in abundance of nitrogen-tolerant lichen species compared to 1976-1977, indicating that these lichen communities have not recovered and had experienced additional changes (ISA, Appendix 3, section 3.4). The recently available evidence on this topic also included a study of six lichen species that reported changes in physiology and functioning including decreased chlorophyll content and chlorophyll fluorescence, decreased photosynthesis and respiration, and increased electrolyte leakage from HNO
                        <E T="52">3</E>
                         exposures for 2-11 weeks (daily peak levels near 50 ppb) in controlled chambers. (ISA, Appendix 3, section 3.4).
                    </P>
                    <HD SOURCE="HD3">(2) Acid Deposition-Related Ecological Effects</HD>
                    <P>
                        The connection between SO
                        <E T="52">X</E>
                         and N oxide emissions to ambient air, 
                        <PRTPAGE P="105707"/>
                        atmospheric deposition of S and/or N compounds, and the acidification of acid-sensitive soils and surface waters is well documented by many decades of evidence, particularly in the eastern U.S. (ISA, section IS.5; Appendix 8, section 8.1). Sulfur oxides and N oxides in ambient air undergo reactions to form acidic compounds that are removed from the atmosphere through deposition. Acidifying deposition can affect biogeochemical processes in soils, with ramifications for terrestrial biota and for the chemistry and biological functioning of associated surface waters (ISA, Appendix 7, section 7.1). These effects depend on the magnitude and rate of deposition, as well as multiple biogeochemical processes that occur in soils and waterbodies.
                    </P>
                    <P>
                        Soil acidification is influenced by the deposition of inorganic acids (HNO
                        <E T="52">3</E>
                         and sulfuric acid [H
                        <E T="52">2</E>
                        SO
                        <E T="52">4</E>
                        ]), NH
                        <E T="52">4</E>
                        <SU>+</SU>
                        , and by chemical and biological processes. When NO
                        <E T="52">3</E>
                        <E T="51">−</E>
                        , or SO
                        <E T="52">4</E>
                        2
                        <E T="51">−</E>
                         leach from soils to surface waters, an equivalent number of positive cations, or countercharge, are also transported. If the countercharge is provided by a base cation (
                        <E T="03">e.g.,</E>
                         calcium, [Ca
                        <SU>2+</SU>
                        ], magnesium [Mg
                        <E T="51">2+</E>
                        ], sodium [Na
                        <E T="51">+</E>
                        ], or potassium [K
                        <E T="51">+</E>
                        ]), rather than hydrogen ions (H
                        <E T="51">+</E>
                        ), the leachate is neutralized, but the soil becomes more acidic from the hydrogen ions left behind, and the base saturation of the soil is reduced by the loss of the base cation. Depending on the relative rates of soil processes that contribute to the soil pools of H
                        <E T="51">+</E>
                         and base cations, such as weathering, continued SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         or NO
                        <E T="52">3</E>
                        <E T="51">−</E>
                         leaching can deplete the soil base cation pool, which contributes to increased acidity of the leaching soil water and by connection, the surface water. Accordingly, the ability of a watershed to neutralize acidic deposition is determined by a variety of biogeophysical factors including weathering rates, bedrock composition, vegetation and microbial processes, physical and chemical characteristics of soils, and hydrology (ISA Appendix 4, section 4.3).
                    </P>
                    <P>
                        Recently available evidence includes some studies describing early stages of recovery from soil acidification in some eastern forests. For example, studies at the Hubbard Brook Experimental Forest in New Hampshire reported indications of acidification recovery in soil solution measurements across the period from 1984 to 2011 (ISA, Appendix 4, section 4.6.1; Fuss et al., 2015). Another study of 27 sites in eastern Canada and the northeastern U.S. found reductions in wet deposition SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         were associated with increases in soil base saturation and decreases in exchangeable aluminum (ISA, Appendix 4, section 4.6.1; Lawrence et al., 2015). Recent modeling analyses indicate extended timeframes for recovery are likely, as well as delays or lags related to accumulated pools of S in forest soils (ISA, Appendix 4, section 4.6.1).
                    </P>
                    <HD SOURCE="HD3">(a) Freshwater Ecosystems</HD>
                    <P>As was the case in the last review, the body of evidence available in this review, including that newly available, is sufficient to infer a causal relationship between N and S deposition and the alteration of freshwater biogeochemistry (ISA, section IS.6.1). Additionally, based on the previously available evidence, the current body of evidence is also sufficient to conclude that a causal relationship exists between acidifying deposition and changes in biota, including physiological impairment and alteration of species richness, community composition, and biodiversity in freshwater ecosystems (ISA, section IS.6.3).</P>
                    <P>
                        The effects of acid deposition on aquatic systems depend largely upon the ability of the system to neutralize additional acidic inputs from the environment, whether from the atmosphere or from surface inputs. There is a large amount of variability among freshwater systems in this regard, which reflects their underlying geology as well as their history of acidic inputs. Accordingly, different freshwater systems (
                        <E T="03">e.g.,</E>
                         in different geographic regions) respond differently to similar amounts of acid deposition. The main factor in determining sensitivity is the underlying geology of an area and its ability to provide soil base cations through weathering to buffer acidic inputs (ISA, Appendix 8, section 8.5.1). As noted in the ISA, “[g]eologic formations having low base cation supply, due mainly to low soil and bedrock weathering, generally underlie the watersheds of acid-sensitive lakes and streams” (ISA, Appendix 8, p. 8-58).
                    </P>
                    <P>Longstanding evidence has well characterized the changes in biogeochemical processes and water chemistry caused by N and S deposition and the ramifications for biological functioning of freshwater ecosystems (ISA, Appendix 8, section 8.1). The more recently available scientific research “reflects incremental improvements in scientific knowledge of aquatic biological effects and indicators of acidification as compared with knowledge summarized in the 2008 ISA” (ISA, Appendix 8, p. 8-80). Previously and newly available studies “indicate that aquatic organisms in sensitive ecosystems have been affected by acidification at virtually all trophic levels and that these responses have been well characterized for several decades” (ISA, Appendix 8, p. 8-80). For example, information reported in the previous 2008 ISA “showed consistent and coherent evidence for effects on aquatic biota, especially algae, benthic invertebrates, and fish that are most clearly linked to chemical indicators of acidification” (ISA, Appendix 8, p. 8-80). These indicators are surface water pH, base cation ratios, ANC, and inorganic aluminum concentration (ISA, Appendix 8, Table 8-9).</P>
                    <P>
                        The effects of waterbody acidification on fish species are especially well documented, with many species (
                        <E T="03">e.g.,</E>
                         brown and brook trout and Atlantic salmon) experiencing adverse effects from acidification and the earliest lifestages being most sensitive (ISA, Appendix 8, section 8.3). Many effects of acidic surface waters on fish, particularly effects on gill function or structure, relate to low pH or the combination of low pH and elevated dissolved aluminum (ISA, Appendix 7, section 7.1.2.5 and Appendix 8, sections 8.3.6.1 and 8.6.4). In general, biological effects in aquatic ecosystems are primarily attributable to low pH and high inorganic aluminum concentration (ISA, p. ES-14). Waterbody pH largely controls the bioavailability of aluminum, which is toxic to fish, and aluminum mobilization is largely confined to waters with a pH below about 5.5, which the ISA describes as corresponding to an ANC in the range of about 10 to 30 microequivalents per liter (μeq/L) in waters of the Northeast with low to moderate levels of dissolved organic carbon (ISA, Appendix 7, section 7.1.2.6 and Appendix 8, section 8.6.4).
                    </P>
                    <P>
                        The parameter ANC is an indicator of the buffering capacity of natural waters against acidification. Although ANC does not directly affect biota, it is an indicator of acidification that relates to pH and aluminum levels (ISA, p. ES-14) or to watershed characteristics like base cation weathering (BCw) rate (ISA, Appendix 8, sections 8.1 and 8.3.6.3). Accordingly, ANC is commonly used to describe the potential sensitivity of a freshwater system to acidification-related effects. It can be measured in water samples and is also often estimated for use in water quality modeling, as is done in the aquatic acidification risk assessment for this review (summarized in section II.A.4. below). Water quality models are generally better at estimating ANC than at estimating other indicators of acidification-related risk, such as pH. 
                        <PRTPAGE P="105708"/>
                        Acid neutralizing capacity is estimated as the molar sum of strong base cations minus the molar sum of strong acid anions, specifically including SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         and NO
                        <E T="52">3</E>
                        <E T="51">−</E>
                         (
                        <E T="03">e.g.,</E>
                         Driscoll et al., 1994). Thus, values below zero indicate a deficit in the ability to buffer acidic inputs, and increasing values above zero represent increasing buffering capability for acidic inputs (ISA, Appendix 7, section 7.1.2.6). In waters with high concentrations of naturally occurring organic acids, however, ANC may not be a good indicator of risk to biota as those acids can reduce bioavailability of aluminum, thus buffering the effects usually associated with low pH and high total aluminum concentrations (Waller et al., 2012; ISA, Appendix 8, section 8.3.6.4).
                    </P>
                    <P>In addition to acidity of surface waters quantified over weeks or months, waterbodies can also experience spikes in acidity in response to episodic precipitation or rapid snowmelt events. In these events (hours-days), a surge or pulse of drainage water, containing acidic compounds, is routed through upper soil horizons rather than the deeper soil horizons that would usually provide buffering for acidic compounds (ISA, Appendix 7, section 7.1). While some streams and lakes may have chronic or base flow chemistry that provides suitable conditions for aquatic biota, they may experience occasional acidic episodes with the potential for deleterious consequences to sensitive biota (ISA, Appendix 8, section 8.5). For example, in some impacted northeastern waterbodies, ANC levels may dip below zero for hours to days or weeks in response to such events, while waterbodies labeled chronically acidic have ANC levels below zero throughout the year (ISA, Appendix 7, section 7.1.1.2; Driscoll et al., 2001). Headwater streams tend to be more sensitive to such episodes due to their smaller watersheds and, in the East, due to their underlying geology (ISA, Appendix 8, section 8.5.1).</P>
                    <P>National survey data available in the last review, and dating back to the early 1980s through 2004, indicated acidifying deposition had acidified surface waters in the southwestern Adirondacks, New England uplands, eastern portion of the upper Midwest, forested Mid-Atlantic highlands, and Mid-Atlantic coastal plain (2008 ISA, section 4.2.2.3; ISA, Appendix 8, section 8.5.1). For example, a 1984-1987 survey of waterbodies in the Adirondacks found 27% of streams to have ANC values below zero, with a minimum value of −134 μeq/L (Sullivan et al., 2006). Values of ANC below 20 μeq/L in Shenandoah stream sites have been reported as having a greater risk of episodic acidification and associated reduced populations of sensitive species, such as the native brook trout, compared to sites with higher ANC (Bulger et al., 1999; Bulger et al., 2000). A more recent study of two groups of Adirondack lakes for which water quality data were available from 1982 and 1992, respectively, reported significant increases in ANC in the large majority of those lakes, with the magnitude of the increases varying across the lakes (Driscoll et al., 2016; ISA, Appendix 7, section 7.1.3.1). As described in the ISA, “[a]cidic waters were mostly restricted to northern New York, New England, the Appalachian Mountain chain, upper Midwest, and Florida” (ISA, Appendix 8, p. 8-60). Despite the appreciable reductions in acidifying deposition that have occurred in the U.S. since the 1960s and 1970s, aquatic ecosystems across the U.S. are still experiencing effects from historical contributions of N and S (ISA, Appendix 8, section 8.6).</P>
                    <HD SOURCE="HD3">(b) Terrestrial Ecosystems</HD>
                    <P>Longstanding evidence, supported and strengthened by evidence newly available in this review, describes the changes in soil biogeochemical processes caused by acidifying deposition of N and S to terrestrial systems that are linked to changes in terrestrial biota, with associated impacts on ecosystem characteristics (ISA, Appendix 5, section 5.1). Consistent with conclusions in the last review, the current body of evidence is sufficient to infer a causal relationship between acidifying deposition and alterations of biogeochemistry in terrestrial ecosystems. Additionally, and consistent with conclusions in the last review, the current body of evidence is sufficient to infer a causal relationship between acidifying N and S deposition and the alteration of the physiology and growth of terrestrial organisms and the productivity of terrestrial ecosystems. The current body of evidence is also sufficient to conclude that a causal relationship exists between acidifying N and S deposition and alterations of species richness, community composition, and biodiversity in terrestrial ecosystems (2008 ISA, sections 4.2.1.1 and 4.2.1.2; 2020 ISA, Appendix 4, section 4.1 and Appendix 5, sections 5.7.1 and 5.7.2).</P>
                    <P>Deposition of acidifying compounds to acid-sensitive soils can cause soil acidification, increased mobilization of aluminum from soil to drainage water, and depletion of the pool of exchangeable base cations in the soil (ISA, Appendix 5, section 5.2 and Appendix 4, sections 4.3.4 and 4.3.5). Physiological effects of acidification on terrestrial biota include slower growth and increased mortality among sensitive plant species, which are generally attributable to physiological impairment caused by aluminum toxicity (related to increased availability of inorganic aluminum in soil water) and a reduced ability of plant roots to take up base cations (ISA, Appendix 4, section 4.3 and Appendix 5, section 5.2).</P>
                    <P>
                        The physiological effects of acidifying deposition on terrestrial biota can also result in changes in species composition whereby sensitive species, such as red spruce and sugar maple, are replaced by more tolerant species, or the sensitive species that were dominant in the community become a minority. For example, increasing soil cation availability (as in Ca
                        <E T="51">2+</E>
                         addition or gradient experiments) has been associated with greater growth and seedling colonization by sugar maple, while American beech is more prevalent on soils with lower levels of base cations where sugar maple is less often found (ISA, Appendix 5, section 5.2.1.3.1; Duchesne and Ouimet, 2009). Soil acid-base chemistry has also been found to be a predictor of understory species composition (ISA, Appendix 5, section 5.2.2.1), and limited evidence has indicated an influence of soil acid-base chemistry on diversity and composition of soil bacteria, fungi, and nematodes (ISA, Appendix 5, section 5.2.4.1). In addition to Ca
                        <E T="51">2+</E>
                         addition experiments, observational gradient studies have also evaluated relationships between soil chemistry indicators of acidification (
                        <E T="03">e.g.,</E>
                         soil pH, base cation to aluminum (Bc:Al) ratio, base saturation, and aluminum) and ecosystem biological endpoints, including physiological and community responses of trees and other vegetation, lichens, soil biota, and fauna (ISA, Appendix 5, Tables 5-2 and 5-6). The 2020 ISA also reports on several large observational studies evaluating statistical associations between tree growth or survival, as assessed at monitoring sites across the U.S., and estimates of average deposition of S or N compounds at those sites over time periods on the order of 10 years (ISA, Appendix 5, section 5.5.2 and Appendix 6, section.6.2.3.1; Dietze and Moorcroft, 2011; Thomas et al., 2010; Horn et al., 2018). Negative associations were observed for survival and growth in several species or species groups with S deposition metrics; positive and negative associations were reported with N deposition (PA, sections 5.3.2.3 and 5.3.4 and Appendix 5B).
                        <PRTPAGE P="105709"/>
                    </P>
                    <P>
                        Although there has been no systematic national survey of U.S. terrestrial ecosystem soils, the forest ecosystems considered the most sensitive to terrestrial acidification from atmospheric deposition include forests of the Adirondack Mountains of New York, Green Mountains of Vermont, White Mountains of New Hampshire, the Allegheny Plateau of Pennsylvania, and mountain top and ridge forest ecosystems in the southern Appalachians (2008 ISA, Appendix 3, section 3.2.4.2; ISA, Appendix 5, section 5.3). Underlying geology is the principal factor governing the sensitivity of both terrestrial and aquatic ecosystems to acidification from S and N deposition. Geologic formations with low base cation supply (
                        <E T="03">e.g.,</E>
                         sandstone, quartzite), due mainly to low weathering rates, generally underlie these acid sensitive watersheds. Other factors also contribute to the overall sensitivity of an area to acidifying nitrogen and sulfur deposition, including topography, soil chemistry, land use, and hydrology (ISA, Appendix 5, section 5.3). For example, “[a]cid-sensitive ecosystems are mostly located in upland mountainous terrain in the eastern and western U.S. and are underlain by bedrock that is resistant to weathering, such as granite or quartzite sandstone” (ISA, Appendix 7, p. 7-45). Further, as well documented in the evidence, biogeochemical sensitivity to deposition-driven acidification (and eutrophication [see following section]) is the “result of historical loading, geologic/soil conditions (
                        <E T="03">e.g.,</E>
                         mineral weathering and S adsorption), and nonanthropogenic sources of N and S loading to the system” (ISA, Appendix 7, p. 7-45 and section 7.1.5).
                    </P>
                    <HD SOURCE="HD3">(3) Nitrogen Enrichment and Associated Ecological Effects</HD>
                    <P>
                        Ecosystems in the U.S. vary in their sensitivity to N enrichment, with organisms in their natural environments commonly adapted to the nutrient availability in those environments. Historically, N has been the primary limiting nutrient for plants in many ecosystems. In such ecosystems, when the limiting nutrient, N, becomes more available, whether from atmospheric deposition, runoff, or episodic events, the subset of plant species able to most effectively use the higher nitrogen levels may out-compete other species, leading to a shift in the community composition that may be dominated by a smaller number of species, 
                        <E T="03">i.e.,</E>
                         a community with lower diversity (ISA, sections IS.6.1.1.2, IS.6.2.1.1 and IS.7.1.1, Appendix 6, section 6.2.4 and Appendix 7, section 7.2.6.6). Thus, change in the availability of nitrogen in nitrogen-limited systems can affect growth and productivity, with ramifications on relative abundance of different species of vegetation and potentially further and broader ramifications on ecosystem processes, structure, and function.
                    </P>
                    <P>Both N oxides and reduced forms of nitrogen can contribute to N enrichment. In addition to atmospheric deposition, other sources of N compounds can play relatively greater or lesser roles in ecosystem N loading, depending on location. For example, many waterbodies receive appreciable amounts of N from agricultural runoff and municipal or industrial wastewater discharges. For many aquatic ecosystems, sources of N other than atmospheric deposition, including fertilizer and waste treatment, contribute more to ecosystem N than atmospheric deposition (ISA Appendix 7, sections 7.1 and 7.2). Additionally, the impacts of historic N deposition in both aquatic and terrestrial ecosystems pose complications to discerning the potential effects of more recent deposition rates.</P>
                    <HD SOURCE="HD3">(a) Aquatic and Wetland Ecosystems</HD>
                    <P>
                        Nitrogen additions to freshwater, estuarine and near-coastal ecosystems, including N from atmospheric deposition, can contribute to eutrophication, which typically begins with nutrient-stimulated rapid algal growth developing into an algal bloom that can, depending on various site-specific factors, be followed by anoxic conditions associated with the algal die-off (ISA, ES.5.2). Decomposition of the plant biomass from the subsequent algal die-off contributes to reduced waterbody oxygen, which in turn can affect higher-trophic-level species, 
                        <E T="03">e.g.,</E>
                         contributing to fish mortality (ISA, p. ES-18). The extensive body of evidence in this area is sufficient to infer causal relationships between N deposition and the alteration of biogeochemistry in freshwater, estuarine and near-coastal marine systems (ISA, Appendix 7, sections 7.1 and 7.2). Consistent with findings in the last review, the current body of evidence is also sufficient to infer a causal relationship between N deposition and changes in biota, including altered growth and productivity, species richness, community composition, and biodiversity due to N enrichment in freshwater ecosystems (ISA, Appendix 9, section 9.1). The body of evidence is sufficient to infer a causal relationship between N deposition and changes in biota, including altered growth, total primary production, total algal community biomass, species richness, community composition, and biodiversity due to N enrichment in estuarine environments (ISA, Appendix 10, section 10.1).
                    </P>
                    <P>Evidence newly available in this review provides insights regarding N enrichment and its impacts in several types of aquatic systems, including freshwater streams and lakes, estuarine and near-coastal systems, and wetlands. With regard to freshwaters, for example, studies published since the 2008 ISA augment the evidence base for high-elevation waterbodies where the main N source is atmospheric deposition. Recent evidence continues to indicate that N limitation is common in oligotrophic waters in the western U.S., with shifts in nutrient limitation, from N limitation, to between N and phosphorus (P) limitation, or to P limitation, reported in some alpine lake studies (ISA, Appendix 9, section 9.1.1.3). Small inputs of N in such water bodies have been reported to increase nutrient availability or alter the balance of N and P, with the potential to stimulate growth of primary producers and contribute to changes in species richness, community composition, and diversity.</P>
                    <P>Another type of N loading effect in other types of freshwater lakes includes a role in the composition of freshwater algal blooms and their toxicity (ISA, Appendix 9, section 9.2.6.1). Information in this review, including studies in Lake Erie, indicates that growth of some harmful algal species, including those that produce microcystin, are favored by increased availability of N and its availability in dissolved inorganic form (ISA, Appendix 9, p. 9-28; Davis et al., 2015; Gobler et al., 2016).</P>
                    <P>
                        The relative contribution of N deposition to total N loading varies among waterbodies. For example, atmospheric deposition is generally considered to be the main source of N inputs to most headwater stream, high-elevation lake, and low-order stream watersheds that are far from the influence of other N sources like agricultural runoff and wastewater effluent (ISA, section ES5.2). In other fresh waterbodies, however, agricultural practices and point source discharges have been estimated to be larger contributors to total N loading (ISA, Appendix 7, section 7.1.1.1). Since the 2008 ISA, several long-term monitoring studies in the Appalachian Mountains, the Adirondacks, and the Rocky Mountains have reported temporal patterns of declines in surface water NO
                        <E T="52">3</E>
                        <E T="51">-</E>
                         concentration corresponding to declines in atmospheric N deposition (ISA, Appendix 9, section 9.1.1.2). 
                        <PRTPAGE P="105710"/>
                        Declines in basin wide NO
                        <E T="52">3</E>
                        <E T="51">-</E>
                         concentrations have also been reported for the nontidal Potomac River watershed and have been attributed to declines in atmospheric N deposition (ISA, Appendix 7, section 7.1.5.1).
                    </P>
                    <P>Nutrient inputs to coastal and estuarine waters are important influences on the health of these waterbodies. Continued inputs of N, the most common limiting nutrient in estuarine and coastal systems, have resulted in N over-enrichment and subsequent alterations to the nutrient balance in these systems (ISA, Appendix 10, p. 10-6). For example, the rate of N delivery to coastal waters is strongly correlated to changes in primary production and phytoplankton biomass (ISA, Appendix 10, section 10.1.3). Algal blooms and associated die-offs can contribute to hypoxic conditions (most common during summer months), which can contribute to fish kills and associated reductions in marine populations (ISA, Appendix 10). Further, the prevalence and health of submerged aquatic vegetation (SAV), which is important habitat for many aquatic species, has been identified as a biological indicator for N enrichment in estuarine waters (ISA, Appendix 10, section 10.2.5). Previously available evidence indicated the role of N loading in SAV declines in multiple U.S. estuaries through increased production of macroalgae or other algae, which reduce sunlight penetration into shallow waters where SAV is found (ISA, Appendix 10, section 10.2.3). Newly available studies have reported findings of increased SAV populations in two tributaries of the Chesapeake Bay corresponding to reduction in total N loading from all sources since 1990 (ISA, Appendix 10, section 10.2.5). The newly available studies also identify other factors threatening SAV, including increasing temperature related to climate change (ISA, Appendix 10, section 10.2.5).</P>
                    <P>The degree to which N enrichment and associated ecosystem impacts are driven by atmospheric N deposition varies greatly and is largely unique to the specific ecosystem. Analyses based on data across two to three decades extending from the 1990s through about 2010 estimate that most of the analyzed estuaries receive 15-40% of their N inputs from atmospheric sources (ISA, section ES 5.2; ISA, Appendix 7, section 7.2.1), though for specific estuaries contributions can vary more widely. In areas along the West Coast, N sources may include coastal upwelling from oceanic waters, as well as transport from watersheds. Common N inputs to estuaries include those associated with freshwater inflows transporting N from agriculture, urban, and wastewater sources, in addition to atmospheric deposition across the watershed (ISA, section IS 2.2.2; ISA, Appendix 7, section 7.2.1).</P>
                    <P>
                        There are estimates of atmospheric N loading to estuaries available from several recent modeling studies (ISA, Table 7-9). One analysis of estuaries along the Atlantic Coast and the Gulf of Mexico, which estimated that 62−81% of N delivered to the eastern U.S coastal zone is anthropogenic in source, also reported that atmospheric N deposition to freshwater that is subsequently transported to estuaries represents 17−21% of the total N loading into the coastal zone (McCrackin et al., 2013; Moore et al., 2011). In the Gulf of Mexico, 26% of the N transported to the Gulf in the Mississippi/Atchafalaya River basin was estimated to be contributed from atmospheric deposition (which may include volatilized losses from natural, urban, and agricultural sources) (Robertson and Saad, 2013). Another modeling analysis identified atmospheric deposition to watersheds as the dominant source of N to the estuaries of the Connecticut, Kennebec, and Penobscot rivers. For the entire Northeast and mid-Atlantic coastal region, however, it was the third largest source (20%), following agriculture (37%) and sewage and population-related sources (28%) (ISA, Appendix 7, section 7.2.1). Estimates for West Coast estuaries indicate much smaller contribution from atmospheric deposition. For example, analyses for Yaquina Bay, Oregon, estimated direct deposition to contribute only 0.03% of N inputs; estimated N input to the watershed from N-fixing red alder (
                        <E T="03">Alnus rubra</E>
                        ) trees was a much larger (8%) source (ISA, Appendix 7, section 7.2.1; Brown and Ozretich, 2009).
                    </P>
                    <P>Evidence in coastal waters has recognized that nutrient enrichment may play a role in acidification of some coastal waters (ISA, Appendix 10, section 10.5). More specifically, nutrient-driven algal blooms may contribute to ocean acidification, possibly through increased decomposition, which lowers dissolved oxygen levels in the water column and contributes to lower pH. Such nutrient-enhanced acidification can also be exacerbated by warming (associated with increased microbial respiration) and changes in buffering capacity (alkalinity) of freshwater inputs (ISA, Appendix 10, section 10.5).</P>
                    <P>The impact of N additions on wetlands, and whether the wetlands may serve as a source, sink, or transformer of atmospherically deposited N varies with the type of wetland and other factors, such as physiography and local hydrology, as well as climate (ISA, section IS.8.1 and Appendix 11, section 11.1). Studies generally show N enrichment to decrease the ability of wetlands to retain and store N, which may diminish the wetland ecosystem service of improving water quality (ISA, section IS.8.1). Consistent with the evidence available in the last review, the current body of evidence is sufficient to infer a causal relationship between N deposition and the alteration of biogeochemical cycling in wetlands. Newly available evidence regarding N inputs and plant physiology expands the evidence base related to species diversity. The currently available evidence, including that newly available, is sufficient to infer a causal relationship between N deposition and the alteration of growth and productivity, species physiology, species richness, community composition, and biodiversity in wetlands (ISA, Appendix 11, section 11.10).</P>
                    <HD SOURCE="HD3">(b) Terrestrial Ecosystems</HD>
                    <P>It is long established that N enrichment of terrestrial ecosystems increases plant productivity (ISA, Appendix 6, section 6.1). Building on this, the currently available evidence, including evidence that is longstanding, is sufficient to infer a causal relationship between N deposition and the alteration of the physiology and growth of terrestrial organisms and the productivity of terrestrial ecosystems (ISA, Appendix 5, section 5.2 and Appendix 6, section 6.2). Responsive ecosystems include those that are N limited and/or contain species that have evolved in nutrient-poor environments. In these ecosystems the N-enrichment changes in plant physiology and growth rates vary among species, with species that are adapted to low N supply being readily outcompeted by species that require more N. In this manner, the relative representation of different vegetation species may be altered, and some species may be eliminated altogether, such that community composition is changed and species diversity declines (ISA, Appendix 6, sections 6.3.2 and 6.3.8). The currently available evidence in this area is sufficient to infer a causal relationship between N deposition and the alteration of species richness, community composition, and biodiversity in terrestrial ecosystems (ISA, section IS.5.3 and Appendix 6, section 6.3).</P>
                    <P>
                        Previously available evidence described the role of N deposition in changing soil carbon and N pools and 
                        <PRTPAGE P="105711"/>
                        fluxes, as well as altering plant and microbial growth and physiology in an array of terrestrial ecosystems (ISA, Appendix 6, section 6.2.1). Nitrogen availability is broadly limiting for productivity in many terrestrial ecosystems (ISA, Appendix 6, section 6.2.1). Accordingly, N additions contribute to increased productivity and can alter biodiversity. Eutrophication, one of the mechanisms by which increased productivity and changes in biodiversity associated with N addition to terrestrial ecosystems can occur, comprises multiple effects that include changes to the physiology of individual organisms, alteration of the relative growth and abundance of various species, transformation of relationships between species, and indirect effects on availability of essential resources other than N, such as light, water, and nutrients (ISA, Appendix 6, section 6.2.1).
                    </P>
                    <P>The currently available evidence for the terrestrial ecosystem effects of N enrichment, including eutrophication, includes studies in a wide array of systems, including forests (tropical, temperate, and boreal), grasslands, arid and semi-arid scrublands, and tundra (PA, section 4.1; ISA, Appendix 6). The organisms affected include trees, herbs and shrubs, and lichen, as well as fungal, microbial, and arthropod communities. Lichen communities, which have important roles in hydrologic cycling, nutrient cycling, and as sources of food and habitat for other species, are also affected by atmospheric N (PA, section 4.1; ISA, Appendix 6). The recently available studies on the biological effects of added N in terrestrial ecosystems include investigations of plant and microbial physiology, long-term ecosystem-scale N addition experiments, regional and continental-scale monitoring studies, and syntheses.</P>
                    <P>The previously available evidence included N addition studies in the U.S. and N deposition gradient studies in Europe that reported associations of N deposition with reduced species richness and altered community composition for grassland plants, forest understory plants, and mycorrhizal fungi (soil fungi that have a symbiotic relationship with plant roots) (ISA, Appendix 6, section 6.3). Newly available evidence for forest communities in this review indicates that N deposition alters the physiology and growth of overstory trees, and that N deposition has the potential to change the community composition of forests (ISA, Appendix 6, section 6.6). Recent studies on forest trees include analyses of long-term forest inventory data collected from across the U.S. and Europe (ISA, Appendix 6, section 6.2.3.1). The recent evidence also includes findings of variation in forest understory and non-forest plant communities with atmospheric N deposition gradients in the U.S. and in Europe. For example, gradient studies in Europe have found higher N deposition to be associated with forest understory plant communities with more nutrient-demanding and shade-tolerant plant species (ISA, Appendix 6, section 6.3.3.2). A recent gradient study in the U.S. found associations between herb and shrub species richness and N deposition, that were related to soil pH (ISA, Appendix 6, section 6.3.3.2).</P>
                    <P>Recent evidence includes associations of variation in lichen community composition with N deposition gradients in the U.S. and Europe, (ISA, Appendix 6, section 6.3.7; Table 6-23). Differences in lichen community composition have been attributed to differences in atmospheric N pollution in forests of the West Coast, Rocky Mountains, and southeastern Alaska. Differences in epiphytic lichen growth or physiology have been observed along atmospheric N deposition gradients in the highly impacted area of southern California and in more remote locations such as Wyoming and southeastern Alaska (ISA, Appendix 6, section 6.3.7). Historical deposition may play a role in observational studies of N deposition effects, complicating the disentangling of responses that may be related to more recent N loading.</P>
                    <P>Newly available findings from N addition experiments expand on the understanding of mechanisms for plant and microbial community composition effects of increased N availability, indicating that competition for resources, such as water in arid and semi-arid environments, may exacerbate the effects of N addition on diversity (ISA, Appendix 6, section 6.2.6). The newly available studies in arid and semiarid ecosystems, particularly in southern California have reported changes in plant community composition, in the context of a long history of significant N deposition, with fewer observations of plant species loss or changes in plant diversity (ISA, Appendix 6, section 6.3.6).</P>
                    <P>Nitrogen limitation in grasslands and the dominance by fast-growing species that can shift in abundance rapidly (in contrast to forest trees) contribute to an increased sensitivity of grassland ecosystems to N inputs (ISA, Appendix 6, section 6.3.6). Studies in southern California coastal sage scrub communities, including studies of the long-term history of N deposition, which was appreciably greater in the past than recent rates, indicate impacts on community composition and species richness in these ecosystems (ISA, Appendix 6, sections 6.2.6 and 6.3.6). The ability of atmospheric N deposition to override the natural spatial heterogeneity in N availability in arid ecosystems, such as the Mojave Desert and California coastal sage scrub ecosystems in southern California, makes these ecosystems sensitive to N deposition (ISA, Appendix 6, section 6.3.8).</P>
                    <P>The current evidence includes relatively few studies of N enrichment recovery in terrestrial ecosystems. Among N addition studies assessing responses after cessation of additions, it has been observed that soil nitrate and ammonium concentrations recovered to levels observed in untreated controls within 1 to 3 years of the cessation of additions, but soil processes such as N mineralization and litter decomposition were slower to recover (ISA, Appendix 6, section 6.3.2; Stevens, 2016). A range of recovery times have been reported for mycorrhizal community composition and abundance from a few years in some systems to as long as 28 or 48 years in others (ISA, Appendix 6, section 6.3.2; Stevens, 2016; Emmett et al., 1998; Strengbom et al., 2001). An N addition study in the midwestern U.S. observed that plant physiological processes recovered in less than 2 years, although grassland communities were slower to recover and still differed from controls 20 years after the cessation of N additions (ISA, Appendix 6, section 6.3.2; Isbell et al., 2013).</P>
                    <HD SOURCE="HD3">(4) Other Deposition-Related Effects</HD>
                    <P>
                        Additional categories of effects for which the current evidence is sufficient to infer causal relationships with deposition of S or N compounds or PM include changes in mercury methylation processes in freshwater ecosystems, changes in aquatic biota due to sulfide phytotoxicity, and ecological effects from PM deposition other than N and S deposition (ISA, Table IS-1). The current evidence, including that newly available in this review, is sufficient to infer a causal relationship between S deposition and the alteration of mercury methylation in surface water, sediment, and soils in wetland and freshwater ecosystems (ISA, Table ES-1). The currently available evidence is also sufficient to infer a new causal relationship between S deposition and changes in biota due to sulfide phytotoxicity, including alteration of growth and productivity, species physiology, species richness, community composition, and 
                        <PRTPAGE P="105712"/>
                        biodiversity in wetland and freshwater ecosystems (ISA, section IS.9).
                    </P>
                    <P>
                        With regard to PM deposition other than N and S deposition, the currently available evidence is sufficient to infer a likely causal relationship between deposition of PM and a variety of effects on individual organisms and ecosystems (ISA, Appendix 15, section 15.1). Particulate matter includes a heterogeneous mixture of particles differing in origin, size, and chemical composition. In addition to N and S and their transformation products, other PM components, such as trace metals and organic compounds, when deposited to ecosystems, may affect biota. Material deposited onto leaf surfaces can alter leaf processes, and PM components deposited to soils and waterbodies may be taken up into biota, with the potential for effects on biological and ecosystem processes. Studies involving ambient air PM, however, have generally involved conditions that would not be expected to meet the current secondary standards for PM. Further, although in some limited cases, effects have been attributed to particle size (
                        <E T="03">e.g.,</E>
                         soiling of leaves by large coarse particles near industrial facilities or unpaved roads), ecological effects of PM have been largely attributed more to its chemical components, such as trace metals, which can be toxic in large amounts (ISA, Appendix 15, sections 15.2 and 15.3.1). The evidence largely comes from studies involving areas experiencing elevated concentrations of PM, such as near industrial areas or historically polluted cities (ISA, Appendix 15, section 15.4).
                    </P>
                    <HD SOURCE="HD3">b. Public Welfare Implications</HD>
                    <P>In evaluating the public welfare implications of the evidence regarding S and N related welfare effects, we must consider the type, severity, and geographic extent of the effects. In this section, we discuss such factors in light of judgments and conclusions regarding effects on the public welfare that have been made in NAAQS reviews.</P>
                    <P>As provided in section 109(b)(2) of the CAA, the secondary standard is to “specify a level of air quality the attainment and maintenance of which in the judgment of the Administrator . . . is requisite to protect the public welfare from any known or anticipated adverse effects associated with the presence of such air pollutant in the ambient air.” The secondary standard is not meant to protect against all known or anticipated welfare effects related to oxides of N and S, and particulate matter, but rather those that are judged to be adverse to the public welfare, and a bright-line determination of adversity is not required in judging what is “requisite” (78 FR 3212, January 15, 2013; 80 FR 65376, October 26, 2015; see also 73 FR 16496, March 27, 2008). Thus, the level of protection from known or anticipated adverse effects to public welfare that is requisite for the secondary standard is a public welfare policy judgment made by the Administrator. The Administrator's judgment regarding the available information and adequacy of protection provided by an existing standard is generally informed by considerations in prior reviews and associated conclusions.</P>
                    <P>
                        The categories of effects identified in the CAA to be included among welfare effects are quite diverse, and among these categories there are many different types of effects that vary broadly with regard to specificity and level of resolution. For example, effects on vegetation and effects on animals are categories identified in CAA section 302(h), and the ISA recognizes effects of N and S deposition at the organism, population, community, and ecosystem level, as summarized in section II.A.3.a. above (ISA, sections IS.5 to IS.9). As noted in the last review of the secondary NAAQS for NO
                        <E T="52">X</E>
                         and SO
                        <E T="52">X</E>
                        , while the CAA section 302(h) lists a number of welfare effects, “these effects do not define public welfare in and of themselves” (77 FR 20232, April 3, 2012).
                    </P>
                    <P>
                        How important ecological impacts are to the public welfare depends on the type, severity and extent of the effects, as well as the societal use of the resource and the significance of the resource to the public welfare. Such factors can also be considered in the context of judgments and conclusions made in some prior reviews regarding public welfare effects. For example, in the context of secondary NAAQS decisions for O
                        <E T="52">3</E>
                        , judgments regarding public welfare significance have given particular attention to effects in areas with special federal protections (such as Class I areas), and lands set aside by states, Tribes, and public interest groups to provide similar benefits to the public welfare (73 FR 16496, March 27, 2008; 80 FR 65292, October 26, 2015).
                        <SU>36</SU>
                        <FTREF/>
                         In the 2015 O
                        <E T="52">3</E>
                         NAAQS review, the EPA recognized the “clear public interest in and value of maintaining these areas in a condition that does not impair their intended use and the fact that many of these lands contain O
                        <E T="52">3</E>
                        -sensitive species” (73 FR 16496, March 27, 2008).
                    </P>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             For example, the fundamental purpose of parks in the National Park System “is to conserve the scenery, natural and historic objects, and wildlife in the System units and to provide for the enjoyment of the scenery, natural and historic objects, and wildlife in such manner and by such means as will leave them unimpaired for the enjoyment of future generations” (54 U.S.C. 100101). Additionally, the Wilderness Act of 1964 defines designated “wilderness areas” in part as areas “protected and managed so as to preserve [their] natural conditions” and requires that these areas “shall be administered for the use and enjoyment of the American people in such manner as will leave them unimpaired for future use and enjoyment as wilderness, and so as to provide for the protection of these areas, [and] the preservation of their wilderness character . . .” (16 U.S.C. 1131 (a) and (c)). Other lands that benefit the public welfare include national forests which are managed for multiple uses including sustained yield management in accordance with land management plans (see 16 U.S.C. 1600(1)-(3); 16 U.S.C. 1601(d)(1)).
                        </P>
                    </FTNT>
                    <P>Judgments regarding effects on the public welfare can depend on the intended use, including conservation, or service (and value) of the affected vegetation, ecological receptors, ecosystems and resources and the significance of that use to the public welfare (73 FR 16496, March 27, 2008; 80 FR 65377, October 26, 2015). Uses or services provided by areas that have been afforded special protection can flow in part or entirely from the vegetation that grows there as well as other natural features and resources. Ecosystem services range from those directly related to the natural functioning of the ecosystem to ecosystem uses for human recreation or profit, such as through the production of lumber or fuel (Costanza et al., 2017; ISA, section IS.13). The spatial, temporal, and social dimensions of public welfare impacts are also influenced by the type of service affected. For example, a national park can provide direct recreational services to the thousands of visitors that come each year but also provide an indirect value to the millions who may not visit but receive satisfaction from knowing it exists and is preserved for the future (80 FR 65377, October 26, 2015).</P>
                    <P>
                        In the last review of the secondary NAAQS for NO
                        <E T="52">X</E>
                         and SO
                        <E T="52">X</E>
                        , ecosystem services were discussed as a method of assessing the magnitude and significance to the public of resources affected by ambient air concentrations of oxides of nitrogen and sulfur and associated deposition in sensitive ecosystems (77 FR 20232, April 3, 2012). That review recognized that although there is no specific definition of adversity to public welfare, one paradigm might involve ascribing public welfare significance to disruptions in ecosystem structure and function. The concept of considering the extent to which a pollutant effect will contribute to such disruptions has been used broadly by the EPA in considering effects. An evaluation of adversity to public welfare might also consider the 
                        <PRTPAGE P="105713"/>
                        likelihood, type, magnitude, and spatial scale of the effect, as well as the potential for recovery and any uncertainties relating to these considerations (77 FR 20218, April 3, 2012).
                    </P>
                    <P>The types of effects on aquatic and terrestrial ecosystems discussed in section II.A.3.1. above differ with regard to aspects important to judging their public welfare significance. For example, in the case of effects on timber harvest, such judgments may consider aspects such as the heavy management of silviculture in the U.S., while judgments for other categories of effects may generally relate to considerations regarding natural areas, including specifically those areas that are not managed for harvest. Effects on tree growth and survival have the potential to be significant to the public welfare through impacts in Class I and other areas given special protection in their natural/existing state, although they differ in how they might be significant.</P>
                    <P>In this context, it may be important to consider that S and N deposition-related effects, such as changes in growth and survival of plant and animal species, could, depending on severity, extent, and other factors, lead to effects on a larger scale including changes in overall productivity and altered community composition (ISA, section IS.2.2.1 and Appendices 5, 6, 8, 9, and 10). Further, effects on individual species could contribute to impacts on community composition through effects on growth and reproductive success of sensitive species in the community, with varying impacts to the system through many factors including changes to competitive interactions (ISA, section IS.5.2 and Appendix 6, section 6.3.2).</P>
                    <P>In acid-impacted surface waters, acidification primarily affects the diversity and abundance of fish and other aquatic life and the ecosystem services derived from these organisms. (2011 PA, section 4.4.5). In addition to other types of services, fresh surface waters support several cultural services, such as aesthetic, recreational, and educational services. The type of service that is likely to be most widely and significantly affected by aquatic acidification is recreational fishing. Multiple studies have documented the economic benefits of recreational fishing. Freshwater rivers and lakes of the northeastern United States, surface waters that have been most affected by acidification, are not a major source of commercially raised or caught fish; they are, however, a source of food for some recreational and subsistence fishers and for other consumers (2009 REA, section 4.2.1.3). It is not known if and how consumption patterns of these fishers may have been affected by the historical impacts of surface water acidification in the affected systems. Non-use services, which include existence (protection and preservation with no expectation of direct use) and bequest values, are arguably a significant source of benefits from reduced acidification (Banzhaf et al., 2006). Since the 2012 review, additional approaches and methods have been applied to estimate the potential effects of aquatic acidification on uses and services of affected aquatic ecosystems; with regard to economic impacts, however, “for many regions and specific services, poorly characterized dose-response between deposition, ecological effect, and services are the greatest challenge in developing specific data on the economic benefits of emission reductions” (ISA, Appendix 14, p. 14-23).</P>
                    <P>Nitrogen loading in aquatic ecosystems, particularly large estuarine and coastal water bodies, has and continues to pose risks to the services provided by those ecosystems, with clear implications to the public welfare (2011 PA, section 4.4.2; ISA, Appendix 14, section 14.3.2). For example, the large estuaries of the eastern U.S. are an important source of fish and shellfish production, capable of supporting large stocks of resident commercial species and serving as breeding grounds and interim habitat for several migratory species (2009 REA, section 5.2.1.3). These estuaries also provide an important and substantial variety of cultural ecosystem services, including water-based recreational and aesthetic services. Additionally, as noted for fresh waters above, these systems have non-use benefits to the public (2011 PA, section 4.4.5). Studies reviewed in the ISA have explored both enumeration of the number of ecosystem services that may be affected by N loading and the pathways by which this may occur, as well as approaches to valuation of such impacts. A finding of one such analysis was that “better quantitative relationships need to be established between N and the effects on ecosystems at smaller scales, including a better understanding of how N shortages can affect certain populations” (ISA, Appendix 14, sections 14.5 and 14.6). The relative contribution of atmospheric deposition to total N loading varies widely among estuaries, however, and has declined in some areas in recent years (ISA, Appendix 10, section 10.10.1).</P>
                    <P>
                        A complication to considering the public welfare implications specific to N deposition in terrestrial systems is the potential for N to increase growth and yield of plants that, depending on the type of plant and its use by human populations (
                        <E T="03">e.g.,</E>
                         food for livestock or human populations, trees for lumber), could be judged beneficial to the public. Such increased growth and yield may be judged and valued differently than changes in growth of other species. As noted in section II.A.3.a. above, enrichment in natural ecosystems can, by increasing growth of N limited plant species, change competitive advantages of species in a community, with associated impacts on the composition of the ecosystem's plant community. The public welfare implications of such effects may vary depending on their severity, prevalence, and magnitude. Impacts on some ecosystem characteristics (
                        <E T="03">e.g.,</E>
                         forest or forest community composition) may be considered of greater public welfare significance when occurring in Class I or other protected areas, due to the value that the public places on such areas. In considering such services in past reviews for secondary standards for other pollutants (
                        <E T="03">e.g.,</E>
                         O
                        <E T="52">3</E>
                        ), the Agency has given particular attention to effects in natural ecosystems, indicating that a protective standard, based on consideration of effects in natural ecosystems in areas afforded special protection, would also “provide a level of protection for other vegetation that is used by the public and potentially affected by O
                        <E T="52">3</E>
                         including timber, produce grown for consumption and horticultural plants used for landscaping” (80 FR 65403, October 26, 2015).
                    </P>
                    <P>
                        Although the welfare effects evidence base describes effects related to ecosystem deposition of N and S compounds, the available information does not yet provide a framework that can specifically tie various magnitudes or prevalences of changes in a biological or ecological indicator (
                        <E T="03">e.g.,</E>
                         lichen abundance or community composition) 
                        <SU>37</SU>
                        <FTREF/>
                         to broader effects on the public welfare. The ISA finds that while there is an improved understanding from information available in this review of the number of pathways by which N and S deposition may affect ecosystem services, most of these relationships remain to be quantified (ISA, Appendix 14, section 14.6).
                        <SU>38</SU>
                        <FTREF/>
                         This 
                        <PRTPAGE P="105714"/>
                        gap creates uncertainties when considering the public welfare implications of some biological or geochemical responses to ecosystem acidification or N enrichment and accordingly complicates judgments on the potential for public welfare significance. That notwithstanding, while shifts in species abundance or composition of various ecological communities may not be easily judged with regard to public welfare significance, at some level, such changes, especially if occurring broadly in specially protected areas, where the public can be expected to place high value, might reasonably be concluded to impact the public welfare. An additional complexity in the current review with regard to assessment of effects associated with existing deposition rates is that the current, much-improved air quality and associated reduced deposition is within the context of a longer history that included appreciably greater deposition in the middle of the last century, the environmental impacts of which may remain, affecting ecosystem responses.
                    </P>
                    <FTNT>
                        <P>
                            <SU>37</SU>
                             As recognized in section II.A.3.a.(3)(b) above, lichen communities have important roles in ecosystem function, such as in hydrologic cycling, nutrient cycling, and as sources of food and habitat for other species (ISA, Appendix 6).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>38</SU>
                             While “there is evidence that N and S emissions/deposition have a range of effects on U.S. ecosystem services and their social value” and 
                            <PRTPAGE/>
                            “there are some economic studies that demonstrate such effects in broad terms,” “it remains methodologically difficult to derive economic costs and benefits associated with specific regulatory decisions/standards” (ISA, Appendix 14, pp. 14-23 to 14-24).
                        </P>
                    </FTNT>
                    <P>In summary, several considerations are important to judgments on the public welfare significance of given welfare effects under different exposures. These include uncertainties and limitations that must be taken into account regarding the magnitude of key effects that might be concluded to be adverse to ecosystem health and associated services. Additionally, there are numerous locations vulnerable to public welfare impacts from S or N deposition-related effects on terrestrial and aquatic ecosystems and their associated services. Other important considerations include the exposure circumstances that may elicit effects and the potential for the significance of the effects to vary in specific situations due to differences in sensitivity of the exposed species, the severity and associated significance of the observed or predicted effect, the role that the species plays in the ecosystem, the intended use of the affected species and its associated ecosystem and services, the presence of other co-occurring predisposing or mitigating factors, and associated uncertainties and limitations.</P>
                    <HD SOURCE="HD3">c. Exposure Conditions and Deposition-Related Metrics</HD>
                    <P>
                        The ecological effects identified in section II.A.3.a. above vary widely in their extent and the resolution of the available information that describes the exposure circumstances under which they occur. The information for direct effects of SO
                        <E T="52">X</E>
                        , N oxides and PM in ambient air is somewhat more straight-forward to consider as it is generally presented in terms of concentrations in air. For deposition-related effects, the information may be about S and N compounds in soil or water or may be for metrics intended to represent atmospheric deposition of those compounds. For the latter, as recognized in section II.A.1.c. above, we face the challenge of relating that information to patterns of ambient air concentrations.
                    </P>
                    <P>
                        With regard to the more complex consideration of deposition-related effects such as ecosystem acidification and N enrichment, there is also wide variation in the extent and level of detail of the evidence available to describe the ecosystem characteristics (
                        <E T="03">e.g.,</E>
                         physical, chemical, and geological characteristics, as well as atmospheric deposition history) that influences the degree to which deposition of N and S associated with the oxides of S and N and PM in ambient air may be linked to ecological effects. One reason for this relates to the contribution of many decades of uncontrolled atmospheric deposition before the establishment of NAAQS for PM, oxides of S and oxides of N (in 1971), followed by the subsequent decades of continued deposition as standards were implemented and updated. The impacts of this deposition history remain in soils of many parts of the U.S. today (
                        <E T="03">e.g.,</E>
                         in the Northeast and portions of the Appalachian Mountains in both hardwood and coniferous forests, as well as areas in and near the Los Angeles Basin), with recent signs of recovery in some areas (ISA, Appendix 4, section 4.6.1; 2008 ISA, section 3.2.1.1). This backdrop and associated site-specific characteristics are among the challenges faced in identifying deposition targets that might be expected to provide protection going forward from the range of effects for which we have evidence as a result of the deposition of the past.
                    </P>
                    <P>
                        Critical loads (CLs) are frequently used in studies that investigate associations between various chemical, biological, ecological and ecosystem characteristics and a variety of N or S deposition-related metrics. The term critical load, which refers to an amount (or a rate of addition) of a pollutant to an ecosystem that is estimated to be at (or just below) that which would result in an ecological effect of interest, has multiple interpretations and applications (ISA, p. IS-14). The dynamic nature of ecosystem pollutant processing and the broad array of factors that influence it adds complications to critical load identification and interpretation. Time is an important dimension, which is sometimes unstated (
                        <E T="03">e.g.,</E>
                         in empirical or observational analyses) and is sometimes explicit (
                        <E T="03">e.g.,</E>
                         in steady-state or dynamic modeling analyses) (ISA, section IS.2.2.4). Further, this variety in meanings stems in part from differing judgments and associated identifications regarding the ecological effect (both type and level of severity) on which the critical load focuses and judgment of its significance or meaning.
                    </P>
                    <P>Studies, based on which CLs are often identified, vary widely with regard to the specific ecosystem characteristics being evaluated, as well as the benchmarks selected for judging them. The specific details of these various judgments influence the strengths and limitations, and associated uncertainty, of using critical load information from such studies for different applications. The summary that follows is intended to reach beyond individual critical loads developed over a variety of studies and ecosystems and consider the underlying study findings about key aspects of the environmental conditions and ecological characteristics studied. A more quantitative variation of this is the methodology developed for the aquatic acidification REA in this review, presented in the PA and summarized in section II.A.4. below. In those analyses, the concept of a critical load is employed with steady-state modeling that relates deposition to waterbody acid neutralizing capacity.</P>
                    <P>
                        While recognizing the inherent connections between watersheds and waterbodies, such as lakes and streams, the organization of this section recognizes the more established state of the information, tools, and data for aquatic ecosystems for characterizing relationships between atmospheric deposition and acidification and/or nutrient enrichment effects under air quality associated with the current standards (PA, Chapter 5).
                        <SU>39</SU>
                        <FTREF/>
                         Further, we 
                        <PRTPAGE P="105715"/>
                        recognize the generally greater role of atmospheric deposition in waterbodies impacted by aquatic acidification compared to its role in eutrophication-related impacts of surface waters, particularly rivers and estuaries in and downstream of populated watersheds, to which direct discharges have also long contributed, as recognized in section II.A.3.a(3) above (ISA, Appendix 13, section 13.1.3.1; ISA, Appendix 7, section 7.1.1.1; 2008 ISA, section 3.2). Therefore, with regard to deposition-related effects, we focus first on the quantitative information for aquatic ecosystem effects in sections II.A.3.c.(1) below. Section II.A.3.c.(2) discusses the available evidence regarding relationships between deposition-related exposures and the occurrence and severity of effects on trees and understory communities in terrestrial ecosystems. Section II.A.3.c.(3) discusses the currently available information related to consideration of exposure concentrations associated with other welfare effects of nitrogen and sulfur oxides and PM in ambient air.
                    </P>
                    <FTNT>
                        <P>
                            <SU>39</SU>
                             With regard to other deposition-related effects of S compounds, quantitative tools or approaches for relating S deposition to ecosystem impacts are not currently well developed. As summarized in section II.A.3.a.(4) above, these effects, in wetland and freshwater ecosystems, include the alteration of Hg methylation in surface water, sediment, and soils; and changes in biota due to sulfide phytotoxicity including alteration of growth and productivity, species physiology, species richness, community composition, and biodiversity. No studies are in the available evidence regarding the estimation of critical loads for SO
                            <E T="52">X</E>
                             deposition related to these non-acidifying effects of S deposition into these ecosystems (ISA, Appendix 12, section 12.6).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(1) Acidification and Nitrogen Enrichment in Aquatic Ecosystems</HD>
                    <P>
                        Prior to the peak in S deposition levels that occurred in the 1970s and early 1980s, when deposition likely exceeded 30 kg S/ha-yr in some areas (PA, Appendix B, Figure 5B-9), surface water SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         concentrations were increasing in response to the extremely high S deposition of the preceding years. Subsequently, and especially more recently, surface water SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         concentrations have generally decreased, particularly in the Northeast (Robinson et al., 2008; ISA, section 7.1.5.1.4). Some studies of long-term projections in some waterbodies (
                        <E T="03">e.g.,</E>
                         in the Blue Ridge Mountains region in Virginia), however, continue to indicate little or slow reduction in acidic ions, even as emissions have declined. This is an example of the competing role of changes in S adsorption on soils and the release of historically deposited S from soils into surface water,
                        <SU>40</SU>
                        <FTREF/>
                         which some modeling has suggested will delay chemical recovery in those water bodies (ISA, Appendix 7, sections 7.1.2.2 and 7.1.5.1).
                    </P>
                    <FTNT>
                        <P>
                            <SU>40</SU>
                             Some modeling studies in some areas have indicated the potential for a lagged response even as emissions and deposition decline; this lag reflects a reduction in soil absorption of SO
                            <E T="52">4</E>
                            <E T="51">−2</E>
                             and leaching of previously accumulated S from watersheds (ISA, Appendix 7, section 7.1.2.2).
                        </P>
                    </FTNT>
                    <P>
                        In the 2012 review of the oxides of N and S, quantitative analyses relating deposition in recent times (
                        <E T="03">e.g.,</E>
                         since 2000) to ecosystem acidification, and particularly aquatic acidification, were generally considered to be less uncertain, and the ability of those analyses to inform NAAQS policy judgments more robust, than analyses related to deposition and ecosystem nutrient enrichment or eutrophication (2011 PA). While quantitative assessment approaches for aquatic eutrophication as a result of total N loading are also well established, and the evidence base regarding atmospheric deposition and nutrient enrichment has expanded since the 2012 review, the significance of non-air N loading to rivers, estuaries and coastal waters (as recognized in section II.A.3.a. above) continues to complicate the assessment of nutrient enrichment-related risks specifically related to atmospheric N deposition. Accordingly, the REA analyses developed in this review focus on aquatic acidification. The REA and its findings regarding deposition rates associated with different levels of aquatic acidification risk are summarized in section II.A.4. below. Thus, the paragraphs below focus on available quantitative information regarding atmospheric deposition and N enrichment in aquatic ecosystems.
                        <SU>41</SU>
                        <FTREF/>
                         The overview provided here draws on the summary in the PA of the evidence as characterized in the ISA with regard to deposition level estimates that studies have related to various degrees of different effects with associated differences in potential for or clarity in public welfare significance (PA, section 5.2).
                    </P>
                    <FTNT>
                        <P>
                            <SU>41</SU>
                             Separate quantitative analyses have not been performed in this review for N enrichment-related effects in these waterbodies in recognition of a number of factors, including modeling and assessment complexities, and site- or waterbody-specific data requirements, as well as, in some cases, issues of apportionment of atmospheric sources separate from other influential sources.
                        </P>
                    </FTNT>
                    <P>The eutrophication of wetlands and other aquatic systems is primarily associated with nitrogen inputs, whether from deposition or other sources. Atmospheric deposition is the main source of new N inputs to some freshwater wetlands and fresh waterbodies, such as headwater streams and high-elevation lakes, while other N inputs, such as agricultural runoff and wastewater effluent, can be significant contributors to waterbodies in agricultural and populated areas (ISA, Appendix 9, section 9.1 and Appendix 11, section 11.3.1). Rates of total N deposition associated with eutrophication-related effects in aquatic systems ranges from a few kilograms per hectare per year (kg/ha-yr) for differences in diatom community composition in high elevation lakes to over 500 kg N/ha-yr for some effects in saltwater wetlands. While the evidence for these effects contributes to ISA causal determinations, it is often very location-specific and less informative for other uses, such as in quantitative assessments relating deposition to waterbody response across broad geographic areas.</P>
                    <P>In estuaries and coastal systems, the well-established relationships between N loading and algal blooms and associated water quality impacts have been the focus of numerous water quality modeling projects that have quantified eutrophication processes across a wide variety of U.S. ecosystems. These projects, which have generally involved quantification of N loading and association with various water quality indicators, have informed management decision-making in multiple estuaries, including Chesapeake Bay, Narraganset Bay, Tampa Bay, Neuse River Estuary and Waquoit Bay (ISA, Appendix 7, section 7.2). The indicators of nutrient enrichment employed include chlorophyll a, dissolved oxygen, and reduced abundance of submerged aquatic vegetation, among others (ISA, section IS.7.3 and Appendix 10, section 10.6).</P>
                    <P>
                        The decision-making in these projects generally focuses on identification of total N loading targets for purposes of attaining water quality standards, informed by modeling work that includes apportionment of sources, which vary by system. We note that the assignment of targets to different source types (
                        <E T="03">e.g.,</E>
                         groundwater, surface water runoff, and atmospheric deposition) in different waterbodies and watersheds varies for both practical and policy reasons. Further, during the multi-decade time period across which these activities have occurred, atmospheric deposition of N in coastal areas has declined. In general, however, atmospheric deposition targets for N for the large systems summarized above have been approximately 10 kg/ha-yr.
                    </P>
                    <P>
                        The establishment of target N loads to surface waterbodies is in many areas related to implementation of the total maximum daily load (TMDL) requirements of section 303(d) of the Clean Water Act.
                        <SU>42</SU>
                        <FTREF/>
                         Nutrient load allocation and reduction activities in some large estuaries predate 
                        <PRTPAGE P="105716"/>
                        development of CWA 303(d) TMDLs. The multiple Chesapeake Bay Agreements signed by the U.S. EPA, District of Columbia, and states of Virginia, Maryland, and Pennsylvania first established the voluntary government partnership that directs and manages bay cleanup efforts and subsequently included commitments for reduction of N and phosphorus loading to the bay. Efforts prior to 2000 focused largely on point-source discharges, with slower progress for nonpoint-source reductions via strategies such as adoption of better agricultural practices, reduction of atmospheric N deposition, enhancement of wetlands and other nutrient sinks, and control of urban sprawl (2008 ISA, section 3.3.8.3). Studies since 2000 estimate atmospheric deposition as a major N source in the overall N budget for the Chesapeake Bay 
                        <SU>43</SU>
                        <FTREF/>
                         (ISA, section 7.2.1; Howarth, 2008; Boyer et al., 2002). The TMDL established for the Chesapeake Bay in 2010, under requirements of section 303(d) of the Clean Water Act, included a loading allocation for atmospheric deposition of N directly to tidal waters, which was projected to be achieved by 2020 based on air quality progress under existing CAA regulations and programs (U.S. EPA, 2010).
                        <SU>44</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>42</SU>
                             Under the CWA, section 303(d), every two years, states and other jurisdictions are required to list impaired waterbodies not meeting water quality standards. For waterbodies on the list, a TMDL must be developed that identifies the maximum amount of pollutant a waterbody can receive and still meet water quality standards, 
                            <E T="03">e.g.,</E>
                             standards for dissolved oxygen and chlorophyll a (which are indicators of eutrophication).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>43</SU>
                             For example, a 2011 analysis estimated atmospheric deposition to the Chesapeake Bay watershed to account for approximately 25% of total N inputs to the estuary (ISA, Appendix 7, section 7.2.1).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>44</SU>
                             As recognized on the EPA web page describing this activity, the TMDL, formally established in December 2010 “is designed to ensure that all pollution control measures needed to fully restore the Bay and its tidal rivers are in place by 2025.” The website also indicates that “EPA expects practices in place by 2017 to meet 60 percent of the necessary reductions,” and for some areas to recover before others, but for it to take years after 2025 for the Bay and its tributaries to fully recover (
                            <E T="03">https://www.epa.gov/chesapeake-bay-tmdl/frequent-questions-about-chesapeake-bay-tmdl</E>
                            ).
                        </P>
                    </FTNT>
                    <P>
                        Jurisdictions for other U.S. estuaries have also developed TMDLs to address nutrient loading causing eutrophication. For example, atmospheric deposition in 2000 was identified as the third largest source of N loading to Narragansett Bay via the watershed and directly to the Bay, at 20% of the total (ISA, Appendix 7, section 7.2.1). Similarly, atmospheric deposition was estimated to account for approximately a third of N input to several small- to medium-sized estuaries of southern New England, with the percentage varying widely for individual estuaries (ISA, Appendix 7, section 7.2.1; Latimer and Charpentier, 2010).
                        <SU>45</SU>
                        <FTREF/>
                         Another modeling study in the Waquoit Bay estuaries in Cape Cod, Massachusetts, using data since 1990, estimated atmospheric deposition to have decreased by about 41% while wastewater inputs increased 80%, with a net result that total loads were concluded to not have changed over that time period (ISA, Appendix 7, section 7.2.1). Another well-studied estuarine system is Tampa Bay, for which a 2013 study estimated atmospheric sources to account for more than 70% of total N loading based on 2002 data (ISA, Appendix 7, section 7.2.1). The TMDL for Tampa Bay allocates 11.8 kg/ha-yr N loading to atmospheric deposition (ISA, Appendix 16, section 16.4.2; Janicki Environmental, 2013). The Neuse River Estuary is another for which modeling work has investigated the role of N loading from multiple sources on nutrient enrichment 
                        <SU>46</SU>
                        <FTREF/>
                         and associated water quality indicators, including chlorophyll a (ISA, Appendix 10, section 10.2).
                    </P>
                    <FTNT>
                        <P>
                            <SU>45</SU>
                             For example, across the 74 estuaries in the 3-state coastal region studied, N from atmospheric deposition to estuary watersheds was generally estimated to account for less than 25% of total N inputs, while estimates for a few small estuaries in CT were higher than 51% (but below 75%) (Latimer and Charpentier, 2010).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>46</SU>
                             One evaluation of progress in achieving mandated N reductions in the Neuse River Basin in NC found that flow-normalized N loading from NO
                            <E T="52">3</E>
                            <E T="51">−</E>
                             decreased beginning in the 1992-1996 period (ISA Appendix 10, section 10.2; Lebo et al., 2012).
                        </P>
                    </FTNT>
                    <P>Nitrogen loading to estuaries has also been considered specifically for impacts on submerged aquatic vegetation. For example, eelgrass coverage was estimated to be markedly reduced in shallow New England estuaries with N loading at or above 100 kg N/ha-yr (ISA, Appendix 10, section 10.2.5). Another study estimated loading rates above 50 kg/ha-yr as a threshold at which habitat extent may be impacted (ISA, Appendix 10, section 10.2.5; Latimer and Rego, 2010). Factors that influence the impact of N loading on submerged vegetation include flushing and drainage in estuaries (ISA, Appendix 10, section 10.6).</P>
                    <HD SOURCE="HD3">(2) Deposition-Related Effects in Terrestrial Ecosystems</HD>
                    <P>The subsections below describe the available information for quantitative relationships between atmospheric deposition rates and acidification and N enrichment-related effects in terrestrial systems. In the 2012 review, analyses included a critical load-based quantitative modeling analysis focused on BC:Al ratios in soils for terrestrial acidification and a qualitative characterization of nutrient enrichment (2009 REA). The more qualitative approach taken for nutrient enrichment in the 2012 review involved describing deposition ranges identified from observational or modeling research as associated with potential effects/changes in species, communities, and ecosystems, with recognition of uncertainties associated with quantitative analysis of these depositional effects (2011 PA, section 3.2.3). In this review, rather than performing new quantitative analyses focused on terrestrial ecosystems, we draw on analyses in the 2009 REA and on more recent published studies recognized in the ISA that provide information pertaining to deposition levels associated with effects related to terrestrial acidification and N enrichment.</P>
                    <P>Several recent publications have added to the information available in the last review including analyses of large datasets from field assessments of tree growth and survival, as well as analyses of understory plant community richness, containing estimates of atmospheric N and/or S deposition (ISA, Appendix 6, section 6.5). The understory plant studies investigate the existence of associations of variations in plant community structure and other metrics including species richness, growth, and survival with variations in deposition during an overlapping time period, generally of a decade or two in duration. Soil acidification modeling and observational studies, as well as experimental addition studies, each with their various design features and associated strengths and limitations (as noted immediately below), inform consideration of N and S deposition levels of interest in the review.</P>
                    <P>
                        In general, observational or gradient studies differ from the chemical mass balance modeling approach in a number of ways that are relevant to their consideration and use for our purposes in this review. One difference of note is the extent to which their findings address the ecosystem impacts of historical deposition. Observational studies describe variation in indicators in the current context, which may include stores of historically deposited chemicals. In these studies, such historical loading, and its associated impacts, can contribute to effects quantified by the study ecological metrics, yet the metric values are assessed in relation to estimates of more recent deposition. Mass balance modeling for steady-state conditions is commonly used for estimating critical loads for acidification risk but does not usually address the complication of historical deposition impacts that can play a significant role in timing of system recovery. In this type of modeling, timelines of the various processes are not addressed. While this provides a simple approach that may facilitate consideration unrelated to 
                        <PRTPAGE P="105717"/>
                        recovery timelines, it cannot address the potential for changes in influential factors that may occur over time with different or changed deposition patterns. Thus, while observational studies contribute to the evidence base on the potential for N/S deposition to contribute to ecosystem effects (and thus are important evidence in the ISA determinations regarding causality), their uncertainties (and underlying assumptions) differ from those of modeling analyses, and they may be somewhat less informative with regard to identification of specific N and S deposition levels that may elicit ecosystem impacts of interest. Both types of studies, as well as N addition experiments, which are not generally confounded by exposure changes beyond those assessed (yet may have other limitations), have been considered, with key findings summarized below.
                    </P>
                    <HD SOURCE="HD3">(a) Deposition and Risks to Trees</HD>
                    <P>
                        The 2009 REA performed a steady-state modeling analysis to estimate the annual amounts of S and N acidifying deposition at or below which one of three BC:Al target values would be met in a 24-state area in which the acid-sensitive species, red spruce and sugar maple, occur. A range of acid deposition was estimated for each of the three target values. Recent estimates of total S and N deposition in regions of the U.S. appear to meet all but the most restrictive of these targets, for which the uncertainty is greatest (
                        <E T="03">e.g.,</E>
                         ISA, Appendix 2, sections 2.6 and 2.7).
                        <SU>47</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>47</SU>
                             Uncertainties associated with the 2009 REA analyses include those associated with the limited dataset of laboratory-generated data on which the BC:Al target values are based (PA, section 5.3.2) as well as in the steady-state modeling parameters, most prominently those related to base cation weathering and acid neutralizing capacity (2009 REA, section 4.3.9). A new approach to estimating weathering has more recently been employed and reported to reduce the uncertainty associated with this parameter (
                            <E T="03">e.g.,</E>
                             Phelan et al., 2014; McDonnell et al., 2012; ISA, Appendix 4, sections 4.6.2.1 and 4.8.4 and Appendix 5, section 5.4).
                        </P>
                    </FTNT>
                    <P>
                        Experimental addition studies of S, or S plus N have been performed in eastern locations, focusing on a small set of tree species, and generally involving S and N additions greater than 20 kg/ha-yr, in combination with appreciable background deposition at the time, and have generally not reported growth reductions (PA, Appendix 5B, Table 5B-1; ISA, Appendix 5, section 5.5.1). Uncertainties associated with these analyses include the extent to which the studies reflect steady-state conditions. Given the variability in the durations across these studies and the relatively short durations for some (
                        <E T="03">e.g.,</E>
                         less than five years), it might be expected that steady-state conditions have not been reached, such that the S/N loading is within the buffering capacity of the soils. With regard to N addition alone, the available studies have reported mixed results for growth and survival (PA, Table 5B-1; Magill et al., 2004; McNulty et al., 2005; Pregitzer et al., 2008; Wallace et al., 2007). It is not clear the extent to which such findings may be influenced by species-specific sensitivities or soils and trees already impacted by historic deposition, or other environmental factors.
                    </P>
                    <P>
                        With regard to S deposition, two large observational studies that analyzed growth and/or survival measurements in tree species at sites in the eastern U.S. or across the country reported negative associations of tree survival for 9 of the 10 species' functional type groupings with the S deposition metric and of tree survival and growth for nearly half of the species individually (Dietze and Moorcroft, 2011; Horn et al., 2018).
                        <SU>48</SU>
                        <FTREF/>
                         Interestingly, survival for the same 9 species groups was also negatively associated with long-term average O
                        <E T="52">3</E>
                         (Dietze and Moorcroft, 2011). The S deposition metrics for the two studies were mean annual average deposition estimates for total S or sulfate (wet deposition) during different, but overlapping, time periods of roughly 10-year durations. The full range of average SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         deposition estimated for the 1994-2005 period assessed by Dietze and Moorcroft (2011) for the eastern U.S. study area was 4 to 30 kg S/ha-yr. The second study covered the more recent time period (2000-2013) and 71 species distributed across the U.S. To draw on this study with regard to S deposition levels of interest, the distribution of S deposition estimates for each species were considered in the PA; the range of median S deposition for sites of those species for which negative associations with growth or survival were reported was 5 to 12 kg S/ha-yr, with few exceptions (Appendix 5B, section 5B.2 and Attachments 2A and 2B; Horn et al., 2018).
                        <SU>49</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>48</SU>
                             The study by Horn et al. (2018) constrained the S analyses to preclude a positive association with S.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>49</SU>
                             This range is for median S deposition estimates (based on measurement interval average, occurring within the years 2000-2013) of nonwestern species with negative associations with growth or survival ranged (Horn et al., 2018).
                        </P>
                    </FTNT>
                    <P>
                        Regarding N deposition, the three large observational studies that analyzed growth and/or survival measurements in tree species samples at sites in the northeastern or eastern U.S., or across the country, reported associations of tree survival and growth with several N deposition metrics (Dietze and Moorcroft, 2011; Thomas et al., 2010; Horn et al., 2018). Estimates of average N deposition across the full set of sites analyzed by Thomas et al. (2010) in 19 states in the northeastern quadrant of the U.S. ranged from 3 to 11 kg N/ha-yr for the period 2000-2004. The N deposition metrics for these three studies were mean annual average deposition estimates for total N or nitrate (wet deposition) during different, but overlapping, time periods that varied from 5 to more than 10 years. The full range of average NO
                        <E T="52">3</E>
                        <E T="51">−</E>
                         deposition estimated for the 1994-2005 period assessed by Dietze and Moorcroft (2011) for the eastern U.S. study area was 6 to 16 kg N/ha-yr. Median N deposition estimated (measurement interval average [falling within the years 2000-2013]) at sites of nonwestern species for which associations with growth or survival were negative (either over full range or at median for species) ranged from 7 to 12 kg N/ha-yr (Horn et al., 2018).
                    </P>
                    <P>
                        In considering what can be drawn from these studies with regard to deposition levels of potential interest for tree species effects, such as the ranges identified above, a number of uncertainties are recognized. For example, several factors were not accounted for that have potential to influence tree growth and survival. Although O
                        <E T="52">3</E>
                         was analyzed in one of the three studies, soil characteristics and other factors with potential to impact tree growth and survival (other than climate) were not assessed, contributing uncertainty to their interpretations. Also, the influence of historical deposition patterns and associated impacts is unknown.
                        <SU>50</SU>
                        <FTREF/>
                         Further, differences in findings for the various species (or species' groups) may relate to differences in geographic distribution of sampling locations, which may 
                        <PRTPAGE P="105718"/>
                        contribute to differences in ranges of deposition history, geochemistry etc.
                    </P>
                    <FTNT>
                        <P>
                            <SU>50</SU>
                             The influence of historically higher deposition (
                            <E T="03">e.g.,</E>
                             versus deposition over the measurement interval) on observations is unknown. Given the influence of deposition on soil conditions that affect tree growth and survival, and generally similar geographic variation for recent and historic deposition, a quantitative interpretation of uncertainty is the extent to which similarity of the two studies' findings indicate a potential for both metrics to reflect geographic variation in impacts stemming from historic deposition. Although geographic deposition patterns have changed little across the time period of the studies, annual S and N deposition rates have changed appreciably (
                            <E T="03">e.g.,</E>
                             PA, Appendix 5B, Figures 5B-9 through 5B-12), which may also contribute uncertainty to interpretation of specific deposition rates associated with patterns of tree growth and survival. Few studies on recovery in historically impacted areas that might address such uncertainties are available (
                            <E T="03">e.g.,</E>
                             ISA, section IS.11).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(b) Deposition Studies of Herbs, Shrubs and Lichens</HD>
                    <P>Studies evaluating the effects of N addition on herbs, shrubs and lichens include observational studies of herbaceous species richness at sites in a multi-state study area and of grassland or coastal sage scrub communities in southern California, and experimental addition studies in several western herb or shrub ecosystems. The experimental addition studies indicate effects on community composition associated with annual N additions of 10 kg N/ha-yr (in the context of background deposition on the order of 6 kg N/ha-yr [PA, Appendix 5B, Table 5B-7]) and higher (PA, sections 5.3.3.1 and 5.3.4.2; ISA, Appendix 6, section 6.3.6). Experiments involving additions of 5 kg N/ha-yr variously reported no response or increased cover for one species (in context of background deposition estimated at 5 kg N/ha-yr). The landscape-level analysis of coastal sage scrub community history in southern California observed a greater likelihood of recovery of sites with relatively low levels of exotic invasive grasses when the N deposition metric level was below 11 kg N/ha-yr. Lastly, the multi-state analysis of herbaceous species richness reported a negative association with N deposition metric values above 8.7 kg N/ha-yr at open-canopy sites and above 6.5 kg/ha-yr and low pH sites. In forested sites, negative associations were found above 11.6 kg N/ha-yr in sites with acidic soil pH at or above 4.5 (PA, section 5.3.3).</P>
                    <P>
                        Limitations and associated uncertainties vary between the two types of studies (experimental addition and observational), but both are limited with regard to consideration of the impacts of long-term deposition. Such studies are necessarily limited in scope with regard to species and ecosystem, and while there are some experimental addition studies lasting more than 20 years, many are for fewer than 10 years. In the case of observational studies, these studies generally have not accounted for the influence of historical pollution (including decades of S and N deposition and elevated concentrations of O
                        <E T="52">3</E>
                         and N oxides) on the associations observed with more recent deposition metrics. Further, there is uncertainty associated with the extent to which the exposure metric utilized reflects the particular conditions that may be eliciting the ecosystem response quantified by the ecosystem metric.
                    </P>
                    <P>
                        The few studies of lichen species diversity and deposition-related metrics, while contributing to the evidence that relates deposition to relative abundance of different lichen species, are more limited in the extent to which they inform an understanding of specific exposure conditions in terms of deposition rates that may elicit specific responses. Related factors include uncertainties related to the methods employed to represent N deposition, the potential role of other unaccounted-for environmental factors (including O
                        <E T="52">3</E>
                        , SO
                        <E T="52">2</E>
                        , S deposition and historical air quality and associated deposition), and uncertainty concerning the independence of any effect of deposition levels from residual effects of past patterns of deposition (PA, section 5.3.3.2). Information on exposure conditions associated with effects of oxides of N such as HNO
                        <E T="52">3</E>
                         on lichen species is also addressed in section II.A.3.c.(3) below.
                    </P>
                    <HD SOURCE="HD3">
                        (3) Other Effects of N Oxides, SO
                        <E T="52">X</E>
                         and PM in Ambient Air
                    </HD>
                    <P>
                        The evidence related to exposure conditions for other effects of SO
                        <E T="52">X</E>
                        , N oxides and PM in ambient air includes concentrations of SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">2</E>
                         associated with effects on plants, concentrations of NO
                        <E T="52">2</E>
                         and HNO
                        <E T="52">3</E>
                         associated with effects on plants and lichens, and concentrations of PM mass or PM loading (much higher than those associated with the existing standard) that affect plant photosynthesis. With regard to oxides of N and S, we note that some effects described as direct may be related to dry deposition of SO
                        <E T="52">2</E>
                         and HNO
                        <E T="52">3</E>
                         onto plant and lichen surfaces, exposure pathways that would be captured in observational studies and could also be captured in some fumigation experiments.
                    </P>
                    <P>
                        With regard to SO
                        <E T="52">2</E>
                        , the evidence primarily includes field studies for the higher concentrations associated with visible foliar injury and laboratory studies for other effects, 
                        <E T="03">e.g.,</E>
                         depressed photosynthesis and reduced growth or yield (ISA, Appendix 3, section 3.2; 1982 AQCD, section 8.3). The recently available information also includes observational studies reporting increased tree growth in association with reductions in SO
                        <E T="52">2</E>
                         emissions, although these studies do not generally report the SO
                        <E T="52">2</E>
                         concentrations in ambient air or account for the influence of changes in concentrations of co-occurring pollutants such as O
                        <E T="52">3</E>
                         (ISA, Appendix 3, section 3.2). With regard to foliar injury, the current ISA states there to be limited research since the 1982 AQCD and “no clear evidence of acute foliar injury below the level of the current standard” (ISA, p. IS-37). Few studies report yield effects from acute exposures, with the available ones reporting relatively high concentrations, such as multiple hours with concentrations above 1 ppm or 1000 ppb (1982 AQCD, section 8.3). Effects have also been reported on photosynthesis and other functions in a few lichen species groups, although recovery of these functions was observed from short, multi-hour exposures to concentrations below about 1 ppm (ISA, Appendix 3, section 3.2).
                    </P>
                    <P>
                        With regard to oxides of N, the evidence indicates that effects on plants and lichens occur at much lower exposures to HNO
                        <E T="52">3</E>
                         (than to NO
                        <E T="52">2</E>
                        ). The laboratory and field studies of oxides of N vary regarding their limitations; field studies are limited regarding identification of threshold exposures for the reported effects, and uncertainties associated with controlled experiments include whether the conditions under which the observed effects occur would be expected in the field. Plant studies reported in the ISA did not report effects on photosynthesis and growth resulting from exposures of NO
                        <E T="52">2</E>
                         concentrations below 0.1 ppm (ISA, Appendix 3, section 3.3).
                    </P>
                    <P>
                        With regard to the HNO
                        <E T="52">3</E>
                        , the elevated concentrations of NO
                        <E T="52">2</E>
                         and HNO
                        <E T="52">3</E>
                         in the Los Angeles area in the 1970s-90s are well documented as is the decline of lichen species in the Los Angeles Basin during that time, although such an analysis is not available elsewhere in the U.S. (PA, section 5.4.2; ISA, Appendix 3).
                        <SU>51</SU>
                        <FTREF/>
                         Other evidence specific to HNO
                        <E T="52">3</E>
                        , which can deposit on and bind to leaf or needle surfaces, includes controlled exposure studies describing foliar effects on several tree species. Studies of ponderosa pine, white fir, California black oak and canyon live oak involving continuous chamber exposure over a month to 24-hour average HNO
                        <E T="52">3</E>
                         concentrations generally ranging from 10 to 18 µg/m
                        <SU>3</SU>
                         (moderate treatment) or 18 to 42 µg/m
                        <SU>3</SU>
                         (high treatment), with the average of the highest 10% of concentrations generally ranging from 18 to 42 µg/m
                        <SU>3</SU>
                         (30-60 µg/m
                        <SU>3</SU>
                         peak) or 89 to 155 µg/m
                        <SU>3</SU>
                         (95-160 µg/m
                        <SU>3</SU>
                         peak), resulted in damage to foliar surfaces of the 1 to 2-year old plants (ISA, Appendix 3, section 3.4; Padgett et al., 2009). Available evidence for lichens 
                        <PRTPAGE P="105719"/>
                        also includes a recent laboratory study of daily HNO
                        <E T="52">3</E>
                         exposures for 18 to 78 days, with daily peaks near 50 ppb (~75 µg/m
                        <SU>3</SU>
                        ) that reported decreased photosynthesis, among other effects (ISA, Appendix 6, section 6.2.3.3; Riddell et al., 2012). Based on studies extending back to the 1980s, HNO
                        <E T="52">3</E>
                         has been suspected to have had an important role in the dramatic declines of lichen communities that occurred in the Los Angeles basin (ISA, Appendix 3, section 3.4; Nash and Sigal, 1999; Riddell et al., 2008; Riddell et al., 2012). In more recent studies, variation in eutrophic lichen abundance has been associated with variation in N deposition metrics (ISA, Appendix 6, section 6.2.3.3), although the extent to which these associations are influenced by residual impacts of historic air quality is unclear and the extent to which similar atmospheric conditions and ecological relationships exist in other locations in the U.S. is uncertain.
                    </P>
                    <FTNT>
                        <P>
                            <SU>51</SU>
                             For example, concentrations of HNO
                            <E T="52">3</E>
                             reported in forested areas of California in the 1980s ranged up to 33 ug/m
                            <SU>3</SU>
                            , and annual average NO
                            <E T="52">2</E>
                             concentrations in the Los Angeles area ranged from 0.078 ppm in 1979 to 0.053 ppm in the early 1990s (PA, section 5.4.2). Ambient air concentrations of HNO
                            <E T="52">3</E>
                             in the Los Angeles metropolitan area have declined markedly, as shown in Figure 2-23 of the PA, which compares concentrations at CASTNET monitoring sites between 2019 and 1996 (PA, section 2.4.1).
                        </P>
                    </FTNT>
                    <P>
                        Little information is available on welfare effects of airborne PM at concentrations commonly occurring in the U.S. today, and the available information does not indicate effects to occur under such conditions. The concentrations at which PM has been reported to affect vegetation (
                        <E T="03">e.g.,</E>
                         through effects on leaf surfaces, which may affect function, or through effects on gas exchange processes) are generally higher than those associated with conditions meeting the current standards and may be focused on specific particulate chemicals rather than on the mixture of chemicals in PM occurring in ambient air (ISA, Appendix 15, sections 15.4.3 and 15.4.6). Studies involving ambient air PM have generally involved conditions that are much higher than those common to the U.S. today (ISA, Appendix 15, sections 15.4.3 and 15.4.4).
                    </P>
                    <HD SOURCE="HD3">4. Overview of Exposure and Risk Assessment for Aquatic Acidification</HD>
                    <P>
                        Our consideration of the scientific evidence available in the current review is informed by results from quantitative analyses of estimated acidic deposition and associated risk of aquatic acidification (PA, section 5.1 and Appendix 5A). These REA analyses, like those in the last review, make use of well-established modeling tools and assessment approaches for this endpoint. Other categories of effects of S and N deposition have been the subject of quantitative analyses, both in the last review (
                        <E T="03">e.g.,</E>
                         terrestrial acidification) and in other contexts (
                        <E T="03">e.g.,</E>
                         eutrophication of large rivers and estuaries), each with associated complexities and specificity. The PA, while focusing the new analyses on aquatic acidification risks, as summarized here, also draws on findings of available analyses for the other categories of effects.
                    </P>
                    <P>The REA analyses, summarized here and presented in detail in Appendix 5A of the PA, have focused on ANC as an indicator of aquatic acidification risk (PA, section 5.1 and Appendix 5A). This focus is consistent with such analyses performed in the 2012 review and with the longstanding evidence that continues to demonstrate a causal relationship between S and N deposition and alteration of freshwater biogeochemistry and between acidifying S and N deposition and changes in biota, including physiological impairment and alteration of species richness, community composition, and biodiversity in freshwater ecosystems (ISA, Table ES-1), as summarized in section II.A.3 above.</P>
                    <P>Section II.A.4.a. summarizes key aspects of the assessment design, including the conceptual approach and tools, indicator reference or benchmark concentrations, the assessment scales, study areas and waterbodies analyzed, and exposure and risk metrics derived. Key limitations and uncertainties associated with the assessment are identified in section II.A.4.b. and the exposure and risk estimates are summarized in section II.A.4.c. An overarching focus of these analyses is characterization of aquatic acidification risk in sensitive ecoregions associated with different deposition conditions.</P>
                    <HD SOURCE="HD3">a. Key Design Aspects</HD>
                    <P>
                        The REA for this review entailed a multi-scale analysis of waterbodies in the contiguous U.S. that assessed waterbody-specific aquatic acidification at three spatial scales: national, ecoregion, and case study area (PA, Appendix 5A). The assessment involved evaluation of deposition and water quality response (ANC) at the waterbody site level. The results are then summarized at the national, ecoregion, and case study level. The national-scale analysis included all waterbody sites across the U.S. for which relevant data were available.
                        <SU>52</SU>
                        <FTREF/>
                         The ecoregion-scale analysis focused on waterbodies with relevant data in a set of 25 ecoregions generally characterized as acid-sensitive; and the more localized case study-scale analysis focused on such waterbodies in five case study areas across the U.S., within each of which were Class I areas.
                    </P>
                    <FTNT>
                        <P>
                            <SU>52</SU>
                             The national-scale analysis focused on the contiguous U.S. as there are insufficient data available for Hawaii, Alaska, and the territories. Of the four hierarchical levels of ecoregion categorization, the REA utilized level III which divides the contiguous U.S. into 84 ecoregions (Omernik and Griffith, 2014). The 69 of these 84 ecoregions in which there was at least one site with sufficient data comprised the national scale.
                        </P>
                    </FTNT>
                    <P>
                        The impact of acidifying S or N deposition estimated for five different time periods (2001-03, 2006-08, 2010-12, 2014-16 and 2018-20) was evaluated using a CL approach that relied on comparison of waterbody location-specific deposition estimates to waterbody location-specific CL estimates derived for other applications and available in the National Critical Loads Database (NCLD) 
                        <SU>53</SU>
                        <FTREF/>
                         (PA, Appendix 5A). The CL estimates used in the assessment were largely based on steady-state modeling, and the modeling applications focused on ANC, producing CL estimates (acidifying deposition in terms of kg/ha-yr or meq/m
                        <SU>2</SU>
                        -yr [milliequivalents per square meter per year] for S and N compounds) for different target or threshold ANC concentrations (also termed benchmarks). Of the 84 ecoregions in the contiguous U.S., 64 have at least one waterbody site with a CL estimate (PA, Appendix 5A). Given its common use in categorizing waterbody sensitivity, ANC was used as the indicator of acidification risk in this assessment (PA, section 5.1.2.2). Deposition estimates, as 3-year averages of annual TDep estimates for each site, were compared to the CL estimates for three different ANC benchmark concentrations (targets or thresholds), in recognition of the watershed variability and associated uncertainties, as an approach for characterizing aquatic acidification risk (PA, section 5.1).
                    </P>
                    <FTNT>
                        <P>
                            <SU>53</SU>
                             The NCLD is comprised of CLs calculated from several common models: (1) steady-state mass-balance models such as the Steady-State Water Chemistry (SSWC), (2) dynamic models such as Model of Acidification of Groundwater In Catchments (MAGIC) (Cosby et al., 1985) or Photosynthesis EvapoTranspiration Biogeochemical model (PnET-BGC) (Zhou et. al., 2015) run out to year 2100 or 3000 to model steady-state conditions and (3) regional regression models that use results from dynamic models to extrapolate to other waterbodies (McDonnell et. al., 2012; Sullivan et al., 2012a). Data and CL estimates in the NCLD are generally focused on waterbodies impacted by deposition-driven acidification and are described in documentation for the database version (PA, section 5.1.2.3; Lynch et al., 2022).
                        </P>
                    </FTNT>
                    <P>
                        The available evidence and scientific judgments were considered in identifying the three ANC benchmark concentrations: 20 μeq/L, 30 μeq/L, 50 μeq/L (PA, section 5.1.2.2). Selection of these benchmark ANC concentrations reflects several considerations. For example, most aquatic CL studies conducted in the U.S. since 2010 use an ANC of 20 and/or 50 μeq/L, because 20 μeq/L has been suggested to provide 
                        <PRTPAGE P="105720"/>
                        protection for a “natural” or “historical” 
                        <SU>54</SU>
                        <FTREF/>
                         range of ANC, and 50 μeq/L to provide greater protection, particularly from episodic acidification events 
                        <SU>55</SU>
                        <FTREF/>
                         (Dupont et al., 2005; Fakhraei et al., 2014; Lawrence et al., 2015; Lynch et al., 2022; McDonnell et al., 2012, 2014; Sullivan et al., 2012a, 2012b). For example, levels below 20 μeq/L have been associated with fish species reductions in some sensitive waterbodies of the Shenandoah and Adirondack Mountains. Levels of ANC ranging from 30 to 40 μeq/L have been reported to provide sufficient buffering to withstand acidic inputs associated with episodic springtime rain or snowmelt events. An ANC value of 50 μeq/L has often been cited in the literature as a target for many areas, and in the 2012 review, ANC values at or above 50 μeq/L were described as providing an additional level of protection although with increasingly greater uncertainty for values at/above 75 μeq/L 
                        <SU>56</SU>
                        <FTREF/>
                         (2011 PA, pp. 7-47 to 7-48). In the western U.S., lakes and streams vulnerable to deposition-driven aquatic acidification are often found in the mountains where surface water ANC levels are naturally low and typically vary between 0 and 30 μeq/L (Williams and Labou, 2017; Shaw et al., 2014). For these reasons, this assessment also develops results for an ANC threshold of 50 μeq/L for sites in the East and 20 μeq/L for sites in the West (denoted as “50/20” μeq/L).
                        <SU>57</SU>
                        <FTREF/>
                         Thus, the set of benchmark concentrations used in this REA includes ANC concentrations that are naturally occurring in many areas and also includes concentrations that, depending on watershed characteristics, may provide additional buffering in times of episodic acidification events.
                    </P>
                    <FTNT>
                        <P>
                            <SU>54</SU>
                             For example, dynamic modeling simulations in acid-sensitive streams of the southern Blue Ridge Mountains have predicted all streams to have pre-industrial time ANC levels above 20 μeq/L, while also predicting more than a third of the streams to have pre-industrial ANC levels below 50 μeq/L (Sullivan et al., 2011).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>55</SU>
                             As noted in section II.A.3.a. above, events such as spring snowmelt and heavy rain events can contribute to episodic acidification events. For example, in some impacted northeastern waterbodies, particularly headwater streams, ANC levels may dip below zero for hours to days or weeks in response to such events, while waterbodies labeled chronically acidic have ANC levels below zero throughout the year (ISA, Appendix 6, section 6.1.1.1; Driscoll et al., 2001).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>56</SU>
                             In considering higher ANC levels (
                            <E T="03">e.g.,</E>
                             up to 80 μeq/L and higher), it was also recognized that many waterbodies, particularly in acid-sensitive regions of the contiguous U.S., never had an ANC that high and would never reach an ANC that high naturally (Williams and Labou 2017; Shaw et al., 2014; PA, section 5.1.2.2). Additionally, in conveying its advice in the 2012 review, the CASAC expressed its view that “[l]evels of 50 μeq/L and higher would provide additional protection, but the Panel has less confidence in the significance of the incremental benefits as the level increases above 50 μeq/L” (Russell and Samet, 2010a; pp. 15-16).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>57</SU>
                             This approach is also used in multiple studies and the NCLD (PA, section 5.1.2.2).
                        </P>
                    </FTNT>
                    <P>Since acidification of waterbodies is controlled by local factors such as geology, hydrology, and other landscape factors, aquatic CLs for acidification were determined at the waterbody level (based on site-specific data) and then summarized at the national, ecoregion, and case study level. National-scale analyses were performed using two approaches: one considering acid deposition of N and S compounds combined and one for S deposition only. Findings from these analyses indicated that across the five different time periods analyzed, the percent of waterbodies exceeding their CLs was similar for the two approaches (PA, Appendix 5A, sections 5A.1.6.2 and 5A.2.1). Thus, to facilitate interpretation of the results, further analysis of the results focused on the findings for S only deposition.</P>
                    <P>
                        Critical load estimates for specific waterbody sites across the contiguous U.S. were drawn from the NCLD (version 3.2.1) 
                        <SU>58</SU>
                        <FTREF/>
                         for comparison to total deposition estimates in the same locations for the five time periods. Comparisons were only performed for sites at which CL estimates were greater than zero, indicating that achievement of the associated ANC benchmark concentration would be feasible.
                        <SU>59</SU>
                        <FTREF/>
                         The results of these analyses are summarized with regard to the spatial extent and severity of deposition-related acidification effects and the protection from these effects associated with a range of annual S deposition.
                    </P>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             A waterbody is represented as a single CL value. In many cases, a waterbody has more than one CL value calculated for it because different studies determined a value for the same waterbody. When more than one CL exists, the CL from the most recent study was selected, while the CL values were averaged when the publications are from the same timeframe (PA, Appendix 5A, section 5A.1.5).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>59</SU>
                             Critical load estimates are estimates of the S deposition rate at which a particular waterbody site is estimated to be able to achieve a specified ANC level. A CL estimate at or below zero would indicate that no S deposition estimate would provide for such a result.
                        </P>
                    </FTNT>
                    <P>
                        The ecoregion-scale analyses focused on 25 ecoregions,
                        <SU>60</SU>
                        <FTREF/>
                         18 in the East and 7 in the West. Ecoregions are areas of similarity regarding patterns in vegetation, aquatic, and terrestrial ecosystem components. The 25 ecoregions in this analysis each had more than 50 waterbody sites (or locations) for which a prior modeling application had developed a CL estimate, which was available in the NCLD (PA, section 5A.2.2.2). Although a total of 32 ecoregions had more than 50 CL sites,
                        <SU>61</SU>
                        <FTREF/>
                         four in the West were excluded as having very low deposition that resulted in no CL exceedances across the complete 20-year analysis period. An additional three ecoregions (
                        <E T="03">i.e.,</E>
                         Southeastern Plains, Southern Coastal Plain, and Atlantic Coastal Pine Barrens) were excluded as they are known to have naturally acidic surface waters, and the low CL estimates for these ecoregions (and resulting CL exceedances) are likely driven by natural acidity linked to high levels of dissolved organic carbon, hydrology, and natural biogeochemical processes rather than atmospheric deposition (2008 ISA, section 3.2.4.2; Baker et al., 1991; Herlihy et al., 1991).
                    </P>
                    <FTNT>
                        <P>
                            <SU>60</SU>
                             The ecoregion classification scheme used to group waterbody sites into ecoregions is based on that described in Omernik (1987), which classifies regions through the analysis of the patterns and the composition of biotic and abiotic characteristics that affect or reflect differences in ecosystem quality and integrity (
                            <E T="03">e.g.,</E>
                             geology, physiography, vegetation, climate, soils, land use, wildlife, and hydrology).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>61</SU>
                             In light of the size of the level III ecoregions, 50 was identified as an appropriate minimum number of CL sites within an ecoregion to include it in the analysis.
                        </P>
                    </FTNT>
                    <P>The case study scale represents the smallest scale at which CLs and their comparison to deposition estimates were summarized and is intended to give some insight into potential local impacts of aquatic acidification. Five case study areas across the U.S. were examined: Shenandoah Valley Area, White Mountain National Forest, Northern Minnesota, Sierra Nevada Mountains, and Rocky Mountain National Park (details presented in PA, section 5.1.3.3 and Appendix 5A, section 5A.2.1). These areas include a number of national parks and forests that vary in their sensitivity to acidification but represent high value or protected ecosystems, such as Class 1 areas, wilderness, and national forests (PA, Appendix 5A, section 5A.2.1). The most well studied of these, the Shenandoah Valley Area case study, includes the Class I area, Shenandoah National Park, and waterbodies in each of three ecoregions. The number of waterbody sites with CLs available in the NCLD for the Shenandoah study area (4,977 sites) is nearly an order of magnitude greater than the total for the four other areas combined (524 sites).</P>
                    <P>
                        The analyses at different scales differed in how results were summarized and evaluated. For example, at the national scale, percentages of water bodies with deposition estimates exceeding their CLs (for the different ANC benchmarks) were reported for each of the five time periods for which deposition was assessed (PA, Table 5-1). From the case 
                        <PRTPAGE P="105721"/>
                        study scale analyses, we focused primarily on the distribution of CL estimates in each study area. In so doing, the CLs for each case study area were characterized in terms of the average and two lower percentiles (
                        <E T="03">e.g.,</E>
                         the 30th percentile CL, which is the value below 70% of the CL estimates for that study area, and the 10th percentile).
                    </P>
                    <P>
                        In the ecoregion-scale analyses, percentages of waterbody sites per ecoregion that exceeded their estimated CLs and percentages of waterbody sites that fell at or below them—for each of the three ANC benchmarks—were summarized by ecoregion for each of the five time periods: 2001-2003, 2006-2008, 2010-2012, 2014-2016 and 2018-2020 (PA, section 5.1.3.2 and Appendix 5A, section 5A.2.2). Percentages of waterbody sites that did not exceed their estimated CLs were described as achieving the associated ANC benchmark (or target). These results of the site-specific ANC modeling were then considered in two ways. The first is based on a binning of this dataset of percentages of waterbodies per ecoregion-time period combinations that were estimated to achieve each of the ANC targets by the median deposition for that ecoregion during that time period (
                        <E T="03">e.g.,</E>
                         percentage achieving ANC target of 20 μeq/L when ecoregion median deposition was at/below 5 kg/ha-yr).
                        <SU>62</SU>
                        <FTREF/>
                         The second approach involved summarizing ecoregion-specific trends in percentage of waterbodies per ecoregion estimated to achieve the three threshold or target ANC values (or estimated to exceed the associated CLs).
                    </P>
                    <FTNT>
                        <P>
                            <SU>62</SU>
                             The percentages of waterbodies in an ecoregion with estimated ANC at/above a target ANC is paired with the median deposition for that ecoregion. The percentages are then binned by the median deposition values.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">b. Key Limitations and Uncertainties</HD>
                    <P>The nature and magnitude of associated uncertainties and their impact on the REA estimates are characterized with a mainly qualitative approach, informed by several quantitative sensitivity analyses (PA, Appendix 5A, section 5A.3). The mainly qualitative approach used to characterize uncertainty here and in quantitative analyses in other NAAQS reviews is described by World Health Organization (WHO, 2008). Briefly, with this approach, we have identified key aspects of the assessment approach that may contribute to uncertainty in the conclusions and provided the rationale for their inclusion. Then, we characterized the magnitude and direction of the influence on the assessment for each of these identified sources of uncertainty. Consistent with the WHO (2008) guidance, we scaled the overall impact of the uncertainty by considering the degree of uncertainty as implied by the relationship between the source of uncertainty and the exposure and risk estimates. A qualitative characterization of low, moderate, and high was assigned to the magnitude of influence and knowledge base uncertainty descriptors, using quantitative observations relating to understanding the uncertainty, where possible. The direction of influence, whether the source of uncertainty was judged to potentially over-estimate (“over”), under-estimate (“under”), or have an unknown impact to exposure/risk estimates was also characterized. Two types of quantitative analyses of the variability and uncertainty associated with the CL estimates used in the REA support the overall uncertainty characterization. The first type of analysis is a sensitivity analysis using Monte Carlo techniques to quantify CL estimate uncertainty associated with several model inputs, and the second is an analysis of the variation in CL estimates among the three primary modeling approaches on which the CLs used in this assessment were based.</P>
                    <P>As overarching observations regarding uncertainty associated with this REA, we note two overarching aspects of the assessment. The first relates to interpretation of specific thresholds of ANC, and the second to our understanding of the biogeochemical linkages between deposition of S and N compounds and waterbody ANC, and the associated estimation of CLs. While ANC is an established indicator of aquatic acidification risk, there is uncertainty in our understanding of relationships between ANC and risk to native biota, particularly in waterbodies in geologic regions prone to waterbody acidity. Such uncertainties relate to the varying influences of site-specific factors other than ANC, such as soil type. Uncertainty associated with our understanding of the biogeochemical linkages between deposition and ANC and the determination of steady-state CLs is difficult to characterize and assess. Uncertainty in CL estimates is associated with parameters used in the steady-state CL models. While the Steady-State Water Chemistry (SSWC) and other CL models are well conceived and based on a substantial amount of research and applications available in the peer-reviewed literature, there is uncertainty associated with the availability of the necessary data to support certain model components.</P>
                    <P>
                        The strength of the CL estimates and the exceedance calculation rely on the ability of models to estimate the catchment-average base-cation supply (
                        <E T="03">i.e.,</E>
                         input of base cations from weathering of bedrock and soils and air), runoff, and surface water chemistry. The uncertainty associated with runoff and surface water parameters relates to availability of measurements; however, the ability to accurately estimate the catchment supply of base cations to a water body is still difficult and uncertain (PA, Appendix 5A, section 5A.3). This area of uncertainty is important because the catchment supply of base cations from the weathering of bedrock and soils is the factor with the greatest influence on the CL calculation and has the largest uncertainty (Li and McNulty, 2007). For example, the well-established models generally rely on input or simulated values for BCw rate, a parameter the ISA notes to be “one of the most influential yet difficult to estimate parameters in the calculation of critical acid loads of N and S deposition for protection against terrestrial acidification” (ISA, section IS.14.2.2.1). Obtaining accurate estimates of weathering rates is difficult because weathering is a process that occurs over very long periods of time, and the estimates on an ecosystem's ability to buffer acid deposition rely on accurate estimates of weathering. Although the approach to estimate base-cation supply for the national case study (
                        <E T="03">e.g.,</E>
                         F-factor approach) has been widely published and analyzed in Canada and Europe and has been applied in the U.S. (
                        <E T="03">e.g.,</E>
                         Dupont et al., 2005 and others), the uncertainty in this estimate is unclear and could be large in some cases.
                    </P>
                    <P>
                        In light of the significant contribution of this input to the CL estimates, a quantitative uncertainty analysis of CL estimates based on state-steady CL modeling was performed (PA, Appendix 5A, section 5A.3.1). This analysis, involving many model simulations for the more than 14,000 waterbodies, drawing on Monte Carlo sampling, provided a description of the uncertainty around the CL estimate in terms of the confidence interval for each waterbody mean result. The size of the confidence interval for S CL estimates ranged from 0.1 kg S/ha-yr at the 5th percentile to 5.3 kg S/ha-yr at the 95th percentile. Smaller confidence intervals were associated with CLs determined with long-term water quality data and low variability in runoff measurements. Estimates of CL determined by one or very few water quality measurements, and in areas where runoff is quite variable (
                        <E T="03">e.g.,</E>
                         the western U.S.), had larger confidence intervals, indicating greater uncertainty. Critical load estimates with the lowest uncertainty 
                        <PRTPAGE P="105722"/>
                        were for waterbody sites in the eastern U.S., particularly along the Appalachian Mountains, in the Upper Midwest, and in the Rocky Mountains, which are areas for which there are relatively larger site-specific datasets (
                        <E T="03">e.g.,</E>
                         for water quality parameters). Greater uncertainty is associated with CLs in the Midwest and South and along the California to Washington coast. This uncertainty in the Midwest is associated with most of the CLs in waterbodies in this area being based on one or a few water quality measurements, while the high uncertainty for sites along the California and Washington coasts relates to variability in runoff values. On average, the size of the confidence interval for the vast majority of CLs (those based on the widely used steady-state water chemistry model) was 7.68 meq S/m
                        <SU>2</SU>
                        -yr or 1.3 kg S/ha-yr, giving a confidence interval of ±3.84 meq/m
                        <SU>2</SU>
                        -yr or ±0.65 kg S/ha-yr. While a comprehensive analysis of uncertainty had not been completed for these estimates prior to this assessment, judgment by EPA experts suggested the uncertainty for combined N and S CLs to be on average about ±0.5 kg/ha-yr (3.125 meq/m
                        <SU>2</SU>
                        -yr), which is generally consistent with the range of uncertainty determined from this quantitative uncertainty analysis (PA, Appendix 5A, section 5A.3).
                    </P>
                    <P>
                        At the ecoregion scale, 51 ecoregions had sufficient data to calculate the 5th to 95th percentile (PA, Appendix 5A, Table 5A-56). Smaller confidence intervals around the mean CL (
                        <E T="03">i.e.,</E>
                         lower uncertainty CLs) were associated with ecoregions in the Appalachian Mountains (
                        <E T="03">e.g.,</E>
                         Northern Appalachian and Atlantic Maritime Highlands, Blue Ridge, Northern Lakes and Forests, and North Central Appalachians) and Rockies (
                        <E T="03">e.g.,</E>
                         Sierra Nevada, Southern Rockies, and Idaho Batholith). Ecoregions with more uncertain CLs included the Northeastern Coastal Zone, Cascades, Coast Range, Interior Plateau, and Klamath Mountains/California High North Coast Range.
                    </P>
                    <P>Although the vast majority of CLs in this assessment were based on the SSWC model, an analysis was conducted to understand differences in the CLs calculated with the different methods. There are three main CL approaches, all based on the watershed mass-balance approach where acid-base inputs are balanced. The three approaches include: (1) SSWC model and F-Factor that is based on quantitative relationships to water chemistry (Dupont et al., 2005; Scheffe et al., 2014; Lynch et al., 2022), (2) Statistical Regression Model that extrapolated weathering rates across the landscape using water quality or landscape factors (Sullivan et al., 2012b; McDonnell et al., 2014), and (3) Dynamic Models (Model of Acidification of Groundwater In Catchments [MAGIC)] or Photosynthesis EvapoTranspiration Biogeochemcial model [Pnet-BGC]). Critical load values were compared between these models to determine model biases. Results from the comparison between different CL methods that were used to calculate the critical loads in the NCLD are summarized in PA Appendix 5A, section 5A.3.1, for lakes in New England and the Adirondacks and streams in the Appalachian Mountains. Overall, good agreement was found between the three methods used to calculate CLs, indicating there was not a systematic bias between the methods and that they should produce comparable results when used together as they were in these analyses (PA, Appendix 5A, section 5A.3).</P>
                    <HD SOURCE="HD3">c. Summary of Results</HD>
                    <P>
                        The findings from the aquatic acidification REA are summarized in terms of S deposition due to the finding of a negligible additional influence of N deposition compared to S deposition on acidification in this assessment 
                        <SU>63</SU>
                        <FTREF/>
                         (PA, Appendix 5A, section 5A.2.1). As summarized more fully below, the analyses of five case study areas, including the acidification-impacted Shenandoah Valley area, indicate that with annual average S deposition below 12 and 10 kg/ha yr, the average waterbody in each area (average as to acid-sensitivity) would be estimated to achieve the ANC benchmarks of 20 and 50 µeq/L, respectively. Seventy percent of waterbodies in each area would be estimated to achieve these benchmarks with deposition below 10 and 7 kg/ha-yr, respectively. At the ecoregion-scale, the results from the analysis of 25 ecoregions, dominated by acid-sensitive waterbodies, indicate acid buffering capabilities to have improved substantially over the past 20 years, and particularly between the first and second decades of the period. By the 2010-2012 period, the percentages of waterbodies achieving the three ANC benchmarks in all 25 ecoregions exceeded 80%, 80% and 70% (for 20, 30 and 50 µeq/L, respectively). By the subsequent analysis period (2014-2016), these percentages were 90%, 80% and 80%. The ecoregion median annual average deposition in all 25 ecoregions was below 8 kg/ha-yr for 2010-2012 and below 5 kg/ha-yr for 2014-2016. An alternate approach to analyzing these estimates (for the 25 ecoregions across all five time periods) suggested that the three ANC benchmarks could be met in more than 80%, 80% and 70% (for 20, 30 and 50 µeq/L, respectively) of waterbodies per ecoregion in all ecoregions and time periods for which annual average ecoregion median deposition is estimated to be at or below 7 kg/ha-yr.
                    </P>
                    <FTNT>
                        <P>
                            <SU>63</SU>
                             More specifically, the percentage of waterbodies across the contiguous U.S. estimated to exceed a CL for combined total S and N are very similar or just slightly higher (
                            <E T="03">e.g.,</E>
                             by 1-2%) than S only percentages of the waterbodies estimated to not meet the ANC benchmarks. This indicates that most of the N deposition entering the watershed is retained within the watershed and/or converted to gaseous N (PA, Appendix 5A, section 5A.2.1).
                        </P>
                    </FTNT>
                    <P>
                        Between the three-year period of 2000-2002, which was the analysis year for the 2009 REA, and 2018-2020, the latest period considered in the REA for this review, national average sulfur deposition has declined appreciably across the U.S. This decline in deposition is reflected in the very different aquatic acidification impact estimates for the two periods. Unlike the findings for 2000-2002 in the 2009 REA, in the national-scale analysis of the current REA, few waterbody sites are estimated to be receiving deposition in excess of their CLs for relevant ANC targets under recent S deposition levels. While recognizing inherent limitations and associated uncertainties of any such analysis, the national-scale assessment performed as part of the current review indicates that under deposition scenarios for the 2018-2020 period, the percentage of waterbodies nationwide that might not be able to maintain an ANC of 50 µeq/L is less than 5% (table 1; PA, Table 5-1).
                        <PRTPAGE P="105723"/>
                    </P>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,12,12,12,12,12">
                        <TTITLE>Table 1—Percentage of Waterbodies Nationally for Which Annual Average S Deposition During the Five Time Periods Assessed Exceed the Waterbody CL (for CLs Greater Than 0) for Each of the Specified ANC Targets</TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                ANC
                                <LI>(µeq/L)</LI>
                            </CHED>
                            <CHED H="1">
                                2001-2003 
                                <LI>%</LI>
                            </CHED>
                            <CHED H="1">
                                2006-2008 
                                <LI>%</LI>
                            </CHED>
                            <CHED H="1">
                                2010-2012 
                                <LI>%</LI>
                            </CHED>
                            <CHED H="1">
                                2014-2016 
                                <LI>%</LI>
                            </CHED>
                            <CHED H="1">
                                2018-2020 
                                <LI>%</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">20</ENT>
                            <ENT>22</ENT>
                            <ENT>16</ENT>
                            <ENT>5</ENT>
                            <ENT>3</ENT>
                            <ENT>1</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">30</ENT>
                            <ENT>25</ENT>
                            <ENT>19</ENT>
                            <ENT>7</ENT>
                            <ENT>4</ENT>
                            <ENT>2</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">50</ENT>
                            <ENT>28</ENT>
                            <ENT>24</ENT>
                            <ENT>11</ENT>
                            <ENT>6</ENT>
                            <ENT>4</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">50/20 *</ENT>
                            <ENT>28</ENT>
                            <ENT>23</ENT>
                            <ENT>10</ENT>
                            <ENT>6</ENT>
                            <ENT>4</ENT>
                        </ROW>
                        <TNOTE>* This combination refers to the use of a target of 50 µeq/L in eastern ecoregions and 20 µeq/L in western ecoregions.</TNOTE>
                    </GPOTABLE>
                    <P>
                        The case study analyses provide estimates of S deposition (with associated uncertainties) that might be expected to allow these geographically diverse locations to meet the three ANC targets (PA, Table 5-6). Focusing on the three eastern case studies, the CL modeling indicates that at an annual average S deposition of 9-10 kg/ha-yr, the sites in these areas, on average,
                        <SU>64</SU>
                        <FTREF/>
                         might be expected to achieve an ANC at or above 50 µeq/L. At an annual average S deposition of about 6-9 kg/ha-yr, 70% of the sites in the areas are estimated to achieve an ANC at or above 20 µeq/L and at about 5-8 kg S/ha-yr, 70% are estimated to achieve an ANC at or above 30 µeq/L. Lower S deposition values are estimated to achieve higher ANC across more sites. Across the three eastern areas, the CL estimates for each ANC target are lowest for the White Mountains National Forest study area, and highest for the Shenandoah Valley study area.
                    </P>
                    <FTNT>
                        <P>
                            <SU>64</SU>
                             The term “average” here refers to the average CL estimated for the specified ANC across all sites with CL estimates in each case study area (PA, Table 5-6).
                        </P>
                    </FTNT>
                    <P>The ecoregion-level analyses of 25 acid-sensitive ecoregions for the five periods from 2001-2003 through 2018-2020 illustrate the spatial variability and magnitude of the findings for the three target ANC levels and the temporal changes across the 20-year period, as described in the PA, section 5.1.3.2. For example, during the two most recent 3-year periods, the median S deposition estimates for each of the 25 ecoregions were all below 5 kg/ha-yr in 2014-2016 and all below 4 kg/ha-yr in 2018-2020 (table 2). Across all five time periods, the range of ecoregion median S deposition extended from below 2 kg/ha-yr up to nearly 18 kg/ha-yr, with the higher values occurring in the eastern ecoregions (table 2).</P>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,10,10,10,10,10">
                        <TTITLE>Table 2—Summary of Ecoregion Medians Derived as Median of S Deposition Estimates at CL Sites Within an Ecoregion</TTITLE>
                        <BOXHD>
                            <CHED H="1"> </CHED>
                            <CHED H="1">Ecoregion median * total sulfur deposition (kg S/ha-yr)</CHED>
                            <CHED H="2">2001-03</CHED>
                            <CHED H="2">2006-08</CHED>
                            <CHED H="2">2010-12</CHED>
                            <CHED H="2">2014-16</CHED>
                            <CHED H="2">2018-20</CHED>
                        </BOXHD>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">All 25 Ecoregions:</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="03">Minimum</ENT>
                            <ENT>1.18</ENT>
                            <ENT>1.22</ENT>
                            <ENT>1.02</ENT>
                            <ENT>1.08</ENT>
                            <ENT>0.62</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Maximum</ENT>
                            <ENT>17.27</ENT>
                            <ENT>14.44</ENT>
                            <ENT>7.25</ENT>
                            <ENT>4.58</ENT>
                            <ENT>3.88</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="03">Median</ENT>
                            <ENT>7.77</ENT>
                            <ENT>6.50</ENT>
                            <ENT>3.71</ENT>
                            <ENT>2.32</ENT>
                            <ENT>1.73</ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">18 Eastern Ecoregions:</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="03">Minimum</ENT>
                            <ENT>4.01</ENT>
                            <ENT>3.10</ENT>
                            <ENT>2.34</ENT>
                            <ENT>1.88</ENT>
                            <ENT>1.31</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Maximum</ENT>
                            <ENT>17.27</ENT>
                            <ENT>14.44</ENT>
                            <ENT>7.25</ENT>
                            <ENT>4.58</ENT>
                            <ENT>3.88</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="03">Median</ENT>
                            <ENT>11.08</ENT>
                            <ENT>9.36</ENT>
                            <ENT>4.76</ENT>
                            <ENT>2.97</ENT>
                            <ENT>2.04</ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">7 Western Ecoregions:</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="03">Minimum</ENT>
                            <ENT>1.18</ENT>
                            <ENT>1.22</ENT>
                            <ENT>1.02</ENT>
                            <ENT>1.08</ENT>
                            <ENT>0.62</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Maximum</ENT>
                            <ENT>1.94</ENT>
                            <ENT>1.83</ENT>
                            <ENT>1.47</ENT>
                            <ENT>1.56</ENT>
                            <ENT>1.19</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Median</ENT>
                            <ENT>1.40</ENT>
                            <ENT>1.52</ENT>
                            <ENT>1.29</ENT>
                            <ENT>1.17</ENT>
                            <ENT>0.87</ENT>
                        </ROW>
                        <TNOTE>* The ecoregion medians for which descriptive statistics are presented here are medians of the deposition estimates across each ecoregion's waterbody sites with CL estimates.</TNOTE>
                    </GPOTABLE>
                    <P>
                        The ecoregion-scale results (
                        <E T="03">e.g.,</E>
                         percentage of waterbodies per ecoregion estimated to achieve the various ANC targets, or alternatively to exceed the associated CLs) for the 18 eastern and 7 western ecoregions are summarized in two ways. One approach, summarized further below, is framed by the temporal trends in median S deposition per ecoregion, and the second approach is in terms of ecoregion-time period combinations, using ecoregion S deposition estimates (medians of deposition estimates at waterbodies with CLs in each ecoregion) as the organizing parameter. For example, table 3 presents the percentages of waterbody sites per ecoregion estimated to achieve the three ANC target levels, summarized by bins for different magnitudes of ecoregion median annual average S deposition (regardless of the 3-year period in which it occurred). For the 18 eastern ecoregions and five time periods, there are 90 ecoregion-time period combinations, and for each of these, there are waterbody percentages for each of the three ANC targets. In table 3, the three percentages (for the three ANC targets) for each of the 18 
                        <PRTPAGE P="105724"/>
                        eastern ecoregions in each of the five time periods are grouped in the bins describing the median S deposition in that ecoregion and time period. As can be seen from this table, fewer than half of the eastern ecoregion-time period combinations had an ecoregion median S deposition estimate at or below 4 kg/ha-yr.
                        <SU>65</SU>
                        <FTREF/>
                         Table 3 indicates that lower levels of S deposition at the ecoregion scale are associated with improved ANC values and greater percentages of waterbodies expected to reach ANC targets. Across the ecoregion-time period dataset of CL exceedances for the three ANC targets for all 90 eastern ecoregion-time period combinations (for which ecoregion median S deposition was at or below 18 kg/ha-yr), 73% of the combinations had at least 90% of waterbodies per ecoregion estimated to achieve ANC at or above 20 µeq/L, and 60% had at least 90% of the waterbodies estimated to achieve ANC at or above 50 µeq/L (table 3). For ecoregion median S deposition estimates at or below 9 kg/ha-yr (approximately three quarters of the combinations), at least 90% of all waterbodies per ecoregion were estimated to achieve ANC at or above 20, 30 and 50 µeq/L in 87%, 81% and 72% of combinations, respectively. For S deposition estimates at or below 5 kg S/ha-yr (the lowest ecoregion median deposition bin that includes at least half of the full dataset), these values are 96%, 92% and 82% of combinations. For the 75 western ecoregion-time period combinations, all of which had ecoregion median S deposition estimates below 4 kg/ha-yr, at least 90% of waterbodies per ecoregion were estimated to achieve an ANC at or above 50 µeg/L (PA, Table 5-5).
                    </P>
                    <FTNT>
                        <P>
                            <SU>65</SU>
                             The ecoregion median S deposition in all seven of the western ecoregions in all five time periods were at or below 2 kg/ha-yr (PA, Table 5-4).
                        </P>
                    </FTNT>
                    <GPOTABLE COLS="17" OPTS="L2,p7,7/8,i1" CDEF="s25,12,4,4,4,4,4p,4,4,4,4,4p,4,4,4,4,4">
                        <TTITLE>Table 3—Percentage of Ecoregion-Time Periods Combinations With at Least 90, 85, 80, 75 and 70% of Waterbodies Estimated To Achieve an ANC at/Above the ANC Targets of 20, 30 and 50 µeq/L as a Function of Annual Average S Deposition for 18 Eastern Ecoregions (90 Ecoregion-Time Period Combinations)</TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                Total sulfur deposition
                                <LI>(kg S/ha-yr) at/below:</LI>
                            </CHED>
                            <CHED H="1">
                                Number of
                                <LI>ecoregion-</LI>
                                <LI>time </LI>
                                <LI>periods</LI>
                            </CHED>
                            <CHED H="1">% Waterbodies per ecoregion-time period meeting specified ANC target</CHED>
                            <CHED H="2">90%</CHED>
                            <CHED H="2">85%</CHED>
                            <CHED H="2">80%</CHED>
                            <CHED H="2">75%</CHED>
                            <CHED H="2">70%</CHED>
                            <CHED H="2">90%</CHED>
                            <CHED H="2">85%</CHED>
                            <CHED H="2">80%</CHED>
                            <CHED H="2">75%</CHED>
                            <CHED H="2">70%</CHED>
                            <CHED H="2">90%</CHED>
                            <CHED H="2">85%</CHED>
                            <CHED H="2">80%</CHED>
                            <CHED H="2">75%</CHED>
                            <CHED H="2">70%</CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="25"> </ENT>
                            <ENT O="xl"/>
                            <ENT A="04">ANC target of 20 µeq/L</ENT>
                            <ENT A="04">ANC target of 30 µeq/L</ENT>
                            <ENT A="04">ANC target of 50 µeq/L</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>10</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>29</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>97</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>41</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>95</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>93</ENT>
                            <ENT>98</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>51</ENT>
                            <ENT>96</ENT>
                            <ENT>98</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>92</ENT>
                            <ENT>98</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>82</ENT>
                            <ENT>94</ENT>
                            <ENT>96</ENT>
                            <ENT>98</ENT>
                            <ENT>100</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">6</ENT>
                            <ENT>59</ENT>
                            <ENT>93</ENT>
                            <ENT>98</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>88</ENT>
                            <ENT>98</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>78</ENT>
                            <ENT>93</ENT>
                            <ENT>97</ENT>
                            <ENT>98</ENT>
                            <ENT>100</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">7</ENT>
                            <ENT>63</ENT>
                            <ENT>92</ENT>
                            <ENT>98</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>87</ENT>
                            <ENT>97</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>78</ENT>
                            <ENT>92</ENT>
                            <ENT>95</ENT>
                            <ENT>98</ENT>
                            <ENT>100</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">8</ENT>
                            <ENT>67</ENT>
                            <ENT>87</ENT>
                            <ENT>94</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>82</ENT>
                            <ENT>91</ENT>
                            <ENT>99</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>73</ENT>
                            <ENT>87</ENT>
                            <ENT>93</ENT>
                            <ENT>96</ENT>
                            <ENT>100</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">9</ENT>
                            <ENT>69</ENT>
                            <ENT>87</ENT>
                            <ENT>94</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>81</ENT>
                            <ENT>91</ENT>
                            <ENT>99</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>72</ENT>
                            <ENT>87</ENT>
                            <ENT>93</ENT>
                            <ENT>96</ENT>
                            <ENT>100</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">10</ENT>
                            <ENT>73</ENT>
                            <ENT>85</ENT>
                            <ENT>92</ENT>
                            <ENT>99</ENT>
                            <ENT>99</ENT>
                            <ENT>99</ENT>
                            <ENT>78</ENT>
                            <ENT>89</ENT>
                            <ENT>97</ENT>
                            <ENT>99</ENT>
                            <ENT>99</ENT>
                            <ENT>70</ENT>
                            <ENT>85</ENT>
                            <ENT>92</ENT>
                            <ENT>95</ENT>
                            <ENT>99</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">11</ENT>
                            <ENT>76</ENT>
                            <ENT>83</ENT>
                            <ENT>91</ENT>
                            <ENT>97</ENT>
                            <ENT>99</ENT>
                            <ENT>99</ENT>
                            <ENT>76</ENT>
                            <ENT>88</ENT>
                            <ENT>96</ENT>
                            <ENT>99</ENT>
                            <ENT>99</ENT>
                            <ENT>68</ENT>
                            <ENT>83</ENT>
                            <ENT>91</ENT>
                            <ENT>95</ENT>
                            <ENT>99</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">12</ENT>
                            <ENT>79</ENT>
                            <ENT>81</ENT>
                            <ENT>89</ENT>
                            <ENT>95</ENT>
                            <ENT>96</ENT>
                            <ENT>97</ENT>
                            <ENT>73</ENT>
                            <ENT>86</ENT>
                            <ENT>94</ENT>
                            <ENT>96</ENT>
                            <ENT>96</ENT>
                            <ENT>66</ENT>
                            <ENT>81</ENT>
                            <ENT>89</ENT>
                            <ENT>92</ENT>
                            <ENT>96</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">13</ENT>
                            <ENT>81</ENT>
                            <ENT>80</ENT>
                            <ENT>88</ENT>
                            <ENT>95</ENT>
                            <ENT>96</ENT>
                            <ENT>98</ENT>
                            <ENT>73</ENT>
                            <ENT>85</ENT>
                            <ENT>94</ENT>
                            <ENT>96</ENT>
                            <ENT>96</ENT>
                            <ENT>65</ENT>
                            <ENT>80</ENT>
                            <ENT>88</ENT>
                            <ENT>93</ENT>
                            <ENT>96</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">14</ENT>
                            <ENT>84</ENT>
                            <ENT>77</ENT>
                            <ENT>86</ENT>
                            <ENT>93</ENT>
                            <ENT>95</ENT>
                            <ENT>96</ENT>
                            <ENT>70</ENT>
                            <ENT>83</ENT>
                            <ENT>92</ENT>
                            <ENT>94</ENT>
                            <ENT>95</ENT>
                            <ENT>63</ENT>
                            <ENT>79</ENT>
                            <ENT>86</ENT>
                            <ENT>90</ENT>
                            <ENT>94</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">15</ENT>
                            <ENT>86</ENT>
                            <ENT>76</ENT>
                            <ENT>84</ENT>
                            <ENT>91</ENT>
                            <ENT>93</ENT>
                            <ENT>95</ENT>
                            <ENT>69</ENT>
                            <ENT>81</ENT>
                            <ENT>90</ENT>
                            <ENT>92</ENT>
                            <ENT>93</ENT>
                            <ENT>62</ENT>
                            <ENT>77</ENT>
                            <ENT>84</ENT>
                            <ENT>88</ENT>
                            <ENT>92</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">16</ENT>
                            <ENT>88</ENT>
                            <ENT>75</ENT>
                            <ENT>83</ENT>
                            <ENT>90</ENT>
                            <ENT>92</ENT>
                            <ENT>94</ENT>
                            <ENT>68</ENT>
                            <ENT>81</ENT>
                            <ENT>89</ENT>
                            <ENT>91</ENT>
                            <ENT>92</ENT>
                            <ENT>61</ENT>
                            <ENT>76</ENT>
                            <ENT>83</ENT>
                            <ENT>88</ENT>
                            <ENT>91</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">17</ENT>
                            <ENT>88</ENT>
                            <ENT>75</ENT>
                            <ENT>83</ENT>
                            <ENT>90</ENT>
                            <ENT>92</ENT>
                            <ENT>94</ENT>
                            <ENT>68</ENT>
                            <ENT>81</ENT>
                            <ENT>89</ENT>
                            <ENT>91</ENT>
                            <ENT>92</ENT>
                            <ENT>61</ENT>
                            <ENT>76</ENT>
                            <ENT>83</ENT>
                            <ENT>88</ENT>
                            <ENT>91</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">18</ENT>
                            <ENT>90</ENT>
                            <ENT>73</ENT>
                            <ENT>81</ENT>
                            <ENT>88</ENT>
                            <ENT>90</ENT>
                            <ENT>92</ENT>
                            <ENT>67</ENT>
                            <ENT>79</ENT>
                            <ENT>87</ENT>
                            <ENT>89</ENT>
                            <ENT>90</ENT>
                            <ENT>60</ENT>
                            <ENT>74</ENT>
                            <ENT>81</ENT>
                            <ENT>86</ENT>
                            <ENT>89</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        Given the decreasing temporal trend in S deposition across all ecoregions, we also analyzed the aquatic acidification results at the ecoregion scale across the 20 years represented by the five time periods (2001-03, 2006-08, 2010-12, 2014-16, 2018-20) from a temporal perspective. With regard to percentages of waterbodies per ecoregion estimated to achieve the three ANC targets, an appreciable improvement is observed for the latter three time periods compared to the initial two time periods (
                        <E T="03">e.g.,</E>
                         PA, Figure 5-13). By the 2010-2012 time period, more than 70% of waterbodies in all 25 ecoregions are estimated to achieve an ANC at or above 50 µeq/L, and at least 85% are able to achieve an ANC at or above 20 µeq/L (figure 1; PA, Table 7-2). By the 2014-2016 period, the percentages are 85% and nearly 90%, respectively. The median deposition for the CL sites in each of the 18 eastern ecoregions during the latter three time periods ranges from 1.3 kg S/h-yr to 7.3 kg S/h-yr, and with each reduction in S deposition in each subsequent time period, more waterbodies in each of the eastern ecoregions are estimated to be able to achieve the ANC targets. Nearly 90% of the 18 eastern ecoregions are estimated to have at least 90% of their waterbodies achieving an ANC of 20 µeq/L in the 2010-12 period and achieving an ANC of 50 µeq/L in the 2014-16 period. When the 7 western ecoregions are included in a summary based on ANC targets of 20 µeq/L for the West and 50 µeq/L for the East,
                        <SU>66</SU>
                        <FTREF/>
                         over 70% of the full set of ecoregions are estimated to have at least 90% of their waterbodies achieving the ANC targets by the 2010-12 period. More than 90% of the ecoregions are estimated to have at least 90% of their waterbodies achieving the ANC targets by the 2014-16 period (figure 1; 
                        <SU>67</SU>
                        <FTREF/>
                         PA, Table 7-2).
                    </P>
                    <FTNT>
                        <P>
                            <SU>66</SU>
                             This combination of targets recognizes the naturally and typically low ANC levels observed in western waterbodies while also including a higher target for the East (as described in the PA, section 5.1.2.2).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>67</SU>
                             The right panel of this figure has been corrected from the version that was in the proposal. The right panel of this figure in the proposal (89 FR 26656, April 15, 2024) had a few extraneous datapoints in the space between the 2006-2008 and 2010-2012 vertical lines. These extraneous datapoints are also in the right panel of an earlier version of this figure in the PA (PA, Figure 7-1). Also, in the left panel of the PA, Figure 7-1, the datapoints for the 2018-2020 period were placed to the left of the 2018-2020 vertical line.
                        </P>
                    </FTNT>
                    <BILCOD>BILLING CODE 6560-50-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="105725"/>
                        <GID>ER27DE24.000</GID>
                    </GPH>
                    <PRTPAGE P="105726"/>
                    <BILCOD>BILLING CODE 6560-50-C</BILCOD>
                    <HD SOURCE="HD2">B. Conclusions</HD>
                    <HD SOURCE="HD3">1. Basis for Proposed Decision</HD>
                    <P>
                        In reaching his proposed decision on the existing secondary standards for SO
                        <E T="52">X</E>
                        , N oxides and PM (presented in section II.B.1.c.), the Administrator took into account the available evidence in the ISA, along with the policy-relevant, evidence-based and air quality-, exposure- and risk-based considerations discussed in the PA (summarized in section II.B.1.a.), as well as advice from the CASAC (section II.B.1.b.). In general, the role of the PA is to help “bridge the gap” between the Agency's assessment of the current evidence and quantitative analyses of air quality, exposure and risk, and the judgments required of the Administrator in determining whether it is appropriate to retain or revise the NAAQS. Evidence-based considerations draw upon the EPA's integrated assessment of the scientific evidence presented in the ISA (summarized in section II.A.3. above) to address key policy-relevant questions in the review. Similarly, the air quality-, exposure- and risk-based considerations draw upon our assessment of air quality, exposure, and associated risk (summarized in section II.A.4. above).
                    </P>
                    <P>
                        This approach to reviewing the secondary standards is consistent with requirements of the provisions of the CAA related to the review of the NAAQS and with how the EPA and the courts have historically interpreted the CAA. As discussed in section I.A. above, these provisions require the Administrator to establish secondary standards that, in the Administrator's judgment, are requisite (
                        <E T="03">i.e.,</E>
                         neither more nor less stringent than necessary) to protect the public welfare from known or anticipated adverse effects associated with the presence of the pollutant in the ambient air. Consistent with the Agency's approach across all NAAQS reviews, the EPA's approach to informing these judgments is based on a recognition that the available welfare effects evidence generally reflects a continuum that includes ambient air-related exposures for which scientists generally agree that effects are likely to occur, through lower levels at which the likelihood and magnitude of response become increasingly uncertain. The CAA does not require the Administrator to establish secondary standards at a zero-risk level, but rather at levels that reduce risk sufficiently so as to protect the public welfare from known or anticipated adverse effects. The proposed decision on the secondary standards for SO
                        <E T="52">X</E>
                        , N oxides and PM described below is a public welfare policy judgment by the Administrator that draws upon the scientific evidence for welfare effects, quantitative analyses of air quality, exposure, and risks, as available, and judgments about how to consider the uncertainties and limitations that are inherent in the scientific evidence and quantitative analyses. The four basic elements of the NAAQS (
                        <E T="03">i.e.,</E>
                         indicator, averaging time, form, and level) have been considered collectively in evaluating the public welfare protection afforded by the current standards. The Administrator's final decision additionally considers public comments received on this proposed decision.
                    </P>
                    <HD SOURCE="HD3">a. Policy-Relevant Evaluations in the Policy Assessment</HD>
                    <P>
                        The PA presented an evaluation of the evidence and quantitative analyses of air quality, exposure and potential risk related to ecological effects of SO
                        <E T="52">X</E>
                        , N oxides and PM. These ecological effects include both direct effects of the three criteria pollutants on biota and ecological effects of ecosystem deposition of N and S associated with these pollutants. The PA identified an array of policy options for consideration by the Administrator. For SO
                        <E T="52">X</E>
                        , the PA identified options for adoption of an annual average SO
                        <E T="52">2</E>
                         standard, averaged over three years, with a level within the range extending below 15 ppb and down to 5 ppb. For N oxides and PM
                        <E T="52">2.5</E>
                        , the PA identified options for retention of the existing standards, without revision, and options for revision, although with recognition of appreciable associated uncertainty. The PA also considered the potential for establishment of a revised secondary standard or suite of standards with alternate indicator(s) that might target specific N or S containing chemicals (
                        <E T="03">e.g.,</E>
                         particulate NO
                        <E T="52">3</E>
                        <E T="51">−</E>
                        , SO
                        <E T="52">4</E>
                        <SU>2</SU>
                        <E T="51">−</E>
                        , NH
                        <E T="52">4</E>
                        <SU>+</SU>
                        ), but recognized there to be a number of associated uncertainties and complications, including uncertainties in how to interpret air measurements and deposition estimates from remote areas in the context of concentrations near sources, without finding there to be a clear advantage to this approach. The PA additionally recognized that, in secondary NAAQS reviews in general, decisions by the Administrator on the adequacy of existing standards or the appropriateness of new or revised standards depend in part on public welfare policy judgments, science policy judgments regarding aspects of the evidence and exposure/risk estimates, and judgments about the level of public welfare protection that is requisite under the CAA.
                    </P>
                    <P>
                        In its evaluation of policy options, the PA considered the evidence, as evaluated in both the current and prior reviews, with regard to the EPA's overall conclusions on the ecological effects of SO
                        <E T="52">X</E>
                        , N oxides and PM in ambient air and once deposited into ecosystems. The PA also considers the available information related to the general approach or framework in which to evaluate public welfare protection of the standard and the currently available quantitative information on environmental exposures likely to occur in areas of the U.S. where the standards are met. In so doing, the PA takes into account associated limitations and uncertainties, as well as the significance of these exposures with regard to the potential for effects, their potential severity and any associated public welfare implications. The PA also considers judgments about the uncertainties in the scientific evidence and quantitative analyses that are integral to consideration of whether the currently available information supports or calls into question the adequacy of the current secondary standards.
                    </P>
                    <HD SOURCE="HD3">(1) Effects Not Related to S and N Deposition</HD>
                    <P>
                        In considering the currently available evidence and quantitative information pertaining to ecological effects of SO
                        <E T="52">X</E>
                        , N oxides and PM in ambient air, other than those associated with ecosystem deposition of S and N, the PA focused on the extent to which the newly available information alters our scientific understanding of the ecological effects of SO
                        <E T="52">X</E>
                        , N oxides and PM in ambient air; the extent to which the currently available information indicates the potential for exposures associated with ecological effects under air quality meeting the existing standards and whether such effects might be of sufficient magnitude, severity, extent and/or frequency such that they might reasonably be judged to be adverse to public welfare; and to what extent important uncertainties identified in past reviews have been reduced and/or whether new uncertainties emerged. These considerations are summarized below, first for SO
                        <E T="52">X</E>
                        , followed by N oxides and then PM.
                    </P>
                    <HD SOURCE="HD3">(a) Sulfur Oxides</HD>
                    <P>
                        Most of the available evidence for the direct effects of SO
                        <E T="52">X</E>
                         on vegetation is not new to the current review. Among the gaseous SO
                        <E T="52">X</E>
                        —which include SO, SO
                        <E T="52">2</E>
                        , sulfur trioxide, and disulfur monoxide—only SO
                        <E T="52">2</E>
                         is present in the lower troposphere at concentrations 
                        <PRTPAGE P="105727"/>
                        relevant for environmental considerations (ISA, Appendix 2, section 2.1). The available evidence is focused primarily on the effects of SO
                        <E T="52">2</E>
                         on vegetation, including foliar injury, depressed photosynthesis and reduced growth or yield (ISA, Appendix 3, section 3.2). The newer studies continue to support the determination that the evidence is sufficient to infer a causal relationship between gas-phase SO
                        <E T="52">2</E>
                         and injury to vegetation (ISA, section 3.6.1). In general, direct effects on plants, including foliar injury, occur at SO
                        <E T="52">2</E>
                         exposures higher than a 3-hour average concentration of 0.5 ppm (500 ppb).
                    </P>
                    <P>
                        Uncertainties associated with the current information relate to limitations in reflecting the natural environment and in untangling effects of SO
                        <E T="52">2</E>
                         from those of other pollutants that may have influenced the analyzed effects. Even with these uncertainties, the evidence indicates effects are generally associated with air concentrations and durations not expected to occur when the existing standard (0.5 ppm, as a 3-hour average, not to be exceeded more than once per year) is met (PA, section 7.1.1; ISA, Appendix 2, section 2.1).
                    </P>
                    <HD SOURCE="HD3">(b) Nitrogen Oxides</HD>
                    <P>
                        The currently available information on direct effects of gaseous N oxides in ambient air on plants and lichens is composed predominantly of studies of NO
                        <E T="52">2</E>
                        , HNO
                        <E T="52">3</E>
                        , and PAN. The very few studies newly available in this review do not alter our prior understanding of effects of these N oxides, which include visible foliar injury, as well as effects on photosynthesis and growth at exposures much higher than current levels in ambient air (ISA, section 3.3). Thus, as in the last review, the body of evidence is sufficient to infer a causal relationship between gas-phase NO, NO
                        <E T="52">2</E>
                        , and PAN and injury to vegetation (ISA, section IS.4.2).
                    </P>
                    <P>
                        Information is limited regarding the potential for exposure levels associated with ecological effects to occur under air quality meeting the existing NO
                        <E T="52">2</E>
                         secondary standard. With regard to the risk posed by N oxides, and particularly HNO
                        <E T="52">3</E>
                        , the evidence summarized in the ISA indicates the potential for effects on lichen species related to air quality occurring during periods when the current secondary standard was not met. Evidence is more limited for consideration of effects under conditions meeting the current standard (PA, section 7.1.2). Uncertainties also remain in our interpretation of the evidence, including those related to limitations and uncertainties of the various study types.
                    </P>
                    <HD SOURCE="HD3">(c) Particulate Matter</HD>
                    <P>
                        The evidence for ecological effects of PM is consistent with that available in the last review and focused on effects associated with PM loading (
                        <E T="03">e.g.,</E>
                         to leaf surfaces), rather than direct effects of PM suspended in ambient air. In this review, as in the last one, the ecological effects evidence was found to be sufficient to conclude there is likely to exist a causal relationship between deposition of PM (other than N and S deposition) and a variety of effects on individual organisms and ecosystems (ISA, Appendix 15; 2012 p.m. ISA, section 9.4). While some uncertainties remain, new uncertainties have not emerged since the last review. There is little information available on effects of PM concentrations likely to occur under conditions meeting the current secondary standards, and the limited available information does not indicate effects to occur under those conditions (PA, section 7.1.3).
                    </P>
                    <HD SOURCE="HD3">(2) Evidence of Ecosystem Effects of S and N Deposition</HD>
                    <P>
                        The evidence base of ecological effects related to atmospheric deposition of N and S compounds has expanded since the last review with regard to acidic deposition in aquatic and terrestrial ecosystems and regarding ecosystem N enrichment. Both S and N compounds have contributed to ecosystem acidification, with relative contributions varying with emissions, air concentrations, and atmospheric chemistry, among other factors. Ecological effects have been documented comprehensively in waterbodies of the Adirondack and Appalachian Mountains, and in forests of the Northeast, at the organism to ecosystem scale. With regard to N enrichment, research on its effects in estuaries and large river systems across the U.S. extends back at least four decades, and there is longstanding evidence of effects in estuaries along the East and Gulf Coasts of the U.S., as summarized in more detail in Chapters 4 and 5 of the PA (ISA, Appendix 7, section 7.2.9; 2008 ISA, section 3.3.2.4; Officer et al., 1984). Information on the effects of N enrichment in terrestrial ecosystems, primarily in grassland and forested ecosystems, augmented in the current review, also includes evidence that was available in the last review (
                        <E T="03">e.g.,</E>
                         2008 ISA, sections 3.3.3 and 3.3.5; ISA, Appendix 6).
                    </P>
                    <P>
                        With regard to uncertainties, some that were associated with the evidence available in the 2012 review remain, and some additional important uncertainties have been identified. In addition to uncertainties related to the specific air quality circumstances associated with effects (
                        <E T="03">e.g.,</E>
                         magnitude, duration, and frequency of concentrations associated with effects), there are also uncertainties associated with the effects of N and S deposition expected under changing environmental circumstances. Such uncertainties include atmospheric loading that has declined since 2000, with associated changes to soil and waterbody biogeochemistry and meteorological changes associated with changing climate (ISA, section IS.12; PA section, 7.2.1). The PA also recognizes important uncertainties associated with the various assessment approaches employed by different study types (PA, sections 5.3 and 7.2.1). Additionally, there are uncertainties contributed by variation in physical, chemical, and ecological responses to N and S deposition and by the potential influence of unaccounted-for stressors on response measures.
                    </P>
                    <P>In sum, a wealth of scientific evidence, spanning many decades, demonstrates effects of acidifying deposition associated with N and S compounds in aquatic and terrestrial ecosystems (ISA, sections ES.5.1, IS.5.1, IS.5.3, IS.6.1 and IS.6.3; 2008 ISA, section 3.2; U.S. EPA, 1982b, Chapter 7). This evidence base supports conclusions also reached in the 2008 ISA (for the review completed in 2012) of causal relationships between N and S deposition and alteration of soil and aquatic biogeochemistry, alteration of the physiology and growth of terrestrial organisms and of associated productivity, changes in aquatic biota, including physiological impairment, and alteration of species richness, community composition, and biodiversity in both aquatic and terrestrial ecosystems (ISA, Table ES-1). Similarly, a robust evidence base demonstrates effects of N enrichment in both estuarine and freshwater ecosystems, supporting conclusions also reached in the last review of a causal relationship between N deposition and changes in biota, including altered growth and productivity, and alteration of species richness, community composition and biodiversity due to N enrichment (ISA, sections ES.5.2, IS.6, and IS.7, and Table ES-1). Additional effects of N deposition in wetlands, also recognized in the last review, include alteration of biogeochemical cycling, growth, productivity, species physiology, species richness, community composition, and biodiversity (ISA, Table ES-1).</P>
                    <P>
                        In terrestrial ecosystems, as in the last review, the now expanded evidence 
                        <PRTPAGE P="105728"/>
                        base supports determination of a causal relationship between N deposition and alteration of species richness, community composition, and biodiversity (ISA, Table ES-1). The ISA additionally determines there to be a causal relationship for alteration of the physiology and growth of terrestrial organisms and associated productivity, a category of effects not included in the 2008 ISA (ISA, Table ES-1). Other evidence of effects causally associated with S deposition in wetland and freshwater ecosystems includes that related to chemical transformation and associated toxicity, most specifically alteration of mercury methylation, which was also recognized in the last review. The other category of effects, not included in the last review, is related to sulfide phytotoxicity and its associated effects in wetland and freshwater ecosystems (ISA, Table ES-1).
                    </P>
                    <P>
                        Thus, while an array of effects is associated with S and N deposition, information important for quantitative analysis varies across the array. For some categories of effects (
                        <E T="03">e.g.,</E>
                         sulfide phytotoxicity) the information regarding environmental levels that relate to effects is limited and/or quite variable across locations, thus hindering analysis. For other effect categories, the information on linkages to criteria pollutants is limited and/or quite variable. The information with clearest implications to NAAQS decisions pertains to SO
                        <E T="52">X</E>
                         and S deposition-related ecosystem acidification. While the information regarding effects associated with N loading to ecosystems is extensive, information to support quantitative analysis to inform NAAQS decisions regarding N oxides and PM is not clear, with multiple complicating factors. Such factors include contributions from other, non-criteria pollutants (such as NH
                        <E T="52">3</E>
                        ) and challenges in assessing N deposition-related effects of ambient air concentrations of N oxides and PM. While the role of N deposition in aquatic acidification is evaluated in the REA, the available information does not provide effective support for analysis of other N deposition-related effects of N oxides and PM independent of effects from other (non-criteria) pollutants or, in some cases, from other (non-air) sources.
                    </P>
                    <HD SOURCE="HD3">
                        (3) Sulfur Deposition and SO
                        <E T="52">X</E>
                    </HD>
                    <P>
                        Evidence- and exposure/risk-based considerations discussed in the PA pertaining to S deposition and SO
                        <E T="52">X</E>
                         in ambient air are summarized in the subsections below. These considerations reflect discussion in the PA, which draws on the available welfare effects evidence described in the current ISA, the 2008 NO
                        <E T="52">X</E>
                        /SO
                        <E T="52">X</E>
                         ISA, the 2009 p.m. ISA, and past AQCDs, as well as information available from quantitative analyses (summarized in Chapters 5 and 6 of the PA), both analyses developed in this review and those available from the 2009 REA.
                    </P>
                    <P>In considering potential public welfare protection from S deposition-related acidification effects in aquatic ecosystems and forested areas, the PA recognizes the public welfare implications of various effects of acidifying deposition on the natural resources in these areas, including the differences in response between waterbodies and trees, as well as the severity and extent of such effects. Given the more extensive quantitative analyses for aquatic acidification in this review, the PA discusses the public welfare implications of S deposition-related effects in aquatic ecosystems with an eye toward their prominence for decision-making in this review (PA, sections 4.5 and 7.2.2.2). In its consideration of options for S deposition-related effects and in recognizing linkages between watershed soils and waterbody acidification, as well as terrestrial effects, the PA conveys that focusing on public welfare protection from aquatic acidification-related effects may reasonably be expected to also contribute protection for terrestrial effects (PA, section 7.4).</P>
                    <P>The PA notes that, as also recognized in the 2012 review, aquatic ecosystems provide a number of services important to the public welfare, ranging from recreational and commercial fisheries to recreational activities engaged in by the public (77 FR 20232, April 3, 2012). Because aquatic acidification affects the diversity and abundance of aquatic biota, it also affects the ecosystem services that are derived from the fish and other aquatic life found in these surface waters (PA, section 4.5; ISA, Appendix 14, section 14.3.1). Fresh surface waters support several cultural services, such as aesthetic and educational services; the type of service that is likely to be most widely and significantly affected by aquatic acidification is recreational fishing, with associated economic and other benefits. Other potentially affected services include provision of food for some recreational and subsistence fishers and for other consumers, as well as non-use services, including existence (protection and preservation with no expectation of direct use) and bequest values (PA, section 4.5).</P>
                    <P>The PA recognizes that some level of S deposition and associated risk of aquatic acidification, including those associated with past decades of acidifying deposition in the Northeast, can impact the public welfare and thus might reasonably be judged adverse to the public welfare. Depending on magnitude and associated impacts, there are many locations in which S deposition and associated aquatic acidification can adversely affect the public welfare. For example, there is evidence in some waterbodies that aquatic acidification resulting in reduced acid buffering capacity can adversely affect waterbodies and associated fisheries, which in addition to any commercial ramifications can have ramifications on recreational enjoyment of affected areas (PA, sections 5.1.1 and 4.5).</P>
                    <P>
                        In other secondary NAAQS reviews, the EPA's consideration of the public welfare significance of the associated effects has recognized a particular importance of Class I areas and other similarly protected areas. Accordingly, we note that waterbodies that have been most affected by acidic deposition are in the eastern U.S., including in several Class I areas and other national and State parks and forests (PA, section 5.1.2.1),
                        <SU>68</SU>
                        <FTREF/>
                         with two such areas included as case studies in the aquatic acidification REA (PA, section 5.1.3.3). Assuring continued improvement of affected waterbodies throughout the U.S. (
                        <E T="03">e.g.,</E>
                         through lower S deposition than the levels of the past) may reasonably be considered to be of public welfare importance and may be particularly important in Class I and similarly protected areas. In this review, in considering the potential public welfare significance of aquatic acidification effects of differing levels of S deposition, the PA summarizes the REA ecoregion-scale results in terms of percentages of ecoregions in which differing percentages of waterbodies are estimated to achieve the three acid buffering capacity targets. The PA summarized results in this way to inform identification of S deposition estimates in the context of potential policy options.
                    </P>
                    <FTNT>
                        <P>
                            <SU>68</SU>
                             A comparison of Figures 4-4 and 5-6 of the PA indicates multiple Class I areas in ecoregions considered acid sensitive.
                        </P>
                    </FTNT>
                    <P>
                        The first subsection below, II.B.1.a.(3)(a), focuses on the aquatic acidification REA analyses (summarized in section II.A.4. above), considering first the use of ANC as an indicator of acidification risk, then evaluating the risk estimates as to what they indicate about acidification risks in freshwater streams and lakes of the contiguous U.S. for S deposition rates estimated to have occurred over the past two decades 
                        <PRTPAGE P="105729"/>
                        (much of which is newly assessed in this review),
                        <SU>69</SU>
                        <FTREF/>
                         and lastly identifying important uncertainties associated with the estimates. Section II.B.1.a.(3)(b) considers the evidence and quantitative exposure/risk information from a public welfare protection perspective, focusing first on what might be indicated regarding deposition conditions under which waterbodies in acid-sensitive ecoregions might be expected to achieve acid buffering capacity of interest and what the available information indicates pertaining to the consideration of public welfare protection from S deposition related effects in aquatic ecosystems. Section II.B.1.a.(3)(b) also considers what the published quantitative information regarding S deposition and terrestrial acidification indicates regarding deposition levels of potential concern, along with associated uncertainties in this information. Section II.B.1.a.(3)(c) then summarizes considerations in relating SO
                        <E T="52">X</E>
                         air quality metrics to deposition of S compounds.
                    </P>
                    <FTNT>
                        <P>
                            <SU>69</SU>
                             Aquatic acidification risk analyses in the last review considered deposition estimates for 2002 and 2006 derived from CMAQ modeling, 2002 emissions estimates (2009 REA, Appendix 1).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(a) Quantitative Information for Ecosystem Risks Associated With S Deposition</HD>
                    <P>As in the last review, the PA gives primary attention to the quantitative assessment of aquatic acidification (including particularly that attributable to S deposition) and recognizes these results to be informative to the identification of S deposition levels associated with potential for aquatic acidification effects of concern, as summarized below. This assessment of quantitative linkages between S deposition and potential for aquatic acidification is one component of the approach implemented in the PA for informing judgments on the likelihood of occurrence of such effects under differing air quality conditions. Although the approaches and tools for assessing aquatic acidification have often been applied for S and N deposition in combination, the REA approach for this review focused on S deposition. This focus is supported by analyses in the PA indicating the relatively greater contribution of S deposition than N deposition to aquatic acidification risk under the more recent air quality conditions that are the focus of this review (PA, Appendix 5A). As summarized in section II.A.4. above, the aquatic acidification REA relied on well-established site-specific water quality modeling applications with a widely recognized indicator of aquatic acidification, ANC.</P>
                    <P>
                        Quantitative tools are also available for the assessment of terrestrial acidification related to S deposition (PA, section 5.3.2.1; 2009 REA, section 4.3).
                        <SU>70</SU>
                        <FTREF/>
                         In the last review, analyses that related estimated atmospheric deposition of acidic N and S compounds (during the early 2000s) to terrestrial effects, or indicators of terrestrial ecosystem risk, were generally considered to be more uncertain than conceptually similar modeling analyses for aquatic ecosystems (2009 REA, section 7.5; 2011 PA, section 1.3). The PA for this review also notes that quantitative tools and approaches are not well developed for other ecological effects associated with atmospheric deposition of S compounds, such as mercury methylation and sulfide toxicity in aquatic systems (PA, sections 4.2.3.1 and 4.2.3.2).
                    </P>
                    <FTNT>
                        <P>
                            <SU>70</SU>
                             Given findings from the 2009 REA that aquatic acidification provided a more sensitive measure for use in assessing deposition related to ecosystem acidification, and consideration of recent information not likely to result in a different finding, the REA for the current review focused on aquatic acidification.
                        </P>
                    </FTNT>
                    <P>As described in sections II.A.3.a.(2)(a) and II.A.4. above, ANC is an indicator of susceptibility or risk of acidification-related effects in waterbodies, with lower levels indicating relatively higher potential for acidification and related waterbody effects. The PA recognized strong support in the evidence for use of ANC for purposes of making judgments regarding risk to aquatic biota in streams impacted by acidifying deposition and for consideration of the set of targets analyzed in the aquatic acidification REA: 20, 30, and 50 µeq/L (PA, section 5.1). There is longstanding evidence of an array of impacts on aquatic biota and species richness reported in surface waters with ANC values below zero and in some historically impacted waterbodies with ANC values below 20 µeq/L (PA, section 5.1.2.2). The severity of impacts is greatest at the lowest ANC levels. This evidence derives primarily from lakes and streams of the Adirondack Mountains and areas along the Appalachian Mountains. As recognized in the 2012 review, in addition to providing protection during base flow situations, ANC is a water quality characteristic that affords protection against the likelihood of decreased pH from episodic events in impacted watersheds. For example, some waterbodies with ANC below 20 µeq/L have been associated with increased probability of low pH events, that, depending on other factors as noted above, may have potential for reduced survival or loss of fitness of sensitive biota or lifestages (2008 ISA, section 5.1.2.1). As noted in the ISA, “[s]treams that are designated as episodically acidic (chronic ANC from 0 to 20 μeq/L) are considered marginal for brook trout because acidic episodes are likely” (ISA, Appendix 8, p. 8-26). In general, the higher the ANC level above zero, the lower the risk presented by episodic acidity. In summarizing and considering the acidification risk estimates for the different scales of analysis (national, ecoregion and case study) and using the water quality modeling-based CLs derived for three different ANC targets (20, 30 and 50 µeq/L), the PA recognizes both the differing risk that might be ascribed to the different ANC targets and the variation in ANC response across waterbodies that may be reasonable to expect with differences in geology, history of acidifying deposition, and patterns of S deposition.</P>
                    <P>
                        The PA also recognizes limitations and uncertainties in the use of ANC as an indicator for model-based risk assessments (PA, section 7.2.2.1). The support is strongest in aquatic systems low in organic material such as historically affected waterbodies in the eastern U.S. (
                        <E T="03">e.g.,</E>
                         in the Adirondack Mountains) and Canada. In waterbodies with relatively higher levels of dissolved organic material, the presence of organic acid anions contributes to reduced pH, but these organic acids can also create complexes with dissolved aluminum that protect resident biota against aluminum toxicity such that biota in such systems tolerate lower ANC values (and pH) than biota in waterbodies with low dissolved organic carbon (ISA, Appendix 8, section 8.3.6.2; PA, section 7.2.2.1). Thus, while the evidence generally supports the use of ANC as an acidification indicator and as a useful metric for judging the potential for ecosystem acidification effects to occur, the relationship between ANC and potential risk varies depending on the presence of naturally occurring organic acids, which can affect the responsiveness of ANC to acidifying deposition. For these reasons, ANC is less well supported as an indicator for acidic deposition-related effects (and waterbodies are less responsive to changes in acidic deposition) due to dissolved organic material in some areas, including the Middle Atlantic Coastal Plain, Southern Coastal Plains, and Atlantic Coastal Pine Barrens ecoregions (PA, section 5.1.2.2).
                    </P>
                    <P>
                        The REA national-scale analysis of more than 13,000 waterbody sites in 69 ecoregions demonstrated an appreciable 
                        <PRTPAGE P="105730"/>
                        reduction in risk over the 20-year period of analysis (PA, section 5.1.3) with the percentage of waterbodies unable to achieve an ANC of 20 µeq/L or greater declining from 20% for the 2001-2003 period to 1% by the 2018-20 period (table 1). The 25 ecoregions included in the ecoregion-scale analyses (
                        <E T="03">i.e.,</E>
                         18 in the East and 7 in the West in which there are at least 50 waterbody sites with CL estimates) are dominated by ecoregions categorized as acid sensitive (PA, Table 5A-5) and exclude the three ecoregions identified above as having natural acidity related to organic acids (PA, section 5.1.2.1). Due to the dominance of the acid-sensitive ecoregions among the 25 ecoregions analyzed, the percentages of waterbodies not able to meet the ANC targets are higher than the national percentages. Specifically, in the most affected ecoregion (Central Appalachians), more than 50% of waterbodies were estimated to be unable to achieve an ANC of 20 µeq/L or greater based on S deposition estimates for the 2001-2003 period (figure 1 above, and PA, Figure 5-13). By the 2018-2020 period, less than 10% of waterbodies in any of the 25 ecoregions (and less than 5% in all but one) were estimated to be unable to achieve an ANC of 20 µeq/L, and less than 15% of waterbodies in the most affected ecoregion were estimated to be unable to achieve an ANC of 50 µeq/L (figure 1 above and PA, Figure 5-13).
                    </P>
                    <P>
                        The PA recognizes uncertainty associated with two overarching aspects of the aquatic acidification assessment of effects (PA, section 5.1.4 and Appendix 5A, section 5A.3). The first relates to interpretation of specific thresholds or benchmark concentrations of ANC with regard to aquatic acidification risk to aquatic biota. While ANC is a well-established indicator of aquatic acidification risk, uncertainty remains in our understanding of relationships between ANC and risk to native biota, particularly in waterbodies in geologic regions prone to waterbody acidity. Such uncertainties relate to the varying influences of site-specific factors, such as the prevalence of organic acids in the watershed, and to historical loading to watershed soils that can influence acidity of episodic high-flow events (PA, sections 5.1.4 and 7.2.2.1 and Appendix 5A, section 5A.3). The second overarching aspect of uncertainty relates to our understanding of the biogeochemical model linkages between deposition of S and N compounds and waterbody ANC, which is reflected in the modeling employed, and the associated estimation of CLs, as described in section II.A.4.b. above. Although the approaches to estimate base-cation supply in the REA (
                        <E T="03">e.g.,</E>
                         the F-factor approach) have been widely published and analyzed in Canada and Europe, and have been applied in the U.S. (
                        <E T="03">e.g.,</E>
                         Dupont et al., 2005), the magnitude of uncertainty in the base-cation supply estimate is unclear and could be large in some cases. The REA's quantitative analysis of uncertainty in CL estimates indicates lower uncertainty associated with CLs estimated for sites with more extensive and longer-term water quality datasets and relatively low variability in the runoff measurements, such as CLs for waterbody sites in the eastern U.S. (PA, Appendix 5A, section 5A.3.1).
                    </P>
                    <HD SOURCE="HD3">(b) General Approach for Considering Public Welfare Protection</HD>
                    <P>
                        In discussing key considerations in judging public welfare protection from S deposition associated with the secondary standard for SO
                        <E T="52">X</E>
                        , the PA first focused on what the aquatic acidification REA indicated about deposition conditions under which waterbodies in sensitive ecoregions might be expected to achieve ANC levels of interest. Particular focus was given to the ecoregion and case-study analyses, which use the waterbody-specific comparisons of estimated deposition and waterbody CLs to provide ecoregion wide and cross-ecoregion summaries of estimated waterbody responses to ecoregion estimates of deposition. The PA also considered the extent to which waterbodies in each ecoregion analyzed were estimated to achieve or exceed the three target ANC levels in the context of the variation in ANC response reasonably expected across waterbodies in an ecoregion due to differences in watershed sensitivity to S deposition impacts and different spatial or geographic patterns of S deposition.
                    </P>
                    <P>Based on the array of CL-based analyses, the PA provides a general sense of the ANC values that waterbodies in sensitive regions across the continental U.S. may be able to achieve, including for areas heavily affected by a long history of acidifying deposition, such as waterbodies in the well-studied Shenandoah Valley area (4,977 sites distributed across three ecoregions). For the other case study areas (White Mountain National Forest, Northern Minnesota, Sierra Nevada Mountains and Rocky Mountain National Park), there are appreciably fewer waterbody sites for which modeling has been performed to estimate CLs, and accordingly greater uncertainty. Yet, the case study area averages of waterbody CLs for achieving ANC at or above each of the three targets (20, 30 or 50 µeq/L) are quite similar across the five case studies (PA, Table 5-6). The PA found the case study estimates to suggest that a focus on S deposition below 10 kg/ha-yr may be appropriate.</P>
                    <P>
                        Findings from the ecoregion-scale analyses of 25 ecoregions (18 East and 7 West), nearly all of which are considered acid sensitive, indicated ranges of deposition (summarized in terms of ecoregion medians) associated with high percentages of waterbodies estimated to achieve the three ANC targets that are similar to the case study results immediately above. This was true when considering the ecoregion-scale analysis results in both of the ways they were presented: (1) in terms of ecoregion median deposition regardless of time period or ecoregion (ecoregion-time period combinations), and (2) in terms of temporal trends in S deposition and waterbody percentages achieving ANC targets. In total, the ecoregion-time periods presentation indicates the likelihood of appreciably more waterbodies achieving the acid buffering capacity targets among the combinations with ecoregion median deposition at or below 9 kg/ha-yr (and for the bins for lower values) in eastern ecoregions compared to the estimates of waterbodies achieving acid buffering targets based on the full dataset that includes ecoregion median deposition estimates up to 18 kg/ha-yr (table 4 below). For example, in the ecoregion-time period combinations presentation, at least 90% of waterbody sites in 87% of the eastern ecoregion-time period combinations are estimated to be able to achieve an ANC at or above 20 µeq/L with ecoregion median S deposition at or below 9 kg/ha-yr and in 96% of those combinations for ecoregion median S deposition at or below 5 kg/ha-yr (table 4). Additionally, these percentages increase across the bins for the lower deposition estimates, although they are also based on smaller proportions of the supporting dataset (
                        <E T="03">i.e.,</E>
                         fewer ecoregion-time period combinations in each subsequently lower deposition bin) contributing to increased uncertainty for those results.
                        <PRTPAGE P="105731"/>
                    </P>
                    <GPOTABLE COLS="11" OPTS="L2,p7,7/8,i1" CDEF="s30,12,6,6,6p,6,6,6p,6,6,6">
                        <TTITLE>Table 4—Summary of the Eastern Ecoregion and Time Period Combinations Achieving Different ANC Targets With Estimated S Deposition at or Below Different Values</TTITLE>
                        <BOXHD>
                            <CHED H="1">S deposition (kg/ha-yr) *</CHED>
                            <CHED H="1">
                                % of
                                <LI>combinations</LI>
                                <LI>included</LI>
                            </CHED>
                            <CHED H="1">% of Eastern ecoregion-time period combinations ** with at least 90%, 80% or 70% waterbodies per ecoregion achieving ANC target</CHED>
                            <CHED H="2">&gt;90% of waterbodies</CHED>
                            <CHED H="3">20</CHED>
                            <CHED H="3">30</CHED>
                            <CHED H="3">50</CHED>
                            <CHED H="2">&gt;80% of waterbodies</CHED>
                            <CHED H="3">20</CHED>
                            <CHED H="3">30</CHED>
                            <CHED H="3">50</CHED>
                            <CHED H="2">&gt;70% of waterbodies</CHED>
                            <CHED H="3">20</CHED>
                            <CHED H="3">30</CHED>
                            <CHED H="3">50</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="22">ANC (µeq/L) at/below:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">≤18</ENT>
                            <ENT>100</ENT>
                            <ENT>73</ENT>
                            <ENT>67</ENT>
                            <ENT>60</ENT>
                            <ENT>88</ENT>
                            <ENT>87</ENT>
                            <ENT>81</ENT>
                            <ENT>92</ENT>
                            <ENT>90</ENT>
                            <ENT>89</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">≤13</ENT>
                            <ENT>90</ENT>
                            <ENT>80</ENT>
                            <ENT>73</ENT>
                            <ENT>65</ENT>
                            <ENT>95</ENT>
                            <ENT>94</ENT>
                            <ENT>88</ENT>
                            <ENT>98</ENT>
                            <ENT>96</ENT>
                            <ENT>96</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">≤11</ENT>
                            <ENT>84</ENT>
                            <ENT>83</ENT>
                            <ENT>76</ENT>
                            <ENT>68</ENT>
                            <ENT>97</ENT>
                            <ENT>96</ENT>
                            <ENT>91</ENT>
                            <ENT>99</ENT>
                            <ENT>99</ENT>
                            <ENT>99</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">≤9</ENT>
                            <ENT>77</ENT>
                            <ENT>87</ENT>
                            <ENT>81</ENT>
                            <ENT>72</ENT>
                            <ENT>100</ENT>
                            <ENT>99</ENT>
                            <ENT>93</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">≤7</ENT>
                            <ENT>70</ENT>
                            <ENT>92</ENT>
                            <ENT>87</ENT>
                            <ENT>78</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>95</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">≤6</ENT>
                            <ENT>66</ENT>
                            <ENT>93</ENT>
                            <ENT>88</ENT>
                            <ENT>78</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>97</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">≤5</ENT>
                            <ENT>57</ENT>
                            <ENT>96</ENT>
                            <ENT>92</ENT>
                            <ENT>82</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>96</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                            <ENT>100</ENT>
                        </ROW>
                        <TNOTE>* These values are ecoregion median estimates across all waterbody sites in an ecoregion with a CL estimate.</TNOTE>
                        <TNOTE>** These percentages are from the more extensive presentation of results in PA, Table 5-5.</TNOTE>
                    </GPOTABLE>
                    <P>
                        The PA observes that estimates from the temporal trend perspective similarly indicate appreciable percentages of waterbodies per ecoregion being estimated to achieve the acid buffering capacity targets with ecoregion median deposition below a range of approximately 5 to 8 kg/ha-yr. For example, by the 2010-2012 period, by which time all 25 ecoregions are estimated to have more than 70% of waterbodies able to achieve an ANC at or above 50 µeq/L (and at least 85% able to achieve an ANC at or above 20 µeq/L), median deposition in the ecoregions analyzed was below 8 kg S/ha-yr, ranging from 1.3 to 7.3 kg S/ha-yr (PA, Table 7-2). As shown in table 5 below, with each reduction in S deposition in each subsequent time period, more waterbodies in each of the eastern ecoregions are estimated to be able to achieve the ANC targets. Nearly 90% of the 18 eastern ecoregions are estimated to have at least 90% of their waterbodies achieving an ANC of 20 µeq/L in the 2010-12 period and achieving an ANC of 50 µeq/L in the 2014-16 period. When the 7 western ecoregions are included in a summary based on ANC targets of 20 µeq/L for the West and 50 µeq/L for the East,
                        <SU>71</SU>
                        <FTREF/>
                         over 70% of the full set of ecoregions are estimated to have at least 90% of their waterbodies achieving the ANC targets by the 2010-12 period (table 5). By the 2014-2016 and 2018-2020 periods, 24 of the 25 ecoregions were estimated to have more than 90% of waterbodies able to achieve an ANC at/above 50 µeq/L, and median S deposition in all 25 ecoregions was below 5 kg/ha-yr (table 5).
                    </P>
                    <FTNT>
                        <P>
                            <SU>71</SU>
                             This combination of targets recognizes the naturally and typically low ANC levels observed in western waterbodies while also including a higher target for the East, as described in section 5.1.2.2 of the PA.
                        </P>
                    </FTNT>
                    <GPOTABLE COLS="12" OPTS="L2,p7,7/8,i1" CDEF="s30,10,10,8,9,9p,8,9,9p,8,9,9">
                        <TTITLE>Table 5—Ecoregions Estimated To Have Different Percentages of Waterbodies Achieving Different ANC Targets for the Five Deposition Periods Analyzed</TTITLE>
                        <BOXHD>
                            <CHED H="1">Time period</CHED>
                            <CHED H="1">% (n) of ecoregions with specified percentage of waterbodies per ecoregion achieving specified ANC</CHED>
                            <CHED H="2">ANC:</CHED>
                            <CHED H="3">
                                Ecoregion median S deposition
                                <LI>(kg/ha-yr)</LI>
                            </CHED>
                            <CHED H="4">Min</CHED>
                            <CHED H="4">Max</CHED>
                            <CHED H="2">20 µeq/L</CHED>
                            <CHED H="3">
                                Percent of waterbodies per
                                <LI>ecoregion</LI>
                            </CHED>
                            <CHED H="4">90%</CHED>
                            <CHED H="4">80%</CHED>
                            <CHED H="4">70%</CHED>
                            <CHED H="2">30 µeq/L</CHED>
                            <CHED H="3">Percent of waterbodies per ecoregion</CHED>
                            <CHED H="4">90%</CHED>
                            <CHED H="4">80%</CHED>
                            <CHED H="4">70%</CHED>
                            <CHED H="2">50 µeq/L</CHED>
                            <CHED H="3">Percent of waterbodies per ecoregion</CHED>
                            <CHED H="4">90%</CHED>
                            <CHED H="4">80%</CHED>
                            <CHED H="4">70%</CHED>
                        </BOXHD>
                        <ROW RUL="s">
                            <ENT I="22"> </ENT>
                            <ENT A="01">East</ENT>
                            <ENT A="08">Of 18 Eastern Ecoregions</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2001-03</ENT>
                            <ENT>4.0</ENT>
                            <ENT>17.3</ENT>
                            <ENT>39% (7)</ENT>
                            <ENT>67% (12)</ENT>
                            <ENT>72% (13)</ENT>
                            <ENT>28% (5)</ENT>
                            <ENT>61% (11)</ENT>
                            <ENT>72% (13)</ENT>
                            <ENT>22% (4)</ENT>
                            <ENT>50% (9)</ENT>
                            <ENT>72% (13)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2006-08</ENT>
                            <ENT>3.1</ENT>
                            <ENT>14.4</ENT>
                            <ENT>44 (8)</ENT>
                            <ENT>72 (13)</ENT>
                            <ENT>89 (16)</ENT>
                            <ENT>33 (6)</ENT>
                            <ENT>72 (13)</ENT>
                            <ENT>78 (14)</ENT>
                            <ENT>33 (6)</ENT>
                            <ENT>67 (12)</ENT>
                            <ENT>72 (13)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2010-12</ENT>
                            <ENT>2.3</ENT>
                            <ENT>7.3</ENT>
                            <ENT>89 (16)</ENT>
                            <ENT>100 (18)</ENT>
                            <ENT>100 (18)</ENT>
                            <ENT>83 (15)</ENT>
                            <ENT>100 (18)</ENT>
                            <ENT>100 (18)</ENT>
                            <ENT>61 (11)</ENT>
                            <ENT>89 (16)</ENT>
                            <ENT>100 (18)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2014-16</ENT>
                            <ENT>1.9</ENT>
                            <ENT>4.6</ENT>
                            <ENT>94 (17)</ENT>
                            <ENT>100 (18)</ENT>
                            <ENT>100 (18)</ENT>
                            <ENT>94 (17)</ENT>
                            <ENT>100 (18)</ENT>
                            <ENT>100 (18)</ENT>
                            <ENT>89 (16)</ENT>
                            <ENT>100 (18)</ENT>
                            <ENT>100 (18)</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">2018-20</ENT>
                            <ENT>1.3</ENT>
                            <ENT>3.9</ENT>
                            <ENT>100 (18)</ENT>
                            <ENT>100 (18)</ENT>
                            <ENT>100 (18)</ENT>
                            <ENT>94 (17)</ENT>
                            <ENT>100 (18)</ENT>
                            <ENT>100 (18)</ENT>
                            <ENT>94 (17)</ENT>
                            <ENT>100 (18)</ENT>
                            <ENT>100 (18)</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="22"> </ENT>
                            <ENT A="01">All</ENT>
                            <ENT A="08">Of 25 Ecoregions (18 East, 7 West)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2001-03</ENT>
                            <ENT>1.2</ENT>
                            <ENT>17.3</ENT>
                            <ENT>56 (14)</ENT>
                            <ENT>76 (19)</ENT>
                            <ENT>80 (20)</ENT>
                            <ENT>48 (12)</ENT>
                            <ENT>72 (18)</ENT>
                            <ENT>80 (20)</ENT>
                            <ENT>44 (11)</ENT>
                            <ENT>64 (16)</ENT>
                            <ENT>80 (20)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2006-08</ENT>
                            <ENT>1.2</ENT>
                            <ENT>14.4</ENT>
                            <ENT>60 (15)</ENT>
                            <ENT>80 (20)</ENT>
                            <ENT>92 (23)</ENT>
                            <ENT>52 (13)</ENT>
                            <ENT>80 (20)</ENT>
                            <ENT>84 (21)</ENT>
                            <ENT>52 (13)</ENT>
                            <ENT>76 (19)</ENT>
                            <ENT>80 (20)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2010-12</ENT>
                            <ENT>1.0</ENT>
                            <ENT>7.3</ENT>
                            <ENT>92 (23)</ENT>
                            <ENT>100 (25)</ENT>
                            <ENT>100 (25)</ENT>
                            <ENT>88 (22)</ENT>
                            <ENT>100 (25)</ENT>
                            <ENT>100 (25)</ENT>
                            <ENT>72 (18)</ENT>
                            <ENT>92 (23)</ENT>
                            <ENT>100 (25)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2014-16</ENT>
                            <ENT>1.1</ENT>
                            <ENT>4.6</ENT>
                            <ENT>96 (24)</ENT>
                            <ENT>100 (25)</ENT>
                            <ENT>100 (25)</ENT>
                            <ENT>96 (24)</ENT>
                            <ENT>100 (25)</ENT>
                            <ENT>100 (25)</ENT>
                            <ENT>92 (23)</ENT>
                            <ENT>100 (25)</ENT>
                            <ENT>100 (25)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2018-20</ENT>
                            <ENT>0.62</ENT>
                            <ENT>3.9</ENT>
                            <ENT>100 (25)</ENT>
                            <ENT>100 (25)</ENT>
                            <ENT>100 (25)</ENT>
                            <ENT>96 (24)</ENT>
                            <ENT>100 (25)</ENT>
                            <ENT>100 (25)</ENT>
                            <ENT>96 (24)</ENT>
                            <ENT>100 (25)</ENT>
                            <ENT>100 (25)</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Note:</E>
                             Estimates for ANC of 50 µeq/L (East) and 20 µeq/L (West) are identical to those for 50 in all 25 ecoregions.
                        </TNOTE>
                    </GPOTABLE>
                    <P>The temporal trends in percentage of waterbodies estimated to achieve the target ANC levels for each of the 25 individual ecoregions document a large difference between the time periods prior to 2010 and subsequent time periods (figure 1 above). For the S deposition estimated for the 2010-2012 period, more than 70% of waterbodies are estimated to be able to achieve an ANC of 50 ueq/L in all 25 ecoregions (figure 1, left panel), and 85% to 100% of waterbodies in all ecoregions are estimated to be able to achieve an ANC of 20 ueq/L (figure 1, right panel).</P>
                    <P>
                        Given the dependency of the ANC estimates on S deposition estimates, this distinction between the period prior to 2010 and the subsequent decade is also seen in the ecoregion deposition 
                        <PRTPAGE P="105732"/>
                        estimates for the 25 REA ecoregions (figure 2; PA, Figure 7-2).
                        <SU>72</SU>
                        <FTREF/>
                         The distribution of deposition estimates at waterbody sites assessed in each ecoregion, and particularly the temporal pattern for the upper percentiles, illustrates the deposition estimates that are driving temporal pattern in the REA estimates.
                        <SU>73</SU>
                        <FTREF/>
                         For example, across the 25 ecoregions (figure 2, left panel), the median of the ecoregion 90th percentiles 
                        <SU>74</SU>
                        <FTREF/>
                         of S deposition during the two earliest periods ranged from approximately 14 to 17 kg/ha-yr and the highest ecoregion 90th percentile values were above 20 kg/ha-yr. In contrast, during the latter three periods (2010-2020), the median of ecoregion 90th percentile values ranged from approximately 2 to 5 kg/ha-yr and all ecoregion 90th percentile estimates were below approximately 8 kg/ha-yr (figure 2). The contrast is less sharp for the ecoregion medians, as the median is a statistic less influenced by changes in the magnitude of values at the upper end of the distribution (figure 2). Overall, this indicates the significant reduction in the highest levels of deposition within each ecoregion over the time periods analyzed.
                    </P>
                    <FTNT>
                        <P>
                            <SU>72</SU>
                             In Figure 7-2 of the PA (which is an earlier version of figure 2), the box and whiskers presented for the medians were incorrect. They are correct in figure 2 here, and they were also correct in figure 2 of the proposal.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>73</SU>
                             Figure 2 presents temporal trends for three different statistics for deposition within the REA ecoregions. For example, the leftmost box and whiskers among the set of three presents the distribution of values that are the 90th percentile deposition estimates (at REA assessed waterbodies) in the 25 ecoregions. The rightmost box and whiskers presents the distribution of median deposition estimates for these ecoregions (figure 2, left panel).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>74</SU>
                             The median of the ecoregion 90th percentiles is the horizontal line in the leftmost box of the set of three. This is a measure of the central tendency of the 90th percentile deposition (across REA sites) in the 25 assessed ecoregions.
                        </P>
                    </FTNT>
                    <BILCOD>BILLING CODE 6560-50-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="105733"/>
                        <GID>ER27DE24.001</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 6560-50-C</BILCOD>
                    <P>
                        Thus, in considering identification of S deposition levels that may be associated with a desired level of ecosystem protection for a SO
                        <E T="52">X</E>
                          
                        <PRTPAGE P="105734"/>
                        standard, the PA took note of the increased percentages of waterbodies estimated to achieve more protective ANC levels across the five time periods. The pattern of estimated improving water quality over the 20-year study period is paralleled by the pattern of declining deposition (figure 2). This temporal pattern indicates an appreciable reduction in ecoregion S deposition between the first and second decades of the period with associated reduction in aquatic acidification risk. As noted immediately above, the risk estimates associated with the deposition estimates of the second decade indicate generally high percentages of waterbodies per ecoregion as able to achieve or exceed the three ANC targets. Similarly, the ecoregion-time period binning summary also indicates generally high percentages of waterbodies achieving ANC targets for ecoregion median S deposition at or below about 8 or 9 kg/ha-yr (table 4). Thus, in light of these observations,
                        <SU>75</SU>
                        <FTREF/>
                         the PA describes S deposition, on an areawide basis (
                        <E T="03">i.e.,</E>
                         ecoregion median), that falls at or below approximately 5 to 9 (differing slightly depending on the supporting analysis), as being associated with the potential to achieve acid buffering capacity levels of interest in an appreciable portion of sensitive areas.
                    </P>
                    <FTNT>
                        <P>
                            <SU>75</SU>
                             The PA also suggested, based on the case study CL estimates, a focus on deposition below 10 kg/ha-yr, although the deposition estimates discussed in the case study analysis are smaller scale, 
                            <E T="03">e.g.,</E>
                             site-level (PA, section 5.1.3.3).
                        </P>
                    </FTNT>
                    <P>In considering what the quantitative information for S deposition and terrestrial acidification indicates regarding deposition levels of potential concern for acidification-related effects (and the associated uncertainties), the PA considers soil chemistry modeling analyses (both in published studies and in the 2009 REA), studies involving experimental additions of S compounds to defined forestry plots, and observational studies of potential relationships between terrestrial biota assessments and metrics for S deposition (PA, section 5.3). With regard to soil chemistry modeling analyses performed in the last review, the PA found the 2009 soil acidification modeling to indicate that a focus on aquatic acidification might reasonably be expected to also provide protection from soil acidification effects on terrestrial biota. With regard to studies involving S additions to experimental forested areas, the PA observes that effects on the sensitive tree species analyzed have not been reported with S additions below 20 kg/ha-yr (which is in addition to the atmospheric deposition occurring during the experiment).</P>
                    <P>
                        The PA also considers the recently available quantitative information on S deposition and terrestrial acidification drawn from recent observational studies that report associations of tree growth and/or survival metrics with various air quality or S deposition metrics (PA, section 5.3.2.3 and Appendix 5B, section 5B.3.2). The metrics used in the two largest studies include site-specific estimates of average SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         deposition and of average total S deposition over the interval between tree measurements, generally on the order of 10 years (Dietze and Moorcroft, 2011; Horn et al., 2018). In the study that used SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         as the indicator of acidic S deposition, and for which the study area was the eastern half of the contiguous U.S., site-specific average SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         deposition (1994-2005) ranged from a minimum of 4 kg/ha-yr to a maximum of 30 kg/ha-yr (Dietze and Moorcroft, 2011). Review of the study area for this study and a map indicating geographic patterns of deposition during the period of the deposition data indicate the lowest deposition areas to be west of the Mississippi River, northern New England (
                        <E T="03">e.g.,</E>
                         Maine) and southern Georgia and Florida (in which S deposition in the 2000-2002 period was estimated to fall below 8 kg/ha-yr), and the highest deposition areas to be a large area extending from New York through the Ohio River valley (PA, Appendix 5B, Figures 5B-1 and 5B-11). In the second study, deposition at the sites with species for which growth or survival was negatively associated with S deposition ranged from a minimum below 5 kg/ha-yr to a site maximum above 40 kg/ha-yr, with medians for these species generally ranging from around 5 to 12 kg S/ha-yr (PA, Appendix 5B, section 5B.3.2.3; Horn et al., 2018).
                    </P>
                    <P>
                        In considering these study observations, the PA notes the history of appreciable acidic deposition in the eastern U.S., with its associated impacts on soil chemistry, that has the potential to be exerting a legacy influence on tree growth and survival more recently (PA, section 5.3.2 and Appendix 5B). Further, the PA notes that, at a national scale, the geographic deposition patterns (
                        <E T="03">e.g.,</E>
                         locations of relatively greater 
                        <E T="03">versus</E>
                         relatively lesser deposition) in more recent times appear to be somewhat similar to those of several decades ago (
                        <E T="03">e.g.,</E>
                         PA, sections 2.5.4 and 6.2.1). This similarity in patterns is recognized to have the potential to influence findings of observational studies that assess associations between variation in tree growth and survival with variation in levels of a metric for recent deposition at the tree locations, and to contribute uncertainty with regard to interpretation of these studies as to a specific magnitude of deposition that might be expected to elicit specific tree responses, such as those for which associations have been found. The PA notes that, as recognized in the study by Dietze and Moorcroft (2011), which grouped species into plant functional groups, acidification impacts on tree mortality rates are the result of cumulative long-term deposition, and patterns reported by their study should be interpreted with that in mind (PA, section 5.3.1 and Appendix 5B).
                    </P>
                    <HD SOURCE="HD3">(c) Relating Air Quality Metrics to S Deposition</HD>
                    <P>
                        In considering what the available information and air quality analyses indicate regarding relationships between air quality metrics and S deposition, the PA evaluated trends over the past two decades as well as a series of analyses of relationships between S deposition and ambient air concentrations of SO
                        <E T="52">2</E>
                         (in terms of 3-year averages of the existing SO
                        <E T="52">2</E>
                         standard and of an annual average),
                        <SU>76</SU>
                        <FTREF/>
                         and between S deposition and ambient air concentrations of other S compounds (
                        <E T="03">e.g.,</E>
                         SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         or the sum of SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         and SO
                        <E T="52">2</E>
                        ) at 27 Class I area sites (collocated CASTNET and IMPROVE network sites), as summarized in section II.B. above. With regard to the latter, lower correlations were observed for total S deposition estimates collocated with ambient air concentrations of S-containing pollutants (SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         and the sum of S in SO
                        <E T="52">2</E>
                         and SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                        ) in 27 Class I areas than between S deposition and annual average SO
                        <E T="52">2</E>
                         concentrations (averaged over three years) at SLAMS monitors (PA, Figure 6-31, center and right panels, and Table 6-4). Thus, while information for S compounds other than SO
                        <E T="52">2</E>
                         are available at the Class I area sites, the analyses based on data from SLAMS are considered particularly relevant given that those sites are primarily in areas of higher SO
                        <E T="52">2</E>
                         concentrations (near emissions sources) and collect FRM/FEM measurements for 
                        <PRTPAGE P="105735"/>
                        existing NAAQS monitoring. Data from these monitoring sites informed the PA consideration of how changes in SO
                        <E T="52">2</E>
                         emissions, reflected in ambient air concentrations, may relate to changes in deposition and, correspondingly, what secondary standard options might best relate to ambient air concentrations such that deposition in areas of interest is maintained at or below range of levels identified above (PA, section 7.2.2.3).
                    </P>
                    <FTNT>
                        <P>
                            <SU>76</SU>
                             The air quality metrics include one based on the current secondary SO
                            <E T="52">2</E>
                             NAAQS, which is the second highest 3-hour daily maximum in a year, as well as an annual average SO
                            <E T="52">2</E>
                             air quality metric (averaged over three years). Since many factors contribute variability to S deposition, the analyses focus on a 3-year average of all of the air quality and deposition metrics and include multiple years of data, generally on the order of 20 years and covering a period of declining concentrations and deposition. Of the two air quality metrics analyzed, the PA focused primarily on the annual average of SO
                            <E T="52">2</E>
                             concentrations, averaged over 3 years, given the focus on control of long-term S deposition and the greater stability of the metric (PA, section 7.2.2.3).
                        </P>
                    </FTNT>
                    <P>
                        Together the air quality and deposition data and analyses in the PA indicate a significant association of S deposition with SO
                        <E T="52">2</E>
                         concentrations, with statistically significant correlation coefficients ranging from approximately 0.5 to 0.7 from the trajectory-based and SLAMS analyses for the five 3-year time periods (during 2001-2020) across all ecoregions. Higher correlations were observed for dry S deposition and at sites in the eastern U.S. (PA, section 7.2.2.3). As summarized in section II.A.2. above, S deposition is generally higher in the East and dry S deposition is generally higher near SO
                        <E T="52">2</E>
                         emissions sources. A strength of the analyses for concentrations and deposition estimates at SLAMS locations is the capturing of near-source deposition, while a strength of the trajectory-based analyses is accounting for the role of transport and transformation in contributing to downwind deposition.
                    </P>
                    <P>
                        While recognizing the significant correlations between SO
                        <E T="52">2</E>
                         concentrations and S deposition, the PA additionally took note of the variability in, and uncertainty associated with, these relationships. The variability derives from the complexity of the atmospheric chemistry, pollutant transport, and deposition processes (PA, sections 2.1.1 and 2.5). The uncertainty in these relationships relates to a number of factors, including uncertainty in our estimates of S deposition (PA, section 2.5.2) and spatial distribution of monitor sites, including the representation of significant SO
                        <E T="52">2</E>
                         emissions sources, as well as elements of the trajectory-based analysis, 
                        <E T="03">e.g.,</E>
                         inclusion criteria for identifying monitoring sites of influence (PA, section 6.3 and Table 6-13). The PA concluded that it is unclear how much and in what way each of these various uncertainties in the data and analyses, and the inherent variability of the physical and chemical processes involved, might impact the conclusions concerning ambient air SO
                        <E T="52">2</E>
                         concentrations related to S deposition estimates at different scales (PA, section 7.2.2.3). In light of such uncertainty and variability, the REA aquatic acidification analyses and discussion of S deposition levels focused on statistics for deposition estimates representing large areas (
                        <E T="03">e.g.,</E>
                         at the ecoregion median and 75th or 90th percentile, and case study area average or 70th and 90th percentile CLs). While uncertainty may be greater for relating concentrations to higher points on the distribution of deposition in an ecoregion, the PA recognized that it is the higher deposition estimates, if focused on individual waterbodies, that will contribute most to aquatic acidification risk. The PA additionally observed that the distribution of S deposition estimates within ecoregions has narrowed in more recent years, with 90th percentile estimates falling much closer to the medians than in the first decade of the 20-year period (figure 2 above).
                    </P>
                    <P>
                        In identifying levels for consideration for a potential annual average SO
                        <E T="52">2</E>
                         standard, the PA first considered SO
                        <E T="52">2</E>
                         concentrations at SLAMs and associated S deposition levels, focusing on the most recent of the five time periods analyzed (
                        <E T="03">i.e.,</E>
                         since 2010) when the REA indicated appreciably improved levels of acid buffering capability in the waterbodies of the 25 analyzed ecoregions (when ANC targets were met or exceeded in a high percentage of water bodies across a high percentage of ecoregions). Since 2010 (when ecoregion median and 90th percentile S deposition estimates for the 25 REA ecoregions were below 10 kg/ha-yr), the highest 3-year average annual SO
                        <E T="52">2</E>
                         concentrations were generally somewhat below 10 ppb (with some exceptions during the 2019-2021 period) (PA, Figure 7-5, left panel).
                        <SU>77</SU>
                        <FTREF/>
                         The PA also considered SO
                        <E T="52">2</E>
                         concentrations at monitoring sites of influence identified in the trajectory-based analyses across different ranges of downwind ecoregion S deposition estimates. Across all 84 ecoregions in the contiguous U.S., the maximum annual average SO
                        <E T="52">2</E>
                         concentrations, as 3-year averages, at sites of influence to downwind ecoregions with median S deposition below 9 kg down to 6 kg/ha-yr,
                        <SU>78</SU>
                        <FTREF/>
                         were all below 15 ppb, and 75% of the concentrations at these sites were at or below 10 ppb (PA, Figure 7-3).
                        <SU>79</SU>
                        <FTREF/>
                         In the 25 REA ecoregions, for the ecoregion median S deposition below 9 down to 6 kg/ha-yr, the concentrations for the metric based on maximum concentration at upwind sites of influence (EAQM-max) range as high as 15 ppb, with more than half below 10 ppb (PA, Figure 7-4, left panel). The EAQM-max concentrations associated with ecoregion median S deposition below 6 kg/ha-yr were all below 10 ppb. This PA presentation further indicates that for the 25 REA ecoregions, when the highest EAQM-max concentration is at approximately 11 or 10 ppb, both the median and 90th percentile deposition are both below 9 kg/ha-yr, with the overwhelming majority below 6 kg/ha-yr (PA, Figure 7-4).
                    </P>
                    <FTNT>
                        <P>
                            <SU>77</SU>
                             The similar pattern observed for annual average SO
                            <E T="52">2</E>
                             concentrations as 3-year averages suggests little year-to-year variability in this metric (PA, Figure 7-5).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>78</SU>
                             The bin for “&lt;9-6 kg/ha-yr” is discussed here as it is the bin closest to the deposition target range of 10 or 8 to 5 kg/ha-yr identified above.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>79</SU>
                             Figure 7-3 of the PA presents the pairs of median deposition estimates and associated upwind sites of influence EAQM-max SO
                            <E T="52">2</E>
                             concentrations from the trajectory-based analysis in section 6.2.4 of the PA (specifically, the combined datasets presented in PA, Figure 6-41).
                        </P>
                    </FTNT>
                    <P>
                        In its use of the trajectory-based analyses to identify a range of annual average SO
                        <E T="52">2</E>
                         EAQM-max concentrations associated with an ecoregion median S deposition target range, the PA recognizes several important considerations. First, monitor concentrations of SO
                        <E T="52">2</E>
                         can vary substantially across the U.S., complicating consideration of the relationship between maximum contributing monitors identified in the trajectory-based analysis and S deposition levels in downwind ecosystems. Additionally, the substantial scatter in the relationship between S deposition estimates and measured SO
                        <E T="52">2</E>
                         concentrations with ecoregion median S deposition values below about 5 kg/ha-yr contributes increased uncertainty to conclusions regarding potential secondary standard SO
                        <E T="52">2</E>
                         metric levels intended to relate to ecoregion median deposition levels at or below 5 kg/ha-yr (PA, section 7.2.2.3). The PA additionally discusses limitations in the context of the two metrics (weighted and max). Between these metrics, somewhat stronger correlations were found for the annual average SO
                        <E T="52">2</E>
                         weighted EAQM (which provides for proportional weighting of air concentrations from locations projected to contribute more heavily to a particular ecoregion), compared to the EAQM-max, particularly for the first two to three time periods of the 20-year period. This difference is related to the extent to which monitor concentrations can be indicative of atmospheric loading. The weighted EAQM is intended to more closely represent the atmospheric loading for the locations (and associated sources) of the contributing (sites of influence) monitors than a single contributing monitor can. However, the weighted metric is not directly translatable to a standard level (which is an upper limit 
                        <PRTPAGE P="105736"/>
                        on concentrations in individual locations).
                    </P>
                    <P>
                        The PA also considered relationships between S deposition and PM
                        <E T="52">2.5</E>
                        , noting the poor correlations for total S deposition estimates with PM
                        <E T="52">2.5</E>
                         at the 27 Class I area sites (r = 0.33, PA, Figure 6-31), and not much stronger correlations for ecoregion S deposition estimates with PM
                        <E T="52">2.5</E>
                         at upwind sites of influence from the trajectory-based analysis (r = −0.22 and 0.48, PA, Table 6-12). The PA also considered relationships between total S deposition and ambient air SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         concentrations noting that they are focused on remote locations (Class I areas), distant from sources of SO
                        <E T="52">2</E>
                         emissions, and that the relationship is not stronger than that for SO
                        <E T="52">2</E>
                         at the SLAMS, which are generally near sources monitoring SO
                        <E T="52">2</E>
                         (the source for atmospheric SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                        ). In light of these considerations, the PA found that the available analyses did not indicate an advantage for an indicator based on SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         measurements (or SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         and SO
                        <E T="52">2</E>
                         combined), such as is currently collected at CASTNET sites, or PM
                        <E T="52">2.5</E>
                         mass over options for a potential annual average standard metric focused on SO
                        <E T="52">2</E>
                         concentrations (based on FRM/FEMs).
                        <SU>80</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>80</SU>
                             It is also of note that use of SO
                            <E T="52">4</E>
                            <E T="51">2−</E>
                             measurements, alone or in combination with SO
                            <E T="52">2</E>
                             concentrations, as an indicator of a new standard would entail development of sample collection and analysis FRM/FEMs and of a surveillance network.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(4) Nitrogen Deposition and N Oxides and PM</HD>
                    <P>The evidence and exposure/risk-based considerations of the PA pertaining to N deposition and concentrations of N oxides and PM in ambient air draw on the available welfare effects evidence described in the current ISA (as well as prior ISAs and AQCDs), and discussed in Chapters 4, 5 and 6 of the PA. The focus of these considerations is primarily on N deposition and effects other than aquatic acidification (PA, sections 4.3, 5.2 and 5.3). As recognized in section II.A.4. above, the PA finds S deposition to be the dominant influence on aquatic acidification risk in the 20-year period analyzed (2001-2020), based on the finding that the inclusion of acidic N deposition to the aquatic acidification risk analyses did not appreciably change patterns and percentages of waterbodies estimated to exceed CLs for the three ANC targets (PA, section 5.1.2.4).</P>
                    <P>In considering potential public welfare protection from N deposition-related effects (in light of the evidence summarized in sections II.A.3. and II.A.3.c. above), the PA recognizes the potential public welfare implications of the effects of N deposition in both aquatic and terrestrial ecosystems (PA, section 7.2.3.2). For example, the public welfare significance of eutrophication in large estuaries and coastal waters of the eastern U.S. related to decades of N loading is illustrated by the broad state, local and national government engagement in activities aimed at assessing and reducing the loading (PA, section 5.2.3). This significance relates both to the severity of the effects and the wide-ranging public uses dependent on these waters, including as important sources of fish and shellfish production, providing support for large stocks of resident commercial species, serving as breeding grounds and interim habitat for several migratory species, and providing an important and substantial variety of cultural ecosystem services. The public also benefits from water-based recreational uses and aesthetic values placed on aquatic systems. Many impacts of eutrophication relate to reduced waterbody oxygen, which contributes to fish mortality, and changes in aquatic habitat related to changes in resident plant and animal species, with associated ecosystem effects (PA, section 4.3; ISA, Appendix 7).</P>
                    <P>
                        The relative contribution of atmospheric deposition to total N loading, however, varies widely among estuaries and has declined in recent years, contributing a complexity to considerations in this review. While N loading in smaller, more isolated fresh waterbodies is primarily from atmospheric deposition, the evidence with regard to public welfare significance of any small deposition-related effects in these systems is less clear and well established. For example, the public welfare implications of relatively subtle effects of N enrichment in aquatic systems, such as shifts in phytoplankton species communities in remote alpine lakes, are not clear. Additionally, the public welfare implications of HNO
                        <E T="52">3</E>
                         effects on lichens (which might be considered to be “direct” effects or the result of deposition onto plant surfaces) are also not clear and might depend on the extent to which they impact whole communities, other biota, or ecosystem structure and function (PA, section 7.2.3.2).
                    </P>
                    <P>
                        The effects of N enrichment in terrestrial ecosystems may vary with regard to public welfare implications. As noted above with regard to impacts of aquatic acidification, the PA recognizes that some level of N deposition and associated effects on terrestrial ecosystems can impact the public welfare and thus might reasonably be judged adverse to the public welfare. Depending on magnitude and the associated impacts, there are situations in which N deposition and associated nutrient enrichment-related impacts might reasonably be concluded to be significant to the public welfare, such as N deposition that alters forest ecosystem community structures in ways that appreciably affect use and enjoyment of those areas by the public (PA, section 7.2.3.2). A complication to consideration of public welfare implications that is specific to N deposition in terrestrial systems is its potential to increase growth and yield of plants that, depending on the plant and its use by human populations (
                        <E T="03">e.g.,</E>
                         trees for lumber, food for livestock or human populations), may be considered beneficial to the public. Nitrogen enrichment in natural ecosystems can, by increasing growth of N limited plant species, change competitive advantages of species in a community, with associated impacts on the composition of the ecosystem's plant community. The public welfare implications of such effects may vary depending on their severity, prevalence or magnitude. For example, only those rising to a particular severity (
                        <E T="03">e.g.,</E>
                         with associated significant impact on key ecosystem functions or other services), magnitude or prevalence may be considered of public welfare significance (PA, section 7.2.3.2).
                    </P>
                    <HD SOURCE="HD3">(a) Quantitative Information for Ecosystem Risks Associated With N Deposition</HD>
                    <P>
                        The PA considers the available information regarding air quality and atmospheric deposition and risk or likelihood of occurrence of ecosystem effects under differing conditions. In so doing, the PA notes the varying directionality of some of the N enrichment-related effects in terrestrial ecosystems, such that some effects can, in particular ecosystems and for particular species, seem beneficial (
                        <E T="03">e.g.,</E>
                         to growth or survival of those species), although in a multispecies system, effects are more complex with potential for alteration of community composition. The information is also considered with regard to the key limitations and associated uncertainties of this evidence.
                    </P>
                    <P>
                        Beginning with the appreciable evidence base documenting assessments of N loading to waterbodies across the U.S., the PA notes the waterbody-specific nature of such responses and the relative role played by atmospheric deposition, among other N sources. For example, the relative contribution to such loading from atmospheric 
                        <PRTPAGE P="105737"/>
                        deposition compared to other sources (
                        <E T="03">e.g.,</E>
                         agricultural runoff and wastewater discharges) varies among waterbody types and locations, which can be a complicating factor in quantitative analyses. Additionally, characteristics of resident biota populations and other environmental factors are influential in waterbody responses to N loading, 
                        <E T="03">e.g.,</E>
                         temperature, organic microbial community structure, and aquatic habitat type, among others (ISA, Appendix 7). Based on identification of eutrophication as a factor in impacts on important fisheries in some estuaries across the U.S., multiple government and nongovernment organizations have engaged in research and water quality management activities over the past several decades in large and small estuaries and coastal waters across the U.S. These activities have generally involved quantitative modeling of relationships between N loading and water quality parameters such as dissolved oxygen (ISA, Appendix 7, section 7.2). This research documents both the impacts of N enrichment in these waterbodies and the relationships between effects on waterbody biota, ecosystem processes and functions, and N loading (PA, section 5.2.3). The evidence base recognizes N loading to have contributions from multiple types of sources to these large waterbodies and their associated watersheds, including surface and ground water discharges, as well as atmospheric deposition. Accordingly, loading targets or reduction targets identified for these systems have generally been identified in light of policy and management considerations related to the different source types, as discussed further in section II.B.1.(4)(b) below.
                    </P>
                    <P>Focused assessments in freshwater lakes, including alpine lakes, where atmospheric deposition may be the dominant or only source of N loading, also provide evidence linking N loading with seemingly subtle changes, such as whether P or N is the nutrient limiting phytoplankton growth (and productivity) and shifts in phytoplankton community composition (PA, section 5.2.2); public welfare implications of such changes are less clear (PA, section 7.2.3.1).</P>
                    <P>
                        With regard to terrestrial ecosystems and effects on trees and other plants, the PA recognizes the complexity, referenced above, that poses challenges to approaches for simulating terrestrial ecosystem responses to N deposition across areas diverse in geography, geology, native vegetation, deposition history, and site-specific aspects of other environmental characteristics. In its consideration of the different types of quantitative analysis, the PA recognizes limitations particular to each and associated uncertainties. Uncertainties associated with the soil acidification modeling analyses in the last review include those associated with the limited dataset of laboratory-generated data on which the BC:Al targets are based, as well as the steady-state modeling parameters, most prominently those related to base cation weathering and acid-neutralizing capacity (PA, section 5.3.4.1). Uncertainties associated with experimental addition analyses include the extent to which the studies reflect steady-state conditions, as well as a lack of information regarding historic deposition at the study locations (PA, section 5.3.4.1). Several aspects of observational or gradient studies of tree growth and survival (or of species richness for herbs, shrubs and lichens) contribute uncertainties to identification of deposition levels of potential concern for tree species effects, including unaccounted-for factors with potential influence on tree growth and survival (
                        <E T="03">e.g.,</E>
                         ozone and soil characteristics), as well as the extent to which associations may reflect the influence of historical deposition patterns and associated impact. Thus, while the evidence is robust as to ecological effects of ecosystem N loading, a variety of factors, including the history of deposition and variability of response across the landscape, complicate our ability to quantitatively relate specific N deposition rates, associated with various air quality conditions, to N enrichment-related risks of harm to forests and other plant communities in areas across the U.S. (PA, section 5.3.4).
                    </P>
                    <HD SOURCE="HD3">(b) General Approach for Considering Public Welfare Protection</HD>
                    <P>
                        In considering public welfare protection with regard to N enrichment, the PA notes, as an initial matter, that the effects of acidification on plant growth and survival, at the individual level, are generally directionally harmful, including reduced growth and survival. In contrast, the effects of N enrichment can, in particular ecosystems and for particular species, be beneficial or harmful (
                        <E T="03">e.g.,</E>
                         to growth or survival of those species). Accordingly, the PA recognizes added complexity to risk management policy decisions for this category of effects, including the lack of established risk management targets or objectives, particularly in light of historical deposition and its associated effects that have influenced the current status of terrestrial ecosystems and their biota, structure, and function.
                    </P>
                    <P>
                        Further, the PA recognizes the complication posed by the contribution to N deposition of atmospheric pollutants other than the criteria pollutants N oxides and PM, most significantly the contribution of NH
                        <E T="52">3</E>
                         (PA, section 6.2.1). In light of the contrasting temporal trends for emissions of oxidized and reduced N compounds, the PA observes a declining influence of ambient air concentrations of N oxides and PM on N deposition over the past 20 years, complicating consideration of the protection from N deposition-related effects that can be provided by secondary NAAQS for these pollutants. This declining trend in N oxides emissions and associated oxidized N deposition coincides with increases in NH
                        <E T="52">3</E>
                         emissions and deposition of reduced N compounds, such that reduced N deposition has generally been more than half of total N deposition at CASTNET sites since 2015 (PA, Figures 6-3, 6-17, 6-18 and 6-19). In 2021, estimated dry deposition of NH
                        <E T="52">3</E>
                         was as much as 65% of total N deposition across the 92 CASTNET sites (PA, Figure 6-19). At 25% of the CASTNET sites, more than 30% of N deposition is from dry deposition of NH
                        <E T="52">3</E>
                         (PA, Figure 6-19), a noteworthy observation given the preponderance of CASTNET sites in the West and relatively few in the areas of highest NH
                        <E T="52">3</E>
                         emissions where the percentage would be expected to be higher still (PA, Figures 2-9 and 2-17). In light of this information, the PA finds that NH
                        <E T="52">3</E>
                        , which is not a criteria pollutant, and its contribution to total N deposition, particularly in parts of the U.S. where N deposition is highest, are complicating factors in considering policy options related to NAAQS for addressing ecological effects related to N deposition (
                        <E T="03">e.g.,</E>
                         PA, Figure 6-18 and 6-13).
                    </P>
                    <P>
                        In considering what the currently available quantitative information regarding terrestrial ecosystem responses to N deposition indicates about levels of N deposition that may be associated with increased concern for adverse effects, the PA focuses first on the evidence for effects of N deposition on trees that is derived from experimental addition studies and observational studies of potential relationships between tree growth and survival and metrics for N deposition. With regard to the experimental addition studies, while recognizing study limitations and associated uncertainties, the PA notes that the lowest N addition that elicited forest effects was 15 kg/ha-yr over the 14 years from 1988 to 2002 (PA, sections 5.3.2 
                        <PRTPAGE P="105738"/>
                        and 7.2.3.2 and Appendix 5B, Table 5B-1; McNulty et al., 2005). Based on the estimates from several observational studies, the PA observed that N deposition ranging from 7 to 12 kg/ha-yr, on a large area basis, reflects conditions for which statistical associations have been reported for terrestrial effects, such as reduced tree growth and survival.
                        <SU>81</SU>
                        <FTREF/>
                         (PA, sections 5.3.4 and 7.2.3.2).
                    </P>
                    <FTNT>
                        <P>
                            <SU>81</SU>
                             The largest study reported associations of tree survival and growth with N deposition that varied from positive to negative across the range of deposition at the measurement plots for some species, and also varied among species (PA, section 5.3.2, Appendix 5B, section 5B.3.2.3; Horn et al., 2018). Among the species for which the association varied from negative to positive across deposition levels, this is the range for those species for which the association was negative at the median deposition value (PA, section 5.3.4). This also excluded species for which sample sites were limited to the western U.S. based on recognition by the study authors of greater uncertainty in the west (Horn et al., 2018).
                        </P>
                    </FTNT>
                    <P>
                        With regard to studies of herb and shrub community metrics, the PA considered several recently available addition experiments, recent gradient studies of coastal sage scrub in southern California, and a larger observational study of herb and shrub species richness in open- and closed-canopy communities. As summarized in section II.A.3.c.(2)(b) above, N deposition estimates ranging from 6.5 kg/ha-yr to 11.6 kg/ha-yr were identified from these studies as reflecting conditions for which statistical associations have indicated potential for effects in herb and shrub communities (PA, section 5.3.3.1 and Appendix 5B, sections 5B.3.1 and 5B.3.2; Cox et al., 2014; Fenn et al., 2010). Lastly, the PA notes the observational studies that have analyzed variation in lichen community composition in relation to indicators of N deposition, but recognize limitations with regard to interpretation, as well as uncertainties such as alternate methods for utilizing N deposition estimates as well as the potential influence of unaccounted-for environmental factors, 
                        <E T="03">e.g.,</E>
                         ozone, SO
                        <E T="52">2</E>
                        , and historical air quality and associated deposition (PA, section 5.3.3.2 and Appendix 5B, section 5B.4.2).
                    </P>
                    <P>With regard to the evidence for effects of N deposition in aquatic ecosystems, the PA recognizes several different types of information including the observational studies utilizing statistical modeling to estimate critical loads, such as those related to subtle shifts in the composition of phytoplankton species communities in western lakes. There are also many decades of research on the impacts and causes of eutrophication in large rivers and estuaries. As noted above, the public attention, including government expenditures, that has been given to N loading and eutrophication in multiple estuarine and coastal systems are indicative of the recognized public welfare implications of related impacts. In large aquatic systems across the U.S., the relationship between N loading and algal blooms, and associated water quality impacts (both short- and longer-term), has led to numerous water quality modeling projects to inform water quality management decision-making in multiple estuaries, including the Chesapeake Bay, Narraganset Bay, Tampa Bay, Neuse River Estuary and Waquoit Bay (ISA, Appendix 7, section 7.2). These projects often use indicators of nutrient enrichment, such as chlorophyll a, dissolved oxygen, and abundance of submerged aquatic vegetation (ISA, section IS.7.3 and Appendix 10, section 10.6). For these estuaries, the available information regarding atmospheric deposition and the establishment of associated target loads varies across estuaries (ISA, Appendix 7, Table 7-9), and in many cases atmospheric loading has decreased since the initial modeling analyses.</P>
                    <P>As summarized in section II.A.3.c.(1) above, analyses in multiple East Coast estuaries—including the Chesapeake Bay, Tampa Bay, Neuse River Estuary and Waquoit Bay—have addressed atmospheric deposition as a source of N loading (ISA, Appendix 7, section 7.2.1). Total estuary loading or loading reductions were established in TMDLs developed under the Clean Water Act for these estuaries. Levels identified for allocation of atmospheric N loading in the first three of these estuaries were 6.1, 11.8 and 6.9 kg/ha-yr, respectively, and atmospheric loading estimated to be occurring in the fourth was below 5 kg/ha-yr (PA, section 7.3). This information, combined with the information from terrestrial studies summarized above, led to the PA identifying 7-12 kg/ha-yr as an appropriate N deposition range on which to focus in considering policy options (PA, section 7.2.3.2).</P>
                    <HD SOURCE="HD3">(c) Relating Air Quality Metrics to N Deposition Associated With N Oxides and PM</HD>
                    <P>
                        In exploring how well various air quality metrics relate to N deposition, the PA finds the analyses utilizing data from monitors using FRM/FEM to collect ambient air concentration data for evaluation with the NAAQS (
                        <E T="03">e.g.,</E>
                         to identify violations) to be particularly relevant given that the current standards are judged using design values derived from FRM/FEM measurements at existing SLAMS (PA, section 7.2.3.3). Given their role in monitoring for compliance with the NAAQS, most or many of these monitors are located in areas of relatively higher pollutant concentrations, such as near large sources of NO
                        <E T="52">2</E>
                         or PM. Accordingly, the PA recognized the information from these monitoring sites as having potential for informing how changes in NO
                        <E T="52">2</E>
                         and/or PM emissions, reflected in ambient air concentrations, may relate to changes in deposition and, correspondingly, for informing consideration of secondary standard options that might best regulate ambient air concentrations such that deposition in sensitive ecosystems of interest is maintained at or below levels of potential concern.
                    </P>
                    <P>
                        In considering the information and findings of these analyses of N deposition and N oxides and PM in ambient air, the PA notes, as an initial matter, that relationships between N deposition and NO
                        <E T="52">2</E>
                         and PM air quality are affected by NH
                        <E T="52">3</E>
                         emissions and non-N-containing components of PM (PA, section 6.4.2). The PA further notes that the influence of these factors on the relationships has varied across the 20-year evaluation period and varies across different regions of the U.S. (PA, section 6.2.1). Both factors (NH
                        <E T="52">3</E>
                         emissions and non-N-containing components of PM) are recognized to influence relationships between total N deposition and NO
                        <E T="52">2</E>
                         and PM air quality metrics. For example, for total N deposition estimated for TDep grid cells with collocated SLAMS monitors, the correlations with annual average NO
                        <E T="52">2</E>
                         concentrations, averaged over three years, are generally low across all sites and particularly in the East (PA, Table 6-6). This likely reflects the relatively greater role of NH
                        <E T="52">3</E>
                         in N deposition in the East, which for purposes of the analyses in this PA extends across the Midwest (PA, section 6.4.2). The correlation between estimates of total N deposition in eastern ecoregions and annual average NO
                        <E T="52">2</E>
                         concentrations at upwind monitor sites of influence for the five periods from 2001-2020 is low to moderate, with the earlier part of the 20-year period, when NO
                        <E T="52">2</E>
                         concentrations were higher and NH
                        <E T="52">3</E>
                         emissions were lower (as indicated by Figures 6-6 and 6-5 of the PA), having relatively higher correlation than the later part (
                        <E T="03">e.g.,</E>
                         correlation coefficients below 0.4, except for EAQM-weighted in 2001-03 [PA, Table 6-10]). The correlation is negative or near zero for the western ecoregions (PA, section 6.2.4).
                    </P>
                    <P>
                        Based on the decreasing trends in NO
                        <E T="52">2</E>
                         emissions and oxidized N deposition in 
                        <PRTPAGE P="105739"/>
                        the past 10 years, and coincident trend of increased NH
                        <E T="52">3</E>
                         emissions and deposition of reduced N (NH
                        <E T="52">3</E>
                         and NH
                        <E T="52">4</E>
                        <SU>+</SU>
                        ), most particularly in areas of the Midwest, Texas, Florida and North Carolina (PA, Figures 6-16 and 6-17), the PA finds NO
                        <E T="52">2</E>
                         emissions to have much less influence on total N deposition now than in the past (PA, sections 6.2.1 and 6.4). In terms of ecoregion median statistics, the PA observes the decreasing trend in ecoregion median total N deposition across the period from 2001 through 2012, while taking note that from 2012 onward, total N deposition increases, most particularly in ecoregions where most of the total deposition is from reduced N (PA, Figure 7-6). The PA also considers the impact of increasing deposition of reduced N on the 20-year trend in total N deposition as illustrated by TDep estimates at the 92 CASTNET sites. At these sites, the median percentage of total N deposition comprised by oxidized N species, which is driven predominantly by N oxides, has declined from more than 70% to less than 45% (PA, Figure 6-19). Based on examination of the trends for components of reduced N deposition, the PA notes that the greatest influence on the parallel increase in N deposition percentage composed of reduced N is the increasing role of NH
                        <E T="52">3</E>
                         dry deposition. The percentage of total N deposition at the CASTNET sites that is from NH
                        <E T="52">3</E>
                         has increased, from a median below 10% in 2000 to a median somewhat above 25% in 2021 (PA, Figure 6-19).
                    </P>
                    <P>
                        Recognizing limitations in the extent to which CASTNET sites can provide information representative of the U.S. as a whole, the PA also analyzed TDep estimates across the U.S. for the most recent period assessed (2018-2020). In areas with ecoregion median total N deposition above 9 kg/ha-yr (PA, Figure 7-7, upper panel), the ecoregion median percentage of total N deposition composed of reduced N is greater than 60% (PA, Figure 7-7, lower panel). The 2019-2021 TDep estimates across individual TDep grid cells similarly show that the areas of the U.S. where total N deposition is highest and greater than potential N deposition targets (identified in section 7.2.3.2 of the PA) are also the areas with the greatest deposition of NH
                        <E T="52">3</E>
                         (PA, Figure 7-8), comprising more than 30% of total N deposition. That is, the PA finds that NH
                        <E T="52">3</E>
                         driven deposition is greatest in regions of the U.S. where total deposition is greatest (PA, section 7.2.3.3).
                    </P>
                    <P>
                        Turning to PM
                        <E T="52">2.5</E>
                        , the PA notes that the correlation for ecoregion median N deposition and PM
                        <E T="52">2.5</E>
                         concentrations at upwind sites of influence is poor and negative or moderate (r=0.45) depending on the metric (PA, section 6.2.4). For total N deposition and PM
                        <E T="52">2.5</E>
                         concentrations at SLAMS, a low to moderate correlation is observed (PA, section 6.2.3). In considering NH
                        <E T="52">3</E>
                         emissions and non-N containing components of PM, the PA notes that some NH
                        <E T="52">3</E>
                         transforms to NH
                        <E T="52">4</E>
                        <E T="51">+</E>
                        , which is a component of PM
                        <E T="52">2.5</E>
                        , while also noting that, in the areas of greatest N deposition, the portion represented by deposition of gaseous NH
                        <E T="52">3</E>
                         generally exceeds 30%. Additionally, while NH
                        <E T="52">3</E>
                         emissions have been increasing over the past 20 years, the proportion of PM
                        <E T="52">2.5</E>
                         that is composed of N compounds has declined. The median percentage of PM
                        <E T="52">2.5</E>
                         comprised by N compounds has declined from about 25% in 2006-2008 to about 17% in 2020-2022 and the highest percentage across sites declined from over 50% to 30% (PA, section 6.4.2 and Figure 6-56). Further, the percentages vary regionally, with sites in the nine southeast states having less than 10% of PM
                        <E T="52">2.5</E>
                         mass composed of N compounds (PA, Figure 6-56).
                    </P>
                    <P>
                        In summary, the PA concludes that in recent years, NH
                        <E T="52">3</E>
                         contributes appreciably to total N deposition, particularly in parts of the country where N deposition is highest (as illustrated by comparison of Figures 6-13 and 6-18 of the PA). The PA finds that this situation—of an increasing, and spatially variable, portion of N deposition not being derived from N oxides or PM—complicates assessment of policy options for protection against ecological effects related to N deposition associated with N oxides and PM, and for secondary standards for those pollutants that may be associated with a desired level of welfare protection. The PA recognizes that the available information as a whole also suggests the potential for future reductions in N oxide-related N deposition to be negated by increasing reduced N deposition. Further, the PA notes that the results also suggest that while the PM
                        <E T="52">2.5</E>
                         annual average standard may provide some control of N deposition associated with PM and N oxides, PM
                        <E T="52">2.5</E>
                         monitors also capture other non-S and non-N related pollutants (
                        <E T="03">e.g.,</E>
                         organic and elemental carbon) as part of the PM
                        <E T="52">2.5</E>
                         mass (PA, section 7.2.3.3). The amounts of each category of compounds vary regionally (and seasonally), and as noted above, N compounds generally comprise less than 30% of total PM
                        <E T="52">2.5</E>
                         mass (PA, section 6.3 and 6.4).
                    </P>
                    <P>
                        In considering relationships between air quality metrics based on indicators other than those of the existing standards and N deposition (and associated uncertainties), the PA drew on the analyses of relationships for collocated measurements and modeled estimates of N compounds other than NO
                        <E T="52">2</E>
                         with N deposition in a subset of 27 CASTNET sites located in 27 Class I areas, the majority of which (21 of 27) are located in the western U.S. (PA, sections 6.2.2, 6.3 and 6.4.2). The analyses indicate that total N deposition in these rural areas has a moderate correlation with air concentrations of nitric acid and particulate nitrate for the 20-year dataset (2000-2020) (PA, Figure 6-32). The correlations are comparable to the correlation of NO
                        <E T="52">2</E>
                         with total N deposition at western SLAMS, a not unexpected observation given that more than 75% of the 27 CASTNET sites are in the West. A much lower correlation was observed at SLAMS in the East, and with the trajectory-based dataset. The PA notes that deposition at the western U.S sites is generally less affected by NH
                        <E T="52">3</E>
                         (PA, section 6.4.2). Further, the observed trend of increasing contribution to N deposition of NH
                        <E T="52">3</E>
                         emissions over the past decade suggests that such correlations of N deposition with oxidized N may be still further reduced in the future. Thus, the PA concludes that the evidence does not provide support for the oxidized N compounds (as analyzed at the 27 Class I sites) as indicators of total atmospheric N deposition, especially in areas where NH
                        <E T="52">3</E>
                         is prevalent (PA, section 7.2.3.3).
                    </P>
                    <P>
                        The analyses involving N deposition and N-containing PM components at the 27 Class I area sites do not yield higher correlation coefficients than those for N deposition (TDep) and PM
                        <E T="52">2.5</E>
                         at SLAMS monitors (PA, section 7.2.3.3 and Figures 6-33, 6-39 [upper panel], and 6-32 [left panel]). Further, the graphs of total N deposition estimates 
                        <E T="03">versus</E>
                         total particulate N in ambient air at the 27 Class I area sites indicate the calculated correlations (and slopes) likely to be appreciably influenced by the higher concentrations occurring in the first decade of the 20-year timeframe (PA, Figure 6-33). Thus, the PA concludes that the available analyses of N-containing PM
                        <E T="52">2.5</E>
                         components at the small dataset of sites remote from sources also do not indicate an overall benefit or advantage of N-containing PM
                        <E T="52">2.5</E>
                         components over consideration of PM
                        <E T="52">2.5</E>
                         (PA, section 7.4). As a whole, the PA finds that the limited dataset with varying analytical methods and monitor locations, generally distant from sources, does not clearly support a conclusion that such alternative indicators might provide better control of N deposition related to N oxides and 
                        <PRTPAGE P="105740"/>
                        PM over those used for the existing standards (PA, section 7.2.3.3). The PA also notes that use of the NO
                        <E T="52">3</E>
                        <E T="51">−</E>
                         or particulate N measurements analyzed with deposition estimates at the 27 Class I area sites, alone or in combination with NO
                        <E T="52">2,</E>
                         as an indicator for a new standard would entail development of sample collection and analysis FRM/FEMs 
                        <SU>82</SU>
                        <FTREF/>
                         and of a surveillance network.
                    </P>
                    <FTNT>
                        <P>
                            <SU>82</SU>
                             For example, sampling challenges have long been recognized for particulate NH
                            <E T="52">4</E>
                            <E T="51">+</E>
                             (
                            <E T="03">e.g.,</E>
                             ISA, Appendix 2, sections 2.4.5; 2008 ISA, section 2.7.3).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">b. CASAC Advice</HD>
                    <P>The CASAC provided advice and recommendations regarding the standards review based on the CASAC's review of the draft PA. In the letter conveying its advice, the CASAC first recognized that “translation of deposition-based effects to an ambient concentration in air is fraught with difficulties and complexities” (Sheppard, 2023, pp. 1-2). Further, the CASAC expressed its view that, based on its interpretation of the CAA, NAAQS could be in terms of atmospheric deposition, which it concluded “would be a cleaner, more scientifically defensible approach to standard setting.” Accordingly, the CASAC recommended that direct atmospheric deposition standards be considered in future reviews (Sheppard, 2023, pp. 2 and 5). The CASAC then, as summarized below, provided recommendations regarding standards based on air concentrations.</P>
                    <P>
                        With regard to protection from effects other than those associated with ecosystem deposition of S and N compounds, the CASAC concluded that the existing SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">2</E>
                         secondary standards provide adequate protection for direct effects of those pollutants on plants and lichens, providing consensus recommendations that these standards should be retained without revision for this purpose (Sheppard, 2023, p. 5 of letter and p. 23 of Response to Charge Questions). With regard to deposition-related effects of S and N compounds, the CASAC members did not reach consensus, with their advice divided between a majority opinion and a minority opinion. Advice conveyed from both the majority and minority groups of members concerning deposition-related effects is summarized here.
                    </P>
                    <P>
                        With regard to deposition-related effects of S and standards for SO
                        <E T="52">X</E>
                        , the majority of CASAC members recommended a new annual SO
                        <E T="52">2</E>
                         standard with a level in the range of 10 to 15 ppb,
                        <SU>83</SU>
                        <FTREF/>
                         which these members concluded would generally maintain ecoregion median S deposition below 5 kg/ha-yr 
                        <SU>84</SU>
                        <FTREF/>
                         based on consideration of the trajectory-based SO
                        <E T="52">2</E>
                         analyses (and associated figures) in the draft PA (Sheppard, 2023, Response to Charge Questions, p. 25). They concluded that such a level of S deposition would afford protection for tree and lichen species 
                        <SU>85</SU>
                        <FTREF/>
                         and aquatic ecosystems. Regarding aquatic ecosystems, these members cited the ecoregion-scale estimates (from the aquatic acidification REA analyses) associated with median S deposition bins for the 90 ecoregion-time period combinations (PA, section 5.1.3.2) in conveying that for S deposition below 5 kg/ha-yr, 80%, 80% and 70% of waterbodies per ecoregion are estimated to achieve an ANC at or above 20, 30 and 50 µeq/L, respectively, in all ecoregion-time period combinations (Sheppard, 2023, Response to Charge Questions, p. 25).
                        <SU>86</SU>
                        <FTREF/>
                         In recommending an annual SO
                        <E T="52">2</E>
                         standard with a level in the range of 10 to 15 ppb, these members stated that such a standard would “preclude the possibility of returning to deleterious deposition values as observed associated with the emergence of high annual average SO
                        <E T="52">2</E>
                         concentrations near industrial sources in 2019, 2020, and 2021,” citing Figure 2-25 of the draft PA 
                        <SU>87</SU>
                        <FTREF/>
                         (Sheppard, 2023, Response to Charge Questions, p. 24).
                    </P>
                    <FTNT>
                        <P>
                            <SU>83</SU>
                             Although the CASAC letter does not specify the form for such a new annual standard, the justification provided for this recommendation cites two figures in the draft PA (Figures 6-17 and 6-18) which presented annual average SO
                            <E T="52">2</E>
                             concentrations averaged over three consecutive years (Sheppard, 2023, Response to Charge Questions, p. 25). Therefore, we are interpreting the CASAC majority recommendation to be for an annual standard, averaged over three years.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>84</SU>
                             Although the CASAC letter does not specify the statistic for the 5 kg/ha-yr value, the draft PA analyses referenced in citing that value, both the trajectory analyses and the ecoregion-scale summary of aquatic acidification results, focus on ecoregion medians. Further, the draft PA presentations of ecoregion percentages of waterbodies achieving the three ANC targets were for bins at or below specific deposition values (
                            <E T="03">e.g.,</E>
                             “at/below” 5, 6 or 7 kg/ha-yr [draft PA, table 5-4]). Therefore, we are interpreting the CASAC advice on this point to pertain to ecoregion median at or below 5 kg/ha-yr.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>85</SU>
                             In making this statement, these CASAC members cite two observational data studies with national-scale study areas published after the literature cut-off date for the ISA: one study is on lichen species richness and abundance and the second is on tree growth and mortality (Geiser et al., 2019; Pavlovic et al., 2023). The lichen study by Geiser et al. (2019) relies on lichen community surveys conducted at U.S. Forest Service sites from 1990 to 2012. The tree study by Pavlovic et al. (2023) uses machine learning models with the dataset from the observational study by Horn et al. (2018) to estimate confidence intervals for CLs for growth and survival for 108 species based on the dataset first analyzed by Horn et al. (2018).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>86</SU>
                             As seen in tables 3 and 4 in this preamble, these levels of protection are also achieved in ecoregion-time period combinations for which the ecoregion median S deposition estimate is at or below 7 kg/ha-yr (PA, section 7.2.2.2 and Table 7-1).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>87</SU>
                             The figure cited by the CASAC majority is the prior version of Figure 2-28 in section 2.4.2 of the final PA. The figure presents temporal trend in distribution (box and whiskers) of annual average SO
                            <E T="52">2</E>
                             concentrations since 2000 at SLAMS.
                        </P>
                    </FTNT>
                    <P>
                        One CASAC member dissented from this recommendation for an annual SO
                        <E T="52">2</E>
                         standard 
                        <SU>88</SU>
                        <FTREF/>
                         and instead recommended adoption of a new 1-hour SO
                        <E T="52">2</E>
                         secondary standard identical in form, averaging time, and level to the existing primary standard based on the conclusion that the ecoregion 3-year average S deposition estimates for the most recent periods are generally below 5 kg/ha-yr and that those periods correspond to the timing of implementation of the existing primary SO
                        <E T="52">2</E>
                         standard (established in 2010), indicating the more recent lower deposition to be a product of current regulatory requirements (Sheppard, 2023, Appendix A, p. A-2).
                        <SU>89</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>88</SU>
                             Also dissenting from this advice was a member of the CASAC Oxides of Nitrogen, Oxides of Sulfur and Particulate Matter Secondary NAAQS Panel who was not also a member of the CASAC (Sheppard, 2023, Response to Charge Questions, p. 23). The former is a Panel formed for this review, while the latter is the standing Committee specified in the CAA.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>89</SU>
                             This member stated that the existing primary NAAQS for the three pollutants were significantly more restrictive than the existing secondary standards and provide adequate protection for deposition-related effects (Sheppard, 2023, Appendix A).
                        </P>
                    </FTNT>
                    <P>
                        With regard to N oxides and protection against deposition-related welfare effects of N, the majority of CASAC members recommended revision of the existing annual NO
                        <E T="52">2</E>
                         standard to a level “&lt;10-20 ppb” (Sheppard, 2023, Response to Charge Questions, p.24). The justification these members provided was related to their consideration of the relationship presented in the draft PA of median ecosystem N deposition with the weighted 
                        <SU>90</SU>
                        <FTREF/>
                         annual average NO
                        <E T="52">2</E>
                         metric concentrations, averaged over three years, at monitoring sites linked to the ecosystems by trajectory-based analyses and a focus on total N deposition estimates at or below 10 kg/ha-yr 
                        <SU>91</SU>
                        <FTREF/>
                         (Sheppard, 2023, Response to Charge Questions, p. 24). These members 
                        <PRTPAGE P="105741"/>
                        additionally recognized, however, that “when considering all ecoregions, there is no correlation between annual average NO
                        <E T="52">2</E>
                         and N deposition” (Sheppard, 2023, Response to Charge Questions, p. 24). Their focus on total N deposition estimates at or below 10 kg/ha-yr appears to relate to consideration of TMDL analyses in four East Coast estuaries: Chesapeake Bay, Tampa Bay, Neuse River Estuary and Waquoit Bay (Sheppard, 2023, Response to Charge Questions, pp. 12-14 and 29). Levels identified for allocation of atmospheric N loading in the first three of these estuaries were 6.1, 11.8 and 6.9 
                        <SU>92</SU>
                        <FTREF/>
                         kg/ha-yr, respectively, and atmospheric loading estimated in the fourth was below 5 kg/ha-yr (Sheppard, 2023, Response to Charge Questions, pp. 12-14). These members also concluded that 10 kg N/ha-yr is “at the middle to upper end of the N critical load threshold for numerous species effects (
                        <E T="03">e.g.,</E>
                         richness) and ecosystem effects (
                        <E T="03">e.g.,</E>
                         tree growth) in U.S. forests grasslands, deserts, and shrublands (
                        <E T="03">e.g.,</E>
                         Pardo et al., 2011; Simkin et al., 2016) and thus 10 kg N/ha-yr provides a good benchmark for assessing the deposition-related effects of NO
                        <E T="52">2</E>
                         in ambient air” (Sheppard, 2023, Response to Charge Questions, p. 23).
                    </P>
                    <FTNT>
                        <P>
                            <SU>90</SU>
                             The weighted metric is constructed by applying weighting to concentrations to the monitors identified as sites of influence, with the weighting equal to the relative contribution of air from the monitor location to the downwind ecoregion based on the trajectory analysis (PA, section 6.2.4). Values of this metric are not directly translatable to individual monitor concentrations or to potential standard levels.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>91</SU>
                             The metric for N deposition in these analyses is the median of the TDep estimates across each ecoregion (PA, section 6.2.4).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>92</SU>
                             The CASAC letter states that the Neuse River Estuary TMDL specified a 30% reduction from the 1991-1995 loading estimate of 9.8 kg/ha-yr, yielding a remaining atmospheric load target of 6.9 kg/ha-yr (Sheppard, 2023, Response to Charge Questions, p. 13).
                        </P>
                    </FTNT>
                    <P>
                        One CASAC member disagreed with revision of the existing annual NO
                        <E T="52">2</E>
                         standard and instead recommended adoption of a new 1-hour NO
                        <E T="52">2</E>
                         secondary standard identical in form, averaging time and level to the existing primary standard based on the conclusion that the N deposition estimates for the most recent periods generally reflect reduced deposition that is a product of current regulatory requirements, including implementation of the existing primary standards for NO
                        <E T="52">2</E>
                         and PM (Sheppard, 2023, Appendix A). This member additionally noted that bringing into attainment the areas still out of attainment with the 2013 primary annual PM
                        <E T="52">2.5</E>
                         standard (12.0 µg/m
                        <SU>3</SU>
                        ) will provide further reductions in N deposition. This member also noted his analysis of NO
                        <E T="52">2</E>
                         annual and 1-hour design values for the past 10 years (2013-2022) as indicating that the current primary NO
                        <E T="52">2</E>
                         standard provides protection for annual average NO
                        <E T="52">2</E>
                         concentrations below 31 ppb (Sheppard, 2023, Appendix A).
                    </P>
                    <P>
                        With regard to PM and effects related to deposition of N and S, the CASAC focused on the PM
                        <E T="52">2.5</E>
                         standards and made no recommendations regarding the PM
                        <E T="52">10</E>
                         standard. In considering the annual PM
                        <E T="52">2.5</E>
                         standard, the majority of CASAC members recommended revision of the annual secondary PM
                        <E T="52">2.5</E>
                         standard to a level of 6 to 10 µg/m
                        <SU>3</SU>
                        . In their justification for this range, these members focus on rates of total N deposition at or below 10 kg/ha-yr and total S deposition at or below 5 kg/ha-yr that they state would “afford an adequate level of protection to several species and ecosystems across the U.S.” (Sheppard, 2023, Response to Charge Questions, p. 23). In reaching this conclusion for protection from N deposition, the CASAC majority cited studies of U.S. forests, grasslands, deserts and shrublands that are included in the ISA. For S deposition, the CASAC majority notes the Pavlovic et al. (2023) analysis of the dataset used by Horn et al. (2018). Conclusions of the latter study (Horn et al., 2018), which is characterized in the ISA and discussed in sections 5.3.2.3 and 7.2.2.2 of the PA (in noting median deposition of 5-12 kg S/ha-yr in ranges of species for which survival and/or growth was observed to be negatively associated with S deposition), are consistent with the more recent analysis in the 2023 publication (ISA, Appendix 6, sections 6.2.3 and 6.3.3).
                    </P>
                    <P>
                        As justification for their recommended range of annual PM
                        <E T="52">2.5</E>
                         levels (6-10 µg/m
                        <SU>3</SU>
                        ), this group of CASAC members provided several statements, without further explanation, regarding PM
                        <E T="52">2.5</E>
                         annual concentrations and estimates of S and N deposition for which they cited several figures in the draft PA. Citing figures in the draft PA with TDep deposition estimates and IMPROVE and CASTNET monitoring data, they stated that “[i]n remote areas, IMPROVE PM
                        <E T="52">2.5</E>
                         concentrations in the range of 2-8 µg/m
                        <SU>3</SU>
                         for the periods 2014-2016 and 2017-2019 correspond with total S deposition levels &lt;5 kg/ha-yr (Figure 6-12), with levels generally below 3 kg/ha-yr, and with total N deposition levels ≤10 kg/ha-yr (Figure 6-13)” (Sheppard, 2023, Response to Charge Questions, p. 23). With regard to S deposition, these members additionally cited a figure in the draft PA as indicating ecosystem median S deposition estimates at/below 5 kg/ha-yr occurring with PM
                        <E T="52">2.5</E>
                         EAQM-max values in the range of 6 to 12 µg/m
                        <SU>3</SU>
                         (Sheppard, 2023, Response to Charge Questions, pp. 23-24). With regard to N deposition, these members additionally cited figures in the draft PA as indicating that areas of 2019-2021 total N deposition estimates greater than 15 kg/ha-yr (“in California, the Midwest, and the East”) correspond with areas where the annual PM
                        <E T="52">2.5</E>
                         design values for 2019-2021 range from 6 to 12 µg/m
                        <SU>3</SU>
                        ,
                        <SU>93</SU>
                        <FTREF/>
                         and other figures (based on trajectory analyses) as indicating ecosystem median N deposition estimates below 10 kg N/ha-yr occurring only with PM
                        <E T="52">2.5</E>
                         weighted EAQM values below 6 µg/m
                        <SU>3</SU>
                        ,
                        <SU>94</SU>
                        <FTREF/>
                         and PM
                        <E T="52">2.5</E>
                         EAQM-max values below 8 µg/m
                        <SU>3</SU>
                         (Sheppard, 2023, Response to Charge Questions, pp. 23-24). The CASAC also noted the correlation coefficient for N deposition with the EAQM weighted metric (which was a moderate value of about 0.5), while also recognizing that the correlation coefficient for the EAQM-max was “minimal.” The bases for the N and S deposition levels targeted in this CASAC majority recommendation are described in the paragraphs earlier in this section.
                    </P>
                    <FTNT>
                        <P>
                            <SU>93</SU>
                             We note, however, that the design value figure cited by these members indicate California sites to have design values as high as 17.8 µg/m
                            <SU>3</SU>
                            , 
                            <E T="03">i.e.,</E>
                             violating the current PM
                            <E T="52">2.5</E>
                             secondary standard (draft PA, Figure 2-27; PA, Figure 2-31).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>94</SU>
                             As noted earlier in this section, weighted EAQM values are not directly translatable to concentrations at individual monitors or to potential standard levels.
                        </P>
                    </FTNT>
                    <P>
                        One CASAC member recommended revision of the annual secondary PM
                        <E T="52">2.5</E>
                         standard to a level of 12 µg/m
                        <SU>3</SU>
                         based on his interpretation of figures in the draft PA that present S and N deposition estimates for five different 3-year time periods from 2001 to 2020. This member observed that these figures indicate ecoregion median S and N deposition estimates in the last 10 years below 5 and 10 kg/ha-yr, respectively. This member concluded this to indicate that the 2013 primary annual PM
                        <E T="52">2.5</E>
                         standard of 12.0 µg/m
                        <SU>3</SU>
                         provides adequate protection against long-term annual S and N deposition-related effects (Sheppard, 2023, Appendix A).
                    </P>
                    <P>
                        Regarding the existing 24-hour PM
                        <E T="52">2.5</E>
                         secondary standard, the majority of CASAC members recommended revision of the level to 25 ug/m
                        <SU>3</SU>
                         or revision of the indicator and level to deciviews 
                        <SU>95</SU>
                        <FTREF/>
                         and 20 to 25, respectively (Sheppard, 2023, Response to Charge Questions, p 25). These members variously cited “seasonal variabilities” of “[e]cological sensitivities,” describing sensitive lichen species to be influenced by fog or cloud water from which they state S and N contributions to be highly episodic, and visibility impairment (Sheppard, 2023, Response to Charge Questions, p 25). These members did not provide further specificity regarding their reference to lichen species and fog or cloud water. With regard to visibility impairment, these members described 
                        <PRTPAGE P="105742"/>
                        the EPA solicitation of comments that occurred with the separate EPA action to reconsider the 2020 decision to retain the existing PM
                        <E T="52">2.5</E>
                         standards as the basis for their recommendations on the secondary 24-hr PM
                        <E T="52">2.5</E>
                         standard (Sheppard, 2023, Response to Charge Questions, p 25; 88 FR 5562-5663, January 27, 2023).
                        <SU>96</SU>
                        <FTREF/>
                         One CASAC member dissented from this view and supported retention of the existing secondary 24-hr PM
                        <E T="52">2.5</E>
                         standard.
                    </P>
                    <FTNT>
                        <P>
                            <SU>95</SU>
                             Deciviews, units derived from light extinction, are frequently used in the scientific and regulatory literature to assess visibility (U.S. EPA 2019, section 13.2).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>96</SU>
                             Protection from impairment of visibility effects was one of the welfare effects within the scope of the PM NAAQS reconsideration rather than the scope of this review (U.S. EPA, 2016, 2017). In that action, the Administrator proposed not to change the 24-hour secondary PM NAAQS for visibility protection and also solicited comment on revising the level of the current secondary 24-hour PM
                            <E T="52">2.5</E>
                             standard to a level as low as 25 µg/m
                            <SU>3</SU>
                            ; in the final action, the Administrator concluded that the current secondary PM standards provide requisite protection against PM-related visibility effects and retained the existing standards without revision (88 FR 5558, January 27, 2023; 89 FR 16202, March 6, 2024).
                        </P>
                    </FTNT>
                    <P>
                        Among the CASAC comments on the draft PA 
                        <SU>97</SU>
                        <FTREF/>
                         was the comment that substantial new evidence has been published since development of the 2020 ISA that supports changes to the draft PA conclusions on N deposition effects. Accordingly, in the final PA, a number of aspects of Chapters 4 and 5 were revised from the draft PA; these changes took into account the information emphasized by the CASAC while also referring to the ISA and studies considered in it (PA, section 7.3). More recent studies cited by the CASAC generally concerned effects described in the ISA based on studies available at that time. While the newer studies include additional analyses and datasets, the ISA and studies in it also generally support the main points raised and observations made by the CASAC (PA, section 7.3).
                    </P>
                    <FTNT>
                        <P>
                            <SU>97</SU>
                             Consideration of CASAC comments and areas of the PA in which revisions have been made between the draft and this final document are described in section 1.4 of the PA.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">c. Administrator's Proposed Conclusions</HD>
                    <P>
                        In reaching his proposed conclusions on the adequacy of the existing secondary standards for SO
                        <E T="52">X</E>
                        , N oxides, and PM, and on what revisions or alternatives may be appropriate, the Administrator drew on the ISA conclusions regarding the weight of the evidence for both the direct effects of SO
                        <E T="52">X</E>
                        , N oxides, and PM in ambient air and for effects associated with ecosystem deposition of N and S compounds, and associated areas of uncertainty; quantitative analyses of aquatic acidification risk and of air quality and deposition estimates, and associated limitations and uncertainties; staff evaluations of the evidence, exposure/risk information, and air quality information in the PA; CASAC advice; and public comments received by that time. The Administrator recognized the evidence of direct biological effects associated with elevated short-term concentrations of SO
                        <E T="52">X</E>
                         and N oxides that formed the basis for the existing secondary SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">2</E>
                         standards, the evidence of ecological effects of PM in ambient air, primarily associated with loading on vegetation surfaces, and also the extensive evidence of ecological effects associated with atmospheric deposition of N and S compounds into sensitive ecosystems. The Administrator also took note of the quantitative analyses and policy evaluations documented in the PA that, with CASAC advice, informed his judgments in reaching his proposed decisions in this review.
                    </P>
                    <P>
                        With regard to the secondary standard for SO
                        <E T="52">X</E>
                         and the adequacy of the existing standard for providing protection of the public welfare from direct effects on biota and from ecological effects related to ecosystem deposition of S compounds, the Administrator considered the evidence regarding direct effects, as described in the ISA and evaluated in the PA, which is focused on SO
                        <E T="52">2</E>
                        . He took note of the PA finding that the evidence indicates SO
                        <E T="52">2</E>
                         concentrations associated with direct effects to be higher than those allowed by the existing SO
                        <E T="52">2</E>
                         secondary standard (PA sections 5.4.1, 7.1.1 and 7.4). Additionally, he took note of the CASAC unanimous conclusion that the existing standard provides protection from direct effects of SO
                        <E T="52">X</E>
                         in ambient air, as summarized in section II.B.1.b. above. Based on all of these considerations, he judged the existing secondary SO
                        <E T="52">2</E>
                         standard to provide the needed protection from direct effects of SO
                        <E T="52">X</E>
                        .
                    </P>
                    <P>
                        The Administrator next considered the ISA findings for ecological effects related to ecosystem deposition of S compounds. He first recognized the long-standing evidence of the role of SO
                        <E T="52">X</E>
                         in ecosystem acidification and related ecological effects. While he additionally noted the ISA determinations of causality for S deposition with two other categories of effects related to mercury methylation and sulfide phytotoxicity (ISA, Table ES-1; PA, section 4.4), he recognized that quantitative assessment tools and approaches are not well developed for ecological effects associated with atmospheric deposition of S other than ecosystem acidification (PA, section 7.2.2.1). Accordingly, he gave primary attention to effects related to acidifying deposition, given the robust evidence base and available quantitative tools, as well as the longstanding recognition of impacts in acid-sensitive ecosystems across the U.S. In so doing, the Administrator focused on the findings of the aquatic acidification REA and related policy evaluations in the PA. The range of ecoregion deposition estimates across the contiguous U.S. analyzed during the 20-year period from 2001 through 2020 extended up to as high as 20 kg S/ha-yr,
                        <SU>98</SU>
                        <FTREF/>
                         and design values for the existing SO
                        <E T="52">2</E>
                         standard (second highest 3-hour average in a year), in all States except Hawaii,
                        <SU>99</SU>
                        <FTREF/>
                         were below its current level of 500 ppb, and generally well below (PA, section 6.2.1). The Administrator took note of the aquatic acidification risk estimates that indicate that the pattern of S deposition, estimated to have occurred during periods when the existing standard was met (
                        <E T="03">e.g.,</E>
                         2001-2003), is associated with 20% to more than half of waterbody sites in each affected eastern ecoregion 
                        <SU>100</SU>
                        <FTREF/>
                         being unable to achieve even the lowest of the three acid buffering capacity targets or benchmarks (ANC of 20 µeq/L), and he judged such risks to be of public welfare significance. The Administrator also considered the advice from both the majority and the minority of CASAC that recommended adoption of a new SO
                        <E T="52">2</E>
                         standard for this purpose in light of conclusions that the existing standard did not provide such needed protection. Thus, based on the findings of the REA, associated policy evaluations in the PA with regard to S deposition and acidification-related effects in sensitive ecosystems, and in consideration of advice from the CASAC, the Administrator proposed to judge that the current SO
                        <E T="52">2</E>
                         secondary standard is not requisite to protect the public welfare from adverse effects associated with acidic deposition of S compounds in sensitive ecosystems.
                    </P>
                    <FTNT>
                        <P>
                            <SU>98</SU>
                             During 2001-2003, the 90th percentile S deposition per ecoregion of sites assessed in the REA was at or above 15 kg/ha-yr in half of the 18 eastern ecoregions and ranged up above 20 kg/ha-yr (figure 2).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>99</SU>
                             This analysis excluded Hawaii where it is not uncommon for there to be high SO
                            <E T="52">2</E>
                             values in areas with recurring volcanic eruptions (PA, section 2.4.2).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>100</SU>
                             Aquatic acidification risk estimates for the 2001-2020 deposition estimates in the eight western ecoregions indicated ANC levels achieving all three targets in at least 90% of all sites assessed in each ecoregion (PA, Table 5-4). Ecoregion median deposition estimates were at or below 2 kg/ha-yr in all eight western ecoregions (PA, Table 5-3).
                        </P>
                    </FTNT>
                    <P>
                        Having reached this proposed conclusion that the existing secondary SO
                        <E T="52">2</E>
                         standard does not provide the 
                        <PRTPAGE P="105743"/>
                        requisite protection of the public welfare from adverse S deposition-related effects, most prominently those associated with aquatic acidification, the Administrator then considered options for a secondary standard that would provide the requisite protection from S deposition-related effects (
                        <E T="03">i.e.,</E>
                         a standard that is neither more nor less stringent than necessary, as discussed in section II.A. above). In so doing, the Administrator turned first to the policy evaluations and staff conclusions in the PA, and the quantitative analyses and information described in Chapter 5 of the PA, for purposes of identifying S deposition rates that might be judged to provide an appropriate level of public welfare protection from acidification-related effects. In this context, he took note of the PA focus on the aquatic acidification risk estimates and recognition of linkages between watershed soils and waterbody acidification, as well as terrestrial effects. He concurred with the PA view regarding such linkages and what they indicate with regard to the potential for a focus on protecting waterbodies from reduced acid buffering capacity (with ANC as the indicator) to also provide protection for watershed soils and terrestrial effects. Accordingly, he focused on the PA evaluation of the risk estimates in terms of waterbodies estimated to achieve the three acid buffering capacity benchmarks (20, 30 and 50 µeq/L). In so doing, he concurred with the PA consideration of the ecosystem-scale estimates as appropriate for his purposes in identifying conditions that provide the requisite protection of the public welfare.
                    </P>
                    <P>
                        The Administrator gave particular attention to the findings of the aquatic acidification REA for the 18 well-studied, acid-sensitive eastern ecoregions, and considered the PA evaluation of ecoregion median S deposition values at and below which the risk estimates indicated a high proportion of waterbodies in a high proportion of ecoregions would achieve ANC values at or above the three benchmarks (20, 30 and 50 µeq/L), as summarized in Tables 7-1 and 5-5 of the PA. In so doing, he recognized a number of factors, as described in the PA, which contribute variability and uncertainty to waterbody estimates of ANC and to interpretation of acidification risk associated with different values of ANC (PA, section 5.1.4 and Appendix 5A, section 5A.3). The Administrator additionally took note of the approach taken by the CASAC majority in considering the ecoregion-scale risk estimates. These members considered the summary of results for the ecoregion-scale analysis of ecoregion median deposition bins (in the draft PA) 
                        <SU>101</SU>
                        <FTREF/>
                         and focused on the results with acid buffering capacity at or above the three ANC benchmarks in 80% (for ANC of 20 and 30 µeq/L) or 70% (for ANC of 50 µeq/L) of waterbodies in all ecoregion-time period combinations 
                        <SU>102</SU>
                        <FTREF/>
                         (Sheppard, p. 25 of the Response to Charge Questions). As recognized in the PA, these results are observed for median S-deposition at or below 7 kg/ha-yr for all time periods for the 18 eastern ecoregions. When considering all 25 analyzed ecoregions, somewhat higher percentages are achieved (as seen in tables 4 and 5 above).
                        <SU>103</SU>
                        <FTREF/>
                         The Administrator additionally considered the PA evaluation of the temporal trend (or pattern) of ecoregion-scale risk estimates across the five time periods in relation to the declining S deposition estimates for those periods. Based on the PA observation of appreciably improved acid buffering capacity (
                        <E T="03">i.e.,</E>
                         increased ANC) estimates by the third time period (2010-2012), the PA focused on the REA risk and deposition estimates for this and subsequent periods. By 2010-2012, ecoregion median S deposition (across CL sites) ranged from 2.3 to 7.3 kg/ha-yr in the 18 eastern ecoregions (with the highest ecoregion 90th percentile at approximately 8 kg/ha-yr) and more than 70% of waterbodies per ecoregion were estimated to be able to achieve an ANC of 50 µeq/L in all 25 ecoregions, and more than 80% of waterbodies per ecoregion in all ecoregions were estimated to be able to achieve an ANC of 20 µeq/L (table 5 and figures 1 and 2 above). The Administrator observed that these estimates of acid buffering capacity achievement for the 2010-12 period deposition—achieving the ANC benchmarks in at least 70% to 80% (depending on the specific benchmark) of waterbodies per ecoregion—are consistent with the objectives identified by the CASAC majority (in considering estimates from the ecoregion-scale analysis). By the 2014-2016 period, when deposition estimates were somewhat lower, the ANC benchmarks were estimated to be achieved in 80% to 90% of waterbodies per ecoregion. In his consideration of these ANC achievement percentages identified by the CASAC majority, while noting the variation across the U.S. waterbodies with regard to site-specific factors that affect acid buffering (as summarized in sections II.A.3.a.(2) and II.A.4. above and section 5.1.4 of the PA), the Administrator concurred with the PA conclusion on considering ecoregion-scale ANC achievement results of 70% to 80% and 80% to 90% with regard to acid buffering capacity objectives for the purposes of protecting ecoregions from aquatic acidification risk of a magnitude with potential to be considered of public welfare significance.
                    </P>
                    <FTNT>
                        <P>
                            <SU>101</SU>
                             While the final PA provides additional presentations of aquatic acidification risk estimates, including those at the ecoregion-scale, the estimates are unchanged from those in the draft PA (PA, section 5.1.3).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>102</SU>
                             The presentation of such percentages in the draft PA (reviewed by the CASAC) were specific to the 90 ecoregion-time period combinations for the 18 eastern ecoregions. Inclusion of the 7 western ecoregions yields higher percentages, as more than 90% of waterbodies in those ecoregions were estimated to achieve all three ANC concentration in all time periods (PA, Table 5-4).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>103</SU>
                             Ecoregion median deposition was below 2 kg S/ha-yr in all 35 ecoregion-time period combinations for the eight western ecoregions (PA, Table 5-4).
                        </P>
                    </FTNT>
                    <P>
                        With regard to the variation in deposition across areas within ecoregions, the Administrator noted the PA observation that the sites estimated to receive the higher levels of deposition are those most influencing the extent to which the potential objectives for aquatic acidification protection are or are not met. He further noted the PA observation of an appreciable reduction across the 20-year analysis period in the 90th percentile deposition estimates, as well as the median, for REA sites in the 25 ecoregions analyzed (figure 2 above). In this context, the Administrator took note of the PA findings that the ecoregion-scale acid buffering objectives identified by the CASAC (more than 70% to 80% of waterbody sites in all ecoregions assessed achieving or exceeding the set of ANC benchmarks) might be expected to be met when ecoregion median and upper (90th) percentile deposition estimates at sensitive ecoregions are generally at and below about 5 to 8 kg/ha-yr. He also took note of the PA identification of deposition rates at and below about 5 to 8 or 10 kg/ha-yr 
                        <SU>104</SU>
                        <FTREF/>
                         as associated with a potential to achieve acid buffering capacity benchmarks in an appreciable portion of acid sensitive areas based on consideration of uncertainties associated with the deposition estimates and associated aquatic acidification risk estimates at individual waterbody sites 
                        <PRTPAGE P="105744"/>
                        (PA, section 5.1.4), as well as the REA case study analysis estimates.
                    </P>
                    <FTNT>
                        <P>
                            <SU>104</SU>
                             The PA's consideration of the case study analyses as well as the ecoregion-scale results for both the ecoregion-time period groups and the temporal perspectives indicated a range of S deposition below approximately 5 to 8 or 10 kg/ha-yr to be associated with a potential to achieve acid buffering capacity levels of interest in an appreciable portion of acid sensitive areas (PA, section 7.4).
                        </P>
                    </FTNT>
                    <P>
                        Based on all of the above considerations, the Administrator focused on identification of a secondary standard that might be associated with S deposition of such a magnitude. In so doing he recognized the complexity of identifying a NAAQS focused on protection of the public welfare from adverse effects associated with national patterns of atmospheric deposition (rather than on protection from national patterns of ambient air concentrations directly). In light of the influence of emissions from multiple, distributed sources, atmospheric chemistry and transport on air concentrations and the influence of air concentrations and other factors on atmospheric deposition (ecosystem loading), the Administrator concurred with the PA judgment that consideration of the location of source emissions and expected pollutant transport (in addition to the influence of physical and chemical processes) is important to understanding relationships between SO
                        <E T="52">2</E>
                         concentrations at ambient air monitors and S deposition rates in sensitive ecosystems of interest. Accordingly, the Administrator concurred with the PA that to achieve a desired level of protection from aquatic acidification effects associated with S deposition in sensitive ecosystems, SO
                        <E T="52">2</E>
                         emissions must be controlled at their sources, and that associated NAAQS compliance monitoring includes regulatory SO
                        <E T="52">2</E>
                         monitors generally sited near large SO
                        <E T="52">2</E>
                         emissions sources.
                    </P>
                    <P>
                        The Administrator considered findings of the PA analyses of relationships between ambient air concentrations and S deposition estimates, conducted in recognition of the variation across the U.S. in the source locations and magnitude of SO
                        <E T="52">X</E>
                         emissions, as well as the processes that govern transport and transformation of SO
                        <E T="52">X</E>
                         to eventual deposition of S compounds. Recognizing the linkages connecting SO
                        <E T="52">X</E>
                         emissions and S deposition-related effects, the Administrator considered the current information with regard to support for SO
                        <E T="52">2</E>
                         as the indicator for a new or revised standard for SO
                        <E T="52">X</E>
                         that would be expected to provide protection from aquatic acidification-related risks of S deposition in sensitive ecoregions. The Administrator noted the PA analyses demonstrated there to be an association between SO
                        <E T="52">2</E>
                         concentrations and nearby or downwind S deposition (PA, section 7.4) based on the general association of higher local S deposition estimates with higher annual average SO
                        <E T="52">2</E>
                         concentrations at SLAMS, in addition to the correlations observed for ecoregion median S deposition with upwind SO
                        <E T="52">2</E>
                         monitoring sites of influence in the EAQM analyses (PA, sections 6.4.1 and 7.4). He additionally took note of the PA findings of parallel trends of SO
                        <E T="52">2</E>
                         emissions and S deposition in the U.S. over the past 20 years, including the sharp declines, that indicate the strong influence of SO
                        <E T="52">2</E>
                         in ambient air on S deposition (PA, sections 6.4.1 and 7.4), and of the PA finding of parallel temporal trends of ecoregion S deposition estimates and REA aquatic acidification risk estimates across the five time periods analyzed. In light of all of these considerations, the Administrator judged SO
                        <E T="52">2</E>
                         to be the appropriate indicator for a standard addressing S deposition-related effects.
                    </P>
                    <P>
                        With regard to the appropriate averaging time and form for such a standard, the Administrator took note of the PA focus on a year's averaging time based on the recognition that longer-term averages (such as over a year) most appropriately relate to ecosystem deposition and associated effects, and of the recommendation from the CASAC majority for an annual average standard. The quantitative analyses of air quality and deposition in the PA also used a 3-year average form based on a recognition in the NAAQS program that such a form affords a stability to air quality management programs that contributes to effective environmental protection.
                        <SU>105</SU>
                        <FTREF/>
                         Similarly, the CASAC majority recommendation focused on a 3-year average form. In consideration of these conclusions of the PA and the CASAC majority, the Administrator focused on annual average SO
                        <E T="52">2</E>
                         concentrations, averaged over three years, as the appropriate averaging time and form for a revised standard providing public welfare protection from adverse effects associated with long-term atmospheric deposition of S compounds.
                    </P>
                    <FTNT>
                        <P>
                            <SU>105</SU>
                             A 3-year form, common to recently adopted NAAQS, provides a desired stability to the air quality management programs which is considered to contribute to improved public health and welfare protection (
                            <E T="03">e.g.,</E>
                             78 FR 3198, January 15, 2013; 80 FR 65352, October 26, 2015; 85 FR 87267, December 31, 2020).
                        </P>
                    </FTNT>
                    <P>
                        In considering a level for such a standard, the Administrator again noted the complexity associated with identifying a NAAQS focused on protection from national patterns of atmospheric deposition. As discussed further in the PA and the proposal, in identifying a standard to provide a pattern of ambient air concentrations that together contribute to deposition across the U.S., it is important to consider the distribution of air concentrations to which the standard will apply.
                        <SU>106</SU>
                        <FTREF/>
                         In identifying an appropriate range of concentrations for a standard level, the Administrator considered the evaluations and associated findings of the PA and advice from the CASAC. In so doing, he considered the two PA options of somewhat below 15 ppb to a level of 10 ppb and a level ranging below 10 ppb to 5 ppb, with a 3-year average form. He additionally recognized that uncertainties in aspects of the aquatic acidification risk modeling contribute uncertainty to the resulting estimates, and that uncertainty in the significance of aquatic acidification risk is greater with lower deposition levels (PA, section 5.1.4). Accordingly, the Administrator took note of additional and appreciably greater uncertainty associated with consideration of a standard level below 10 ppb, including uncertainties in the relationships between S deposition and annual average SO
                        <E T="52">2</E>
                         concentrations below 10 ppb (PA, Chapter 6, section 7.4). Thus, the Administrator recognized there to be, on the whole across the various linkages, increased uncertainty for lower SO
                        <E T="52">2</E>
                         concentrations and S deposition rates. The Administrator additionally considered the CASAC majority recommended range of 10 to 15 ppb for an annual average SO
                        <E T="52">2</E>
                         standard to address S deposition-related ecological effects, as described in section II.B.1.b. above. These members indicated that this range of levels was “generally” associated with S deposition “at &lt;5 kg/ha-yr” in the two most recent trajectory analysis periods in the PA, and that a standard level in this range would afford protection against ecological effects in terrestrial ecosystems as well as aquatic ecosystems. These members also stated that such a standard would “preclude the possibility of returning to deleterious deposition values” (Sheppard, Response to Charge Questions, pp. 24-25). Thus, based on analyses and evaluations in the PA, including judgments related to uncertainties in relating ambient air concentrations to deposition estimates for the purpose of identifying a standard level associated with a desired level of ecological protection, and based on advice from the CASAC majority, the 
                        <PRTPAGE P="105745"/>
                        Administrator judged that a level within the range from 10 to 15 ppb would be appropriate for an annual average SO
                        <E T="52">2</E>
                         standard requisite to protect the public welfare from adverse effects related to S deposition.
                    </P>
                    <FTNT>
                        <P>
                            <SU>106</SU>
                             As recognized in section II.B.1.a. above, the trajectory analyses relate contributions from individual monitor locations to deposition in receiving ecosystems (without explicitly addressing the multiple factors at play), with the somewhat higher correlations of the EAQM-weighted than the EAQM-max metric likely reflecting the weighting of concentrations across multiple upwind monitors to represent relative loading.
                        </P>
                    </FTNT>
                    <P>
                        The Administrator also considered the extent to which a new annual average standard might be expected to control short-term concentrations (
                        <E T="03">e.g.,</E>
                         of three hours duration) and accordingly provide protection from direct effects that is currently provided by the existing 3-hour secondary standard. In this context, he noted the analyses and conclusions of the PA with regard to the extent of control for short-term concentrations (
                        <E T="03">e.g.,</E>
                         of three hours duration) that might be expected to be provided by an annual secondary SO
                        <E T="52">2</E>
                         standard. These analyses indicate that in areas and periods when the annual SO
                        <E T="52">2</E>
                         concentration (annual average, averaged over three years) is below 15 ppb, design values for the existing 3-hour standard are well below the existing secondary standard level of 0.5 ppm SO
                        <E T="52">2</E>
                         (PA, Figure 2-29). Based on these findings of the PA, the Administrator proposed that it is appropriate to consider revision of the existing secondary SO
                        <E T="52">2</E>
                         standard to an annual standard, with a 3-year average form and a level in the range from 10 to 15 ppb.
                    </P>
                    <P>
                        The Administrator also took note of the recommendation from the CASAC minority to establish a 1-hour SO
                        <E T="52">2</E>
                         secondary standard, identical to the primary standard (section II.B.1.b. above; Sheppard, 2023, p. A-2), based on its observation that most of the S deposition estimates for the last 10 years are less than 5 kg/ha-yr and a judgment that this indicates that the existing 1-hour primary SO
                        <E T="52">2</E>
                         standard adequately protects against long-term annual S deposition-related effects. The Administrator preliminarily concluded an annual standard to be a more appropriate form to address deposition-related effects, but also recognized that greater weight could be given to consideration of the effectiveness of the existing 1-hour primary standard in controlling emissions and associated deposition. In light of these considerations, the EPA solicited comment on such an alternate option for the secondary SO
                        <E T="52">2</E>
                         standard.
                    </P>
                    <P>
                        In summary, based on all of the considerations identified above, including the currently available evidence in the ISA, the quantitative and policy evaluations in the PA, and the CASAC advice, the Administrator proposed to revise the existing secondary SO
                        <E T="52">2</E>
                         standard to an annual average standard, with a 3-year average form and a level within the range from 10 to 15 ppb as requisite to protect the public welfare. The EPA also solicited comment on a lower level for a new annual standard down to 5 ppb, as well as on whether the existing 3-hour secondary standard should be retained in addition to establishing a new annual SO
                        <E T="52">2</E>
                         standard. The EPA also solicited comment on the option of revising the existing secondary SO
                        <E T="52">2</E>
                         standard to be equal to the current primary standard in all respects.
                    </P>
                    <P>
                        With regard to the secondary PM standards, the Administrator considered the available information and the PA evaluations and conclusions regarding S deposition-related effects. In so doing, he took note of the information indicating the variation in PM
                        <E T="52">2.5</E>
                         composition across the U.S. (PA, section 2.4.3), with non-S containing compounds typically comprising more than 70% of total annual PM
                        <E T="52">2.5</E>
                         mass in much of the country. Further, he considered the PA findings of appreciable variation in associations, and generally low correlations, between S deposition and PM
                        <E T="52">2.5</E>
                        , as summarized in section II.A.2. above (PA, sections 6.2.2.3 and 6.2.4.2). He also took note of the discussion above in support of his decision regarding a revised secondary SO
                        <E T="52">2</E>
                         standard, including the atmospheric chemistry information which indicates the dependency of S deposition on airborne SO
                        <E T="52">X</E>
                        , as evidenced by the parallel trends of SO
                        <E T="52">2</E>
                         emissions and S deposition. Based on all of these considerations, the Administrator judged that protection of sensitive ecosystems from S deposition is more effectively achieved through a revised SO
                        <E T="52">2</E>
                         standard than a standard for PM, and that a revised PM standard is not warranted to provide protection against the effects of S deposition.
                    </P>
                    <P>
                        Based on his consideration of the secondary standards for N oxides and PM with regard to the protection afforded from direct ecological effects and from ecological effects related to ecosystem N deposition, the Administrator proposed to retain the existing NO
                        <E T="52">2</E>
                         and PM standards. With regard to protection from direct effects of N oxides in ambient air, the Administrator noted that the evidence of welfare effects at the time this standard was established in 1971 indicated the direct effects of N oxides on vegetation and that the currently available information continues to document such effects, as summarized in section II.B.1.a.(1) above (ISA, Appendix 3, sections 3.3 and 3.4; PA, sections 4.1 and 5.4.2). With regard to the direct effects of NO
                        <E T="52">2</E>
                         and NO, the Administrator concurred with the PA conclusion that the evidence does not call into question the adequacy of protection provided by the existing standard. With regard to the N oxide, HNO
                        <E T="52">3</E>
                        , consistent with the conclusion in the PA, the Administrator judged the limited evidence to lack a clear basis for concluding that effects associated with air concentrations and associated HNO
                        <E T="52">3</E>
                         dry deposition on plant and lichen surfaces might have been elicited by air quality that met the secondary NO
                        <E T="52">2</E>
                         standard. Thus, the Administrator recognized the limitations of the evidence for these effects, and associated uncertainties, and judges them too great to provide support to a revised secondary NO
                        <E T="52">2</E>
                         standard, additionally taking note of the unanimous view of the CASAC that the existing secondary NO
                        <E T="52">2</E>
                         standard provides protection from direct effects of N oxides (section II.B.1.b. above).
                    </P>
                    <P>
                        The Administrator next turned to consideration of the larger information base of effects related to N deposition in ecosystems. In so doing, he recognized the complexities and challenges associated with quantitative characterization of N enrichment-related effects in terrestrial or aquatic ecosystems across the U.S. that might be expected to occur due to specific rates of atmospheric deposition of N over prolonged periods, and the associated uncertainties (PA, section 7.2.3). The Administrator also found there to be substantially more significant limitations and uncertainties associated with the evidence base for ecosystem effects related to N deposition associated with N oxides and PM, and with the available air quality information related to the limited potential for control of N deposition in areas across the U.S., in light of the impacts of other pollutants (
                        <E T="03">i.e.,</E>
                         NH
                        <E T="52">3</E>
                        ) on N deposition. The first set of limitations and uncertainties relates to quantitative relationships between N deposition and ecosystem effects, based on which differing judgments may be made in decisions regarding protection of the public welfare. In the case of protection of the public welfare from adverse effects associated with nutrient enrichment, there is also complexity associated with identification of appropriate protection objectives in the context of changing conditions in aquatic and terrestrial systems as recent deposition has declined from the historical rates of loading. The second set of limitations and uncertainties relates to the emergence of NH
                        <E T="52">3</E>
                        , which is not a criteria pollutant, as a greater influence on N deposition than N oxides 
                        <PRTPAGE P="105746"/>
                        and PM over the more recent years,
                        <SU>107</SU>
                        <FTREF/>
                         and the variation in PM composition across the U.S.
                    </P>
                    <FTNT>
                        <P>
                            <SU>107</SU>
                             Further, this influence appears to be exerted in areas with some of the highest N deposition estimates for those years.
                        </P>
                    </FTNT>
                    <P>Additionally, the Administrator recognized additional complexities in risk management and policy judgments, including with regard to identifying risk management objectives for public welfare protection from an ecosystem stressor like N enrichment, for which as the CASAC recognized, in terrestrial systems, there are both “benefits and disbenefits” (Sheppard, 2023, p. 8). As noted in the PA, the existence of benefits complicates the judgment of effects that may be considered adverse to the public welfare (PA, section 7.4). For aquatic systems, identification of appropriate public welfare protection objectives is further complicated by N contributions to many of these systems from multiple sources other than atmospheric deposition, as well as by the effects of historical deposition that have influenced the current status of soils, surface waters, associated biota, and ecosystem structure and function.</P>
                    <P>
                        In considering the evidence and air quality information related to N deposition, the Administrator took note of the fact that ecosystem N deposition is influenced by air pollutants other than N oxides, particularly, NH
                        <E T="52">3</E>
                        , which is not a CAA criteria pollutant (PA, sections 6.1, 6.2.1 and 7.2.3.3). As noted above, the extent of this contribution varies appreciably across the U.S. and has increased during the past 20 years, with the areas of highest N deposition appearing to correspond to the areas with the greatest deposition of NH
                        <E T="52">3</E>
                         (PA, Figure 7-8).
                        <SU>108</SU>
                        <FTREF/>
                         The Administrator concurred with the PA conclusion that this information complicates his consideration of the currently available information with regard to protection from N deposition-related effects that might be afforded by the secondary standard for N oxides, particularly when considering the information since 2010 (and in more localized areas prior to that). That is, while the information regarding recent rates of ecoregion N deposition may in some individual areas (particularly those for which reduced N, specifically NH
                        <E T="52">3</E>
                        , has a larger role) indicate rates greater than the range of values identified in the PA for consideration (
                        <E T="03">e.g.,</E>
                         7-12 kg/ha-yr based on the considerations in section 7.2.3 of the PA and the benchmark of 10 kg/ha-yr, as conveyed in the advice from the CASAC), the PA notes that the extent to which this occurrence relates to the existing NO
                        <E T="52">2</E>
                         secondary standard is unclear. The lack of clarity is both because of uncertainties in relating ambient air NO
                        <E T="52">2</E>
                         concentrations to rates of deposition, and because of the increasing contribution of NH
                        <E T="52">3</E>
                         to N deposition.
                    </P>
                    <FTNT>
                        <P>
                            <SU>108</SU>
                             This associated lessening influence of N oxides on total N deposition is also evidenced by the lower correlations between N deposition and annual average NO
                            <E T="52">2</E>
                             concentrations than observed for S deposition and SO
                            <E T="52">2</E>
                             concentrations (PA, sections 6.2.3 and 6.2.4), which may be related to increasing emissions of NH
                            <E T="52">3</E>
                             in more recent years and at eastern sites (PA, section 2.2.3 and Figure 6-5).
                        </P>
                    </FTNT>
                    <P>
                        The Administrator additionally noted the PA finding that the temporal trend in ecoregion N deposition differs for ecoregions in which N deposition is driven by reduced N compared to those where reduced N comprises less of the total (
                        <E T="03">e.g.,</E>
                         PA, Figures 7-6 and 7-7). In light of the PA evaluations of N deposition and relative contribution from reduced and oxidized N compounds, the Administrator concurred with the PA conclusion that, based on the current air quality and deposition information and trends, a secondary standard for N oxides cannot be expected to effectively control total N deposition (PA, section 7.4).
                    </P>
                    <P>
                        The Administrator additionally considered the two sets of advice from the CASAC regarding an NO
                        <E T="52">2</E>
                         annual standard in consideration of N deposition effects (section II.B.1.b. above). The CASAC majority recommended revision of the existing annual NO
                        <E T="52">2</E>
                         standard level to a value “&lt;10 to 20 ppb” (Sheppard, 2023, p. 24). The basis for this advice, however, relates to a graph in the draft PA of the dataset of results from the trajectory-based analyses for the weighted annual NO
                        <E T="52">2</E>
                         metric (annual NO
                        <E T="52">2</E>
                         EAQM-weighted), which, as noted in section II.B.1.b. above, is not directly translatable to concentrations at individual monitors or to potential standard levels. Additionally, these results found no correlation between the ecoregion deposition and the EAQM-weighted or EAQM-max values at upwind locations, as also recognized by CASAC members and indicated in the final PA (PA, Table 6-10). Accordingly, based on the lack of a correlation for N deposition with the EAQMs, as well as the lack of translatability of the EAQM-weighted values to monitor concentrations or standard levels, the PA did not find the information highlighted by the CASAC majority for relating N deposition levels to ambient air concentrations to provide scientific support for their recommended levels. In light of this, the Administrator did not find agreement with the CASAC majority recommendations on revisions to the annual NO
                        <E T="52">2</E>
                         standard.
                    </P>
                    <P>
                        The CASAC minority recommended revision of the secondary NO
                        <E T="52">2</E>
                         standard to be identical to the primary standard based on their conclusion that the recent N deposition levels meet its desired objectives and that the primary standard is currently the controlling standard (Sheppard, 2023, Appendix A). As noted in the PA, among the NO
                        <E T="52">2</E>
                         primary and secondary NAAQS, the 1-hour primary standard (established in 2010) may currently be the controlling standard for ambient air concentrations, and annual average NO
                        <E T="52">2</E>
                         concentrations, averaged over three years, in areas that meet the current 1-hour primary standard, have generally been below approximately 35 to 40 ppb.
                        <SU>109</SU>
                        <FTREF/>
                         The Administrator also considered the PA revision option (
                        <E T="03">i.e.,</E>
                         revision to a level below the current level of 53 ppb to as low as 35 to 40 ppb [PA, section 7.4]), taking note of the PA characterization that support for this option is “not strong” (PA, section 7.4). He further noted the PA conclusion that while the option may have potential to provide some level of protection from N deposition related to N oxides, there is significant uncertainty as to the level of protection that would be provided, with this uncertainty relating most prominently to the influence of NH
                        <E T="52">3</E>
                         on total N deposition separate from that of N oxides (PA, section 7.2.3.3). The Administrator further recognized the PA statement that the extent to which the relative roles of these two pollutants (N oxides and NH
                        <E T="52">3</E>
                        ) may change in the future is not known. As evaluated in the PA, these factors together affect the extent of support for, and contribute significant uncertainty to, a judgment as to a level of N oxides in ambient air that might be expected to provide requisite protection from N deposition-related effects on the public welfare.
                    </P>
                    <FTNT>
                        <P>
                            <SU>109</SU>
                             The air quality information regarding annual average NO
                            <E T="52">2</E>
                             concentrations at SLAMS monitors indicates more recent NO
                            <E T="52">2</E>
                             concentrations are well below the existing standard level of 53 ppb. As noted in the PA, the temporal trend figures indicate that, subsequent to 2011-2012, when median N deposition levels in 95% of the eastern ecoregions of the continental U.S. have generally been at or below 11 kg N/ha-yr, annual average NO
                            <E T="52">2</E>
                             concentrations, averaged across three years, have been at or below 35 ppb (PA, section 7.2.3.3).
                        </P>
                    </FTNT>
                    <P>
                        In light of the considerations recognized above, the Administrator found that the existing evidence does not clearly call into question the adequacy of the existing secondary NO
                        <E T="52">2</E>
                         standard, additionally noting that recent median N deposition estimates are below the N deposition benchmark identified by the CASAC majority of 10 kg/ha-yr in ecoregions for which approximately half or more of recent total N deposition is estimated to be 
                        <PRTPAGE P="105747"/>
                        oxidized N, driven by N oxides (PA, section 7.2.3.3). In addition to the substantial uncertainty described above regarding the need for control of N deposition from N oxides that might be provided by a secondary standard for N oxides, the PA found there to be substantial uncertainty about the effect of a secondary standard for N oxides on the control of N deposition, such that it is also not clear whether the available information provides a sufficient basis for a revised standard that might be judged to provide the requisite protection. In light of this PA finding, the current information on air quality and N deposition, and all of the above considerations, the Administrator proposed to also judge that the available evidence in this review is sufficient to conclude a revision to the secondary annual NO
                        <E T="52">2</E>
                         standard is not warranted. Based on all of these considerations, he proposed to retain the existing secondary NO
                        <E T="52">2</E>
                         standard, without revision. The EPA also solicited comments on the alternative of revising the level and form of the existing secondary NO
                        <E T="52">2</E>
                         standard to a level within the range from 35 to 40 ppb with a 3-year average form.
                    </P>
                    <P>
                        Lastly, the Administrator considered the existing standards for PM. He took note of the PA discussion and conclusion that the available information does not call into question the adequacy of protection afforded by the secondary PM
                        <E T="52">2.5</E>
                         standards from direct effects and deposition of pollutants other than S and N compounds (PA, sections 7.1.3 and 7.4). The evidence characterized in the ISA and summarized in the PA indicates such effects to be associated with conditions associated with concentrations much higher than the existing standards. Thus, the Administrator proposed to conclude that the current evidence does not call into question the adequacy of the existing PM standards with regard to direct effects and deposition of pollutants other than S and N compounds.
                    </P>
                    <P>
                        With regard to N deposition and PM
                        <E T="52">2.5</E>
                        , the Administrator considered the analyses and evaluations in the PA, as well as advice from the CASAC. He took note of the substantial and significant limitations and uncertainties associated with the evidence base for ecosystem effects related to N deposition associated with PM and with the available air quality information related to the limited potential for control of N deposition in areas across the U.S. in light of the impacts of NH
                        <E T="52">3</E>
                         on N deposition, and the variation in PM composition across the U.S., as summarized earlier. For example, as noted in the PA, the variable composition of PM
                        <E T="52">2.5</E>
                         across the U.S. contributes to geographic variability in the relationship between N deposition and PM
                        <E T="52">2.5</E>
                         concentrations, and there is an appreciable percentage of PM
                        <E T="52">2.5</E>
                         mass that does not contribute to N deposition. The PA further notes that this variability in percentage of PM
                        <E T="52">2.5</E>
                         represented by N (or S) containing pollutants contributes a high level of uncertainty to our understanding of the potential effect of a PM
                        <E T="52">2.5</E>
                         standard on patterns of N deposition.
                    </P>
                    <P>
                        In considering the advice from the CASAC for revision of the existing annual secondary PM
                        <E T="52">2.5</E>
                         standard, the Administrator noted that the CASAC provided two different recommendations for revising the level of the standard: one for a level in the range from 6 to 10 µg/m
                        <SU>3</SU>
                         and the second for a level of 12 µg/m
                        <SU>3</SU>
                        . As summarized in the PA, the specific rationale for the range from 6 to 10 ug/m
                        <SU>3</SU>
                         is unclear, with levels within this range described as both relating to N deposition in a preferred range (at or below 10 kg N/ha-yr) and relating to deposition above that range.
                        <SU>110</SU>
                        <FTREF/>
                         The PA noted that this “overlap” illustrates the weakness and variability of relationships of PM
                        <E T="52">2.5</E>
                         with N deposition across the U.S. (PA, section 7.4). Further, the PA notes the low correlation for total N deposition estimates with annual average PM
                        <E T="52">2.5</E>
                         design values in the last 10 years at SLAMS (PA, Table 6-7). The second recommendation, from the CASAC minority, was based on their conclusion that the recent N (and S) deposition levels meet their desired targets and that the primary annual PM
                        <E T="52">2.5</E>
                         standard, which has been 12 µg/m
                        <SU>3</SU>
                         since 2013, has been the controlling standard for annual PM
                        <E T="52">2.5</E>
                         concentrations (Sheppard, 2023, Appendix A).
                    </P>
                    <FTNT>
                        <P>
                            <SU>110</SU>
                             For example, the justification provided for the range of levels recommended by the CASAC majority for a revised PM
                            <E T="52">2.5</E>
                             annual standard (6 to 10 µg/m
                            <SU>3</SU>
                            ) refers both to annual average PM
                            <E T="52">2.5</E>
                             concentrations (3-yr averages) ranging from 2 to 8 µg/m
                            <SU>3</SU>
                             in 27 Class I areas (as corresponding to N deposition estimates at or below 10 kg/ha-yr) and to annual average PM
                            <E T="52">2.5</E>
                             concentrations (3-year averages) ranging from 6 to 12 µg/m
                            <SU>3</SU>
                             (at design value sites in areas of N deposition estimates greater than 15 kg/ha-yr), as summarized in section II.B.1.b. above.
                        </P>
                    </FTNT>
                    <P>
                        Based on the currently available information, taking into account its limitations and associated uncertainties, and in consideration of all of the above, the Administrator proposed to conclude that PM
                        <E T="52">2.5</E>
                         is not an appropriate indicator for a secondary standard intended to provide protection of the public welfare from adverse effects related to N deposition. In reaching this proposed conclusion, the Administrator focused in particular on the weak correlation between annual average PM
                        <E T="52">2.5</E>
                         design values and N deposition estimates in recent time periods, and additionally noted the PA conclusion that the available evidence, as evaluated in the PA, is reasonably judged insufficient to provide a basis for revising the PM
                        <E T="52">2.5</E>
                         annual standard with regard to effects of N deposition related to PM. Thus, based on consideration of the PA analyses and conclusions, as well as consideration of advice from the CASAC, the Administrator further proposed to conclude that no change to the annual secondary PM
                        <E T="52">2.5</E>
                         standard is warranted, and he proposed to retain the existing PM
                        <E T="52">2.5</E>
                         secondary standard, without revision. The EPA solicited comment on this proposed decision and also solicited comment on revising the existing standard level to a level of 12 µg/m
                        <SU>3</SU>
                        , in light of the recommendation and associated rationale provided by the CASAC minority.
                    </P>
                    <P>
                        With regard to other PM standards, the Administrator concurred with the PA's finding of a lack of information that would call into question the adequacy of protection afforded by the existing PM
                        <E T="52">10</E>
                         secondary standard for ecological effects, and thus concluded it is appropriate to propose retaining this standard without revision. With regard to the 24-hour PM
                        <E T="52">2.5</E>
                         standard, the Administrator took note of the PA conclusion that the evidence available in this review, as documented in the ISA, or cited by the CASAC,
                        <SU>111</SU>
                        <FTREF/>
                         does not call into question the adequacy of protection provided by the 24-hour PM
                        <E T="52">2.5</E>
                         standard from ecological effects (PA, section 7.4). The Administrator also considered the comments of the CASAC majority and recommendations for revision of this standard to a lower level or to an indicator of deciviews, as summarized in section II.B.1.b. The Administrator noted the PA consideration of the lack of quantitative information in the ISA related to the specific type of N deposition raised by the CASAC comments. Further, the specific revision options recommended by the CASAC majority were based on visibility considerations, although the adequacy of protection provided by the secondary PM
                        <E T="52">2.5</E>
                         standard from visibility effects has been addressed in the 
                        <PRTPAGE P="105748"/>
                        reconsideration of the 2020 p.m. NAAQS decision (89 FR 16202, March 6, 2024) and is not included in this review. The Administrator additionally noted the recommendation from the CASAC minority to retain the existing 24-hour secondary PM
                        <E T="52">2.5</E>
                         standard without revision. Based on all of these considerations, the Administrator proposed to retain the existing 24-hour secondary PM
                        <E T="52">2.5</E>
                         standard, without revision. Additionally, based on the lack of evidence calling into question the adequacy of the secondary PM
                        <E T="52">10</E>
                         standards, he also proposed to retain the secondary PM
                        <E T="52">10</E>
                         standards without revision.
                    </P>
                    <FTNT>
                        <P>
                            <SU>111</SU>
                             As summarized in section II.B.1.b. above, the CASAC majority, in its recommendation for revision of the existing standard, did not provide specificity regarding the basis for its statements on lichen species and fog or cloud water, and the available evidence as characterized in the ISA does not provide estimates of this deposition or describe associated temporal variability, or specifically describe related effects on biota (ISA, Appendix 2).
                        </P>
                    </FTNT>
                    <P>
                        In reaching the proposed conclusions regarding protection of the public welfare from ecological effects associated with ecosystem deposition of N and S compounds, the Administrator also noted the PA consideration of the potential for indicators different from those for the current standards that may target specific chemicals that deposit N and S, 
                        <E T="03">e.g.,</E>
                         NO
                        <E T="52">3</E>
                        <E T="51">−</E>
                        , SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                        , NH
                        <E T="52">4</E>
                        <E T="51">+</E>
                         (PA, sections 7.2.2.3, 7.2.3.3 and 7.4). In so doing, however, he recognized a number of uncertainties and gaps in the available information important to such consideration. Based on these, the Administrator judged that the currently available information does not support standards based on such indicators at this time. In so doing, he also recognized that additional data collection and analysis is needed to develop the required evidence base to inform more comprehensive consideration of such alternatives.
                    </P>
                    <HD SOURCE="HD3">2. Comments on the Proposed Decisions</HD>
                    <P>Over 27,000 individuals and organizations indicated their views in public comments on the proposed decision. Nearly all of these are associated with mass mail campaigns or petitions. Approximately 20 separate submissions were also received from individuals, organizations, or groups of organizations. Many of the individual commenters made a general recommendation to “strengthen” the standards under review, emphasizing giving attention to the scientific information and recommendations from the CASAC, and protection of natural ecosystems and associated wildlife. Among the organizations commenting were State and federal agencies, a Tribal organization, environmental protection advocacy organizations, industry organizations and regulatory policy-focused organizations.</P>
                    <P>
                        Some commentors expressed the overarching view that none of the standards for the three pollutants in this review should be revised, generally stating that the implementation work by State agencies associated with new standards would be for no environmental gain in light of the emissions reductions and “dramatic improvements” in associated air quality that have already occurred since 2000. While the EPA recognizes that air quality has improved over the last two decades, we note that the existence of such trends and the fact of the CAA requirements for implementation of NAAQS, alone or in combination, are not appropriate bases for the Administrator's decision under section 109 of the Act. Accordingly, in finding that revision to the existing SO
                        <E T="52">X</E>
                         standard is necessary to provide the requisite public welfare protection for SO
                        <E T="52">X</E>
                        , while revisions to the N oxides and PM standards are not necessary to provide the requisite public welfare protection for those pollutants, the Administrator has based his decisions on the evidence of welfare effects, air quality information and the extent of public welfare protection provided by the existing standards, as described in section II.B.3. below. Other comments on the proposed decisions in the review of the secondary standards for protection of ecological effects of SO
                        <E T="52">X</E>
                        , N oxides and PM are addressed below.
                    </P>
                    <P>
                        Comments regarding the proposed decision to revise the secondary standard for SO
                        <E T="52">X</E>
                         are addressed in section II.B.2.a., and those regarding the proposed decision to retain the secondary standards for N oxides and PM are addressed in sections II.B.2.b. and II.B.2.c., respectively. Other comments, including comments related to other legal, procedural, or administrative issues, those related to issues not germane to this review, and comments related to the Endangered Species Act are addressed in the separate Response to Comments document.
                    </P>
                    <HD SOURCE="HD3">a. Sulfur Oxides</HD>
                    <HD SOURCE="HD3">(1) Comments Regarding Adequacy of the Existing Secondary Standard</HD>
                    <P>
                        With regard to welfare effects associated with SO
                        <E T="52">X</E>
                         in ambient air, including those related to deposition of S compounds, in consideration of the welfare effects evidence, quantitative analyses of ecosystem exposure and risk and advice from the CASAC, the Administrator proposed to judge that the existing 3-hour secondary SO
                        <E T="52">2</E>
                         standard is not requisite to protect the public welfare from adverse effects associated with acidic deposition of S compounds in sensitive ecosystems. An array of comments was received regarding the Administrator's proposed decision to address this insufficiency in protection through revision to an annual average standard. These comments are addressed in the following section.
                    </P>
                    <HD SOURCE="HD3">(2) Comments in Support of Proposed Adoption of a New Annual Standard</HD>
                    <P>
                        In consideration of the welfare effects evidence, quantitative analyses of ecosystem exposure and risk, and advice from the CASAC majority to adopt an annual standard with a level within the range of 10 to 15 ppb to address the deposition-related effects of SO
                        <E T="52">X</E>
                        , the Administrator proposed revision of the existing standard to be an annual standard, as summarized in section II.B.1.c. above. Commenters expressed several views concerning the level of such a standard; these comments are addressed in the subsections below.
                    </P>
                    <HD SOURCE="HD3">(a) Comments Agreeing With a Level Within the Proposed Range</HD>
                    <P>
                        The EPA received multiple comments in support of the proposed establishment of an annual standard, with a 3-year form and level within the proposed range. Some of these comments concurred with the full range of levels as proposed, while some recommended a range of levels that overlapped with the lower end of the proposed range and also extended below it. The commenters in agreement with the full proposed range variously cited, concurred with, and expanded upon information discussed in the proposal, in addition to noting consistency of the proposed decision with recommendations from the majority of CASAC. In so doing, one commenter expressed the view that the proposed new standard would provide protection for direct vegetation effects and ecosystem deposition-related effects including aquatic acidification, which they noted affects the diversity and abundance of fish and aquatic life, thus providing support to cultural services and recreational fishing, which have long-term societal and economic benefits. Another comment expressed the view that the new standard would support Tribal efforts to protect lakes and streams from deposition-related effects including potential impacts to cultural fishing practices. One comment, in advocating for a level within the range of 5 to 10 ppb (which overlaps with the proposed range at a level of 10 ppb), expressed the view that “to meet statutory requirements and act rationally and respond to CASAC consensus scientific expertise, EPA must,” among several recommendations, “[s]et an annual secondary SO
                        <E T="52">2</E>
                         standard of 5-10 ppb to 
                        <PRTPAGE P="105749"/>
                        protect against deposition effects and maintain total sulfur deposition at &lt;5 kg/ha on an annual basis.”
                    </P>
                    <P>The EPA agrees with the comment that a new annual standard with a level in the proposed range (of 10-15 ppb) would be expected to provide protection for direct effects on vegetation and for ecosystem deposition-related effects, including specifically those associated with aquatic acidification. The EPA also agrees that such a standard, by protecting against acidifying atmospheric deposition in aquatic and terrestrial ecosystems, can be expected to impact an array of societal and economic benefits from this protection. As summarized in section II.A.3.b. above and recognized in the Administrator's conclusions in section II.B.3. below, such benefits include providing protection for recreational and subsistence fisheries, as well as for recreational uses of sensitive forests and protected waterbodies.</P>
                    <P>
                        Additionally, with regard to the lower end of the proposed range and its overlap with the commenter-recommended-range of 5 to 10 ppb, the EPA agrees with the commenter that a standard with a level of 10 ppb would generally be associated with S deposition at or below 5 kg/ha annually in sensitive ecosystems, consistent with comments by the CASAC majority in its rationale for recommending a new annual standard with a level in the range of 10 to 15 ppb, which it described as “generally” maintaining S deposition below 5 kg/ha-yr (as summarized in section II.B.1.b. above). The CASAC majority based its conclusion regarding annual SO
                        <E T="52">2</E>
                         standard levels associated with S deposition at/below 5 kg/ha-yr on analyses in the draft PA, as described in section II.B.1.b.
                    </P>
                    <P>
                        In reaching his proposed decision for a level in the range of 10 to 15 ppb, the Administrator considered the expanded analyses and conclusions in the final PA. In reaching his final decision, as described in section II.B.3. below, the Administrator also considered additional analyses in a technical memorandum to the docket that extend the PA air quality and deposition analyses (Sales et al., 2024). These ecoregion-based analyses of air quality and deposition from five 3-year time periods from 2001 through 2020 indicate that when annual average SO
                        <E T="52">2</E>
                         concentrations (as a 3-year average) are at or below 10 ppb, median S deposition in associated downwind ecoregions is generally at or below 5 kg/ha-yr. Specifically, more than 85% of associated downwind ecoregions are at or below 5 kg/ha-yr, with 95% below about 6 kg/ha-yr and all below about 8 kg/ha-yr. This analysis additionally found that in every instance of the upwind maximum annual SO
                        <E T="52">2</E>
                         concentration above 10 ppb, the associated downwind ecoregion median deposition was greater than 5 kg/ha-yr, ranging from about 6 kg/ha-yr up to about 18 kg/ha-yr and with 75% of occurrences greater than 9 kg/ha-yr (Sales et al., 2024). In consideration of these findings, among other considerations, the Administrator judged a level of 10 ppb to provide the requisite protection of public welfare for the new annual secondary SO
                        <E T="52">2</E>
                         standard, as described in section II.B.3.
                    </P>
                    <HD SOURCE="HD3">(b) Comments in Support of a Level Below the Proposed Range</HD>
                    <P>
                        Three comments indicated support or potential support for a new annual standard with a level below 10 ppb (
                        <E T="03">i.e.,</E>
                         below the proposed range). In addition to the comment referenced above that expressed support for a level in the range from 5 to 10 ppb, a second comment, that expressed support for an annual standard with a level within the proposed range of 10 to 15 ppb, additionally expressed support for a level as low as 5 ppb to the extent it could “be supported by the current science.” A third comment expressed support for an annual standard level of 5 ppb, stating the view that such a standard could provide necessary protection for the public welfare and for resources managed by the U.S. National Park Service. Beyond a statement by one of these comments (also discussed in section II.B.2.a.(2)(a) above) that their recommended range of 5 to 10 ppb was needed to “maintain sulfur deposition at &lt;5 kg/ha on an annual basis,” none of these commenters presented a specific scientific rationale for a specific standard level below 10 ppb. One comment stated that 71% of national parks are experiencing wet deposition of S greater than 1 kg/ha-yr and suggested that this indicates harmful impacts to park soil, waterbodies, and associated wildlife.
                    </P>
                    <P>With regard to the latter comment regarding wet S deposition above 1 kg/ha-yr, the commenter did not provide evidence to support their conclusion of harmful impacts for such a level, and the EPA has not found the available evidence to support such a finding in this review. In describing the 1 kg/ha-yr value (for wet deposition of both S and N), the comment cited two papers that are focused on N deposition as a basis for the conclusion that conditions of wet deposition below 1 kg/ha-yr are “good” while greater levels indicate acidification conditions. These papers—Baron et al. (2011) and Sheibley et al. (2014)—are summarized in addressing another comment in section II.B.2.b.(2)(b) below. Neither paper, however, addresses S deposition. Based on this and consideration of the evidence and quantitative analyses available in this review, the EPA does not find that wet S deposition greater than 1 kg/ha-yr in national parks indicates adverse impacts to the public welfare.</P>
                    <P>
                        We note that the phrase regarding maintaining S deposition “at &lt;5 kg/ha” on an annual basis is consistent with the phrase used by the CASAC majority in its justification for its recommended range of 10-15 ppb, for which it cited analyses in the draft PA. As summarized above, and discussed in section II.B.3. below, the Administrator has considered the CASAC advice and the findings of the analyses in the final PA, in combination with additional presentations in Sales et al (2024), which he judged to provide support for his decision to adopt an annual SO
                        <E T="52">2</E>
                         standard with a level of 10 ppb, a value within the commenter-supported range of 5 to 10 ppb.
                    </P>
                    <P>
                        The commenter that recommended a level of 5 ppb additionally expressed their view that a standard with a higher level (within the proposed range of 10 to 15 ppb) would not prevent effects of S deposition in Class I areas that they described as harmful, improve air quality, or reduce S deposition in Class I areas. Based on this view and their judgment that a further reduction in ambient air concentrations is needed, this commenter recommended that EPA set the level for a new annual standard below recent annual average SO
                        <E T="52">2</E>
                         concentrations, stating that a standard level of 5 ppb “could” reduce S deposition from current levels. However, this commenter did not elaborate as to what magnitude of S deposition would be expected to be associated with a standard level of 5 ppb or why such a magnitude would provide an appropriate level for protection of the public welfare from S deposition-related effects. As a basis for their conclusion that harmful effects of S deposition are associated with current S deposition rates in national parks that are Class I areas, this commenter referred to National Park Services analyses that assign grades or “conditions” to these areas based on S deposition estimates and “park-specific critical loads” and stated that current S deposition levels in National Park Service managed Class I areas are above these loads for multiple ecosystem components. This commenter indicated that these analyses show that natural 
                        <PRTPAGE P="105750"/>
                        resources in these parks are in fair or poor condition and that a standard with a level around 5 ppb “could improve air quality and reduce S deposition levels” in areas that the commenter states are already experiencing S deposition impacts.
                    </P>
                    <P>
                        Although the commenter provided tables listing numbers of areas that they stated are in poor or fair condition for various ecosystem components (
                        <E T="03">e.g.,</E>
                         aquatic systems, trees) and potential threats (
                        <E T="03">e.g.,</E>
                         acidification by S deposition, growth effects and S deposition), the commenter submitted no information (beyond their statement that there are critical load exceedances) on how they reach such conclusions. As support for the general statement that the term critical load describes the amount of pollution above which harmful changes in sensitive ecosystems occur, the commenter cited a publication that discusses the concept of critical loads and the potential for their usefulness in natural resources management. We note, however, that this publication does not provide details (
                        <E T="03">e.g.,</E>
                         specific deposition rates associated with specific types of effect in specific types of ecosystems) that might inform the EPA's consideration of the type, severity and prevalence of particular effects that would be expected from specific levels of deposition. Such information, as that provided by the aquatic acidification REA and the evidence underlying it, is needed in judgments regarding deposition levels and deposition-related effects of public welfare significance, which are integral to the Administrator's decision on the secondary standard for SO
                        <E T="52">X</E>
                        . Further, the commenter did not provide or refer to evidence relating a standard level of 5 ppb to expected S deposition levels. As discussed in section II.B.3. below, the Administrator has based his decision for an annual secondary SO
                        <E T="52">2</E>
                         standard with a level of 10 ppb on his consideration of the available evidence and quantitative analyses supporting the Agency's understanding of relationships between S deposition-related effects and S deposition levels and SO
                        <E T="52">2</E>
                         concentrations, and also on his judgments regarding the public welfare significance of the S deposition-related effects assessed in his decision.
                    </P>
                    <P>As we describe in section II.A.3.c. above, the term critical load has multiple interpretations and applications (ISA, p. IS-14). The variety in meanings stems in part from differing judgments and associated identifications regarding the ecological effect (both type and level of severity) on which the critical load focuses and from judgment of its significance or meaning. Accordingly, all CLs are not comparable with regard to severity or significance of harm or, as is more pertinent to decision-making in this review, with regard to potential for adversity to the public welfare. Rather, science policy judgments in these areas are required in order to reach conclusions regarding impacts for which secondary standards should be established. For example, the analysis in the PA which utilized CLs—the aquatic acidification REA—described their basis in detail. Further, in the Administrator's consideration of the REA results, he recognized the variation and uncertainty associated in the CLs and their relevance to different waterbodies. Thus, while we appreciate the comment, we find the information provided by the commenter to be insufficient for reaching judgments as to the significance and strength of the various CLs in their technical analysis, and likewise insufficient for concluding that reduced deposition levels are necessary to avoid adverse public welfare effects in Class I areas (or for assessing what level of deposition would be associated with a 5 ppb standard).</P>
                    <HD SOURCE="HD3">(3) Comments in Disagreement With Proposed Adoption of a New Annual Standard</HD>
                    <P>
                        Several public comments expressed disagreement with the proposed adoption of a new annual secondary standard to address S deposition-related effects of SO
                        <E T="52">X</E>
                         in ambient air. These comments cited a variety of reasons in support of this position, including the view that the EPA lacks authority to set a secondary standard to address public welfare effects of acid deposition. This comment is addressed in section II.B.2.a.(3)(a) below. Other reasons described in some comments advocating this position include the view that the proposed standard has no “benefits” and is therefore not “necessary” or “requisite.” Some other comments variously cite implementation burdens (
                        <E T="03">e.g.,</E>
                         SIP preparation), uncertainties in the scientific basis, and a lack of CASAC consensus. Another commenter expressed the view that the proposal did not adequately discuss how effects are adverse to the public welfare and additionally stated that the ANC targets used in reaching conclusions on the need for protection from acid deposition relied on the judgments of others, rather than EPA. These other comments are addressed in section II.B.2.a.(3)(b) Some comments in opposition to a new annual standard expressed support for a secondary standard identical in all respects to the primary standard. Those comments are addressed in section II.B.2.a.(3)(c).
                    </P>
                    <HD SOURCE="HD3">(a) Authority for a Secondary Standard Based on Acid Deposition</HD>
                    <P>
                        A few commenters that disagreed with the proposed decision to adopt a new annual standard to address deposition-related effects expressed the view that the EPA lacks authority to set a secondary standard based on acid deposition, stating that the specific focus of the Acid Rain Program (CAA, title IV) on acidification preempts action on the same issue through the secondary NAAQS.
                        <SU>112</SU>
                        <FTREF/>
                         These commenters argue that the enactment of title IV of the CAA in 1990 displaced the EPA's authority to address acidification through the setting of NAAQS, contending that the existence of a specific regulatory program to address the acidification effects of oxides of nitrogen and sulfur, that was established subsequent to the establishment of the NAAQS program in 1970, supplants the EPA's general authority under the Act. In support of this contention, the commenters cite a Supreme Court decision pertaining to regulation of tobacco by the FDA (
                        <E T="03">Food &amp; Drug Admin.</E>
                         v. 
                        <E T="03">Brown &amp; Williamson Tobacco Corp.,</E>
                         529 U.S. 120 (2000)) and also claim that their view regarding a lack of authority for the NAAQS program is demonstrated by the legislative history and a close reading of section 404 of the Act, which required the EPA to report to Congress on the feasibility of developing an acid deposition standard and the actions that would be required to integrate such a program into the CAA. The required report described in section 404, commenters argue, demonstrates that Congress had concluded that the EPA lacked the authority under section 109 of the CAA to establish a secondary NAAQS to address acid deposition. Commenters also claimed that the EPA has in the past recognized that the NAAQS program does not provide an effective mechanism for addressing acid deposition and has not adequately explained its change in position. These commenters additionally cite comments from the CASAC, made in its review of the draft PA for this NAAQS review, regarding challenges in identifying a concentration-based standard to address deposition-related effects as supporting 
                        <PRTPAGE P="105751"/>
                        the commenter's view that the CASAC also recognized a mismatch between the NAAQS program and regulation of acid deposition.
                    </P>
                    <FTNT>
                        <P>
                            <SU>112</SU>
                             One comment additionally cited the CASAC statement (in its advice to the Administrator in this review, summarized in section II.B.1.b.) that the CASAC's view was that a standard in terms of atmospheric deposition would be a more appropriate means of addressing deposition-related effects as indicative of a lack of CASAC support for a revised SO
                            <E T="52">2</E>
                             standard to address deposition-related effects of SO
                            <E T="52">X</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        The EPA does not agree with commenters that the enactment of title IV of the Act displaced the EPA's authority under section 109 to adopt NAAQS to address adverse effects on public welfare associated with deposition of SO
                        <E T="52">X</E>
                         from the ambient air. We note that the purpose of title IV “is to reduce the adverse effects of acid deposition” by reducing sulfur dioxide emissions by 10 million tons (and NO
                        <E T="52">X</E>
                         emissions by 2 million tons) from 1980 levels (CAA section 401(b)). By contrast, section 109 directs the Administrator to set a standard that is “requisite to protect public welfare from any known or anticipated adverse effects,” based on the air quality criteria (CAA section 109(b)(2)). Congress explicitly requires the air quality criteria and standards be reviewed every five years, and has thus required secondary standards to reflect the latest scientific information (CAA section 109(d)(1)). There is no reason to believe that a Congressional effort to achieve 10 million tons in reductions of SO
                        <E T="52">2</E>
                         was intended to supersede EPA's ongoing obligations to assess the impact of SO
                        <E T="52">2</E>
                         on public welfare. See 
                        <E T="03">Whitman</E>
                         v. 
                        <E T="03">Am. Trucking Ass'ns,</E>
                         531 U.S. 457, 468 (2001) (“Congress, we have held, does not alter the fundamental details of a regulatory scheme in vague terms or ancillary provisions—it does not, one might say, hide elephants in mouseholes.”).
                    </P>
                    <P>These two provisions are not in conflict, but represent the combined approach often taken by Congress to address the frequently complex problems of air pollution. There is nothing unusual about the CAA relying on multiple approaches to improve air quality, and in particular relying on the NAAQS to identify the requisite level of air quality and relying on both State implementation plans as well as federal CAA programs to control emissions of criteria pollutants in order to attain and maintain the NAAQS. For example, the existence of title II of the Act (Emission Standards for Moving Sources) does not divest the EPA of authority to set a NAAQS for ozone, despite the fact that many mobile source controls are adopted to control ozone precursors and indeed may be sufficient in some areas to attain and maintain the ozone NAAQS. Had Congress wanted to channel the EPA's authority to address acidification exclusively through title IV it could have done so explicitly. For example, it generally excluded criteria pollutants from regulation under section 111(d) and 112. Instead, at the same time that it enacted title IV, Congress also added section 108(g) to the CAA, specifying that the air quality criteria used for setting the NAAQS “may assess the risks to ecosystems from exposure to criteria air pollutants.”</P>
                    <P>
                        In adding title IV to the CAA, Congress created a new program to reduce the emissions of SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">X</E>
                         from electric generating units, the most significant sources of acidifying pollution in 1990. Nothing in the text or the legislative history of title IV of the Act indicates that in creating additional authority Congress intended to foreclose the EPA's authority to address acid deposition through the NAAQS process. Indeed, to the extent that Congress addressed the impact of title IV on other provisions of the CAA, it made clear that title IV had no impact on the compliance obligations of covered sources under other CAA provisions. See CAA section 413, “Except as expressly provided, compliance with the requirements of this subchapter shall not exempt or exclude the owner or operator of any source subject to this subchapter from compliance with any other applicable requirements of this chapter.”
                    </P>
                    <P>
                        The legislative history of the title IV program makes clear that Congress was acting to provide the EPA with additional tools to address the problem of acidification more effectively. See, 
                        <E T="03">e.g.,</E>
                         S. Rep. No.101-228, at 289-291 (1989). Congress did not conclude that the EPA lacked the regulatory authority to address acidification but rather concluded that “a major acid deposition control program [was] warranted . . . because of the evidence of damage that had already occurred as well the likelihood of further damage in the absence of Congressional action” (H.R. Rep. No 101-490, at 360 (1990)). The Senate Report made it clear that while the EPA envisioned CAA section 109 as providing authority to adopt a secondary NAAQS to address the effects of acid deposition, the EPA remained concerned about the effectiveness of this and other regulatory approaches (S. Rep. No. 101-228, at 290-291). Congress addressed these issues by adding the new authorities found in title IV but made no mention of supplanting the EPA's authority under section 109 to address acidification effects. There is no discussion in the legislative history of title IV of curtailing the EPA's authority under the NAAQS program.
                    </P>
                    <P>
                        As such, the requirement in section 404 of the 1990 CAA Amendments that the EPA send to Congress “a report on the feasibility and effectiveness of an acid deposition standard or standards” does not demonstrate that Congress concluded that an amendment to the CAA would be necessary to give the EPA the authority to issue standards addressing acidification under section 109. See CAA section 401. The significance of the report required by section 404 can be understood in the overall context of (1) the history of Congress' and the EPA's attempts to understand and to address the causes and effects of acid deposition; (2) the distinction between an acid deposition standard (expressed as kg/ha-yr) and an ambient air quality standard addressing effects of deposition (expressed as ppb); 
                        <SU>113</SU>
                        <FTREF/>
                         and (3) the EPA's proposed conclusion in 1988 that the scientific uncertainties associated with acid deposition were too great to allow the Agency to establish a secondary NAAQS at that time to address those effects. The EPA notes that it was clear at the time of the 1990 CAA Amendments that a program to address acid deposition was needed and that the primary and most important of these provisions is title IV of the Act, establishing the Acid Rain Program. The Report required under section 404 of the Amendments reflects this concern and requires an evaluation of an acid deposition standard and a comparison of its effectiveness to the effectiveness of various other regulatory authorities under the Act, including the authority for a secondary NAAQS under section 109 (CAA Amendments, Public Law 101-549, 104 Stat. 2399, 2632 (1990) (describing that “Reports” under CAA 404 (42 U.S.C. 7651), should include “(6) . . . other control strategies including ambient air quality standards”)). This indicates the existence of an ongoing authority under section 109. Likewise, in preparing the Report itself, EPA concluded that “[i]t may be possible to set acid deposition standards under existing statutory authority” (U.S. EPA, 1995b, at 100).
                    </P>
                    <FTNT>
                        <P>
                            <SU>113</SU>
                             For example, the 1995 Report discusses potential ranges for an acid deposition standard as measured by kg/ha/year (
                            <E T="03">e.g.,</E>
                             U.S. EPA [1995b] at 118).
                        </P>
                    </FTNT>
                    <P>
                        For these reasons, the commenters' analogy to tobacco regulation, at issue in 
                        <E T="03">FDA</E>
                         v. 
                        <E T="03">Brown &amp; Williamson Tobacco Corp.,</E>
                         529 U.S. 120 (2000), is entirely inapt. The issue before the Supreme Court in that case was whether the FDA had authority to regulate tobacco at all, and the Court held that where the FDA consistently took the position it did not have such authority, and Congress enacted multiple statutes consistent with that position, Congress had ratified the FDA's understanding of its authority and had created a separate regulatory structure. By contrast, while the EPA has on multiple occasions noted the 
                        <PRTPAGE P="105752"/>
                        scientific difficulties associated with identifying a standard to protect against acid deposition, EPA has engaged with those scientific difficulties because the EPA's longstanding interpretation of section 109 is that acid deposition is within the scope of adverse effects on public welfare to be addressed under section 109. There is no reason to understand Congressional action to establish programs to reduce emissions of SO
                        <E T="52">X</E>
                         under title IV as depriving EPA of authority to specify a level of air quality the attainment and maintenance of which is requisite to protect the public welfare against effects of SO
                        <E T="52">X</E>
                         under section 109. See 
                        <E T="03">Massachusetts</E>
                         v. 
                        <E T="03">EPA,</E>
                         549 U.S. 497, 530 (2007) (distinguishing 
                        <E T="03">Brown &amp; Williamson</E>
                         where EPA jurisdiction would not lead to extreme results, was not counterintuitive and EPA had never disavowed its authority).
                    </P>
                    <P>The EPA now concludes, as discussed in section II.B.2.b.(2)(a) below, that it does not have the authority to set a deposition standard under the existing CAA, and the EPA is not adopting a deposition standard in this action. Rather, consistent with the Agency's longstanding approach, the EPA has concluded that it must consider the effects of acid deposition in setting an air quality standard. Section 109 of the Act requires the Administrator to set an ambient air quality standard the attainment of which protects against “any known or anticipated adverse effects associated with the presence of [the] air pollutant in the ambient air.” The EPA has concluded that the best interpretation of this language is that a deposition standard is not an “air quality” standard because a deposition standard focuses not on concentrations of the pollutant in the ambient air but rather on quantities deposited on surfaces (as discussed in section II.B.2.b.(2)(a) below). Rather, the EPA has consistently viewed the best interpretation of this language to require consideration of the adverse effects that can be anticipated from presence of the pollutant in the ambient air, including via deposition of the pollutant to aquatic and other ecosystems. The CASAC indicated in its comments to the Administrator (as summarized in section II.B.1.b. above) that a deposition standard would be more scientifically appropriate, and it may be that Congress will at some point revisit the question of whether the EPA should also have authority to adopt an acid deposition standard, but such a question is independent of the scope of the authority, and obligation, the EPA currently has under section 109.</P>
                    <P>In assessing the import of section 404, the EPA has noted in the past that “Congress reserved judgment as to whether further action might be necessary or appropriate in the longer term” to address any problems remaining after implementation of the title IV program, and “if so, what form it should take” (58 FR 21356, April 21, 1993; 77 FR 20223, April 3, 2012). Such reservation of judgment by Congress concerned whether Congress should adopt additional statutory provisions to address the effects of acid deposition, as it did in 1990. It does not indicate a view that the EPA lacked authority under CAA section 109 to establish a secondary NAAQS to address acid deposition.</P>
                    <P>The EPA's decision in both the 1993 and 2012 reviews reflects the view that there is ongoing authority to address the effects of acid deposition under section 109 of the Act and does not indicate that the EPA believed that title IV implicitly amended the CAA and removed all such regulatory authority outside of title IV. In both the 1993 and 2012 decisions on the question of whether to revise the secondary NAAQS to address acid deposition-related effects, the EPA decided not to adopt a standard targeting deposition-related effects. The EPA noted the consistency of this decision with Congress' actions in the 1990 amendments but nowhere indicated that Congress' actions meant the EPA no longer had the authority to adopt a secondary NAAQS to address acid deposition. Instead, in the 1993 and 2012 decisions, the EPA stated that due to scientific uncertainty, the Agency would not at those times adopt a secondary NAAQS targeting deposition-related effects but would instead gather additional data and perform research and would determine in the future what further action to take under CAA section 109 (77 FR 20263, April 3, 2012; 75 FR 28157-58, April 21, 1993).</P>
                    <P>
                        Although substantial progress was made between the 1993 and 2012 reviews addressing some areas of uncertainty, the Administrator again concluded in 2012 that uncertainties associated with setting a NAAQS to address acidification were too substantial to allow her to set a standard that in her judgment would be requisite to protect the welfare from such effects. More than 10 years later, the evidence base on air quality, deposition and deposition-related effects has progressed substantially. That evidence base and associated quantitative analyses developed in the current review provide the foundation for the current decision for a NAAQS to protect against acid deposition. Thus, although we recognize the CASAC's view to be that a deposition standard would be a more appropriate means of addressing deposition-related effects, we find that for SO
                        <E T="52">2</E>
                         the relationship between ambient air concentrations and deposition is sufficiently well established to support a revised secondary SO
                        <E T="52">2</E>
                         NAAQS.
                        <SU>114</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>114</SU>
                             We have explained in section II.B.2.b.(2)(a), below, why we do not view section 109 as authorizing a deposition standard.
                        </P>
                    </FTNT>
                    <P>We do not understand the CASAC as suggesting that, in the absence of a deposition standard, the EPA should decline to set an air quality standard to address deposition-related effects. Rather, contrary to the implication of the commenter that the CASAC did not support a NAAQS to address deposition, the CASAC expressed strong consensus support for the EPA setting a NAAQS for this purpose and recommended concentration-based standards to the EPA for consideration. In summary, the EPA disagrees with the commenters' interpretation of the information cited and does not agree that the Administrator lacks the authority to set a secondary standard to address acid deposition-related effects.</P>
                    <HD SOURCE="HD3">(b) Other Comments in Opposition to the Proposed Annual Standard</HD>
                    <P>
                        In addition to the view discussed immediately above regarding the EPA's authority to set a NAAQS to address effects related to atmospheric deposition, some commenters cited other reasons in opposition to the proposed annual secondary SO
                        <E T="52">2</E>
                         standard. For example, based on the EPA's analyses indicating that the proposed revision of the secondary standard would not require emissions reductions beyond those needed to meet the primary standard, some commenters stated that revision of secondary standard has no “benefits” and is therefore not “necessary” and not “requisite.” Some additionally cited implementation requirements on States (
                        <E T="03">e.g.,</E>
                         SIP preparation) as a reason that the standard should not be revised, in light of the view that current air quality conditions do not pose a risk of adverse welfare effects. Some commenters expressed the view that the uncertainties are too great and the scientific basis for a standard to address acid deposition-related effects is lacking. One commenter stated that the EPA should thoroughly review the scientific studies published since the cut-off publication date for studies included in the ISA, and that to allow for this, the EPA should retain the existing standard pending that review 
                        <PRTPAGE P="105753"/>
                        and the associated creation of an up-to-date record in the next NAAQS review. One commenter additionally noted the lack of CASAC consensus on recommendations for a standard to address deposition-related effects and stated the view that this lack of consensus further weakens support for such a new standard. One comment expressed the view that the proposal did not adequately discuss how effects are adverse to public welfare and additionally stated that the ANC targets used in reaching conclusions regarding the need for protection from acid deposition relied on the judgments of others, rather than the EPA.
                    </P>
                    <P>
                        Regarding the view that a new annual standard to address deposition-related effects is not “necessary” or “requisite,” the EPA disagrees that simply because current or projected air quality in areas that meet the existing primary standard is expected to achieve the new standard, the current standard is already requisite to protect the public welfare, and a revised standard is unnecessary. The CAA requires secondary NAAQS to be set at the level of air quality requisite to protect the public welfare from known or anticipated adverse effects (CAA, section 109(b)(2)). The EPA recognizes the clear evidence, the CASAC consensus conclusions, and the Administrator's judgment, described in section II.B.3. below, that the current secondary standard does not provide protection for deposition-related effects of SO
                        <E T="52">X</E>
                         and is therefore not requisite. Accordingly, based on the available information and CASAC advice, the Administrator proposed to revise the existing standard to reflect a level of air quality that would provide the needed protection (89 FR 26620, April 15, 2024). Such a revision is “necessary” to address the requirements of the Act. In adopting a new annual standard, as described in section II.B.3. below, the Administrator has considered a range of options for limiting deposition-related effects with an air quality standard and identified such a standard that, in his judgment, is neither more nor less stringent than necessary to achieve the desired level of protection from welfare effects, most particularly those associated with atmospheric deposition of S compounds in sensitive ecosystems.
                    </P>
                    <P>With regard to implementation requirements, while the Administrator's decision on revision of the secondary standard to provide the requisite public welfare protection is not expected to result in changes to existing air quality, he has not considered implementation requirements in reaching his decision on the revised standard. Consistent with the CAA requirements described in section I.A. above, the Administrator is barred by CAA section 109 from considering costs of implementation in judging the adequacy of a standards, and he has not done so.</P>
                    <P>
                        The EPA additionally disagrees with the view that the secondary SO
                        <E T="52">2</E>
                         standard should not be revised because a revised standard would not be expected to require emissions reductions beyond those already required for meeting the primary SO
                        <E T="52">2</E>
                         standard, such that there would be little or no emissions reductions. As the D.C. Circuit has held in a prior challenge to SO
                        <E T="52">2</E>
                         NAAQS, “Nothing in the CAA requires EPA to give the current air quality such a controlling role in setting NAAQS” (
                        <E T="03">Nat'l Envtl. Dev. Association's Clean Air Project</E>
                         v. 
                        <E T="03">EPA,</E>
                         686 F.3d 803, 813 ([D.C. Cir. 2012]). In this review, the EPA is engaged in the task of identifying a secondary standard that provides the requisite public welfare protection under the Act. The fact that the existing primary SO
                        <E T="52">2</E>
                         standard is expected, based on recent data, to control air quality such that the new annual secondary SO
                        <E T="52">2</E>
                         standard may also be met does not satisfy the requirements of CAA section 109(b)(2) or 
                        <E T="03">a priori</E>
                         make the secondary standard not requisite or without benefit. The benefit is assurance of the protection of the public welfare that is required of the secondary standard separate from the protection of the public health that is required of the primary standard. Further, the CAA requires the establishment of secondary standards requisite to protect against known or anticipated effects, and that requirement is separate and independent of the obligation to establish primary standards to protect the public health with an adequate margin of safety. The implication of the comment is that when the EPA next revises the primary NAAQS for SO
                        <E T="52">X,</E>
                         the Administrator would be required to consider the effect of any revisions to the primary NAAQS on both public health and welfare, a consideration inconsistent with the entire purpose of having distinct standards, as well as the text of section 109.
                    </P>
                    <P>
                        Furthermore, while air quality is currently expected to meet the new annual secondary standard when the primary standard is met, patterns of SO
                        <E T="52">2</E>
                         concentrations may change in some areas in the future, such that both the new annual secondary standard and the existing primary standard are violated or such that the secondary standard could be violated without a violation of the primary standard. The analyses of SO
                        <E T="52">2</E>
                         concentrations described in the PA illustrate how SO
                        <E T="52">2</E>
                         concentration patterns have changed over the past two decades in response to various changes in the largest emissions sources and in emissions controls implemented on such sources. Thus, sometimes changes occur over the long term in the multiple factors that influence air quality, that can contribute to future air quality patterns that may differ from those prevalent currently. Regardless, we recognize that section 109 of the Act does not only require establishment of standards that will result in changes in existing air quality. Rather, the Act specifies that there be secondary standards in place that will provide the requisite protection in the face of current and future air quality. And, as discussed above and in section II.B.3. below, the existing secondary SO
                        <E T="52">2</E>
                         standard does not provide the requisite protection from known or anticipated adverse effects on the public welfare related to atmospheric deposition of S compounds associated with SO
                        <E T="52">X</E>
                         in ambient air. The Administrator's decision is therefore to revise the standard to one that in his judgment will provide that protection, as described in section II.B.3. below.
                    </P>
                    <P>
                        The EPA disagrees with the comment stating that the Agency should retain the existing secondary SO
                        <E T="52">2</E>
                         standard pending review of the scientific studies that have been published since the cut-off date for studies considered in the ISA. Given the need for thorough consideration and CASAC review of studies that are part of the air quality criteria on which NAAQS must be based, there is always a cut-off date for studies to be considered in the ISA, and there are always studies published after the cut-off date. The NAAQS are subject to regular review precisely to allow for EPA to base its review of the standards on the latest available science and to also revisit the standards in the future based on additional scientific information. As noted in section I.D. above, in consideration of public comments received on this action, the EPA has provisionally considered all such “new” studies cited in comments and concluded that they do not materially change the broad scientific conclusions of the ISA (Weaver, 2024). Thus, the EPA has concluded that reopening the air quality criteria is not warranted. Therefore, as discussed in section II.B.3. below, the Administrator has considered the available evidence, as summarized in the ISA, the quantitative and policy evaluations in the PA, and the related additional analyses (Sales et al., 2024), as well as CASAC advice and public comment on 
                        <PRTPAGE P="105754"/>
                        the proposed decision and judged this an appropriate basis for his decision in the current review.
                    </P>
                    <P>
                        The EPA also disagrees with commenters' claims that the uncertainties are too great to provide the necessary scientific support for a new annual secondary standard or that consensus advice is needed from the CASAC. With regard to the advice from the CASAC, we disagree that consensus is needed before the Administrator can make a decision in a NAAQS review. The CAA does not require the CASAC to reach consensus in its advice on revisions to the standards. The EPA has made decisions on NAAQS in multiple reviews in which the CASAC did not reach consensus on its advice for the standards (
                        <E T="03">e.g.,</E>
                         85 FR 87256, December 31, 2020 and 89 FR 16202, March 6, 2024). In reaching his decision in this review, as described in section II.B.3. below, the Administrator has considered advice provided from both the majority and the minority of the CASAC.
                    </P>
                    <P>
                        In support of their claim that uncertainties are too great, commenters list statements from the proposal that recognize specific technical areas of uncertainty in our understanding of deposition-related effects of SO
                        <E T="52">2</E>
                         in ambient air. We note that many of these statements are simply recognizing aspects of the evidence base that illustrate the complexity of addressing deposition-related effects. For example, one statement cited by commenters as indicative of significant uncertainty that should preclude action in this review recognized that there is not a simple one-to-one relationship between ambient air concentrations and any one indicator of S or N deposition. This statement simply recognizes the complexity inherent in analyses supporting this review. This complexity relates in part to the complex atmospheric chemistry and meteorology as well as aspects of ambient air monitoring and deposition estimation datasets (ISA, Appendix 2; PA, Chapters 2 and 6). In light of these factors, as summarized in the proposal and in section II.A.2. and II.B.1.a. above, we analyzed multiple datasets that investigate relationships between concentrations for different metrics in different types of locations.
                    </P>
                    <P>
                        While we recognize the uncertainties and complexities of the evidence base and quantitative information, we have taken them into account in our evaluations, and we disagree that the available information is insufficient to permit a reasoned judgment about a secondary SO
                        <E T="52">2</E>
                         standard that may be considered to provide the appropriate protection from adverse effects on the public welfare. For example, some of the areas cited by commenters relate to uncertainty in how quickly sensitive ecosystems might respond to the already reduced deposition. While we recognize there to be uncertainty in estimates related to ecosystem response times, the EPA does not find predictions of this to be necessary in this decision, and accordingly has not considered timing of future recoveries as a factor in determining the standard that would provide the desired level of protection. Other areas cited by commenters simply recognize the inherent variability of environmental response to varying patterns of SO
                        <E T="52">2</E>
                         concentrations. The Agency has recognized this variability in its focus on a year's averaging time for the new standard, which will not be affected by short-term variability, and in its focus on medians in characterizing ecosystem deposition targets.
                    </P>
                    <P>
                        Lastly, the commenters noted uncertainty associated with the trajectory-based analysis (or EAQM approach), citing areas of uncertainty identified in the PA or proposal, and comments by the CASAC in its review of the draft PA, which stated that the description in the draft PA was insufficiently detailed and that sensitivity analyses were needed to characterize associated uncertainty. In addition to CASAC comments, these public comments quoted statements by three individual members of the CASAC Panel for this review that state there are uncertainties and shortcomings of the EAQM approach, state that there are poor correlations of S deposition with ambient air concentrations and suggest a need for peer review. With regard to correlations, we disagree that the correlation coefficients for the two SO
                        <E T="52">2</E>
                         EAQMs in the final PA analyses (0.49 and 0.56 when considering the full dataset in the final PA), which are statistically significant at the 0.05 level, are fairly characterized as “poor” (PA, Table 6-8). That said, the use of such relationships in this review is not for the development of a function to generate precise predictions of S deposition associated with individual monitor air concentrations. Rather, the analyses and the statistical significance of the deposition-to-EAQM value associations support the conclusion that higher upwind SO
                        <E T="52">2</E>
                         concentrations contribute to higher downwind S deposition. With this support, they also inform judgments regarding standard levels through consideration of the patterns of downwind deposition rates that have occurred during periods associated with different maximum upwind SO
                        <E T="52">2</E>
                         concentrations.
                    </P>
                    <P>With regard to peer review, in addition to noting the scientific peer review provided by the CASAC Panel for this review which resulted in substantial improvements in the analyses from the draft to the final PA, we also note that the trajectory analyses are based on a well-established and peer-reviewed model, HYSPLIT (Stein et al., 2015). This model, as described further in the PA, is commonly used to compute simple air parcel trajectories using historical meteorological data and to simulate the trajectories of air parcels as they are transported through the atmosphere for a given set of meteorological conditions (PA, Appendix 6A).</P>
                    <P>
                        In consideration of the robust scientific and technical peer review provided by the CASAC and its Oxides of Nitrogen, Oxides of Sulfur and Particulate Matter Secondary National Ambient Air Quality Standards Panel in their review of the draft PA, several improvements were implemented. For example, sensitivity analyses were conducted to judge the influence of key aspects of the approach employed (
                        <E T="03">e.g.,</E>
                         duration of the trajectory simulations and criteria used to identify influential upwind monitors), and findings from these analyses informed development of the trajectory-based approach for the final PA. As a result, the final PA includes substantially more detail in describing the approach and in the presentation of results, including for the various sensitivity analyses. Thus, as noted in the final PA, analyses presented in that document were revised and additional information added to address the CASAC concerns (PA, section 1.4).
                    </P>
                    <P>
                        While the PA includes multiple approaches for analyzing relationships between ambient air concentrations and ecosystem deposition of S compounds, the trajectory-based approach is the only one that accounts for pollutant transport, which is integral to how SO
                        <E T="52">2</E>
                         emissions and associated concentrations contribute to acidic precipitation and acidification of ecosystems many miles away.
                        <SU>115</SU>
                        <FTREF/>
                         Such transport modeling has been used for years, with its use verified twenty years ago by a study documenting the movement of air 
                        <PRTPAGE P="105755"/>
                        masses containing elevated concentrations of SO
                        <E T="52">4</E>
                        <E T="51">2 −</E>
                         from the Ohio River Valley to the eastern U.S. and Canada (Hennigan et al., 2006), where acid-sensitive waterbodies have been impacted by acidification (ISA, Appendix 16, section 16.2). Thus, consideration of the trajectory-based analyses by the Administrator in reaching his proposed and final conclusions rely on different analyses (from those described in the draft PA) that have been improved to address comments by the CASAC, and consideration of these analyses (in addition to the other approaches) presented in the final PA is important to identifying a secondary standard that accounts for pollutant transport to downwind sensitive ecosystems.
                    </P>
                    <FTNT>
                        <P>
                            <SU>115</SU>
                             The importance of this transport, with co-occurring transformation of SO
                            <E T="52">2</E>
                             to SO
                            <E T="52">4</E>
                            <E T="51">2 −</E>
                            , in contributing to ecosystem acidification was recognized decades ago in the 1982 AQCD for PM and SO
                            <E T="52">X</E>
                             which stated that “[b]ecause of long range transport, acidic precipitation in a particular state or region can be the result of emissions from sources in states or regions many miles away, rather than from local sources” (1982 p.m. and SO
                            <E T="52">X</E>
                             AQCD, p. 7-2; Altshuller 1976).
                        </P>
                    </FTNT>
                    <P>
                        With regard to our recognition of the uncertainties associated with issues in this review, we note that Congress and the courts have recognized that some uncertainties in assessing the effects of air pollution are inevitable, and the Administrator is required to exercise his judgment in the face of imperfect information. See, 
                        <E T="03">e.g., Lead Indus. Ass'n, Inc.</E>
                         v. 
                        <E T="03">EPA,</E>
                         647 F.2d 1130, 1155 &amp; n.50 (D.C. Cir. 1980) (quoting H.R. Rep. No. 95-294, at 50). Only when the Administrator judges that the uncertainties are so great as to preclude the ability to identify a standard that would be expected to provide the requisite protection do uncertainties justify a decision to not act. See, 
                        <E T="03">Center for Biological Diversity</E>
                         v. 
                        <E T="03">EPA,</E>
                         749 F.3d 1079, 1087 (D.C. Cir. 2014). As discussed further in section II.B.3. below, that is not the case for this standard. Thus, the EPA's judgment is that the available information, including evidence of the effect of SO
                        <E T="52">X</E>
                         on sensitive ecosystems and the analyses of transport of pollutants across airsheds, is sufficient to allow the Administrator to make a reasoned judgment about where to set a revised SO
                        <E T="52">2</E>
                         NAAQS, while recognizing that substantial uncertainties remain.
                        <SU>116</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>116</SU>
                             As recognized in section II.A. above, the Administrator's decisions in secondary NAAQS reviews draw upon scientific information and analyses about welfare effects, exposures and risks, as well as judgments about the appropriate response to the range of uncertainties that are inherent in the scientific evidence and analyses. As described in section II.B.3. below, the Administrator's decision reflects these considerations.
                        </P>
                    </FTNT>
                    <P>
                        Regarding the comment that the proposal insufficiently evaluated or discussed how the effects to be addressed by the new annual secondary standard are adverse to public welfare, we note the evidence of aquatic acidification and its effects on fisheries in lakes and streams across the northeast and Appalachian Mountains. This evidence was evaluated and documented in the current and last ISA and prior AQCDs (
                        <E T="03">e.g.,</E>
                         ISA, Appendix 8, section 8.5.2 and Appendix 16, section 16.2.3.2.1; 2008 ISA, sections 3.2.4.4 and 3.2.4.5; 1982 AQCD, section 7.1.1.1). For example, acidified aquatic habitats have a lower number of species (species richness) of fishes, including culturally and recreationally important species, as well as shifts in biodiversity of both flora and fauna. This evidence and the findings of the quantitative aquatic acidification REA, as well as the analyses of relationships between air quality and S deposition, and advice from the CASAC were considered by the Administrator in reaching his proposed decision that the existing SO
                        <E T="52">2</E>
                         standard does not provide the requisite protection of the public welfare from known or anticipated adverse effect. This information, and public comments, have also been considered in his decision on revisions to the SO
                        <E T="52">2</E>
                         standard, as discussed further in section II.B.3. below. Further, the public welfare implications of aquatic acidification-related effects, including the influence of their severity and geographic extent, on harm posed to the public welfare, are described in the PA, the proposal and section II.A.3.b. above (PA, section 4.5; 89 FR 26641-26644, April 15, 2024). In reaching his decision on the existing standard and on the revisions that would provide the requisite protection, the Administrator has considered these factors (severity and geographic extent of acidification-related effects), as well as the evidence of varying sensitivity of ecoregions across the U.S. In the end, as noted in sections I.A. and II.A. above, the CAA recognizes that judgments on effects to the public welfare that are adverse are within the purview of the Administrator in reaching his decision on secondary standards.
                    </P>
                    <P>In judging the existing standard to not provide the requisite protection of the public welfare, the Administrator has considered the evidence, evaluations in the PA, strengths and uncertainties in the evidence, and quantitative analyses. In so doing, he focused particularly on the REA findings for aquatic acidification risk estimates for the earliest part of the 20-year assessment period. With the pattern of deposition estimated for this period (when the existing standard was met), the REA found more than a third of waterbody sites in the five most affected ecoregions unable to achieve even the lowest of the three acid buffering capacity benchmarks used as risk indicators (below which the increased risk of episodic acidification events may threaten survival of sensitive aquatic species), and more than half of waterbody sites unable to meet this benchmark in the single most affected ecoregion. The Administrator judged that this level of aquatic acidification risk, associated with deposition levels estimated to have occurred when the existing standard was met, can be anticipated to cause adverse effects on the public welfare.</P>
                    <P>
                        Lastly, we disagree with the view of one commenter that the ANC benchmarks used in reaching conclusions regarding the need for protection from acid deposition relied on the judgments of others, rather than the EPA. Rather, as described in the PA and summarized in section II.A.4. above, the quantitative REA employed an array of ANC benchmarks in recognition of variation among waterbodies in their ability to achieve different benchmarks and in the associated risk to fisheries, to specifically avoid putting undue weight on a single value. In characterizing risk and levels of protection associated with different S deposition circumstances in the REA, we reported the percentages of waterbodies per ecoregion estimated to achieve the different benchmarks. The PA focused on this pattern of percentages in characterizing risk and the CASAC majority also considered this pattern in expressing its recommendations for a revised standard. Similarly, in weighing the evidence and the REA findings, the Administrator also considered these patterns and the weight to place on different benchmarks for ANC as an indicator of acidification risk, as well as the CASAC majority consideration of them in its recommendation of a range of standards expected to achieve a desired level of public welfare protection. In so doing, as described in section II.B.3. below, he judged it appropriate to consider patterns of ANC across ecoregion waterbodies, rather than limiting his judgment to consideration of a single ANC benchmark in all areas. Thus, contrary to the view of the commenter, the Administrator made all relevant judgments on the weight to place on different tools for indicating acidification risk, including ANC benchmarks in reaching a decision on the secondary SO
                        <E T="52">2</E>
                         standard.
                    </P>
                    <HD SOURCE="HD3">(c) Comments Recommending Revision To Be Identical to the Primary Standard</HD>
                    <P>
                        In disagreeing with the EPA's proposal to revise the 3-hour secondary SO
                        <E T="52">2</E>
                         standard to an annual standard for the reasons discussed in the two 
                        <PRTPAGE P="105756"/>
                        sections above, a few commenters additionally expressed support for an alternate revision that would set the secondary standard to be identical to the primary standard, in all respects. One commenter stated that this option would be supported by a finding of no locations in the U.S. that would not achieve an annual standard with a level at the low end of the proposed range. The other commenter cited comments from the minority of CASAC that also recommended this option based on a judgment that the 1-hour primary standard is currently controlling of air quality and the view that most deposition values during the period since the primary standard was established have been less than 5 kg/ha-yr. This commenter additionally quoted the EPA's March 9, 2024, technical memorandum 
                        <SU>117</SU>
                        <FTREF/>
                         regarding the highest annual average concentrations observed during the period 2017-2022 in areas that do not violate the primary standard. Additionally, one commenter expressed support for “any alternatives,” including revising the secondary standard to be identical to the primary standard in all respects, “that can be supported by the current science,” without providing further elaboration.
                    </P>
                    <FTNT>
                        <P>
                            <SU>117</SU>
                             This memorandum in the docket (Docket ID No. EPA-HQ-OAR-2014-0128-0039) describes the basis for the EPA's decision that a Regulatory Impact Analysis was not warranted for the proposed decision (89 FR 26692, April 15, 2024).
                        </P>
                    </FTNT>
                    <P>
                        While the EPA agrees with the commenters regarding the air quality and deposition estimates in recent years, the EPA considered the available quantitative analyses, including the additional analyses presented in the technical memorandum to the docket (Sales et al., 2024), and finds that a secondary standard identical to the existing primary standard (75 ppb, as the annual 99th percentile daily maximum 1-hour concentration, averaged over three consecutive years) would be expected to provide a greater stringency in SO
                        <E T="52">2</E>
                         concentrations than required to generally maintain S deposition levels of interest. As indicated by the additional analyses, a higher level (
                        <E T="03">e.g.,</E>
                         of 120 ppb) for a 1-hour standard, with averaging time and form identical to the primary standard, is associated with downwind ecoregion median S deposition levels more like those associated with an annual SO
                        <E T="52">2</E>
                         standard of 10 ppb than is such a 1-hour standard with a level of 75 ppb (Sales et al., 2024). Thus, the EPA disagrees with these commenters that a 1-hour secondary standard identical in all respects to the existing primary standard would provide the requisite protection of the public welfare, noting that it may provide more control than necessary to achieve the desired protection. As described in section II.B.3. below, the Administrator judges that an annual average standard, averaged over three years, with a level of 10 ppb can be expected to provide the needed protection of the public welfare.
                    </P>
                    <HD SOURCE="HD3">(4) Comments Regarding Retaining the Existing Secondary Standard</HD>
                    <P>
                        The very few comments that addressed the issue of retaining the existing 0.5 ppm (500 ppb) 3-hour standard recommended retention, variously noting that this standard is important for short-term direct impacts of SO
                        <E T="52">2</E>
                        , that such a standard would prevent peak episodic events, and that in the past this standard was the controlling standard for many areas and its retention would ensure those areas maintain adequate protections. With regard to protection from the short-term direct impacts of SO
                        <E T="52">2</E>
                         in ambient air, the EPA agrees that the existing standard provides such protection, as concluded by the Administrator in the proposal and by the CASAC. We further note, however, that the additional air quality analyses conducted in response to public comments indicate that in areas with SO
                        <E T="52">2</E>
                         concentrations from 2000 through 2021 that would meet an annual standard of 10 ppb (excluding Hawaii),
                        <SU>118</SU>
                        <FTREF/>
                         virtually all 3-hour standard design values (the second highest annual 3-hour concentration at regulatory monitors) are less than 0.25 ppm (Sales et al., 2024, Figure 10). These analyses further indicate that more than 99% of the highest 3-hour concentrations at monitored sites in each of the more recent years of the analysis period (2011-2021) are below 0.2 ppm (Sales et al., 2024, Table 6). Reflecting the evidence in the ISA and prior AQCDs for SO
                        <E T="52">X</E>
                        , the PA summary of the lowest short-term concentrations (
                        <E T="03">e.g.,</E>
                         over a few hours) associated with effects on plants or lichens does not include any concentrations below 0.25 ppm (PA, section 5.4.2; ISA, Appendix 3, section 3.2; 1982 AQCD, section 8.3). Together this information indicates that short-term concentrations in areas that would be expected to meet an annual standard of 10 ppb are well below those that have been associated with effects on plants or lichens. In light of information such as this, as described in section II.B.3. below, the Administrator judges that short-term peak concentrations of potential concern for welfare effects are adequately controlled by an annual average standard of 10 ppb, such that revision of the secondary standard to this annual standard provides requisite protection from both short-term effects of SO
                        <E T="52">2</E>
                         in the ambient air and effects related to the deposition of S compounds in sensitive ecosystems.
                    </P>
                    <FTNT>
                        <P>
                            <SU>118</SU>
                             This analysis excluded Hawaii where it is not uncommon for there to be high SO
                            <E T="52">2</E>
                             values in areas with recurring volcanic eruptions (PA, section 2.4.2).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">b. Nitrogen Oxides and Particulate Matter</HD>
                    <HD SOURCE="HD3">(1) Comments in Support of the Proposed Decisions</HD>
                    <HD SOURCE="HD3">(a) Nitrogen Oxides</HD>
                    <P>
                        Among the few comments received on the proposed judgment that the existing secondary NO
                        <E T="52">2</E>
                         standard provides the needed protection from direct effects of N oxides in ambient air on plant and lichen surfaces, all expressed support. In the context of ecological effects of N oxides more broadly, including deposition-related effects, several public comments expressed support for the proposed decision to retain the existing standard, which was based on the Administrator's proposed judgment that the available evidence does not clearly call into question the adequacy of the existing standard. In expressing support for the proposed decision, commenters raised several uncertainties, referencing the discussion in the proposal. These uncertainties include those related to the weak relationship between NO
                        <E T="52">2</E>
                         concentrations and N deposition; the increasing contribution of NH
                        <E T="52">3</E>
                         to N deposition; the expected impacts of current deposition levels absent residual historic impacts and the identification of appropriate protection objectives in this context of changing conditions; and the role of N benefits and disbenefits. We agree that these are important uncertainties in the evidence base, and, as discussed in section II.B.3. below, these factors are among those the EPA considered in reaching the decision to retain the existing NO
                        <E T="52">2</E>
                         standard.
                    </P>
                    <P>
                        Some other commenters, in support of their position that the N oxides standard should not be revised, further expressed the view that N oxides emissions is one of the principal sources of acidic compounds and that the EPA lacks authority to set standards based on acidic deposition, citing CAA section 401(a). As discussed in section II.B.2.a.(3)(a) above, the EPA disagrees with the view that NAAQS cannot be established to provide protection for acidic deposition-related effects. We additionally note the REA conclusion, however, that under current air quality and based on the current information, as discussed in section 5.1.2.4 and 
                        <PRTPAGE P="105757"/>
                        Appendix 5A, section 5A.2.1 of the PA, the contribution of N compounds to acidification is negligible.
                    </P>
                    <HD SOURCE="HD3">(b) Particulate Matter</HD>
                    <P>
                        Among the public comments on the proposed decisions to retain the current secondary PM standards, only a few were received on the proposed judgment that the existing secondary PM standards provide the needed protection from the effects of PM in ambient air associated with direct contact with and loading onto plant and lichen surfaces. All of these comments expressed support for that judgment. In the context of ecological effects of PM more broadly, including deposition-related effects, comments received in support of the Administrator's proposed decision to retain the current secondary PM standards, without revision, generally noted aspects of the rationale presented in the proposal. For example, some comments noted uncertainties in the relationship between concentrations of PM
                        <E T="52">2.5</E>
                         and deposition of N or S compounds. One comment, focused on the PM
                        <E T="52">10</E>
                         standard, expressed the view that the scientific information does not support revision of the PM
                        <E T="52">10</E>
                         standard. The EPA agrees with the view that the available information does not support revision of the PM NAAQS.
                    </P>
                    <P>In support of their position that the PM standards should not be revised, one commenter, noting a PA statement regarding PM components that may contribute to ecosystem acidification risk, expressed the view that the EPA lacks authority to set standards based on acidic deposition. As discussed in section II.B.2.a.(3)(a) above, the EPA disagrees with the view that NAAQS cannot be established to provide protection from acidic deposition-related effects. Accordingly, as discussed in section II.B.3. below, the decision to retain the existing PM standards without revision is not based on such a premise.</P>
                    <HD SOURCE="HD3">(2) Comments in Disagreement With the Proposed Decisions</HD>
                    <P>
                        Most of the comments received in opposition to the proposed decisions to retain the existing secondary NO
                        <E T="52">2</E>
                         and PM standards, without revision, expressed the view that the standards should be revised to address N deposition and associated effects. Some of these comments additionally take note of the information indicating that the contribution of reduced N compounds has increased such that NH
                        <E T="52">4</E>
                        <SU>+</SU>
                         is a greater contributor to N deposition than in the past. Further, some commenters expressed the views that the CAA supports a standard in terms of N deposition and that the CAA also supports consideration of NH
                        <E T="52">3</E>
                         as a criteria pollutant.
                    </P>
                    <HD SOURCE="HD3">(a) Nitrogen Deposition</HD>
                    <P>
                        Most of the commenters that disagreed with the proposed decisions on the secondary standards for N oxides and PM focus on N deposition and related effects in describing their rationales. Some commenters expressed the view that current N deposition is having impacts on resources in national parks (including parks that are also Class I areas); this comment is addressed in section II.B.2.b.(2)(b) below. These commenters also generally expressed the view that setting a deposition standard would be the best and/or a more scientifically defensible approach to standard setting, noting the CASAC advice in this regard. In so doing, one group of commenters noted the increasing role of NH
                        <E T="52">3</E>
                         in N deposition in recent times and expressed the view that the most effective way to address the NH
                        <E T="52">3</E>
                         contribution to N deposition and associated effects would be to set a standard in terms of total N deposition. Some other commenters expressed disagreement with the CASAC advice regarding establishment of a deposition standard under section 109 of the CAA, stating that given the EPA's definition of ambient air as a portion of the atmosphere, an ambient air standard cannot be defined in terms of deposition rate.
                    </P>
                    <P>
                        As also discussed in section II.B.2.a.(3)(a) above, we disagree with the premise that the CAA supports setting a NAAQS in terms of rates of deposition of a pollutant from the air onto surfaces. In addition, it is important to note that the criteria pollutants under review are PM and oxides of nitrogen, not nitrogen. Thus, the EPA is reviewing the standards intended to address the anticipated effects resulting from the presence of PM and N oxides in the ambient air, not the anticipated effects of NH
                        <E T="52">3</E>
                         in the ambient air, nor the effects of total N deposition in aquatic and terrestrial ecosystems generally. With regard to setting a NAAQS in terms of deposition rate, the commenters note the view of the CASAC in claiming the Act does not prevent the EPA from setting a standard in terms of atmospheric deposition rates. In so claiming, and in expressing their view on interpretation of the term “level of air quality,” the commenters indicate that the term might variously (depending on the impact a pollutant has on the public welfare) be interpreted as “the pollution carried in the air that is deposited,” or the pollutant suspended in the air. Without further explanation, the commenters cite section 108 of the CAA as providing support for such a view.
                    </P>
                    <P>
                        We disagree with the commenter's interpretation of the Act. The EPA agrees that under section 108 the air quality criteria shall “reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of such pollutant in the ambient air.” However, (as noted in section I.A above) section 109(b)(2) of the Act specifies that “[a]ny national secondary ambient air quality standard prescribed under subsection (a) shall specify a level of air quality the attainment and maintenance of which in the judgment of the Administrator, based on such criteria, is requisite to protect the public welfare from any known or anticipated adverse effects associated with the presence of such air pollutant in the ambient air.” Consistent with this statutory direction, the EPA has always understood the goal of the NAAQS is to identify a requisite level of air quality, and the means of achieving a specific level of air quality is to set a standard expressed as a concentration of a pollutant in the ambient air, such as in terms of parts per million (ppm), parts per billion (ppb), or micrograms per cubic meter (μg/m
                        <SU>3</SU>
                        ). Additionally, as noted by some other commenters, the definition of ambient air in 40 CFR 50.1(e) describes ambient air as a portion of “the atmosphere” (“external to buildings, to which the general public has access”).
                        <SU>119</SU>
                        <FTREF/>
                         Thus, taking section 108 and section 109 together, the EPA concludes that deposition-related effects are included within the “adverse effects associated with the presence of such air pollutant in the ambient air,” but the standard itself must define a level of air quality. The EPA disagrees that a standard that quantifies atmospheric 
                        <PRTPAGE P="105758"/>
                        deposition onto surfaces qualifies as such an air quality standard.
                    </P>
                    <FTNT>
                        <P>
                            <SU>119</SU>
                             In expressing their disagreement with the CASAC position that a NAAQS in terms of deposition rate is supported by the Act, some commenters emphasize that deposition is a process rather than a “level of air quality” as specified by section 109 of the CAA, and also cite the definition of ambient air under 40 CFR 50.1(e). These commenters additionally express the view that if the CASAC's position were correct and the Act supported NAAQS in terms of deposition rate, then Congress would not have adopted title IV of the Act to address control of acid deposition. We do not agree with this latter view. Regardless of the role of NAAQS or of a potential role of acid deposition standards, as discussed more fully in section II.B.2.a.(3)(a), the action of Congress in adopting title IV into the Act simply provided the EPA with additional tools to address the problem of acid deposition more effectively.
                        </P>
                    </FTNT>
                    <P>
                        In support of their disagreement with the EPA's proposed decisions to retain the NO
                        <E T="52">2</E>
                         and PM
                        <E T="52">2.5</E>
                         standards without revision, commenters claim that the EPA's “approach to N deposition” is unlawful and arbitrary because in their view if NH
                        <E T="52">3</E>
                         is a precursor to PM then, under the definition of “air pollutant” in CAA section 302(g), NH
                        <E T="52">3</E>
                         “effectively” becomes a criteria pollutant. The EPA disagrees that precursors to criteria pollutants should be themselves treated as criteria air pollutants for all purposes. Section 108 of the Act is quite explicit that only air pollutants that have been listed by the Administrator are criteria air pollutants, and the Administrator has never listed NH
                        <E T="52">3</E>
                         as a criteria pollutant. Of course, criteria air pollutants may have precursors and in considering strategies to attain and maintain the NAAQS, it is important to understand whether criteria pollutants are emitted into the air or formed in the atmosphere from precursor pollutants. However, those precursors are controlled to attain and maintain the NAAQS for the criteria pollutants—not because they themselves “effectively” become criteria pollutants that must be controlled.
                        <SU>120</SU>
                        <FTREF/>
                         For example, in some areas, ozone formation is NO
                        <E T="52">X</E>
                         limited, such that controls on VOC emissions may have little or no impact on ozone formation. State implementation plans for such an area will differ from those in an area where ozone formation is VOC-limited, because control of precursors is a means to the end of controlling ozone.
                        <SU>121</SU>
                        <FTREF/>
                         It would be unnecessary to require controls on both VOCs and NO
                        <E T="52">X</E>
                         in every area simply to control ozone. Thus, EPA disagrees that it should treat every precursor, including NH
                        <E T="52">3</E>
                        , as a criteria pollutant.
                    </P>
                    <FTNT>
                        <P>
                            <SU>120</SU>
                             To the extent CAA section 302(g) is relevant it simply provides discretion to the Administrator to treat precursors as pollutants where appropriate. While treating precursors as pollutants may be appropriate in some circumstances when implementing the NAAQS, the Administrator does not find it appropriate to treat precursors as criteria pollutants for purposes of reviewing and revising the NAAQS.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>121</SU>
                             Additionally, precursors may be regulated in their own right as pollutants. For example, oxides of nitrogen are both a criteria pollutant and precursors to ozone, and VOCs may be regulated both as NESHAP and as ozone precursors. See CAA section 112(b)(2). However, in those cases the pollutant has independently satisfied the prerequisites for regulation under the relevant programs.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(b) Nitrogen Oxides</HD>
                    <P>
                        The public comments that disagreed with the proposed decision to retain the secondary NO
                        <E T="52">2</E>
                         standard, without revision, expressed support for revision of the standard level to a value within the range that was recommended by the CASAC majority, with some commenters additionally citing the CASAC majority comments on the draft PA. In support of the position that the NO
                        <E T="52">2</E>
                         standard should be revised as recommended by the CASAC majority, commenters variously claimed that in not revising the standard, the EPA is not fully considering CASAC recommendations, or that the scientific evidence for N deposition demonstrates “harmful” or concerning impacts of current N deposition in national parks. Also, some of the commenters that support revision of the NO
                        <E T="52">2</E>
                         standard to a level within the range recommended by the CASAC majority (“&lt;10-20 ppb”) stated that the existing standard does not include all forms of nitrogen that contribute to acidification, eutrophication, or nutrient enrichment, and the standard would need to be much lower in consideration of relationships with total nitrogen deposition. One comment also expressed support for both retaining the existing standard and for revising the standard to a level of 35-40 ppb, averaged over three years, “as supported by the scientific evidence,” without elaboration. Another comment recommended revision of the indicator of the existing standard to include nitric oxide (NO) in addition to NO
                        <E T="52">2</E>
                        , while recommending no other revisions.
                    </P>
                    <P>
                        We disagree with the commenters' position that the NO
                        <E T="52">2</E>
                         standard needs revision to provide public welfare protection from total N deposition. As an initial matter, we note that, as discussed in section II.B.2.b.(2)(a) above, not all nitrogen compounds are criteria pollutants and accordingly, the CAA does not require the consideration of NAAQS for all N compounds or for total N deposition. Further, the secondary standard for N oxides is not required by the Act to address pollutants other than N oxides. Additionally, the air quality and deposition analyses developed in this review (
                        <E T="03">e.g.,</E>
                         PA, Chapter 6 and Sales et al., 2024) describe appreciable geographic (and temporal) variation in the portion of total N deposition contributed by N oxides, potentially explaining the poor or lack of correlation between NO
                        <E T="52">2</E>
                         concentrations and total N deposition observed in the PA analyses,
                        <SU>122</SU>
                        <FTREF/>
                         which indicates that a NO
                        <E T="52">2</E>
                         standard would have little likelihood of efficacy in such a use.
                    </P>
                    <FTNT>
                        <P>
                            <SU>122</SU>
                             For example, as recognized by the CASAC majority “when considering all ecoregions, there is no correlation between annual average NO
                            <E T="52">2</E>
                             and N deposition” (Sheppard, 2023, Response to Charge Questions, p. 24). The final PA reported negative correlation coefficients for both NO
                            <E T="52">2</E>
                             EAQMs and a coefficient below 0.4 for SLAMS NO
                            <E T="52">2</E>
                             concentrations.
                        </P>
                    </FTNT>
                    <P>
                        One commenter stated that the current N deposition is resulting in harm to national park resources and expressed the view that the scientific evidence of N deposition adverse effects outweighs uncertainties associated with N critical loads. In so doing, the commenter claimed that justifications described in the PA for the option of retaining the NO
                        <E T="52">2</E>
                         standard, without revision, included (1) a lack of clarity of the role of current and legacy deposition in causing harm, and (2) the position that CLs involve designations of harm based on “arbitrary” levels of change. In so stating, the commenter conveyed their view that CLs are often based on studies that they stated demonstrate that reducing N deposition improves the resource condition even if N deposition continues to exceed a resource-specific CL.
                    </P>
                    <P>
                        As an initial matter, the EPA disagrees that the PA conclusions relied on a judgment that critical loads are “arbitrary” to support the option of retaining the NO
                        <E T="52">2</E>
                         standard and notes that is also not part of the basis for the proposed decision to retain this standard. As described in sections II.A.3.c. and II.B.2.a.(2)(a), the EPA recognizes the usefulness of the CL concept in appropriate contexts and has utilized CLs in the aquatic acidification REA. The findings from the REA, based on the use of CLs for a set of ANC benchmarks, are a critical aspect of the Administrator's decision on the secondary SO
                        <E T="52">X</E>
                         standard, as discussed in section II.B.3. below. Thus, while this concept can inform decision-making in NAAQS reviews, the science policy judgments associated with secondary NAAQS decisions, including those regarding risk levels associated with CL values and the weight to place on the evidence supporting them (with its various limitations and associated uncertainties), are to be made by the Administrator. The EPA does not agree with the view that a deposition rate identified as a CL is necessarily synonymous with environmental loading anticipated to elicit effects that are adverse to public welfare. Simply being labelled a CL does not confer such a status on a level of ecosystem loading without, for example, consideration of the strength of the evidence on which the CL is based, and a characterization of the ecological response (including severity and scale) for which it is estimated.
                        <PRTPAGE P="105759"/>
                    </P>
                    <P>
                        In making their statement that assignment of a “poor” or “fair” conditions rating indicates impacts on national park resources, the commenter referred to a National Park Service technical analysis of “park-specific critical loads” and deposition, without providing that analysis or describing the basis for their judgments of harm for instances when estimated deposition in a specific area exceeds the critical loads they have derived.
                        <SU>123</SU>
                        <FTREF/>
                         In addition, the commenter also did not provide any evidence specific to N oxides or deposition of oxidized N to support their claim regarding the N oxides standard. Rather the comment implied the view that impacts associated with total N deposition are attributable to N oxides. We disagree with the commenter's view that deposition from N oxides under the existing standard is causing harm. As described in the proposal (section II.E.3.), in the PA, and, in greater detail, in the additional analyses presented in Sales et al. (2024), for the areas of highest total N deposition, such as areas where average total N deposition is above 10 kg/ha-yr, which is the benchmark emphasized by the CASAC in making its recommendations regarding standards to address the ecological effects of N compounds (as described in section II.B.1.b. above), oxidized N is no longer playing the leading role. Rather, reduced N contributes the majority of N deposition in these areas.
                        <SU>124</SU>
                        <FTREF/>
                         Unlike the situation in 2000-2002, when oxidized N deposition accounted for up to approximately 80% of total N deposition, on average, in States with average total N deposition greater than 10 kg/ha-yr, oxidized N deposition is now approximately half or less of total N deposition (Sales et al., 2024, Table 5). In fact, in the most recent period analyzed (2019-2021), mean oxidized N deposition is below 5 kg/ha-yr in all States of the CONUS; this is also the case for median oxidized N deposition in all CONUS ecoregions (Sales et al., 2024).
                    </P>
                    <FTNT>
                        <P>
                            <SU>123</SU>
                             The comment did not discuss why this approach to assigning a “poor,” or other than “good,” rating is evidence of N deposition-related impacts that could be addressed by revision of the NO
                            <E T="52">2</E>
                             or PM
                            <E T="52">2.5</E>
                             national ambient air quality standards or that indicates a potential for adverse effect to the public welfare.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>124</SU>
                             For example, in the 14 ecoregions with median N deposition estimated to be above 10 kg/ha-yr in the 2019-2021 period, reduced N comprises more than 50% of total N deposition (Sales et al., 2024, Table 3).
                        </P>
                    </FTNT>
                    <P>
                        Another group of commenters also referenced the National Park Service descriptions of park conditions related to N (and S) deposition in stating that 95% of parks are experiencing wet deposition of N greater than 1 kg/ha-yr. They claimed that the occurrence of this level of deposition indicates harmful impacts to park soil, waterbodies and associated wildlife and indicated that such an occurrence supports their position that the secondary NO
                        <E T="52">2</E>
                         (and PM) standards should be revised as recommended by the CASAC majority. As support for the 1 kg/ha-yr benchmark below which a “good” condition is assigned (and above which is assigned a “fair” or “poor” rating which the commenters characterized as indicative of harm), the commenters cited two studies.
                    </P>
                    <P>
                        The EPA notes, however, that the cited studies are limited in scope (to a lake in Washington State and a group of high-altitude lakes in some western and eastern regions) and include judgments by the authors of specific measures on which the authors base their CLs. One of the two studies actually identifies CLs ranging up to 8 kg/ha-yr (Baron et al., 2011).
                        <SU>125</SU>
                        <FTREF/>
                         Yet, the comment focuses on 1 kg/ha-yr, without consideration of 8 kg/ha-yr. In light of the limited scope of these studies, and the fact that a number of the identified CLs exceed 1 kg/ha-yr, among other factors, the EPA does not agree that these studies provide a basis for concluding that adverse public welfare effects are occurring in 95% of parks based on estimated deposition at/above 1 kg/ha-yr (a level far below the level referenced by the CASAC majority in advice regarding protective standards). These commenters also did not indicate how the National Park Service assignments of conditions in parks support the position that the NO
                        <E T="52">2</E>
                         standard should be revised to a level of &lt;10-20 ppb, and we are unaware of any linkage. Further, as noted above, an appreciable amount of total N deposition is deposition of reduced N which is not influenced by N oxides in ambient air and consequently would not be affected by changes in a NAAQS for N oxides.
                    </P>
                    <FTNT>
                        <P>
                            <SU>125</SU>
                             This study estimates multiple CLs that differ for nutrient enrichment- and acidification-related effects and for eastern and western lakes, relying on data generally dating from 1997 to 2006 (Baron et al., 2011). The second study uses a lake sediment core indicating a period of changed phytoplankton composition, estimated to be around 1969-75, and N deposition estimates for the 1969-75 period (Sheibley et al., 2014).
                        </P>
                    </FTNT>
                    <P>
                        With regard to acidification risk posed by deposition of N compounds, we additionally note the REA finding that recent deposition conditions indicate negligible contribution of N compounds to aquatic acidification risk. Accordingly, as discussed in section II.B.3. below, the decision to revise the SO
                        <E T="52">2</E>
                         standard is intended to address the main contributor to ecosystem acidification, S compounds associated with ambient air concentrations of SO
                        <E T="52">X</E>
                        . Thus, in consideration of the preceding discussion and other factors further discussed in section II.B.3. below, the Administrator judges that, based on the available evidence in this review, revision to the secondary annual NO
                        <E T="52">2</E>
                         standard is not warranted.
                    </P>
                    <P>
                        The commenter recommending revision of the standard indicator to include NO, in addition to NO
                        <E T="52">2</E>
                        , expressed the view that the EPA should not assume that effects reported to be associated with short-term NO
                        <E T="52">2</E>
                         concentrations in ambient air have no relationship to NO, which the commenter stated is also present in ambient air. In so doing, the commenter cited a controlled human exposure study of diesel exhaust and brain function indicator changes, additionally cites an epidemiologic study that reports an association of health care costs with ambient air concentrations of NO
                        <E T="52">2</E>
                         and NO and noted that NO concentrations are higher than NO
                        <E T="52">2</E>
                         concentrations (in terms of ppb) in areas near traffic or oil and methane gas extraction activities. The EPA disagrees with the commenter that the effects on which the commenter focused—subtle changes in cellular activity in a specific region of human brain as reported in a controlled human exposure study of short-duration diesel exhaust exposures (in which NO
                        <E T="52">2</E>
                         [but not NO] was one of the components analyzed) and health care costs—are welfare effects; thus, their relevance for this review is unclear.
                    </P>
                    <P>
                        Further, in support of their statement that NO
                        <E T="52">2</E>
                         concentrations in ambient air have no relationship to NO concentrations,
                        <SU>126</SU>
                        <FTREF/>
                         the commenter simply referenced tables of hourly NO and NO
                        <E T="52">2</E>
                         concentrations available from Colorado Department of Public Health and Environment, which are clearly labeled as data collected in real-time that “have not been corrected nor validated.” We note that, although the data have not been validated, they generally illustrate the expected diurnal pattern for these pollutants near combustion sources (
                        <E T="03">e.g.,</E>
                         with NO initially increasing with morning traffic, and then declining as it is converted to NO
                        <E T="52">2</E>
                         [1971 AQCD, p. 6-1]). While recognizing these common patterns in the relationship between the two 
                        <PRTPAGE P="105760"/>
                        chemicals, we further note that the form of the existing standard is an annual average, and the commenter did not provide validated data or analyses that might assess the existence of a, or support their view that there is no, relationship between annual average concentrations of NO and NO
                        <E T="52">2</E>
                        .
                    </P>
                    <FTNT>
                        <P>
                            <SU>126</SU>
                             In describing their position that the indicator should be revised, the commenter also suggests that the NAAQS ambient air monitoring system is inadequate. The commenter provided no evidence in support of this suggestion, and we continue to find that the current ambient air monitoring network for NAAQS is appropriate.
                        </P>
                    </FTNT>
                    <P>
                        The comment also does not include any information related to concentrations of either pollutant, or both in combination, at which welfare effects of concern may occur and relate that to ambient air concentrations associated with the existing secondary NO
                        <E T="52">2</E>
                         standard. The evidence in 1971 when the existing standard was set describes the conversion of NO to NO
                        <E T="52">2</E>
                         in the presence of oxygen, with NO
                        <E T="52">2</E>
                         being the more stable air pollutant away from sites of combustion and the one for which analytical methodology existed for its direct analysis at that time (1971 AQCD). While there is a study from the mid-1980s for effects of NO on photosynthesis, which indicates a potential for greater toxicity of NO to some plant species, the NO concentrations reported for this study are nearly two orders of magnitude greater than those found in ambient air. Further, the vegetation effects evidence base is much more extensive (with regard to species and specific effects studied) for NO
                        <E T="52">2</E>
                         and includes studies that investigate both NO and NO
                        <E T="52">2</E>
                         together (ISA, Appendix 3, section 3.3). The NO
                        <E T="52">2</E>
                         standard is intended to provide protection from anticipated effects of oxides of nitrogen, including NO and NO
                        <E T="52">2</E>
                        , but the commenter does not provide a basis for concluding that an annual average NO
                        <E T="52">2</E>
                         standard is insufficient to provide the requisite protection. Thus, we find no support in the available information in this review that might support their claim that the existing standard should be revised to be an annual average concentration of 53 ppb, in terms of the sum of NO and NO
                        <E T="52">2</E>
                        .
                    </P>
                    <HD SOURCE="HD3">(c) Particulate Matter</HD>
                    <P>
                        Comments opposed to the proposed decision to retain the secondary PM standards generally focused on PM
                        <E T="52">2.5</E>
                         and called for more stringent secondary standards. In so doing, these commenters cited the specific PM
                        <E T="52">2.5</E>
                         standard revisions recommended by the CASAC majority, summarized in II.B.1.b. above. With regard to the annual PM
                        <E T="52">2.5</E>
                         standard, these commenters also discussed analyses presented in the PA, which they stated provide support to the use of the annual PM
                        <E T="52">2.5</E>
                         standard to address total N deposition. In support of a revision to the PM
                        <E T="52">2.5</E>
                         standard, some commenters noted the increased role of NH
                        <E T="52">3</E>
                         in total N deposition, including in estuaries and coastal waters where eutrophication has been reported or in national parks. These commenters expressed the view that the contribution of NH
                        <E T="52">3</E>
                         to N deposition and related effects can be addressed through revisions to the PM
                        <E T="52">2.5</E>
                         standard. In so doing, they further stated that the EPA's proposed decision to retain the existing standard is based on uncertainties and complexities related to NH
                        <E T="52">3</E>
                         and that such uncertainties and complexities are an insufficient basis for retaining the existing standard, additionally citing a 2002 court decision regarding EPA acting when it has enough information to do so (
                        <E T="03">Am. Trucking Ass'ns</E>
                         v. 
                        <E T="03">EPA,</E>
                         283 F.3d 355, 380 [D.C. Cir. 2002]). In support of their position, the commenters stated that the EPA must act when enough information is available to anticipate such effect, and deciding not to revise is inconsistent with the Act's protective direction. Commenters additionally suggest that the EPA inappropriately imposed limits on its consideration of the trajectory-based analyses so as to provide support for the EPA conclusion that the NO
                        <E T="52">2</E>
                         and PM
                        <E T="52">2.5</E>
                         metrics do not provide adequate vehicles for regulating N deposition. Another commenter, in support of their position that the existing PM
                        <E T="52">2.5</E>
                         standards should be revised as recommended by the CASAC majority, expressed the view that reduced N deposition has become the dominant form of N deposition, which they stated is impacting national park resources in many areas of the U.S. such that a revised standard would help to reduce such pollutants. Additionally, a comment recommending revision of the PM
                        <E T="52">2.5</E>
                         standard stated that the range of revised levels suggested by the CASAC majority would keep S deposition below 5 kg/ha-yr and N deposition at or below 10 kg/ha-yr and stated that the CASAC majority range was based on NADP and IMPROVE monitoring data and modeled results, without further explanation. Another comment recommended revision of the annual PM
                        <E T="52">2.5</E>
                         standard to 12 μg/m
                        <SU>3</SU>
                        ,
                        <SU>127</SU>
                        <FTREF/>
                         based on their view that it would add no additional requirements and could streamline implementation plan development and compliance. Lastly, some commenters additionally expressed that the 24-hour PM
                        <E T="52">2.5</E>
                         standard should be revised, again citing recommendations from the CASAC majority and protection against short-term episodic deposition and visibility impairment.
                    </P>
                    <FTNT>
                        <P>
                            <SU>127</SU>
                             This was also the advice of the CASAC minority, with 12 μg/m
                            <SU>3</SU>
                             being the level of the annual primary standard when CASAC provided its advice.
                        </P>
                    </FTNT>
                    <P>
                        For the reasons stated below, elsewhere in section II.B.2., in section II.B.3. and in the Response to Comments document, the EPA disagrees that these comments provide a sufficient justification for revising the PM secondary standards. In support of their position that the PM
                        <E T="52">2.5</E>
                         standard is an appropriate tool for controlling particulate N and should be revised to a value within the range of 6 to 10 μg/m
                        <SU>3</SU>
                         recommended by the CASAC majority, some commenters state that NH
                        <E T="52">4</E>
                        <SU>+</SU>
                         has been increasing in cloud water and in PM
                        <E T="52">2.5</E>
                         and reference statistically significant correlation coefficients for total N deposition estimates and concentrations of PM
                        <E T="52">2.5</E>
                         mass (and N components) in remote Class I areas (PA, Figure 6-32), which they suggest supports their view that use of PM
                        <E T="52">2.5</E>
                         “as an ambient air quality indicator to total nitrogen deposition is not unreasonable.” They also claim that Figure 6-32 in the final PA, and Figure 6-33 presenting total N deposition estimates versus total particulate N and NH
                        <E T="52">4</E>
                        <SU>+</SU>
                         at 27 Class I area sites, provide support for the CASAC majority recommendation on revising the PM
                        <E T="52">2.5</E>
                         standard, which they endorse.
                    </P>
                    <P>
                        As an initial matter, we disagree with the view that effects of total N deposition (from all contributing pollutants) are a determinative consideration in judging the adequacy of the secondary PM
                        <E T="52">2.5</E>
                         standard, as discussed in section II.B.2.b.(2)(a) above. Further, we disagree that NH
                        <E T="52">4</E>
                        <SU>+</SU>
                         in PM
                        <E T="52">2.5</E>
                         has been increasing, finding instead that the contribution of NH
                        <E T="52">4</E>
                        <SU>+</SU>
                         to PM
                        <E T="52">2.5</E>
                         mass at sites across the U.S. has been decreasing over the past decade (Sales et al., 2024). Further, to the extent the commenters are claiming the CASAC majority recommended range of annual PM
                        <E T="52">2.5</E>
                         standard levels, which they endorse, to be supported by the pattern of PM
                        <E T="52">2.5</E>
                         concentrations and total N deposition estimates at 27 Class I area IMPROVE monitoring sites (in either draft PA Figure 6-13 or final PA Figure 6-32), we disagree that this information provides a basis for decisions on the standard. The commenters are overlooking several relevant aspects of the available information.
                        <FTREF/>
                        <SU>128</SU>
                          
                        <PRTPAGE P="105761"/>
                        Particularly important is that the monitoring sites represented by these figures comprise just a small subset of the more than a thousand PM
                        <E T="52">2.5</E>
                         monitoring sites across the U.S., and this subset of monitors is in remote areas. Accordingly, these monitors are not in areas where PM
                        <E T="52">2.5</E>
                         concentrations are highest. Thus, the PM
                        <E T="52">2.5</E>
                         concentrations in the remote area figure are not representative of PM
                        <E T="52">2.5</E>
                         concentrations that would need to be controlled to limit deposition across the U.S., including in these areas. Such deposition is necessarily related to atmospheric transport, among other factors, and a focus solely on remote areas cannot be expected to identify the level for a PM
                        <E T="52">2.5</E>
                         standard (that would need to be met across the U.S.) with the potential to yield the desired deposition rate in these areas. This is because at the time of the deposition levels observed in these areas, the PM
                        <E T="52">2.5</E>
                         concentrations are higher in areas not represented in the figure that may contribute to deposition at the sites in the figure (and at other sites).
                        <SU>129</SU>
                        <FTREF/>
                         Further, the PA analyses of N deposition and PM
                        <E T="52">2.5</E>
                         concentrations at SLAMs also do not provide a basis for identifying 3-year average annual PM
                        <E T="52">2.5</E>
                         concentrations that might be expected to constrain nearby N deposition below certain target levels (
                        <E T="03">e.g.,</E>
                         PA, Figure 6-39).
                        <SU>130</SU>
                        <FTREF/>
                         For all of these and related reasons, the Administrator, in making his proposed and final judgments regarding the secondary PM standards, did not find the CASAC majority focus on remote area analyses to be informative in making decisions on the annual PM
                        <E T="52">2.5</E>
                         standard.
                    </P>
                    <FTNT>
                        <P>
                            <SU>128</SU>
                             One aspect overlooked is that the PA Figure 6-32 cited by the commenter in referencing correlation coefficients presents a different metric than the figure in the draft PA cited by the CASAC majority in conveying its PM
                            <E T="52">2.5</E>
                             standard recommendations. Figure 6-13 in the draft PA that was cited by the CASAC majority presents 3-year average concentrations of data from 2002 to 2019 (using different 3-year periods than those used throughout the rest of the PA), while the final figure 
                            <PRTPAGE/>
                            in the final PA presents annual averages from 2000 to 2019 (PA, Figure 6-32).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>129</SU>
                             In the period from 2014 through 2019 (the period emphasized in the CASAC majority justification that relied on draft PA Figure 6-13) when TDep estimated N deposition is at/below 10 kg/ha-yr and annual average PM
                            <E T="52">2.5</E>
                             concentrations are at/below 10 μg/m
                            <SU>3</SU>
                             at the 27 Class I area sites, annual average PM
                            <E T="52">2.5</E>
                             concentrations are much higher in other areas of the U.S. that are more fully represented in the regulatory monitoring network (PA, Figure 2-37). As indicated by recent PM
                            <E T="52">2.5</E>
                             design values, the highest concentrations sites are generally in the far west of the country, which given prevailing wind patterns, are generally upwind from the Class I areas (PA, Figures 2-31 and 2-32).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>130</SU>
                             Concentrations at SLAMS from just above 15 μg/m
                            <SU>3</SU>
                             down to approximately 4 μg/m
                            <SU>3</SU>
                             since 2010 had nearby total N deposition (in same grid cell) both above and at/below 10 kg/ha-yr (PA, Figure 6-39), and the SLAMS analyses did not provide information on ecoregion median deposition for the ecoregion of SLAMS monitor.
                        </P>
                    </FTNT>
                    <P>
                        Regarding the commenters' criticism of the EPA's consideration of the trajectory-based analyses for N deposition and the PM
                        <E T="52">2.5</E>
                         metric, we note that the commenters do not identify a technical flaw in EPA's considerations or state what they conclude from the trajectory-based analyses and how they do so. The EPA has fully considered the trajectory-based analysis results presented in the PA (PA, section 6.2.4.2, 6.4, 7.2.3.3 and 7.4) and summarized in section II.A.2. above. We note that, while, when considering the full dataset, there is a positive correlation of downwind total N deposition and upwind values of the EAQM-weighted metric, with a low-moderate coefficient value, the correlation coefficient value is essentially zero in the most recent time period (PA, Table 6-11). And, importantly, there is a poor and negative correlation for the EAQM-max metric; this correlation is negative both for the overall dataset inclusive of all five time periods and for each of the five time periods individually (PA, Table 6-11). Thus, we disagree with commenters that we have inappropriately or inadequately considered the trajectory-based analyses for PM
                        <E T="52">2.5</E>
                         and N deposition. Also, rather than limiting consideration of these results to a narrow temporal window, as claimed by the commenters, we have considered multiple aspects of the full results. As described in section II.B.3. below, these considerations were part of the basis for the Administrator's conclusion on the PM standards.
                    </P>
                    <P>
                        Also overlooked by the commenters is the fact, as discussed in section II.A.2. above, that the percentage of PM
                        <E T="52">2.5</E>
                         mass comprised of N compounds is no higher than about 30% in the recent period, and ranges down to less than 5% across the U.S., varying widely from region to region (PA, Figure 6-56 [upper panel]; Sales et al., 2024). We note that focus by the commenters (and the CASAC majority) on a small subset of the PM
                        <E T="52">2.5</E>
                         monitors across the U.S. (
                        <E T="03">i.e.,</E>
                         monitors in 27 Class I area sites [PA Figure 6-32]) would not necessarily reflect the variability of PM
                        <E T="52">2.5</E>
                         mass composition occurring across the U.S. Nonetheless, the percentage of PM
                        <E T="52">2.5</E>
                         mass comprised of N compounds affects the extent to which a particular level for an annual secondary PM
                        <E T="52">2.5</E>
                         standard levels can be expected to control N deposition rates to meet a particular objective for protection from deposition-related effects. As described in section I.A. above, the Administrator is required to set a NAAQS that is neither more stringent nor less stringent that necessary. Given the fact that up to 95% of PM
                        <E T="52">2.5</E>
                         in some regions of the U.S. (and no more than 70% in others) is not N compounds, we are unable to make a reasoned judgment about levels of N deposition that would result from control measures to reduce PM
                        <E T="52">2.5</E>
                         concentrations to any particular level. In fact, based on the information available, annual average PM
                        <E T="52">2.5</E>
                         concentrations could be reduced in some areas, 
                        <E T="03">e.g.,</E>
                         to meet a lower standard, without reducing concentrations of the N components of PM
                        <E T="52">2.5</E>
                         and, therefore, without affecting N deposition derived from PM
                        <E T="52">2.5</E>
                        . Thus, contrary to the commenters' claims, including that revision to a level within the CASAC majority recommended range would keep N deposition at or below 10 kg/ha-yr, the current information indicates that a PM
                        <E T="52">2.5</E>
                         standard would not be expected to provide effective control of particulate N compounds.
                    </P>
                    <P>
                        With regard to the comment that the EPA should revise the PM
                        <E T="52">2.5</E>
                         standard to address the effects of N deposition contributed by NH
                        <E T="52">3</E>
                        , we first note that while some NH
                        <E T="52">3</E>
                         (a gas) transforms to NH
                        <E T="52">4</E>
                        <SU>+</SU>
                         (a particulate N compound in PM
                        <E T="52">2.5</E>
                        ), some NH
                        <E T="52">3</E>
                         is directly deposited in dry deposition. Further, some NH
                        <E T="52">3</E>
                         is captured in raindrops, where it transforms into NH
                        <E T="52">4</E>
                        <SU>+</SU>
                         as it is deposited in wet deposition (PA, section 2.5.2; Sales et al., 2024). We additionally note, as discussed in section II.B.2.b.(2)(a), that NH
                        <E T="52">3</E>
                         is not a criteria pollutant. As described above and discussed in section II.B.3., the Administrator has considered the PM
                        <E T="52">2.5</E>
                         standard with regard to ecological effects of N deposition associated with PM and protection of the public welfare from such effects. In so doing, he has understood that the percentage of PM
                        <E T="52">2.5</E>
                         relevant to such effects ranges from 30% down to 5% or less that is N compounds, and that this percentage varies across the U.S. In light of this and other relevant factors, the Administrator has judged that the PM
                        <E T="52">2.5</E>
                         standard would be ineffective with regard to control of deposition of particulate N compounds, and, as discussed more fully in section II.B.3., has decided to retain the existing standard, without revision.
                    </P>
                    <P>
                        The EPA also disagrees with the view that the uncertainties and complexities (and limitations) associated with the evidence base and air quality information that were cited by the EPA in its proposed decision to retain the PM standards are an insufficient basis for retaining the existing standard. Although these uncertainties and complexities include those related to NH
                        <E T="52">3</E>
                        , they are not, as the commenter suggests, limited to those related to NH
                        <E T="52">3</E>
                        . In support of the commenters' view, they note that the EPA must act when enough information is available to anticipate such effect and then assert that to not revise the secondary PM
                        <E T="52">2.5</E>
                         standards “is inconsistent with the Act's protective direction.” While we agree 
                        <PRTPAGE P="105762"/>
                        that the EPA must act when enough information is available to anticipate effects, and we recognize that revising the NAAQS generally requires acting in the face of uncertainties to provide necessary protection (as the Administrator is doing in setting a new SO
                        <E T="52">2</E>
                         standard), the Administrator cannot set a standard if he lacks any ability to make a reasoned judgment about the effect of the standard. As recognized above and discussed in section II.B.3. below, the uncertainties and limitations of the information with regard to support for a PM
                        <E T="52">2.5</E>
                         standard that can be concluded to provide control for deposition-related effects of particulate N compounds, including NH
                        <E T="52">4</E>
                        <SU>+</SU>
                        , preclude our ability to characterize the extent of control that can be expected.
                    </P>
                    <P>
                        In addition, the EPA disagrees with commenters who support revising the PM
                        <E T="52">2.5</E>
                         standard based on their view that this would maintain S deposition generally at/below 5 kg/ha-yr. First, we find that the PM
                        <E T="52">2.5</E>
                         indicator is not an appropriate tool and cannot be expected to be an effective tool for controlling S deposition in light of the fact that, in recent periods, SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         (the predominant particulate S compound) is not the dominant component of PM
                        <E T="52">2.5</E>
                         across the U.S. and is a small component in many areas (ISA, Appendix 2, Figure 2-5 [panel B, 2013-2015]; PA, Figure 2-30 [2019-2021]). The variability in the fraction of PM
                        <E T="52">2.5</E>
                         comprised of S compounds likely contributes to the PA findings on correlations of S deposition with PM
                        <E T="52">2.5</E>
                         concentrations (PA, Chapter 6). The correlation coefficients for this relationship in the trajectory-based analyses are lower than those for the relationship between S deposition and SO
                        <E T="52">2</E>
                         concentrations, with the correlation for the PM
                        <E T="52">2.5</E>
                         EAQM-max actually being negative (PA, Tables 6-12 and 6-8). In light of such findings, the Administrator has not found PM
                        <E T="52">2.5</E>
                         to be an appropriate indicator for a secondary standard to provide protection from ecosystem effects of S compound deposition. Rather, as discussed in section II.B.3. below, based on the available information and analyses, the Administrator has judged that a new annual secondary SO
                        <E T="52">2</E>
                         standard of 10 ppb can be expected to achieve the target identified by the CASAC majority of generally maintaining S deposition at/below approximately 5 kg/ha-yr. This new SO
                        <E T="52">2</E>
                         standard provides a much more explicit and precise approach for controlling S deposition-related effects of SO
                        <E T="52">X</E>
                         and particulate S compounds.
                    </P>
                    <P>
                        The comment that recommended revision of the annual PM
                        <E T="52">2.5</E>
                         standard to be 12 μg/m
                        <SU>3</SU>
                        , based on the view that it would not present additional requirements and could streamline implementation plan development and compliance, provided no information related to the extent of public welfare protection that might be provided by such a revision, or information indicating that the existing standard does not provide adequate protection. As explained in section II.B.3. below, the EPA disagrees with the commenter's recommendation for such a revision, and the Administrator finds that the available information supports retaining the current standard.
                    </P>
                    <P>
                        The comment regarding revision of the 24-hour PM
                        <E T="52">2.5</E>
                         standard to address short-term episodic deposition and visibility impairment expresses support for the CASAC majority recommendation on this. Beyond this reference to the CASAC majority recommendation, the comment provided no evidence to support their view that there are adverse effects of episodic deposition that would be appropriately addressed by revision of the standard level to 25 μg/m
                        <SU>3</SU>
                         (from 35 μg/m
                        <SU>3</SU>
                        ). As described in section II.B.1.b. above, the CASAC majority recommendation, while alluding to a potential for seasonal variability in deposition and in sensitivity of some species, did not provide evidence for such potentials or evidence to support the conclusion that a revised standard is needed to protect against adverse ecological effects on the public welfare, and the EPA is not aware of such evidence. Thus, as described in section II.B.3. below, the Administrator has decided to retain the existing 24-hour secondary PM
                        <E T="52">2.5</E>
                         standard.
                    </P>
                    <P>
                        Regarding visibility impairment, as conveyed in the IRP, PA and proposed decision document for this review, PM
                        <E T="52">2.5</E>
                         effects on visibility are outside the scope and are not being addressed in this review because they were addressed in the recently completed PM NAAQS review, which also revised the primary NAAQS for PM
                        <E T="52">2.5</E>
                         (89 FR 16202, March 6, 2024). The commenters advocating for consideration of visibility here erroneously state that these effects were addressed in setting the primary PM
                        <E T="52">2.5</E>
                         NAAQS and further state that this is not a reason for excluding them from consideration in this review. We note, however, that the primary PM
                        <E T="52">2.5</E>
                         NAAQS are not intended to address visibility impairment. Rather, the recently completed review covered both the primary PM
                        <E T="52">2.5</E>
                         NAAQS as well as review of the secondary NAAQS for visibility, materials damage and climate effects. See 89 FR 16202 at 16311-16343 (rationale for decisions on the secondary NAAQS). Thus, visibility is a welfare effect that has been addressed in assessing the protection provided for the public welfare by the secondary PM
                        <E T="52">2.5</E>
                         standard in the 2020 PM NAAQS decision and the reconsideration of that decision which was completed earlier this year (89 FR 16202, March 6, 2024) and is outside the scope of this review.
                    </P>
                    <HD SOURCE="HD3">3. Administrator's Conclusions</HD>
                    <P>
                        Having carefully considered the public comments, as discussed above, the Administrator believes that the fundamental scientific conclusions on the ecological effects of SO
                        <E T="52">X</E>
                        , N oxides, and PM reached in the ISA and summarized in the PA and in section II.C. of the proposal remain valid. Additionally, the Administrator believes that the judgments he reached in the proposal (section II.E.3.) with regard to consideration of the evidence and quantitative assessments and advice from the CASAC remain appropriate. Thus, as described below, the Administrator concludes that the current secondary SO
                        <E T="52">2</E>
                         standard is not requisite to protect the public welfare from known and anticipated adverse effects associated with the presence of SO
                        <E T="52">X</E>
                         in the ambient air and that the standard should be revised. Further, based on the information available in this review and summarized in the proposal, including advice from the CASAC, as well as public comment and additional analyses developed in consideration of public comments, the Administrator concludes that revision of the existing 3-hour secondary SO
                        <E T="52">2</E>
                         standard to an annual standard of 10 ppb, averaged over three years, is required to provide additional needed protection from atmospheric deposition-related effects. He additionally concludes that it is appropriate to retain the existing secondary standards for N oxides and PM.
                    </P>
                    <P>
                        In his consideration of the adequacy of the existing secondary standards for SO
                        <E T="52">X</E>
                        , N oxides, and PM, and what revisions or alternatives are appropriate, the Administrator has carefully considered the available evidence and conclusions contained in the ISA regarding the weight of the evidence for both the direct effects of SO
                        <E T="52">X</E>
                        , N oxides, and PM on plants and lichens and for effects related to atmosphere deposition in ecosystems of N and S compounds associated with the presence of these pollutants in ambient air, and associated areas of uncertainty. In so doing, he recognizes the evidence of direct biological effects associated with elevated short-term concentrations of SO
                        <E T="52">X</E>
                         and N oxides that formed the basis for the existing secondary SO
                        <E T="52">2</E>
                         and NO
                        <E T="52">2</E>
                         standards, the evidence of ecological effects of PM in ambient air, primarily 
                        <PRTPAGE P="105763"/>
                        associated with loading on vegetation surfaces, and also the extensive evidence of ecological effects associated with atmospheric deposition of N and S compounds into sensitive ecosystems. He has also considered the quantitative analyses of aquatic acidification risk and of air quality and deposition estimates, with associated limitations and uncertainties; policy evaluations of the evidence, exposure/risk information, and air quality information in the PA; and the related additional analyses (Sales et al., 2024). Together, these conclusions, analyses, and evaluations, along with CASAC advice and public comments, inform his judgments in reaching his decisions on secondary standards for SO
                        <E T="52">X</E>
                        , N oxides, and PM that provide the requisite protection under the CAA.
                    </P>
                    <P>In recognizing that a prominent part of this review is the consideration of secondary NAAQS with regard to ecological effects related to deposition of S and N compounds, the Administrator notes the view of the CASAC regarding deposition standards. In its advice to the Administrator in this review, the CASAC expressed the view that the CAA does not preclude the establishment of a NAAQS in terms of atmospheric deposition (section II.B.1.b. above). As discussed in sections II.B.2.b.(2)(a) and II.B.2.b.(3)(a) above, the EPA disagrees with this view. Rather, the EPA concludes that it does not have the authority to set a deposition standard under the existing CAA, and the EPA is not adopting a deposition standard in this action.</P>
                    <P>
                        With regard to the adequacy of public welfare protection provided by the existing secondary SO
                        <E T="52">2</E>
                         standard, the Administrator first considers the adequacy of protection the existing standard provides for ecological effects related to ecosystem deposition of S compounds associated with the presence of SO
                        <E T="52">X</E>
                         in ambient air. As an initial matter, the Administrator recognizes the long-standing evidence of the role of SO
                        <E T="52">X</E>
                         in ecosystem acidification and related ecological effects. While he also notes the ISA determinations of causality for S deposition with two other categories of effects related to mercury methylation and sulfide phytotoxicity (ISA, Table ES-1; PA, section 4.4), he recognizes, as noted in section II.A.3.c. above, that quantitative tools and approaches are not well developed for ecological effects associated with atmospheric deposition of S other than ecosystem acidification (PA, section 7.2.2.1).
                        <SU>131</SU>
                        <FTREF/>
                         In this context, he notes that the current evidence does not indicate such effects to be associated with S deposition at lower rates than those posing risks of ecosystem acidification, and judges that a decision focused on providing the requisite protection for acidification-related effects will also contribute protection for other effects. Thus, he gives primary consideration to effects related to acidifying deposition, given the robust evidence base and available quantitative tools, as well as the longstanding recognition of historical impacts in acid-sensitive ecosystems across the U.S.
                    </P>
                    <FTNT>
                        <P>
                            <SU>131</SU>
                             For example, there are no studies in the available evidence investigating linkages of S deposition, in terms of quantitative estimates, such as CLs, with other non-acidifying effects (ISA, Appendix 12, section 12.6); these effects, in wetland and freshwater ecosystems, include the alteration of Hg methylation in surface water, sediment, and soils; and changes in biota due to sulfide phytotoxicity including alteration of growth and productivity, species physiology, species richness, community composition, and biodiversity (ISA, Appendix 12, section 12.7).
                        </P>
                    </FTNT>
                    <P>
                        As an initial matter, the Administrator notes that, during the 20-year period from 2001 through 2020, the range of median S deposition estimates for the 84 ecoregions in the contiguous U.S. extend up to 20 kg S/ha-yr (PA, Appendix 5A, Table 5A-11) and that during this period the existing secondary SO
                        <E T="52">2</E>
                         standard was met (Sales et al., 2024). Over this 20-year period in the contiguous U.S., design values for the existing secondary SO
                        <E T="52">2</E>
                         standard (second highest 3-hour average in a year) were generally well below the standard level of 500 ppb (PA, section 6.2.1). For example, in the earliest 3-yr period analyzed (2001-2003), when median total S deposition was estimated to be approximately 20 kg/ha-yr in the Western Allegheny Plateau ecoregion (which includes the Ohio River Valley) and just over 16 kg/ha-yr in the Central Appalachians ecoregion (PA, Appendix 5A, Table 5A-11), virtually all design values for the existing 3-hour secondary standard were below 400 ppb (across the CONUS) and the 75th percentile of 3-hour design values was below 100 ppb (PA, Figure 2-27). With regard to the 18 eastern ecoregions assessed in the REA, the Administrator notes that during this period, the ecoregion median deposition ranged above 15 kg/ha-yr and the 90th percentile 
                        <SU>132</SU>
                        <FTREF/>
                         S deposition estimates for half of these 18 ecoregions were at or above 15 kg/ha-yr, ranging up above 20 kg/ha-yr in the highest ecoregion (figure 2 above).
                    </P>
                    <FTNT>
                        <P>
                            <SU>132</SU>
                             This refers to the 90th percentile in the distribution of S deposition estimates for TDep grid cells in each ecoregion in which there were waterbody sites assessed in the REA.
                        </P>
                    </FTNT>
                    <P>
                        In considering the extent to which this magnitude of estimated S deposition (summarized immediately above) indicates a potential for effects on the public welfare, the Administrator turns to consideration of the aquatic acidification risk indicated for such estimates by the REA. Specifically, he takes note of the REA estimates of aquatic acidification risk associated with the S deposition estimated to have occurred in 2001-2003, when the existing standard was met. In this time period, the REA finds that across the 18 acid-sensitive ecoregions analyzed, the pattern of S deposition in the five most affected ecoregions is associated with more than about a third of waterbody sites in the ecoregions being unable to achieve even the lowest of the three acid buffering capacity benchmarks used as risk indicators (ANC of 20 μeq/L). And, in the single most affected ecoregion, more than half of waterbody sites are unable to meet this benchmark. In considering these results, the Administrator recognizes the use of ANC as an indicator of aquatic acidification risk and as a quantitative tool within a larger framework of considerations pertaining to the public welfare significance of acid deposition-related effects. In this framework, he takes note of the PA description of the three benchmarks used in the REA, with the value of 20 μeq/L considered to represent a level of acid buffering capacity consistent with a natural or historically occurring ANC range and 50 μeq/L to provide greater protection, particularly from episodic acidification events, additionally recognizing that ANC levels below 20 μeq/L have been associated with reductions in number of fish species (and species population sizes) in some sensitive waterbodies of the Shenandoah and Adirondack Mountains (as summarized in section II.A.4.a. above).
                        <SU>133</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>133</SU>
                             Effects of elevated acid deposition have been evident for decades in the Adirondack region of New York, USA (Driscoll et al 2016). Fisheries surveys by NY DEC in the 1980s indicated reductions in fish populations in Adirondack lakes which researchers indicate may relate to acidification in these lakes (Baker and Schofield, 1985). For example, a survey of 1469 Adirondack lakes conducted in 1984-87 found chronic acidity (ANC below 0 μeq/L) in 27% of lakes (Kretser et al., 1989). An additional 21% of Adirondack lakes were found to have summertime ANC values between 0 and 50 μeq/L, indicating a potential for ANC to dip to values near or below 0 μeq/L during periods of high discharge, such as snowmelt or precipitation events (Kretser et al., 1989).
                        </P>
                    </FTNT>
                    <P>
                        The Administrator also takes note of the PA discussion of the potential public welfare impacts of aquatic acidification that can include reductions in recreational and subsistence fisheries, and related reductions in recreational and cultural usage of these areas by the public, summarized in sections II.A.3.b. and II.B.1.a.(3) above. For example, he 
                        <PRTPAGE P="105764"/>
                        recognizes that aquatic acidification affects the diversity and abundance of fish and other aquatic biota in the affected waters, and consequently also affects the array of public uses of these waterbodies. With this in mind, he focuses on the prevalence of elevated aquatic acidification risk across multiple waterbodies in multiple ecoregions (with ANC as the acidification risk indicator) recognizing that the significance of aquatic acidification-related impacts on the public welfare (
                        <E T="03">e.g.,</E>
                         associated with reductions in public usage of aquatic ecosystems in which fisheries have been affected by acidification) increases with greater prevalence of affected waterbodies and ecoregions. In this context, the Administrator judges that the prevalence of waterbodies concluded to be unable to achieve the lowest ANC benchmark (below which the increased risk of episodic acidification events may threaten survival of sensitive aquatic species) during the 2001-2003 period—extending from more than 30% to just over 50% in the five most affected eastern ecoregions (figure 1 above)—can be anticipated to cause adverse effects on the public welfare. The Administrator also considers the advice from the CASAC in considering deposition-related effects of S compounds, noting the CASAC consensus that the existing standard does not provide protection from such effects. Lastly, he notes the lack of public comments conveying the position that the existing standard provides protection from deposition-related effects (section II.B.2.a. above). Thus, based on the findings of the REA, associated policy evaluations in the PA with regard to S deposition and acidification-related effects in sensitive ecosystems, and in consideration of advice from the CASAC and public comments on the proposed decision, the Administrator judges that the current SO
                        <E T="52">2</E>
                         secondary standard is not requisite to protect the public welfare from adverse effects associated with acidic deposition of S compounds in sensitive ecosystems.
                    </P>
                    <P>
                        Having reached this conclusion that the existing secondary SO
                        <E T="52">2</E>
                         standard does not provide the requisite protection of the public welfare from adverse S deposition-related effects, most prominently those associated with aquatic acidification, the Administrator next turns to identification of a secondary standard to provide such protection. In so doing, consistent with the approach employed in the PA, he focuses first on identifying S deposition rates that might be judged to provide an appropriate level of public welfare protection from deposition-related effects. As in reaching his proposed decision, the Administrator focuses primarily on the aquatic acidification risk estimates as presented and evaluated in the PA (PA, sections 5.1, 7.1 and 7.3, and Appendix 5A) and summarized in sections II.A.4. and II.B.1.a.(3) above. In this context and consistent with his consideration of these estimates in judging the existing SO
                        <E T="52">2</E>
                         standard to be inadequate, he finds the PA evaluation of the risk estimates in terms of waterbodies estimated to achieve the three acid buffering capacity benchmarks (20, 30 and 50 μeq/L) to be an appropriate basis for his consideration of levels of protection. Further, he judges that a focus on the ecosystem-scale estimates, in particular, is appropriate for his purposes in identifying conditions that provide the requisite protection of the public welfare.
                    </P>
                    <P>
                        The Administrator recognizes that the CAA requires the establishment of secondary standards that are, in the Administrator's judgment, requisite (
                        <E T="03">i.e.,</E>
                         neither more nor less stringent than necessary) to protect the public welfare from known or anticipated adverse effects associated with the presence of the pollutant in the ambient air. As in all NAAQS reviews, the EPA's approach to informing these judgments is based on a recognition that the available welfare effects evidence generally reflects a continuum that includes ambient air-related exposures for which scientists generally agree that effects are likely to occur, through lower levels at which the likelihood and magnitude of response become increasingly uncertain. The Administrator recognizes that the CAA does not require establishment of secondary standards at a zero-risk level, but rather at levels that reduce risk sufficiently so as to protect the public welfare from known or anticipated adverse effects. Thus, the Administrator recognizes that his decision on the secondary standard for SO
                        <E T="52">X</E>
                         is inherently a public welfare policy judgment that draws upon the scientific evidence for welfare effects, quantitative analyses of air quality, exposure, and risks, as available, and judgments about how to consider the uncertainties and limitations that are inherent in the scientific evidence and quantitative analyses.
                    </P>
                    <P>
                        In his consideration of deposition conditions that provide the requisite protection of the public welfare, as in reaching his proposed decision, the Administrator focuses on the ecoregion-scale findings of the aquatic acidification REA, with particular attention to the waterbody-specific risk estimates summarized in the PA for each of the 18 well-studied, acid-sensitive eastern ecoregions and the five time periods. The PA summarizes the percentages of waterbodies per ecoregion estimated to achieve (
                        <E T="03">i.e.,</E>
                         to meet or exceed) the three ANC benchmarks in each time period in terms of the ecoregion median S deposition value for that time period, which are grouped into bins (
                        <E T="03">e.g.,</E>
                         percentages for ecoregion-time period combinations with median ecoregion S deposition at/below 10 kg/ha-yr, or 8 kg/ha-yr or 5 kg/ha-yr). The Administrator considers particularly the ecoregion median S deposition values at and below which the associated waterbody-specific risk estimates indicated a high proportion of waterbodies in a high proportion of ecoregions would achieve ANC values at or above the three acid buffering capacity benchmarks (as summarized in tables 3 and 4 above). In so doing, he recognizes a number of factors, as described in the PA, which contribute variability and uncertainty to waterbody estimates of ANC and to interpretation of acidification risk associated with different values of ANC (PA, section 5.1.4 and Appendix 5A, section 5A.3). In light of these factors, rather than focusing on REA ecoregion-scale results for a single ANC benchmark, he finds it appropriate to consider the pattern of REA results across all three benchmarks, as evaluated in the PA and considered by the CASAC majority (summarized in section II.B.1.b. above).
                    </P>
                    <P>
                        In considering the summary of results for the ecoregion-scale analysis of ecoregion median deposition bins (in the draft PA),
                        <SU>134</SU>
                        <FTREF/>
                         the CASAC majority focused on a level of S deposition estimated to achieve acid buffering capacity at or above the three ANC benchmarks in 80% (for ANC of 20 and 30 μeq/L) or 70% (for ANC of 50 μeq/L) of waterbodies in all ecoregion-time period combinations 
                        <SU>135</SU>
                        <FTREF/>
                         (Sheppard, p. 25 of the Response to Charge 
                        <PRTPAGE P="105765"/>
                        Questions). The CASAC majority identify S deposition levels “generally” at or below 5 kg/ha-yr as associated with this pattern of acid buffering. The Administrator notes that, as recognized in the PA and the proposal, the REA found ecoregion median S deposition at or below 7 kg/ha-yr in the 18 eastern ecoregions also yields these percentages of waterbodies achieving the three ANC benchmarks (as seen in tables 3 and 4 above).
                        <SU>136</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>134</SU>
                             While the final PA provides additional presentations of aquatic acidification risk estimates, including those at the ecoregion-scale, the estimates for percentages of waterbodies per ecoregion achieving ANC targets at or below different S deposition values are unchanged from those in the draft PA (PA, section 5.1.3; Table 5-5 [draft PA, Table 5-4]).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>135</SU>
                             The presentation of such percentages in the draft PA (reviewed by the CASAC) were specific to the 90 ecoregion-time period combinations for the 18 eastern ecoregions (draft PA, Table 5-4; PA, Table 5-5). Inclusion of the 7 western ecoregions would yield higher percentages, as more than 90% of waterbodies in those ecoregions were estimated to achieve all three ANC concentration in all time periods (PA, Table 5-4).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>136</SU>
                             The results for median S deposition at or below 7 kg/ha-yr further indicate that 90% of waterbodies per ecoregion achieve ANC at or above 20, 30 and 50 μeq/L in 96%, 92% and 82%, respectively, of eastern ecoregion-time period combinations (as summarized in section II.A.4.c.).
                        </P>
                    </FTNT>
                    <P>The Administrator additionally takes note of the PA evaluation of the temporal trend of the ecoregion-scale risk estimates across the five time periods, in the 20 years analyzed, which shows a decline in response to the declining S deposition estimates for those periods. As summarized in the PA and the proposal, the vast majority of the decline occurred across the first decade of the 20-year period. The S deposition estimated to be occurring in the 2010-2012 period included ecoregion medians (across CL sites) ranging from 2.3 to 7.3 kg/ha-yr in the 18 eastern ecoregions (and lower in the 7 western ecoregions), and the highest ecoregion 90th percentile was approximately 8 kg/ha-yr (table 5 and figure 2 above). For this pattern of deposition, the REA estimated more than 70% of waterbodies in all 25 ecoregions assessed to be able to achieve an ANC of 50 ueq/L (figure 1, left panel, above), and more than 80% of waterbodies in all ecoregions to be able to achieve an ANC of 20 ueq/L (figure 1, right panel). The Administrator observes that these estimates of acid buffering capacity achievement for the 2010-12 period deposition—achieving the ANC benchmarks in at least 70% to 80% (depending on the specific benchmark) of waterbodies per ecoregion—are consistent with the objectives identified by the CASAC majority (in emphasizing ecoregion ANC achievement estimates of 70%, 80% and 80% for ANC benchmarks of 50, 30 and 20 μeq/L, respectively). Based on these evaluations of the REA estimates in the PA and advice from the CASAC majority, the Administrator judges that these ecoregion-scale ANC achievement estimates for the three ANC benchmarks (70%, 80% and 80% for ANC benchmarks of 50, 30 and 20 μeq/L, respectively) are reasonable acid buffering capacity objectives for the purposes of protecting ecoregions from aquatic acidification risk of a magnitude of potential public welfare significance. Further, as discussed earlier in this section, the Administrator recognizes that the significance of aquatic acidification-related impacts on the public welfare, including those associated with reductions in public usage of aquatic ecosystems with fisheries affected by acidification, increases with greater prevalence of affected waterbodies and ecoregions. Thus, he finds the CASAC-identified percentages of waterbodies per ecoregion that meet (or exceed) the three ANC benchmarks to be appropriate minimum percentages (for each ANC benchmark) for ecoregions across the U.S. for use in his identification of a secondary NAAQS that will provide the appropriate level of protection against risks of potential public welfare significance. In so doing, he additionally notes that these percentages are met (or exceeded) for the most recent time periods analyzed in the REA (through 2018-2020).</P>
                    <P>
                        In turning to his consideration of S deposition levels that might be expected to maintain such a level of protection from aquatic acidification risk, the Administrator considers the CASAC majority recommended range of annual average secondary SO
                        <E T="52">2</E>
                         standard levels (
                        <E T="03">i.e.,</E>
                         10-15 ppb) that, in the view of these members, would generally maintain S deposition at or below 5 kg/ha-yr. As recognized in the PA, the CASAC majority reference to S deposition associated with their acid buffering objectives was in terms of ecoregion median values in the REA ecoregion-scale analysis.
                        <SU>137</SU>
                        <FTREF/>
                         The Administrator additionally takes note of the PA observation of an appreciable reduction in S deposition across the 20-year analysis period in the 25 REA ecoregions, both in terms of the 90th percentile across REA sites in each ecoregion and in terms of the median such that in the second decade of the period (since 2010), the difference in S deposition value between the ecoregion median and 90th percentile is much reduced from what it was in the 2001-2003 period. Although the ecoregion 90th percentile and median estimates for the REA ecoregions ranged up to approximately 22 and 17 kg/ha-yr, respectively, in the 2001-2003 period, both types of estimates fall below approximately 7 to 8 kg/ha-yr by the 2010-2012 period (figure 2 above). In light of this trend, as well as the temporal trend in the REA estimates, and also while recognizing the uncertainties associated with the deposition estimates at individual waterbody sites and with the associated estimates of aquatic acidification risk (PA, section 5.1.4), the Administrator concurs with the PA findings that the ecoregion-scale acid buffering objectives identified above (more than 70% to 80% of waterbody sites in all ecoregions assessed achieving or exceeding the set of ANC benchmarks) can be expected to be met when the median and upper (90th) percentile deposition estimates for sensitive ecoregions are generally at and below about 5 kg/ha-yr with a few occurrences as high as about 8 kg/ha-yr. Thus, he considers it appropriate to focus on S deposition generally at or below about 5 kg/ha-yr, with infrequent occurrences as high as about 8 kg/ha-yr. Based on all of these considerations, the Administrator judges that a secondary standard that would generally maintain a pattern of ecoregion median S deposition consistent with these objectives (at or below 5 kg/ha-yr, with only infrequent occurrences as high as 8 kg/ha-yr) would provide the appropriate level of public welfare protection from aquatic acidification risk.
                    </P>
                    <FTNT>
                        <P>
                            <SU>137</SU>
                             While the REA ecoregion-scale analysis summarizes risk estimates for each ecoregion in terms of the ecoregion median of the sites analyzed in each ecoregion, the PA notes that the sites estimated to receive the higher levels of deposition are those most influencing the extent to which the potential objectives for aquatic acidification protection are or are not met.
                        </P>
                    </FTNT>
                    <P>
                        In his consideration of deposition levels that might provide for protection from aquatic acidification consistent with his identified objectives, the Administrator also considers protection of terrestrial ecosystems from effects related to S deposition. In so doing, he notes that in primarily focusing on the aquatic acidification risk estimates in its evaluation of options for a standard to address deposition-related effects, the PA recognized the linkages between watershed soils and waterbody acidification, suggesting that such linkages indicate that protecting waterbodies from reduced acid buffering capacity (with ANC as the indicator) will also, necessarily, provide protection for watershed soils (PA, section 7.4).
                        <SU>138</SU>
                        <FTREF/>
                         The Administrator also notes that a revised standard that would be associated with lower S deposition in sensitive ecoregions than the existing standard (consistent with his decision reached above) would necessarily be associated with lower S deposition in both terrestrial and aquatic ecosystems. 
                        <PRTPAGE P="105766"/>
                        He also notes the PA evaluation of the current evidence, particularly with regard to terrestrial plants, including the PA's identification of S deposition levels extending from 5 kg/ha-yr (up to 12 kg/ha-yr), as summarized in section II.A.3.c.(2) above.
                        <SU>139</SU>
                        <FTREF/>
                         He further recognizes that this range includes the benchmark referenced by the CASAC majority (generally at or below 5 kg/ha-yr) as affording protection to various tree and lichen species (as summarized in section II.B.1.b. above). In so doing, he recognizes the overlap of these values with his objectives identified above (S deposition generally at or below about 5 kg/ha-hr, with infrequent higher occurrences). Thus, based on the PA, and in consideration of CASAC advice and public comments, the Administrator judges that his focus on aquatic acidification risk and on a pattern of ecoregion median S deposition consistent with his objectives identified above will also provide protection for terrestrial ecosystems, such that a different standard is not needed to provide protection for terrestrial effects.
                    </P>
                    <FTNT>
                        <P>
                            <SU>138</SU>
                             The PA additionally considered the terrestrial acidification risk analyses in the last review which found that total deposition estimates in recent years appear to meet all but the most restrictive of acid deposition target values, with which the PA observed uncertainties to be the greatest (PA, section 5.3.2.1).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>139</SU>
                             This range of S deposition levels reflects the PA analysis of studies of effects on terrestrial biota (PA, section 5.3.4 and Appendix 5B). For example, from the most recent observational study evaluated in the ISA and PA, for the non-western tree species that were reported to have a negative association of growth or survival with S deposition, this encompasses the species-specific median deposition estimates for the sites where these species were assessed (PA, section 5.3.4.1 and Appendix 5B, sections 5B.2.2.3 and 5B.2.3).
                        </P>
                    </FTNT>
                    <P>
                        The Administrator next turns to identification of a secondary standard that can be expected to generally maintain a pattern of ecoregion median S deposition at or below 5 kg/ha-yr, with potentially very few occurrences up to about 8 kg/ha-yr. In so doing, he recognizes the complexity of identifying a national ambient air quality standard focused on protection of the public welfare from adverse effects associated with national patterns of atmospheric deposition, particularly given the degree to which those patterns are influenced by transport and chemical transformation of emissions. As more specifically described in the PA, atmospheric deposition (ecosystem loading) of S is, in a simple sense, the product of atmospheric concentrations of S compounds, factors affecting S transfer from air to surfaces, and time. Further, atmospheric concentrations in an ecosystem are, themselves, the result of emissions from multiple, distributed sources both near and far, atmospheric chemistry, and transport. Accordingly, the Administrator concurs with the PA that consideration of the location of source emissions and expected pollutant transport, in addition to the influence of physical and chemical processes, is important to understanding relationships between SO
                        <E T="52">2</E>
                         concentrations at ambient air monitors and S deposition rates in sensitive ecosystems of interest.
                    </P>
                    <P>
                        Based on these considerations, the Administrator concurs with the PA conclusion that to achieve the requisite level of protection from aquatic acidification effects associated with S deposition in sensitive ecosystems, SO
                        <E T="52">2</E>
                         emissions must be controlled at their sources. Accordingly, the Administrator considers findings of the PA analyses of relationships between S deposition estimates and SO
                        <E T="52">2</E>
                         concentrations near SO
                        <E T="52">2</E>
                         monitors, including at NAAQS regulatory monitors, which are often near large sources of SO
                        <E T="52">2</E>
                         emissions. To account for the relationship between upwind concentrations near sources and deposition in downwind areas, the Administrator also considers PA analyses of relationships between ecoregion S deposition estimates and SO
                        <E T="52">2</E>
                         concentrations at upwind sites of influence, identified by trajectory analyses (sections II.A.2. and II.B.1.a.(3) above, and PA, sections 6.2.2 through 6.2.4). As evidence of the influence of SO
                        <E T="52">2</E>
                         in ambient air on S deposition, all of these analyses demonstrated a positive association between SO
                        <E T="52">2</E>
                         concentrations and nearby or downwind S deposition (PA, section 7.4).
                    </P>
                    <P>
                        With regard to an indicator for a standard to address the effects of S deposition associated with SO
                        <E T="52">X</E>
                         in ambient air, the Administrator finds his proposed decision for an SO
                        <E T="52">2</E>
                         indicator to be appropriate. He reaches this decision based on consideration of the PA evaluations of the linkages connecting SO
                        <E T="52">X</E>
                         emissions and S deposition-related effects, including the parallel trends of SO
                        <E T="52">2</E>
                         emissions and S deposition in the U.S. over the past 20 years that indicate the strong influence of SO
                        <E T="52">2</E>
                         in ambient air on S deposition (PA, sections 6.4.1 and 7.4) and the PA finding of SO
                        <E T="52">2</E>
                         as a good indicator for a secondary standard to address S deposition (PA, sections 6.4.1 and 7.4). Specific aspects of the PA findings include the declining trend of S deposition that is consistent with and parallel to the sharp declines in annual average SO
                        <E T="52">2</E>
                         emissions across the 20-year period, as well as the general association of higher annual average SO
                        <E T="52">2</E>
                         concentrations (averaged over three years) at SLAMS with higher local S deposition estimates, in addition to the statistically significant positive correlations observed for ecoregion median S deposition with SO
                        <E T="52">2</E>
                         concentrations at upwind monitoring sites of influence in the EAQM analyses. In reaching this decision, the Administrator also notes the CASAC consensus advice and public comments that recommended a standard with SO
                        <E T="52">2</E>
                         as an indicator to address ecosystem effects of sulfur deposition.
                    </P>
                    <P>
                        The Administrator has also considered PM
                        <E T="52">2.5</E>
                         with regard to its potential to be an effective indicator for a standard providing public welfare protection from S deposition-related effects. In so doing, he recognizes that the S species that deposits in ecosystems, SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                        , is a component of PM
                        <E T="52">2.5</E>
                        . However, he also recognizes that SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         constitutes less than half of PM
                        <E T="52">2.5</E>
                        , by mass, across the country, with non-S containing compounds most typically comprising more than 70% of the total annual PM
                        <E T="52">2.5</E>
                         mass in the East and even more in the West (PA, section 2.4.3). He finds that this generally low presence of SO
                        <E T="52">4</E>
                        <E T="51">2−</E>
                         in PM
                        <E T="52">2.5</E>
                         and the extent to which it varies across the country inhibit his ability to identify a PM
                        <E T="52">2.5</E>
                         standard level that might be expected to provide the desired level of protection from S deposition related effects, an inhibition that does not exist in his use of the SO
                        <E T="52">2</E>
                         standard for this purpose. In addition, he takes note of the discussion above in support of his decision regarding a revised secondary SO
                        <E T="52">2</E>
                         standard, including the atmospheric chemistry information which indicates the dependency of S deposition on airborne SO
                        <E T="52">X</E>
                        , as evidenced by the parallel trends of SO
                        <E T="52">2</E>
                         emissions and S deposition. Based on all of these considerations, the Administrator judges that protection of sensitive ecosystems from S deposition-related effects is more effectively achieved through a revised SO
                        <E T="52">2</E>
                         standard than a standard for PM. Thus, the Administrator judges SO
                        <E T="52">2</E>
                         to be the appropriate indicator for a standard addressing S deposition-related effects.
                    </P>
                    <P>
                        With regard to averaging time and form, the Administrator continues to find his proposed decision (for an averaging time of a year and a form that averages the annual values across three consecutive years) to be appropriate, based on consideration of the PA findings and related analyses, advice from the CASAC majority, and public comments. Among the public commenters that supported adoption of a standard to address deposition-related effects, none objected to the conclusion of the PA that an annual standard would be appropriate for this purpose, although some commenters did support a secondary standard with the same averaging time, form and level of the primary standard, apparently for implementation reasons (discussed in 
                        <PRTPAGE P="105767"/>
                        section II.B.2.a.(3)(c) above).
                        <SU>140</SU>
                        <FTREF/>
                         In the quantitative analyses of air quality and deposition, the PA generally focused on a year's averaging time based on the recognition that longer-term averages (such as over a year, compared to one or a few hours) most appropriately relate to deposition and associated ecosystem effects. The PA analyses also used a 3-year form based on a recognition in the NAAQS program that such a form affords stability to the associated air quality management programs that contributes to effective environmental protection. Similarly, in the advice of the CASAC majority on a standard addressing S deposition, these members recommended an annual average standard, and, while these members did not explicitly address form, the information cited in the justification for their recommendation focused on a 3-year form (section II.B.1.b. above). In consideration of these conclusions of the PA and the CASAC majority, and public comments (as discussed in section II.B.2.a. above), the Administrator judges an averaging time and form in terms of annual average SO
                        <E T="52">2</E>
                         concentrations, averaged over three years,
                        <SU>141</SU>
                        <FTREF/>
                         to be appropriate for a secondary standard providing public welfare protection from adverse effects associated with long-term atmospheric deposition of S compounds.
                    </P>
                    <FTNT>
                        <P>
                            <SU>140</SU>
                             As discussed further below, the EPA is not adopting such a standard identical to the existing primary standard because such as standard would be more stringent than necessary.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>141</SU>
                             A 3-year form is common to NAAQS adopted over the more recent past. This form provides a desired stability to the air quality management programs which is considered to contribute to improved public health and welfare protection (
                            <E T="03">e.g.,</E>
                             78 FR 3198, January 15, 2013; 80 FR 65352, October 26, 2015; 85 FR 87267, December 31, 2020).
                        </P>
                    </FTNT>
                    <P>In turning to consideration of a level for such a standard, as an initial matter, the Administrator again notes the complexity associated with identifying a national ambient air quality standard focused on protection from national patterns of atmospheric deposition, and the associated uncertainty, as described in section II.E.3. of the proposal. Particularly in this case of identifying a standard to provide a pattern of ambient air concentrations that as a whole contributes to deposition across the U.S., it is important to consider the distribution of air concentrations to which the standard will apply. The Administrator considers the evaluations and associated findings of the PA, as well as findings of the related additional analyses, advice from the CASAC, and public comments on the proposed decision for a level within the range of 10 to 15 ppb.</P>
                    <P>
                        With regard to the advice from the CASAC, the Administrator notes that, as described in section II.B.1.b. above, the majority of the CASAC recommended adoption of an annual SO
                        <E T="52">2</E>
                         standard with a level within the range of 10 to 15 ppb. These members indicated their view that this range of levels “generally maintains” S deposition at or below 5 kg/ha-yr (based on their consideration of the draft PA).
                        <SU>142</SU>
                        <FTREF/>
                         The CASAC majority further conveyed that a standard level in this range would afford protection to tree and lichen species, as well as achieve the acid buffering targets in waterbodies of sensitive ecoregions (described above), and further stated that such a standard would “preclude the possibility of returning to deleterious deposition values” (Sheppard, Response to Charge Questions, pp. 24-25).
                    </P>
                    <FTNT>
                        <P>
                            <SU>142</SU>
                             As noted in section II.B.1.b. above, the PA analyses the CASAC majority cited were in terms of ecoregion median S deposition at/below values. Accordingly, the PA and the Administrator, in his judgments here, focuses on consideration of S deposition values in terms of such ecoregion medians.
                        </P>
                    </FTNT>
                    <P>
                        The Administrator also takes note of the air quality and deposition analyses described in the PA and summarized in sections II.A.2. and II.B.1.a.(3) above. In so doing, the Administrator focused particularly on the results of the PA's trajectory-based analyses for the EAQM-max metric, including the related additional analyses developed in consideration of public comments (Sales et al., 2024). He notes that these results indicate that when the maximum upwind annual SO
                        <E T="52">2</E>
                         concentration (3-year average) was no higher than 10 ppb, median deposition in the downwind ecoregion was below 5 kg/ha-yr in more than 90% of the ecoregion-time period combinations in the analysis and below about 6 kg/ha-yr in at least 95% of combinations, with deposition in the remaining few combinations no higher than about 8 kg/ha-yr. Further, he notes the analysis finding that in every instance of upwind maximum annual SO
                        <E T="52">2</E>
                         concentrations (averaged over three years) above 10 ppb, the associated estimates of downwind ecoregion median S deposition are all above 5 kg/ha-yr, extending from about 6 kg/ha-yr to as high as approximately 18 kg/ha-yr with 75% of the occurrences above 9 kg/ha-yr (Sales et al., 2024). He judges this magnitude of ecoregion S deposition associated with standard levels above 10 ppb to be well above his objectives. Thus, he finds that a standard level greater than 10 ppb would provide insufficient control of S deposition and related effects and accordingly would not provide the requisite public welfare protection. With regard to a level of 10 ppb, however, the Administrator finds these analyses to indicate that such a level is associated with a pattern of ecoregion median deposition consistent with his previously identified objectives of ecoregion median deposition generally below about 5 kg/ha-yr, with few occurrences of higher levels up to or below about 8 kg/ha-yr. The Administrator additionally finds a level of 10 ppb and the ecoregion median estimates of associated S deposition to be in general agreement with the advice from the CASAC majority including their recommended range of 10-15 ppb for an annual standard level, and their characterization of “generally” maintaining S deposition at or below 5 kg/ha-yr.
                    </P>
                    <P>
                        Before reaching his decision on a standard that in his judgment would provide the requisite protection from deposition-related effects, the Administrator also considered the protection that might be afforded by an annual SO
                        <E T="52">2</E>
                         standard, averaged over three years, with a level below 10 ppb. In so doing, he focused on consideration of the level of 5 ppb that was raised in public comment, as discussed in section II.B.2.a.(2) above, considering the findings of the additional analyses of the PA trajectory-based dataset that summarize the ecoregion median S deposition associated with maximum annual average concentrations, averaged over three years, no higher than 5 ppb at upwind sites of influence (Sales et al., 2024). The Administrator notes that for a maximum upwind annual average concentration no higher than 5 ppb, the trajectory-based analyses indicate downwind ecoregions to have ecoregion median S deposition appreciably below his objectives, which as noted above are for such deposition generally at or below 5 kg/ha-yr, with infrequent higher occurrences, very rarely as high as about 8 kg/ha-yr. Specifically, the analyses indicate ecoregion median deposition below approximately 4.5 kg/ha-yr in all of the ecoregion-time period combinations, with 75% below approximately 2.5 kg/ha-yr. The Administrator judges this magnitude of ecoregion S deposition associated with a standard level of 5 ppb to be well below his identified objectives. Thus, in light of his judgments, described above, regarding the pattern of ecoregion deposition associated with his and the CASAC majority's acidification protection targets, the Administrator finds an annual SO
                        <E T="52">2</E>
                         standard, averaged over three years, with a level below 10 ppb, to be associated with air quality 
                        <PRTPAGE P="105768"/>
                        more stringent than necessary to provide the requisite protection of the public welfare under the Act.
                    </P>
                    <P>
                        Further, in consideration of public comments and the recommendation from the CASAC minority, the Administrator additionally considered the public welfare protection that might be afforded by an alternate secondary standard in terms of a standard identical to the existing primary standard in all respects. In so doing, he notes the PA observations that most of the ecoregion median S deposition estimates for the last 10 years are less than 5 kg/ha-yr, and he notes the views expressed by the CASAC minority and in public comments that this indicates that the existing 1-hour primary SO
                        <E T="52">2</E>
                         standard adequately protects against long-term annual S deposition-related effects. He additionally notes the additional analyses related to the PA trajectory-based analyses that indicate the stringency, with regard to expected control of associated S deposition, associated with a 1-hour standard identical to the primary standard (Sales et al., 2024, section 4.2). As discussed in II.B.2.a.(3)(c) above, such a standard is associated with ecoregion median S deposition well below the Administrator's objectives (summarized above). Specifically, the trajectory analyses indicate that for upwind sites of influence at or below 75 ppb, in terms of the existing primary standard (3-year average of 99th percentile daily maximum 1-hour average concentrations), the downwind ecoregion median S deposition estimates for all ecoregion-time period combinations are below 3 kg/ha-yr, with 95% of them below 2 kg/ha-yr. Thus, he judges such a standard would be more stringent than necessary and accordingly not provide the requisite protection of the public welfare.
                    </P>
                    <P>
                        In light of all of the above, along with analyses and evaluations in the PA, including judgments related to uncertainties in relating ambient air concentrations to deposition estimates for the purpose of identifying a standard level associated with a desired level of ecological protection, advice from the CASAC majority, and consideration of public comment, the Administrator judges that a SO
                        <E T="52">2</E>
                         standard in terms of an annual average, averaged over three years, with a level of 10 ppb would provide the requisite protection of the public welfare from adverse effects related to S deposition.
                    </P>
                    <P>
                        The Administrator also considered the extent to which a new annual average standard might be expected to control short-term SO
                        <E T="52">2</E>
                         concentrations (
                        <E T="03">e.g.,</E>
                         of three hours duration) and accordingly also provide the necessary protection from direct effects of SO
                        <E T="52">X</E>
                         that is currently provided by the existing 3-hour secondary standard. In this context, he notes the analyses and conclusions of the PA, and particularly the related additional analyses, with regard to the extent of control for short-term concentrations that might be expected to be provided by an annual secondary standard (Sales et al., 2024). The Administrator also notes that these analyses are of air quality data from across the U.S. collected over the past 20 years, thus capturing a broad array of air quality conditions and their influences on relationships between the short-term and annual air quality metrics. As also discussed in section II.B.2.a.(4) above, these analyses indicate that in areas and periods when the annual SO
                        <E T="52">2</E>
                         concentration (annual average, averaged over three years) is at or below 10 ppb, design values for the existing 3-hour standard are well below the existing secondary standard level of 0.5 ppm SO
                        <E T="52">2</E>
                         and short-term SO
                        <E T="52">2</E>
                         concentrations are below those associated with direct effects on vegetation or lichens (PA, Figure 2-29; Sales et al., 2024). Based on these findings, the Administrator judges that revision of the existing standard to a new annual standard, with a 3-year average form and a level of 10 ppb, will provide the necessary protection for direct effects of SO
                        <E T="52">X</E>
                         on plants and lichens, as well as effects associated with longer-term deposition of S compounds in ecosystems. Thus, based on all of the considerations identified above, including the currently available evidence in the ISA, the quantitative and policy evaluations in the PA, related analyses, the advice from the CASAC, and public comment, the Administrator judges it appropriate to revise the existing secondary SO
                        <E T="52">2</E>
                         standard, to be an annual average standard, with a 3-year average form and a level of 10 ppb in order to provide the requisite protection of the public welfare from known or anticipated adverse effects.
                    </P>
                    <P>
                        Having reached his decision with regard to the welfare effects of SO
                        <E T="52">X</E>
                        , including those related to deposition of S compounds in sensitive ecosystems, the Administrator now turns to consideration of the secondary standards for N oxides and PM. As described below, the Administrator has decided to retain the existing NO
                        <E T="52">2</E>
                         and PM standards. These decisions are based on his consideration of the welfare effects evidence as characterized in the ISA and evaluated in the PA; the public welfare implications of these effects; the quantitative information concerning N oxides, PM and N deposition presented in the ISA and PA, and additional analyses developed in consideration of public comments (
                        <E T="03">e.g.,</E>
                         Sales et al., 2024); the majority and minority advice from the CASAC; and public comments (as discussed in section II.B.2.b. above and in the Response to Comments document).
                    </P>
                    <P>
                        With regard to the secondary standard for N oxides, the Administrator turns first to consideration of the protection afforded for effects of N oxides associated with direct contact on surfaces of plants and lichens. In so doing, he notes that the evidence of such effects was the basis for the establishment of the existing standard in 1971, and that the currently available information, summarized in section II.A.3.a.(1) above, continues to document such effects (ISA, Appendix 3, sections 3.3 and 3.4; PA, sections 4.1, 5.4.2 and 7.4). With regard to the adequacy of the existing standard in protecting against such effects, the Administrator's conclusions reflect those in the proposal, which he notes are consistent with the unanimous view of the CASAC (summarized in section II.B.1.b. above). Specifically, he finds that the evidence for NO
                        <E T="52">2</E>
                         and NO does not indicate effects associated with ambient air concentrations allowed by the existing standard. With regard to the N oxide, HNO
                        <E T="52">3</E>
                        , he considered the PA evaluation of the evidence of effects associated with air concentrations and associated HNO
                        <E T="52">3</E>
                         dry deposition on plant and lichen surfaces, and uncertainty as to the extent to which exposures associated with such effects may be allowed by the existing secondary NO
                        <E T="52">2</E>
                         standard (PA sections 7.1.2 and 5.4.2, and Appendix 5B, section 5B.4). In so doing, the Administrator judges that the limited evidence, with associated uncertainties, are insufficient to conclude that air quality that meets the secondary NO
                        <E T="52">2</E>
                         standard will nevertheless elicit such effects. Thus, he concludes that the existing standard continues to provide the needed protection from the direct effects of N oxides.
                    </P>
                    <P>
                        The Administrator next turns to consideration of the welfare effects related to atmospheric N deposition and the contribution of N oxides to such effects. In so doing, he notes that the information for N deposition and N oxides includes substantially more significant complexities, limitations of the available information, and related uncertainties than is the case for S deposition and S oxides. These complexities and limitations are generally technical or science policy in 
                        <PRTPAGE P="105769"/>
                        nature, or both. Those of a technical nature include the untangling of historic N deposition impacts (
                        <E T="03">e.g.,</E>
                         in terrestrial ecosystems) from impacts that might be expected from specific annual deposition rates absent that history, and also the complexity—more prominent for many aquatic systems, including those receiving some of the highest N loading—associated with estimating the portion of N inputs, and associated contribution to effects, derived from atmospheric sources (and specifically sources of N oxides). The science policy-related complexities relate to judgments regarding the implications of N deposition-related biological or ecological effects in the context of the Administrator's judgments concerning protection of the public welfare from adverse effects. Lastly, both technical and science policy challenges are presented by the coincidence in this review of the substantially reduced influence of N oxides on N deposition and the emergence of NH
                        <E T="52">3</E>
                        , which is not a criteria pollutant, as a major N deposition influence, particularly in areas with some of the highest N deposition estimates.
                    </P>
                    <P>
                        With regard to science policy judgments, the Administrator recognizes particular complexity associated with judging the requisite public welfare protection for an ecosystem stressor like N enrichment, for which as the CASAC recognized, in terrestrial systems there are both “benefits and disbenefits” (Sheppard, 2023, p. 8). As noted by the CASAC, “[b]enefits include fertilization of crops and trees and the potential for improved sequestration of carbon in soils and plant biomass” (Sheppard, 2023, p. 8). As noted in the PA, this also complicates conclusions regarding the extent to which some ecological effects may be judged adverse to the public welfare (PA, section 7.4). In many aquatic systems, identification of appropriate public welfare protection objectives is further complicated by N contributions to these systems from multiple sources other than atmospheric deposition,
                        <SU>143</SU>
                        <FTREF/>
                         as well as by the effects of historical deposition that have influenced the current status of soils, surface waters, associated biota, and ecosystem structure and function. For example, changes to ecosystems that have resulted from past, appreciably higher levels of atmospheric deposition in those areas have the potential to affect how the ecosystem responds to current, lower levels of deposition or to different N inputs in the future.
                    </P>
                    <FTNT>
                        <P>
                            <SU>143</SU>
                             For example, a study of the Chesapeake Bay and its sources of N loading concluded that “ `about one-third' of the total N load for the Bay is the result of direct deposition to the Bay or deposition to the watershed which is transported to the Bay” (U.S. EPA, 2010, p. 4-33), indicating that two thirds of N loading comes from non-air sources.
                        </P>
                    </FTNT>
                    <P>
                        Further, the Administrator notes that his decision under the Act regarding the secondary NAAQS for N oxides is necessarily based on his judgments related to protection from the effects associated with N oxides. Yet, he recognizes that there are contributions to ecosystem N deposition, and related effects, from pollutants other than—and not derived from—N oxides in ambient air, most prominently NH
                        <E T="52">3</E>
                        . He additionally notes that the influence of NH
                        <E T="52">3</E>
                         on N deposition varies appreciably across the U.S. and has grown over the past 20 years, while the contribution of N oxides to N deposition has declined. In a related manner, he takes note of the findings of the PA and the additional analyses that indicate ecoregions and States with highest N deposition (
                        <E T="03">e.g.,</E>
                         above 10 kg/ha-yr) include areas with some of the highest deposition rates for reduced N and NH
                        <E T="52">3</E>
                         (PA, Figure 7-8; Sales et al., 2024). This associated lessening influence of N oxides on total N deposition is also evidenced by the generally poor (r&lt;0.4) or negative correlations between N deposition and annual average NO
                        <E T="52">2</E>
                         concentrations, in the SLAMS and full trajectory-based datasets, respectively,, and also in the most recent period analyzed, 2018-2020(PA, sections 6.2.3 and 6.2.4). While low-moderate positive correlations are observed in both sets of analysis for eastern sites when including all time periods, correlations are only statistically significant in the earlier periods, prior to 2014, which may be related to increasing emissions of NH
                        <E T="52">3</E>
                         in more recent years (PA, section 2.2.3 and Figure 6-5).
                    </P>
                    <P>
                        More specifically, the analyses of N deposition over the years since 2002 period 
                        <SU>144</SU>
                        <FTREF/>
                         document the reductions in N deposition that correspond to reductions in emissions of N oxides, while additionally documenting the increased role of NH
                        <E T="52">3</E>
                         in N deposition and the co-occurring and associated tempering of total N deposition reductions nationwide. For example, in all 14 ecoregions with median total N deposition in 2019-2021 greater than 10 kg/ha-yr, deposition of NH
                        <E T="52">3</E>
                         has increased since 2000 (Sales et al., 2024).
                        <SU>145</SU>
                        <FTREF/>
                         And, in five of these 14 ecoregions, the increases in NH
                        <E T="52">3</E>
                         deposition and associated NH
                        <E T="52">4</E>
                        <SU>+</SU>
                         deposition are greater than the reductions in oxidized N deposition such that overall N deposition, in terms of ecoregion median, has increased. In the 14 ecoregions with total N deposition greater than 10 kg/ha-yr, the N deposition arising directly from N oxides (oxidized N deposition) constitutes the minority (approximately 23 to 42%) of total N deposition (Sales et al., 2024, Table 3). Across the other 70 ecoregions in CONUS 
                        <SU>146</SU>
                        <FTREF/>
                         with median total N deposition below 10 kg/ha-yr in 2019-2021, ecoregion median oxidized N deposition, on average, declined (from 4.7 to 2.4 kg N/ha-yr) while ecoregion median NH
                        <E T="52">3</E>
                         deposition, on average, more than doubled (from 0.7 to 1.6 kg N/ha-yr) (Sales et al., 2024, Table 4). At a State-level scale, average rates of oxidized N deposition have also declined in all 48 States of the CONUS, including where total N deposition has increased as a result of increased deposition from reduced N compounds associated with NH
                        <E T="52">3</E>
                        . In the most recent period, oxidized N deposition, in terms of Statewide average, is below 5 kg N/ha-yr in all 48 States (Sales et al., 2024). And in the six States with average total N deposition above 10 kg/ha-yr in the 2019-2021 period, oxidized N deposition comprises less than 40% (Sales et al., 2024, Table 5). The Administrator recognizes that these findings augment those of the PA analyses and indicate a much lower influence of N oxides on total N deposition relative to the influence of reduced N compounds in areas of the U.S. where N deposition is currently the highest (PA, section 7.2.3.3).
                    </P>
                    <FTNT>
                        <P>
                            <SU>144</SU>
                             Modeling estimates of N deposition in 2002 were the basis for the risk analyses in the 2013 review (2009 REA, sections 3.2.3 and 3.3.3). After also considering estimates and wet deposition measurements for 2003-2005, the 2009 REA concluded “overall, for each case study area, the amount of nitrogen deposition in 2002 is generally representative of current conditions” (2009 REA, p. 3-30). The total deposition estimates at that time relied on a different and less advanced modeling approach than that used in the current review (PA, section 2.5).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>145</SU>
                             Ecoregion median NH
                            <E T="52">3</E>
                             deposition has also increased since 2002 in 68 of the other 70 CONUS ecoregions; in the remaining two ecoregions, it is unchanged (Sales et al., 2024).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>146</SU>
                             The TDep estimates of N deposition are only available for the CONUS and not for parts of the U.S. outside of the CONUS.
                        </P>
                    </FTNT>
                    <P>
                        The Administrator also considers both the majority and minority advice from the CASAC regarding an NO
                        <E T="52">2</E>
                         annual standard in consideration of total N deposition effects. In so doing, he notes that in considering the justification provided by the CASAC majority for its recommendation, the PA did not find the information highlighted by the CASAC for relating total N deposition levels to ambient air concentrations of NO
                        <E T="52">2</E>
                         to provide scientific support for their recommended revision. The Administrator additionally notes that, as summarized in section II.B.1.b. above, 
                        <PRTPAGE P="105770"/>
                        notwithstanding the CASAC majority recognition of a lack of correlation between NO
                        <E T="52">2</E>
                         concentrations and ecoregion total N deposition, these members recommend an annual NO
                        <E T="52">2</E>
                         standard with a level of “&lt;10-20 ppb” based on their objective of N deposition below 10 kg/ha-yr based on studies of total N deposition. He finds their recommendation less than persuasive because for an NO
                        <E T="52">2</E>
                         standard to exert control of N deposition, there would need to be a significant positive relationship (
                        <E T="03">e.g.,</E>
                         correlation) between NO
                        <E T="52">2</E>
                         concentrations and N deposition. As discussed above, the correlations reported in the PA between NO
                        <E T="52">2</E>
                         concentrations and downwind ecoregions are generally low or negative, particularly in recent periods. Further, the justification provided by the CASAC majority for its recommended revision focuses on the results of the trajectory-based analysis in the draft PA, about which they also expressed concerns, with a focus on the EAQM-weighted metric, although, as described in section II.B.1.a.(2), concentrations of this metric are not directly translatable to potential standard levels due to the weighting across multiple monitors. In light of these limitations in the CASAC majority advice and based on current air quality and deposition information and trends as summarized above, the Administrator judges that, a secondary standard for N oxides cannot be expected to effectively control total N deposition.
                    </P>
                    <P>
                        With regard to the minority CASAC recommendation to revise the secondary standard to be identical to the primary NO
                        <E T="52">2</E>
                         standard in all respects, the Administrator notes the justification provided by the minority CASAC, which observed that the primary standard has been met over the last 10 years and indicated that “most of the N deposition values within the last 10 years” are less than 10 kg/ha-yr. The Administrator does not find this rationale sufficient to support a decision for revision as the CASAC minority recommended. The fact that N deposition has declined in many locations to less than 10 kg/ha-yr and that all areas meet the current primary standard does not signify that a secondary standard set equal to the primary would be effective in controlling total N deposition, given the rise in reduced N deposition just discussed, or that such a standard would be requisite for protection of the public welfare.
                    </P>
                    <P>
                        In this context, the Administrator considers the implications of N deposition directly related to N oxides with regard to welfare effects. In so doing, he notes that the information available at the time of proposal (presented in the PA) was unclear with regard to the extent to which occurrences of ecoregion median N deposition greater than the total N deposition values identified by the CASAC majority (10 kg/ha-yr) and in section 7.2.3. of the PA (7-12 kg/ha-yr) may relate to the existing NO
                        <E T="52">2</E>
                         secondary standard (89 FR 26682, April 15, 2024). However, the more recent additional analyses (developed in consideration of public comments) now provide clarification. These additional analyses indicate that ecoregion median levels of oxidized N (the component of total N deposition directly related to N oxides) are well below the PA-identified range of values (Sales et al., 2024). Specifically, median oxidized N deposition in all ecoregions of the CONUS is below 5 kg N/ha-yr, less than half of the N deposition benchmark considered by the CASAC (and below the lower end of the N deposition range [7-12 kg/ha-yr] identified by the PA), with the majority of ecoregions (45 of 84) having a median below 3 kg N/ha-yr (Sales et al., 2024). These analyses further indicate that the Statewide averages of oxidized N deposition in all 50 States are below the CASAC identified N deposition benchmark and the PA identified range, with the average across States well below half these values (Sales et al., 2024, Table 5).
                    </P>
                    <P>
                        In light of all of the considerations above, the Administrator notes first that the N deposition benchmark identified by the CASAC majority, and the range of levels identified in the PA for consideration, are in terms of total N deposition. He notes that most ecoregions have total N deposition levels below the CASAC majority and PA identified levels (that might be considered appropriate levels of protection for effects associated with total N deposition) but that some areas have higher total N deposition with levels above such benchmarks of potential public welfare significance. He notes that in areas with total N deposition above the CASAC majority and PA identified levels, available evidence indicates the level of total N deposition is predominantly the result of deposition from reduced N, which is increasing, while deposition of oxides of N is playing a notably smaller role (with such contributions decreasing over recent years). Based on these patterns and the current analyses, he notes his conclusion above, that, based on the information available in this review, a secondary standard for N oxides cannot be expected to effectively control total N deposition. Further, he notes that recent levels of oxidized N deposition (N deposition derived from N oxides in ambient air) are well below the CASAC majority and PA identified levels. With respect to the adequacy of protection for effects related to oxidized N deposition, he does not find a basis in the evidence for concluding that revisions to the current ambient air standard for N oxides are necessary. Therefore, based on all the considerations above, including the minority contribution of N oxides to total N deposition and the general lack of correlation between ambient air NO
                        <E T="52">2</E>
                         concentrations and such deposition, the Administrator finds that the existing evidence does not call into question the adequacy of protection of the existing secondary NO
                        <E T="52">2</E>
                         standard with regard to deposition-related effects of N oxides. Further, based on the findings of the PA and additional analyses of recent information on air quality and N deposition, and all the above considerations, the Administrator judges, based on the available evidence in this review, that revision to the secondary annual NO
                        <E T="52">2</E>
                         standard is not warranted and the existing secondary NO
                        <E T="52">2</E>
                         standard should be retained, without revision.
                    </P>
                    <P>
                        Lastly, the Administrator turns to consideration of the existing secondary standards for PM. As an initial matter, he takes note of the PA discussion and conclusion that the available information does not call into question the adequacy of protection afforded by the secondary PM
                        <E T="52">2.5</E>
                         standards from direct effects and deposition of pollutants other than S and N compounds (PA, sections 7.1.3 and 7.4). As also discussed in the proposal, the evidence characterized in the ISA and summarized in the PA indicates such effects to be associated with conditions associated with concentrations much higher than those associated with the existing standards. Thus, as in the proposal, the Administrator judges that the current evidence does not call into question the adequacy of the existing PM standards with regard to direct effects and deposition of pollutants other than S and N compounds.
                    </P>
                    <P>
                        With regard to S deposition and PM, as noted earlier in this section, the Administrator judges that protection of sensitive ecosystems from S deposition-related effects is more effectively achieved through a revised SO
                        <E T="52">2</E>
                         standard than a standard for PM. Accordingly, as discussed above, the Administrator has decided to revise the existing secondary SO
                        <E T="52">2</E>
                         standard to provide for such protection. Thus, the Administrator judges that revising one or more of the secondary PM standards 
                        <PRTPAGE P="105771"/>
                        in consideration of protection of the public welfare from effects related to S deposition is not warranted.
                    </P>
                    <P>
                        With regard to N deposition and adequacy of the secondary PM standards, the Administrator considers the analyses and evaluations in the PA, related analyses conducted in consideration of public comments, advice from the CASAC, and public comments. As an initial matter, the Administrator takes note of the substantial and significant limitations and uncertainties associated with the evidence base for ecosystem effects related to N deposition associated with PM (similar to those recognized above for N oxides). With regard to limitations and associated uncertainties of the current information related to N deposition arising from PM, the Administrator notes, as an initial matter, the PA findings, based on the full 20-year dataset, of negative to barely moderate correlations between N deposition estimates and annual average PM
                        <E T="52">2.5</E>
                         concentrations at upwind locations, with low or a negative correlation in the most recent time period (PA, sections 6.2.4 and 7.2.3.3). Across the SLAMS sites, the strength of a N deposition estimates with nearby PM
                        <E T="52">2.5</E>
                         concentrations is also seen to consistently decline across the five time periods analyzed since 2001 (PA, Table 6-7).
                        <SU>147</SU>
                        <FTREF/>
                         As discussed in the PA, these findings are likely related to both the increased impacts of NH
                        <E T="52">3</E>
                         on N deposition (as summarized earlier), and the declining presence of N compounds in PM (specifically in PM
                        <E T="52">2.5</E>
                        ) over the past two decades, as well as the current relatively low and variable representation of N compounds in PM (PA, section 6.4.2).
                    </P>
                    <FTNT>
                        <P>
                            <SU>147</SU>
                             Further, as noted in section II.B.2.b.(2)(c) above, the PA analysis of N deposition and PM
                            <E T="52">2.5</E>
                             concentrations at SLAMs does not provide a basis for identifying 3-year average annual PM
                            <E T="52">2.5</E>
                             concentrations that might be expected to constrain nearby N deposition below certain levels, such as an ecoregion median of 10 kg/ha-yr (
                            <E T="03">e.g.,</E>
                             PA, Figure 6-39).
                        </P>
                    </FTNT>
                    <P>
                        While the Administrator recognizes that NH
                        <E T="52">4</E>
                        <SU>+</SU>
                        , a transformation product of NH
                        <E T="52">3</E>
                        , exists in particles and is a component of PM
                        <E T="52">2.5</E>
                        , he also recognizes that the combined presence of all N-containing compounds in PM
                        <E T="52">2.5</E>
                         constitutes less than 30% of total PM
                        <E T="52">2.5</E>
                         mass at sites across the U.S. (PA, section 6.2.4; Sales et al., 2024). The Administrator additionally takes note of the finding that the composition of PM
                        <E T="52">2.5</E>
                         across the U.S. varies appreciably. Specifically, the percentage of PM
                        <E T="52">2.5</E>
                         represented by N compounds at the 120 CSN sites in the 2020-2022 period (that inform our current understanding for the various regions across the U.S.) ranges from a high of about 30% down to 5 to 15% across the South and Northwest and just below 5% in some areas (PA, section 6.4.2; Sales et al., 2024). As discussed in the PA, this contributes to geographic variability in the relationship between N deposition and annual PM
                        <E T="52">2.5</E>
                         concentrations (PA, section 6.4.2; Sales et al., 2024). The Administrator recognizes these findings together to indicate that an appreciable percentage of PM
                        <E T="52">2.5</E>
                         mass does not contribute to N deposition, and that the contributing amount varies across regions of the U.S. He further recognizes that this indicates that PM
                        <E T="52">2.5</E>
                         concentrations can be controlled or reduced without necessarily having any effect on concentrations of particulate N compounds. The Administrator also takes note that while deposition of the particulate N species associated with NH
                        <E T="52">3</E>
                         emissions (
                        <E T="03">i.e.,</E>
                         NH
                        <E T="52">4</E>
                        <SU>+</SU>
                        ) has increased since 2000-2002, the percentage of PM
                        <E T="52">2.5</E>
                         mass comprised by nitrogen compounds has declined, as has the percentage comprised by NH
                        <E T="52">4</E>
                        <SU>+</SU>
                        , alone (Sales et al., 2024). In this context, he additionally notes that deposition of NH
                        <E T="52">3</E>
                         (which is not particulate) is estimated to be more than a third of total N deposition in some ecoregions and States, including those the highest total deposition (Sales et al., 2024). The Administrator concludes that collectively, this information indicates that a PM mass standard is unlikely to achieve a predictable or specified amount of control on N deposition across the U.S.
                    </P>
                    <P>
                        In considering the advice from the CASAC for revision of the annual PM
                        <E T="52">2.5</E>
                         secondary standard, the Administrator notes that, as discussed in the PA, summarized in section II.B.1.b. above and recognized in reaching his proposed decision, the specific rationale for the range of standard levels recommended by the CASAC majority is unclear. The EPA does not find the CASAC majority observations regarding PM
                        <E T="52">2.5</E>
                         concentrations in remote areas or in areas of higher concentrations in 2019-2021 or in the trajectory-based analyses to demonstrate that an annual PM
                        <E T="52">2.5</E>
                         standard, with a level of 6 to 10 µg/m
                        <SU>3</SU>
                        , would be expected to control total N deposition at or below 10 kg/ha-yr. As recognized in the proposal, in the CASAC majority comments, PM
                        <E T="52">2.5</E>
                         concentrations within its recommended range were both described as relating to N deposition at/below its recommended benchmark (10 kg N/ha-yr) and relating to deposition above that range (as summarized in II.B.1.c. above). Additionally, as discussed in section II.B.2.b.(2)(c) above, the EPA disagrees that the PA analyses of PM
                        <E T="52">2.5</E>
                         concentrations and N deposition estimates in remote areas, without consideration of information for areas where PM
                        <E T="52">2.5</E>
                         is emitted or produced, are informative in this regard.
                        <SU>148</SU>
                        <FTREF/>
                         Regarding the trajectory-based analyses, as discussed in section II.B.1.b. above, and noted above, the correlation coefficient for N deposition with PM
                        <E T="52">2.5</E>
                         concentrations at the maximum upwind monitor (the EAQM-Max metric) does not indicate a positive relationship. In light of these limitations in the information cited by the CASAC majority and based on the broader consideration above of the variability of PM
                        <E T="52">2.5</E>
                         composition across the U.S., including with regard to N components, among other factors, the Administrator disagrees with the CASAC majority's recommendation on revision of the annual PM
                        <E T="52">2.5</E>
                         standard. In so doing, he also notes that the recommendation by these members to consider a new total N PM
                        <E T="52">2.5</E>
                         indicator, based on their view that it would achieve a better measure of total reactive N deposition, was offered in the context of such consideration “in the next review” (Sheppard, 2023, Letter, p. 5), and notes that the record in this review does not provide a basis for considering, much less adopting, a new indicator in the current review.
                    </P>
                    <FTNT>
                        <P>
                            <SU>148</SU>
                             The CASAC majority reference to concentrations in non-remote areas was with regard to the range of recent design values observed in areas where N deposition estimates ranged above 15 kg/ha-yr in California, the Midwest and the East; although not noted in the justification, design values at California sites were as high as 17.3 µg/m
                            <SU>3</SU>
                             (as summarized in section II.B.1.c. above), and the justification does not address how this may relate to a relationship of these concentrations to N deposition.
                        </P>
                    </FTNT>
                    <P>
                        The CASAC minority recommendation, based on a conclusion that the 2013 annual primary PM
                        <E T="52">2.5</E>
                         standard was controlling N deposition as needed since its establishment (as described in section II.B.1.b. above), cited scatterplots in the draft PA of N deposition estimates and annual average PM
                        <E T="52">2.5</E>
                         concentrations and did not address the issue of variable PM composition or lack of analyses for a 1-hour metric. As described earlier, the Administrator finds the issue of variability in PM
                        <E T="52">2.5</E>
                         composition to be an important consideration in his decision and accordingly, he finds the minority CASAC recommendation to not be well supported by the full record at this time in this review.
                    </P>
                    <P>
                        Based on the currently available information, taking into account its limitations and associated uncertainties, and in consideration of all of the above, 
                        <PRTPAGE P="105772"/>
                        the Administrator concludes that given the variable composition of PM
                        <E T="52">2.5</E>
                         across the U.S., the relatively low percentage of PM
                        <E T="52">2.5</E>
                         represented by N compounds (lower now than in the past), and the contributors to total N deposition that are not PM components, a PM
                        <E T="52">2.5</E>
                         standard could not, as discussed above, be expected to provide predictable and effective control of total N deposition. Accordingly, he judges that PM
                        <E T="52">2.5</E>
                         is not an appropriate indicator for a secondary standard intended to provide protection of the public welfare from adverse effects related to N deposition. Additionally, he notes that while it is unclear whether any PM standard would provide an appropriate indicator for consideration of N deposition-related effects, this issue may warrant evaluation in future reviews.
                    </P>
                    <P>
                        Further, as in his decision for N oxides above, the Administrator recognizes the factors identified here to contribute appreciable uncertainty to an understanding of the level of protection from N deposition-related effects associated with PM that might be afforded by the existing or an alternate secondary standard for PM
                        <E T="52">2.5</E>
                        . Thus, he is unable to identify a standard that would provide requisite protection from known or anticipated adverse N-deposition-related effects to the public welfare associated with the presence of PM in the ambient air. In summary, based on all these considerations, the Administrator concludes after considering the available evidence as assessed in the ISA, the quantitative analyses and associated evaluations in the PA and related more recent additional analyses, that no change to the annual secondary PM
                        <E T="52">2.5</E>
                         standard is warranted and he is retaining the existing PM
                        <E T="52">2.5</E>
                         secondary standard, without revision.
                    </P>
                    <P>
                        With regard to the 24-hour PM
                        <E T="52">2.5</E>
                         standard, the Administrator takes note of the PA conclusion that the evidence available in this review, as documented in the ISA, does not call into question the adequacy of protection provided by the 24-hour PM
                        <E T="52">2.5</E>
                         standard from ecological effects (PA, section 7.4). He additionally notes the agreement of this finding with the recommendation of the CASAC minority to retain the existing standard. The Administrator also considers the comments of the CASAC majority and recommendations for revision of this standard to a lower level or to an indicator of deciviews (with a level of 20 to-25 deciviews), based on the CASAC majority's consideration of visibility impairment and short-term fog or cloud-related deposition events that these members indicate may threaten sensitive lichen species, as summarized in section II.B.1.b. above. With regard to short-term fog or cloud-related events, the Administrator considers the PA finding in evaluating these recommendations, that, while the available evidence in the ISA recognizes there to be N deposition associated with cloud water or fog, it does not provide estimates of this deposition, describe associated temporal variability, or present evidence of effects on biota from such events (ISA, Appendix 2; PA, section 7.3).
                        <SU>149</SU>
                        <FTREF/>
                         Thus, he does not find a basis in the evidence base for this review for the CASAC majority revisions or their stated intention of addressing short-term events and lichen sensitivity. Further, the justification of the specific revision options recommended by the CASAC majority focuses on consideration of visibility impairment, and the Administrator notes that the adequacy of protection provided by the secondary PM
                        <E T="52">2.5</E>
                         standard from visibility effects has been addressed in his reconsideration of the 2020 p.m. NAAQS decision (89 FR 16202, March 6, 2024) and is not included in this review. Thus, based on his judgment that the evidence does not call the existing standard into question, the Administrator retains the existing 24-hour secondary PM
                        <E T="52">2.5</E>
                         standard, without revision.
                    </P>
                    <FTNT>
                        <P>
                            <SU>149</SU>
                             As noted in the PA and summarized in section II.B.1.b. above, the CASAC majority, in its justification for revision of the existing standard, did not identify studies in support of its statements related to lichen species and fog or cloud water.
                        </P>
                    </FTNT>
                    <P>
                        Regarding the PM
                        <E T="52">10</E>
                         standard, the Administrator concurs with the PA's finding of a lack of information that calls into question the adequacy of protection afforded by the existing PM
                        <E T="52">10</E>
                         secondary standard for ecological effects. Thus, he also retains the secondary PM
                        <E T="52">10</E>
                         standard without revision.
                    </P>
                    <HD SOURCE="HD2">C. Decision on the Secondary Standards</HD>
                    <P>
                        For the reasons discussed above and considering the evidence assessed in the ISA, the qualitative assessments and policy evaluations presented in the PA and associated technical memorandum, the advice and recommendations of the CASAC, and the public comments, the Administrator is revising the secondary standard for SO
                        <E T="52">X</E>
                         to provide the requisite protection of the public welfare from known and anticipated adverse effects. More specifically, the Administrator is revising the secondary SO
                        <E T="52">2</E>
                         standard to be an annual average, averaged over three years, with a level of 10 ppb SO
                        <E T="52">2</E>
                        . With this decision, the Agency is also making corresponding revisions to data handling conventions are specified in revisions to appendix T, discussed in section III. below.
                    </P>
                    <P>With regard to the secondary standards for N oxides and PM, based on the evidence assessed in the ISA, the qualitative assessments and policy evaluations presented in the PA and associated technical memorandum, the advice and recommendations of the CASAC, and the public comments, and for the reasons discussed above, the Administrator concludes that no changes are warranted, and is retaining the existing standards, without revision.</P>
                    <HD SOURCE="HD1">
                        III. Interpretation of the Secondary SO
                        <E T="0132">2</E>
                         NAAQS
                    </HD>
                    <P>
                        The EPA received no comments regarding the proposed data handling procedures for SO
                        <E T="52">2</E>
                         monitoring data for purposes of determining when the new annual secondary SO
                        <E T="52">2</E>
                         NAAQS is met. Therefore, the EPA is finalizing the proposed revisions to appendix T to 40 CFR part 50, Interpretation of the Primary National Ambient Air Quality Standards for Oxides of Sulfur, to establish data handling procedures for the new annual secondary SO
                        <E T="52">2</E>
                         standard. The regulatory text at 40 CFR 50.21, which sets the averaging period, level, indicator, and form of the annual standard, refers to this appendix T. The revised appendix T details the computations necessary for determining when the annual secondary SO
                        <E T="52">2</E>
                         NAAQS is met. The revised appendix T also addresses data reporting, data completeness considerations, and rounding conventions.
                    </P>
                    <HD SOURCE="HD2">A. Background</HD>
                    <P>
                        The general purpose of a data interpretation appendix is to provide the practical details on how to make a comparison between multi-day and possibly multi-monitor ambient air concentration data and the level of the NAAQS, so that determinations of attainment and nonattainment are as objective as possible. Data interpretation guidelines also provide criteria for determining whether there are sufficient data to make a NAAQS level comparison at all. The regulatory language for the secondary SO
                        <E T="52">2</E>
                         NAAQS adopted in 1971 does not contain detailed data interpretation instructions. This situation contrasts with the primary NO
                        <E T="52">2</E>
                        , ozone, PM
                        <E T="52">2.5</E>
                        , PM
                        <E T="52">10</E>
                        , lead, and primary SO
                        <E T="52">2</E>
                         NAAQS regulations, for which there are detailed data interpretation appendices in 40 CFR part 50 addressing issues that can arise in comparing monitoring data to the NAAQS. The existing appendix T includes these detailed data interpretation requirements for the 1-hour primary SO
                        <E T="52">2</E>
                         NAAQS, thus the 
                        <PRTPAGE P="105773"/>
                        revision provides similar information for the new annual secondary SO
                        <E T="52">2</E>
                         NAAQS. The EPA has used its experience developing and applying this data interpretation appendix to develop the revisions to the text in appendix T to address the new annual secondary SO
                        <E T="52">2</E>
                         standard.
                    </P>
                    <HD SOURCE="HD2">
                        B. Interpretation of the Secondary SO
                        <E T="54">2</E>
                         Standard
                    </HD>
                    <P>
                        The purpose of the data interpretation provisions for the secondary SO
                        <E T="52">2</E>
                         NAAQS is to give effect to the form, level, averaging time, and indicator specified in the regulatory text at 40 CFR 50.21, anticipating and resolving in advance various future situations that could occur. The revised appendix T provides definitions and requirements that apply to the annual secondary standard for SO
                        <E T="52">2</E>
                        . The requirements clarify how ambient air data are to be reported, what ambient air data are to be used for comparisons with the SO
                        <E T="52">2</E>
                         NAAQS, and how to calculate design values for comparisons with the SO
                        <E T="52">2</E>
                         NAAQS. The data already required to be reported by ambient air SO
                        <E T="52">2</E>
                         monitors for use in calculating design values for the current 1-hour primary SO
                        <E T="52">2</E>
                         NAAQS are also sufficient for use in calculating design values for the new annual secondary SO
                        <E T="52">2</E>
                         NAAQS.
                    </P>
                    <P>
                        The revised appendix T specifies that the annual secondary SO
                        <E T="52">2</E>
                         NAAQS is met at an ambient air quality monitoring site when the valid annual secondary standard design value is less than or equal to 10 ppb. The annual secondary standard design value for an ambient air quality monitoring site is described as the mean of the annual means for three consecutive years, with the annual mean derived as the annual average of daily means, with rounding and data completeness specified as described below. The use of a daily mean value in deriving the design value is consistent with the existing data handling requirements for the current 1-hour primary SO
                        <E T="52">2</E>
                         NAAQS.
                    </P>
                    <P>
                        Data completeness requirements for the annual secondary standard in the revised appendix T follow past EPA practice for other NAAQS pollutants by requiring that in general at least 75% of the monitoring data that should have resulted from following the planned monitoring schedule in a period must be available for the key air quality statistic from that period to be considered valid. These data completeness requirements are consistent with the current data completeness requirements for the 1-hour primary SO
                        <E T="52">2</E>
                         NAAQS in appendix T, and the revised appendix T does not change those requirements. For the annual secondary SO
                        <E T="52">2</E>
                         NAAQS, the key air quality statistics are the annual average of daily mean (24-hour average, midnight-to-midnight) concentrations in three successive years. It is important that daily means are representative of the 24-hour period and that all seasons of the year are well represented. Hence, the 75% requirement is applied at the daily and quarterly levels. These completeness requirements, including the calculation of the daily mean, are consistent with existing completeness requirements for the current 1-hour primary SO
                        <E T="52">2</E>
                         NAAQS.
                    </P>
                    <P>
                        Recognizing that there may be years with incomplete data, the text provides that a design value derived from incomplete data will nevertheless be considered valid if at least 75 percent of the days in each quarter of each of three consecutive years have at least one reported hourly value, and the 3-year annual average design value calculated according to the procedures specified in the revised appendix T is above the level of the secondary annual standard. Additionally, following provisions in the revised appendix T, a substitution test may be used to demonstrate validity of incomplete design values above the level of the standard by substituting a “low” daily mean value from the same calendar quarter in the 3-year design value period. Similarly, another substitution test may be used to demonstrate validity of incomplete design values below the level of the standard by substituting a “high” daily mean value from the same calendar quarter in the 3-year design value period. These substitution tests are consistent with existing substitution tests for the current 1-hour primary SO
                        <E T="52">2</E>
                         NAAQS.
                    </P>
                    <P>It should be noted that one possible outcome of applying the substitution test is that a year with incomplete data may nevertheless be determined to not have a valid design value and thus to be unusable in making annual secondary NAAQS compliance determinations for that 3-year period. However, the intention of the substitution test is to reduce the frequency of such occurrences.</P>
                    <P>
                        The EPA Administrator has general discretion to use incomplete monitoring data to calculate design values that would be treated as valid for comparison to the NAAQS despite the incompleteness, either at the request of a State or at the Administrator's own initiative. Similar provisions exist already for the PM
                        <E T="52">2.5</E>
                        , NO
                        <E T="52">2</E>
                        , lead, and 1-hour primary SO
                        <E T="52">2</E>
                         NAAQS. The EPA may consider monitoring site closures/moves, monitoring diligence, and nearby concentrations in determining whether to use such data.
                    </P>
                    <P>
                        The rounding conventions for the new annual secondary SO
                        <E T="52">2</E>
                         NAAQS are consistent with rounding conventions used for the current 1-hour primary SO
                        <E T="52">2</E>
                         NAAQS. Specifically, hourly SO
                        <E T="52">2</E>
                         measurement data shall be reported to EPA's regulatory database in units of ppb, to at most one place after the decimal, with additional digits to the right being truncated with no further rounding. Daily mean values and the annual mean of those daily values are not rounded. Further, the annual secondary standard design value is calculated pursuant to the revised appendix T and then rounded to the nearest whole number or 1 ppb (decimals 0.5 and greater are rounded up to the nearest whole number, and any decimal lower than 0.5 is rounded down to the nearest whole number).
                    </P>
                    <HD SOURCE="HD1">
                        IV. Ambient Air Monitoring Network for SO
                        <E T="0132">2</E>
                    </HD>
                    <P>
                        In the NPRM, the EPA did not propose any changes to the minimum monitoring requirements as part of the proposal to revise the secondary SO
                        <E T="52">2</E>
                         NAAQS. Based on a review of the network history, current network design, reported data, and monitoring objectives (Watkins et al., 2024), and in recognition of the network's adaptability and flexibility provided in 40 CFR part 58, the Agency proposed and took comment on its determination that the current network is adequate to provide the data needed to implement the new secondary SO
                        <E T="52">2</E>
                         standard. The EPA also concluded that the Agency, along with State, local, Tribal, and industry stakeholders, have the authority and ability to adjust monitoring efforts and redirect resources needed to ensure that the monitoring objectives of the SO
                        <E T="52">2</E>
                         network continue to be met, and thus no changes to minimum monitoring requirements are necessary.
                    </P>
                    <HD SOURCE="HD2">A. Public Comments</HD>
                    <P>
                        The EPA received a few comments related to the ambient air monitoring network design prescribed by the minimum monitoring requirements in 40 CFR part 58, section 4.4 as it relates to supporting the implementation of the new standard. The commenters recognized the value and importance of the network, with one stating that they support the use of ambient air quality monitoring data in designation activities, and that they believe “the existing monitoring network is adequate for making attainment decisions.” Another commenter expressed the view that “EPA must maintain a ground monitoring network that supports science-based decision making in the NAAQS standard setting process, as 
                        <PRTPAGE P="105774"/>
                        well as for compliance with a standard once it is set,” and concurred with a CASAC comment that monitoring networks, including the SLAMS, which are required through 40 CFR part 58, are “essential to provide the scientific basis for this review” (Sheppard, 2023).
                    </P>
                    <P>
                        Another commenter recommended that EPA “[i]ncrease monitoring in high-risk areas and ensure strict enforcement of the NAAQS,” including by deploying monitors in areas the commenter calls “frontline and fence-line communities,” and making the data publicly accessible. With regard to this comment, the EPA notes that the current network already has a significant subset of sites with monitoring objectives that provide for measurements in areas of higher SO
                        <E T="52">2</E>
                         emissions and in locations of expected maximum concentrations. Measurements from monitors with those objectives provide the data needed to support the new standard. However, the same monitors, sited in locations of expected maximum concentrations, can also be in “frontline and fence-line communities.” Further, all monitoring conducted by State, local, and Tribal air agencies, as well as data from industry that fulfill the requirements of 40 CFR parts 50, 53, and 58, the regulations that set out minimum monitoring requirements, and other requirements are publicly available through various means. These include but are not limited to obtaining the data directly from the air monitoring agencies themselves, from EPA's Air Data website, or from EPA's Air Quality System (AQS) database.
                    </P>
                    <HD SOURCE="HD2">B. Conclusion on the Monitoring Network</HD>
                    <P>
                        The EPA stated in the proposal that it believes that the current ambient air SO
                        <E T="52">2</E>
                         monitoring network design, deployment, and monitoring objectives are adequate to provide the data needed to implement the new secondary SO
                        <E T="52">2</E>
                         NAAQS. After consideration of public comments, and with reliance on EPA's assessment of the monitoring network provided as part of the proposal for this review, the Agency still asserts that the network is adequate and that no network design changes are necessary because EPA, State, local, Tribal, and industry stakeholders have the authority and ability to adjust monitoring efforts and redirect resources as needed to ensure that the monitoring objectives of the SO
                        <E T="52">2</E>
                         network continue to be met. The Administrator has therefore chosen to retain the existing minimum monitoring requirements for SO
                        <E T="52">2</E>
                         without modification, as currently prescribed, operated, and maintained in accordance with 40 CFR parts 50, 53, and 58, as proposed.
                    </P>
                    <HD SOURCE="HD1">
                        V. Clean Air Act Implementation Considerations for the Revised Secondary SO
                        <E T="0132">2</E>
                         Standard
                    </HD>
                    <P>
                        The EPA's revision to the secondary SO
                        <E T="52">2</E>
                         NAAQS will trigger a number of implementation-related activities that were described in the proposal. The two most immediate implementation impacts following a final new or revised NAAQS are related to stationary source permitting and the initial area designations process. Permitting implications are discussed in section V.C., and designation implications are discussed in section V.A. The Agency is finalizing an action retaining the secondary NO
                        <E T="52">2</E>
                         and PM NAAQS. Retention of existing secondary standards does not trigger any new implementation actions. Additional implementation information is available in the proposal preamble in section V.
                    </P>
                    <P>
                        At the outset, promulgation of a new or revised NAAQS triggers a process through which States 
                        <SU>150</SU>
                        <FTREF/>
                         would make recommendations to the Administrator regarding initial area designations. States also would be required to make a new SIP submission to establish that they meet the necessary structural requirements for such new or revised NAAQS pursuant to CAA section 110(a)(1) and (2), also referred to as the “infrastructure SIP submission” (more on this submission below). This section provides background information for understanding the implementation implications of the secondary SO
                        <E T="52">2</E>
                         NAAQS changes and describes the EPA's intentions for providing guidance regarding implementation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>150</SU>
                             This and all subsequent references to “state” are meant to include State, local and Tribal agencies responsible for the implementation of a SO
                            <E T="52">2</E>
                             control program.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">A. Designation of Areas</HD>
                    <P>
                        As described in section II.B.3., the EPA is revising the secondary SO
                        <E T="52">2</E>
                         NAAQS to 10 ppb, as an annual average, averaged over three consecutive years. After the EPA establishes a new or revised NAAQS (primary or secondary), the CAA requires the EPA and States to take steps to ensure that the new or revised NAAQS is met. The timeline for initial area designations begins with promulgation of the new NAAQS, as stated in CAA section 107(d)(1)(A). Initial area designations involve identifying areas of the country that either meet or do not meet the new or revised NAAQS, along with the nearby areas contributing to NAAQS violations. The following includes additional information regarding the designations process described in the CAA.
                    </P>
                    <P>
                        Section 107(d)(1)(A) of the CAA states that, “By such date as the Administrator may reasonably require, but not later than 1 year after promulgation of a new or revised [NAAQS] for any pollutant under [section 109], the Governor of each State shall . . . submit to the Administrator a list of all areas (or portions thereof) in the State” and make recommendations for whether the EPA should designate those areas as “nonattainment,” “attainment,” or “unclassifiable.” 
                        <SU>151</SU>
                        <FTREF/>
                         A nonattainment area is any area that does not meet (or that contributes to ambient air quality in a nearby area that does not meet) a NAAQS; an attainment area is any area (other than an area identified as a nonattainment area) that meets a NAAQS; and an unclassifiable area is any area that cannot be classified on the basis of available information as meeting or not meeting a NAAQS.
                        <SU>152</SU>
                        <FTREF/>
                         The CAA provides the EPA with discretion to require States to submit their designations recommendations within a reasonable amount of time not exceeding 1 year after the promulgation of a new or revised NAAQS. CAA section 107(d)(1)(B)(a) also stipulates that “the Administrator may not require the Governor to submit the required list sooner than 120 days after promulgating a new or revised [NAAQS].” This same section further provides, “Upon promulgation or revision of a [NAAQS], the Administrator shall promulgate the designations of all areas (or portions thereof) . . . as expeditiously as practicable, but in no case later than 2 years from the date of promulgation . . . . Such period may be extended for up to one year in the event the Administrator has insufficient information to promulgate the designations.” With respect to the NAAQS setting process, courts have interpreted the term “promulgation” to be signature and widespread dissemination of a final rule.
                        <SU>153</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>151</SU>
                             While the CAA says “designating” with respect to the Governor's letter, in the full context of the CAA section it is clear that the Governor makes a recommendation to which the EPA must respond via a specified process if the EPA does not accept it.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>152</SU>
                             See 42 U.S.C. 7407(d)(1)(A)(i)-(iii).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>153</SU>
                             
                            <E T="03">API</E>
                             v. 
                            <E T="03">Costle,</E>
                             609 F.2d 20 (D.C. Cir. 1979).
                        </P>
                    </FTNT>
                    <P>
                        If the EPA agrees that the State's designations recommendations are consistent with all relevant CAA requirements, then the EPA may proceed to promulgate the designations for such areas. However, if the EPA disagrees that a State's recommendation is consistent with all relevant CAA requirements, then the EPA may make 
                        <PRTPAGE P="105775"/>
                        modifications to the recommended designations by following the process outlined in the CAA. By no later than 120 days prior to promulgating the final designations, the EPA is required to notify States of any intended modifications to the designations of any areas or portions thereof, including the boundaries of areas, as the EPA may deem necessary. States then have an opportunity to comment on the EPA's intended designations decisions. If a State elects not to provide designations recommendations, then the EPA must timely promulgate the designations that it deems appropriate. CAA section 107(d)(1)(B)(ii).
                    </P>
                    <P>
                        While section 107(d) of the CAA specifically addresses the designations process for States, the EPA intends to follow the same process for Tribes to the extent practicable, pursuant to section 301(d) of the CAA regarding Tribal authority, and the Tribal Authority Rule (63 FR 7254, February 12, 1998). To provide clarity and consistency in doing so, the EPA issued a guidance memorandum to our Regional Offices on working with Tribes during the designations process.
                        <SU>154</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>154</SU>
                             “Guidance to Regions for Working with Tribes during the National Ambient Air Quality Standards (NAAQS) Designations Process,” December 20, 2011, Memorandum from Stephen D. Page to Regional Air Directors, Regions 1-X available at 
                            <E T="03">https://www.epa.gov/sites/default/files/2017-02/documents/12-20-11_guidance_to_regions_for_working_with_tribes_naaqs_designations.pdf.</E>
                        </P>
                    </FTNT>
                    <P>Consistent with the process used in previous initial area designations efforts for both primary and secondary standards, the EPA will employ a nationally consistent framework and approach to evaluate each State's designations recommendations. Section 107(d) of the CAA explicitly requires that the EPA designate as nonattainment not only the area that is violating the pertinent standard, but also those nearby areas that contribute to ambient air quality in the violating area. Consistent with past practice, the EPA plans to address issues relevant to the initial area designations more fully in a separate designations-specific memorandum.</P>
                    <P>
                        The EPA intends to issue the designations for the secondary SO
                        <E T="52">2</E>
                         NAAQS based on the most recent 3 years of complete, certified, and valid air quality monitoring data in the areas where monitors are installed and operating. The EPA intends to use such available air quality monitoring data from the current SO
                        <E T="52">2</E>
                         monitoring network. For further information on the adequacy of the monitoring network, refer to the memorandum in the docket for this action titled “Ambient Air SO
                        <E T="52">2</E>
                         Monitoring Network Review and Background” (Watkins et al., 2024). Monitoring data are currently available from existing FEM and FRM monitors sited and operated in accordance with 40 CFR parts 50 and 58 to determine compliance with the revised secondary SO
                        <E T="52">2</E>
                         NAAQS.
                    </P>
                    <P>
                        State or Tribal air agencies may flag air quality data for certain days in the Air Quality System (AQS) database due to potential impacts from exceptional events. CAA section 319(b) defines an exceptional event as an event that (i) affects air quality; (ii) is not reasonably controllable or preventable; (iii) is an event caused by human activity that is unlikely to recur at a particular location or a natural event; and (iv) is determined by the Administrator through the process established in the regulations to be an exceptional event (
                        <E T="03">e.g.,</E>
                         volcanic activity for SO
                        <E T="52">2</E>
                        ). For emissions affecting air quality to be considered an exceptional event, there must be a clear causal relationship between the specific event and the monitored exceedance or violation. Air quality monitoring data affected by exceptional events may be excluded from use in determinations of exceedances or violations if the data meet the criteria for exclusion under CAA section 319(b) and EPA's “Treatment of Data Influenced by Exceptional Events” Final Rule (81 FR 68216; October 3, 2016) (Exceptional Events Rule) codified at 40 CFR 50.1, 50.14, and 51.930. For events affecting initial area designations, the air agency is required to follow the exceptional events demonstration submission deadlines that are identified in table 2 to 40 CFR 50.14(c)(2)(vi), “Schedule for Initial Notification and Demonstration Submission for Data Influenced by Exceptional Events for Use in Initial Area Designations.” The EPA encourages air agencies to work collaboratively with the appropriate EPA Regional office after identifying any exceptional event influencing ambient air quality concentrations in a way that could affect area designations for the annual SO
                        <E T="52">2</E>
                         secondary NAAQS.
                    </P>
                    <HD SOURCE="HD2">B. Section 110(a)(1) and (2) Infrastructure SIP Requirements</HD>
                    <P>
                        As discussed in the proposal preamble section V.B., the CAA directs States to address basic SIP requirements to implement, maintain, and enforce the NAAQS. Under CAA sections 110(a)(1) and (2), States are required to have State implementation plans that provide the necessary air quality management infrastructure including, among other things, enforceable emissions limitations, an ambient air monitoring program, an enforcement program, air quality modeling capabilities, and adequate personnel, resources, and legal authority to carry out the implementation of the SIP. After the EPA promulgates a new or revised NAAQS, States are required to make a new SIP submission to establish that they meet the necessary structural requirements for such new or revised NAAQS or make changes to do so. The EPA refers to this type of SIP submission as an “infrastructure SIP submission.” Under CAA section 110(a)(1), all States are required to make these infrastructure SIP submissions within 3 years after promulgation of a new or revised standard. While the CAA authorizes the EPA to set a shorter time for States to make these SIP submissions, the EPA is requiring submission of infrastructure SIPs within 3 years of the promulgation date of this revised secondary SO
                        <E T="52">2</E>
                         NAAQS. Section 110(b) of the CAA also provides that the EPA may extend the deadline for the “infrastructure” SIP submission for a revised secondary NAAQS by up to 18 months beyond the initial 3 years. If a state requests an extension pursuant to CAA section 110(b) and 40 CFR 51.341 and the Administrator determines an extension is necessary, the EPA will set additional time for that state for the infrastructure SIP submittal in a separate action from this final rule. The EPA does not anticipate that extensions will be necessary as most, if not all, states' existing infrastructure SIPs may already be sufficient to satisfy the infrastructure SIP requirements for this revised secondary SO
                        <E T="52">2</E>
                         NAAQS, and those states can reiterate that they have met the requirements in their infrastructure SIP submissions.
                    </P>
                    <P>
                        Under CAA sections 110(a)(1) and (2), States are required to make SIP submissions that address requirements pertaining to implementation, maintenance, and enforcement of a new or revised NAAQS. The specific subsections in CAA section 110(a)(2) require States to address a number of requirements, as applicable: (A) emissions limits and other control measures; (B) ambient air quality monitoring/data system; (C) programs for enforcement of control measures and for construction or modification of stationary sources; (D)(i) interstate pollution transport and (ii) interstate and international pollution abatement; (E) adequate resources and authority, conflict of interest, and oversight of local governments and regional agencies; (F) stationary source monitoring and reporting; (G) emergency powers; (H) SIP revisions; (I) 
                        <PRTPAGE P="105776"/>
                        plan revisions for nonattainment areas; (J) consultation with government officials, public notification, Prevention of Significant Deterioration (PSD) and visibility protection; (K) air quality modeling and submission of modeling data; (L) permitting fees; and (M) consultation and participation by affected local entities. These requirements apply to all SIP submissions in general, but the EPA has provided specific guidance to States concerning its interpretation of these requirements in the specific context of infrastructure SIP submissions for a new or revised NAAQS.
                        <SU>155</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>155</SU>
                             
                            <E T="03">See</E>
                             “Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clean Air Act sections 110(a)(1) and 110(a)(2)” September 2013, Memorandum from Stephen D. Page to Regional Air Directors, Regions 1-10.
                        </P>
                    </FTNT>
                    <P>
                        As a reminder, States are not required to address nonattainment plan requirements for purposes of the revised secondary SO
                        <E T="52">2</E>
                         NAAQS on the same schedule as infrastructure SIP requirements. For the reasons explained below, the EPA interprets the CAA such that (1) the portion of CAA section 110(a)(2)(C), programs for enforcement of control measures and for construction or modification of sources that applies to permit programs applicable in designated nonattainment areas, (known as “nonattainment new source review”) under part D; and (2) CAA section 110(a)(2)(I) in its entirety are not subject to the 3-year submission deadline of CAA section 110(a)(1), and thus States are not required to address them in the context of an infrastructure SIP submission. Accordingly, the EPA does not expect States to address the requirement for a new or revised NAAQS in the infrastructure SIP submissions to include regulations or emissions limits developed specifically for attaining the relevant standard in areas designated nonattainment for the revised secondary SO
                        <E T="52">2</E>
                         NAAQS. States are required to submit infrastructure SIP submissions for the secondary SO
                        <E T="52">2</E>
                         NAAQS before they are required to submit nonattainment plan SIP submissions to demonstrate attainment with the same NAAQS. As a general matter, states would be required to submit nonattainment plans to provide for attainment and maintenance of the revised secondary SO
                        <E T="52">2</E>
                         NAAQS within 3 years from the effective date of nonattainment area designations as required under CAA section 172(b). In addition, because this NAAQS is a secondary standard, CAA section 110(b) also provides that the EPA may extend the deadline for the nonattainment plan for up to 18 months beyond the initial 3 years. If a state requests an extension pursuant to CAA section 110(b) and 40 CFR 51.341 and the Administrator determines an extension is necessary, the EPA will set additional time for the nonattainment plan submittal in a separate action from this final rule. The EPA reviews and acts upon these later SIP submissions through a separate process. For these reasons, the EPA does not expect States to address new nonattainment area emissions controls per CAA section 110(a)(2)(I) in their infrastructure SIP submissions.
                    </P>
                    <P>
                        Another required infrastructure SIP element is that each State's SIP must contain adequate provisions to prohibit, consistent with the provisions of title I of the CAA, emissions from within the State that will significantly contribute to nonattainment in, or interfere with maintenance by, any other State of the primary or secondary NAAQS.
                        <SU>156</SU>
                        <FTREF/>
                         This element is often referred to as the “good neighbor” or “interstate transport” provision.
                        <SU>157</SU>
                        <FTREF/>
                         The provision has two prongs: significant contribution to nonattainment (prong 1) and interference with maintenance (prong 2). The EPA and States must give independent significance to prong 1 and prong 2 when evaluating downwind air quality problems under CAA section 110(a)(2)(D)(i)(I).
                        <SU>158</SU>
                        <FTREF/>
                         Further, case law has established that the EPA and States must implement requirements to meet interstate transport obligations in alignment with the applicable statutory attainment schedule of the downwind areas impacted by upwind-State emissions.
                        <SU>159</SU>
                        <FTREF/>
                         The EPA anticipates coordinating with States with respect to the requirements of CAA section 110(a)(2)(D)(i)(I) for implementation of the secondary SO
                        <E T="52">2</E>
                         NAAQS.
                    </P>
                    <FTNT>
                        <P>
                            <SU>156</SU>
                             CAA section 110(a)(2)(D)(i)(I).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>157</SU>
                             CAA section 110(a)(2)(D)(i)(II) also addresses certain interstate effects that States must address and thus is also sometimes referred to as relating to “interstate transport.”
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>158</SU>
                             
                            <E T="03">See North Carolina</E>
                             v. 
                            <E T="03">EPA,</E>
                             531 F.3d 896, 909-11 (D.C. Cir. 2008).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>159</SU>
                             
                            <E T="03">See id.</E>
                             at 911-13. 
                            <E T="03">See also Wisconsin</E>
                             v. 
                            <E T="03">EPA,</E>
                             938 F.3d 303, 313-20 (D.C. Cir. 2019); 
                            <E T="03">Maryland</E>
                             v. 
                            <E T="03">EPA,</E>
                             958 F.3d 1185, 1203-04 (D.C. Cir. 2020).
                        </P>
                    </FTNT>
                    <P>Each State has the authority and responsibility to review its air quality management program's existing SIP provisions in light of each new or revised NAAQS to determine whether any revisions to the State's regulations or program are necessary to implement a new or revised NAAQS. Most States have revised and updated their SIPs in recent years to address requirements associated with other revised NAAQS. For some States, it may be the case that, for a number of infrastructure elements, the State may believe it already has adequate State regulations adopted and approved into the SIP to address a particular requirement with respect to any new or revised NAAQS. For such portions of the State's infrastructure SIP submission, the State could provide an explanation of how its existing SIP provisions are adequate.</P>
                    <P>
                        If a State determines that existing SIP-approved provisions, such as those approved for the 1-hour primary SO
                        <E T="52">2</E>
                         NAAQS, remain adequate in light of the new annual secondary SO
                        <E T="52">2</E>
                         NAAQS with respect to a given infrastructure SIP element (or sub-element), then the State may make a SIP submission containing relevant supporting information “certifying” that the existing SIP contains provisions that address those requirements of the specific CAA section 110(a)(2) infrastructure elements.
                        <SU>160</SU>
                        <FTREF/>
                         In the case of such a certification submission, the State would not have to include a copy of the relevant provision (
                        <E T="03">e.g.,</E>
                         rule or statute) itself. Rather, this certification submission should provide citations to the EPA-approved State statutes, regulations, or non-regulatory measures, as appropriate, in or referenced by the already EPA-approved SIP that meet particular infrastructure SIP element requirements. The State's infrastructure SIP submission should also include an explanation as to how the State has determined that those existing provisions meet the relevant requirements.
                    </P>
                    <FTNT>
                        <P>
                            <SU>160</SU>
                             A “certification” approach would not be appropriate for the interstate pollution control requirements of CAA section 110(a)(2)(D)(i).
                        </P>
                    </FTNT>
                    <P>Like any other SIP submission, that State can make such an infrastructure SIP submission certifying that it has already met some or all of the applicable requirements only after it has provided reasonable notice and opportunity for public hearing. This “reasonable notice and opportunity for public hearing” requirement for infrastructure SIP submissions is to meet the requirements of CAA sections 110(a) and 110(l). Under the EPA's regulations at 40 CFR part 51, if a public hearing is held, an infrastructure SIP submittal must include a certification by the State that the public hearing was held in accordance with the EPA's procedural requirements for public hearings. See 40 CFR part 51, appendix V, 2.1(g); and see 40 CFR 51.102.</P>
                    <P>
                        In consultation with its EPA Regional Office, a State should follow all applicable EPA regulations governing infrastructure SIP submissions in 40 CFR part 51—
                        <E T="03">e.g.,</E>
                         subpart I (Review of New Sources and Modifications), subpart J (Ambient Air Quality 
                        <PRTPAGE P="105777"/>
                        Surveillance), subpart K (Source Surveillance), subpart L (Legal Authority), subpart M (Intergovernmental Consultation), subpart O (Miscellaneous Plan Content Requirements), subpart P (Protection of Visibility), and subpart Q (Reports). For the EPA's general criteria for infrastructure SIP submissions, refer to 40 CFR part 51, appendix V, Criteria for Determining the Completeness of Plan Submissions. The EPA recommends that States electronically submit their infrastructure SIPs to the EPA through the State Plan Electronic Collaboration System (SPeCS),
                        <SU>161</SU>
                        <FTREF/>
                         an online system available through the EPA's Central Data Exchange. The EPA acknowledges that the timeline for submission of infrastructure SIPs for the secondary SO
                        <E T="52">2</E>
                         NAAQS may overlap in part with the timeline for submission of infrastructure SIPs for the recently revised primary PM
                        <E T="52">2.5</E>
                         NAAQS. Air Agencies may elect to streamline their infrastructure SIP submittal and development by combining the two distinct infrastructure SIP submissions for both NAAQS into one submission. The EPA appreciates the obligations may differ for some infrastructure elements, and simply notes that this option may represent a more streamlined approach for some areas.
                    </P>
                    <FTNT>
                        <P>
                            <SU>161</SU>
                             
                            <E T="03">https://cdx.epa.gov/.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">
                        C. Prevention of Significant Deterioration and Nonattainment New Source Review Programs for the Revised Secondary SO
                        <E T="54">2</E>
                         Standard
                    </HD>
                    <P>The CAA, at parts C and D of title I, contains preconstruction review and permitting programs applicable to new major stationary sources and major modifications of existing major sources. The preconstruction review of each new major stationary source and major modification applies on a pollutant-specific basis, and the requirements that apply for each pollutant depend on whether the area in which the source is situated is designated as attainment (or unclassifiable) or nonattainment for that pollutant. In areas designated attainment or unclassifiable for a pollutant, the PSD requirements under part C apply to construction at major sources. In areas designated nonattainment for a pollutant, the Nonattainment New Source Review (NNSR) requirements under part D apply to major source construction. Collectively, those two sets of permit requirements are commonly referred to as the “major New Source Review” or “major NSR” programs.</P>
                    <P>
                        The statutory requirements for a PSD permit program set forth under part C of title I of the CAA (sections 160 through 169) are implemented through the EPA's PSD regulations found at 40 CFR 51.166 (minimum requirements for an approvable PSD SIP) and 40 CFR 52.21 (PSD permitting program for permits issued under the EPA's Federal permitting authority). Whenever a proposed new major source or major modification triggers PSD requirements for SO
                        <E T="52">2</E>
                        , either 40 CFR 52.21 or State regulations based on 40 CFR 51.166 will apply for undesignated areas and for areas that are designated as attainment or as unclassifiable for the revised secondary SO
                        <E T="52">2</E>
                         NAAQS.
                    </P>
                    <P>
                        For PSD, a “major stationary source” is one with the potential to emit 250 tons per year (tpy) or more of any regulated NSR pollutant, unless the new or modified source is classified under a list of 28 source categories contained in the statutory definition of “major emitting facility” in CAA section 169(1). For those 28 source categories, a “major stationary source” is one with the potential to emit 100 tpy or more of any regulated NSR pollutant. A “major modification” is a physical change or a change in the method of operation of an existing major stationary source that results, first, in a significant emissions increase of a regulated NSR pollutant and, second, in a significant net emissions increase of that pollutant. 
                        <E T="03">See</E>
                         40 CFR 51.166(b)(2)(i), 52.21(b)(2)(i). The EPA PSD regulations define the term “regulated NSR pollutant” to include any pollutant for which a NAAQS has been promulgated and any pollutant identified in the EPA regulations as a constituent or precursor to such pollutant. 
                        <E T="03">See</E>
                         40 CFR 51.166(b)(49), 52.21(b)(50). Thus, the PSD program currently requires the review and control of emissions of SO
                        <E T="52">2,</E>
                         as applicable. Among other things, for each regulated NSR pollutant emitted or increased in a significant amount, the PSD program requires a new major stationary source or a major modification to apply the “best available control technology” (BACT) and to conduct an air quality impact analysis to demonstrate that the proposed major stationary source or major modification will not cause or contribute to a violation of any NAAQS or PSD increment.
                        <FTREF/>
                        <SU>162</SU>
                          
                        <E T="03">See</E>
                         CAA section 165(a)(3)-(4), 40 CFR 51.166(j) and (k), 52.21(j) and (k). The PSD requirements may also include, in appropriate cases, an analysis of potential adverse impacts on Class I areas. 
                        <E T="03">See</E>
                         CAA sections 162(a) and 165, 40 CFR 51.166(p), 52.21(p)).
                        <SU>163</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>162</SU>
                             By establishing the maximum allowable level of ambient air pollutant concentration increase in a particular area, an increment defines “significant deterioration” of air quality in that area. Increments are defined by the CAA as maximum allowable increases in ambient air concentrations above a baseline concentration and are specified in the PSD regulations by pollutant and area classification (Class I, II and III). 40 CFR 51.166(c), 52.21(c); 75 FR 64864; October 20, 2010. The EPA has developed the Guideline on Air Quality Models and other documents to, among other things, provide methods and guidance for demonstrating compliance the NAAQS and PSD increments including the annual SO
                            <E T="52">2</E>
                             standard. See 40 CFR part 51, appendix W; 82 FR 5182, January 17, 2017.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>163</SU>
                             Congress established certain Class I areas in section 162(a) of the CAA, including international parks, national wilderness areas, and national parks that meet certain criteria. Such Class I areas, known as mandatory Federal Class I areas, are afforded special protection under the CAA. In addition, states and Tribal governments may establish Class I areas within their own political jurisdictions to provide similar special air quality protection.
                        </P>
                    </FTNT>
                    <P>
                        With regard to nonattainment NSR, the EPA's regulations for the NNSR programs are contained in 40 CFR 51.165, 40 CFR 52.24, and 40 CFR part 51, appendix S. Specifically, the EPA developed minimum program requirements for a NNSR program that is approvable in a SIP, and those requirements, which include requirements for SO
                        <E T="52">2</E>
                        , are contained in 40 CFR 51.165. In addition, 40 CFR part 51, appendix S contains requirements constituting an interim NNSR program. This program enables NNSR permitting in nonattainment areas by States that lack a SIP-approved NNSR permitting program (or a program that does not apply to the relevant pollutant) during the time between the date of the relevant designation and the date that the EPA approves into the SIP a NNSR program. 
                        <E T="03">See</E>
                         40 CFR part 51, appendix S, part I; 40 CFR 52.24(k). Any new NNSR requirements for SO
                        <E T="52">2</E>
                         associated with the revised secondary standard would become applicable upon the effective date of any nonattainment designation for the final standard.
                    </P>
                    <P>
                        As stated in the proposal section V.C., the EPA is not making any changes to the NSR program regulations to implement the revised secondary SO
                        <E T="52">2</E>
                         NAAQS. Under the PSD program, any permit issued on and after the effective date of the new annual secondary SO
                        <E T="52">2</E>
                         NAAQS will require a demonstration that the emissions from the proposed major stationary source or major modification would not cause or contribute to violation of that standard. The EPA has regulations, models, guidance, and other tools for making this showing, and anticipates that sources and reviewing authorities will be able to use most of these existing tools to demonstrate compliance with the revised secondary SO
                        <E T="52">2</E>
                         NAAQS. However, as provided in the NPRM, the EPA developed a separate technical 
                        <PRTPAGE P="105778"/>
                        document (Tillerson et al., 2024),
                        <SU>164</SU>
                        <FTREF/>
                         which provides a technical justification for how a demonstration of compliance with the 1-hour primary SO
                        <E T="52">2</E>
                         standard can suffice to demonstrate compliance with the new SO
                        <E T="52">2</E>
                         secondary standard. The EPA has determined that this alternative compliance demonstration approach is technically justified and can provide for streamlined implementation of the new secondary SO
                        <E T="52">2</E>
                         NAAQS under the PSD program in all areas of the country. Accordingly, the EPA plans to issue a memorandum that explains how permit applicants and permitting authorities may use this alternative compliance demonstration approach and supporting technical analysis in making the required demonstration for the new secondary SO
                        <E T="52">2</E>
                         NAAQS. The EPA intends to issue this memorandum close in time to the effective date of the new secondary SO
                        <E T="52">2</E>
                         NAAQS to help provide for a smooth transition to implementing the revised secondary standard under the PSD program.
                    </P>
                    <FTNT>
                        <P>
                            <SU>164</SU>
                             This technical memo (Tillerson et al., 2024) is available in the docket for this NAAQS review (Docket ID No. EPA-HQ-OAR-2014-0128-0041).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">D. Transportation Conformity Program</HD>
                    <P>
                        As discussed in the proposal section V.E., transportation conformity is required under CAA section 176(c) (42 U.S.C. 7506(c)) to ensure that federally supported highway and transit activities are consistent with (“conform to”) the purpose of the SIP. Transportation conformity applies to areas that are designated as nonattainment areas and to nonattainment areas that have been redesignated to attainment with an approved CAA section 175A maintenance plan (
                        <E T="03">i.e.,</E>
                         maintenance areas) for transportation-related criteria pollutants: carbon monoxide, ozone, NO
                        <E T="52">2</E>
                        , PM
                        <E T="52">2.5</E>
                        , and PM
                        <E T="52">10</E>
                        . Motor vehicles are not significant sources of SO
                        <E T="52">2</E>
                        , and thus transportation conformity does not apply to any SO
                        <E T="52">2</E>
                         NAAQS (40 CFR 93.102(b)(1)), either the existing NAAQS or this revised secondary SO
                        <E T="52">2</E>
                         NAAQS.
                        <SU>165</SU>
                        <FTREF/>
                         Therefore, this final rule does not affect the transportation conformity rule (40 CFR 51.390 and 40 CFR part 93, subpart A).
                    </P>
                    <FTNT>
                        <P>
                            <SU>165</SU>
                             See “VII. Description of the Proposal” in “Criteria and Procedures for Determining Conformity to State or Federal Implementation Plans of Transportation Plans, Programs, and Projects funded or Approved Under Title 23 U.S.C. or the Federal Transit Act.” (58 FR 3768, January 11, 1993). The EPA finalized the original transportation conformity regulations on November 24, 1993 (58 FR 62188). The rule has subsequently been revised and the current provisions of the transportation conformity rule are found at 40 CFR part 93, subpart A.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">E. General Conformity Program</HD>
                    <P>
                        The General Conformity program applies to federal activities that cause emissions of the criteria or precursor pollutants to originate within designated nonattainment areas 
                        <SU>166</SU>
                        <FTREF/>
                         or redesignated attainment areas that operate under approved CAA section 175A maintenance plans (
                        <E T="03">i.e.,</E>
                         maintenance areas). The General Conformity program requirements at 40 CFR part 93, subpart B establish criteria and procedures for determining conformity as required under CAA section 176(c),
                        <SU>167</SU>
                        <FTREF/>
                         which prohibits a Federal agency from taking an action that would interfere with the ability of a State or Tribe to attain or maintain the NAAQS. General Conformity applies only to Federal activities not defined as transportation plans, programs, or projects under 40 CFR 93.102. The program requirements apply to emissions of all six criteria pollutants and their precursors, including NO
                        <E T="52">X</E>
                        , SO
                        <E T="52">X</E>
                        , and PM, per 40 CFR 93.153(b)(1) and (2), but only to the extent the emissions can be characterized as “direct emissions” or “indirect emissions” as defined under 40 CFR 93.152. General federal activities that cause emissions of SO
                        <E T="52">2</E>
                         are subject to General Conformity; however, no change to the regulations is necessary to accommodate any changes to the secondary SO
                        <E T="52">2</E>
                         NAAQS made by this rulemaking.
                    </P>
                    <FTNT>
                        <P>
                            <SU>166</SU>
                             Applicability of the General Conformity program to any newly designated nonattainment area for a specific NAAQS begins one year following the effective date of the final nonattainment designation, as allowed under CAA section 176(c)(6) and 40 CFR 93.153(k).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>167</SU>
                             Under CAA section 176(c)(1), Federal agencies have the affirmative responsibility to assure their actions achieve conformity to the purpose of an implementation plan, where the term “conformity to an implementation plan” is defined at CAA sections 176(c)(1)(A) and 176(c)(1)(B). Under CAA section 176(c)(4), the EPA is required to establish criteria and procedures for determining conformity.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">VI. Statutory and Executive Order Reviews</HD>
                    <P>
                        Additional information about these statutes and Executive orders can be found at 
                        <E T="03">https://www.epa.gov/laws-regulations/laws-and-executive-orders.</E>
                    </P>
                    <HD SOURCE="HD2">A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094: Modernizing Regulatory Review</HD>
                    <P>
                        This action is a “significant regulatory action” as defined in Executive Order 12866, as amended by Executive Order 14094. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for Executive Order 12866 review. Documentation of any changes made in response to the Executive Order 12866 review is available in the docket. The EPA prepared an analysis to determine if additional emission reductions would be needed to meet the revised secondary SO
                        <E T="52">2</E>
                         NAAQS. This analysis is contained in the document “Air Quality Analyses Using Sulfur Dioxide (SO
                        <E T="52">2</E>
                        ) Air Quality Data, Updated” which is available in the docket for this NAAQS review (ID No. EPA-HQ-OAR-2014-0128). The analysis concluded that no additional emissions reductions beyond any needed to meet the current 1-hour primary SO
                        <E T="52">2</E>
                         NAAQS are expected to be necessary to meet the new annual secondary SO
                        <E T="52">2</E>
                         NAAQS of 10 ppb, averaged over three years. Thus, there are no pollution controls expected to be necessary, and accordingly no costs or monetized benefits associated with this NAAQS revision. Accordingly, no regulatory impact analysis has been prepared for this final rule.
                    </P>
                    <HD SOURCE="HD2">B. Paperwork Reduction Act (PRA)</HD>
                    <P>
                        This action does not impose any new information collection burden under the PRA. The OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2060-0084. The data collected through the information collection activities in the existing regulations consist of ambient air concentration measurements for the seven air pollutants with national ambient air quality standards (
                        <E T="03">i.e.,</E>
                         ozone, sulfur dioxide, nitrogen dioxide, lead, carbon monoxide, PM
                        <E T="52">2.5</E>
                         and PM
                        <E T="52">10</E>
                        ), ozone precursors, air toxics, meteorological variables at a select number of sites, and other supporting measurements. Accompanying the pollutant concentration data are quality assurance/quality control data and air monitoring network design information. The EPA and others (
                        <E T="03">e.g.,</E>
                         State and local air quality management agencies, Tribal entities, environmental organizations, academic institutions, and industrial groups) use the ambient air quality data for many purposes including informing the public and other interested parties of an area's air quality, judging an area's air quality in comparison with the established health or welfare standards, evaluating an air quality management agency's progress in achieving or maintaining air pollutant levels below the national and local standards, developing and revising State Implementation Plans (SIPs), evaluating air pollutant control strategies, developing or revising national control policies, providing data for air quality model development and validation, 
                        <PRTPAGE P="105779"/>
                        supporting enforcement actions, documenting episodes and initiating episode controls, assessing air quality trends, and conducting air pollution research.
                    </P>
                    <HD SOURCE="HD2">C. Regulatory Flexibility Act (RFA)</HD>
                    <P>
                        I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. Rather, this final rule establishes national standards for allowable annual average concentrations of SO
                        <E T="52">2</E>
                         in ambient air as required by section 109 of the CAA. See also 
                        <E T="03">American Trucking Associations</E>
                         v. 
                        <E T="03">EPA,</E>
                         175 F.3d 1027, 1044-45 (D.C. Cir. 1999) (NAAQS do not have significant impacts upon small entities because NAAQS themselves impose no regulations upon small entities), rev'd in part on other grounds, 
                        <E T="03">Whitman</E>
                         v. 
                        <E T="03">American Trucking Associations,</E>
                         531 U.S. 457 (2001).
                    </P>
                    <HD SOURCE="HD2">D. Unfunded Mandates Reform Act (UMRA)</HD>
                    <P>
                        This action does not contain an unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. Furthermore, as indicated previously, in setting a NAAQS the EPA cannot consider the economic or technological feasibility of attaining ambient air quality standards, although such factors may be considered to a degree in the development of state plans to implement the standards. See also 
                        <E T="03">American Trucking Associations</E>
                         v. 
                        <E T="03">EPA,</E>
                         175 F. 3d at 1043 (noting that because the EPA is precluded from considering costs of implementation in establishing NAAQS, preparation of the RIA pursuant to the Unfunded Mandates Reform Act would not furnish any information that the court could consider in reviewing the NAAQS).
                    </P>
                    <HD SOURCE="HD2">E. Executive Order 13132: Federalism</HD>
                    <P>This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. However, the EPA recognizes that states will have a substantial interest in this action and any future revisions to associated requirements.</P>
                    <HD SOURCE="HD2">F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments</HD>
                    <P>
                        This action does not have Tribal implications, as specified in Executive Order 13175. It does not have a substantial direct effect on one or more Indian Tribes as Tribes are not obligated to adopt or implement any NAAQS. In addition, Tribes are not obligated to conduct ambient monitoring for SO
                        <E T="52">2</E>
                         or to adopt the ambient air monitoring requirements of 40 CFR part 58. Thus, Executive Order 13175 does not apply to this action. However, consistent with the 
                        <E T="03">EPA Policy on Consultation and Coordination with Indian Tribes,</E>
                         the EPA offered consultation to all 574 Federally Recognized Tribes during the development of this action. Although no Tribes requested consultation, the EPA provided informational meetings and provided information on the monthly National Tribal Air Association calls, and during the public comment period we received comments on the proposed rule from this Tribal organization.
                    </P>
                    <HD SOURCE="HD2">G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks</HD>
                    <P>EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive order.</P>
                    <P>Therefore, this action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk. Since this action does not concern human health, EPA's Policy on Children's Health also does not apply.</P>
                    <HD SOURCE="HD2">H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use</HD>
                    <P>
                        This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The purpose of this action is to revise the existing secondary SO
                        <E T="52">2</E>
                         standard, and also to retain the current secondary standards for NO
                        <E T="52">2</E>
                        , PM
                        <E T="52">2.5</E>
                         and PM
                        <E T="52">10</E>
                        . The action does not prescribe specific pollution control strategies by which these ambient air standards and monitoring revisions will be met. Such strategies will be developed by states on a case-by-case basis, and the EPA cannot predict whether the control options selected by states will include regulations on energy suppliers, distributors, or users. Thus, the EPA concludes that this action does not constitute a significant energy action as defined in Executive Order 13211.
                    </P>
                    <HD SOURCE="HD2">I. National Technology Transfer and Advancement Act (NTTAA)</HD>
                    <P>
                        This action involves environmental monitoring or measurements. The EPA has decided to use the existing indicator, SO
                        <E T="52">2</E>
                        , for measurements in support of this action and is not revising the SO
                        <E T="52">2</E>
                         FRMs or FEMs for measurement of this air pollutant. The EPA employs a Performance-Based Measurement System (PBMS) when designating monitoring methods as either FRM or FEM, which does not require the use of specific, prescribed analytic methods. This performance-based assessment of candidate methods is described in 40 CFR part 50 and the reference and equivalency criteria described in 40 CFR part 53. The EPA does not preclude the use of other methods, whether it constitutes a voluntary consensus standard or not, as long as it meets the specified performance criteria defined in 40 CFR part 53 and is approved by EPA as an FRM or FEM. Our approach in the past has resulted in multiple brands of monitors being approved as FRM for SO
                        <E T="52">2</E>
                        , and we expect this trend to continue.
                    </P>
                    <HD SOURCE="HD2">J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations and Executive Order 14096: Revitalizing Our Nation's Commitment to Environmental Justice for All</HD>
                    <P>
                        The EPA believes that the human health and environmental conditions that exist prior to this action do not result in disproportionate and adverse effects on communities with Environmental Justice (EJ) concerns. As discussed in sections II.A.4. and II.B. above, and chapters 5 and 7 of the PA, the acid buffering capacity of waterbodies in key acid-sensitive ecoregions in recent years is estimated to meet protection targets in high percentages. As discussed in section II.A.3.b. above, impacts on acid-sensitive waterbodies, if sufficiently severe, would have the potential to impact the public welfare through impacts to fisheries. Although recent conditions do not indicate such a level of severity, to the extent local communities relied on such fisheries disproportionately to their representation in the population, such effects of the past (
                        <E T="03">e.g.,</E>
                         effects associated with acidification risks of 20 or more years ago) would have had the potential 
                        <PRTPAGE P="105780"/>
                        for disproportionate impacts. Recent conditions do not indicate risk of aquatic acidification to such a level of severity, and the available information for recent acid buffering capacity levels does not include evidence of disproportionate and adverse impacts on communities with EJ concerns. As the action is to establish a new, more stringent standard to protect acid-sensitive waterbodies to recent levels and protect against recurrence of acidification effects from the past, for which the potential for disproportionate and adverse effects on local communities is unknown, the EPA believes that this action is not likely to result in new disproportionate and adverse effects on communities with EJ concerns. The information supporting this Executive order review is contained in the PA for this review and sections II.A.3., II.A.4., II.B.1. and II.B.3. of this document.
                    </P>
                    <HD SOURCE="HD2">K. Congressional Review Act (CRA)</HD>
                    <P>This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).</P>
                    <HD SOURCE="HD2">L. Judicial Review</HD>
                    <P>
                        Under section 307(b)(1) of the CAA, this final action is “nationally applicable” and petitions for judicial review of this action must be filed in the U.S. Court of Appeals for the District of Columbia Circuit within 60 days from the date this final action is published in the 
                        <E T="04">Federal Register</E>
                        . Filing a petition for reconsideration by the Administrator of this final action does not affect the finality of the action for the purposes of judicial review, nor does it extend the time within which a petition for judicial review must be filed and shall not postpone the effectiveness of such action.
                    </P>
                    <HD SOURCE="HD1">VII. References</HD>
                    <EXTRACT>
                        <FP SOURCE="FP-2">Altshuller, AP (1976). Regional transport and transformation of sulfur dioxide to sulfates in the United States. J Air Poll Contr Assoc 26: 318-324.</FP>
                        <FP SOURCE="FP-2">Baker, LA, Herlihy, AT, Kaufmann, PR, and Eilers, JM (1991). Acidic lakes and streams in the United States: the role of acidic deposition. Science 252: 1151-1154.</FP>
                        <FP SOURCE="FP-2">Baker JP; Schofield CL. (1985). Acidification impacts on fish populations: A review. In: Adams D; Page WP (Eds.), Acid deposition: environmental, economic, and policy issues (pp. 183-221). New York and London: Plenum Press.</FP>
                        <FP SOURCE="FP-2">Banzhaf, S, Burtraw, D, Evans, D and Krupnick, A (2006). Valuation of Natural Resource Improvements in the Adirondacks. Land Econ 82: 445-464.</FP>
                        <FP SOURCE="FP-2">Baron, JS, Driscoll, CT, Stoddard, JL and Richer, EE (2011). Empirical critical loads of atmospheric nitrogen deposition for nutrient enrichment and acidification of sensitive US lakes. Bioscience 61: 602-613.</FP>
                        <FP SOURCE="FP-2">Boyer, EW, Goodale, CL, Jaworski, NA and Howarth, RW (2002). Anthropogenic nitrogen sources and relationships to riverine nitrogen export in the northeastern USA. Biogeochemistry 57: 137-169.</FP>
                        <FP SOURCE="FP-2">Brown, CA and Ozretich, RJ (2009). Coupling between the coastal ocean and Yaquina Bay, Oregon: Importance of oceanic inputs relative to other nitrogen sources. Estuaries Coasts 32: 219-237.</FP>
                        <FP SOURCE="FP-2">Bulger, AJ, Cosby, BJ, Dolloff, CA, Eshleman, KN, Webb, JR and Galloway, JN (1999). SNP:FISH. Shenandoah National Park: Fish in sensitive habitats. Project Final Report-Volume 1-4. Charlottesville, VA, University of Virginia.</FP>
                        <FP SOURCE="FP-2">Bulger, AJ, Cosby, BJ and Webb, JR (2000). Current, reconstructed past, and projected future status of brook trout (Salvelinus fontinalis) streams in Virginia. Can J Fish Aquat Sci 57(7): 1515-1523.</FP>
                        <FP SOURCE="FP-2">Cosby, BJ, Hornberger, GM, Galloway, JN and Wright, RF (1985). Modeling the effects of acid deposition: Assessment of a lumped parameter model of soil water and streamwater chemistry. Water Resour Res 21(1): 51-63.</FP>
                        <FP SOURCE="FP-2">Costanza, R, De Groot, R, Braat, L, Kubiszewski, I, Fioramonti, L, Sutton, P, Farber, S and Grasso, M (2017). Twenty years of ecosystem services: How far have we come and how far do we still need to go? Ecosyst Serv 28: 1-16.</FP>
                        <FP SOURCE="FP-2">
                            Cox, L, Kendall, R and Fernandez, I (2020a). Letter from Louis Cox, Chair, Clean Air Scientific Advisory Committee, Ronald Kendall, Chair, Secondary NAAQS Review Panel for Oxides of Nitrogen and Sulfur and Ivan Fernandez, Immediate Past Chair, Secondary NAAQS Review Panel for Oxides of Nitrogen and Sulfur to the Administrator Andrew R. Wheeler, Re: CASAC Review of the EPA's 
                            <E T="03">Integrated Science Assessment for Oxides of Nitrogen, Oxides of Sulfur, and Particulate Matter—Ecological Criteria (Second External Review Draft—June 2018).</E>
                             May 5, 2020. EPA-CASAC-20-004. Office of the Administrator, Science Advisory Board, Washington, DC Available at: 
                            <E T="03">https://casac.epa.gov/ords/sab/f?p=113:12:1342972375271:::12.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            Cox, L, Kendall, R and Fernandez, I (2020b). Letter from Louis Cox, Chair, Clean Air Scientific Advisory Committee, Ronald Kendall, Chair, Secondary NAAQS Review Panel for Oxides of Nitrogen and Sulfur and Ivan Fernandez, Immediate Past Chair, Secondary NAAQS Review Panel for Oxides of Nitrogen and Sulfur to Administrator Andrew R. Wheeler, Re: Consultation on the EPA's 
                            <E T="03">Review of the Secondary Standards for Ecological Effects of Oxides of Nitrogen, Oxides of Sulfur, and Particulate Matter: Risk and Exposure Assessment Planning Document (August—2018).</E>
                             May 5, 2020. EPA-CASAC-20-005. Office of the Administrator, Science Advisory Board, Washington, DC Available at: 
                            <E T="03">https://casac.epa.gov/ords/sab/f?p=113:12:1342972375271:::12.</E>
                        </FP>
                        <FP SOURCE="FP-2">Cox, RD, Preston, KL, Johnson, RF, Minnich, RA and Allen, EB (2014). Influence of landscape scale variables on vegetation conversion to exotic annual grassland in southern California, USA. Glob Ecol Conserv 2: 190-203.</FP>
                        <FP SOURCE="FP-2">Davis, TW, Bullerjahn, GS, Tuttle, T, Mckay, RM and Watson, SB (2015). Effects of increasing nitrogen and phosphorus concentrations on phytoplankton community growth and toxicity during planktothrix blooms in Sandusky Bay, Lake Erie. Environ Sci Technol 49: 7197-7207.</FP>
                        <FP SOURCE="FP-2">Dietze, MC and Moorcroft, PR (2011). Tree mortality in the eastern and central United States:Patterns and drivers. Glob Change Biol 17(11): 3312-3326.</FP>
                        <FP SOURCE="FP-2">
                            Diez Roux, A and Fernandez, I (2016). Letter from Anna Diez Roux, Chair, Clean Air Scientific Advisory Committee and Ivan Fernandez, Chair, Secondary NAAQS Review Panel for Oxides of Nitrogen and Sulfur, to Administrator Gina McCarthy, Re: CASAC Review of the EPA's 
                            <E T="03">Draft Integrated Review Plan for the National Ambient Air Quality Standards for Oxides of Nitrogen and Oxides of Sulfur.</E>
                             April 1, 2016. EPA-CASAC-16-001. Office of the Administrator, Science Advisory Board, Washington, DC Available at: 
                            <E T="03">https://casac.epa.gov/ords/sab/f?p=113:12:1342972375271:::12.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            Diez Roux, A and Fernandez, I (2017). Letter from Anna Diez Roux, Chair, Clean Air Scientific Advisory Committee and Ivan Fernandez, Chair, Secondary NAAQS Review Panel for Oxides of Nitrogen and Sulfur, to the Honorable Gina McCarthy, Administrator, Re: CASAC Review of the EPA's 
                            <E T="03">Integrated Science Assessment for Oxides of Nitrogen, Oxides of Sulfur, and Particulate Matter—Ecological Criteria (First External Review Draft—February 2017).</E>
                             September 28, 2017. EPA-CASAC-17-004. Office of the Administrator, Science Advisory Board, Washington, DC Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100X9FA.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">Driscoll, CT, Driscoll, KM, Fakhraei, H, Civerolo, K (2016). Long-term temporal trends and spatial patterns in the acid-base chemistry of lakes in the Adirondack region of New York in response to decreases in acidic deposition. Atm Chem 146: 5-14.</FP>
                        <FP SOURCE="FP-2">Driscoll, CT, Lawrence, GB, Bulger, AJ, Butler, TJ, Cronan, CS, Eagar, C, Lambert, KF, Likens, GE, Stoddard, JL and Weathers, KC (2001). Acidic deposition in the northeastern United States: Sources and inputs, ecosystem effects, and management strategies. Bioscience 51: 180-198.</FP>
                        <FP SOURCE="FP-2">Driscoll, CT, Lehtinen, MD and Sullivan, TJ (1994). Modeling the acid-base chemistry of organic solutes in Adirondack, New York, lakes. Water Resour Res 30: 297-306.</FP>
                        <FP SOURCE="FP-2">
                            Duchesne, L and Ouimet, R (2009). Present-day expansion of American beech in 
                            <PRTPAGE P="105781"/>
                            northeastern hardwood forests: Does soil base status matter? Can J For Res 39: 2273-2282.
                        </FP>
                        <FP SOURCE="FP-2">Dupont, J, Clair, TA, Gagnon, C, Jeffries, DS, Kahl, JS, Nelson, SJ and Peckenham, JM (2005). Estimation of critical loads of acidity for lakes in northeastern United States and eastern Canada. Environ Monit Assess 109(1): 275-291.</FP>
                        <FP SOURCE="FP-2">Emmett, BA, Boxman, D, Bredemeier, M, Gunderson, P, Kjonaas, OJ, Moldan, F, Schleppi, P, Tietema, A and Wright, RF (1998). Predicting the effects of atmospheric nitrogen deposition in conifer stands: evidence from the NITREX ecosystem-scale experiments. Ecosystems 1: 352-360.</FP>
                        <FP SOURCE="FP-2">Fakhraeri, H, Driscoll, CT, Selvendiran, P, DePinto, JV, Bloomfield, J, Quinn, S and Rowell, HC (2014). Development of a total maximum daily load (TMDL) for acid-impaired lakes in the Adirondack regon of New York. Atmos Environ 95: 277-287.</FP>
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                            U.S. EPA (1982d). Review of the National Ambient Air Quality Standards for Particulate Matter: Assessment of Scientific and Technical Information. OAQPS Staff Paper. Office of Air Quality Planning and Standards. Research Triangle Park, NC. EPA-450/5-82-001. January 1982. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=2000NH6N.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (1984a). The Acidic Deposition Phenomenon and Its Effects: Critical Assessment Review Papers. Volume I Atmospheric Sciences. Office of Research and Development, Washington DC. EPA600/8-83-016AF. July 1984. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=2000G4AJ.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (1984b). The Acidic Deposition Phenomenon and Its Effects: Critical Assessment Review Papers. Volume II Effects Sciences. Office of Research and Development, Washington DC. EPA-600/8- 83-016BF. July 1984. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=2000G5FI.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (1985). The Acidic Deposition Phenomenon and Its Effects: Critical Assessment Document. Office of Research and Development, Washington, DC. EPA-600/8-85/001. August 1985. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=2000AD53.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (1986). Review of the National Ambient Air Quality Standards for Particulate Matter: Updated Assessment of Scientific and Technical Information. Addendum to the 1982 OAQPS Staff Paper. Office of Air Quality Planning and Standards, Research Triangle Park, NC. EPA-450/05-86-012. December 1986. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=910113UH.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (1993). Air Quality Criteria for Oxides of Nitrogen. Volume I-III. U.S. Office of Research and Development, Research Triangle Park, NC. EPA/600/8-91/049aF-cF. August 1993. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30001LZT.PDF. https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=300056QV.PDF. https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30001NI2.PDF.</E>
                        </FP>
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                            U.S. EPA (1995a). Review of the National Ambient Air Quality Standards for 
                            <PRTPAGE P="105784"/>
                            Nitrogen Dioxide: Assessment of Scientific and Technical Information, OAQPS Staff Paper. Office of Air Quality Planning and Standards, Research Triangle Park, NC. EPA-452/R-95-005. September 1995. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=00002UBE.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (1995b). Acid Deposition Standard Feasibility Study: Report to Congress. Office of Air and Radiation, Acid Rain Division, Washington, DC. EPA-430-R-95-001a. October 1995. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=2000WTGY.PDF.</E>
                        </FP>
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                            U.S. EPA (1996). Review of the National Ambient Air Quality Standards for Particulate Matter: Policy Assessment of Scientific and Technical Information (OAQPS Staff Paper). Office of Air Quality Planning and Standards, Research Triangle Park, NC. EPA-452\R-96-013. July 1996. Available at
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                        </FP>
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                            U.S. EPA (2004a). Air Quality Criteria for Particulate Matter. (Vol I of II). Office of Research and Development, Research Triangle Park, NC. EPA-600/P-99-002aF. October 2004. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100LFIQ.PDF.</E>
                        </FP>
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                            U.S. EPA (2004b). Air Quality Criteria for Particulate Matter. (Vol II of II). Office of Research and Development, Research Triangle Park, NC. EPA-600/P-99-002bF. October 2004. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100LG7Q.PDF.</E>
                        </FP>
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                            U.S. EPA (2005). Review of the National Ambient Air Quality Standards for Particulate Matter: Policy Assessment of Scientific and Technical Information, OAQPS Staff Paper. Office of Air Quality Planning and Standards, Research Triangle Park, NC. EPA-452/R-05-005a. December 2005. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P1009MZM.PDF.</E>
                        </FP>
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                            U.S. EPA (2007). Integrated Review Plan for the Secondary National Ambient Air Quality Standards for Nitrogen Dioxide and Sulfur Dioxide. Office of Research and Development, Research Triangle Park, NC, EPA-452/R-08-006. December 2007. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P1001FDM.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (2008a). Integrated Science Assessment (ISA) for Oxides of Nitrogen and Sulfur Ecological Criteria. Office of Research and Development, Research Triangle Park, NC. EPA/600/R-08/082F. December 2008. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100R7MG.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (2008b). Integrated Review Plan for the National Ambient Air Quality Standards for Particulate Matter. Office of Air Quality Planning and Standards, Research Triangle Park, NC. EPA 452/R-08-004. March 2008. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P1001FB9.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (2009a). Risk and Exposure Assessment for Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen and Oxides of Sulfur (Main Content). Office of Air Quality Planning and Standards, Research Triangle Park, NC. EPA-452/R-09-008a. September 2009. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100FNQV.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (2009b). Integrated Science Assessment for Particulate Matter. Office of Research and Development, Research Triangle Park, NC. EPA/600/R-08/139F. December 2009. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P10060Z4.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (2009c). Particulate Matter National Ambient Air Quality Standards (NAAQS): Scope and Methods Plan for Urban Visibility Impact Assessment. Office of Air Quality Planning and Standards, Research Triangle Park, NC. EPA-452/P-09-001. February 2009. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100FLUX.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (2010). Particulate Matter Urban-Focused Visibility Assessment—Final Document. Office of Air Quality Planning and Standards, Research Triangle Park, NC. EPA-452/R- 10-004. July 2010. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100FO5D.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (2011). Policy Assessment for the Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen and Oxides of Sulfur. Office of Air Quality Planning and Standards, Research Triangle Park, NC. EPA-452/R-11-005a, b. February 2011. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P1009R7U.PDF https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P1009RHY.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (2016). Integrated Review Plan for the National Ambient Air Quality Standards for Particulate Matter. Office of Air Quality Planning and Standards, Research Triangle Park, NC. EPA-452/R-16-005. December 2016. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100R5VE.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (2017). Integrated Review Plan for the Secondary NAAQS for Oxides of Nitrogen and Oxides of Sulfur and Particulate Matter—Final. Office of Air Quality Planning and Standards, Research Triangle Park, NC. EPA-452/R-17-002. January 2017. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDf.cgi?Dockey=P100R607.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (2018). Review of the Secondary Standards for Ecological Effects of Oxides of Nitrogen, Oxides of Sulfur, and Particulate Matter: Risk and Exposure Assessment Planning Document. Office of Air Quality Planning and Standards, Research Triangle Park, NC. EPA-452/D-18-001. August 2018. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100V7JA.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">U.S. EPA (2019). Integrated Science Assessment (ISA) for Particulate Matter (Final Report, Dec 2019). U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-19/188, 2019.</FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (2020a). Integrated Science Assessment (ISA) for Oxides of Nitrogen, Oxides of Sulfur and Particulate Matter Ecological Criteria (Final Report, 2020). Office of Air Quality Planning and Standards, Research Triangle Park, NC. EPA/600/R-20/278. September 2020. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P1010WR3.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (2023). Overview of Particulate Matter (PM) Air Quality in the United States. Available at
                            <E T="03">: https://www.epa.gov/air-quality-analysis/particulate-matter-naaqs-review-analyses-and-data-sets.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            U.S. EPA (2024). Policy Assessment for the Review of the Secondary National Ambient Air Quality Standards for Oxides of Nitrogen, Oxides of Sulfur and Particulate Matter. Office of Air Quality Planning and Standards, Research Triangle Park, NC. EPA-452/R-24-003. January 2024. Available at: 
                            <E T="03">https://www.epa.gov/system/files/documents/2024-01/noxsoxpm-final.pdf.</E>
                        </FP>
                        <FP SOURCE="FP-2">Wallace, ZP, Lovett, GM, Hart, JE and Machona, B (2007). Effects of nitrogen saturation on tree growth and death in a mixed-oak forest. For Ecol Manage 243: 210-218.</FP>
                        <FP SOURCE="FP-2">Waller, K, Driscoll, C, Lynch, J, Newcomb, D and Roy, K (2012). Long-term recovery of lakes in the Adirondack region of New York to decreases in acidic deposition. Atmos Environ 46: 56-64.</FP>
                        <FP SOURCE="FP-2">
                            Watkins, N, Boyette, L and Jager, D (2024). Memorandum to Secondary NO
                            <E T="52">X</E>
                            /SO
                            <E T="52">X</E>
                            /PM NAAQS Review Docket (Docket ID No. EPA-HQ-OAR-2014-0128). Ambient Air SO
                            <E T="52">2</E>
                             Monitoring Network Review and Background (January 2024). January 18, 2024. Office of Air Quality Planning and Standards, Research Triangle Park, NC. Available at 
                            <E T="03">https://www.regulations.gov.</E>
                             Document Identifier EPA-HQ-OAR-2014-0128-0040.
                        </FP>
                        <FP SOURCE="FP-2">
                            Weaver, C (2024). Memorandum to Secondary NO
                            <E T="52">X</E>
                            /SO
                            <E T="52">X</E>
                            /PM NAAQS Review Docket (Docket ID No. EPA-HQ-OAR-2014-0128). List of Studies Identified by Public Commenters That Have Been Provisionally Considered in the Context of the Conclusions of the 2020 Integrated Science Assessment for the Secondary National Ambient Air Quality Standard review of Oxides of Nitrogen, Oxides of Sulfur and Particulate Matter. October 16, 2024. Office of Research and Development, Research Triangle Park, NC. Available at 
                            <E T="03">https://www.regulations.gov.</E>
                             Docket ID No. EPA-HQ-OAR-2014-0128.
                        </FP>
                        <FP SOURCE="FP-2">
                            WHO (World Health Organization) (2008). WHO/IPCS Harmonization Project Document No. 6. Part 1: Guidance Document on Characterizing and Communicating Uncertainty in Exposure Assessment. International Programme on Chemical Safety. World Health Organization. Geneva, Switzerland. Available at: 
                            <E T="03">https://www.who.int/ipcs/methods/harmonization/areas/exposure/en/.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            Williams, J and Labou, S (2017). A database of georeferenced nutrient chemistry data 
                            <PRTPAGE P="105785"/>
                            for mountain lakes of the Western United States. Sci Data 4: 170069.
                        </FP>
                        <FP SOURCE="FP-2">
                            Wolff, GT (1993). Letter from George T. Wolff, Chair, Clean Air Scientific Advisory Committee to the Honorable Carol M. Browner, Administrator, U.S. EPA. Re: Clean Air Scientific Advisory Committee Closure on the Air Quality Criteria Document for Oxides of Nitrogen. September 30, 1993. EPA-SAB-CASAC-LTR-93-015. Office of the Administrator, Science Advisory Board, Washington, DC. Available at: 
                            <E T="03">https://casac.epa.gov/ords/sab/f?p=113:12:1342972375271:::12.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            Wolff, GT (1995). Letter from George T. Wolff, Chair, Clean Air Scientific Advisory Committee to the Honorable Carol M. Browner, Administrator, Re: CASAC Review of the 
                            <E T="03">Staff Paper for the Review of the National Ambient Air Quality Standards for Nitrogen Dioxide: Assessment of Scientific and Technical Information.</E>
                             August 22, 1995. EPA-SAB-CASAC-LTR-95-004. Office of the Administrator, Science Advisory Board, Washington, DC. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100FL6Q.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">
                            Wolff, GT (1996). Letter from George T. Wolff, Chair, Clean Air Scientific Advisory Committee to the Honorable Carol M. Browner, Administrator, Re: Closure by the Clean Air Scientific Advisory Committee (CASAC) on the Staff Paper for Particulate Matter. June 13, 1996. EPA-SAB-CASAC-LTR-96-008. Office of the Administrator, Science Advisory Board, Washington, DC. Available at: 
                            <E T="03">https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=9100TTBM.PDF.</E>
                        </FP>
                        <FP SOURCE="FP-2">Zhou, Q, Driscoll, CT and Sullivan, TJ (2015). Responses of 20 lake-watersheds in the Adirondack region of New York to historical and potential future acidic deposition. Sci Total Environ 511: 186-194.</FP>
                    </EXTRACT>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects in 40 CFR Part 50</HD>
                        <P>Environmental protection, Air pollution control, Nitrogen dioxide, Particulate matter, Sulfur oxides.</P>
                    </LSTSUB>
                    <SIG>
                        <NAME>Michael S. Regan,</NAME>
                        <TITLE>Administrator.</TITLE>
                    </SIG>
                    <P>For the reasons set forth in the preamble, the Environmental Protection Agency is amending chapter I of title 40 of the Code of Federal Regulations as follows:</P>
                    <PART>
                        <HD SOURCE="HED">PART 50—NATIONAL PRIMARY AND SECONDARY AMBIENT AIR QUALITY STANDARDS</HD>
                    </PART>
                    <REGTEXT TITLE="40" PART="52">
                        <AMDPAR>1. The authority citation for part 50 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority: </HD>
                            <P>
                                42 U.S.C. 7401, 
                                <E T="03">et seq.</E>
                            </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="52">
                        <AMDPAR>2. Add § 50.21 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 50.21</SECTNO>
                            <SUBJECT>National secondary ambient air quality standards for sulfur oxides (sulfur dioxide).</SUBJECT>
                            <P>
                                (a) The level of the annual secondary national ambient air quality standard for oxides of sulfur is 10 parts per billion (ppb), measured in the ambient air as sulfur dioxide (SO
                                <E T="52">2</E>
                                ) by a reference method based on appendix A-1 and appendix A-2 of this part, or by a Federal Equivalent Method (FEM) designated in accordance with part 53 of this chapter.
                            </P>
                            <P>
                                (b) The annual secondary standard is met when the 3-year average of the annual SO
                                <E T="52">2</E>
                                 concentration is less than or equal to 10 ppb, as determined in accordance with appendix T of this part.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="40" PART="52">
                        <AMDPAR>3. Revise appendix T to part 50 to read as follows:</AMDPAR>
                        <HD SOURCE="HD1">Appendix T to Part 50—Interpretation of the Primary and Secondary National Ambient Air Quality Standards for Oxides of Sulfur (Sulfur Dioxide)</HD>
                        <EXTRACT>
                            <HD SOURCE="HD1">1. General</HD>
                            <P>
                                (a) This appendix explains the data handling conventions and computations necessary for determining when the primary and secondary national ambient air quality standards for Oxides of Sulfur as measured by Sulfur Dioxide (“SO
                                <E T="52">2</E>
                                 NAAQS”) specified in § 50.17 are met at an ambient air quality monitoring site. Sulfur dioxide (SO
                                <E T="52">2</E>
                                ) is measured in the ambient air by a Federal reference method (FRM) based on appendix A-1 or A-2 to this part or by a Federal equivalent method (FEM) designated in accordance with part 53 of this chapter. Data handling and computation procedures to be used in making comparisons between reported SO
                                <E T="52">2</E>
                                 concentrations and the levels of the SO
                                <E T="52">2</E>
                                 NAAQS are specified in the following sections.
                            </P>
                            <P>(b) Decisions to exclude, retain, or make adjustments to the data affected by exceptional events, including natural events, are made according to the requirements and process deadlines specified in §§ 50.1, 50.14 and 51.930 of this chapter.</P>
                            <P>(c) The terms used in this appendix are defined as follows:</P>
                            <P>
                                <E T="03">Annual mean</E>
                                 refers to the annual average of all the daily mean values as defined in section 5.2 of this appendix.
                            </P>
                            <P>
                                <E T="03">Daily maximum 1-hour values</E>
                                 for SO
                                <E T="52">2</E>
                                 refers to the maximum 1-hour SO
                                <E T="52">2</E>
                                 concentration values measured from midnight to midnight (local standard time) that are used in NAAQS computations.
                            </P>
                            <P>
                                <E T="03">Daily mean values</E>
                                 for SO
                                <E T="52">2</E>
                                 refers to the 24-hour average of 1-hour SO
                                <E T="52">2</E>
                                 concentration values measured from midnight to midnight (local standard time) that are used in NAAQS computations.
                            </P>
                            <P>
                                <E T="03">Design values</E>
                                 are the metrics (
                                <E T="03">i.e.,</E>
                                 statistics) that are compared to the NAAQS levels to determine compliance, calculated as specified in section 5 of this appendix. The design value for the primary 1-hour NAAQS is the 3-year average of annual 99th percentile daily maximum 1-hour values for a monitoring site (referred to as the “1-hour primary standard design value”). The design value for the secondary annual NAAQS is the 3-year average of the annual mean of daily mean values for a monitoring site (referred to as the “annual secondary standard”).
                            </P>
                            <P>
                                <E T="03">99th percentile daily maximum 1-hour value</E>
                                 is the value below which nominally 99 percent of all daily maximum 1-hour concentration values fall, using the ranking and selection method specified in section 5.1 of this appendix.
                            </P>
                            <P>
                                <E T="03">Pollutant Occurrence Code (POC)</E>
                                 refers to a numerical code (1, 2, 3, 
                                <E T="03">etc.</E>
                                ) used to distinguish the data from two or more monitors for the same parameter at a single monitoring site.
                            </P>
                            <P>
                                <E T="03">Quarter</E>
                                 refers to a calendar quarter.
                            </P>
                            <P>
                                <E T="03">Year</E>
                                 refers to a calendar year.
                            </P>
                            <HD SOURCE="HD1">
                                2. Requirements for Data Used for Comparisons With the SO
                                <E T="0132">2</E>
                                 NAAQS and Data Reporting Considerations
                            </HD>
                            <P>
                                (a) All valid FRM/FEM SO
                                <E T="52">2</E>
                                 hourly data required to be submitted to EPA's Air Quality System (AQS), or otherwise available to EPA, meeting the requirements of part 58 of this chapter including appendices A, C, and E shall be used in design value calculations. Multi-hour average concentration values collected by wet chemistry methods shall not be used.
                            </P>
                            <P>
                                (b) Data from two or more monitors from the same year at the same site reported to EPA under distinct Pollutant Occurrence Codes shall not be combined in an attempt to meet data completeness requirements. The Administrator will combine annual 99th percentile daily maximum concentration values from different monitors in different years, selected as described here, for the purpose of developing a valid 1-hour primary standard design value. If more than one of the monitors meets the completeness requirement for all four quarters of a year, the steps specified in section 5.1(a) of this appendix shall be applied to the data from the monitor with the highest average of the four quarterly completeness values to derive a valid annual 99th percentile daily maximum concentration. If no monitor is complete for all four quarters in a year, the steps specified in sections 3.1(c) and 5.1(a) of this appendix shall be applied to the data from the monitor with the highest average of the four quarterly completeness values in an attempt to derive a valid annual 99th percentile daily maximum concentration. Similarly, the Administrator will combine annual means from different monitors in different years, selected as described here, for the purpose of developing a valid annual secondary standard design value. If more than one of the monitors meets the completeness requirement for all four quarters of a year, the steps specified in section 5.2(a) of this appendix shall be applied to the data from the monitor with the highest average of the four quarterly completeness values to derive a valid annual mean. If no monitor is complete for all four quarters in a year, the steps specified in sections 3.2(c) and 5.2(a) of this appendix shall be applied to the data from the monitor with the highest average of the four quarterly completeness values in an attempt to derive a valid annual mean. This paragraph does not 
                                <PRTPAGE P="105786"/>
                                prohibit a monitoring agency from making a local designation of one physical monitor as the primary monitor for a Pollutant Occurrence Code and substituting the 1-hour data from a second physical monitor whenever a valid concentration value is not obtained from the primary monitor; if a monitoring agency substitutes data in this manner, each substituted value must be accompanied by an AQS qualifier code indicating that substitution with a value from a second physical monitor has taken place.
                            </P>
                            <P>
                                (c) Hourly SO
                                <E T="52">2</E>
                                 measurement data shall be reported to AQS in units of parts per billion (ppb), to at most one place after the decimal, with additional digits to the right being truncated with no further rounding.
                            </P>
                            <HD SOURCE="HD1">3. Comparisons With the NAAQS</HD>
                            <HD SOURCE="HD2">
                                3.1 Comparisons With the 1-Hour Primary SO
                                <E T="54">2</E>
                                 NAAQS
                            </HD>
                            <P>
                                (a) The 1-hour primary SO
                                <E T="52">2</E>
                                 NAAQS is met at an ambient air quality monitoring site when the valid 1-hour primary standard design value is less than or equal to 75 parts per billion (ppb).
                            </P>
                            <P>
                                (b) An SO
                                <E T="52">2</E>
                                 1-hour primary standard design value is valid if it encompasses three consecutive calendar years of complete data. A year meets data completeness requirements when all four quarters are complete. A quarter is complete when at least 75 percent of the sampling days for each quarter have complete data. A sampling day has complete data if 75 percent of the hourly concentration values, including State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator, are reported.
                            </P>
                            <P>(c) In the case of one, two, or three years that do not meet the completeness requirements of section 3.1(b) of this appendix and thus would normally not be useable for the calculation of a valid 3-year 1-hour primary standard design value, the 3-year 1-hour primary standard design value shall nevertheless be considered valid if one of the following conditions is true.</P>
                            <P>(i) At least 75 percent of the days in each quarter of each of three consecutive years have at least one reported hourly value, and the design value calculated according to the procedures specified in section 5.1 is above the level of the primary 1-hour standard.</P>
                            <P>
                                (ii)(A) A 1-hour primary standard design value that is equal to or below the level of the NAAQS can be validated if the substitution test in section 3.1(c)(ii)(B) of this appendix results in a “test design value” that is below the level of the NAAQS. The test substitutes actual “high” reported daily maximum 1-hour values from the same site at about the same time of the year (specifically, in the same calendar quarter) for unknown values that were not successfully measured. 
                                <E T="03">Note</E>
                                 that the test is merely diagnostic in nature, intended to confirm that there is a very high likelihood that the original design value (the one with less than 75 percent data capture of hours by day and of days by quarter) reflects the true under-NAAQS-level status for that 3-year period; the result of this data substitution test (the “test design value,” as defined in section 3.1(c)(ii)(B) of this appendix) is not considered the actual design value. For this test, substitution is permitted only if there are at least 200 days across the three matching quarters of the three years under consideration (which is about 75 percent of all possible daily values in those three quarters) for which 75 percent of the hours in the day, including State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator, have reported concentrations. However, maximum 1-hour values from days with less than 75 percent of the hours reported shall also be considered in identifying the high value to be used for substitution.
                            </P>
                            <P>
                                (B) The substitution test is as follows: Data substitution will be performed in all quarter periods that have less than 75 percent data capture but at least 50 percent data capture, including State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator; if any quarter has less than 50 percent data capture then this substitution test cannot be used. Identify for each quarter (
                                <E T="03">e.g.,</E>
                                 January-March) the highest reported daily maximum 1-hour value for that quarter, excluding State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator, looking across those three months of all three years under consideration. All daily maximum 1-hour values from all days in the quarter period shall be considered when identifying this highest value, including days with less than 75 percent data capture. If after substituting the highest reported daily maximum 1-hour value for a quarter for as much of the missing daily data in the matching deficient quarter(s) as is needed to make them 100 percent complete, the procedure in section 5 yields a recalculated 3-year 1-hour standard “test design value” less than or equal to the level of the standard, then the 1-hour primary standard design value is deemed to have passed the diagnostic test and is valid, and the level of the standard is deemed to have been met in that 3-year period. As noted in section 3.1(c)(i) of this appendix, in such a case, the 3-year design value based on the data actually reported, not the “test design value,” shall be used as the valid design value.
                            </P>
                            <P>(iii)(A) A 1-hour primary standard design value that is above the level of the NAAQS can be validated if the substitution test in section 3.1(c)(iii)(B) of this appendix results in a “test design value” that is above the level of the NAAQS. The test substitutes actual “low” reported daily maximum 1-hour values from the same site at about the same time of the year (specifically, in the same three months of the calendar) for unknown hourly values that were not successfully measured. Note that the test is merely diagnostic in nature, intended to confirm that there is a very high likelihood that the original design value (the one with less than 75 percent data capture of hours by day and of days by quarter) reflects the true above-NAAQS-level status for that 3-year period; the result of this data substitution test (the “test design value,” as defined in section 3.1(c)(iii)(B) of this appendix) is not considered the actual design value. For this test, substitution is permitted only if there are a minimum number of available daily data points from which to identify the low quarter-specific daily maximum 1-hour values, specifically if there are at least 200 days across the three matching quarters of the three years under consideration (which is about 75 percent of all possible daily values in those three quarters) for which 75 percent of the hours in the day have reported concentrations. Only days with at least 75 percent of the hours reported shall be considered in identifying the low value to be used for substitution.</P>
                            <P>
                                (B) The substitution test is as follows: Data substitution will be performed in all quarter periods that have less than 75 percent data capture. Identify for each quarter (
                                <E T="03">e.g.,</E>
                                 January-March) the lowest reported daily maximum 1-hour value for that quarter, looking across those three months of all three years under consideration. All daily maximum 1-hour values from all days with at least 75 percent capture in the quarter period shall be considered when identifying this lowest value. If after substituting the lowest reported daily maximum 1-hour value for a quarter for as much of the missing daily data in the matching deficient quarter(s) as is needed to make them 75 percent complete, the procedure in section 5.1 of this appendix yields a recalculated 3-year 1-hour standard “test design value” above the level of the standard, then the 1-hour primary standard design value is deemed to have passed the diagnostic test and is valid, and the level of the standard is deemed to have been exceeded in that 3-year period. As noted in section 3.1(c)(i) of this appendix, in such a case, the 3-year design value based on the data actually reported, not the “test design value”, shall be used as the valid design value.
                            </P>
                            <P>(d) A 1-hour primary standard design value based on data that do not meet the completeness criteria stated in section 3.1(b) of this appendix and also do not satisfy section 3.1(c) of this appendix, may also be considered valid with the approval of, or at the initiative of, the Administrator, who may consider factors such as monitoring site closures/moves, monitoring diligence, the consistency and levels of the valid concentration measurements that are available, and nearby concentrations in determining whether to use such data.</P>
                            <P>(e) The procedures for calculating the 1-hour primary standard design values are given in section 5.1 of this appendix.</P>
                            <HD SOURCE="HD2">
                                3.2 Comparisons With the Annual Secondary SO
                                <E T="54">2</E>
                                 NAAQS
                            </HD>
                            <P>
                                (a) The annual secondary SO
                                <E T="52">2</E>
                                 NAAQS is met at an ambient air quality monitoring site when the valid annual secondary standard design value is less than or equal to 10 parts per billion (ppb).
                            </P>
                            <P>
                                (b) An SO
                                <E T="52">2</E>
                                 annual secondary standard design value is valid if it encompasses three consecutive calendar years of complete data. A year meets data completeness requirements when all four quarters are complete. A quarter is complete when at least 75 percent of the sampling days for each quarter have complete data. A sampling day has complete data if 75 percent of the hourly concentration values, including State-flagged data affected 
                                <PRTPAGE P="105787"/>
                                by exceptional events which have been approved for exclusion by the Administrator, are reported.
                            </P>
                            <P>(c) In the case of one, two, or three years that do not meet the completeness requirements of section 3.2(b) of this appendix and thus would normally not be useable for the calculation of a valid 3-year annual secondary standard design value, the 3-year annual secondary standard design value shall nevertheless be considered valid if one of the following conditions is true.</P>
                            <P>(i) At least 75 percent of the days in each quarter of each of three consecutive years have at least one reported hourly value, and the design value calculated according to the procedures specified in section 5.2 of this appendix is above the level of the secondary annual standard.</P>
                            <P>
                                (ii)(A) An annual secondary standard design value that is equal to or below the level of the NAAQS can be validated if the substitution test in section 3.2(c)(ii)(B) of this appendix results in a “test design value” that is below the level of the NAAQS. The test substitutes actual “high” reported daily mean values from the same site at about the same time of the year (specifically, in the same calendar quarter) for unknown or incomplete (less than 75 percent of hours reported) daily mean values. 
                                <E T="03">Note</E>
                                 that the test is merely diagnostic in nature, intended to confirm that there is a very high likelihood that the original design value (the one with less than 75 percent data capture of hours by day and of days by quarter) reflects the true under-NAAQS-level status for that 3-year period; the result of this data substitution test (the “test design value,” as defined in section 3.2(c)(ii)(B)) of this appendix is not considered the actual design value. For this test, substitution is permitted only if there are at least 200 days across the three matching quarters of the three years under consideration (which is about 75 percent of all possible daily values in those three quarters) for which 75 percent of the hours in the day, including State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator, have reported concentrations. However, daily mean values from days with less than 75 percent of the hours reported shall also be considered in identifying the high daily mean value to be used for substitution.
                            </P>
                            <P>
                                (B) The substitution test is as follows: Data substitution will be performed in all quarter periods that have less than 75 percent data capture but at least 50 percent data capture, including State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator; if any quarter has less than 50 percent data capture then this substitution test cannot be used. Identify for each quarter (
                                <E T="03">e.g.,</E>
                                 January-March) the highest reported daily mean value for that quarter, excluding State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator, looking across those three months of all three years under consideration. All daily mean values from all days in the quarter period shall be considered when identifying this highest value, including days with less than 75 percent data capture. If after substituting the highest daily mean value for a quarter for as much of the missing daily data in the matching deficient quarter(s) as is needed to make them 100 percent complete, the procedure in section 5 of this appendix yields a recalculated 3-year annual standard “test design value” less than or equal to the level of the standard, then the annual secondary standard design value is deemed to have passed the diagnostic test and is valid, and the level of the standard is deemed to have been met in that 3-year period. As noted in section 3.2(c)(i) of this appendix, in such a case, the 3-year design value based on the data actually reported, not the “test design value,” shall be used as the valid design value.
                            </P>
                            <P>(iii)(A) An annual secondary standard design value that is above the level of the NAAQS can be validated if the substitution test in section 3.2(c)(iii)(B) of this appendix results in a “test design value” that is above the level of the NAAQS. The test substitutes actual “low” reported daily mean values from the same site at about the same time of the year (specifically, in the same three months of the calendar) for unknown or incomplete (less than 75 percent of hours reported) daily mean values. Note that the test is merely diagnostic in nature, intended to confirm that there is a very high likelihood that the original design value (the one with less than 75 percent data capture of hours by day and of days by quarter) reflects the true above-NAAQS-level status for that 3-year period; the result of this data substitution test (the “test design value,” as defined in section 3.2(c)(iii)(B) of this appendix) is not considered the actual design value. For this test, substitution is permitted only if there are a minimum number of valid daily mean values from which to identify the low quarter-specific daily mean values, specifically if there are at least 200 days across the three matching quarters of the three years under consideration (which is about 75 percent of all possible daily values in those three quarters) for which 75 percent of the hours in the day have reported concentrations. Only days with at least 75 percent of the hours reported shall be considered in identifying the low daily mean value to be used for substitution.</P>
                            <P>
                                (B) The substitution test is as follows: Data substitution will be performed in all quarter periods that have less than 75 percent data capture. Identify for each quarter (
                                <E T="03">e.g.,</E>
                                 January-March) the lowest reported daily mean value for that quarter, looking across those three months of all three years under consideration. All daily mean values from all days with at least 75 percent capture in the quarter period shall be considered when identifying this lowest value. If after substituting the lowest reported daily mean value for a quarter for as much of the missing daily data in the matching deficient quarter(s) as is needed to make them 75 percent complete, the procedure in section 5.2 of this appendix yields a recalculated 3-year annual standard “test design value” above the level of the standard, then the annual secondary standard design value is deemed to have passed the diagnostic test and is valid, and the level of the standard is deemed to have been exceeded in that 3-year period. As noted in section 3.2(c)(i) of this appendix, in such a case, the 3-year design value based on the data actually reported, not the “test design value,” shall be used as the valid design value.
                            </P>
                            <P>(d) An annual secondary standard design value based on data that do not meet the completeness criteria stated in section 3.2(b) of this appendix and also do not satisfy section 3.2(c) of this appendix, may also be considered valid with the approval of, or at the initiative of, the Administrator, who may consider factors such as monitoring site closures/moves, monitoring diligence, the consistency and levels of the valid concentration measurements that are available, and nearby concentrations in determining whether to use such data.</P>
                            <P>(e) The procedures for calculating the annual secondary standard design values are given in section 5.2 of this appendix.</P>
                            <HD SOURCE="HD1">4. Rounding Conventions</HD>
                            <HD SOURCE="HD2">
                                4.1 Rounding Conventions for the 1-Hour Primary SO
                                <E T="54">2</E>
                                 NAAQS
                            </HD>
                            <P>
                                (a) Hourly SO
                                <E T="52">2</E>
                                 measurement data shall be reported to AQS in units of parts per billion (ppb), to at most one place after the decimal, with additional digits to the right being truncated with no further rounding.
                            </P>
                            <P>(b) Daily maximum 1-hour values and, therefore, the annual 99th percentile of those daily values are not rounded.</P>
                            <P>(c) The 1-hour primary standard design value is calculated pursuant to section 5.1 of this appendix and then rounded to the nearest whole number or 1 ppb (decimals 0.5 and greater are rounded up to the nearest whole number, and any decimal lower than 0.5 is rounded down to the nearest whole number).</P>
                            <HD SOURCE="HD2">
                                4.2 Rounding Conventions for the Annual Secondary SO
                                <E T="54">2</E>
                                 NAAQS
                            </HD>
                            <P>
                                (a) Hourly SO
                                <E T="52">2</E>
                                 measurement data shall be reported to AQS in units of parts per billion (ppb), to at most one place after the decimal, with additional digits to the right being truncated with no further rounding.
                            </P>
                            <P>(b) Daily mean values and the annual mean of those daily values are not rounded.</P>
                            <P>(c) The annual secondary standard design value is calculated pursuant to section 5.2 of this appendix and then rounded to the nearest whole number or 1 ppb (decimals 0.5 and greater are rounded up to the nearest whole number, and any decimal lower than 0.5 is rounded down to the nearest whole number).</P>
                            <HD SOURCE="HD1">5. Calculation Procedures</HD>
                            <HD SOURCE="HD2">
                                5.1 Calculation Procedures for the 1-Hour Primary SO
                                <E T="54">2</E>
                                 NAAQS
                            </HD>
                            <P>
                                (a) 
                                <E T="03">Procedure for identifying annual 99th percentile values.</E>
                                 When the data for a particular ambient air quality monitoring site and year meet the data completeness requirements in section 3.1(b) of this appendix, or if one of the conditions of section 3.1(c) of this appendix is met, or if the Administrator exercises the discretionary authority in section 3.1(d) of this appendix, identification of annual 99th percentile value is accomplished as follows.
                                <PRTPAGE P="105788"/>
                            </P>
                            <P>(i) The annual 99th percentile value for a year is the higher of the two values resulting from the following two procedures.</P>
                            <P>
                                (A) 
                                <E T="03">Procedure 1.</E>
                                 For the year, determine the number of days with at least 75 percent of the hourly values reported.
                            </P>
                            <P>(1) For the year, determine the number of days with at least 75 percent of the hourly values reported including State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator.</P>
                            <P>(2) For the year, from only the days with at least 75 percent of the hourly values reported, select from each day the maximum hourly value excluding State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator.</P>
                            <P>
                                (3) Sort all these daily maximum hourly values from a particular site and year by descending value. (For example: (x[1], x[2], x[3], . . . x[n]). In this case, x[1] is the largest number and x[n] is the smallest value.) The 99th percentile is determined from this sorted series of daily values which is ordered from the highest to the lowest number. Using the left column of table 1, determine the appropriate range (
                                <E T="03">i.e.,</E>
                                 row) for the annual number of days with valid data for year y (cn
                                <E T="52">y</E>
                                ). The corresponding “n” value in the right column identifies the rank of the annual 99th percentile value in the descending sorted list of daily site values for year y. Thus, P
                                <E T="52">0.99, y</E>
                                 = the nth largest value.
                            </P>
                            <P>
                                (B) 
                                <E T="03">Procedure 2.</E>
                                 For the year, determine the number of days with at least one hourly value reported.
                            </P>
                            <P>(1) For the year, determine the number of days with at least one hourly value reported including State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator.</P>
                            <P>(2) For the year, from all the days with at least one hourly value reported, select from each day the maximum hourly value excluding State-flagged data affected by exceptional events which have been approved for exclusion by the Administrator.</P>
                            <P>
                                (3) Sort all these daily maximum values from a particular site and year by descending value. (For example: (x[1], x[2], x[3], . . . x[n]). In this case, x[1] is the largest number and x[n] is the smallest value.) The 99th percentile is determined from this sorted series of daily values which is ordered from the highest to the lowest number. Using the left column of table 1, determine the appropriate range (
                                <E T="03">i.e.,</E>
                                 row) for the annual number of days with valid data for year y (cn
                                <E T="52">y</E>
                                ). The corresponding “n” value in the right column identifies the rank of the annual 99th percentile value in the descending sorted list of daily site values for year y. Thus, P
                                <E T="52">0.99,y</E>
                                 = the nth largest value.
                            </P>
                            <P>(b) The 1-hour primary standard design value for an ambient air quality monitoring site is mean of the three annual 99th percentile values, rounded according to the conventions in section 4.1 of this appendix.</P>
                            <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s50,20">
                                <TTITLE>Table 1</TTITLE>
                                <BOXHD>
                                    <CHED H="1">
                                        Annual number of days with valid data for year “y”
                                        <LI>
                                            (cn
                                            <E T="0732">y</E>
                                            )
                                        </LI>
                                    </CHED>
                                    <CHED H="1">
                                        P
                                        <E T="0732">0.99,y</E>
                                         is the nth
                                        <LI>maximum value of</LI>
                                        <LI>the year, where n</LI>
                                        <LI>is the listed number</LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">1-100</ENT>
                                    <ENT>1</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">101-200</ENT>
                                    <ENT>2</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">201-300</ENT>
                                    <ENT>3</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">301-366</ENT>
                                    <ENT>4</ENT>
                                </ROW>
                            </GPOTABLE>
                            <HD SOURCE="HD2">
                                5.2 Calculation Procedures for the Annual Secondary SO
                                <E T="54">2</E>
                                 NAAQS
                            </HD>
                            <P>(a) When the data for a site and year meet the data completeness requirements in section 3.2(b) of this appendix, or if the Administrator exercises the discretionary authority in section 3.2(c), the annual mean is simply the arithmetic average of all the daily mean values.</P>
                            <P>(b) The annual secondary standard design value for an ambient air quality monitoring site is the mean of the annual means for three consecutive years, rounded according to the conventions in section 4.2 of this appendix.</P>
                        </EXTRACT>
                    </REGTEXT>
                </SUPLINF>
                <FRDOC>[FR Doc. 2024-29463 Filed 12-26-24; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 6560-50-P</BILCOD>
            </RULE>
        </RULES>
    </NEWPART>
    <VOL>89</VOL>
    <NO>248</NO>
    <DATE>Friday, December 27, 2024</DATE>
    <UNITNAME>Notices</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="105789"/>
            <PARTNO>Part III</PARTNO>
            <AGENCY TYPE="P">Department of Energy</AGENCY>
            <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
            <HRULE/>
            <TITLE>Interregional Transfer Capability Study: Strengthening Reliability Through the Energy Transformation; Notice</TITLE>
        </PTITLE>
        <NOTICES>
            <NOTICE>
                <PREAMB>
                    <PRTPAGE P="105790"/>
                    <AGENCY TYPE="F">DEPARTMENT OF ENERGY</AGENCY>
                    <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                    <SUBJECT>Interregional Transfer Capability Study: Strengthening Reliability Through the Energy Transformation</SUBJECT>
                    <HD SOURCE="HD1">Notice of Request for Comments</HD>
                    <P>
                        On November 19, 2024, the North American Electric Reliability Corporation (NERC) submitted to the Federal Energy Regulatory Commission (Commission) an Interregional Transfer Capability Study (ITC Study) pursuant to section 322 of the Fiscal Responsibility Act of 2023 (Fiscal Responsibility Act).
                        <SU>1</SU>
                        <FTREF/>
                         On November 25, 2024, the Commission issued a Notice of Request for comments stating that all interested persons are invited to file comments on this ITC Study. This supplemental notice is issued to include the ITC Study and associated NERC transmittal letter.
                        <SU>2</SU>
                        <FTREF/>
                         Comments should be filed no later than 60 days after the date of publication of this supplemental notice in the 
                        <E T="04">Federal Register</E>
                        . We request the public to submit comments in the format indicated below.
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             Fiscal Responsibility Act of 2023, Public Law 118-5, 137 Stat 10, sec. 322 (2023).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             The full text of this document is available on eLibrary in PDF and Microsoft Word formats (with color graphics) for viewing, printing, and/or downloading.
                        </P>
                    </FTNT>
                    <P>
                        In June 2023, Congress passed the Fiscal Responsibility Act, which requires the Commission-approved Electric Reliability Organization (
                        <E T="03">i.e.,</E>
                         NERC),
                        <SU>3</SU>
                        <FTREF/>
                         in consultation with each regional entity and each transmitting utility 
                        <SU>4</SU>
                        <FTREF/>
                         that has facilities interconnected with a transmitting utility in a neighboring transmission planning region, to conduct a study of total transfer capability 
                        <SU>5</SU>
                        <FTREF/>
                         between transmission planning regions. The Fiscal Responsibility Act requires the ITC Study to include:
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             Federal Power Act (FPA) section 215 provides that the Commission may certify an Electric Reliability Organization, the purpose of which is to develop mandatory and enforceable Reliability Standards, subject to Commission review and approval. 16 U.S.C. 824o(c). The Commission subsequently certified NERC as the Electric Reliability Organization. 
                            <E T="03">N. Am. Elec. Reliability Corp.,</E>
                             116 FERC ¶ 61,062, 
                            <E T="03">order on reh'g and compliance,</E>
                             117 FERC ¶ 61,126 (2006), 
                            <E T="03">aff'd sub nom. Alcoa, Inc.</E>
                             v. 
                            <E T="03">FERC,</E>
                             564 F.3d 1342 (D.C. Cir. 2009).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             Transmitting utility is defined in 16 U.S.C. 796 as “an entity (including an entity described in section 824(f) of [title 16]) that owns, operates, or controls facilities used for the transmission of electric energy—(A) in interstate commerce; (B) for the sale of electric energy at wholesale.”
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             18 CFR 37.6(b)(1)(vi) (2024).
                        </P>
                    </FTNT>
                    <P>(1) Current total transfer capability between each pair of neighboring transmission planning regions.</P>
                    <P>(2) A recommendation of prudent additions to total transfer capability between each pair of neighboring transmission planning regions that would demonstrably strengthen reliability within and among such neighboring transmission planning regions.</P>
                    <P>(3) Recommendations to meet and maintain total transfer capability together with such recommended prudent additions to total transfer capability between each pair of neighboring transmission planning regions.</P>
                    <P>
                        The Fiscal Responsibility Act requires NERC to submit the ITC Study to the Commission no later than 18 months after the date of enactment of the Act (
                        <E T="03">i.e.,</E>
                         by December 2, 2024). After the ITC Study is submitted to the Commission, the Commission must publish the study for public comment and, no later than 12 months after the end of the public comment period, submit a report on its conclusions to Congress and include recommendations, if any, for statutory changes.
                        <SU>6</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             Fiscal Responsibility Act of 2023, Public Law 118-5, 137 Stat 10, sec. 322 (2023).
                        </P>
                    </FTNT>
                    <P>
                        Comments may be filed electronically via the internet.
                        <SU>7</SU>
                        <FTREF/>
                         Instructions are available on the Commission's website 
                        <E T="03">http://www.ferc.gov/docs-filing/efiling.asp.</E>
                         For assistance, please contact FERC Online Support at 
                        <E T="03">FERCOnlineSupport@ferc.gov</E>
                         or toll free at 1-866-208-3676, or for TTY, (202) 502-8659. Although the Commission strongly encourages electronic filing, documents may also be paper-filed. To paper-file, submissions sent via the U.S. Postal Service must be addressed to: Federal Energy Regulatory Commission, Office of the Secretary, 888 First Street NE, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Federal Energy Regulatory Commission, Office of the Secretary, 12225 Wilkins Avenue, Rockville, Maryland 20852.
                    </P>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             
                            <E T="03">See</E>
                             18 CFR 385.2001(a)(1)(iii) (2024).
                        </P>
                    </FTNT>
                    <P>
                        For more information about this Notice, please contact Jessica L. Cockrell at 
                        <E T="03">jessica.cockrell@ferc.gov</E>
                         or 202-502-8190. For legal information, please contact Gonzalo E. Rodriguez at 
                        <E T="03">gonzalo.rodriguez@ferc.gov</E>
                         or 202-502-8568.
                    </P>
                    <SIG>
                        <DATED>Dated: December 17, 2024.</DATED>
                        <NAME>Debbie-Anne A. Reese,</NAME>
                        <TITLE>Secretary.</TITLE>
                    </SIG>
                    <HD SOURCE="HD1">Requested Format for ITC Study Comments</HD>
                    <P>We request that commenters use the following format, based on the correlated headings in the ITC Study submittal, to indicate which aspects of the submittal are being addressed in a comment. Commenters need not address all headings outlined below.</P>
                    <EXTRACT>
                        <HD SOURCE="HD1">Appendix A: Interregional Transfer Capability Study 2024</HD>
                        <FP SOURCE="FP-2">A. Chapter 1: The Reliability Value of Transfer Capability</FP>
                        <FP SOURCE="FP-2">B. Chapter 2: Overview of ITC Study Scope and Terminology</FP>
                        <FP SOURCE="FP1-2">1. ITC Study Scope</FP>
                        <FP SOURCE="FP1-2">2. Stakeholder Participation</FP>
                        <FP SOURCE="FP1-2">3. General Comments on the ITC Study Scope and Terminology</FP>
                        <FP SOURCE="FP-2">C. Transfer Capability Analysis (Part 1)</FP>
                        <FP SOURCE="FP1-2">1. Chapter 3: Transfer Capability (Part 1) Study Process</FP>
                        <FP SOURCE="FP1-2">2. Chapter 4: Transfer Capability (Part 1) Study Results</FP>
                        <FP SOURCE="FP1-2">3. Other Comments on the Transfer Capability Analysis (Part 1)</FP>
                        <FP SOURCE="FP-2">D. Recommendations for Prudent Additions To Transfer Capability (Part 2) and Recommendations To Meet and Maintain Transfer Capability (Part 3)</FP>
                        <FP SOURCE="FP1-2">1. Chapter 5: Prudent Additions (Part 2) Inputs</FP>
                        <FP SOURCE="FP1-2">2. Chapter 6: Prudent Additions (Part 2) Process, Including Energy Margin Analysis Results</FP>
                        <FP SOURCE="FP1-2">3. Chapter 7: Prudent Additions (Part 2) Recommendations</FP>
                        <FP SOURCE="FP1-2">4. Chapter 8: Prudent Additions (Part 2) Sensitivity Analysis</FP>
                        <FP SOURCE="FP1-2">5. Chapter 9: Prudent Additions (Part 2) Transmission Planning Region-Specific Results</FP>
                        <FP SOURCE="FP1-2">6. Chapter 10: Meeting and Maintaining Transfer Capability (Part 3)</FP>
                        <FP SOURCE="FP1-2">7. Other Comments on Prudent Additions (Part 2)</FP>
                        <FP SOURCE="FP1-2">8. Other Comments on Meeting and Maintaining Transfer Capability (Part 3)</FP>
                        <FP SOURCE="FP-2">E. Future Work</FP>
                        <FP SOURCE="FP-2">F. ITC Study Appendices (A-J)</FP>
                        <FP SOURCE="FP-2">G. Additional Comments Outside the Specific Report Sections</FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">United States Of America  Before the  Federal Energy Regulatory Commission</HD>
                    <FP SOURCE="FP-1">North American Electric Reliability Corporation, Docket No.  _____ </FP>
                    <HD SOURCE="HD1">North American Electric Reliability Corporation</HD>
                    <HD SOURCE="HD1">Interregional Transfer Capability Study as Directed in the Fiscal Responsibility Act of 2023</HD>
                    <EXTRACT>
                        <FP>
                            Candice Castaneda, Senior Counsel, North American Electric Reliability Corporation, (202) 400-3000, 
                            <E T="03">candice.castaneda@nerc.net</E>
                            .
                        </FP>
                        <FP>
                            <E T="03">Counsel for the North American Electric Reliability Corporation</E>
                            .
                        </FP>
                        <P>November 19, 2024.</P>
                    </EXTRACT>
                    <HD SOURCE="HD1">Table of Contents</HD>
                    <EXTRACT>
                        <FP SOURCE="FP-2">I. Executive Summary</FP>
                        <FP SOURCE="FP-2">I. Introduction to NERC and the ERO Enterprise</FP>
                        <FP SOURCE="FP-2">II. Overview of the Interregional Tranfer Capability Study</FP>
                        <FP SOURCE="FP1-2">
                            a. Calculating Current Total Transfer Capability
                            <PRTPAGE P="105791"/>
                        </FP>
                        <FP SOURCE="FP1-2">b. Identifying Prudent Additions to Transfer Capability to Demonstrably Strengthen Reliability</FP>
                        <FP SOURCE="FP1-2">c. Recommendations To Meet and Maintain Sufficient Transfer Capability</FP>
                        <FP SOURCE="FP-2">III. Consultation With Regional Entities and Transmitting Utilities</FP>
                        <FP SOURCE="FP-2">IV. Conclusion</FP>
                        <FP SOURCE="FP-2">Appendix A—Interregional Transfer Capability Study 2024</FP>
                        <FP SOURCE="FP-2">Appendix B—List of Stakeholder Engagement Activities</FP>
                        <FP SOURCE="FP-2">Appendix C—Letters to Transmitting Utilities Regarding Interregional Transfer Capability Study</FP>
                        <FP SOURCE="FP-2">Appendix D—Advisory Group Roster, ITCS Study Team Roster, and Schedule of Monthly Public Advisory Group Meetings</FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">United States of America  Before the  Federal Energy Regulatory Commission</HD>
                    <FP SOURCE="FP-1">North American Electric Reliability Corporation, Docket No.  _____ </FP>
                    <HD SOURCE="HD1">North American Electric Reliability Corporation</HD>
                    <HD SOURCE="HD1">Interregional Transfer Capability Study as Directed in the Fiscal Responsibility Act of 2023</HD>
                    <EXTRACT>
                        <P>
                            The North American Electric Reliability Corporation (“NERC”) respectfully submits the Interregional Transfer Capability Study (“ITCS” or “Study”) directed by the United States (“U.S.”) Congress in the Fiscal Responsibility Act of 2023 (“Fiscal Responsibility Act”) for Federal Energy Regulatory Commission consideration.
                            <SU>8</SU>
                            <FTREF/>
                             The ITCS was prepared by NERC as the Electric Reliability Organization (“ERO”) 
                            <SU>9</SU>
                            <FTREF/>
                             in consultation with NERC's six Regional Entities (together with NERC, the “ERO Enterprise”) 
                            <SU>10</SU>
                            <FTREF/>
                             and transmitting utilities.
                        </P>
                        <FTNT>
                            <P>
                                <SU>8</SU>
                                 Fiscal Responsibility Act, H.R. 3746 (2023) [hereinafter Fiscal Responsibility Act]. 
                                <E T="03">See</E>
                                 Section 322 of the Fiscal Responsibility Act (providing, “The Electric Reliability Organization . . . in consultation with each regional entity . . . and each transmitting utility (as that term is defined in section 3(23) of such Act) that has facilities interconnected with a transmitting utility in a neighboring transmission planning region, shall conduct a study of total transfer capability as defined in section 37.6(b)(1)(vi) of title 18, Code of Federal Regulations, between transmission planning regions that contains the following:
                            </P>
                            <P>(1) Current total transfer capability, between each pair of neighboring transmission planning regions.</P>
                            <P>(2) A recommendation of prudent additions to total transfer capability between each pair of neighboring transmission planning regions that would demonstrably strengthen reliability within and among such neighboring transmission planning regions.</P>
                            <P>(3) Recommendations to meet and maintain total transfer capability together with such recommended prudent additions to total transfer capability between each pair of neighboring transmission planning regions.”).</P>
                        </FTNT>
                        <FTNT>
                            <P>
                                <SU>9</SU>
                                 
                                <E T="03">Rules Concerning Certification of the Electric Reliability Organization; and Procedures for the Establishment, Approval, and Enforcement of Electric Reliability Standards,</E>
                                 Order No. 672, 114 FERC ¶ 61,104, 
                                <E T="03">order on reh'g,</E>
                                 Order No. 672-A, 114 FERC ¶ 61,328 (2006) [hereinafter Order No. 672]. NERC was certified by the Commission as the ERO, pursuant to § 215(c) of the Federal Power Act (“FPA”), by Commission order issued July 20, 2006. 
                                <E T="03">Order Certifying the North American Electric Reliability Corporation as the Electric Reliability Organization and Ordering Compliance Filing,</E>
                                 116 FERC ¶ 61,062 (2006) [hereinafter NERC ERO Certification Order].
                            </P>
                        </FTNT>
                        <FTNT>
                            <P>
                                <SU>10</SU>
                                 The Regional Entities are (i) Midwest Reliability Organization (“MRO”); (ii) Northeast Power Coordinating Council, Inc. (“NPCC”); (iii) ReliabilityFirst Corporation (“ReliabilityFirst”); (iv) SERC Reliability Corporation (“SERC”); (v) Texas Reliability Entity, Inc. (“Texas RE”); and (vi) Western Electricity Coordinating Council (“WECC”). Please note, unless otherwise defined herein, all capitalized terms should be assigned the meanings reflected in the NERC Glossary posted on NERC's website.
                            </P>
                        </FTNT>
                        <P>Over the past 15 months, NERC has developed the attached ITCS (Appendix A) in consultation with stakeholders to provide:</P>
                        <P>
                            (i) Current total transfer capability (“TTC” or “transfer capability”) between each pair of neighboring transmission planning regions in the U.S.; 
                            <SU>11</SU>
                            <FTREF/>
                        </P>
                        <FTNT>
                            <P>
                                <SU>11</SU>
                                 In addition, results that include transfer capabilities between the U.S. to Canada and between Canadian provinces is planned for the first quarter of 2025. While evaluating Canada is outside the specific congressional mandate, the interconnectedness of the North American BPS warrants analysis of Canada.
                            </P>
                        </FTNT>
                        <P>
                            (ii) Recommendations for technically prudent additions to TTC between pairs of neighboring transmission planning regions where these additions would demonstrably strengthen reliability; 
                            <SU>12</SU>
                            <FTREF/>
                        </P>
                        <FTNT>
                            <P>
                                <SU>12</SU>
                                 Prudence means whether the recommendations are the type that a reasonable entity would make in good faith under the same circumstances, and at the relevant point in time. 
                                <E T="03">See infra</E>
                                 Section II.b. The ITCS is not an evaluation of economics, siting, or environmental impacts.
                            </P>
                        </FTNT>
                        <P>(iii) Recommendations on how to meet and maintain TTC now and as enhanced in response to the ITCS findings.</P>
                        <P>
                            As stated herein and detailed in the attached materials, the ITCS is the first-of-its-kind assessment of transmission transfer capability under a common set of assumptions.
                            <SU>13</SU>
                            <FTREF/>
                             Transmission assessments, like the ITCS, are crucial to mitigating future risks to Bulk Power System (“BPS”) reliability, although other approaches beyond transmission (such as local generation or demand-side solutions) can also mitigate future energy risks. The ITCS focuses on transfer capability in accordance with the congressional directive, while acknowledging that other processes and pending projects may help support a reliable future grid. The ITCS is not designed to be a transmission plan or blueprint.
                        </P>
                        <FTNT>
                            <P>
                                <SU>13</SU>
                                 Transfer capability or “TTC” is the amount of electric power that can be moved or transferred reliably from one area to another area of the interconnected transmission system by way of all transmission lines (or paths) between those areas under specified system conditions. 18 CFR 37.6(b)(1)(vi).
                            </P>
                        </FTNT>
                        <P>
                            The ITCS demonstrates that sufficient transfer capability and resources exist at present to maintain energy adequacy under most scenarios. As discussed below and in the attached ITCS, however, when calculating current transfer capability and projected future conditions,
                            <SU>14</SU>
                            <FTREF/>
                             the ITCS identifies potential energy inadequacy across several transmission planning regions in the event of extreme weather. This finding confirms congressional and electric industry concerns that North American transmission infrastructure may become insufficient to maintain energy adequacy when considering the changing resource mix, extreme weather events, and increasing demand. Therefore, using the assumptions underlying the analysis, the ITCS recommends an increase of 35 GW of transfer capability across different regions as technically prudent additions to demonstrably strengthen reliability. The ITCS bases its analysis of prudence and the extent to which recommendations would demonstrably strengthen reliability according to the anticipated impact of the recommendations on BPS reliability in terms of energy adequacy. Further, the ITCS recommends region-specific enhancements to transfer capability, because a one-size-fits all approach across the U.S. may be inefficient and ineffective.
                        </P>
                        <FTNT>
                            <P>
                                <SU>14</SU>
                                 Via an energy margin analysis that uses a ten-year forward-looking case that accounts for extreme weather, resources, and demand growth as described below and detailed in Appendix A.
                            </P>
                        </FTNT>
                        <P>The ITCS is an essential element of the continuing transmission discussion in North America. The ITCS demonstrates a significant opportunity to improve the use of surplus resources when they are available during extreme weather events and shows how interregional transmission can maximize the use of local resources, including storage and demand response. Further, it highlights the continuing importance of integrated transmission and resource planning, as increasing transfer capability without surplus available energy would be inefficient. NERC looks forward to the Commission's proceeding to examine the ITCS, opportunities identified therein, and stakeholder comments in anticipation of the Commission's report to U.S. Congress.</P>
                        <HD SOURCE="HD1">I. Executive Summary</HD>
                        <P>The Bulk Power System is a complex grid that has evolved over the past several decades to include an integrated network of generation, transmission, and distribution across vast geographic areas. NERC is focused on assuring the reliability of the BPS throughout the ongoing North American energy transformation. As the grid modernizes, governmental authorities and the electric industry are rising to the challenge to ensure that continued reliability accompanies that growth.</P>
                        <P>
                            On June 3, 2023, the President signed into law the Fiscal Responsibility Act in which Congress (as part of measures associated with the debt ceiling) required NERC to conduct an assessment by December 2, 2024 of the total transfer capability between transmission planning regions.
                            <SU>15</SU>
                            <FTREF/>
                             The resulting ITCS analyzes the amount of energy that can be moved or transferred reliably from one area to another area of the interconnected transmission systems. This transfer capability is a measure of the system's ability to address energy deficiencies by relying on resources in neighboring regions and is a key component of a reliable and resilient BPS. Recent and 
                            <PRTPAGE P="105792"/>
                            continuing resource mix changes require greater access and deliverability of resources between neighboring systems to maintain reliability, particularly during widespread, extreme weather conditions.
                        </P>
                        <FTNT>
                            <P>
                                <SU>15</SU>
                                 
                                <E T="03">Supra</E>
                                 note 1.
                            </P>
                        </FTNT>
                        <P>
                            Ensuring a transmission system with sufficient transfer capability between transmission planning regions is important to support energy adequacy. In the interest of public health, safety, and security, the electric industry must continue advancing improved planning to support reliable energy supplies under an evolving grid with more frequent extreme weather conditions. As a result of the changing resource mix and extreme weather, interregional energy transfers play an increasingly pivotal role.
                            <SU>16</SU>
                            <FTREF/>
                             NERC assessments and experiences during recent events, such as the Western Interconnection Heatwaves of 2020 and 2022, Winter Storm Uri in 2021, and Winter Storm Elliott in 2022, demonstrate that action is warranted to support energy adequacy going forward. More transfer capability and a carefully planned resource mix are desirable to address these identified challenges (such as extreme weather, existing resource retirements,
                            <SU>17</SU>
                            <FTREF/>
                             and natural gas reliance), as well as the ongoing electrification of the economy with its growing transportation sector, industrial loads, and data centers. The ITCS is an integral part of that discourse by providing an independent, reliability-focused assessment of the extent of transfer capability across the transmission system and opportunities to harness that potential as we collectively prepare for the future.
                        </P>
                        <FTNT>
                            <P>
                                <SU>16</SU>
                                 An explanation of the grid can be found on the U.S. Energy Information Administration website. U.S. Energy Information Administration, 
                                <E T="03">Electricity Explained</E>
                                 (Mar. 26, 2024), 
                                <E T="03">https://www.eia.gov/energyexplained/electricity/</E>
                                 (including detailed subtopics under “Also in Electricity Explained”).
                            </P>
                        </FTNT>
                        <FTNT>
                            <P>
                                <SU>17</SU>
                                 
                                <E T="03">See</E>
                                 Appendix A, ITCS at p. 1 and Chapter 11 (summarizing ITCS limitations and potential further considerations).
                            </P>
                        </FTNT>
                        <P>
                            In the first part of the ITCS, NERC calculates current transfer capability in a manner that combines base transfer levels together with first contingency incremental transfer capability for each of the winter and summer seasons, (
                            <E T="03">see infra</E>
                             Section II.a.). Based on these calculations, NERC determines that transfer capability varies widely across North America with import capability anywhere between 1% to 92% of the associated peak loads. The ITCS shows that transfer capability varies seasonally, regionally, and under different system conditions. The ITCS also generally finds lower transfer capability in the Mountain States, Great Plains, Southwest, and Northeast, with greater capability in the West Coast, Great Lakes, and Mid-Atlantic areas. The magnitude of transfer capability is not itself a measure of energy adequacy, however, these findings informed the second part of the ITCS.
                        </P>
                        <P>
                            The second part of the ITCS contains an energy margin analysis that enabled NERC to identify whether a particular transmission planning region would be at risk for energy inadequacy considering the calculated TTCs and extreme weather events. The ITCS characterizes this risk for energy inadequacy as a “deficiency.” In each scenario where the ITCS identifies a deficiency in a transmission planning region, NERC further applied a six-step process to examine the extent to which additional transfer capability could mitigate that deficiency and thereby demonstrably strengthen reliability.
                            <SU>18</SU>
                            <FTREF/>
                             The Part 1 TTC calculation (which includes simultaneous import capability analysis) together with the Part 2 prudent additions analysis (which includes energy margin analysis of past weather events applied to the projected resource mix and demand) ensure the reasonableness and therefore prudence of ITCS recommended additions to transfer capability. The last part of the ITCS provides recommendations to meet and maintain transfer capability. The resulting recommendations identify directional (rather than prescriptive) guidance for policymakers and industry. The ITCS provides a roadmap for understanding where it may be beneficial to enhance transmission to support a reliable future grid, without mandating specific projects or a minimum level of transfer capability.
                        </P>
                        <FTNT>
                            <P>
                                <SU>18</SU>
                                 The energy margin analysis (which identified the deficiencies) constitutes steps 1 and 2 of the 6-step process.
                            </P>
                        </FTNT>
                        <P>The ITCS is a unique assessment centered on reliability. Transmission planners, regional transmission organizations/independent system operators (“RTOs/ISOs”), and policymakers might consider other factors such as economics, environmental effects, and broader policy objectives when deciding which solutions to implement to address reliability issues. Different markets, RTOs/ISOs, or regions of the U.S. may have different approaches to evaluate transfer capability and prudent additions thereto. The ITCS, for example, in some instances subdivided RTO/ISO and Commission Order No. 1000 areas to avoid masking issues between neighboring transmitting utilities within the scope of the Congressional directive. The ERO Enterprise approach was specifically designed to evaluate TTC and potential prudent additions to transfer capability that would demonstrably strengthen reliability without regard to specific market structures, economic considerations, or policy matters in the expectation that the Commission, U.S. Congress, States, and industry will use NERC's ITCS as part of this broader evaluation.</P>
                        <P>Based on the analysis in Part 2 of the ITCS, NERC identifies that in the present year, there are relatively few deficiencies across transmission planning regions. As a result, the ITCS suggests that existing infrastructure is generally sufficient at this time to maintain energy adequacy under most scenarios (barring severe conditions such as limitations on gas generation performance during cold weather and natural gas production and transportation challenges for electric generators). This conclusion also establishes 2024 as a useful reference point for future comparisons.</P>
                        <P>
                            Nevertheless, when examining the ten-year forward-looking case that accounts for the future resource mix and forecasted load, energy inadequacy was identified across almost half of the studied transmission planning regions.
                            <SU>19</SU>
                            <FTREF/>
                             This confirms congressional and electric industry concern that, given the changing resource mix, extreme weather, and anticipated demand, transmission infrastructure may place a strain on energy adequacy in the future. As a result, based on calculated deficiencies and the broader six-step approach to identify prudent additions to demonstrably strengthen reliability, the ITCS recommends 35 GW of additional transfer capability across different areas of the U.S. As discussed in Section II.b. below, transmission planning regions across North America would benefit from increased transfer capability. Since the needed import capability, as analyzed, varied significantly across the U.S., a one-size fits all requirement or approach to additional transfer capability is expected to be inefficient and ineffective. The increased transfer capability recommended in the ITCS, in addition to other measures outside of its scope, such as resource adequacy and fuel assurance, would demonstrably improve energy adequacy under reasonably anticipated extreme conditions.
                            <SU>20</SU>
                            <FTREF/>
                        </P>
                        <FTNT>
                            <P>
                                <SU>19</SU>
                                 Specifically, 11 out of 23 transmission planning regions.
                            </P>
                        </FTNT>
                        <FTNT>
                            <P>
                                <SU>20</SU>
                                 NERC highlights that transmission and TTC are part of a more expansive equation underlying energy adequacy in a modern grid, which includes matters such as available generation. The ITCS relies, for example, on future resource assumptions. If these change it could impact the energy margin analysis underlying the Part 2 analysis.
                            </P>
                        </FTNT>
                        <P>
                            Part 3 of the ITCS also provides recommendations how to meet and maintain transfer capability. 
                            <E T="03">See infra</E>
                             Section II.c. These recommendations should be taken, together with remainder of the ITCS, as foundational insights for further discussions and decisions on regulatory and legislative solutions. Planners, for example, should consider conditions impacting their systems and those of neighboring transmitting utilities while also considering resource adequacy.
                            <SU>21</SU>
                            <FTREF/>
                             The ITCS also does not evaluate particular projects. Rather, under a holistic approach, the Study recommends how much additional transfer capability at each interface would strengthen the grid.
                        </P>
                        <FTNT>
                            <P>
                                <SU>21</SU>
                                 Please see the ITCS for discussion of additional factors that stakeholders may analyze.
                            </P>
                        </FTNT>
                        <HD SOURCE="HD1">I. Notices and Communications</HD>
                        <P>Notices and communications with respect to this filing may be addressed to:</P>
                        <FP SOURCE="FP-1">
                            Sonia Rocha, Senior Vice President, General Counsel, and Corporate Secretary, North American Electric Reliability Corporation, 1401 H Street NW, Suite 410, Washington, DC 20005, 202-400-3000 office, 
                            <E T="03">sonia.rocha@nerc.net</E>
                        </FP>
                        <FP SOURCE="FP-1">
                            Candice Castaneda, Senior Counsel, North American Electric Reliability Corporation, 1401 H St. NW, Suite 410, Washington, DC 20005, 202-400-3000, 
                            <E T="03">candice.castaneda@nerc.net</E>
                        </FP>
                        <HD SOURCE="HD1">I. Introduction to NERC and the ERO Enterprise</HD>
                        <P>
                            Electricity is a key component of the fabric of modern society. NERC's mission is to assure the effective and efficient reduction of risks to the reliability and security of the grid. The vision of the ERO Enterprise is a 
                            <PRTPAGE P="105793"/>
                            highly reliable and secure North American BPS. The Regional Entities help NERC support reliability across various interconnections with differing needs and characteristics.
                            <SU>22</SU>
                            <FTREF/>
                        </P>
                        <FTNT>
                            <P>
                                <SU>22</SU>
                                 NERC's relationship with the Regional Entities is governed by Regional Delegation Agreements or “RDAs” filed with the Commission every five years. 18 CFR 39.8. A delegation agreement shall not be effective until it is approved by the Commission. 
                                <E T="03">See also, N. Am. Elec. Reliability Corp.,</E>
                                 133 FERC ¶ 61,061 (2010), 
                                <E T="03">order denying reh'g,</E>
                                 134 FERC ¶ 61,179 (2011), 
                                <E T="03">order on compliance filing,</E>
                                 137 FERC ¶ 61,028 (2011). 
                                <E T="03">N. Am. Elec. Reliability Corp.,</E>
                                 153 FERC ¶ 61,135 (2015) (approving pro forma and individual RDAs, subject to compliance filing) and 
                                <E T="03">N. Am. Elec. Reliability Corp.,</E>
                                 Docket No. RR15-12-001 (Mar. 23, 2016) (delegated letter order) (accepting final pro forma and individual RDAs) (collectively “2015 RDA Order”); and Order Conditionally Approving Revised 
                                <E T="03">Pro Forma</E>
                                 Delegation Agreement and Revised Delegation Agreements with Regional Entities, 173 FERC ¶ 61,277 (2020).
                            </P>
                        </FTNT>
                        <P>
                            When Congress enacted the Energy Policy Act of 2005 
                            <SU>23</SU>
                            <FTREF/>
                             and section 215 of the Federal Power Act, it entrusted the Commission with: (i) approving and enforcing rules to ensure the reliability of the BPS; and (ii) certifying an ERO that would be charged with developing and enforcing mandatory Reliability Standards, subject to Commission approval, and with assessing reliability and adequacy of the BPS in North America.
                            <SU>24</SU>
                            <FTREF/>
                             Section 215 and Commission regulation reflect certification of an ERO subject to Commission oversight.
                            <SU>25</SU>
                            <FTREF/>
                             In 2006, the Commission certified NERC as the ERO.
                            <SU>26</SU>
                            <FTREF/>
                        </P>
                        <FTNT>
                            <P>
                                <SU>23</SU>
                                 Public Law 109-58, title XII, § 1211(b), Aug. 8, 2005, 119 Stat. 946.
                            </P>
                        </FTNT>
                        <FTNT>
                            <P>
                                <SU>24</SU>
                                 16 U.S.C. 824o(a)(2). 
                                <E T="03">See also</E>
                                 § 824o(c) (providing the ERO certification criteria). 
                                <E T="03">See also</E>
                                 Public Law 109-58, title XII, § 1211(b), Aug. 8, 2005, 119 Stat. 946 (clarifying, “[t]he Electric Reliability Organization. . . and any regional entity delegated enforcement authority. . . are not departments, agencies, or instrumentalities of the United States Government.”).
                            </P>
                        </FTNT>
                        <FTNT>
                            <P>
                                <SU>25</SU>
                                 Order No. 672 at PP 183-191.
                            </P>
                        </FTNT>
                        <FTNT>
                            <P>
                                <SU>26</SU>
                                 
                                <E T="03">See</E>
                                 NERC ERO Certification Order.
                            </P>
                        </FTNT>
                        <P>
                            Consistent with NERC's responsibility to “conduct periodic assessments of the reliability and adequacy of the bulk-power system in North America” 
                            <SU>27</SU>
                            <FTREF/>
                             such as NERC's Long-Term Reliability Assessment (“LTRA”), Summer Assessment, Winter Assessment, and special assessments, the Fiscal Responsibility Act tasked NERC with preparing the ITCS in consultation with the Regional Entities and transmitting utilities.
                        </P>
                        <FTNT>
                            <P>
                                <SU>27</SU>
                                 16 U.S.C. 824o(g).
                            </P>
                        </FTNT>
                        <HD SOURCE="HD1">II. Overview of the Interregional Tranfer Capability Study</HD>
                        <P>The Fiscal Responsibility Act requires the ERO, in consultation with the Regional Entities and transmitting utilities with facilities neighboring another in a neighboring transmission planning region (referred to generally as “neighboring transmitting utilities”), to conduct a study of total transfer capability (also known as “TTC”) between transmission planning regions that contains:</P>
                        <P>(1) Current total transfer capability between each pair of neighboring transmission planning regions.</P>
                        <P>(2) A recommendation of prudent additions to total transfer capability between each pair of neighboring transmission planning regions that would demonstrably strengthen reliability within and among such neighboring transmission planning regions.</P>
                        <P>
                            (3) Recommendations to meet and maintain total transfer capability together with such recommended prudent additions to total transfer capability between each pair of neighboring transmission planning regions.
                            <SU>28</SU>
                            <FTREF/>
                        </P>
                        <FTNT>
                            <P>
                                <SU>28</SU>
                                 
                                <E T="03">Supra</E>
                                 note 1.
                            </P>
                        </FTNT>
                        <P>
                            Consistent with NERC's collaborative process and congressional directive, the ITCS was prepared over a 15-month period with significant stakeholder engagement, as discussed in Section III below and reflected in Appendices B through D. The ITCS examined current TTC as Part 1 of the analysis. Part 2 of the Study completed an energy margin analysis that compared TTC against 12 weather years (including extreme weather) to identify transmission planning region energy deficiencies that warrant prudent additions to TTC to demonstrably strengthen reliability.
                            <SU>29</SU>
                            <FTREF/>
                             As Part 3 of the ITCS, the ITCS recommended methods to meet and maintain current TTC and enhanced TTC. These recommendations interpreted the ITCS as part of the broader discourse between the Commission, U.S. Congress, States, other policymakers, and the electric industry to leverage the ITCS findings along with more specific regional, policy, market, economic, and environmental considerations. Finally, the ERO Enterprise plans to continue regular assessments of transfer capability that will consider the latest developments in resource mixes, transmission infrastructure, new load projections, and changing weather and climate patterns.
                        </P>
                        <FTNT>
                            <P>
                                <SU>29</SU>
                                 The 12 weather years to ensure the ITCS examined extreme weather were selected from 2007-2023 and are non-contiguous.
                            </P>
                        </FTNT>
                        <HD SOURCE="HD2">a. Calculating Current Total Transfer Capability</HD>
                        <P>
                            In accordance with the Fiscal Responsibility Act, the fundamental question of the ITCS is the ability of the BPS to support transfers of energy between transmission planning regions when needed to ensure adequate energy to meet demand. The first required component of the ITCS is calculating current transfer capability, or TTC, between pairs of neighboring transmission planning regions.
                            <SU>30</SU>
                            <FTREF/>
                        </P>
                        <FTNT>
                            <P>
                                <SU>30</SU>
                                 
                                <E T="03">Supra</E>
                                 note 1.
                            </P>
                        </FTNT>
                        <P>
                            To calculate TTC, the ITCS study team, comprised of ERO Enterprise staff and consultants, first determined appropriate transmission planning regions for purposes of the Study after coordinating with the ITCS Advisory Group. To establish transmission planning regions for purposes of the Study, NERC, working with the Regional Entities, selected a set of interfaces that included all pairs of neighboring transmission planning regions to enable the ITCS performance of transfer analysis from source (exporting) region to sink (importing), and vice versa. Only electrically connected neighboring systems were evaluated to identify the transmission planning regions for purposes of Part 1 of the ITCS.
                            <SU>31</SU>
                            <FTREF/>
                             The ITCS regions were smaller than the Commission's Order No. 1000 regions and those that RTOs/ISOs might use to provide a more granular analysis of potential TTC limitations and to enable the ITCS to identify key constraints to interregional TTC.
                        </P>
                        <FTNT>
                            <P>
                                <SU>31</SU>
                                 Some geographic neighbors that were not electrically connected were evaluated as potential new connections in Part 2 of the ITCS as NERC evaluated potential recommendations to enhance transfer capability.
                            </P>
                        </FTNT>
                        <P>As reflected in NERC's August 2024 posted materials, the transmission planning regions were established as follows:</P>
                        <GPH SPAN="3" DEEP="326">
                            <PRTPAGE P="105794"/>
                            <GID>EN27DE24.052</GID>
                        </GPH>
                        <P>
                            After the identification of transmission planning regions, the ITCS calculated TTC according to the following steps: 
                            <SU>32</SU>
                            <FTREF/>
                        </P>
                        <FTNT>
                            <P>
                                <SU>32</SU>
                                 
                                <E T="03">See</E>
                                 ITCS Appendix A (providing detailed explanation on the Study and its design).
                            </P>
                        </FTNT>
                        <P>
                            (i) Select base cases using relevant Eastern Interconnection and Western Interconnection base cases created through Reliability Standard MOD-032-1 processes; 
                            <SU>33</SU>
                            <FTREF/>
                        </P>
                        <FTNT>
                            <P>
                                <SU>33</SU>
                                 Base cases are computer models that simulate the behavior of the electrical system under various conditions as a snapshot in time. Base cases were not required for ERCOT and Québec Interconnections for purposes of the ITCS as they were only tied with the Eastern Interconnection via dc ties. Also, small ERCOT dc ties to Mexico were omitted from evaluation and the ERCOT-Mexico interface was outside the scope of the document.
                            </P>
                        </FTNT>
                        <P>
                            (ii) Calculate TTC using Area Interchange method as the sum of base transfer levels together with first contingency incremental transfer capability; 
                            <SU>34</SU>
                            <FTREF/>
                        </P>
                        <FTNT>
                            <P>
                                <SU>34</SU>
                                 Contingencies were based on NERC Reliability Standard TPL-001-5.1 category P1 contingencies (100 kV and above).
                            </P>
                        </FTNT>
                        <P>(iii) Adjust for facility monitoring criteria and thresholds to prevent undue limitation of transfer capability results based on heavily loaded, electrically distant elements to avoid the appearance of artificially constrained TTC;</P>
                        <P>(iv) Ensure special interface considerations (such as pertinent remedial action schemes) are understood and properly reflected in study results; and</P>
                        <P>(v) Analyze total import capabilities of each transmission planning region (although not required under the Fiscal Responsibility Act) as technically requisite to appropriately model system capability for purposes of the Part 2 analysis of any prudent enhancements to TTC.</P>
                        <P>
                            This analysis identified current TTC as illustrated in the maps discussed in more detail in the ITCS at Appendix A. These TTC results are highly dependent on the base cases and modeling assumptions described in the ITCS. The ITCS did not attempt to optimize dispatch or topology to maximize TTC, just as it also was designed to avoid underestimating TTC. The ITCS used the steps highlighted above to avoid the appearance of artificially constrained TTC.
                            <SU>35</SU>
                            <FTREF/>
                        </P>
                        <FTNT>
                            <P>
                                <SU>35</SU>
                                 As this is a study, observed TTC may differ from the conclusions in the ITCS based on operational conditions.
                            </P>
                        </FTNT>
                        <P>The ITCS found that transfer capability varies seasonally and under different system conditions that limit transmission loading so that it cannot be represented by a single number. Transfer capability also varies widely across North America, with total import capability between 1% and 92% of peak load. Transfer capabilities were observed as generally higher in the West Coast, Great Lakes, and mid-Atlantic areas, while relatively lower in the Mountain States, Great Plains, Southeast, and the Northeast regions. In addition, the ITCS found limited transfer capability between Interconnections (Western Interconnection, Eastern Interconnection, ERCOT Interconnection (“ERCOT”), and Québec). As NERC discussed these Part 1 results with industry during the Summer of 2024, it explained that the findings suggested that Part 2 analysis would probably identify prudent additions to TTC to strengthen reliability. NERC underscored that the magnitude of transfer capability is not itself a measure of energy adequacy. Rather, the identified TTC provides the foundation for subsequent energy margin analysis in Part 2 of the ITCS.</P>
                        <HD SOURCE="HD2">b. Identifying Prudent Additions to Transfer Capability to Demonstrably Strengthen Reliability</HD>
                        <P>
                            The Fiscal Responsibility Act requires NERC to consider and recommend prudent additions to TTC “between each pair of neighboring transmission planning regions that would demonstrably strengthen reliability within and among such neighboring transmission planning regions.” 
                            <SU>36</SU>
                            <FTREF/>
                             For the purposes of determining a “prudent addition,” NERC looked to the standard used in Commission precedent in electric utility ratemaking proceedings, which provides that “prudence” means a determination of whether (1) a reasonable entity (2) would have made the same decision, (3) in good faith, (4) under the same circumstances, and (5) at the relevant point in time.
                        </P>
                        <FTNT>
                            <P>
                                <SU>36</SU>
                                 
                                <E T="03">Supra</E>
                                 note 1.
                            </P>
                        </FTNT>
                        <P>
                            Determining exactly how much additional transfer capability is “prudent” can depend on the totality of factors and circumstances. For example, as part of examining the totality of circumstances, the Commission has considered matters such as whether activities 
                            <PRTPAGE P="105795"/>
                            have enhanced the ability to restore service, achieved significant efficiencies, reduced costs or time delays, and/or made efficient use of resources to ensure reliability.
                            <SU>37</SU>
                            <FTREF/>
                             As discussed immediately below, NERC applied a six-step process to ensure that the ITCS's tailored recommendations for prudent additions to transfer capability for certain pairs of neighboring transmission planning regions are those that a reasonable entity would have made in good faith under the same circumstances and at the same point in time considering reliability of the system as the driving factor.
                        </P>
                        <FTNT>
                            <P>
                                <SU>37</SU>
                                 
                                <E T="03">See, e.g., New England Power Co.,</E>
                                 31 FERC ¶ 61,047 at 61,084 (1985); and 
                                <E T="03">Potomac-Appalachian Transmission Highline, LLC,</E>
                                 140 FERC ¶ 61,229 at P 82 (Sept. 20, 2012).
                            </P>
                        </FTNT>
                        <P>NERC underscores that nothing in the ITCS should be used as justification for a particular project and that no part of the ITCS is intended as evidence regarding prudence in any ratemaking proceeding. The ITCS does not include economic assessments, project-specific recommendations, transmission expansion analysis, operational mitigation or capacity expansion planning. A holistic view of the BPS and a thorough understanding of its behavior will be essential when calculating or increasing transfer capability.</P>
                        <P>The ITCS particularly examined the extent to which recommended enhancements would be reasonably expected to demonstrably strengthen reliability of the BPS. To do so, the ITCS examined whether the potential recommendation would strengthen reliability, serve load under extreme conditions, and avoid creating unintended reliability concerns as follows:</P>
                        <P>
                            1. 
                            <E T="03">Strengthen Reliability:</E>
                             Provides a potential solution that enables more flexibility between transmission planning regions and access to resources that may be available during local energy deficits.
                        </P>
                        <P>
                            2. 
                            <E T="03">Serve Load Under Extreme Conditions:</E>
                             Provides a solution that serves future demand during extreme conditions, which is a more restrictive design basis than current resource adequacy constructs.
                        </P>
                        <P>
                            3. 
                            <E T="03">Does Not Create Unintended Reliability Concerns:</E>
                             Recommendations for larger connections between transmission planning regions will require detailed system studies to assure system stability.
                        </P>
                        <GPH SPAN="3" DEEP="177">
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                        </GPH>
                        <P>Under Part 2 of the ITCS, the ITCS conducted energy margin analysis of resource availability and interregional transfers across 12-years of meteorological conditions and extreme weather data to examine whether the transfer capability calculated for a pair of neighboring transmission planning regions would be unable to meet energy needs under times of stress, being thus “deficient” and reflecting a risk of energy inadequacy for those regions.</P>
                        <P>As a result, where the ITCS energy margin analysis found a deficiency and corresponding risk, NERC led a further layer of study that applied several considerations and criteria under a six-step process to evaluate whether, and how much, additional transfer capability would mitigate the potential risk of energy inadequacy created by the deficiency.</P>
                        <P>The six-step process entails the following and is discussed in detail in Chapter 6 of the ITCS at Appendix A:</P>
                        <FP SOURCE="FP-2">i. Identify hours of resource deficiency</FP>
                        <FP SOURCE="FP-2">ii. Quantify the maximum resource deficiency</FP>
                        <FP SOURCE="FP-2">iii. Prioritize constrained interfaces</FP>
                        <FP SOURCE="FP-2">iv. Allocate additional transfer capability</FP>
                        <FP SOURCE="FP-2">v. Iterate until resource deficiencies are mitigated</FP>
                        <FP SOURCE="FP-2">vi. Finalize prudent level of transfer capability</FP>
                        <P>A diagram of the analysis will help explain further:</P>
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                        </GPH>
                        <PRTPAGE P="105797"/>
                        <P>The ITCS recommended prudent additions to transfer capability to the extent that results reflected that enhanced transfer capability would assuage the risk of energy inadequacy (as reflected by the deficiencies shown after energy margin analysis).</P>
                        <P>
                            In total, across various regions of the U.S., the ITCS recommends 35 GW of additional transfer capability to demonstrably strengthen reliability. These recommendations are detailed in the ITCS at Appendix A and break down according to the following table Table ES.1: 
                            <SU>38</SU>
                            <FTREF/>
                        </P>
                        <FTNT>
                            <P>
                                <SU>38</SU>
                                 In two cases, it was not possible to eliminate all energy deficiencies, even by increasing transfer capability, due to wide-area resource shortages. In ERCOT and California North, resource deficiencies remained even after increasing transfer capability by 14 GW and 1 GW, respectively.
                            </P>
                        </FTNT>
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                        <P>
                            In making these recommendations, NERC acknowledges that transfer capability is only one part of the overall equation and that other elements such as generation resource availability, new load projections, additional weather information, and demand response should also be taken into account.
                            <SU>39</SU>
                            <FTREF/>
                             Moreover, these recommendations do not account for economic, environmental, permitting or policy considerations that the Commission, U.S. Congress, other policymakers, and the electric industry may apply following the ITCS.
                        </P>
                        <FTNT>
                            <P>
                                <SU>39</SU>
                                 Please see NERC's website for more information regarding these issues. 
                                <E T="03">See also,</E>
                                 ITCS, Appendix A, Chapter 11 (providing further considerations). NERC has focused the ITCS on transfer capability in accordance with Congressional directive.
                            </P>
                        </FTNT>
                        <HD SOURCE="HD2">c. Recommendations To Meet and Maintain Sufficient Transfer Capability</HD>
                        <P>
                            The final requirement of the Fiscal Responsibility Act of 2023 is to develop recommendations to meet and maintain transfer capability together with recommended prudent additions.
                            <SU>40</SU>
                            <FTREF/>
                             The ITCS provided recommendations to support transfer capability in the future without specifying a particular set of projects or approach. This recognizes that increased transfer capability is one of many options for addressing the identified energy deficiencies. Such options at a high level include:
                        </P>
                        <FTNT>
                            <P>
                                <SU>40</SU>
                                 
                                <E T="03">Supra</E>
                                 note 1.
                            </P>
                        </FTNT>
                        <FP SOURCE="FP-1">• Increase transfer capability to neighbors with surplus resources</FP>
                        <FP SOURCE="FP-1">• Construct local generation</FP>
                        <FP SOURCE="FP-1">• Increase demand response resources</FP>
                        <FP SOURCE="FP-1">• Accept the identified risks during extreme events (assuming other reliability thresholds are met)</FP>
                        <P>Timing for these approaches may vary, so further studies are needed for implementation. Grid operators must also be prepared to maintain BPS reliability through emergency measures (including rotating outages if necessary) meanwhile.</P>
                        <P>If planners elect to increase transfer capability to meet the recommendations listed in the ITCS, options to consider include:</P>
                        <P>
                            • 
                            <E T="03">Upgraded transmission infrastructure:</E>
                             Such as building new lines and reconductoring existing lines or raising existing tower structures where feasible.
                        </P>
                        <P>
                            • 
                            <E T="03">Remedial action schemes (“RAS”):</E>
                             Increasing transfer capability via adjustments to RAS may be helpful in the short-term while other solutions are implemented. RAS are not advised as a long-term solution as these schemes introduce higher operational complexity.
                        </P>
                        <P>
                            • 
                            <E T="03">Dynamic line ratings (“DLR”):</E>
                             DLR could use real-time and forecasted weather conditions to continuously calculate the thermal capacity of transmission lines and may at times facilitate increased transfer capability during favorable weather conditions. However, DLR may not be suitable in all situations.
                        </P>
                        <P>
                            • 
                            <E T="03">Power flow control devices:</E>
                             Power flow control devices with newer digital control 
                            <PRTPAGE P="105798"/>
                            technology that allows for faster responses to system needs may help support transfer capability and enhance the transmission planning process.
                        </P>
                        <P>With regard to maintaining transfer capability, the ITCS explained that actual transfer capability available during real-time operations may be different from that calculated due to system conditions during actual operations. A certain level of transfer capability cannot always be maintained due to those changing system conditions and, therefore, the ITCS focused on what can be accomplished during the planning horizon. These recommendations to maintain transfer capability include:</P>
                        <P>
                            • 
                            <E T="03">Coordination Agreements:</E>
                             Strong coordination procedures and agreements can maximize available support during stress conditions (such as extreme weather events). This coordination could include rigorous maintenance activities and coordinated maintenance to avoid overlapping with periods of increased stress.
                        </P>
                        <P>
                            • 
                            <E T="03">Future Studies:</E>
                        </P>
                        <P>
                            ○ 
                            <E T="03">ERO Enterprise Studies:</E>
                             The ERO Enterprise, working with industry, is planning to conduct regular assessments rolled into future Long-Term Reliability Assessment reports that will consider developments in this area. NERC is also considering the issues as part of its Energy Assessment Strategy.
                        </P>
                        <P>
                            ○ 
                            <E T="03">Planning/Maintenance:</E>
                             Planners can evaluate changes in transfer capability as part of regular processes.
                        </P>
                        <P>
                            • 
                            <E T="03">Regulatory and Policy Mechanisms:</E>
                        </P>
                        <P>○ The ITCS noted that a uniform minimum transfer capability requirement may not be an effective or efficient approach to ensure energy adequacy.</P>
                        <P>○ The ITCS recommended that policy makers consider mechanisms to address existing challenges associated with siting/permit approvals, cost-allocation, and multi-party operating and maintenance agreements.</P>
                        <P>
                            • 
                            <E T="03">Reliability Standards:</E>
                        </P>
                        <P>○ The ITCS clarified that it is not NERC's intent to develop Reliability Standard modifications to require entities to meet and maintain a certain transfer capability, without prejudice to NERC's consideration of modifications in the future of matters such as assessments associated with planned transfer capability.</P>
                        <P>○ NERC has two standard development projects (Project 2022-03 Energy Assurance with Energy-Constrained Resources and 2024-02 Planning Energy Assurance) related to energy assurance and the assessment of energy adequacy.</P>
                        <P>
                            System studies are urged to ensure careful deployment of ITCS recommendations. To give these recommendations meaning, transmission planners and planning coordinators will need detailed studies to select projects or actions that take advantage of the opportunity identified in the ITCS without inadvertent consequences. The ITCS explained limitations on its scope as well as steps that stakeholders could take to further build on the opportunities identified therein.
                            <SU>41</SU>
                            <FTREF/>
                             As highlighted throughout the ITCS and this filing, the ITCS is intended as a launch-pad to further North America's efforts to plan infrastructure and coordination that supports a modern grid.
                        </P>
                        <FTNT>
                            <P>
                                <SU>41</SU>
                                 Without limitation on future analysis or action, NERC does not recommend any Reliability Standards changes at this time as a result of the ITCS.
                            </P>
                        </FTNT>
                        <P>NERC urges policymakers and industry to carefully consider how to leverage the recommended additions to transfer capability outlined in the ITCS. As mentioned above, the recommendations identify directional, rather than prescriptive, guidance. The ITCS provides a roadmap for understanding where transmission may benefit from enhancement, without mandating specific projects or a minimum level of transfer capability. While the ITCS recommends increased transfer capability on particular interfaces, NERC does not endorse projects or particular approaches. This is intentional because planners must evaluate potential downstream impacts of increased transfer capability. For example, while greater transfer capability can improve energy adequacy, there can be situations where a large transfer of energy has consequences for other aspects of reliable system operations such as system stability, voltage control, and measures to minimize the potential for cascading outages. Transmission planning regions must coordinate system enhancements to support rational and effective implementation of the ITCS findings. Further, planners might consider other options not within the scope of the ITCS. While the ITCS focuses on transfer capability per congressional directive, regions might construct additional resources or increase demand response resources. Further, the ITCS acknowledges that existing or planned projects may also be responsive to the opportunities and recommendations identified in the ITCS. As stated above, the ITCS findings should be considered foundational insights for further discussions and decisions.</P>
                        <HD SOURCE="HD1">III. Consultation With Regional Entities and Transmitting Utilities</HD>
                        <P>
                            The Fiscal Responsibility Act requires that NERC conduct the ITCS in consultation with the six Regional Entities and neighboring transmitting utilities.
                            <SU>42</SU>
                            <FTREF/>
                             Consultation is understood as a meaningful exchange of information prior to final decision-making.
                            <SU>43</SU>
                            <FTREF/>
                             Consistent with Congressional directive and NERC's regular collaborative process as the ERO Enterprise coordinating with stakeholders to ensure reliability, NERC frequently consulted with the Regional Entities and transmitting utilities throughout the design and execution of the ITCS.
                        </P>
                        <FTNT>
                            <P>
                                <SU>42</SU>
                                 
                                <E T="03">Supra</E>
                                 note 1.
                            </P>
                        </FTNT>
                        <FTNT>
                            <P>
                                <SU>43</SU>
                                 
                                <E T="03">See, e.g., Envtl. Def. Ctr., Inc.</E>
                                 v. 
                                <E T="03">U.S. Envtl. Protection Agency,</E>
                                 344 F.3d 832 (9th Cir. 2003) (highlighting that consultation was reflected by activities such as circulating a draft report to stakeholders, establishing an advisory committee, holding several meetings as part of that advisory committee, and obtaining input from State and municipal representatives on drafts); and 
                                <E T="03">South Carolina</E>
                                 v. 
                                <E T="03">United States,</E>
                                 329 F. Supp. 3d 214 (2018) (finding that the Department of Energy engaged in a meaningful exchange of information and views with governor prior to the decision); 
                                <E T="03">cf. Cal. Wilderness Coalition</E>
                                 v. 
                                <E T="03">U.S. Dep't of Energy,</E>
                                 631 F.3d 1072, 1087, 1080, 1085) (2011) (explaining that consultation entails a meaningful exchange and more than public comment).
                            </P>
                        </FTNT>
                        <P>As illustrated below, the stakeholder engagement process included 14 Advisory Group meetings, three letters to transmitting utilities seeking input and feedback, presentations at NERC Board of Trustee (“Board”) meetings and over 100 industry and trade group meetings. In addition, to facilitate these conversations and ongoing exchange of perspectives as NERC led the ITCS, NERC publicly published scoping documents and quarterly updates associated with the ITCS on NERC's ITCS web page. Further, NERC published the parts of the ITCS via a series of three reports (an introductory Overview report, transfer capability analysis Part 1 report, and prudent recommended additions to transfer capability Part 2 and 3 report) prior to finalizing and consolidating these portions into the attached ITCS (Appendix A).</P>
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                        <P>
                            This consultation process is consistent with the ITCS Framework that NERC published in the summer of 2023. That Framework established NERC's plan to engage with its executive leadership, Regional Entities across different levels of leadership and technical expertise, and industry. This plan included the ERO Enterprise's coordination with an ITCS Advisory Group comprised of diverse industry experts (including, for example, those from the Department of Energy (“DOE”), the Commission, and transmission planners from across the BPS), as well as additional outreach to transmitting utilities. 
                            <E T="03">See,</E>
                             Appendix B (list of stakeholder engagement activities), Appendix C (letters to transmitting utilities for feedback); and Appendix D (Advisory Group and ITCS Study Team Rosters and List of Public Meetings).
                        </P>
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                        <P>
                            In accordance with the Framework illustrated above, NERC involved Regional Entities in the ITCS on a weekly basis to design and execute the ITCS and has met with the Advisory Group approximately every month to obtain input on ITCS design, execution, and findings. These groups were also asked to provide feedback on draft materials, such as the initial draft Framework, subsequent scope documents for different parts of the ITCS, and the portions of the ITCS that were rolled out in phases and culminated in the ITCS attached at Appendix A. All Advisory Group meeting presentations were publicly posted on NERC's ITCS web page. Comments from Advisory Group members on various parts of the ITCS were also posted on NERC's ITCS web page along with NERC's consideration and responses. The process ensured that NERC received input during each stage of the ITCS from its initial framing to more detailed scoping and throughout the ITCS while the ERO Enterprise study team examined the issues and finalized decisions.
                            <SU>44</SU>
                            <FTREF/>
                        </P>
                        <FTNT>
                            <P>
                                <SU>44</SU>
                                 Examples included the decision to study simultaneous import capability and use 2024/2025 system conditions (or “base cases”) to calculate current total transfer capability.
                            </P>
                        </FTNT>
                        <P>
                            To maximize the opportunity for stakeholder consultation, NERC published draft portions of the ITCS on its web page (after seeking Advisory Group feedback) in stages. First, NERC published an Overview report introducing the ITCS and its approach in June 2024. Second, NERC published its calculated total transfer capability in August 2024. Third, in November 2024, NERC published its proposed recommended prudent additions to total transfer capability in certain regions of the U.S. and recommended means to meet and maintain transfer capability today and as enhanced after consideration of the ITCS recommendations. (Part 2 &amp; 3 Report). These three parts were consolidated after final revisions into the attached ITCS (Appendix A). NERC plans to issue a fourth report in 2025 studying transfer capabilities from the U.S. to Canada and between Canadian provinces.
                            <SU>45</SU>
                            <FTREF/>
                        </P>
                        <FTNT>
                            <P>
                                <SU>45</SU>
                                 While this part is outside the specific congressional mandate, the interconnectedness of the North American BPS warrants analysis of Canada.
                            </P>
                        </FTNT>
                        <P>
                            In addition, NERC sent three sets of letters to all transmitting utilities in 2024 to obtain feedback on the ITCS.
                            <SU>46</SU>
                            <FTREF/>
                             The first letter was sent in January of 2024 seeking input generally on the ITCS, posted framework, and scope documents. The second letter was sent in September of 2024 to solicit input from transmitting utilities on the ITCS Overview report, total transfer capability report (Part 1), and Advisory Group materials (which included material on considerations and criteria to determine any recommended prudent additions to transfer capability). NERC's third letter to transmitting utilities was issued November 4, 2024, after the final in-person Advisory Group meeting, to solicit input on NERC's proposed recommended prudent additions and recommendations on how to meet and maintain current total transfer capability and transfer capability as enhanced by any additions (the Part 2 &amp; 3 report). NERC's preliminary recommendations for prudent additions were also shared with the Advisory Group in September 2024 with publicly posted materials available on the ITCS web page to provide ample opportunity for comments before the Part 2 and 3 publication and before finalizing a final report.
                        </P>
                        <FTNT>
                            <P>
                                <SU>46</SU>
                                 The Fiscal Responsibility Act required NERC to consult with neighboring transmitting utilities, however, to facilitate the broadest opportunity for consultation NERC sent these letters to all transmitting utilities.
                            </P>
                        </FTNT>
                        <P>NERC takes this opportunity to thank all those stakeholders and members of the ERO Enterprise who participated in the ITCS. This feedback has been instrumental in developing a nuanced study that is unique in terms of its geographic magnitude and overall approach to assessing energy adequacy under extreme conditions.</P>
                        <HD SOURCE="HD1">IV. Conclusion</HD>
                        <P>
                            Therefore, for the reasons set forth above, NERC hereby submits this ITCS to the Commission as directed by the U.S. Congress in the Fiscal Responsibility Act. The ITCS finds that while current total transfer capability is largely sufficient to support energy adequacy at present, when calculating energy margin analysis and extreme weather over a forward-looking ten-year outlook, there may likely be insufficient transfer 
                            <PRTPAGE P="105801"/>
                            capability. Based on the identified deficiencies that reveal certain transmission planning regions at risk for energy inadequacy, the ITCS recommends 35 GW of additional total transfer capability as a prudent measure to demonstrably strengthen reliability subject to coordination between governmental authorities, policy makers, and industry. NERC also plans to continue evaluating transfer capability as a regular part of its assessments going forward such as the LTRA. NERC on behalf of itself and the full ERO Enterprise, looks forward to continuing to participate in this discourse and preparing North America to meet the needs of the modern grid.
                        </P>
                        <P>Respectfully submitted,</P>
                        <FP>/s/Candice Castaneda</FP>
                        <FP>
                            Candice Castaneda, Senior Counsel, North American Electric Reliability Corporation, 1401 H St. NW, Suite 410, Washington, DC 20005, (202) 400-3000, 
                            <E T="03">candice.castaneda@nerc.net.</E>
                        </FP>
                        <FP>
                            <E T="03">Counsel for the North American Electric Reliability Corporation.</E>
                        </FP>
                        <P>Date: November 19, 2024.</P>
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                        <GID>EN27DE24.233</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="105977"/>
                        <GID>EN27DE24.234</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="105978"/>
                        <GID>EN27DE24.235</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="105979"/>
                        <GID>EN27DE24.236</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="105980"/>
                        <GID>EN27DE24.237</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="105981"/>
                        <GID>EN27DE24.238</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="105982"/>
                        <GID>EN27DE24.239</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="608">
                        <PRTPAGE P="105983"/>
                        <GID>EN27DE24.240</GID>
                    </GPH>
                </PREAMB>
                <FRDOC>[FR Doc. 2024-30493 Filed 12-26-24; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 6717-01-C</BILCOD>
            </NOTICE>
        </NOTICES>
    </NEWPART>
    <VOL>89</VOL>
    <NO>248</NO>
    <DATE>Friday, December 27, 2024</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="105985"/>
            <PARTNO>Part IV</PARTNO>
            <AGENCY TYPE="P">Environmental Protection Agency</AGENCY>
            <CFR>40 CFR Part 63</CFR>
            <HRULE/>
            <TITLE>Review of National Emission Standards for Hazardous Air Pollutants for Polyether Polyols Production Industry; Proposed Rule</TITLE>
        </PTITLE>
        <PRORULES>
            <PRORULE>
                <PREAMB>
                    <PRTPAGE P="105986"/>
                    <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                    <CFR>40 CFR Part 63</CFR>
                    <DEPDOC>[EPA-HQ-OAR-2023-0282; FRL-10854-01-OAR]</DEPDOC>
                    <RIN>RIN 2060-AW01</RIN>
                    <SUBJECT>Review of National Emission Standards for Hazardous Air Pollutants for Polyether Polyols Production Industry</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Environmental Protection Agency (EPA).</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Proposed rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>The U.S. Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) under the Clean Air Act (CAA) that apply to the Polyether Polyols (PEPO) Production industry (referred to as the PEPO NESHAP in this document). The EPA is proposing decisions resulting from the Agency's technology review of the PEPO NESHAP and decisions based on its reconsideration of certain issues raised in an administrative petition for reconsideration. Furthermore, the EPA is proposing to strengthen the emission standards for ethylene oxide (EtO) emissions after considering the results of a risk assessment for the PEPO NESHAP. The EPA is also proposing to require performance testing once every 5 years, to add work practice standards for certain activities where alternatives are appropriate, and to add provisions for electronic reporting. We estimate that the proposed amendments to the PEPO NESHAP, excluding the EtO emission standards, would reduce hazardous air pollutant (HAP) emissions from PEPO sources by approximately 157 tons per year (tpy). Additionally, the proposed EtO emission standards are expected to reduce EtO emissions by approximately 14 tpy. We also estimate that these proposed amendments to the NESHAP will reduce excess emissions of HAP from flares in the PEPO Production source category by an additional 75 tpy.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P/>
                        <P>
                            <E T="03">Comments.</E>
                             Comments must be received on or before February 25, 2025. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before January 27, 2025.
                        </P>
                        <P>
                            <E T="03">Public hearing.</E>
                             If anyone contacts us requesting a public hearing on or before January 3, 2025, we will hold a virtual public hearing. See 
                            <E T="02">SUPPLEMENTARY INFORMATION</E>
                             for information on requesting and registering for a public hearing.
                        </P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>You may send comments, identified by Docket ID No. EPA-HQ-OAR-2023-0282, by any of the following methods:</P>
                        <P>
                            • 
                            <E T="03">Federal eRulemaking Portal: https://www.regulations.gov</E>
                             (our preferred method). Follow the online instructions for submitting comments.
                        </P>
                        <P>
                            • 
                            <E T="03">Email: a-and-r-docket@epa.gov.</E>
                             Include Docket ID No. EPA-HQ-OAR-2023-0282 in the subject line of the message.
                        </P>
                        <P>
                            • 
                            <E T="03">Fax:</E>
                             202-566-9744. Attention Docket ID No. EPA-HQ-OAR-2023-0282.
                        </P>
                        <P>
                            • 
                            <E T="03">Mail:</E>
                             U.S. Environmental Protection Agency, EPA Docket Center, Docket ID No. EPA-HQ-OAR-2023-0282, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
                        </P>
                        <P>
                            • 
                            <E T="03">Hand/Courier Delivery:</E>
                             EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket Center's hours of operation are 8:30 a.m.-4:30 p.m., Monday-Friday (except Federal Holidays).
                        </P>
                        <P>
                            <E T="03">Instructions:</E>
                             All submissions received must include the Docket ID No. for this rulemaking. Comments received may be posted without change to 
                            <E T="03">https://www.regulations.gov/,</E>
                             including any personal information provided. For detailed instructions on sending comments and additional information on the rulemaking process, see the 
                            <E T="02">SUPPLEMENTARY INFORMATION</E>
                             section of this document.
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>
                            For questions about this proposed action, contact U.S. EPA, Attn: Ms. Johanna Klein, Mail Drop: E143-01, 109 T.W. Alexander Drive, P.O. Box 12055, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-2283; and email address: 
                            <E T="03">klein.johanna@epa.gov.</E>
                             For specific information regarding the risk modeling methodology, contact U.S. EPA, Attn: Ms. Dianna Francisco, Mail Drop: C539-02, 109 T.W. Alexander Drive, P.O. Box 12055, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-3182; and email address: 
                            <E T="03">francisco.dianna@epa.gov.</E>
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <P/>
                    <P>
                        <E T="03">Participation in virtual public hearing.</E>
                         To request a virtual public hearing, contact the public hearing team at (888) 372-8699 or by email at 
                        <E T="03">SPPDpublichearing@epa.gov.</E>
                         If requested, the hearing will be held via virtual platform. The EPA will announce the date of the hearing and further details on the virtual public hearing at 
                        <E T="03">https://www.epa.gov/stationary-sources-air-pollution/polyether-polyols-production-national-emission-standards-hazardous.</E>
                         The hearing will convene at 11:00 a.m. Eastern Time (ET) and will conclude at 4:00 p.m. ET. The EPA may close a session 15 minutes after the last pre-registered speaker has testified if there are not additional speakers.
                    </P>
                    <P>
                        The EPA will begin pre-registering speakers for the hearing no later than 1 business day after a request has been received. To register to speak at the virtual hearing, please use the online registration form available at 
                        <E T="03">https://www.epa.gov/stationary-sources-air-pollution/polyether-polyols-production-national-emission-standards-hazardous</E>
                         or contact the public hearing team at (888) 372-8699 or by email at 
                        <E T="03">SPPDpublichearing@epa.gov.</E>
                         The last day to pre-register to speak at the hearing will be January 13, 2025. Prior to the hearing, the EPA will post a general agenda that will list pre-registered speakers at: 
                        <E T="03">https://www.epa.gov/stationary-sources-air-pollution/polyether-polyols-production-national-emission-standards-hazardous.</E>
                    </P>
                    <P>The EPA will make every effort to follow the schedule as closely as possible on the day of the hearing; however, please plan for the hearings to run either ahead of schedule or behind schedule.</P>
                    <P>Each commenter will have 4 minutes to provide oral testimony. The EPA encourages commenters to submit a copy of their oral testimony as written comments to the rulemaking docket.</P>
                    <P>The EPA may ask clarifying questions during the oral presentations but will not respond to the presentations at that time. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral testimony and supporting information presented at the public hearing.</P>
                    <P>
                        Please note that any updates made to any aspect of the hearing will be posted online at 
                        <E T="03">https://www.epa.gov/stationary-sources-air-pollution/polyether-polyols-production-national-emission-standards-hazardous.</E>
                         While the EPA expects the hearing to go forward as set forth above, please monitor these websites or contact the public hearing team at (888) 372-8699 or by email at 
                        <E T="03">SPPDpublichearing@epa.gov</E>
                         to determine if there are any updates. The EPA does not intend to publish a document in the 
                        <E T="04">Federal Register</E>
                         announcing updates.
                        <PRTPAGE P="105987"/>
                    </P>
                    <P>If you require the services of a translator or a special accommodation such as audio description, please pre-register for the hearing with the public hearing team and describe your needs by January 7, 2025. The EPA may not be able to arrange accommodations without advance notice.</P>
                    <P>
                        <E T="03">Docket.</E>
                         The EPA has established a docket for this rulemaking under Docket ID No. EPA-HQ-OAR-2023-0282. All documents in the docket are listed in 
                        <E T="03">https://www.regulations.gov.</E>
                         Although listed, some information is not publicly available, 
                        <E T="03">e.g.,</E>
                         Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy. With the exception of such material, publicly available docket materials are available electronically in 
                        <E T="03">Regulations.gov</E>
                        .
                    </P>
                    <P>
                        <E T="03">Instructions.</E>
                         Direct your comments to Docket ID No. EPA-HQ-OAR-2023-0282. The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at 
                        <E T="03">https://www.regulations.gov,</E>
                         including any personal information provided, unless the comment includes information claimed to be CBI or other information whose disclosure is restricted by statute. Do not submit electronically to 
                        <E T="03">https://www.regulations.gov</E>
                         any information that you consider to be CBI or other information whose disclosure is restricted by statue. This type of information should be submitted as discussed below.
                    </P>
                    <P>
                        The EPA may publish any comment received to its public docket. Multimedia submissions (audio, video, 
                        <E T="03">etc.</E>
                        ) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (
                        <E T="03">i.e.,</E>
                         on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit 
                        <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets.</E>
                    </P>
                    <P>
                        The 
                        <E T="03">https://www.regulations.gov</E>
                         website allows you to submit your comment anonymously, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through 
                        <E T="03">https://www.regulations.gov,</E>
                         your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any digital storage media you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should not include special characters or any form of encryption and be free of any defects or viruses. For additional information about the EPA's public docket, visit the EPA Docket Center homepage at 
                        <E T="03">https://www.epa.gov/dockets.</E>
                    </P>
                    <P>
                        <E T="03">Submitting CBI.</E>
                         Do not submit information containing CBI to the EPA through 
                        <E T="03">https://www.regulations.gov/.</E>
                         Clearly mark the part or all of the information that you claim to be CBI. For CBI information on any digital storage media that you mail to the EPA, note the docket ID, mark the outside of the digital storage media as CBI, and identify electronically within the digital storage media the specific information that is claimed as CBI. In addition to one complete version of the comments that includes information claimed as CBI, you must submit a copy of the comments that does not contain the information claimed as CBI directly to the public docket through the procedures outlined in 
                        <E T="03">Instructions</E>
                         above. If you submit any digital storage media that does not contain CBI, mark the outside of the digital storage media clearly that it does not contain CBI and note the docket ID. Information not marked as CBI will be included in the public docket and the EPA's electronic public docket without prior notice. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2.
                    </P>
                    <P>
                        Our preferred method to receive CBI is for it to be transmitted electronically using email attachments, File Transfer Protocol (FTP), or other online file sharing services (
                        <E T="03">e.g.,</E>
                         Dropbox, OneDrive, Google Drive). Electronic submissions must be transmitted directly to the Office of Air Quality Planning and Standards (OAQPS) CBI Office at the email address 
                        <E T="03">oaqpscbi@epa.gov</E>
                         and, as described above, should include clear CBI markings and note the docket ID. If assistance is needed with submitting large electronic files that exceed the file size limit for email attachments, and if you do not have your own file sharing service, please email 
                        <E T="03">oaqpscbi@epa.gov</E>
                         to request a file transfer link. If sending CBI information through the postal service, please send it to the following address: U.S. EPA, Attn: OAQPS Document Control Officer, Mail Drop: C404-02, 109 T.W. Alexander Drive, P.O. Box 12055, Research Triangle Park, North Carolina 27711, Attention Docket ID No. EPA-HQ-OAR-2023-0282. The mailed CBI material should be double wrapped and clearly marked. Any CBI markings should not show through the outer envelope.
                    </P>
                    <P>
                        <E T="03">Preamble acronyms and abbreviations.</E>
                         Throughout this preamble the use of “we,” “us,” or “our” is intended to refer to the EPA. We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, the EPA defines the following terms and acronyms here:
                    </P>
                    <EXTRACT>
                        <FP SOURCE="FP-1">ACC American Chemistry Council</FP>
                        <FP SOURCE="FP-1">ACS American Community Survey</FP>
                        <FP SOURCE="FP-1">ADAF age-dependent adjustment factor</FP>
                        <FP SOURCE="FP-1">AEGL acute exposure guideline levels</FP>
                        <FP SOURCE="FP-1">AERMOD American Meteorological Society/EPA Regulatory Model dispersion modeling system</FP>
                        <FP SOURCE="FP-1">AIHA American Industrial Hygiene Association</FP>
                        <FP SOURCE="FP-1">ANSI American National Standards Institute</FP>
                        <FP SOURCE="FP-1">APCD air pollution control device</FP>
                        <FP SOURCE="FP-1">ASME American Society of Mechanical Engineers</FP>
                        <FP SOURCE="FP-1">ATSDR Agency for Toxic Substances and Disease Registry</FP>
                        <FP SOURCE="FP-1">1-BP 1-bromopropane</FP>
                        <FP SOURCE="FP-1">BACT best available control technology</FP>
                        <FP SOURCE="FP-1">BTU British thermal units</FP>
                        <FP SOURCE="FP-1">CAA Clean Air Act</FP>
                        <FP SOURCE="FP-1">CBI Confidential Business Information</FP>
                        <FP SOURCE="FP-1">CDX Central Data Exchange</FP>
                        <FP SOURCE="FP-1">CEDRI Compliance and Emissions Data Reporting Interface</FP>
                        <FP SOURCE="FP-1">CFR Code of Federal Regulations</FP>
                        <FP SOURCE="FP-1">CMAS Chemical Manufacturing Area Sources</FP>
                        <FP SOURCE="FP-1">CMPU chemical manufacturing process unit</FP>
                        <FP SOURCE="FP-1">CO carbon monoxide</FP>
                        <FP SOURCE="FP-1">
                            CO
                            <E T="52">2</E>
                             carbon dioxide
                        </FP>
                        <FP SOURCE="FP-1">DNA deoxyribonucleic acid</FP>
                        <FP SOURCE="FP-1">EAV equivalent annualized value</FP>
                        <FP SOURCE="FP-1">ECHO Enforcement and Compliance History Online</FP>
                        <FP SOURCE="FP-1">ECO extended cookout</FP>
                        <FP SOURCE="FP-1">EFR external floating roof</FP>
                        <FP SOURCE="FP-1">EIA Economic Impact Analysis</FP>
                        <FP SOURCE="FP-1">EJ environmental justice</FP>
                        <FP SOURCE="FP-1">EMACT Ethylene Production MACT</FP>
                        <FP SOURCE="FP-1">EPA Environmental Protection Agency</FP>
                        <FP SOURCE="FP-1">ERPG emergency response planning guidelines</FP>
                        <FP SOURCE="FP-1">ERT Electronic Reporting Tool</FP>
                        <FP SOURCE="FP-1">EtO ethylene oxide</FP>
                        <FP SOURCE="FP-1">FID flame ionization detector</FP>
                        <FP SOURCE="FP-1">FTIR Fourier transform infrared spectrometry</FP>
                        <FP SOURCE="FP-1">
                            GACT generally available control technologies
                            <PRTPAGE P="105988"/>
                        </FP>
                        <FP SOURCE="FP-1">HAP hazardous air pollutant(s)</FP>
                        <FP SOURCE="FP-1">HCl hydrochloric acid</FP>
                        <FP SOURCE="FP-1">HEM Human Exposure Model</FP>
                        <FP SOURCE="FP-1">HF hydrofluoric acid</FP>
                        <FP SOURCE="FP-1">HON Hazardous Organic NESHAP</FP>
                        <FP SOURCE="FP-1">HQ hazard quotient</FP>
                        <FP SOURCE="FP-1">HRVOC highly reactive volatile organic compound</FP>
                        <FP SOURCE="FP-1">ICR information collection request</FP>
                        <FP SOURCE="FP-1">IFR internal floating roof</FP>
                        <FP SOURCE="FP-1">IRIS Integrated Risk Information System</FP>
                        <FP SOURCE="FP-1">ISA Integrated Science Assessment</FP>
                        <FP SOURCE="FP-1">km kilometer</FP>
                        <FP SOURCE="FP-1">kPa kilopascals</FP>
                        <FP SOURCE="FP-1">LAER lowest achievable emission rate</FP>
                        <FP SOURCE="FP-1">lb/hr pounds per hour</FP>
                        <FP SOURCE="FP-1">LDAR leak detection and repair</FP>
                        <FP SOURCE="FP-1">LEAN Louisiana Environmental Action Network</FP>
                        <FP SOURCE="FP-1">LEL lower explosive limit</FP>
                        <FP SOURCE="FP-1">MACT maximum achievable control technology</FP>
                        <FP SOURCE="FP-1">MIR maximum individual lifetime [cancer] risk</FP>
                        <FP SOURCE="FP-1">MON Miscellaneous Organic Chemical Manufacturing NESHAP</FP>
                        <FP SOURCE="FP-1">MTVP maximum true vapor pressure</FP>
                        <FP SOURCE="FP-1">NAAQS National Ambient Air Quality Standard</FP>
                        <FP SOURCE="FP-1">NAICS North American Industry Classification System</FP>
                        <FP SOURCE="FP-1">NEI National Emissions Inventory</FP>
                        <FP SOURCE="FP-1">NESHAP national emission standards for hazardous air pollutants</FP>
                        <FP SOURCE="FP-1">NHVcz net heating value in the combustion zone gas</FP>
                        <FP SOURCE="FP-1">NHVdil net heating value dilution parameter</FP>
                        <FP SOURCE="FP-1">NHVvg net heating value in the vent gas</FP>
                        <FP SOURCE="FP-1">
                            NO
                            <E T="52">X</E>
                             nitrogen oxides
                        </FP>
                        <FP SOURCE="FP-1">NRDC Natural Resources Defense Council</FP>
                        <FP SOURCE="FP-1">NSPS new source performance standards</FP>
                        <FP SOURCE="FP-1">NTTAA National Technology Transfer and Advancement Act</FP>
                        <FP SOURCE="FP-1">OAQPS Office of Air Quality Planning and Standards</FP>
                        <FP SOURCE="FP-1">OAR Office of Air and Radiation</FP>
                        <FP SOURCE="FP-1">OLD Organic Liquids Distribution</FP>
                        <FP SOURCE="FP-1">OMB Office of Management and Budget</FP>
                        <FP SOURCE="FP-1">P&amp;R I Group I Polymers and Resins NESHAP</FP>
                        <FP SOURCE="FP-1">PDF portable document format</FP>
                        <FP SOURCE="FP-1">PEPO polyether polyol</FP>
                        <FP SOURCE="FP-1">PMPU polyether polyol manufacturing process unit</FP>
                        <FP SOURCE="FP-1">POM polycyclic organic matter</FP>
                        <FP SOURCE="FP-1">ppmv parts per million by volume</FP>
                        <FP SOURCE="FP-1">ppmw parts per million by weight</FP>
                        <FP SOURCE="FP-1">PRA Paperwork Reduction Act</FP>
                        <FP SOURCE="FP-1">psia pounds per square inch absolute</FP>
                        <FP SOURCE="FP-1">psig pounds per square inch gauge</FP>
                        <FP SOURCE="FP-1">PRD pressure relief devices</FP>
                        <FP SOURCE="FP-1">PV present value</FP>
                        <FP SOURCE="FP-1">RACT reasonably available control technology</FP>
                        <FP SOURCE="FP-1">RDL representative detection limit</FP>
                        <FP SOURCE="FP-1">REL Reference Exposure Level</FP>
                        <FP SOURCE="FP-1">RFA Regulatory Flexibility Act</FP>
                        <FP SOURCE="FP-1">RfC reference concentration</FP>
                        <FP SOURCE="FP-1">RTR Risk and Technology Review</FP>
                        <FP SOURCE="FP-1">SAB Science Advisory Board</FP>
                        <FP SOURCE="FP-1">SCAQMD South Coast Air Quality Management District</FP>
                        <FP SOURCE="FP-1">scmm standard cubic meters per minute</FP>
                        <FP SOURCE="FP-1">scf standard cubic foot</FP>
                        <FP SOURCE="FP-1">SOCMI Synthetic Organic Chemical Manufacturing Industry</FP>
                        <FP SOURCE="FP-1">
                            SO
                            <E T="52">2</E>
                             sulfur dioxide
                        </FP>
                        <FP SOURCE="FP-1">SSM startup, shutdown, and malfunction</FP>
                        <FP SOURCE="FP-1">TCEQ Texas Commission on Environmental Quality</FP>
                        <FP SOURCE="FP-1">THF tetrahydrofuran</FP>
                        <FP SOURCE="FP-1">TOC total organic compound</FP>
                        <FP SOURCE="FP-1">TOSHI target organ-specific hazard index</FP>
                        <FP SOURCE="FP-1">tpy tons per year</FP>
                        <FP SOURCE="FP-1">TRE total resource effectiveness</FP>
                        <FP SOURCE="FP-1">TRIM Total Risk Integrated Methodology</FP>
                        <FP SOURCE="FP-1">UF uncertainty factor</FP>
                        <FP SOURCE="FP-1">UMRA Unfunded Mandates Reform Act</FP>
                        <FP SOURCE="FP-1">URE unit risk estimate</FP>
                        <FP SOURCE="FP-1">U.S. United States</FP>
                        <FP SOURCE="FP-1">U.S.C. United States Code</FP>
                        <FP SOURCE="FP-1">USGS U.S. Geological Survey</FP>
                        <FP SOURCE="FP-1">VCS voluntary consensus standards</FP>
                        <FP SOURCE="FP-1">VOC volatile organic compound(s)</FP>
                        <FP SOURCE="FP-1">μg/m3 micrograms per cubic meter</FP>
                    </EXTRACT>
                    <P>
                        <E T="03">Organization of this document.</E>
                         The information in this preamble is organized as follows:
                    </P>
                    <EXTRACT>
                        <FP SOURCE="FP-2">I. General Information</FP>
                        <FP SOURCE="FP1-2">A. Does this action apply to me?</FP>
                        <FP SOURCE="FP1-2">B. Where can I get a copy of this document and other related information?</FP>
                        <FP SOURCE="FP-2">II. Background</FP>
                        <FP SOURCE="FP1-2">A. What is the statutory authority for this action?</FP>
                        <FP SOURCE="FP1-2">B. What is the source category and how do the current standards regulate its HAP emissions?</FP>
                        <FP SOURCE="FP1-2">C. What data collection activities were conducted to support this action?</FP>
                        <FP SOURCE="FP1-2">D. What other relevant background information and data are available?</FP>
                        <FP SOURCE="FP1-2">E. What outreach was conducted?</FP>
                        <FP SOURCE="FP-2">III. Analytical Procedures and Decision-Making</FP>
                        <FP SOURCE="FP1-2">A. How do we consider risk in our decision-making?</FP>
                        <FP SOURCE="FP1-2">B. How do we estimate post-MACT risk posed by the source category?</FP>
                        <FP SOURCE="FP1-2">C. How do we perform the technology review?</FP>
                        <FP SOURCE="FP1-2">D. How do we determine a MACT floor and consider beyond-the-floor?</FP>
                        <FP SOURCE="FP-2">IV. Analytical Results and Proposed Decisions</FP>
                        <FP SOURCE="FP1-2">A. What are the results of the risk assessment and analyses?</FP>
                        <FP SOURCE="FP1-2">B. What are our proposed decisions regarding risk acceptability, ample margin of safety, and adverse environmental effect?</FP>
                        <FP SOURCE="FP1-2">C. What are the results and proposed decisions based on our technology review?</FP>
                        <FP SOURCE="FP1-2">D. What actions are we taking pursuant to CAA sections 112(d)(2) and (3) and 112(h)?</FP>
                        <FP SOURCE="FP1-2">E. What other actions are we proposing?</FP>
                        <FP SOURCE="FP1-2">F. What compliance dates are we proposing?</FP>
                        <FP SOURCE="FP-2">V. Summary of Cost, Environmental, and Economic Impacts</FP>
                        <FP SOURCE="FP1-2">A. What are the affected sources?</FP>
                        <FP SOURCE="FP1-2">B. What are the air quality impacts?</FP>
                        <FP SOURCE="FP1-2">C. What are the cost impacts?</FP>
                        <FP SOURCE="FP1-2">D. What are the economic impacts?</FP>
                        <FP SOURCE="FP1-2">E. What are the benefits?</FP>
                        <FP SOURCE="FP1-2">F. What analysis of environmental justice did we conduct?</FP>
                        <FP SOURCE="FP1-2">G. What analysis of children's environmental health did we conduct?</FP>
                        <FP SOURCE="FP-2">VI. Request for Comments</FP>
                        <FP SOURCE="FP-2">VII. Submitting Data Corrections</FP>
                        <FP SOURCE="FP-2">VIII. Statutory and Executive Order Reviews</FP>
                        <FP SOURCE="FP1-2">A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094: Modernizing Regulatory Review</FP>
                        <FP SOURCE="FP1-2">B. Paperwork Reduction Act (PRA)</FP>
                        <FP SOURCE="FP1-2">C. Regulatory Flexibility Act (RFA)</FP>
                        <FP SOURCE="FP1-2">D. Unfunded Mandates Reform Act (UMRA)</FP>
                        <FP SOURCE="FP1-2">E. Executive Order 13132: Federalism</FP>
                        <FP SOURCE="FP1-2">F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments</FP>
                        <FP SOURCE="FP1-2">G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks</FP>
                        <FP SOURCE="FP1-2">H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use</FP>
                        <FP SOURCE="FP1-2">I. National Technology Transfer and Advancement Act (NTTAA) and 1 CFR Part 51</FP>
                        <FP SOURCE="FP1-2">J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations and Executive Order 14096: Revitalizing Our Nation's Commitment to Environmental Justice for All</FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">I. General Information</HD>
                    <HD SOURCE="HD2">A. Does this action apply to me?</HD>
                    <P>
                        This action applies to the PEPO Production source category (and whose facilities, sources, and processes we often refer to as “PEPO” for purposes of the NESHAP). The PEPO NESHAP is codified at 40 CFR part 63, subpart PPP. The North American Industry Classification System (NAICS) code for PEPO facilities is 325199, although this is not intended to be exhaustive but rather to provide a guide for readers regarding the entities that this proposed action is likely to affect. The proposed standards, once promulgated, will be directly applicable to the affected sources. Federal, State, local, and Tribal government entities would not be affected by this proposed action. As defined in the 
                        <E T="03">Initial List of Categories of Sources Under Section 112(c)(1) of the Clean Air Act Amendments of 1990</E>
                         (see 57 FR 31576, July 16, 1992) and 
                        <E T="03">Documentation for Developing the Initial Source Category List, Final Report</E>
                         (see EPA-450/3-91-030, July 1992), the PEPO Production source category is any facility which “manufactures these polymers by starting with cyclic ethers (
                        <E T="03">e.g.,</E>
                         oxides, epoxides) and initiating polymerization by adding ethylene oxide, butylene oxide, propylene oxide or other chemicals which would result in the potential emission of HAPs. The reaction is base-catalyzed, with potassium hydroxide being the most commonly used catalyst. The physical 
                        <PRTPAGE P="105989"/>
                        properties of the polyols are influenced primarily by the functionality of the initiator molecules and by the type and quantity of alkylene oxide and hydroxyl groups present in the polyol.” In the development of NESHAP for this source category, the EPA considered emission sources associated with equipment leaks (including leaks from heat exchange systems), process vents, storage vessels, and wastewater collection and treatment systems.
                    </P>
                    <HD SOURCE="HD2">B. Where can I get a copy of this document and other related information?</HD>
                    <P>
                        In addition to being available in the docket, an electronic copy of this action is available on the internet. In accordance with 5 U.S.C. 553(b)(4), a brief summary of this rulemaking may be found at 
                        <E T="03">https://www.regulations.gov,</E>
                         Docket ID No. EPA-HQ-OAR-2023-0282. Following signature by the EPA Administrator, the EPA will post a copy of this proposed action at 
                        <E T="03">https://www.epa.gov/stationary-sources-air-pollution/polyether-polyols-production-national-emission-standards-hazardous.</E>
                         Following publication in the 
                        <E T="04">Federal Register</E>
                        , the EPA will post the 
                        <E T="04">Federal Register</E>
                         version of the proposal and key technical documents at this same website.
                    </P>
                    <P>
                        A memorandum showing the edits that would be necessary to incorporate the changes to the PEPO NESHAP (40 CFR part 63, subpart PPP) proposed in this action is available in the docket (Docket ID No. EPA-HQ-OAR-2023-0282). Following signature by the EPA Administrator, the EPA also will post a copy of this document to 
                        <E T="03">https://www.epa.gov/stationary-sources-air-pollution/polyether-polyols-production-national-emission-standards-hazardous.</E>
                    </P>
                    <HD SOURCE="HD1">II. Background</HD>
                    <HD SOURCE="HD2">A. What is the statutory authority for this action?</HD>
                    <HD SOURCE="HD3">1. NESHAP</HD>
                    <P>
                        The statutory authority for this action is provided by sections 112 and 301 of the CAA, as amended (42 U.S.C. 7401 
                        <E T="03">et seq.</E>
                        ). Section 112 of the CAA establishes a two-stage regulatory process to develop standards for emissions of HAP from stationary sources. Generally, the first stage involves establishing technology-based standards and the second stage involves evaluating those standards that are based on maximum achievable control technology (MACT) to determine whether additional standards are needed to address any remaining risk associated with HAP emissions. This second stage is commonly referred to as the “residual risk review.” In addition to the residual risk review, the CAA also requires the EPA to review standards set under CAA section 112 every 8 years and revise the standards as necessary taking into account any “developments in practices, processes, or control technologies.” This review is commonly referred to as the “technology review.” When the two reviews are combined into a single rulemaking, it is commonly referred to as the “risk and technology review.” The discussion that follows identifies the most relevant statutory sections and briefly explains the contours of the methodology used to implement these statutory requirements. A more comprehensive discussion appears in the document titled 
                        <E T="03">CAA Section 112 Risk and Technology Reviews: Statutory Authority and Methodology,</E>
                         in the docket for this rulemaking.
                    </P>
                    <P>In the first stage of the CAA section 112 standard setting process, the EPA promulgates technology-based standards under CAA section 112(d) for categories of sources listed under section 112(c) and identified as emitting one or more of the HAP listed in CAA section 112(b). Sources of HAP emissions are either major sources or area sources, and CAA section 112 establishes different requirements for major source standards and area source standards. “Major sources” are those that emit or have the potential to emit 10 tpy or more of a single HAP or 25 tpy or more of any combination of HAP. All other sources are “area sources.” For major sources, CAA section 112(d)(2) provides that the technology-based NESHAP must reflect the maximum degree of emission reductions of HAP achievable (after considering cost, energy requirements, and non-air quality health and environmental impacts). These standards are commonly referred to as MACT standards. CAA section 112(d)(3) also establishes a minimum control level for MACT standards, known as the MACT “floor,” that the EPA must establish without consideration of costs. Under CAA section 112(d)(2), the EPA must also consider control options that are more stringent than the floor, taking into consideration costs, non-air quality health and environmental impacts, and energy requirements. Standards more stringent than the floor are commonly referred to as “beyond-the-floor” or “BTF” standards. In certain instances, as provided in CAA section 112(h), the EPA may set work practice standards in lieu of numerical emission standards. For area sources, CAA section 112(d)(5) gives the EPA discretion to set standards based on generally available control technologies or management practices (GACT standards) in lieu of MACT standards.</P>
                    <P>
                        The second stage in standard-setting focuses on identifying and addressing any remaining 
                        <E T="03">(i.e.,</E>
                         “residual”) risk pursuant to CAA section 112(f). For source categories subject to MACT standards, section 112(f)(2) of the CAA requires the EPA to determine whether promulgation of additional standards is needed to provide an ample margin of safety to protect public health or to prevent an adverse environmental effect. Section 112(d)(5) of the CAA provides that this residual risk review is not required for categories of area sources subject to GACT standards. Section 112(f)(2)(B) of the CAA further expressly preserves the EPA's use of the two-step approach for developing standards to address any residual risk and the Agency's interpretation of “ample margin of safety” developed in the 
                        <E T="03">National Emissions Standards for Hazardous Air Pollutants: Benzene Emissions from Maleic Anhydride Plants, Ethylbenzene/Styrene Plants, Benzene Storage Vessels, Benzene Equipment Leaks, and Coke By-Product Recovery Plants</E>
                         (Benzene NESHAP) (54 FR 38044, September 14, 1989). The EPA notified Congress in the Residual Risk Report that the Agency intended to use the Benzene NESHAP approach in making CAA section 112(f) residual risk determinations (EPA-453/R-99-001, p. ES-11). The EPA subsequently adopted this approach in its residual risk determinations and the United States Court of Appeals for the District of Columbia Circuit affirmed that CAA section 112(f)(2) incorporates the approach established in the Benzene NESHAP. 
                        <E T="03">See Natural Resources Defense Council (NRDC)</E>
                         v. 
                        <E T="03">EPA,</E>
                         529 F.3d 1077, 1083 (D.C. Cir. 2008).
                    </P>
                    <P>
                        The approach incorporated into the CAA and used by the EPA to evaluate residual risk and to develop standards under CAA section 112(f)(2) is a two-step approach. In the first step, the EPA determines whether risks are acceptable. This determination “considers all health information, including risk estimation uncertainty, and includes a presumptive limit on maximum individual lifetime [cancer] risk (MIR) 
                        <SU>1</SU>
                        <FTREF/>
                         of approximately 1 in 10 thousand.” (54 FR 38045). If risks are unacceptable, the EPA must determine the emissions standards necessary to reduce risk to an acceptable level without considering costs. In the second step of the approach, the EPA 
                        <PRTPAGE P="105990"/>
                        considers whether the emissions standards provide an ample margin of safety to protect public health “in consideration of all health information, including the number of persons at risk levels higher than approximately 1 in 1 million, as well as other relevant factors, including costs and economic impacts, technological feasibility, and other factors relevant to each particular decision.” 
                        <E T="03">Id.</E>
                         The EPA must promulgate emission standards necessary to provide an ample margin of safety to protect public health or determine that the standards being reviewed provide an ample margin of safety without any revisions. After conducting the ample margin of safety analysis, we consider whether a more stringent standard is necessary to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect.
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             Although defined as “maximum individual risk,” MIR refers only to cancer risk. MIR, one metric for assessing cancer risk, is the estimated risk if an individual were exposed to the maximum level of a pollutant for a lifetime.
                        </P>
                    </FTNT>
                    <P>
                        CAA section 112(d)(6) separately requires the EPA to review standards promulgated under CAA section 112 and revise them “as necessary (taking into account developments in practices, processes, and control technologies)” no less often than every 8 years. In conducting this review, which we call the “technology review,” the EPA is not required to recalculate the MACT floors that were established during earlier rulemakings. 
                        <E T="03">NRDC</E>
                         v. 
                        <E T="03">EPA,</E>
                         529 F.3d at 1084 (D.C. Cir. 2008); 
                        <E T="03">Association of Battery Recyclers, Inc.</E>
                         v. 
                        <E T="03">EPA,</E>
                         716 F.3d 667 (D.C. Cir. 2013). The EPA may consider cost in deciding whether to revise the standards pursuant to CAA section 112(d)(6). The EPA is required to address regulatory gaps, such as missing MACT standards for listed air toxics known to be emitted from the source category. 
                        <E T="03">Louisiana Environmental Action Network (LEAN)</E>
                         v. 
                        <E T="03">EPA,</E>
                         955 F.3d 1088 (D.C. Cir. 2020).
                    </P>
                    <P>The EPA conducted a residual risk and technology review (RTR) for the PEPO NESHAP in 2014, concluding that there was no need to revise the PEPO NESHAP under the provisions of either CAA sections 112(f) or (d)(6). However, the EPA did address emissions during periods of startup, shutdown, and malfunction (SSM), including from pressure relief devices (PRDs) in organic HAP service that release to the atmosphere, and also required electronic reporting of performance test results (see 79 FR 17340, March 27, 2014). As part of the 2014 residual risk review, the EPA conducted a risk assessment, and based on the results of the risk assessment, determined that the then current level of control called for by the existing MACT standards both reduced HAP emissions to levels that presented an acceptable level of risk and provided an ample margin of safety to protect public health.</P>
                    <P>
                        This action constitutes another CAA section 112(d)(6) technology review for the PEPO NESHAP. This action also constitutes an updated CAA section 112(f) risk review based on new information for the PEPO NESHAP. As noted above, CAA section 112(f)(2)(A) requires the EPA to promulgate standards that “provide an ample margin of safety to protect public health” and prevent “an adverse environmental effect.” While CAA section 112(f) does not require the EPA to periodically revisit a residual risk review, neither does it preclude the EPA from exercising its inherent authority to revisit a previous regulatory decision where new scientific, technical, or other relevant information indicates such action is warranted. Moreover, the Act does include a gap-filling provision that reinforces the authority for the EPA to do so. CAA section 301(a)(1) provides authority to the Administrator “to prescribe such regulations as are necessary to carry out his functions” under the CAA. Such authority extends to the EPA's discretion to revisit its section 112(f) residual risk review where the Agency deems warranted. 
                        <E T="03">See NRDC</E>
                         v. 
                        <E T="03">EPA,</E>
                         22 F.3d 1125, 1148 (D.C. Cir. 1994) (“[Section 301] is sufficiently broad to allow the promulgation of rules that are necessary and reasonable to effect the purposes of the Act.”). We note that although there is no statutory CAA obligation under CAA section 112(f) for the EPA to conduct a second residual risk review of the PEPO NESHAP, the EPA retains discretion to revisit its residual risk reviews where the Agency deems that it is warranted. 
                        <E T="03">See, e.g., Fed. Commc'ns Comm'n</E>
                         v. 
                        <E T="03">Fox Television Stations, Inc.,</E>
                         556 U.S. 502, 515 (2009); 
                        <E T="03">Motor Vehicle Mfrs. Ass'n</E>
                         v. 
                        <E T="03">State Farm Mut. Auto. Ins. Co.,</E>
                         463 U.S. 29, 42 (1983); 
                        <E T="03">Ethylene Oxide Emissions Standards for Sterilization Facilities; Final Decision,</E>
                         71 FR 17712, 17715 col. 1 (April 7, 2006) (in the 2006 residual risk review of the EtO emissions standards for sterilization facilities, the EPA asserted its “authority to revisit (and revise, if necessary) any rulemaking if there is sufficient evidence that changes within the affected industry or significant improvements to science suggests the public is exposed to significant increases in risk as compared to the risk assessment prepared for the rulemaking (
                        <E T="03">e.g.,</E>
                         CAA section 301).”). Here, the specific changes to health information related to a certain pollutant emitted by the PEPO Production source category led us to determine that it is appropriate, in this case, to conduct this second residual risk review under CAA section 112(f). In particular, the EPA is concerned about the cancer risks posed from the PEPO Production source category based on the EPA's 2016 updated Integrated Risk Information System (IRIS) inhalation unit risk estimate (URE) for EtO, which shows EtO to be significantly more toxic than previously known.
                        <SU>2</SU>
                        <FTREF/>
                         The EPA's 2014 RTR could not have had the benefit of this updated URE at the time it was conducted, but if it had the RTR would have necessarily resulted in different conclusions about risk acceptability and the PEPO NESHAP's provision of an ample margin of safety to protect public health. To ensure our standards provide an ample margin of safety to protect public health following the new IRIS inhalation URE for EtO, we are exercising our discretion and conducting a risk assessment in this action for PEPO Production sources. In sum, even though we do not have a mandatory duty to conduct repeated residual risk reviews under CAA sections 112(f)(2) and 301(a)(1), we have the authority to revisit any rulemaking if there is sufficient evidence of changes within the affected industry or significant new scientific information suggesting the public is exposed to higher risks than previously understood. Our conducting a discretionary second residual risk review for the PEPO Production source category to account for the new IRIS inhalation URE for EtO is consistent with recent similar actions regarding other source categories. See 89 FR 24090, April 5, 2024, and 89 FR 42932, May 16, 2024.
                    </P>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             U.S. EPA. 
                            <E T="03">Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (CASRN 75-21-8) In Support of Summary Information on the Integrated Risk Information System (IRIS).</E>
                             December 2016. EPA/635/R-16/350Fa. Available at: 
                            <E T="03">https://cfpub.epa.gov/ncea/iris/iris_documents/documents/toxreviews/1025tr.pdf.</E>
                             See also, 87 FR 77985 (Dec. 21, 2022), 
                            <E T="03">Reconsideration of the 2020 National Emission Standards for Hazardous Air Pollutants: Miscellaneous Organic Chemical Manufacturing Residual Risk and Technology Review,</E>
                             Final action; reconsideration of the final rule.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Petition for Reconsideration</HD>
                    <P>
                        In addition to the proposed action under sections 112 and 301 of the CAA described above, this action includes proposed amendments to the PEPO NESHAP based on the EPA's reconsideration of certain aspects of the NESHAP that were raised in an administrative petition submitted pursuant to section 307(d)(7)(B) of the CAA. In May 2014, the EPA received one petition for reconsideration of the PEPO NESHAP (40 CFR part 63, subpart 
                        <PRTPAGE P="105991"/>
                        PPP), Pesticide Active Ingredient Production NESHAP (40 CFR part 63, subpart MMM), and Group IV Polymers and Resins NESHAP (40 CFR part 63, subpart JJJ) pursuant to CAA section 307(d)(7)(B) from the Louisiana Environmental Action Network, Ohio Valley Environmental Coalition, and Sierra Club. A copy of the petition and subsequent EPA correspondence granting reconsideration is provided in the docket for this rulemaking (see Docket No. EPA-HQ-OAR-2023-0282).
                    </P>
                    <P>
                        For the PEPO NESHAP, the petitioners requested that the EPA: (1) remove the affirmative defense provisions from the rules in light of the court opinion in 
                        <E T="03">Natural Resources Defence Council</E>
                         v. 
                        <E T="03">EPA</E>
                         (D.C. Cir. April 18, 2014); (2) provide adequate opportunity to comment on the requirements associated with emissions from PRDs (including associated compliance dates, the EPA's decision to not specifically require electronic indicators and alarms to monitor PRD releases to the atmosphere, and the standard's applicability to PRDs in organic HAP service versus PRDs in total HAP service); (3) redo the risk assessment using updated emission factors; (4) set additional monitoring requirements for flares to reduce flaring emissions; (5) set fenceline monitoring requirements; (6) reconsider its decision not to set standards that account for developments in leak detection and repair (LDAR); and (7) use existing regulatory authority to strengthen chemical facility safety and prevent accidents in accordance with the U.S. Chemical Safety and Hazard Investigation Board and Executive Order 13650. On August 26, 2014, the EPA sent a letter to the petitioners informing them that the EPA was granting their request for reconsideration at least on issues (1) and (2) above. A copy of the August 26, 2014, letter is provided in the docket for this rulemaking (see Docket No. EPA-HQ-OAR-2023-0282). In the letter, the EPA also indicated that it would be initiating a notice and comment rulemaking on the issues for which we granted reconsideration; therefore, one purpose of this action is to formally respond to the issues raised in the petition with respect to the PEPO NESHAP.
                        <SU>3</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             Although the issues identified in this paragraph (in addition to one other issue related to alternative compliance demonstration methods for periods of startup and shutdown) were also raised for 40 CFR part 63, subparts JJJ and MMM; this action does not respond to the reconsideration of these NESHAP, as the EPA is not reviewing these subparts in this action.
                        </P>
                    </FTNT>
                    <P>In a separate rulemaking (see 89 FR 52425, June 24, 2024), the EPA is addressing issue (1), the affirmative defense against civil penalties for violations occurring during malfunctions. That separate rulemaking removes affirmative defense provisions from both NSPS and NESHAP rules, including the PEPO NESHAP. Therefore, this proposed action does not address removal of the affirmative defense provisions.</P>
                    <P>This action presents the EPA's proposed revisions to the PEPO NESHAP based on the EPA's reconsideration of issue (2) in the petition (see section IV.E.1 of this preamble for details about these proposed amendments). Coincidentally, we also believe this action addresses issues (3), (4), (5), and (6) in our normal course of review of the PEPO NESHAP in accordance with sections 112 and 301 of the CAA. See sections IV.A and IV.B of this preamble for our proposed decisions relvant to issue (3), section IV.D.1 of this preamble for our proposed decisions relevant to issue (4), section IV.C.6 of this preamble for our proposed decisions relevant to issue (5), and sections IV.B.2.b and IV.C.5 of this preamble for our proposed decisions relevant to issue (6). With regard to issue (7), the EPA's authority to address catastrophic releases under the NESHAP program was viewed as limited under the pre-1990 CAA. Congress added CAA section 112(r) to address this gap. In light of the extensive history and efforts of the agency on inherently safer technology specifically and catastrophic accidents generally under the section 112(r) program, and in light of the statutory structure of section 112, we view the request to enact such provisions in this rulemaking to be outside the scope of section 112(f)(2) and section 112(d)(6). We note that the EPA's regulations on catastrophic releases appear in 40 CFR part 68. Prompted by Executive Order 13650, “Improving Chemical Facility Safety and Security,” the Risk Management Program regulations were amended on January 13, 2017, to include new provisions on safer technology and alternatives analysis and other prevention program elements; most recently, the regulations were amended on March 11, 2024, to further enhance the accident prevention and emergency preparedness requirements (89 FR 17622).</P>
                    <HD SOURCE="HD2">B. What is the source category and how do the current standards regulate its HAP emissions?</HD>
                    <P>
                        The source category that is the subject of this proposal is the PEPO Production source category subject to the PEPO NESHAP. The EPA promulgated the PEPO NESHAP on June 1, 1999 (64 FR 29420), and codified the NESHAP at 40 CFR part 63, subpart PPP. As promulgated in 1999, and further amended on July 1, 2004 (69 FR 39862) and March 27, 2014 (59 FR 17340), the PEPO NESHAP regulates HAP emissions from polyether polyol manufacturing process units (PMPUs) that produce PEPO as its primary product.
                        <E T="51">4 5</E>
                        <FTREF/>
                         A PMPU consists of purification systems, reactors and their associated product separators and recovery devices, distillation units and their associated distillate receivers and recovery devices, other associated unit operations, storage vessels, surge control vessels, bottoms receivers, product transfer racks, connected ducts and piping, combustion, recovery, or recapture devices or systems. A PMPU also includes pumps, compressors, agitators, PRDs, sampling connection systems, open-ended valves or lines, valves, connectors, and instrumentation systems.
                    </P>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             PEPO are compounds formed through the polymerization of EtO or propylene oxide or other cyclic ethers with compounds having one or more reactive hydrogens (
                            <E T="03">i.e.,</E>
                             a hydrogen atom bonded to nitrogen, oxygen, phosphorus, sulfur, 
                            <E T="03">etc.</E>
                            ) to form polyethers (
                            <E T="03">i.e.,</E>
                             compounds with two or more ether bonds). This definition of PEPO excludes cellulose ethers (such as methyl cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxy ethyl cellulose, and hydroxypropyl methyl cellulose) and materials regulated under the HON, such as glycols and glycol ethers.
                        </P>
                        <P>
                            <SU>5</SU>
                             A PMPU also includes flexible operation process units when an owner or operator cannot determine that a PEPO is not the primary product, and a PEPO is produced or anticipated to be produced during time spans described in 40 CFR 63.1420(e)(2).
                        </P>
                    </FTNT>
                    <P>
                        PEPO are used to make a variety of other products including lubricants, adhesives, sealants, cosmetics, pharmaceuticals, soaps, and a feedstock for polyurethanes production. Urethane grade PEPO (
                        <E T="03">i.e.,</E>
                         those that are free of water) are used as raw material in the production of polyurethanes, including slabstock and molded flexible foams, rigid foams and other polyurethanes, including microcellular products, surface coatings, elastomers, fibers, adhesives, and sealants.
                    </P>
                    <P>
                        PEPO can be produced by either polymerization of epoxides (
                        <E T="03">i.e.,</E>
                         a three-membered cyclic ether, such as EtO or propylene oxide) or tetrahydrofuran (THF). The former process is usually conducted as a batch process, while production of polyols using THF is generally a continuous process. EtO and propylene oxide are both HAP, but THF is not. For the MACT regulation, the EPA created two subcategories of PEPO based on the use of either epoxides or THF in polymerization.
                        <PRTPAGE P="105992"/>
                    </P>
                    <P>The HAP emission sources at PEPO facilities include process vents, storage vessels, equipment leaks, and wastewater. Additionally, some facilities have cooling towers or other heat exchangers which could become HAP emission sources if process fluids leak into the heat exchange water. In the production of PEPO, HAP are used primarily as reactants or extraction solvents. HAP emitted from PEPO facilities include EtO, propylene oxide, toluene, methanol, and glycol ethers. The MACT standards for PEPO production include emission limits for process vents; a combination of equipment standards and work practices for storage vessels, wastewater, and equipment leaks; and work practice standards for cooling towers.</P>
                    <P>
                        As of March 1, 2024, the EPA identified 25 PEPO facilities in operation that are subject to the PEPO NESHAP. The list of facilities located in the United States that are part of the PEPO Production source category with processes subject to the PEPO NESHAP is presented in the document titled 
                        <E T="03">List of Facilities Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this action (Docket ID No. EPA-HQ-OAR-2023-0282).
                    </P>
                    <HD SOURCE="HD2">C. What data collection activities were conducted to support this action?</HD>
                    <P>
                        The EPA used several data sources to determine the facilities that are subject to the PEPO NESHAP discussed in section II.B of this preamble. We identified facilities in the 2017 National Emissions Inventory (NEI) and the Toxics Release Inventory system having a primary facility NAICS code beginning with 325, Chemical Manufacturing. We also used information from the 2014 PEPO NESHAP RTR, other facility lists from the EPA's recent chemical sector rulemakings (
                        <E T="03">e.g.,</E>
                         HON), and the Office of Enforcement and Compliance Assurance's Enforcement and Compliance History Online (ECHO) tool (
                        <E T="03">https://echo.epa.gov</E>
                        ). To inform our reviews of the Agency's emission standards, we reviewed the EPA's Reasonably Available Control Technology (RACT)/Best Available Control Technology (BACT)/Lowest Achievable Emission Rate (LAER) Clearinghouse and regulatory development efforts for similar sources published after the PEPO NESHAP was developed. The EPA also reviewed air emissions permits issued by State regulatory agencies to determine facilities subject to the PEPO NESHAP. Additionally, we met with industry representatives from the American Chemistry Council (ACC) to collect data and discuss industry practices.
                    </P>
                    <P>
                        In January 2022, the EPA issued requests, pursuant to CAA section 114, to collect information from synthetic organic chemical manufacturing industry (SOCMI) facilities subject to the hazardous organic NESHAP (HON) at 40 CFR part 63, subparts F, G, and H (nine facilities being also subject to the PEPO NESHAP) owned and operated by eight entities (
                        <E T="03">i.e.,</E>
                         corporations). Many of the entities chosen for the CAA section 114 request own or operate facilities that produce, use, and emit EtO, which is a pollutant with considerable concern for cancer risk for the PEPO Production source category. This CAA section 114 request focused on gathering comprehensive information about process equipment, control technologies, point and fugitive emissions, and other aspects of facility operations. Additionally, the EPA requested stack testing for certain emission sources (
                        <E T="03">e.g.,</E>
                         pollutants for vent streams associated with each EtO production line). Also, the EPA required, as part of the January 2022 CAA section 114 request, that facilities conduct fugitive emission testing (
                        <E T="03">i.e.,</E>
                         fenceline monitoring) for any of six specific HAP they emit: benzene; 1,3-butadiene; chloroprene; EtO; ethylene dichloride; and vinyl chloride. Companies submitted responses (and follow-up responses) and testing results to the EPA during the summer and fall of 2022. The EPA used the collected information to fill data gaps, establish the baseline emissions and control levels for purposes of the regulatory reviews, identify the most effective control measures, and estimate the public health and environmental and cost impacts associated with the regulatory options considered and reflected in this proposed action. The information not claimed as CBI by respondents is available in the document titled 
                        <E T="03">Data Received from Information Collection Request for Chemical Manufacturers,</E>
                         in the docket for this action, Docket ID No. EPA-HQ-OAR-2023-0282.
                    </P>
                    <HD SOURCE="HD2">D. What other relevant background information and data are available?</HD>
                    <P>
                        As mentioned above, this action includes proposed amendments to the current flare requirements in the PEPO NESHAP. In proposing these amendments, we relied on certain technical reports and memoranda that the EPA developed for flares used as air pollution control devices (APCDs) in the Petroleum Refinery Sector RTR and new source performance standards (NSPS) rulemaking (80 FR 75178, December 1, 2015). The Petroleum Refinery Sector rulemaking docket is at Docket ID No. EPA-HQ-OAR-2010-0682. For completeness of the rulemaking record for this action and for ease of reference in finding these items in the publicly available Petroleum Refinery Sector rulemaking docket, we are including the most relevant flare-related technical support documents in the docket for this proposed action (Docket ID No. EPA-HQ-OAR-2023-0282) and including a list of all documents used to inform the 2015 flare provisions in the Petroleum Refinery Sector RTR and NSPS rulemaking in the document titled 
                        <E T="03">Control Option Impacts for Flares in the PEPO Production Source Category that Control Emissions from Processes Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <P>We are also relying on data gathered to support the rulemakings for the EMACT standards, HON, and MON, as well as memoranda documenting the technology reviews for those processes. Many of the emission sources for ethylene production facilities, HON facilities, and MON facilities are similar to PEPO facilities, so the EPA analyzed several control options for the PEPO NESHAP that the Agency also analyzed for the rulemakings for the EMACT standards, HON, and MON. The memoranda and background technical information can be found in the Ethylene Production RTR rulemaking docket (Docket ID No. EPA-HQ-OAR-2017-0357), the HON rulemaking docket (Docket ID No. EPA-HQ-OAR-2022-0730), and the MON RTR rulemaking docket (Docket ID No. EPA-HQ-OAR-2018-0746). Additional information related to the promulgation and subsequent amendments of the PEPO NESHAP is available in Docket ID Nos. A-96-38, EPA-HQ-OAR-2004-0467, and EPA-HQ-OAR-2011-0435.</P>
                    <HD SOURCE="HD2">E. What outreach was conducted?</HD>
                    <P>
                        We conducted pre-proposal outreach by sharing an overview of the industry and planned rulemaking to the EPA's national environmental justice (EJ) engagement call on August 20, 2024, and the EPA's monthly call with the National Tribal Air Association on August 31, 2023, and August 29, 2024. We also met with members of the ACC on August 13, 2024. The EPA also previously engaged in outreach activities with communities we expected to be impacted by chemical plants emitting EtO in 2021.
                        <SU>6</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             
                            <E T="03">https://www.epa.gov/hazardous-air-pollutants-ethylene-oxide/inspector-general-follow-ethylene-oxide-0.</E>
                        </P>
                    </FTNT>
                    <PRTPAGE P="105993"/>
                    <HD SOURCE="HD1">III. Analytical Procedures and Decision-Making</HD>
                    <HD SOURCE="HD2">A. How do we consider risk in our decision-making?</HD>
                    <P>
                        As discussed in section II.A of this preamble and in the Benzene NESHAP, in evaluating and developing standards under CAA section 112(f)(2), we apply a two-step approach to determine whether or not risks are acceptable and to determine if the standards provide an ample margin of safety to protect public health. As explained in the Benzene NESHAP, “the first step judgment on acceptability cannot be reduced to any single factor” and, thus, “[t]he Administrator believes that the acceptability of risk under section 112 is best judged on the basis of a broad set of health risk measures and information.” (54 FR 38046). Similarly, with regard to the ample margin of safety determination, “the Agency again considers all of the health risk and other health information considered in the first step. Beyond that information, additional factors relating to the appropriate level of control will also be considered, including cost and economic impacts of controls, technological feasibility, uncertainties, and any other relevant factors.” 
                        <E T="03">Id.</E>
                    </P>
                    <P>
                        The Benzene NESHAP approach provides flexibility regarding factors the EPA may consider in making determinations and how the EPA may weigh those factors for each source category. The EPA conducts a risk assessment that provides estimates of the MIR posed by emissions of HAP that are carcinogens from each source in the source category, the hazard index (HI) for chronic exposures to HAP with the potential to cause noncancer health effects, and the hazard quotient (HQ) for acute exposures to HAP with the potential to cause noncancer health effects.
                        <SU>7</SU>
                        <FTREF/>
                         The assessment also provides estimates of the distribution of cancer risk within the exposed populations, cancer incidence, and an evaluation of the potential for an adverse environmental effect. The scope of the EPA's risk analysis is consistent with the explanation in the EPA's response to comments on our policy under the 1989 Benzene NESHAP:
                    </P>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             The MIR is defined as the cancer risk associated with a lifetime of exposure at the highest concentration of HAP where people are likely to live. The HQ is the ratio of the potential HAP exposure concentration to the noncancer dose-response value; the HI is the sum of HQs for HAP that affect the same target organ or organ system.
                        </P>
                    </FTNT>
                    <EXTRACT>
                        <P>
                            The policy chosen by the Administrator permits consideration of multiple measures of health risk. Not only can the MIR figure be considered, but also incidence, the presence of non-cancer health effects, and the uncertainties of the risk estimates. In this way, the effect on the most exposed individuals can be reviewed as well as the impact on the general public. These factors can then be weighed in each individual case. This approach complies with the 
                            <E T="03">Vinyl Chloride</E>
                             mandate that the Administrator ascertain an acceptable level of risk to the public by employing his expertise to assess available data. It also complies with the Congressional intent behind the CAA, which did not exclude the use of any particular measure of public health risk from the EPA's consideration with respect to CAA section 112 regulations, and thereby implicitly permits consideration of any and all measures of health risk which the Administrator, in his judgment, believes are appropriate to determining what will “protect the public health”.
                        </P>
                    </EXTRACT>
                    <P>
                        (54 FR 38057). Thus, the level of the MIR is only one factor to be weighed in determining acceptability of risk. The Benzene NESHAP explained that “an MIR of approximately one in 10 thousand should ordinarily be the upper end of the range of acceptability. As risks increase above this benchmark, they become presumptively less acceptable under CAA section 112, and would be weighed with the other health risk measures and information in making an overall judgment on acceptability. Or, the Agency may find, in a particular case, that a risk that includes an MIR less than the presumptively acceptable level is unacceptable in the light of other health risk factors.” 
                        <E T="03">Id.</E>
                         at 38045. In other words, risks that include an MIR above 100-in-1 million (1-in-10 thousand) may be determined to be acceptable, and risks with an MIR below that level may be determined to be unacceptable, depending on all of the available health information. Similarly, with regard to the ample margin of safety analysis, the EPA stated in the 1989 Benzene NESHAP that: “EPA believes the relative weight of the many factors that can be considered in selecting an ample margin of safety can only be determined for each specific source category. This occurs mainly because technological and economic factors (along with the health-related factors) vary from source category to source category.” 
                        <E T="03">Id.</E>
                         at 38061. We also consider the uncertainties associated with the various risk analyses, as discussed earlier in this preamble, in our determinations of acceptability and ample margin of safety.
                    </P>
                    <P>The EPA notes that it has not considered certain health information to date in making residual risk determinations. At this time, we do not attempt to quantify the HAP risk that may be associated with emissions from other facilities that do not include the source category under review, mobile source emissions, natural source emissions, persistent environmental pollution, or atmospheric transformation in the vicinity of the sources in the category.</P>
                    <P>
                        The EPA understands the potential importance of considering an individual's total exposure to HAP in addition to considering exposure to HAP emissions from the source category and facility. We recognize that such consideration may be particularly important when assessing noncancer risk, where pollutant-specific exposure health reference levels (
                        <E T="03">e.g.,</E>
                         reference concentrations (RfCs)) are based on the assumption that thresholds exist for adverse health effects. For example, the EPA recognizes that, although exposures attributable to emissions from a source category or facility alone may not indicate the potential for increased risk of adverse noncancer health effects in a population, the exposures resulting from emissions from the facility in combination with emissions from all of the other sources (
                        <E T="03">e.g.,</E>
                         other facilities) to which an individual is exposed may be sufficient to result in an increased risk of adverse noncancer health effects. In May 2010, the Science Advisory Board (SAB) advised the EPA “that RTR assessments will be most useful to decision makers and communities if results are presented in the broader context of aggregate and cumulative risks, including background concentrations and contributions from other sources in the area.” 
                        <SU>8</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             Recommendations of the SAB Risk and Technology Review Methods Panel are provided in their report, which is available at: 
                            <E T="03">https://www.epa.gov/sites/default/files/2021-02/documents/epa-sab-10-007-unsigned.pdf.</E>
                        </P>
                    </FTNT>
                    <P>In response to the SAB recommendations, the EPA incorporates cumulative risk analyses into its RTR risk assessments. The Agency: (1) conducts facility-wide assessments, which include source category emission points, as well as other emission points within the facilities; (2) combines exposures from multiple sources in the same category that could affect the same individuals; and (3) for some persistent and bioaccumulative pollutants, analyzes the ingestion route of exposure. In addition, the RTR risk assessments consider aggregate cancer risk from all carcinogens and aggregated noncancer HQs for all noncarcinogens affecting the same target organ or target organ system.</P>
                    <P>
                        Although we are interested in placing source category and facility-wide HAP risk in the context of total HAP risk from all sources combined in the 
                        <PRTPAGE P="105994"/>
                        vicinity of each source, we are concerned about the uncertainties of doing so. Estimates of total HAP risk from emission sources other than those that we have studied in depth during this RTR review would have significantly greater associated uncertainties than the source category or facility-wide estimates. While we evaluated the risk from HAP emitted by all stationary point sources near facilities within this source category in the community-based risk assessment, that assessment is intended to provide additional context to the public and was not used for decision-making in this proposed rule.
                    </P>
                    <HD SOURCE="HD2">B. How do we estimate post-MACT risk posed by the source category?</HD>
                    <P>In this section, we provide a complete description of the types of analyses that we generally perform during the risk assessment process. In some cases, we do not perform a specific analysis because it is not relevant. For example, in the absence of emissions of HAP known to be persistent and bioaccumulative in the environment (PB-HAP), we would not perform a multipathway exposure assessment. Where we do not perform an analysis, we state that we do not and provide the reason. While we present all of our risk assessment methods, we only present risk assessment results for the analyses actually conducted (see section IV.A of this preamble).</P>
                    <P>
                        The EPA conducts a risk assessment that provides estimates of the MIR for cancer posed by the HAP emissions from each source in the source category, the HI for chronic exposures to HAP with the potential to cause noncancer health effects, and the HQ for acute exposures to HAP with the potential to cause noncancer health effects. The assessment also provides estimates of the distribution of cancer risk within the exposed populations, cancer incidence, and an evaluation of the potential for an adverse environmental effect. The nine sections that follow this paragraph describe how we estimated emissions and conducted the risk assessment. The docket for this rulemaking contains the following document which provides more information on the risk assessment inputs and models: 
                        <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule.</E>
                         The methods used to assess risk (as described in the nine primary steps below) are consistent with those described by the EPA in the document reviewed by a panel of the EPA's SAB in 2009; 
                        <SU>9</SU>
                        <FTREF/>
                         and described in the SAB review report issued in 2010. They are also consistent with the key recommendations contained in that report.
                    </P>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             U.S. EPA. 
                            <E T="03">Risk and Technology Review (RTR) Risk Assessment Methodologies: For Review by the EPA's Science Advisory Board with Case Studies—MACT I Petroleum Refining Sources and Portland Cement Manufacturing,</E>
                             June 2009. EPA-452/R-09-006. 
                            <E T="03">https://www3.epa.gov/airtoxics/rrisk/rtrpg.html.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. How did we estimate actual emissions and identify the emissions release characteristics?</HD>
                    <P>
                        As previously discussed, we updated the risk assessment in this action for the PEPO Production source category because the source category has sources that emit EtO. The EPA developed the list of 25 facilities for the PEPO Production source category as described in section II.B of this preamble. We developed the emissions modeling input files using the EPA's 2017 NEI. However, in a few instances where facility-specific data were not available or not reflective of current controls in the 2017 NEI, we obtained data from a more recent dataset (
                        <E T="03">e.g.,</E>
                         review of emissions inventory data from our CAA section 114 request, more recent inventories submitted to States, or 2018 NEI). The EPA also used the NEI data to develop the other parameters needed to perform the risk modeling analysis including the emissions release characteristics, such as stack heights, stack diameters, volumetric flow rates, temperatures, and emission release point locations. For further details on the assumptions and methodologies used to estimate actual emissions, see appendix 1 of the document titled 
                        <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <HD SOURCE="HD3">2. How did we estimate MACT-allowable emissions?</HD>
                    <P>The available emissions data in the RTR emissions dataset include estimates of the mass of HAP emitted during a specified annual time period. These “actual” emission levels are often lower than the emission levels allowed under the requirements of the current MACT standards. The emissions allowed under the MACT standards are referred to as the “MACT-allowable” emissions. We discussed the consideration of both MACT-allowable and actual emissions in the 2005 final RTR for Coke Oven Batteries (70 FR 19992, 19998-99, April 15, 2005) and in the 2006 proposed and final RTR for the HON (71 FR 34421, 34428, June 14, 2006, and 71 FR 76603, 76609, December 21, 2006, respectively). In those actions, we noted that assessing the risk at the MACT-allowable level is inherently reasonable since that risk reflects the maximum level facilities could emit and still comply with national emission standards. We also explained that it is reasonable to consider actual emissions, where such data are available, in both steps of the risk analysis, in accordance with the Benzene NESHAP approach. (54 FR 38044.)</P>
                    <P>
                        For this analysis, we have determined that the actual emissions data are reasonable estimates of the MACT-allowable emissions levels for the PEPO Production source category, as we are not generally aware of any situations in which a facility is conducting additional work practices or operating a control device such that it achieves a far greater emission reduction than required by the NESHAP. However, in cases where we encountered a permit emissions limit that appeared to be higher than the reported emissions, we recorded that in the allowable emissions column of the modeling file to assess the risk of allowable emissions. For further details on the assumptions and methodologies used to estimate MACT-allowable emissions, see appendix 1 of the document titled 
                        <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <HD SOURCE="HD3">3. How do we conduct dispersion modeling, determine inhalation exposures, and estimate individual and population inhalation risk?</HD>
                    <P>
                        Both long-term and short-term inhalation exposure concentrations and health risk from the source category addressed in this proposal were estimated using the Human Exposure Model (HEM-4).
                        <SU>10</SU>
                        <FTREF/>
                         The HEM-4 performs three primary risk assessment activities: (1) conducting dispersion modeling to estimate the concentrations of HAP in ambient air, (2) estimating long-term and short-term inhalation exposures to individuals residing within 50 kilometers (km) of the modeled sources, and (3) estimating individual and population-level inhalation risk using the exposure estimates and quantitative dose-response information.
                    </P>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             For more information about HEM-4, go to 
                            <E T="03">https://www.epa.gov/fera/risk-assessment-and-modeling-human-exposure-model-hem.</E>
                        </P>
                    </FTNT>
                    <PRTPAGE P="105995"/>
                    <HD SOURCE="HD3">a. Dispersion Modeling</HD>
                    <P>
                        The air dispersion model AERMOD (American Meteorological Society/EPA Regulatory Model dispersion modeling system), used by the HEM-4, is one of the EPA's preferred models for assessing air pollutant concentrations from industrial facilities.
                        <SU>11</SU>
                        <FTREF/>
                         To perform the dispersion modeling and to develop the preliminary risk estimates, HEM-4 draws on three data libraries. The first is a library of meteorological data, which is used for dispersion calculations. This library includes 1 year (2019) of hourly surface and upper air observations from over 800 meteorological stations, selected to provide coverage of the United States and Puerto Rico. A second library of United States Census Bureau census block 
                        <SU>12</SU>
                        <FTREF/>
                         internal point locations and populations provides the basis of human exposure calculations (U.S. Census, 2020). In addition, for each census block, the census library includes the elevation and controlling hill height, which are also used in dispersion calculations. A third library of pollutant-specific dose-response values is used to estimate health risk. These are discussed below.
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             U.S. EPA. Revision to the 
                            <E T="03">Guideline on Air Quality Models: Adoption of a Preferred General Purpose (Flat and Complex Terrain) Dispersion Model and Other Revisions</E>
                             (70 FR 68218, November 9, 2005).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             A census block is the smallest geographic area for which census statistics are tabulated.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">b. Risk From Chronic Exposure to HAP</HD>
                    <P>In developing the risk assessment for chronic exposures, we use the estimated annual average ambient air concentrations of each HAP emitted by each source in the source category. The HAP air concentrations at each nearby census block centroid located within 50 km of the facility are a surrogate for the chronic inhalation exposure concentration for all the people who reside in that census block. A distance of 50 km is consistent with both the analysis supporting the 1989 Benzene NESHAP (54 FR 38044) and the limitations of Gaussian dispersion models, including AERMOD.</P>
                    <P>
                        For each facility, we calculate the MIR as the cancer risk associated with a continuous lifetime (24 hours per day, 7 days per week, 52 weeks per year, 70 years) exposure to the maximum annual average concentration at the centroid of each inhabited census block. We calculate individual cancer risk by multiplying the estimated lifetime exposure to the ambient concentration of each HAP (in micrograms per cubic meter (μg/m
                        <SU>3</SU>
                        )) by its URE. The URE is an upper-bound estimate of an individual's incremental risk of contracting cancer over a lifetime of exposure to a concentration of 1 μg/m
                        <SU>3</SU>
                         of air. For residual risk assessments, we generally use UREs from the EPA's IRIS. For carcinogenic pollutants without IRIS values, we look to other reputable sources of cancer dose-response values, often using California EPA (CalEPA) UREs, where available. In cases where new, scientifically credible dose-response values have been developed in a manner consistent with EPA guidelines and have undergone a peer review process similar to that used by the EPA, we may use such dose-response values in place of, or in addition to, other values, if appropriate. The pollutant-specific dose-response values used to estimate health risk are available at 
                        <E T="03">https://www.epa.gov/fera/dose-response-assessment-assessing-health-risks-associated-exposure-hazardous-air-pollutants.</E>
                    </P>
                    <P>
                        To estimate individual lifetime cancer risks associated with exposure to HAP emissions from each facility in the source category, we sum the risks for each of the carcinogenic HAP 
                        <SU>13</SU>
                        <FTREF/>
                         emitted by the modeled facility. We estimate cancer risk at every census block within 50 km of every facility in the source category. The MIR is the highest individual lifetime cancer risk estimated for any of those census blocks. In addition to calculating the MIR, we estimate the distribution of individual cancer risks for the source category by summing the number of individuals within 50 km of the sources whose estimated risk falls within a specified risk range. We also estimate annual cancer incidence by multiplying the estimated lifetime cancer risk at each census block by the number of people residing in that block, summing results for all of the census blocks, and then dividing this result by a 70-year lifetime.
                    </P>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             The EPA's 2005 
                            <E T="03">Guidelines for Carcinogen Risk Assessment</E>
                             classifies carcinogens as: “carcinogenic to humans,” “likely to be carcinogenic to humans,” and “suggestive evidence of carcinogenic potential.” These classifications also coincide with the terms “known carcinogen,” “probable carcinogen,” and “possible carcinogen,” respectively, which are the terms advocated in the EPA's 
                            <E T="03">Guidelines for Carcinogen Risk Assessment,</E>
                             published in 1986 (51 FR 33992, September 24, 1986). In August 2000, the document, 
                            <E T="03">Supplemental Guidance for Conducting Health Risk Assessment of Chemical Mixtures</E>
                             (EPA/630/R-00/002), was published as a supplement to the 1986 document. Copies of both documents can be obtained from 
                            <E T="03">https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=20533&amp;CFID=70315376&amp;CFTOKEN=71597944.</E>
                             Summing the risk of these individual compounds to obtain the cumulative cancer risk is an approach that was recommended by the EPA's SAB in their 2002 peer review of the EPA's National Air Toxics Assessment (NATA) titled 
                            <E T="03">NATA—Evaluating the National-scale Air Toxics Assessment 1996 Data—an SAB Advisory,</E>
                             available at 
                            <E T="03">https://yosemite.epa.gov/sab/sabproduct.nsf/214C6E915BB04E14852570CA007A682C/$File/ecadv02001.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        To assess the risk of noncancer health effects from chronic exposure to HAP, we calculate either an HQ or a target organ-specific hazard index (TOSHI). We calculate an HQ when a single noncancer HAP is emitted. Where more than one noncancer HAP is emitted, we sum the HQ for each of the HAP that affects a common target organ or target organ system to obtain a TOSHI. The HQ is the estimated exposure divided by the chronic noncancer dose-response value, which is a value selected from one of several sources. The preferred chronic noncancer dose-response value is the EPA RfC, defined as “an estimate (with uncertainty spanning perhaps an order of magnitude) of a continuous inhalation exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime” (
                        <E T="03">https://iaspub.epa.gov/sor_internet/registry/termreg/searchandretrieve/glossariesandkeywordlists/search.do?details=&amp;vocabName=IRIS%20Glossary</E>
                        ). In cases where an RfC from the EPA's IRIS is not available or where the EPA determines that using a value other than the RfC is appropriate, the chronic noncancer dose-response value can be a value from the following prioritized sources, which define their dose-response values similarly to the EPA: (1) the Agency for Toxic Substances and Disease Registry (ATSDR) Minimal Risk Level (
                        <E T="03">https://www.atsdr.cdc.gov/mrls/index.asp</E>
                        ); (2) the CalEPA Chronic Reference Exposure Level (REL) (
                        <E T="03">https://oehha.ca.gov/air/crnr/notice-adoption-air-toxics-hot-spots-program-guidance-manual-preparation-health-risk-0</E>
                        ); or (3) as noted above, a scientifically credible dose-response value that has been developed in a manner consistent with the EPA guidelines and has undergone a peer review process similar to that used by the EPA. The pollutant-specific dose-response values used to estimate health risks are available at 
                        <E T="03">https://www.epa.gov/fera/dose-response-assessment-assessing-health-risks-associated-exposure-hazardous-air-pollutants.</E>
                    </P>
                    <HD SOURCE="HD3">c. Risk From Acute Exposure to HAP That May Cause Health Effects Other Than Cancer</HD>
                    <P>
                        For each HAP for which appropriate acute inhalation dose-response values are available, the EPA also assesses the potential health risks due to acute exposure. For these assessments, the EPA makes health protective 
                        <PRTPAGE P="105996"/>
                        assumptions about emission rates, meteorology, and exposure location. As part of our efforts to continually improve our methodologies to evaluate the risks that HAP emitted from categories of industrial sources pose to human health and the environment,
                        <SU>14</SU>
                        <FTREF/>
                         we revised our treatment of meteorological data to use reasonable worst-case air dispersion conditions in our acute risk screening assessments instead of worst-case air dispersion conditions. This revised treatment of meteorological data and the supporting rationale are described in more detail in the document titled 
                        <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule</E>
                         and in appendix 5 of the report 
                        <E T="03">Technical Support Document for Acute Risk Screening Assessment,</E>
                         which are available in the docket for this rulemaking. This revised approach has been used in this proposed rule and in all other RTR rulemakings proposed on or after June 3, 2019.
                    </P>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             See, 
                            <E T="03">e.g.,</E>
                             U.S. EPA. 
                            <E T="03">Screening Methodologies to Support Risk and Technology Reviews (RTR): A Case Study Analysis</E>
                             (Draft Report, May 2017. (
                            <E T="03">https://www3.epa.gov/ttn/atw/rrisk/rtrpg.html</E>
                            ).
                        </P>
                    </FTNT>
                    <P>
                        To assess the potential acute risk to the maximally exposed individual, we use the peak hourly emission rate for each emission point,
                        <SU>15</SU>
                        <FTREF/>
                         reasonable worst-case air dispersion conditions (
                        <E T="03">i.e.,</E>
                         99th percentile), and the point of highest off-site exposure. Specifically, we assume that peak emissions from the source category and reasonable worst-case air dispersion conditions co-occur and that a person is present at the point of maximum exposure.
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             In the absence of hourly emission data, we develop estimates of maximum hourly emission rates by multiplying the average actual annual emissions rates by a factor (either a category-specific factor or a default factor of 10) to account for variability. This is documented in 
                            <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                             and in appendix 5 of the report: 
                            <E T="03">Technical Support Document for Acute Risk Screening Assessment.</E>
                             Both of these documents are available in the docket for this rulemaking.
                        </P>
                    </FTNT>
                    <P>To characterize the potential health risks associated with estimated acute inhalation exposures to a HAP, we generally use multiple acute dose-response values, including acute RELs, acute exposure guideline levels (AEGLs), and emergency response planning guidelines (ERPG) for 1-hour exposure durations, if available, to calculate acute HQs. The acute HQ is calculated by dividing the estimated acute exposure concentration by the acute dose-response value. For each HAP for which acute dose-response values are available, the EPA calculates acute HQs.</P>
                    <P>
                        An acute REL is defined as “the concentration level at or below which no adverse health effects are anticipated for a specified exposure duration.” 
                        <SU>16</SU>
                        <FTREF/>
                         Acute RELs are based on the most sensitive, relevant, adverse health effect reported in the peer-reviewed medical and toxicological literature. They are designed to protect the most sensitive individuals in the population through the inclusion of margins of safety. Because margins of safety are incorporated to address data gaps and uncertainties, exceeding the REL does not automatically indicate an adverse health impact. AEGLs represent threshold exposure limits for the general public and are applicable to emergency exposures ranging from 10 minutes to 8 hours.
                        <SU>17</SU>
                        <FTREF/>
                         They are guideline levels for “once-in-a-lifetime, short-term exposures to airborne concentrations of acutely toxic, high-priority chemicals.” 
                        <E T="03">Id.</E>
                         at 21. The AEGL-1 is specifically defined as “the airborne concentration (expressed as ppm (parts per million) or mg/m3 (milligrams per cubic meter)) of a substance above which it is predicted that the general population, including susceptible individuals, could experience notable discomfort, irritation, or certain asymptomatic nonsensory effects. However, the effects are not disabling and are transient and reversible upon cessation of exposure.” The document also notes that “Airborne concentrations below AEGL-1 represent exposure levels that can produce mild and progressively increasing but transient and nondisabling odor, taste, and sensory irritation or certain asymptomatic, nonsensory effects.” 
                        <E T="03">Id.</E>
                         AEGL-2 are defined as “the airborne concentration (expressed as parts per million or milligrams per cubic meter) of a substance above which it is predicted that the general population, including susceptible individuals, could experience irreversible or other serious, long-lasting adverse health effects or an impaired ability to escape.” 
                        <E T="03">Id.</E>
                    </P>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             CalEPA issues acute RELs as part of its Air Toxics Hot Spots Program, and the 1-hour and 8-hour values are documented in 
                            <E T="03">Air Toxics Hot Spots Program Risk Assessment Guidelines, Part I, The Determination of Acute Reference Exposure Levels for Airborne Toxicants,</E>
                             which is available at 
                            <E T="03">https://oehha.ca.gov/air/general-info/oehha-acute-8-hour-and-chronic-reference-exposure-level-rel-summary.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             National Academy of Sciences, 2001. 
                            <E T="03">Standing Operating Procedures for Developing Acute Exposure Levels for Hazardous Chemicals,</E>
                             page 2. Available at 
                            <E T="03">https://www.epa.gov/sites/production/files/2015-09/documents/sop_final_standing_operating_procedures_2001.pdf.</E>
                             Note that the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances ended in October 2011, but the AEGL program continues to operate at the EPA and works with the National Academies to publish final AEGLs (
                            <E T="03">https://www.epa.gov/aegl</E>
                            ).
                        </P>
                    </FTNT>
                    <P>ERPGs are developed, by the American Industrial Hygiene Association (AIHA), for emergency planning and are intended to be health-based guideline concentrations for single exposures to chemicals. The ERPG-1 is the maximum airborne concentration, established by AIHA, below which it is believed that nearly all individuals could be exposed for up to 1 hour without experiencing other than mild transient adverse health effects or without perceiving a clearly defined, objectionable odor. Similarly, the ERPG-2 is the maximum airborne concentration, established by AIHA, below which it is believed that nearly all individuals could be exposed for up to 1 hour without experiencing or developing irreversible or other serious health effects or symptoms which could impair an individual's ability to take protective action.</P>
                    <P>An acute REL for 1-hour exposure durations is typically lower than its corresponding AEGL-1 and ERPG-1. Even though their definitions are slightly different, AEGL-1s are often the same as the corresponding ERPG-1s, and AEGL-2s are often equal to ERPG-2s. The maximum HQs from our acute inhalation screening risk assessment typically result when we use the acute REL for a HAP. In cases where the maximum acute HQ exceeds 1, we also report the HQ based on the next highest acute dose-response value (usually the AEGL-1 and/or the ERPG-1).</P>
                    <P>
                        For the PEPO Production source category, we did not use a default acute emissions multiplier of 10, but rather we used process level-specific acute emissions multipliers, generally ranging from a factor of 2 to 10 as was done in past chemical and petrochemical residual risk reviews such as for the 2015 Petroleum Refinery Sector rule, 2024 HON rulemaking, 2020 MON RTR, and 2020 EMACT standards RTR, where similar emission sources and standards exist. These refinements are discussed more fully in appendix 1 of the document titled 
                        <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <P>
                        In our acute inhalation screening risk assessment, acute impacts are deemed negligible for HAP for which acute HQs are less than or equal to 1, and no further analysis is performed for these HAP. In cases where an acute HQ from the screening step is greater than 1, we assess the site-specific data to ensure 
                        <PRTPAGE P="105997"/>
                        that the acute HQ is at an off-site location. For the PEPO Production source category, the data refinements employed consisted of reviewing satellite imagery of the locations of the maximum acute HQ values to determine if the maximum was off facility property. For any maximum value that was determined to be on facility property, the next highest value that was off facility property was used. These refinements are discussed more fully in the document titled 
                        <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <HD SOURCE="HD3">4. How do we conduct the multipathway exposure and risk screening assessment?</HD>
                    <P>
                        The EPA conducts a tiered screening assessment examining the potential for significant human health risks due to exposures via routes other than inhalation (
                        <E T="03">e.g.,</E>
                         ingestion). We first determine whether any sources in the source category emit any HAP known to be persistent and bioaccumulative in the environment, as identified in the EPA's Air Toxics Risk Assessment Library (see Volume 1, appendix D, at 
                        <E T="03">https://www.epa.gov/fera/risk-assessment-and-modeling-air-toxics-risk-assessment-reference-library).</E>
                    </P>
                    <P>
                        For the PEPO Production source category, we identified PB-HAP emissions of arsenic compounds, cadmium compounds, polycyclic organic matter (POM), and mercury, so we proceeded to the next step of the evaluation. Except for lead, the human health risk screening assessment for PB-HAP consists of three progressive tiers. In a Tier 1 screening assessment, we determine whether the magnitude of the facility-specific emissions of PB-HAP warrants further evaluation to characterize human health risk through ingestion exposure. To facilitate this step, we evaluate emissions against previously developed screening threshold emission rates for several PB-HAP that are based on a hypothetical upper-end screening exposure scenario developed for use in conjunction with the EPA's Total Risk Integrated Methodology—Fate, Transport, and Ecological Exposure (TRIM.FaTE) model. The PB-HAP with screening threshold emission rates are arsenic compounds, cadmium compounds, chlorinated dibenzodioxins and furans, mercury compounds, and POM. Based on the EPA estimates of toxicity and bioaccumulation potential, these pollutants represent a health protective list for inclusion in multipathway risk assessments for RTR rules. (See Volume 1, Appendix D at 
                        <E T="03">https://www.epa.gov/sites/production/files/2013-08/documents/volume_1_reflibrary.pdf.</E>
                        ) In this assessment, we compare the facility-specific emission rates of these PB-HAP to the screening threshold emission rates for each PB-HAP to assess the potential for significant human health risks via the ingestion pathway. We call this application of the TRIM.FaTE model the Tier 1 screening assessment. The ratio of a facility's actual emission rate to the Tier 1 screening threshold emission rate is a “screening value.”
                    </P>
                    <P>
                        We derive the Tier 1 screening threshold emission rates for these PB-HAP (other than lead compounds) to correspond to a maximum excess lifetime cancer risk of 1-in-1 million (
                        <E T="03">i.e.,</E>
                         for arsenic compounds, polychlorinated dibenzodioxins and furans, and POM) or, for HAP that cause noncancer health effects (
                        <E T="03">i.e.,</E>
                         cadmium compounds and mercury compounds), a maximum HQ of 1. If the emission rate of any one PB-HAP or combination of carcinogenic PB-HAP in the Tier 1 screening assessment exceeds the Tier 1 screening threshold emission rate for any facility (
                        <E T="03">i.e.,</E>
                         the screening value is greater than 1), we conduct a second screening assessment, which we call the Tier 2 screening assessment. The Tier 2 screening assessment separates the Tier 1 combined fisher and farmer exposure scenario into fisher, farmer, and gardener scenarios that retain upper-bound ingestion rates.
                    </P>
                    <P>In the Tier 2 screening assessment, the location of each facility that exceeds a Tier 1 screening threshold emission rate is used to refine the assumptions associated with the Tier 1 fisher and farmer exposure scenarios at that facility. A key assumption in the Tier 1 screening assessment is that a lake and/or farm is located near the facility. As part of the Tier 2 screening assessment, we use a U.S. Geological Survey (USGS) database to identify actual waterbodies within 50 km of each facility and assume the fisher only consumes fish from lakes within that 50-km zone. We also examine the differences between local meteorology near the facility and the meteorology used in the Tier 1 screening assessment. We then adjust the previously-developed Tier 1 screening threshold emission rates for each PB-HAP for each facility based on an understanding of how exposure concentrations estimated for the screening scenario change with the use of local meteorology and the USGS lakes database.</P>
                    <P>
                        In the Tier 2 farmer scenario, we maintain an assumption that the farm is located within 0.5 km of the facility and that the farmer consumes meat, eggs, dairy, vegetables, and fruit produced near the facility. We may further refine the Tier 2 screening analysis by assessing a gardener scenario to characterize a range of exposures, with the gardener scenario being more plausible in RTR evaluations. Under the gardener scenario, we assume the gardener consumes home-produced eggs, vegetables, and fruit products at the same ingestion rate as the farmer. The Tier 2 screen continues to rely on the high-end food intake assumptions that were applied in Tier 1 for local fish (adult female angler at 99th percentile fish consumption 
                        <SU>18</SU>
                        <FTREF/>
                        ) and locally grown or raised foods (90th percentile consumption of locally grown or raised foods for the farmer and gardener scenarios 
                        <SU>19</SU>
                        <FTREF/>
                        ). If PB-HAP emission rates do not result in a Tier 2 screening value greater than 1, we consider those PB-HAP emissions to pose risks below a level of concern. If the PB-HAP emission rates for a facility exceed the Tier 2 screening threshold emission rates, we may conduct a Tier 3 screening assessment.
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             Burger, J. 2002. 
                            <E T="03">Daily consumption of wild fish and game: Exposures of high end recreationists. International Journal of Environmental Health Research,</E>
                             12:343-354.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             U.S. EPA. 
                            <E T="03">Exposure Factors Handbook 2011 Edition (Final).</E>
                             U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-09/052F, 2011.
                        </P>
                    </FTNT>
                    <P>There are several analyses that can be included in a Tier 3 screening assessment, depending upon the extent of refinement warranted, including validating that the lakes are fishable, locating residential/garden locations for urban and/or rural settings, considering plume-rise to estimate emissions lost above the mixing layer, and considering hourly effects of meteorology and plume-rise on chemical fate and transport (a time-series analysis). If necessary, the EPA may further refine the screening assessment through a site-specific assessment.</P>
                    <P>
                        In evaluating the potential multipathway risk from emissions of lead compounds, rather than developing a screening threshold emission rate, we compare maximum estimated chronic inhalation exposure concentrations to the level of the current National Ambient Air Quality Standard (NAAQS) for lead.
                        <SU>20</SU>
                        <FTREF/>
                         Values below the level of the 
                        <PRTPAGE P="105998"/>
                        primary (health-based) lead NAAQS are considered to have a low potential for multipathway risk.
                    </P>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             In doing so, the EPA notes that the legal standard for a primary NAAQS—that a standard is requisite to protect public health and provide an adequate margin of safety (CAA section 109(b))—differs from the CAA section 112(f) standard 
                            <PRTPAGE/>
                            (requiring, among other things, that the standard provide an “ample margin of safety to protect public health”). However, the primary lead NAAQS is a reasonable measure of determining risk acceptability (
                            <E T="03">i.e.,</E>
                             the first step of the 1989 Benzene NESHAP analysis) since it is designed to protect the most susceptible group in the human population—children, including children living near major lead emitting sources. 73 FR 67002/3; 73 FR 67000/3; 73 FR 67005/1. In addition, applying the level of the primary lead NAAQS at the risk acceptability step is conservative, since that primary lead NAAQS reflects an adequate margin of safety.
                        </P>
                    </FTNT>
                    <P>
                        For further information on the multipathway assessment approach, see the document titled 
                        <E T="03">Residual Risk Assessment for the Polyether Polyols</E>
                         (
                        <E T="03">PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <HD SOURCE="HD3">5. How do we assess risks considering emissions control options?</HD>
                    <P>In addition to assessing baseline inhalation risks and screening for potential multipathway risks, we also estimate risks considering the potential emission reductions that would be achieved by the control options under consideration. In these cases, the expected emission reductions are applied to the specific HAP and emission points in the RTR emissions dataset to develop corresponding estimates of risk and incremental risk reductions.</P>
                    <HD SOURCE="HD3">6. How do we conduct the environmental risk screening assessment?</HD>
                    <HD SOURCE="HD3">a. Adverse Environmental Effect, Environmental HAP, and Ecological Benchmarks</HD>
                    <P>The EPA conducts a screening assessment to examine the potential for an adverse environmental effect as required under section 112(f)(2)(A) of the CAA. Section 112(a)(7) of the CAA defines “adverse environmental effect” as “any significant and widespread adverse effect, which may reasonably be anticipated, to wildlife, aquatic life, or other natural resources, including adverse impacts on populations of endangered or threatened species or significant degradation of environmental quality over broad areas.”</P>
                    <P>The EPA focuses on eight HAP, which are referred to as “environmental HAP,” in its screening assessment: six PB-HAP and two acid gases. The PB-HAP included in the screening assessment are arsenic compounds, cadmium compounds, dioxins/furans, POM, mercury (both inorganic mercury and methyl mercury), and lead compounds. The acid gases included in the screening assessment are hydrochloric acid (HCl) and hydrofluoric acid (HF).</P>
                    <P>HAP that persist and bioaccumulate are of particular environmental concern because they accumulate in the soil, sediment, and water. The acid gases, HCl and HF, are included due to their well-documented potential to cause direct damage to terrestrial plants. In the environmental risk screening assessment, we evaluate the following four exposure media: terrestrial soils, surface water bodies (includes water-column and benthic sediments), fish consumed by wildlife, and air. Within these four exposure media, we evaluate nine ecological assessment endpoints, which are defined by the ecological entity and its attributes. For PB-HAP (other than lead), both community-level and population-level endpoints are included. For acid gases, the ecological assessment evaluated is terrestrial plant communities.</P>
                    <P>An ecological benchmark represents a concentration of HAP that has been linked to a particular environmental effect level. For each environmental HAP, we identified the available ecological benchmarks for each assessment endpoint. We identified, where possible, ecological benchmarks at the following effect levels: probable effect levels, lowest-observed-adverse-effect level, and no-observed-adverse-effect level. In cases where multiple effect levels were available for a particular PB-HAP and assessment endpoint, we use all of the available effect levels to help us to determine whether ecological risks exist and, if so, whether the risks could be considered significant and widespread.</P>
                    <P>
                        For further information on how the environmental risk screening assessment was conducted, including a discussion of the risk metrics used, how the environmental HAP were identified, and how the ecological benchmarks were selected, see appendix 9 of the document titled 
                        <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <HD SOURCE="HD3">b. Environmental Risk Screening Methodology</HD>
                    <P>
                        For the environmental risk screening assessment, the EPA first determined whether any facilities in the PEPO Production source category emitted any of the environmental HAP. For the PEPO Production source category, we identified emissions of arsenic compounds, cadmium compounds, POM, and mercury.
                        <SU>21</SU>
                        <FTREF/>
                         Because one or more of the environmental HAP evaluated are emitted by at least one facility in the PEPO Production source category, we proceeded to the second step of the evaluation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             We note that in many instances, we did not have sufficient information to parse out emissions from PEPO processes from facility-wide emissions inventories; thus, to avoid underestimating emissions from PEPO sources, we modeled most or all of certain facilities' emissions records as if they all are from the PEPO Production source category.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">c. PB-HAP Methodology</HD>
                    <P>The environmental screening assessment includes six PB-HAP, arsenic compounds, cadmium compounds, dioxins/furans, POM, mercury (both inorganic mercury and methyl mercury), and lead compounds. With the exception of lead, the environmental risk screening assessment for PB-HAP consists of three tiers. The first tier of the environmental risk screening assessment uses the same health-protective conceptual model that is used for the Tier 1 human health screening assessment. TRIM.FaTE model simulations were used to back-calculate Tier 1 screening threshold emission rates. The screening threshold emission rates represent the emission rate in tons of pollutant per year that results in media concentrations at the facility that equal the relevant ecological benchmark. To assess emissions from each facility in the category, the reported emission rate for each PB-HAP was compared to the Tier 1 screening threshold emission rate for that PB-HAP for each assessment endpoint and effect level. If emissions from a facility do not exceed the Tier 1 screening threshold emission rate, the facility “passes” the screening assessment, and, therefore, is not evaluated further under the screening approach. If emissions from a facility exceed the Tier 1 screening threshold emission rate, we evaluate the facility further in Tier 2.</P>
                    <P>
                        In Tier 2 of the environmental screening assessment, the screening threshold emission rates are adjusted to account for local meteorology and the actual location of lakes in the vicinity of facilities that did not pass the Tier 1 screening assessment. For soils, we evaluate the average soil concentration for all soil parcels within a 7.5-km radius for each facility and PB-HAP. For the water, sediment, and fish tissue concentrations, the highest value for each facility for each pollutant. If emissions from a facility do not exceed the Tier 2 screening threshold emission rate, the facility “passes” the screening 
                        <PRTPAGE P="105999"/>
                        assessment and typically is not evaluated further. If emissions from a facility exceed the Tier 2 screening threshold emission rate, we evaluate the facility further in Tier 3.
                    </P>
                    <P>
                        As in the multipathway human health risk assessment, in Tier 3 of the environmental screening assessment, we examine the suitability of the lakes around the facilities to support life and remove those that are not suitable (
                        <E T="03">e.g.,</E>
                         lakes that have been filled in or are industrial ponds), adjust emissions for plume rise, and conduct hour-by-hour time-series assessments. If these Tier 3 adjustments to the screening threshold emission rates still indicate the potential for an adverse environmental effect (
                        <E T="03">i.e.,</E>
                         facility emission rate exceeds the screening threshold emission rate), we may elect to conduct a more refined assessment using more site-specific information. If, after additional refinement, the facility emission rate still exceeds the screening threshold emission rate, the facility may have the potential to cause an adverse environmental effect.
                    </P>
                    <P>To evaluate the potential for an adverse environmental effect from lead, we compared the average modeled air concentrations (from HEM-4) of lead around each facility in the source category to the level of the secondary NAAQS for lead. The secondary lead NAAQS is a reasonable means of evaluating environmental risk because it is set to provide substantial protection against adverse welfare effects which can include “effects on soils, water, crops, vegetation, man-made materials, animals, wildlife, weather, visibility and climate, damage to and deterioration of property, and hazards to transportation, as well as effects on economic values and on personal comfort and well-being.”</P>
                    <HD SOURCE="HD3">d. Acid Gas Environmental Risk Methodology</HD>
                    <P>
                        The environmental screening assessment for acid gases evaluates the potential phytotoxicity and reduced productivity of plants due to chronic exposure to HF and HCl. The environmental risk screening methodology for acid gases is a single-tier screening assessment that compares modeled ambient air concentrations (from AERMOD) to the ecological benchmarks for each acid gas. To identify a potential adverse environmental effect (as defined in section 112(a)(7) of the CAA) from emissions of HF and HCl, we evaluate the following metrics: the size of the modeled area around each facility that exceeds the ecological benchmark for each acid gas, in acres and square km; the percentage of the modeled area around each facility that exceeds the ecological benchmark for each acid gas; and the area-weighted average screening value around each facility (calculated by dividing the area-weighted average concentration over the 50-km modeling domain by the ecological benchmark for each acid gas). For further information on the environmental screening assessment approach, see appendix 9 of the document titled 
                        <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <HD SOURCE="HD3">7. How do we conduct facility-wide assessments?</HD>
                    <P>
                        To put the source category risks in context, we typically examine the risks from the entire “facility,” where the facility includes all HAP-emitting operations within a contiguous area and under common control. In other words, we examine the HAP emissions not only from the source category emission points of interest, but also emissions of HAP from all other emission sources at the facility for which we have data. For the PEPO Production source category, we conducted the facility-wide assessment using a dataset compiled from the 2017 NEI and other emissions information discussed in section II.C of this preamble. Once a quality assured source category dataset was available, it was placed back with the remaining records from the NEI for that facility (which in most instances was 2017 NEI data). The facility-wide file was then used to analyze risks due to the inhalation of HAP that are emitted “facility-wide” for the populations residing within 50 km of each facility, consistent with the methods used for the source category analysis described above. For these facility-wide risk analyses, the modeled source category risks were compared to the facility-wide risks to determine the portion of the facility-wide risks that could be attributed to the source category addressed in this proposal. We also specifically examined the facility that was associated with the highest estimate of risk and determined the percentage of that risk attributable to the source category of interest. The document titled 
                        <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                         available through the docket for this rulemaking, provides the methodology and results of the facility-wide analyses, including all facility-wide risks and the percentage of source category contribution to facility-wide risks.
                    </P>
                    <HD SOURCE="HD3">8. How do we conduct community-based risk assessments?</HD>
                    <P>
                        In addition to the source category and facility-wide risk assessments, we also assessed the combined inhalation cancer risk from all local stationary sources of HAP for which we have emissions data. Specifically, we combined the modeled impacts from the facility-wide assessment (which includes category and non-category sources) with other nearby stationary point source model results. Section II.C of this preamble discusses the facility-wide emissions used in this assessment. For the other nearby point sources, we used AERMOD model results with emissions based primarily on the 2020 NEI. After combining these model results, we assessed cancer risks due to the inhalation of all HAP emitted by point sources for the populations residing within 10 km (~6.2 miles) of PEPO facilities. In the community-based risk assessment, we compared the modeled source category and facility-wide cancer risks to the cancer risks from other nearby point sources to determine the portion of the risks that could be attributed to the source category addressed in this proposal. The document titled 
                        <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                         which is available in the docket for this rulemaking, provides the methodology and results of the community-based risks analyses.
                    </P>
                    <HD SOURCE="HD3">9. How do we consider uncertainties in risk assessment?</HD>
                    <P>
                        Uncertainty and the potential for bias are inherent in all risk assessments, including those performed for this proposal. Although uncertainty exists, we believe that our approach, which used health protective tools and assumptions, ensures that our decisions are health and environmentally protective. A brief discussion of the uncertainties in the RTR emissions dataset, dispersion modeling, inhalation exposure estimates, and dose-response relationships follows below. Also included are those uncertainties specific to our acute screening assessments, multipathway screening assessments, and our environmental risk screening assessments. A more thorough discussion of these uncertainties is included in the document titled 
                        <E T="03">
                            Residual Risk Assessment for the Polyether Polyols (PEPO) Production 
                            <PRTPAGE P="106000"/>
                            Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,
                        </E>
                         which is available in the docket for this rulemaking. If a multipathway site-specific assessment was performed for this source category, a full discussion of the uncertainties associated with that assessment can be found in appendix 11 of that document, 
                        <E T="03">Site-Specific Human Health Multipathway Residual Risk Assessment Report.</E>
                    </P>
                    <HD SOURCE="HD3">a. Uncertainties in the RTR Emissions Dataset</HD>
                    <P>Although the development of the RTR emissions dataset involved quality assurance/quality control processes, the accuracy of emissions values will vary depending on the source of the data, the degree to which data are incomplete or missing, the degree to which assumptions made to complete the datasets are accurate, errors in emission estimates, and other factors. The emission estimates considered in this analysis generally are annual totals for certain years, and they do not reflect short-term fluctuations during the course of a year or variations from year to year. The estimates of peak hourly emission rates for the acute effects screening assessment were based on an emission adjustment factor applied to the average annual hourly emission rates, which are intended to account for emission fluctuations due to normal facility operations.</P>
                    <HD SOURCE="HD3">b. Uncertainties in Dispersion Modeling</HD>
                    <P>
                        We recognize there is uncertainty in ambient concentration estimates associated with any model, including the EPA's recommended regulatory dispersion model, AERMOD. In using a model to estimate ambient pollutant concentrations, the user chooses certain options to apply. For RTR assessments, we select some model options that have the potential to overestimate ambient air concentrations (
                        <E T="03">e.g.,</E>
                         not including plume depletion or pollutant transformation). We select other model options that have the potential to underestimate ambient impacts (
                        <E T="03">e.g.,</E>
                         not including building downwash). Other options that we select have the potential to either under- or overestimate ambient levels (
                        <E T="03">e.g.,</E>
                         meteorology and receptor locations). On balance, considering the directional nature of the uncertainties commonly present in ambient concentrations estimated by dispersion models, the approach we apply in the RTR assessments should yield unbiased estimates of ambient HAP concentrations. We also note that the selection of meteorology dataset location could have an impact on the risk estimates. As we continue to update and expand our library of meteorological station data used in our risk assessments, we expect to reduce this variability.
                    </P>
                    <HD SOURCE="HD3">c. Uncertainties in Inhalation Exposure Assessment</HD>
                    <P>Although every effort is made to identify all of the relevant facilities and emission points, as well as to develop accurate estimates of the annual emission rates for all relevant HAP, the uncertainties in our emissions inventory likely dominate the uncertainties in the exposure assessment. Some uncertainties in our exposure assessment include human mobility, using the centroid of each census block, assuming lifetime exposure, and assuming only outdoor exposures. For most of these factors, there is neither an under nor overestimate when looking at the maximum individual risk or the incidence, but the shape of the distribution of risks may be affected. With respect to outdoor exposures, actual exposures may not be as high if people spend time indoors, especially for very reactive pollutants or larger particles. For all factors, we reduce uncertainty when possible. For example, with respect to census-block centroids, we analyze large blocks using aerial imagery and adjust locations of the block centroids to better represent the population in the blocks. We also add additional receptor locations where the population of a block is not well represented by a single location.</P>
                    <HD SOURCE="HD3">d. Uncertainties in Dose-Response Relationships</HD>
                    <P>
                        There are uncertainties inherent in the development of the dose-response values used in our risk assessments for cancer effects from chronic exposures and noncancer effects from both chronic and acute exposures. Some uncertainties are generally expressed quantitatively, and others are generally expressed in qualitative terms. We note, as a preface to this discussion, a point on dose-response uncertainty that is stated in the EPA's 
                        <E T="03">2005 Guidelines for Carcinogen Risk Assessment;</E>
                         namely, that “the primary goal of EPA actions is protection of human health; accordingly, as an Agency policy, risk assessment procedures, including default options that are used in the absence of scientific data to the contrary, should be health protective” (the EPA's 
                        <E T="03">2005 Guidelines for Carcinogen Risk Assessment,</E>
                         page 1-7). This is the approach followed here as summarized in the next paragraphs.
                    </P>
                    <P>
                        Cancer UREs used in our risk assessments are those that have been developed to generally provide an upper bound estimate of risk.
                        <SU>22</SU>
                        <FTREF/>
                         That is, they represent a “plausible upper limit to the true value of a quantity” (although this is usually not a true statistical confidence limit). In some circumstances, the true risk could be as low as zero; however, in other circumstances the risk could be greater.
                        <SU>23</SU>
                        <FTREF/>
                         Chronic noncancer RfC and reference dose values represent chronic exposure levels that are intended to be health-protective levels. To derive dose-response values that are intended to be “without appreciable risk,” the methodology relies upon an uncertainty factor (UF) approach,
                        <SU>24</SU>
                        <FTREF/>
                         which considers uncertainty, variability, and gaps in the available data. The UFs are applied to derive dose-response values that are intended to protect against appreciable risk of deleterious effects.
                    </P>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             IRIS glossary (
                            <E T="03">https://ofmpub.epa.gov/sor_internet/registry/termreg/searchandretrieve/glossariesandkeywordlists/search.do?details=&amp;glossaryName=IRIS%20Glossary</E>
                            ).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>23</SU>
                             An exception to this is the URE for benzene, which is considered to cover a range of values, each end of which is considered to be equally plausible, and which is based on maximum likelihood estimates.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             See 
                            <E T="03">A Review of the Reference Dose and Reference Concentration Processes,</E>
                             U.S. EPA, December 2002, and 
                            <E T="03">Methods for Derivation of Inhalation Reference Concentrations and Application of Inhalation Dosimetry,</E>
                             U.S. EPA, 1994.
                        </P>
                    </FTNT>
                    <P>
                        Many of the UFs used to account for variability and uncertainty in the development of acute dose-response values are quite similar to those developed for chronic durations. Additional adjustments are often applied to account for uncertainty in extrapolation from observations at one exposure duration (
                        <E T="03">e.g.,</E>
                         4 hours) to derive an acute dose-response value at another exposure duration (
                        <E T="03">e.g.,</E>
                         1 hour). Not all acute dose-response values are developed for the same purpose, and care must be taken when interpreting the results of an acute assessment of human health effects relative to the dose-response value or values being exceeded. Where relevant to the estimated exposures, the lack of acute dose-response values at different levels of severity should be factored into the risk characterization as potential uncertainties.
                    </P>
                    <P>
                        Uncertainty also exists in the selection of ecological benchmarks for the environmental risk screening assessment. We established a hierarchy of preferred benchmark sources to allow selection of benchmarks for each environmental HAP at each ecological assessment endpoint. We searched for benchmarks for three effect levels (
                        <E T="03">i.e.,</E>
                         no-effects level, threshold-effect level, 
                        <PRTPAGE P="106001"/>
                        and probable-effect level), but not all combinations of ecological assessment/environmental HAP had benchmarks for all three effect levels. Where multiple effect levels were available for a particular HAP and assessment endpoint, we used all of the available effect levels to help us determine whether risk exists and whether the risk could be considered significant and widespread.
                    </P>
                    <P>Although we make every effort to identify appropriate human health effect dose-response values for all pollutants emitted by the sources in this risk assessment, some HAP emitted by the source category are lacking dose-response assessments. Accordingly, these pollutants cannot be included in the quantitative risk assessment, which could result in quantitative estimates understating HAP risk. To help to alleviate this potential underestimate, where we conclude similarity with a HAP for which a dose-response value is available, we use that value as a surrogate for the assessment of the HAP for which no value is available. To the extent use of surrogates indicates appreciable risk, we may identify a need to increase priority for an IRIS assessment for that substance. We additionally note that, generally speaking, HAP of greatest concern due to environmental exposures and hazard are those for which dose-response assessments have been performed, reducing the likelihood of understating risk. Further, HAP not included in the quantitative assessment are assessed qualitatively and considered in the risk characterization that informs the risk management decisions, including consideration of HAP reductions achieved by various control options.</P>
                    <P>
                        For a group of compounds that are unspeciated (
                        <E T="03">e.g.,</E>
                         groups of compounds that we do not know the exact composition of like glycol ethers), we conservatively use the most protective dose-response value of an individual compound in that group to estimate risk. Similarly, for an individual compound in a group (
                        <E T="03">e.g.,</E>
                         ethylene glycol diethyl ether) that does not have a specified dose-response value, we also apply the most protective dose-response value from the other compounds in the group to estimate risk.
                    </P>
                    <HD SOURCE="HD3">e. Uncertainties in Acute Inhalation Screening Assessments</HD>
                    <P>
                        In addition to the uncertainties highlighted above, there are several factors specific to the acute exposure assessment that the EPA conducts as part of the risk review under section 112 of the CAA. The accuracy of an acute inhalation exposure assessment depends on the simultaneous occurrence of independent factors that may vary greatly, such as hourly emissions rates, meteorology, and the presence of a person. In the acute screening assessment that we conduct under the RTR program, we assume that peak emissions from the source category and reasonable worst-case air dispersion conditions (
                        <E T="03">i.e.,</E>
                         99th percentile) co-occur. We then include the additional assumption that a person is located at this point at the same time. Together, these assumptions represent a reasonable worst-case actual exposure scenario. In most cases, it is unlikely that a person would be located at the point of maximum exposure during the time when peak emissions and reasonable worst-case air dispersion conditions occur simultaneously.
                    </P>
                    <HD SOURCE="HD3">f. Uncertainties in the Multipathway and Environmental Risk Screening Assessments</HD>
                    <P>
                        For each source category, we generally rely on site-specific levels of PB-HAP or environmental HAP emissions to determine whether a refined assessment of the impacts from multipathway exposures is necessary or whether it is necessary to perform an environmental screening assessment. This determination is based on the results of a three-tiered screening assessment that relies on the outputs from models—TRIM.FaTE and AERMOD—that estimate environmental pollutant concentrations and human exposures for five PB-HAP (dioxins, POM, mercury, cadmium, and arsenic) and two acid gases (HF and HCl). For lead, we use AERMOD to determine ambient air concentrations, which are then compared to the secondary NAAQS standard for lead. Two important types of uncertainty associated with the use of these models in RTR risk assessments and inherent to any assessment that relies on environmental modeling are model uncertainty and input uncertainty.
                        <SU>25</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             In the context of this discussion, the term “uncertainty” as it pertains to exposure and risk encompasses both 
                            <E T="03">variability</E>
                             in the range of expected inputs and screening results due to existing spatial, temporal, and other factors, as well as 
                            <E T="03">uncertainty</E>
                             in being able to accurately estimate the true result.
                        </P>
                    </FTNT>
                    <P>
                        Model uncertainty concerns whether the model adequately represents the actual processes (
                        <E T="03">e.g.,</E>
                         movement and accumulation) that might occur in the environment. For example, does the model adequately describe the movement of a pollutant through the soil? This type of uncertainty is difficult to quantify. However, based on feedback received from previous EPA SAB reviews and other reviews, we are confident that the models used in the screening assessments are appropriate and state-of-the-art for the multipathway and environmental screening risk assessments conducted in support of RTRs.
                    </P>
                    <P>Input uncertainty is concerned with how accurately the models have been configured and parameterized for the assessment at hand. For Tier 1 of the multipathway and environmental screening assessments, we configured the models to avoid underestimating exposure and risk. This was accomplished by selecting upper-end values from nationally representative datasets for the more influential parameters in the environmental model, including selection and spatial configuration of the area of interest, lake location and size, meteorology, surface water, soil characteristics, and structure of the aquatic food web. We also assume an ingestion exposure scenario and values for human exposure factors that represent reasonable maximum exposures.</P>
                    <P>In Tier 2 of the multipathway and environmental screening assessments, we refine the model inputs to account for meteorological patterns in the vicinity of the facility versus using upper-end national values, and we identify the actual location of lakes near the facility rather than the default lake location that we apply in Tier 1. By refining the screening approach in Tier 2 to account for local geographical and meteorological data, we decrease the likelihood that concentrations in environmental media are overestimated, thereby increasing the usefulness of the screening assessment. In Tier 3 of the screening assessments, we refine the model inputs again to account for hour-by-hour plume-rise and the height of the mixing layer. We can also use those hour-by-hour meteorological data in a TRIM.FaTE run using the screening configuration corresponding to the lake location. These refinements produce a more accurate estimate of chemical concentrations in the media of interest, thereby reducing the uncertainty with those estimates. The assumptions and the associated uncertainties regarding the selected ingestion exposure scenario are the same for all three tiers.</P>
                    <P>For the environmental screening assessment for acid gases, we employ a single-tiered approach. We use the modeled air concentrations and compare those with ecological benchmarks.</P>
                    <P>
                        For all tiers of the multipathway and environmental screening assessments, our approach to addressing model input uncertainty is generally cautious. We 
                        <PRTPAGE P="106002"/>
                        choose model inputs from the upper end of the range of possible values for the influential parameters used in the models, and we assume that the exposed individual exhibits ingestion behavior that would lead to a high total exposure. This approach reduces the likelihood of not identifying high risks for adverse impacts.
                    </P>
                    <P>
                        Despite the uncertainties, when individual pollutants or facilities do not exceed screening threshold emission rates (
                        <E T="03">i.e.,</E>
                         screen out), we are confident that the potential for adverse multipathway impacts on human health is very low. On the other hand, when individual pollutants or facilities do exceed screening threshold emission rates, it does not mean that impacts are significant, only that we cannot rule out that possibility and that a refined assessment for the site might be necessary to obtain a more accurate risk characterization for the source category.
                    </P>
                    <P>The EPA evaluates the following HAP in the multipathway and/or environmental risk screening assessments, where applicable: arsenic, cadmium, dioxins/furans, lead, mercury (both inorganic and methyl mercury), POM, HCl, and HF. These HAP represent pollutants that can cause adverse impacts either through direct exposure to HAP in the air or through exposure to HAP that are deposited from the air onto soils and surface waters and then through the environment into the food web. These HAP represent those HAP for which we can conduct a meaningful multipathway or environmental screening risk assessment. For other HAP not included in our screening assessments, the model has not been parameterized such that it can be used for that purpose. In some cases, depending on the HAP, we may not have appropriate multipathway models that allow us to predict the concentration of that pollutant. The EPA acknowledges that other HAP beyond these that we are evaluating may have the potential to cause adverse effects and, therefore, the EPA may evaluate other relevant HAP in the future, as modeling science and resources allow.</P>
                    <HD SOURCE="HD2">C. How do we perform the technology review?</HD>
                    <P>Our technology review primarily focuses on the identification and evaluation of developments in practices, processes, and control technologies that have occurred since the previous PEPO NESHAP technology review was promulgated. Where we identify such developments, we analyze their technical feasibility, estimated costs, energy implications, and non-air environmental impacts. We also consider the emission reductions associated with applying each development. This analysis informs our decision of whether it is “necessary” to revise the CAA section 112 emissions standards. In addition, we consider the appropriateness of applying controls to new sources versus retrofitting existing sources. For this exercise, we consider any of the following to be a “development”:</P>
                    <P>• Any add-on control technology or other equipment that was not identified and considered during development of the original MACT standards;</P>
                    <P>• Any improvements in add-on control technology or other equipment (that were identified and considered during development of the original MACT standards) that could result in additional emissions reduction;</P>
                    <P>• Any work practice or operational procedure that was not identified or considered during development of the original MACT standards;</P>
                    <P>• Any process change or pollution prevention alternative that could be broadly applied to the industry and that was not identified or considered during development of the original MACT standards; and</P>
                    <P>• Any significant changes in the cost (including cost effectiveness) of applying controls (including controls the EPA considered during the development of the original MACT standards).</P>
                    <P>In addition to reviewing the practices, processes, and control technologies that were considered at the time we originally developed (or last updated) the PEPO NESHAP, we review a variety of data sources in our investigation of potential practices, processes, or controls to consider. We also review the NESHAP and the available data to determine if there are any unregulated emissions of HAP within the source category, and evaluate these data for use in developing new emission standards. See sections II.C and II.D of this preamble for information on the specific data sources that were reviewed as part of the technology review.</P>
                    <HD SOURCE="HD2">D. How do we determine a MACT floor and consider beyond-the-floor?</HD>
                    <P>MACT standards must reflect the maximum degree of emissions reduction achievable through the application of measures, processes, methods, systems or techniques, including, but not limited to, measures that (1) reduce the volume of or eliminate pollutants through process changes, substitution of materials or other modifications; (2) enclose systems or processes to eliminate emissions; (3) capture or treat pollutants when released from a process, stack, storage or fugitive emissions point; (4) are design, equipment, work practice or operational standards (including requirements for operator training or certification); or (5) are a combination of the above. CAA section 112(d)(2)(A)-(E). The MACT standards may take the form of design, equipment, work practice or operational standards where the EPA first determines either that (1) a pollutant cannot be emitted through a conveyance designed and constructed to emit or capture the pollutant, or that any requirement for, or use of, such a conveyance would be inconsistent with law; or (2) the application of measurement methodology to a particular class of sources is not practicable due to technological and economic limitations. CAA section 112(h)(1)-(2).</P>
                    <P>
                        The MACT “floor” is the minimum control level allowed for MACT standards promulgated under CAA section 112(d)(3) and may not be based on cost considerations. For new sources located at facilities that are major sources of HAP, section 112 of the CAA requires the EPA to establish standards that are no less stringent than the emissions control that is achieved in practice by the best controlled similar source. The statute does not define “achieved in practice” nor does it dictate the manner in which the agency determines which source is the best controlled similar source, instead leaving it to the agency's discretion to make those determinations. For existing sources located at facilities that are major sources of HAP, standards must be no less stringent than the average emissions limitation achieved by the best performing sources for which the EPA has emissions information. Again, the CAA leaves to the EPA's discretion the manner in which to calculate “the average emission limitation achieved” by the best performing sources. Under section 112, the CAA recognizes that source categories and subcategories have differing numbers of sources and provides category size-specific instructions on determining standard stringency for existing sources. Specifically, standards for categories or subcategories with fewer than 30 sources must be based on the average emission limitation achieved by the best performing 5 sources, and standards for categories or subcategories with 30 or more sources must be based on the average emission limitation achieved by the best performing 12 percent of sources for which the EPA has emissions information. In developing MACT standards, the EPA must also 
                        <PRTPAGE P="106003"/>
                        consider control options that are more stringent than the floor (
                        <E T="03">i.e.,</E>
                         “beyond-the-floor” options) under CAA section 112(d)(2). We may establish beyond-the-floor standards more stringent than the floor based on considerations of the cost of achieving the emission reductions, any non-air quality health and environmental impacts, and energy requirements.
                    </P>
                    <HD SOURCE="HD1">IV. Analytical Results and Proposed Decisions</HD>
                    <HD SOURCE="HD2">A. What are the results of the risk assessment and analyses?</HD>
                    <P>
                        As previously discussed, we conducted a risk assessment for the PEPO Production source category. We previously identified EtO as a cancer risk driver from facilities with PEPO NESHAP-subject processes in the first risk assessment we conducted in 2014. However, the EPA's IRIS inhalation URE for EtO was revised in 2016,
                        <SU>26</SU>
                        <FTREF/>
                         based on new data, showing EtO to be more carcinogenic than previously understood (
                        <E T="03">i.e.,</E>
                         resulting in a URE 60 times greater than the previous URE over a 70-year lifetime). We briefly present the results of the risk assessment below and in more detail in the document titled 
                        <E T="03">Residual Risk Assessment for the</E>
                         Polyether Polyols (
                        <E T="03">PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             U.S. EPA. 
                            <E T="03">Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide (CASRN 75-21-8) In Support of Summary Information on the Integrated Risk Information System (IRIS).</E>
                             December 2016. EPA/635/R-16/350Fa. Available at: 
                            <E T="03">https://cfpub.epa.gov/ncea/iris/iris_documents/documents/toxreviews/1025tr.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. Chronic Inhalation Risk Assessment Results</HD>
                    <P>
                        Out of the 25 facilities identified as subject to the PEPO NESHAP, two facilities do not have source category emissions included in our risk assessment. One facility has a PEPO source under construction while the other facility did not report records in its emissions inventory with names that that could be linked to its PEPO process and thus we did not have sufficient information to parse out the source category records.
                        <SU>27</SU>
                        <FTREF/>
                         The results of the chronic baseline inhalation cancer risk assessment, which are estimated using modeling and is the case for all risk results presented here and in subsequent sections, indicate that, based on estimates of current actual emissions, the MIR posed by the source category is 1,000-in-1 million, driven by EtO emissions from wastewater (77 percent) and equipment leaks (21 percent). The total estimated cancer incidence based on actual emission levels is 0.3 excess cancer cases per year (or 1 cancer case every 3.3 years). EtO emissions contribute 99.6 percent of the total cancer incidence. Within 50 km of PEPO NESHAP-subject facilities, the population exposed to cancer risk greater than 100-in-1 million for PEPO NESHAP actual emissions is approximately 3,300 people, and the population exposed to cancer risk greater than or equal to 1-in-1 million is approximately 3.8 million people. Of the 23 facilities that the EPA assessed for source category risk, 6 facilities have an estimated maximum cancer risk greater than 100-in-1 million. In addition, the maximum modeled chronic noncancer TOSHI for the source category based on actual emissions is estimated to be 0.1 (for respiratory effects). No populations are estimated to be exposed to a TOSHI greater than 1.
                    </P>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             When considering all emissions reported by the facility for which we could not identify PEPO emissions records, we estimated a facility-wide maximum cancer risk of 70-in-1 million, so including this facility in the PEPO source category risk assessment would not have changed our decisions on standards to address unacceptable risk.
                        </P>
                    </FTNT>
                    <P>Of the 23 facilities that the EPA assessed for the source category risk, 5 facilities have allowable emissions that differ from the actual emissions (see section III.B.2 of this preamble). For the other 18 facilities, actual emissions equal allowable emissions, and therefore, actual risks equal allowable risks for these 18 facilities. Our risk assessment based on allowable emissions includes all 23 facilities. This assessment estimates the MIR posed by the source category is unchanged at 1,000-in-1 million, driven by EtO emissions from wastewater (77 percent) and equipment leaks (21 percent). The total estimated cancer incidence is 0.4 excess cancer cases per year (or 1 cancer case every 2.5 years). EtO emissions contribute 99.6 percent of the total cancer incidence. Within 50 km of PEPO NESHAP-subject facilities, the population exposed to cancer risk greater than 100-in-1 million for PEPO NESHAP allowable emissions is approximately 6,700 people, and the population exposed to cancer risk greater than or equal to 1-in-1 million is approximately 4.7 million people. Of the 23 facilities that the EPA assessed for source category risk, 8 facilities have an estimated maximum cancer risk greater than 100-in-1 million. In addition, the EPA estimated the maximum modeled chronic noncancer TOSHI for the source category based on allowable emissions to be less than 1.</P>
                    <P>See table 1 of this preamble for a summary of the PEPO NESHAP inhalation risk assessment results.</P>
                    <GPOTABLE COLS="8" OPTS="L2,p7,7/8,i1" CDEF="s50,10,10,10,10,10,r50,10">
                        <TTITLE>
                            Table 1—PEPO Production Source Category Inhalation Risk Assessment Results Based on Actual and Allowable Emissions 
                            <SU>1</SU>
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">Risk assessment</CHED>
                            <CHED H="1">
                                Number of facilities 
                                <SU>2</SU>
                            </CHED>
                            <CHED H="1">
                                Maximum
                                <LI>individual</LI>
                                <LI>cancer risk</LI>
                                <LI>(-in-1</LI>
                                <LI>
                                    million) 
                                    <SU>3</SU>
                                </LI>
                            </CHED>
                            <CHED H="1">
                                Estimated population at
                                <LI>increased risk of cancer</LI>
                            </CHED>
                            <CHED H="2">
                                ≥1-in-1
                                <LI>million</LI>
                            </CHED>
                            <CHED H="2">
                                &gt;100-in-1
                                <LI>million</LI>
                            </CHED>
                            <CHED H="1">
                                Estimated
                                <LI>annual</LI>
                                <LI>cancer</LI>
                                <LI>incidence</LI>
                                <LI>(cases per year)</LI>
                            </CHED>
                            <CHED H="1">Maximum chronic noncancer TOSHI</CHED>
                            <CHED H="1">
                                Refined
                                <LI>maximum</LI>
                                <LI>screening</LI>
                                <LI>acute</LI>
                                <LI>noncancer HQ</LI>
                            </CHED>
                        </BOXHD>
                        <ROW EXPSTB="07" RUL="s">
                            <ENT I="21">
                                <E T="02">Baseline (Pre-control) Actual Emissions</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Source Category</ENT>
                            <ENT>23</ENT>
                            <ENT>1,000</ENT>
                            <ENT>3.8</ENT>
                            <ENT>3,300</ENT>
                            <ENT>0.3</ENT>
                            <ENT>0.1 (respiratory)</ENT>
                            <ENT>1</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">
                                Facility-wide 
                                <SU>4</SU>
                            </ENT>
                            <ENT>25</ENT>
                            <ENT>2,000</ENT>
                            <ENT>7.3</ENT>
                            <ENT>4,000</ENT>
                            <ENT>0.6</ENT>
                            <ENT>3 (respiratory)</ENT>
                        </ROW>
                        <ROW EXPSTB="07" RUL="s">
                            <ENT I="21">
                                <E T="02">Baseline (Pre-control) Allowable Emissions</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">
                                Source Category 
                                <SU>1</SU>
                            </ENT>
                            <ENT>23</ENT>
                            <ENT>1,000</ENT>
                            <ENT>4.7</ENT>
                            <ENT>6,700</ENT>
                            <ENT>0.4</ENT>
                            <ENT>0.1 (respiratory)</ENT>
                        </ROW>
                        <TNOTE>
                            <SU>1</SU>
                             There are allowable emissions for 5 facilities. For the other 18 facilities, actual emissions equal allowable emissions.
                        </TNOTE>
                        <TNOTE>
                            <SU>2</SU>
                             There are 25 PEPO production facilities; however, only 23 of these facilities are included in the source category risk assessment based on available data.
                        </TNOTE>
                        <TNOTE>
                            <SU>3</SU>
                             Maximum individual excess lifetime cancer risk due to HAP emissions.
                        </TNOTE>
                        <TNOTE>
                            <SU>4</SU>
                             See “Facility-Wide Risk Results” in section IV.A.5 of this preamble for more details on this risk assessment.
                        </TNOTE>
                    </GPOTABLE>
                    <PRTPAGE P="106004"/>
                    <HD SOURCE="HD3">2. Screening Level Acute Risk Assessment Results</HD>
                    <P>
                        As presented in table 1 of this preamble, the estimated worst-case off-site acute inhalation exposures to emissions from the PEPO Production source category result in a maximum modeled acute noncancer HQ equal to 1 based on the REL for methoxytriglycol (a glycol ether). Acute impacts are deemed negligible for HAP for which acute HQs are less than or equal to 1, and no further analysis is performed for these HAP. The main body and appendix 10 of the document titled 
                        <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                         which is available in the docket for this rulemaking, provides detailed information about the assessment, including evaluation of the screening-level acute risk assessment results.
                    </P>
                    <HD SOURCE="HD3">3. Multipathway Risk Screening Results</HD>
                    <P>
                        For the PEPO Production source category, three facilities emitted at least 1 PB-HAP, including arsenic, cadmium, mercury, and POM.
                        <SU>28</SU>
                        <FTREF/>
                         Emissions of these PB-HAP from each facility were compared to the respective pollutant-specific Tier 1 screening emission thresholds. The Tier 1 screening analysis for PB-HAP (other than lead, which was evaluated differently), indicated no facilities exceeded the Tier 1 emission threshold for arsenic, cadmium, mercury, or POM.
                    </P>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             Note that while the multipathway risk screening results includes metals (
                            <E T="03">e.g.,</E>
                             arsenic, cadmium, mercury) and POM, the EPA used a health-protective approach and included emissions inventory records that were not clearly labeled (not easily categorized) in modeling of emissions from the PEPO Production source category. This means that emissions from other source categories were likely included for this analysis in certain instances. We have no information suggesting that metals or POM are emitted from PEPO processes. See appendix 1 of the document titled 
                            <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                             which is available in the docket for this rulemaking, for more details about development of the risk modeling file.
                        </P>
                    </FTNT>
                    <P>
                        In evaluating the potential for multipathway risk from emissions of lead, the modeled maximum annual ambient lead concentration (0.000002 μg/m
                        <SU>3</SU>
                        ) was compared to the NAAQS for lead (0.15 μg/m
                        <SU>3</SU>
                        , 3-month rolling average). We did not estimate any exceedance of the NAAQS for lead. The modeled maximum annual lead concentration is well below the NAAQS for lead, indicating low potential for multipathway risk of concern due to lead emissions.
                    </P>
                    <P>
                        Detailed information about the assessment is provided in the document titled 
                        <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <HD SOURCE="HD3">4. Environmental Risk Screening Results</HD>
                    <P>
                        As described in section IV.A of this preamble, we conducted a screening assessment for adverse environmental effects for the PEPO Production source category. The environmental screening assessment included the following HAP: arsenic, cadmium, methyl mercury, divalent mercury, and POM.
                        <SU>29</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             Note that while the environmental risk screening results includes metals (
                            <E T="03">e.g.,</E>
                             arsenic, cadmium, lead, mercury), POM, and acid gases (
                            <E T="03">e.g.,</E>
                             HCl), the EPA used a health-protective approach and included emissions inventory records that were not clearly labeled (not easily categorized) in modeling of emissions from the PEPO Production source category to avoid underestimating emissions from PEPO sources. This means that emissions from other source categories were likely included for this analysis in certain instances. We have no information suggesting that metals, POM, or HCl are emitted from PEPO processes. See appendix 1 of the document titled 
                            <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                             which is available in the docket for this rulemaking, for more details about development of the risk modeling file.
                        </P>
                    </FTNT>
                    <P>In the Tier 1 screening analysis for PB-HAP (other than lead, which was evaluated differently), none of the PB-HAP had exceedances for any ecological benchmark.</P>
                    <P>
                        In evaluating the potential adverse environmental risks associated with emissions of lead, the modeled maximum annual ambient lead concentration (0.000002 μg/m
                        <SU>3</SU>
                        ) was compared to the NAAQS for lead (0.15 μg/m
                        <SU>3</SU>
                        , 3-month rolling average). We did not estimate any exceedance of the NAAQS for lead. The modeled maximum annual lead concentration is well below the NAAQS for lead, indicating low potential for environmental risk of concern due to lead emissions.
                    </P>
                    <P>
                        We also conducted an environmental risk screening assessment specifically for acid gases (
                        <E T="03">i.e.,</E>
                         HCl and HF) for the PEPO Production source category. There are no facilities with HF emissions. There are three facilities with HCl emissions. For HCl, the average modeled concentration around each facility (
                        <E T="03">i.e.,</E>
                         the average concentration of all off-site data points in the modeling domain) did not exceed any ecological benchmark. In addition, each individual modeled concentration of HCl (
                        <E T="03">i.e.,</E>
                         each off-site data point in the modeling domain) was below the ecological benchmarks for all facilities.
                    </P>
                    <P>
                        Based on the results of the environmental risk screening analysis, we do not expect an adverse environmental effect as a result of HAP emissions from this source category. Detailed information about the assessments is provided in the document titled 
                        <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <HD SOURCE="HD3">5. Facility-Wide Risk Results</HD>
                    <P>We assessed facility-wide risk, as described in section III.B.7 of this preamble, to characterize the source category risk in the context of “whole facility” risk using the NEI-based data described in section II.C of this preamble. Facility-wide risk was modeled using post-control emissions from the processes subject to the HON to reflect the emissions reductions expected from the HON rulemaking that was signed in early 2024 (89 FR 42932). The maximum lifetime individual cancer risk posed by the 25 modeled facilities based on facility-wide emissions is 2,000-in-1 million with EtO emissions from wastewater (72 percent) and equipment leaks (20 percent) from PEPO production source category emissions driving the risk. The total estimated cancer incidence based on facility-wide emission levels is 0.6 excess cancer cases per year. EtO emissions contribute 94 percent of the total cancer incidence. Within 50 km of PEPO NESHAP-subject facilities, the population exposed to cancer risk greater than 100-in-1 million for PEPO facility-wide emissions is approximately 4,000 people, and the population exposed to cancer risk greater than or equal to 1-in-1 million is approximately 7.3 million people. The maximum chronic noncancer TOSHI due to facility-wide emissions is estimated to be 3 (for respiratory effects) due to emissions of chlorine from 1 facility. A different facility has a chronic noncancer TOSHI of 2 (for respiratory effects) due to facility-wide emissions of maleic anhydride. Approximately 60 people are estimated to be exposed to a TOSHI greater than 1 due to facility-wide emissions. Of the approximately 60 people, 44 people are exposed to a TOSHI of 3 due to emissions of chlorine and 16 people are exposed to a TOSHI of 2 due to emissions of maleic anhydride.</P>
                    <P>
                        After the controls proposed in this action are implemented for the PEPO Production source category (see section IV.B.2 of this preamble), the post-
                        <PRTPAGE P="106005"/>
                        control facility-wide cancer risk remains greater than 100-in-1 million at two facilities.
                    </P>
                    <HD SOURCE="HD3">6. Community-Based Risk Assessment</HD>
                    <P>We also conducted a community-based risk assessment for PEPO NESHAP-subject facilities. The goal of this assessment was to estimate cancer risk from HAP emitted from all local stationary point sources for which we have emissions data. We estimated the overall inhalation cancer risk due to emissions from all stationary point sources impacting census blocks within 10 km of the 25 PEPO production facilities. Specifically, we combined the modeled impacts from category and non-category HAP sources at PEPO production facilities, as well as other stationary point source HAP emissions. Within 10 km of PEPO NESHAP-subject facilities, we identified 823 non-source category facilities that could potentially also contribute to HAP inhalation exposures. Similar to the facility-wide risk assessment, the community-based risk assessment uses post-control emissions from the processes subject to the HON to reflect the emissions reductions expected from the HON rulemaking that was signed in early 2024 (89 FR 42932).</P>
                    <P>
                        We first looked at what the maximum cancer risk is for communities around PEPO production facilities. The results indicate that the community-level maximum individual cancer risk is the same as both the source category MIR and the maximum individual cancer risk for the facility-wide assessment, 2,000-in-1 million. The community-based risk assessment estimated that greater than 99 percent of the community-level maximum individual cancer risk is attributable to emissions from PEPO production facilities (including both source category and non-category emissions). We then looked at the risks to the communities from all emissions sources for which we had data. Within 10 km, the population exposed to cancer risks greater than 100-in-1 million from all nearby emissions is approximately 5,300. For comparison, approximately 3,300 people have cancer risks greater than 100-in-1 million due to PEPO production emissions and approximately 4,000 people have cancer risks greater than 100-in-1 million due to PEPO facility-wide emissions (see table 2 of this preamble). The overall cancer incidence for this exposed population (
                        <E T="03">i.e.,</E>
                         populations with risks greater than 100-in-1 million living within 10 km of PEPO production facilities) is 0.02, with 84 percent of the cancer incidence from PEPO production processes, 9 percent from non-PEPO processes at PEPO production facilities (a total of 93 percent from PEPO production facilities), and 7 percent from other nearby stationary point sources that are not PEPO production facilities.
                    </P>
                    <P>
                        The population exposed to cancer risks greater than or equal to 1-in-1 million in the community-based assessment is approximately 1.2 million people. For comparison, approximately 830,000 people have cancer risks greater than or equal to 1-in-1 million due to PEPO production process emissions and approximately 1.1 million people have cancer risks greater than 1-in-1 million due to PEPO facility-wide emissions (see table 2 of this preamble). The overall cancer incidence for this exposed population (
                        <E T="03">i.e.,</E>
                         people with risks greater than or equal to 1-in-1 million and living within 10 km of PEPO production facilities) is 0.4, with 34 percent of the incidence due to emissions from PEPO production processes, 30 percent from emissions of non-PEPO processes at PEPO production facilities (that is, a total of 64 percent from emissions from PEPO production facilities) and 36 percent from emissions from other nearby stationary sources that are not PEPO production facilities.
                    </P>
                    <P>After the controls proposed in this action are implemented for the PEPO Production source category (see section IV.B.2 of this preamble), the community-level maximum individual cancer risk will be reduced to the same as the facility-wide assessment, 300-in-1 million. The assessment estimated that 51 percent of the MIR is attributable to emissions from non-PEPO processes at a PEPO production facility, 43 percent from PEPO processes and 6 percent from other nearby stationary point sources that are not PEPO production facilities. The population (within 10 km of PEPO facilities) exposed to cancer risks greater than 100-in-1 million from all nearby emissions will be significantly reduced from 5,300 people to 500 people; a 91 percent reduction from the baseline. The populations exposed to cancer risks greater than 100-in-1 million from the PEPO Production source category and facility-wide emissions are similarly reduced, from 3,300 people to 0 for source category emissions and from 4,000 to 200 for facility-wide emissions (see table 2 of this preamble). Furthermore, the overall cancer incidence for this exposed population is expected to be reduced from 0.02 to 0.001. The percentage of cancer incidence due to emissions from PEPO processes is reduced from 84 percent to 28 percent. The percentage of the cancer incidence due to emissions from non-PEPO processes at PEPO production facilities and emissions from other nearby stationary sources proportionately shifts to 46 percent and 26 percent respectively. EtO emissions across these sources remain the largest source of incidence, accounting for 93 percent of the overall cancer incidence for this exposed population.</P>
                    <P>The post-control population exposed to cancer risks greater than or equal to 1-in-1 million will be reduced from 1.2 million to 1.1 million. In comparison, after the controls proposed in this action, the number of people with risks greater than or equal to 1-in-1 million due to source category emissions would reduce from 830,000 to 560,000 and due to facility-wide emissions from 1.1 million to 1 million (see table 2 of this preamble). The overall cancer incidence for this exposed population is expected to be reduced from 0.4 to 0.3. The percentage of cancer incidence from PEPO processes is expected to decrease from 34 to 11 percent. The cancer incidence from non-PEPO processes at PEPO production facilities and from other nearby stationary sources are expected to proportionately shift to 40 percent and 49 percent, respectively.</P>
                    <P>
                        More results from the community-based assessment are provided in the document titled 
                        <E T="03">Analysis of Demographic Factors For Populations Living Near Polyether Polyols (PEPO) Production Facilities—Community-Based Assessment,</E>
                         which is available in the docket for this rulemaking.
                        <PRTPAGE P="106006"/>
                    </P>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s100,12,12,12">
                        <TTITLE>
                            Table 2—Inhalation Cancer Risk Assessment Results for Communities Living Within 10 
                            <E T="01">km</E>
                             of PEPO Production Facilities
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">Risk assessment</CHED>
                            <CHED H="1">
                                Maximum
                                <LI>individual</LI>
                                <LI>cancer risk </LI>
                                <LI>(-in-1 million)</LI>
                            </CHED>
                            <CHED H="1">
                                Estimated population at
                                <LI>increased risk of cancer</LI>
                            </CHED>
                            <CHED H="2">
                                &gt;100-in-1
                                <LI>million</LI>
                            </CHED>
                            <CHED H="2">≥1-in-1 million</CHED>
                        </BOXHD>
                        <ROW EXPSTB="03" RUL="s">
                            <ENT I="21">
                                <E T="02">Baseline (Pre-control)</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">PEPO Production Source Category</ENT>
                            <ENT>1,000</ENT>
                            <ENT>3,300</ENT>
                            <ENT>830,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Facility-wide</ENT>
                            <ENT>2,000</ENT>
                            <ENT>4,000</ENT>
                            <ENT>1.1 million</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Community-based</ENT>
                            <ENT>2,000</ENT>
                            <ENT>5,300</ENT>
                            <ENT>1.2 million</ENT>
                        </ROW>
                        <ROW EXPSTB="03" RUL="s">
                            <ENT I="21">
                                <E T="02">After Implementation of Proposed Controls (Post-control)</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">PEPO Production Source Category</ENT>
                            <ENT>100</ENT>
                            <ENT>0</ENT>
                            <ENT>560,000</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Facility-wide</ENT>
                            <ENT>300</ENT>
                            <ENT>200</ENT>
                            <ENT>1 million</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Community-based</ENT>
                            <ENT>300</ENT>
                            <ENT>500</ENT>
                            <ENT>1.1 million</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD3">7. What demographic groups might benefit from this regulation?</HD>
                    <P>
                        To examine the potential for EJ concerns, the EPA conducted three different demographic analyses: a proximity analysis, baseline cancer risk-based analysis (
                        <E T="03">i.e.,</E>
                         before implementation of any controls required by this proposed action), and post-control cancer risk-based analysis (
                        <E T="03">i.e.,</E>
                         after implementation of the controls required by this proposed action). The proximity demographic analysis is an assessment of individual demographic groups in the total population living within 10 km (~6.2 miles) and 50 km (~31 miles) of the facilities. The baseline risk-based demographic analysis is an assessment of risks to individual demographic groups in the population living within 10 km and 50 km of the facilities prior to the implementation of any controls required by this proposed action (“baseline”). The post-control risk-based demographic analysis is an assessment of risks to individual demographic groups in the population living within 10 km and 50 km of the facilities after implementation of the controls required by this proposed action (“post-control”). Each of these demographic analyses were performed for the following three different HAP emissions scenarios: PEPO category HAP emissions (10 km and 50 km), whole-facility HAP emissions (10 km and 50 km), and community HAP emissions (10 km only). Demographic groups included in the analyses are: White, Black, American Indian and Alaskan Native, other races and multiracial, Hispanic or Latino, children 17 years of age and under, adults 18 to 64 years of age, adults 65 years of age and over, adults over 25 without a high school diploma, people living below the poverty level, people living below two times the poverty level, and linguistically isolated people. For a detailed discussion of the types of EJ analyses performed for this proposal and their results see section V.F of this preamble, “
                        <E T="03">What analysis of environmental justice did we conduct?</E>
                        ”
                    </P>
                    <HD SOURCE="HD2">B. What are our proposed decisions regarding risk acceptability, ample margin of safety, and adverse environmental effect?</HD>
                    <HD SOURCE="HD3">1. Risk Acceptability Under the Current MACT Standards</HD>
                    <P>As noted in section III.A of this preamble, we weigh a wide range of health risk measures and factors in our risk acceptability determination, including the cancer MIR, the number of persons in various cancer and noncancer risk ranges, cancer incidence, the maximum noncancer TOSHI, the maximum acute noncancer HQ, the extent of noncancer risks, the distribution of cancer and noncancer risks in the exposed population, and risk estimation uncertainties (54 FR 38044, September 14, 1989).</P>
                    <P>Under the current MACT standards for the PEPO Production source category, the risk results indicate that the MIR is 1,000-in-1 million, driven by emissions of EtO, and well above 100-in-1 million, which is the presumptive limit of acceptability. The estimated incidence of cancer due to inhalation exposures is 0.3 excess cancer case per year. The population estimated to be exposed to cancer risks greater than 100-in-1 million is approximately 3,300, and the population estimated to be exposed to cancer risks greater than or equal to 1-in-1 million is approximately 3.8 million. The estimated maximum chronic noncancer TOSHI from inhalation exposure for this source category is 0.1 (for respiratory effects). The acute risk screening assessment of reasonable worst-case inhalation impacts indicates a maximum acute noncancer HQ of 1.</P>
                    <P>Considering all of the health risk information and factors discussed above, particularly the high MIR for the PEPO Production source category, the EPA proposes that the risks for the source category are unacceptable. As noted in section II.A of this preamble, when risks are unacceptable, under the 1989 Benzene NESHAP approach and CAA section 112(f)(2)(A), the EPA must first determine the emissions standards necessary to reduce risk to an acceptable level, and then determine whether further HAP emissions reductions are necessary to provide an ample margin of safety to protect public health or to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect. Therefore, pursuant to CAA section 112(f)(2), we are proposing certain standards for emission sources of EtO in the PEPO Production source category that are more protective than the current PEPO NESHAP MACT standards.</P>
                    <HD SOURCE="HD3">2. Proposed Controls To Address Unacceptable Risks</HD>
                    <P>As previously discussed, we conducted a risk assessment of the PEPO Production source category because the 2016 revision to the EPA's IRIS inhalation URE for EtO showed that EtO is more toxic than previously known.</P>
                    <P>
                        For the PEPO Production source category, we identified EtO as the cancer risk driver from PEPO sources. We are aware of 20 PEPO facilities reporting EtO emissions in their emissions inventories from PEPO production processes. From our residual risk assessment, six facilities with emissions of EtO from process vents, storage vessels, equipment leaks, and wastewater have estimated cancer risks 
                        <PRTPAGE P="106007"/>
                        greater than 100-in-1 million in nearby communities. Additionally, an allowable leak of EtO from a heat exchange system contributes to cancer risks greater than 100-in-1 million. Thus, to reduce emissions of EtO from PEPO processes, the EPA is proposing more stringent control requirements for process vents, storage vessels, equipment leaks, heat exchange systems, and wastewater that emit or have the potential to emit EtO. As discussed later in this preamble, we are proposing that these requirements will reduce risk to an acceptable level and provide an ample margin of safety to protect public health, and no additional requirements are needed to prevent an adverse environmental effect.
                    </P>
                    <P>We discuss the control options we evaluated for reducing EtO emissions from PEPO processes in sections IV.B.2.a through IV.B.2.e of this preamble.</P>
                    <HD SOURCE="HD3">a. Process Vents and Storage Vessels</HD>
                    <P>Process vents that emit EtO are primarily associated with reactors (from batch unit operations and continuous unit operations) that produce PEPO products using epoxides as a reactant. Other unit operations within the PMPU may also have process vents that emit EtO, such as process vents on condensers and distillation units.</P>
                    <P>
                        The PEPO NESHAP (40 CFR 63.1425) specifies control requirements for process vents, based on the PEPO polymerization process (
                        <E T="03">i.e.,</E>
                         polymerization using epoxides versus using THF). For PEPO processes that use epoxides as the reactant, the PEPO NESHAP specifies emissions limits for: (1) epoxide emissions, (2) nonepoxide organic HAP emissions from processes that use nonepoxide HAP to make or modify the product, and (3) nonepoxide organic HAP emissions from catalyst extraction. For the epoxide standards, the PEPO NESHAP (40 CFR 63.1425(b)) requires owners or operators to either: (1) reduce emissions at existing sources by 98 percent and new sources by 99.9 percent; (2) control emissions using a flare (existing sources only); (3) achieve an outlet concentration of 20 parts per million by volume (ppmv) or less; or (4) limit emissions to 1.69 × 10
                        <E T="51">−2</E>
                         kilogram of epoxide per megagram of product at existing sources and 4.43 × 10
                        <E T="51">−3</E>
                         kilogram of epoxide per megagram of product at new sources. We provide more details about process vents in our technology review discussion (see section IV.C.3 of this preamble) including specifics about the process vent standards for nonepoxide organic HAP emissions from processes that use nonepoxide HAP to make or modify the product, and for nonepoxide organic HAP emissions from catalyst extraction.
                    </P>
                    <P>PEPO facilities use storage vessels to hold liquid and gaseous feedstocks for use in a process, as well as to store liquid and gaseous products from a process. Facilities typically store EtO under pressure as a liquified gas, but EtO may also be found in small amounts in atmospheric storage vessels storing liquid products that use EtO as a reactant in their production. Typical emissions from atmospheric storage tanks occur from working and breathing losses, while pressure vessels are considered closed systems and, if properly maintained and operated, should have virtually no emissions. In some instances, there may be low levels of fugitive emissions from pressure vessels, and pressure vessels storing liquefied gases may be vented periodically to purge inerts.</P>
                    <P>
                        The PEPO NESHAP (40 CFR 63.1432) cites the control provisions specified in the HON (40 CFR 63.119 through 63.123) which require owners or operators determine Group 1 or Group 2 designations of affected storage vessels, based on the volume of the storage vessel and maximum true vapor pressure (MTVP) of the material stored. Group 1 storage vessels are those with capacities between 75 m
                        <SU>3</SU>
                         (inclusive) and 151 m
                        <SU>3</SU>
                         and a MTVP greater than or equal to 13.1 kilopascals (kPa), and those with capacities greater than or equal to 151 m
                        <SU>3</SU>
                         and a MTVP greater than or equal to 5.2 kPa. The HON storage vessel standards that PEPO affected sources are currently subject to 
                        <SU>30</SU>
                        <FTREF/>
                         require Group 1 storage vessels to reduce total HAP emissions by 95 percent (or 90 percent if the storage vessel was installed on or before December 31, 1992) by venting emissions through a closed vent system to any combination of control devices or to vent emissions through a closed vent system to a flare. Owners and operators of Group 1 storage vessels storing a liquid with a MTVP of total organic HAP less than 76.6 kPa are also allowed to reduce organic HAP by utilizing an internal floating roof (IFR), an external floating roof (EFR), an EFR converted to an IFR, vapor balancing, or by routing the emissions to a process or a fuel gas system. For Group 1 storage vessels storing a liquid with a MTVP of total organic HAP greater than or equal to 76.6 kPa, owners and operators can reduce organic HAP emissions by 95 percent by venting emissions through a closed vent system to any combination of control devices, controlling emissions by routing them to a process or a fuel gas system, or by using vapor balancing. Pressure vessels (operating in excess of 204.9 kPa without emissions to the atmosphere) may also store materials with EtO. For storage vessels, the PEPO NESHAP, by reference to the HON, allows use of a design evaluation instead of a performance test to determine the percent reduction of control devices for any quantity of total uncontrolled organic HAP emissions being sent to the control device. We provide more details about storage vessels in our technology review discussion (see section IV.C.2 of this preamble).
                    </P>
                    <FTNT>
                        <P>
                            <SU>30</SU>
                             The HON requirements that were added in 2024 (89 FR 42932, May 16, 2024) apply to only the SOCMI source category; therefore, those 2024 HON amendments are currently not applicable to the PEPO Production source category. In other words, when we discuss the current PEPO NESHAP requirements that refer to HON, we mean pre-2024 HON requirements.
                        </P>
                    </FTNT>
                    <P>Based on results from the risk assessment, we determined that the current MACT standards for PEPO process vents and storage vessels do not result in sufficient control of EtO emissions to prevent unacceptable risk. For example, emissions of EtO from PEPO process vents and storage vessels contribute to 72 percent of one facility's maximum individual cancer risk of 500-in-1 million. Therefore, we evaluated available control technologies with a higher level of control, as discussed below.</P>
                    <P>To lower the risk for PEPO facilities with EtO emissions, we analyzed a control option for process vents and storage vessels that are in EtO service which requires all process vents and storage vessels in EtO service to be controlled. This control option is based on requirements that were recently finalized in the MON and HON because of unacceptable risk (see 85 FR 49084, August 12, 2020, and 89 FR 42932, May 16, 2024, respectively). The definitions of process vents and storage vessels “in ethylene oxide service” from the MON and HON are presented here:</P>
                    <P>• For process vents, “in ethylene oxide service” means, when uncontrolled, each process vent contains a concentration of greater than or equal to 1 ppmv undiluted EtO, and when combined, the sum of all process vents within the process would emit uncontrolled EtO emissions greater than or equal to 5 lb/yr.</P>
                    <P>• For storage vessels of any capacity and vapor pressure, “in ethylene oxide service” means that the concentration of EtO within the tank liquid is greater than or equal to 0.1 percent by weight.</P>
                    <P>
                        The MON and HON standards for process vents and storage vessels in EtO service, require owners and operators to route emissions through a closed vent 
                        <PRTPAGE P="106008"/>
                        system to a: (1) control device that reduces EtO by at least 99.9 percent by weight or to a concentration less than 1 ppmv for each process vent and storage vessel vent (or, for multiple process vents within a process, to less than 5 lb/yr for all combined process vents), or (2) flare meeting certain flare operating and monitoring requirements.
                    </P>
                    <P>To ensure emissions from PEPO affected sources are controlled to an acceptable level of risk under the PEPO NESHAP, we are proposing to incorporate the same EtO emissions standards for process vents and storage vessels from the MON and HON into the PEPO NESHAP. Specifically, we are proposing at 40 CFR 63.1423(b) to refer to subpart F of the HON which defines the term “in ethylene oxide service” for process vents to mean each process vent in a process that, when uncontrolled, contains a concentration of greater than or equal to 1 ppmv undiluted EtO, and when combined, the sum of all these process vents within the process would emit uncontrolled EtO emissions greater than or equal to 5 pounds per year (lb/yr) (2.27 kilograms per year, kg/yr). We are also proposing to update the definition of “process vent” at 40 CFR 63.1423(b) to align with this proposed change. We are also proposing in the PEPO NESHAP at 40 CFR 63.1423(b) to refer to subpart F of the HON which defines the term “in ethylene oxide service” for storage vessels to mean that the concentration of EtO of the stored liquid is at least 0.1 percent by weight. We are also proposing that the exemption for “vessels and equipment storing and/or handling material that contains no organic HAP, or organic HAP as impurities only” listed in the definition of “storage vessel” at 40 CFR 63.1423(b) does not apply for storage vessels in EtO service. We are proposing procedures for determining whether process vents and/or storage vessels are in EtO service within the proposed definition of the term “in ethylene oxide service” (by reference to 40 CFR 63.109 for PEPO process vents and storage vessels in EtO service). We are proposing at 40 CFR 63.1425(g) that PEPO process vents in EtO service either reduce emissions of EtO by: (1) venting emissions through a closed vent system to a non-flare control device that reduces EtO by at least 99.9 percent by weight, or to a concentration less than 1 ppmv for each process vent, or to less than 5 lb/yr for all combined process vents within the process; or (2) routing emissions through a closed vent system to a flare meeting the proposed flare operating requirements discussed in section IV.D.1 of this preamble (see proposed 40 CFR 63.1436). We are proposing at 40 CFR 63.1432(a) by reference to the HON (40 CFR 63.119(a)(5)) that PEPO storage vessels in EtO service either reduce emissions of EtO by: (1) venting emissions through a closed vent system to a non-flare control device that reduces EtO by at least 99.9 percent by weight or to a concentration less than 1 ppmv for each storage tank vent; or (2) venting emissions through a closed vent system to a flare meeting the proposed flare operating requirements discussed in section IV.D.1 of this preamble (see proposed 40 CFR 63.1436). We are proposing procedures to determine compliance with these proposed EtO standards at 40 CFR 63.1426(g) (by reference to 40 CFR 63.124 for PEPO process vents in EtO service) and 40 CFR 63.1432(v) (by reference to 40 CFR 63.124 for PEPO storage vessels in EtO service). In section IV.D.1 of this preamble, we recognized flares cannot achieve 99.9 percent EtO reduction. We also noted that as part of the CAA section 114 request, five facilities measured EtO emissions from their EtO emission points and only one of these five facilities currently use a flare to control EtO emissions from process vents or storage vessels. Even so, our modeling file does include several other PEPO facilities that do use flares to control process vents and storage vessels that emit EtO. Therefore, we accounted for these flares operating at 98 percent EtO reduction in our risk assessment and determined that it is not necessary for flares to achieve 99.9 percent EtO reduction to reduce risk to an acceptable level and provide an ample margin of safety to protect public health (provided that owners and operators still comply with the entire suite of EtO control requirements that we are proposing in this action).</P>
                    <P>Additionally, we propose removing the option to allow use of a design evaluation in lieu of performance testing to demonstrate compliance for storage vessels in EtO service to ensure that the required level of control is achieved (see proposed 40 CFR 63.1432(v) by reference to the HON (40 CFR 63.124(a)(2)(i) and (b)(3))). We are also proposing that after promulgation of the rule, owners or operators that choose to control emissions with a non-flare control device conduct an initial performance test according to proposed 40 CFR 63.1426(g) and 63.1432(v) by reference to the HON (40 CFR 63.124) on each existing control device in EtO service and on each newly installed control device in EtO service to verify performance at the required level of control. We are also proposing at 40 CFR 63.1426(g) and 63.1432(v) by reference to the HON (40 CFR 63.124(b)) that owners or operators conduct periodic performance testing on non-flare control devices in EtO service every 5 years.</P>
                    <P>
                        Finally, we are proposing at 40 CFR 63.1427(a) that owners and operators may not use the extended cookout (ECO) pollution prevention technique to show compliance with the proposed standard for PEPO process vents in EtO service. The PEPO NESHAP at 40 CFR 63.1427(a) allows the use of ECO as a means of reducing epoxide emissions by the required percentage (98 or 99.9 percent) or complying with the production-based limit (≤1.69 × 10
                        <E T="51">−2</E>
                         or 4.43 × 10
                        <E T="51">−3</E>
                         kilograms of epoxide emissions per megagram of product made). This pollution prevention technique reduces emissions by extending the time of reaction, thus leaving less unreacted epoxides to be emitted downstream. To demonstrate a percent efficiency, it is necessary to designate the basis, or the “uncontrolled” emissions, for assessing the percent reduction. The point where uncontrolled emissions are to be assessed, called the “onset” of the ECO, is defined in the PEPO NESHAP at 40 CFR 63.1427(c) as the point when the epoxide concentration in the reactor liquid is equal to 25 percent of the concentration of epoxide in the liquid at the end of the epoxide feed. Procedures to calculate epoxide emissions at the end of ECO are provided in 40 CFR 63.1427(d). The EPA determined the default onset of ECO based on CBI from the Society of the Plastics Industry, which indicated the economic breakpoint for when a cookout is no longer economically advantageous (see 62 FR 46804, September 4, 1997). However, new economic conditions suggest the ECO compliance option may no longer be viable. For instance, one facility reported, in response to the EPA's CAA section 114 request, that their customers require less than 1 ppm residual EtO, 
                        <E T="03">i.e.,</E>
                         it is economically advantageous to continue the reaction until 1 ppm is reached. It is impractical to achieve a 99.9 percent reduction from an onset of 1 ppm. Additionally, using the current definition of onset, ECO could lead to high EtO emissions relative to the starting amount of epoxide used. Therefore, we believe it is not appropriate to continue allowing the ECO pollution prevention technique to demonstrate compliance with the proposed EtO emissions standards (
                        <E T="03">i.e.,</E>
                         reduce EtO by at least 99.9 percent by weight) that are intended to control 
                        <PRTPAGE P="106009"/>
                        emissions from process vents and storage vessels to an acceptable risk level. We are also proposing that it is not appropriate to continue to allow the existing production-based limits (
                        <E T="03">i.e.,</E>
                         ≤1.69 × 10
                        <E T="51">−2</E>
                         or 4.43 × 10
                        <E T="51">−3</E>
                         kilograms of epoxide emissions per megagram of product made) in place of the new EtO emissions standards. The 1.69 × 10
                        <E T="51">−3</E>
                         production-based limit is an alternative to the 98 percent emission reduction standard for existing affected sources which is not as stringent as the proposed 99.9 percent emission reduction standard for EtO. While the 4.43 × 10
                        <E T="51">−3</E>
                         production-based limit is an alternative to the 99.9 percent emission reduction standard for new affected sources, it is related to the aggregate reduction of total epoxide emissions and not specifically to EtO emissions. Additionally, it is not clear how these production-based limits (also referred to “as emission factors”) were derived 
                        <SU>31</SU>
                        <FTREF/>
                         and we do not have enough information to set a new production-based limit that would be equivalent to the proposed EtO emissions standards.
                    </P>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             Although the original proposal for the PEPO NESHAP (62 FR 46804, September 4, 1997) mentions that the method for determining these emission factors is detailed in the Supplementary Information Document, we could not locate this derivation in the document titled 
                            <E T="03">Hazardous Air Pollutant Emissions from the Production of Polyether Polyols—Supplementary Information Document for Proposed Standards</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        See the document titled 
                        <E T="03">Analysis of Control Options for Process Vents and Storage Vessels to Reduce Residual Risk of Ethylene Oxide in the PEPO Production Source Category,</E>
                         which is available in the docket for this action, for more information on the control option the EPA evaluated to reduce EtO risk from PEPO process vents and storage vessels.
                    </P>
                    <HD SOURCE="HD3">b. Equipment Leaks</HD>
                    <P>
                        Emissions of EtO from equipment leaks occur in the form of gases or liquids that escape to the atmosphere through connection points (
                        <E T="03">e.g.,</E>
                         threaded fittings) or through the moving parts of valves, pumps, compressors, PRDs, and certain types of process equipment. The PEPO NESHAP defines equipment leaks as “emissions of organic HAP from a connector, pump, compressor, agitator, pressure relief device, sampling connection system, open-ended valve or line, valve, surge control vessel, bottoms receiver, or instrumentation system in organic HAP service.” The equipment leak requirements apply to equipment that contain or contact material that are 5 percent by weight or more of organic HAP, operate 300 hours per year or more, and are not in vacuum service.
                    </P>
                    <P>
                        The PEPO NESHAP requirements for equipment leaks directly reference the provisions in 40 CFR part 63, subpart H (which is part of the HON). The HON equipment leak requirements vary by equipment component type, but require LDAR using monitoring with EPA Method 21 of appendix A-7 to 40 CFR part 60 at certain frequencies (
                        <E T="03">e.g.,</E>
                         monthly, quarterly, every 2 quarters, annually) and varying leak definitions (
                        <E T="03">e.g.,</E>
                         500 ppmv; 1,000 ppmv; 10,000 ppmv) depending on the type of service (
                        <E T="03">e.g.,</E>
                         gas and vapor service or in light liquid service). The LDAR requirements for components in heavy liquid service include sensory monitoring and the use of EPA Method 21 monitoring if a leak is identified. We provide more details about equipment leaks in our technology review discussion (see section IV.C.5 of this preamble).
                    </P>
                    <P>Results from our risk assessment indicate that, for the source category MIR of 1,000-in-1 million, more than 20 percent is from emissions of EtO related to PEPO equipment leaks. We also note that the risk from EtO from PEPO equipment leaks at three facilities (including the facility driving the MIR) is ≥100-in-1 million. To help reduce the risk associated with EtO emissions from equipment leaks in the PEPO Production source category, we performed a review of available measures for reducing EtO emissions from components that are most likely to be in EtO service, which include connectors (in gas and vapor service or light liquid service), pumps (in light liquid service), and valves (in gas or light liquid service). We identified options for further strengthening LDAR practices to find and repair equipment leaks from these three pieces of equipment more quickly, including lowering the leak definitions and/or requiring more frequent monitoring with EPA Method 21 of appendix A-7 to 40 CFR part 60, which align with the recently finalized EtO standards for equipment leaks in the HON (89 FR 42932, May 16, 2024).</P>
                    <P>
                        For gas/vapor and light liquid connectors in EtO service, we identified two options: (1) require connector monitoring at a leak definition of 500 ppmv with annual monitoring and no reduction in monitoring frequency (
                        <E T="03">i.e.,</E>
                         no skip periods), and (2) require connector monitoring at a leak definition of 100 ppmv with annual monitoring and no reduction in monitoring frequency.
                    </P>
                    <P>
                        For light liquid pumps in EtO service, we identified three options: (1) lower the leak definition from 1,000 ppmv to 500 ppmv with monthly monitoring, (2) lower the leak definition from 1,000 ppmv to 100 ppmv with monthly monitoring, or (3) require the use of leakless pumps (
                        <E T="03">i.e.,</E>
                         canned pumps, magnetic drive pumps, diaphragm pumps, pumps with tandem mechanical seals, pumps with double mechanical seals) with annual monitoring and a leak defined as any reading above background concentration levels.
                    </P>
                    <P>For gas/vapor and light liquid valves in EtO service, we identified two options: (1) require a leak definition of 500 ppmv with monthly monitoring and no reduction in monitoring frequency, and (2) lower the leak definition from 500 ppmv to 100 ppmv with monthly monitoring and no reduction in monitoring frequency.</P>
                    <P>Due to the high residual risk for some of the facilities from equipment leaks of EtO and the potential need for greater emission reduction to meet an acceptable level of risk for the PEPO Production source category, we also evaluated a more stringent combined option which requires monthly monitoring for valves (in gas/vapor and light liquid service), connectors (in gas/vapor and light liquid service), and pumps (light liquid service) in EtO service at a leak definition of 100 ppmv for valves and connectors and 500 ppmv for light liquid pumps using EPA Method 21 of appendix A-7 to 40 CFR part 60. This combined option also does not allow equipment in EtO service to be monitored less frequently with skip periods, nor does the option allow facilities to take advantage of the delay of repair provisions. We analyzed increasing the monitoring frequency to monthly for connectors because they are the most numerous equipment components at chemical facilities, and they are the most significant contribution to the baseline emissions from leaking equipment at the EtO-emitting facilities.</P>
                    <P>
                        For the component-specific control options, we calculated the EtO baseline emissions and emissions after implementation of controls for each facility using average volatile organic compound (VOC) emission rates for each component, and the component counts and the EtO weight percent of the process from the responses to the EPA's CAA section 114 request. For the combined option of monthly monitoring of gas and light liquid valves and connectors at 100 ppmv and light liquid pumps at 500 ppmv, we do not have emission factors to estimate reductions for increased monitoring frequencies for connectors. Where a simplified emission factor method for determining the potential reductions of applying the 
                        <PRTPAGE P="106010"/>
                        option did not exist, we estimated emissions reductions based on the approach used in other rules,
                        <SU>32</SU>
                        <FTREF/>
                         where detailed leak data or an assumed leak distribution were available. The equipment leaks model uses a Monte Carlo analysis to estimate emissions from EtO facility equipment leaks. The memorandum 
                        <E T="03">Analysis of Control Options for Equipment Leaks to Reduce Residual Risk of Ethylene Oxide in the PEPO Production Source Category,</E>
                         which is available in the docket for this action, provides a detailed discussion of the model.
                    </P>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             
                            <E T="03">Gas Plant Equipment Leak Monte Carlo Model Code and Instructions.</E>
                             October 21, 2021. EPA Docket No. EPA-HQ-OAR-2021-0317. 
                            <E T="03">Control Options for Equipment Leaks at Gasoline Distribution Facilities.</E>
                             October 20, 2021. EPA Docket No. EPA-HQ-OAR-2020-0371.
                        </P>
                    </FTNT>
                    <P>
                        In this action, we are also proposing the same definition for the term “in ethylene oxide service” for equipment as used in the final amendments to the HON (89 FR 42932, May 16, 2024).
                        <SU>33</SU>
                        <FTREF/>
                         For equipment leaks, we are proposing to define “in ethylene oxide service” in the PEPO NESHAP at 40 CFR 63.1423(b) (by reference to 40 CFR 63.101) to mean any equipment that contains or contacts a fluid (liquid or gas) that is at least 0.1 percent by weight of EtO. We are proposing procedures for determining whether equipment is in EtO service within the proposed definition of the term “in ethylene oxide service” (by reference to 40 CFR 63.109 for PEPO equipment in EtO service). We are proposing that any piece of equipment that is in ethylene oxide service is also in organic HAP service. For PEPO equipment in EtO service, to achieve greater emissions reductions to help meet an acceptable level of risk for the PEPO Production source category, we are proposing the following combined requirements: monitoring of connectors in gas/vapor and light liquid service at a leak definition of 100 ppmv on a monthly basis with no reduction in monitoring frequency or delay of repair; monthly monitoring of light liquid pumps at a leak definition of 500 ppmv; and monthly monitoring of gas/vapor and light liquid valves at a leak definition of 100 ppmv with no reduction in monitoring frequency or delay of repair (see proposed 40 CFR 63.1434(a) by reference to the HON). The document titled 
                        <E T="03">Analysis of Control Options for Equipment Leaks to Reduce Residual Risk of Ethylene Oxide in the PEPO Production Source Category,</E>
                         which is available in the docket for this action, provides additional information on all evaluated control options to reduce EtO risk from PEPO equipment leaks.
                    </P>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             See 40 CFR 63.101.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">c. Heat Exchange Systems</HD>
                    <P>
                        Emissions of EtO from heat exchange systems occur due to corrosion or cracks in internal tubing materials, which allows some process fluids to mix or become entrained with the cooling water. Pollutants (
                        <E T="03">e.g.,</E>
                         EtO) in the process fluids may subsequently be released from the cooling water into the atmosphere when the water is exposed to air (
                        <E T="03">e.g.,</E>
                         in a cooling tower for closed-loop systems or trenches/ponds in a once-through system). The HON heat exchange system standards that PEPO affected sources are currently subject to require owners or operators to monitor heat exchange systems for leaks of process fluids into cooling water and take actions to repair leaks within 45 days if they are detected (facilities may delay the repair of leaks if they meet certain criteria). To comply with the provisions, owners or operators can use any method listed in 40 CFR part 136 to sample cooling water for leaks for the HAP listed in table 4 to subpart F (recirculating systems) and table 9 to subpart G (once-through systems) (and other representative substances such as total organic compounds (TOC) or VOC that can indicate the presence of a leak can also be used). In addition, owners or operators can monitor for leaks using a surrogate indicator (
                        <E T="03">e.g.,</E>
                         ion specific electrode monitoring, pH, conductivity), provided that they meet certain criteria in 40 CFR 63.104(c). We provide more details about heat exchange systems in our technology review discussion (see section IV.C.1 of this preamble).
                    </P>
                    <P>
                        For heat exchange systems, we found that, while we did not identify a report of EtO emissions from a PEPO heat exchange system leak, a model using representative leaks (and the current standards for monitoring and repair) indicated that a potential leak currently allowed by the PEPO NESHAP containing EtO from a facility's cooling tower could significantly contribute to unacceptable risk. Thus, we are proposing to use the same definition of the term “in ethylene oxide service” as used in the final amendments to the HON (89 FR 42932, May 16, 2024). We are proposing in the PEPO NESHAP at 40 CFR 63.1423 to refer to subpart F of the HON which defines the term “in ethylene oxide service” for heat exchange systems to mean any heat exchange system in a process that cools process fluids (liquid or gas) that are 0.1 percent or greater by weight of EtO. We are proposing procedures for determining whether heat exchange systems are in EtO service within the proposed definition of the term “in ethylene oxide service” (by reference to 40 CFR 63.109 for PEPO heat exchange systems in EtO service). We are proposing that any heat exchange system that is in ethylene oxide service is also in organic HAP service. To address risk from EtO allowable emissions due to PEPO heat exchange system leaks, we evaluated the following option for PEPO heat exchange systems “in ethylene oxide service” which: (1) requires use of the Modified El Paso Method (see section IV.C.1 of this preamble), (2) requires quarterly monitoring using the Modified El Paso Method, (3) reduces the allowed amount of repair time from 45 days after finding a leak to 15 days from the sampling date, and (4) prohibits delay of repair. We also evaluated this same option except with varying monitoring frequencies (
                        <E T="03">i.e.,</E>
                         monthly and weekly) instead of quarterly. Using equation 7-2 from appendix P of the Texas Commission on Environmental Quality's (TCEQ) Sampling Procedures Manual,
                        <SU>34</SU>
                        <FTREF/>
                         model leak distributions and concentrations, and other model input parameters, we anticipate the quarterly option would reduce EtO emissions from leaking PEPO heat exchange systems by 54 percent because owners or operators would identify and repair leaks more quickly, which is needed to help reduce potential unacceptable risk from the PEPO Production source category. See section IV.B.4 of this preamble for an analysis of the monthly and weekly options to provide an ample margin of safety. We are proposing weekly monitoring at 40 CFR 63.1435(a) by reference to the HON (40 CFR 63.104(g)(6)) based on that ample margin of safety analysis. The document titled 
                        <E T="03">Analysis of Control Options for Heat Exchange Systems to Reduce Residual Risk of Ethylene Oxide in the PEPO Production Source Category,</E>
                         which is available in the docket for this action, provides additional information on this evaluated control option to reduce EtO risk from PEPO heat exchange systems.
                    </P>
                    <FTNT>
                        <P>
                            <SU>34</SU>
                             See appendix B in the document titled: 
                            <E T="03">The Air Stripping Method (Modified El Paso Method) for Determination of Volatile Organic Compound (VOC) Emissions from Water Sources,</E>
                             which is included in the docket for this rulemaking.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">d. Wastewater</HD>
                    <P>
                        EtO is emitted from wastewater collection, storage, and treatment systems that are uncovered or open to the atmosphere through volatilization of the compound at the liquid surface. Emissions occur by diffusive or convective means, or both. Diffusion occurs when organic pollutant 
                        <PRTPAGE P="106011"/>
                        concentrations at the water surface are much higher than ambient concentrations. The organic pollutants volatilize, or diffuse into the air, to reach equilibrium between the aqueous and vapor phases. Convection occurs when air flows over the water surface, sweeping organic vapors from the water surface into the air. The rate of volatilization is related directly to the speed of the air flow over the water surface.
                    </P>
                    <P>
                        The HON wastewater standards that PEPO affected sources are currently subject to (40 CFR 63.1433 cites the control provisions specified in the HON at 40 CFR 63.132 through 63.147) divide wastewater streams into Group 1 wastewater streams, which require controls, and Group 2 wastewater streams, which generally do not require controls provided they do not exceed Group 1 thresholds. The Group 1 and Group 2 designations for wastewater streams are based on volumetric flow rate and total annual average organic HAP concentration. The HON specifies performance standards for treating Group 1 wastewater streams using open or closed biological treatment systems or using a design steam stripper with vent control. For APCDs (
                        <E T="03">e.g.,</E>
                         thermal oxidizers) used to control emissions from collection system components, steam strippers, or closed biological treatment, the HON provides owners or operators several compliance options including achieving a 95-percent destruction efficiency, achieving a 20-ppmv outlet concentration, or implementing design specifications for temperature and residence time. We provide more details about wastewater streams in our technology review discussion (see section IV.C.4 of this preamble).
                    </P>
                    <P>
                        The results from our risk assessment show that EtO emissions from wastewater contribute 77 percent of the source category MIR (the MIR is 1,000-in-1-million), thus wastewater is one of the EtO emission sources contributing to the EPA's finding of unacceptable risk for the PEPO Production source category. To lower the risk for the PEPO facilities with EtO emissions, we are proposing at 40 CFR 63.1423(b) to use the same definition of the term “in ethylene oxide service” for wastewater as used in the recently amended HON (89 FR 42932, May 16, 2024) which means any wastewater stream that contains total annual average concentration of EtO greater than or equal to 1 part per million by weight (ppmw) at any flow rate. We are proposing procedures for determining whether a wastewater stream is in EtO service within the proposed definition of the term “in ethylene oxide service” (by reference to 40 CFR 63.109 for PEPO wastewater streams in EtO service). We are also proposing, by reference to the amended HON, that a wastewater stream in EtO service would be considered a Group 1 wastewater stream (see 40 CFR 63.1433(a)(23) and (27) and 63.132(c)(1)(iii) and (d)(1)(ii)). In addition, we are proposing to update the definition of “wastewater” at 40 CFR 63.1423(b) to align with these proposed changes. As part of the management and treatment requirements for Group 1 wastewater streams, owners and operators would be required at 40 CFR 63.138(b)(3) and (c)(3) to reduce, by removal or destruction, the concentration of EtO to a level less than 1 ppmw. We anticipate that owners and operators will use stream stripping to comply with this proposed requirement. While we acknowledge EtO can be biodegraded, the compound is not on table 37 to subpart G of the HON, suggesting that it is not a readily biodegradable compound when using a biological treatment method, and EtO would need to be stripped out of the wastewater to meet the standard at 40 CFR 63.138(b)(3) and (c)(3). Therefore, we evaluated Control Option 1 using a steam stripper achieving a 98 percent reduction of EtO emissions (based on the fraction removed (Fr) value of EtO 
                        <SU>35</SU>
                        <FTREF/>
                         in table 9 to subpart G of the HON).
                    </P>
                    <FTNT>
                        <P>
                            <SU>35</SU>
                             The Fr is the fraction of a HAP that is stripped from wastewater and is an indicator of the extent to which a HAP is effectively removed during the steam stripping process, which for EtO is 98 percent.
                        </P>
                    </FTNT>
                    <P>
                        Additionally, we are aware that some chemical manufacturing facilities dispose of certain wastewater streams that contain EtO by adding those wastewaters to the cooling water of their heat exchange systems, rather than considering those EtO-containing streams to be potential sources of wastewater. To help reduce risk from the PEPO Production source category by eliminating these types of EtO emissions from wastewater being injected into heat exchange systems, we are also proposing to prohibit owners and operators from injecting water into or disposing of water through any heat exchange system in a PMPU meeting the conditions of 40 CFR 63.1420 if the water contains any amount of EtO, has been in contact with any process stream containing EtO, or the water is considered wastewater as defined in 40 CFR 63.1423 (see 40 CFR 63.1435(i). The document titled 
                        <E T="03">Analysis of Control Options for Wastewater Streams to Reduce Residual Risk of Ethylene Oxide in the PEPO Production Source Category,</E>
                         which is available in the docket for this action, provides additional information on this evaluated control option to reduce EtO risk from PEPO wastewater streams.
                    </P>
                    <HD SOURCE="HD3">e. Summary</HD>
                    <P>
                        For process vents, storage vessels, equipment leaks, heat exchange systems, and wastewater, we considered the control options described above for reducing EtO risk from the PEPO Production source category that are associated with processes subject to the PEPO NESHAP. To reduce risk from the source category to an acceptable level, we propose to require control of EtO emissions from: (1) process vents, (2) storage vessels, (3) equipment leaks, (4) heat exchange systems, and (5) wastewater in EtO service, as defined in this proposal. For process vents and storage vessels in EtO service, we are proposing owners and operators reduce emissions of EtO by either: (1) venting emissions through a closed vent system to a non-flare control device that reduces EtO by greater than or equal to 99.9 percent by weight or to a concentration less than 1 ppmv for each process vent and storage vessel, or (2) venting emissions through a closed vent system to a flare meeting the proposed operating and monitoring requirements for flares (see section IV.D.1 of this preamble). For process vents, we are also proposing an annual limit of 5 lb/yr or less for all combined process vents as an alternative to the percent control and concentration options. For equipment leaks in EtO service, we are proposing the following combined requirements: monitoring of connectors in gas/vapor and light liquid service at a leak definition of 100 ppmv on a monthly basis with no reduction in monitoring frequency and no delay of repair; monthly monitoring of light liquid pumps at a leak definition of 500 ppmv; and monthly monitoring of gas/vapor and light liquid valves at a leak definition of 100 ppmv with no reduction in monitoring frequency and no delay of repair. For heat exchange systems in EtO service, we are proposing to require owners or operators to conduct more frequent leak monitoring (weekly instead of quarterly) and to repair leaks within 15 days from the sampling date (in lieu of the current 45-day repair requirement after receiving results of monitoring indicating a leak), and to not allow owners or operators to delay repairs. For wastewater in EtO service, we are proposing to revise the Group 1 wastewater stream threshold for sources to include wastewater streams in EtO service, and to prohibit owners and 
                        <PRTPAGE P="106012"/>
                        operators from injecting wastewater in EtO service into or disposing of water through any heat exchange system in a PMPU.
                    </P>
                    <P>In all cases, we are proposing that, if information exists that suggests EtO could be present in these processes, then the emission source is considered to be in EtO service unless the owner or operator conducts the procedures specified in 40 CFR 63.109 to demonstrate that the emission source does not meet the definition of being in EtO service (see proposed definition of the term “in ethylene oxide service” at 40 CFR 63.1423(b) (by reference to 40 CFR 63.101) and proposed 40 CFR 63.1425(g) for process vents, 40 CFR 63.1432(v) for storage vessels, 40 CFR 63.1433(a)(27) for wastewater, 40 CFR 63.1434(a)(6) for equipment leaks, and 40 CFR 63.1435(j) for heat exchange systems). Examples of information that could suggest EtO is present in a process stream include calculations based on safety data sheets, material balances, process stoichiometry, or previous test results provided the results are still relevant to the current operating conditions.</P>
                    <P>Based on the proposed applicability thresholds, we expect that up to 21 PEPO facilities will be affected by one or more of the proposed EtO-specific standards; and we anticipate that all of these facilities will be subject to the process vent, storage vessel, equipment leak, heat exchange system, and wastewater EtO-specific provisions.</P>
                    <HD SOURCE="HD3">3. Determination of Risk Acceptability After Proposed Emission Reductions</HD>
                    <P>
                        As noted in sections II.A.1 and III.A of this preamble and in the 1989 Benzene NESHAP, the EPA sets standards under CAA section 112(f)(2) using a two-step approach, with an analytical first step to determine whether risks are acceptable. This determination “considers all health information, including risk estimation uncertainty, and includes a presumptive limit on maximum individual lifetime [cancer] risk (MIR) of approximately 1 in 10 thousand” (54 FR 38044, 38045/col. 1, September 14, 1989). In the 1989 Benzene NESHAP, the EPA explained that “[i]n establishing a presumption for MIR, rather than a rigid line for acceptability, the Agency intends to weigh it with a series of other health measures and factors” (
                        <E T="03">Id.,</E>
                         at 38045/col. 3). “As risks increase above this benchmark, they become presumptively less acceptable under section 112, and would be weighed with the other health risk measures and information in making an overall judgement on acceptability” (
                        <E T="03">Id.</E>
                        ).
                    </P>
                    <P>
                        Table 3 of this preamble presents the levels of emissions control proposed to address unacceptable risks for the PEPO Production source category, which includes reducing emissions of EtO for PEPO processes and requiring more stringent controls for process vents, storage vessels, equipment leaks, heat exchange systems, and wastewater without considering costs.
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             Owners or operators can also use a flare that meets the proposed requirements at 40 CFR 63.1436 discussed in section IV.D.1 of this preamble).
                        </P>
                        <P>
                            <SU>2</SU>
                             Quarterly monitoring of heat exchange systems addresses the source category's unacceptable risk, but the EPA is proposing to require weekly monitoring to provide an ample margin of safety.
                        </P>
                    </FTNT>
                    <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="s35,xl100,12">
                        <TTITLE>Table 3—EtO Risk Control Options for the PEPO Production Source Category</TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                Emission source 
                                <LI>(in EtO service)</LI>
                            </CHED>
                            <CHED H="1">Description of proposed control option</CHED>
                            <CHED H="1">
                                Percent 
                                <LI>reduction of EtO </LI>
                                <LI>emissions</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Process Vent</ENT>
                            <ENT>
                                Route emissions through a closed vent system to a non-flare control device 
                                <SU>1</SU>
                                 that reduces EtO by greater than or equal to 99.9 percent by weight, to a concentration less than or equal to 1 ppmv for each process vent, or to less than 5 lb/yr for all combined process vents
                            </ENT>
                            <ENT>99.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Storage Vessel</ENT>
                            <ENT>
                                Route emissions through a closed vent system to a non-flare control device 
                                <SU>1</SU>
                                 that reduces EtO by greater than or equal to 99.9 percent by weight or to a concentration less than or equal to 1 ppmv
                            </ENT>
                            <ENT>99.9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Equipment Leaks</ENT>
                            <ENT>For equipment components that are in EtO service, monthly monitoring using EPA Method 21 of connectors in gas/vapor and light liquid service at a leak definition of 100 ppmv with no reduction in monitoring frequency and no repair delays; monthly monitoring of light liquid pumps at a leak definition of 500 ppmv; and monthly monitoring of gas/vapor and light liquid valves at a leak definition of 100 ppmv with no reduction in monitoring frequency and no delay of repair</ENT>
                            <ENT>70</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Heat Exchange Systems</ENT>
                            <ENT>
                                Quarterly 
                                <SU>2</SU>
                                 monitoring for leaks using the Modified El Paso Method and repair of leaks required no later than 15 days after the date sampling occurs.
                            </ENT>
                            <ENT>54</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Wastewater</ENT>
                            <ENT>Control all wastewater with a total annual average concentration of EtO greater than or equal to 1 ppmw at any flow rate as if it were a Group 1 wastewater</ENT>
                            <ENT>98</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        For the PEPO Production source category, after implementation of the proposed controls to address unacceptable risks, the MIR is reduced to 100-in-1 million (down from 1,000-in-1 million) with no facilities or populations exposed to risk levels greater than 100-in-1 million. The population exposed to risk levels greater than or equal to 1-in-1 million living within 50 km of affected facilities would be reduced from 3.8 million people to 1.7 million people. The total estimated cancer incidence for the source category of 0.3 (pre-control) is reduced to 0.08 (post-control) excess cancer cases per year. The maximum modeled chronic noncancer TOSHI for the source category remains unchanged. It is estimated to be 0.1 (for respiratory effects) with no populations estimated to be exposed to a TOSHI greater than 1. The estimated worst-case off-site acute exposures to emissions from the PEPO Production source category also remain unchanged, with a maximum modeled acute noncancer HQ of 1 based on the REL for methoxytriglycol (a glycol ether). Acute impacts are deemed negligible for HAP for which acute HQs are less than or equal to 1. Table 4 of this preamble summarizes the reduction in cancer risks associated with the source category based on the proposed controls. More detail is available in the document titled 
                        <E T="03">
                            Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and 
                            <PRTPAGE P="106013"/>
                            Technology Review Proposed Rule,
                        </E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,12,12,12,12">
                        <TTITLE>Table 4—Cancer Risks After Implementation of Proposed Control for the PEPO Production Source Category</TTITLE>
                        <BOXHD>
                            <CHED H="1">Control scenario</CHED>
                            <CHED H="1">
                                MIR
                                <LI>(x-in-1 million)</LI>
                            </CHED>
                            <CHED H="1">
                                Population
                                <LI>(≥1-in-1</LI>
                                <LI>million)</LI>
                            </CHED>
                            <CHED H="1">
                                Population
                                <LI>(&gt;100-in-1</LI>
                                <LI>million)</LI>
                            </CHED>
                            <CHED H="1">
                                Cancer
                                <LI>incidence</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Pre-Control Baseline</ENT>
                            <ENT>1,000</ENT>
                            <ENT>3,800,000</ENT>
                            <ENT>3,300</ENT>
                            <ENT>0.3</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Post-Control</ENT>
                            <ENT>100</ENT>
                            <ENT>1,700,000</ENT>
                            <ENT>0</ENT>
                            <ENT>0.08</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        As noted earlier in this section, the EPA considers an MIR of “approximately 1-in-10 thousand” (
                        <E T="03">i.e.,</E>
                         100-in-1 million) to be the presumptive limit of acceptability (54 FR 38045, September 14, 1989) and the proposed controls lower the MIR of the PEPO Production source category to 100-in-1 million. This is a significant reduction from the pre-control MIR of 1,000-in-1 million. For noncancer effects, the EPA has not established under section 112 of the CAA a numerical range for risk acceptability as it has with carcinogens, nor has it determined that there is a bright line above which acceptability is denied. However, the Agency has established that, as exposure increases above a reference level (as indicated by a HQ or TOSHI greater than 1), confidence that the public will not experience adverse health effects decreases and the likelihood that an effect will occur increases.
                    </P>
                    <P>Therefore, considering all health information, including risk estimation uncertainty, the EPA proposes that the resulting risks after implementation of the proposed controls for the PEPO Production source category detailed in section IV.B.2 would be acceptable. We solicit comments on all the proposed control requirements to reduce risk to an acceptable level for the PEPO Production source category.</P>
                    <HD SOURCE="HD3">4. Ample Margin of Safety Analysis</HD>
                    <P>
                        The second step in the residual risk decision framework is a determination of whether the emission standards proposed to achieve an acceptable risk level provide an ample margin of safety to protect public health, or whether more stringent emission standards would be required for this purpose. In making this determination, we considered the health risk and other health information considered in our acceptability determination, along with additional factors not considered in the risk acceptability step, including costs and economic impacts of controls, technological feasibility, uncertainties, and other relevant factors, consistent with the approach of the 1989 Benzene NESHAP. Table 5 of this preamble summarizes the costs and EtO emission reductions we estimated for the proposed control requirements to reduce the risks to an acceptable level for the PEPO Production source category. For details on the assumptions and methodologies used in the costs and impacts analyses, see the technical documents titled, 
                        <E T="03">Analysis of Control Options for Process Vents and Storage Vessels to Reduce Residual Risk of Ethylene Oxide in the PEPO Production Source Category; Analysis of Control Options for Equipment Leaks to Reduce Residual Risk of Ethylene Oxide in the PEPO Production Source Category;</E>
                          
                        <E T="03">Analysis of Control Options for Heat Exchange Systems to Reduce Residual Risk of Ethylene Oxide in the PEPO Production Source Category;</E>
                         and 
                        <E T="03">Analysis of Control Options for Wastewater Streams to Reduce Residual Risk of Ethylene Oxide in the PEPO Production Source Category,</E>
                         which are available in the docket for this rulemaking. We note that for three fugitive EtO emission sources (
                        <E T="03">i.e.,</E>
                         equipment leaks, heat exchange systems, and wastewater), the emission reductions (and subsequent cost effectiveness values for EtO) differ from reductions expected to occur from reported emissions inventories due to use of model plants, engineering assumptions made to estimate baseline emissions, and uncertainties in how fugitive emissions may have been calculated for reported inventories compared to our model plants analyses (see the aforementioned technical documents).
                    </P>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,12,12,12,16">
                        <TTITLE>Table 5—Nationwide EtO Emission Reductions and Cost Impacts for Control Options Considered for PEPO Processes</TTITLE>
                        <BOXHD>
                            <CHED H="1">Control option</CHED>
                            <CHED H="1">
                                Total capital
                                <LI>investment</LI>
                                <LI>(MM$)</LI>
                            </CHED>
                            <CHED H="1">
                                Total annualized
                                <LI>costs</LI>
                                <LI>(MM$/yr)</LI>
                            </CHED>
                            <CHED H="1">
                                EtO emission
                                <LI>reductions</LI>
                                <LI>(tpy)</LI>
                            </CHED>
                            <CHED H="1">
                                Cost-effectiveness
                                <LI>($/ton EtO)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">A—Process Vent &amp; Storage Vessel Controls</ENT>
                            <ENT>2.55</ENT>
                            <ENT>2.91</ENT>
                            <ENT>10.8</ENT>
                            <ENT>269,400</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">B—Equipment Leak Controls</ENT>
                            <ENT>0.06</ENT>
                            <ENT>1.23</ENT>
                            <ENT>20.3</ENT>
                            <ENT>60,600</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">C—Heat Exchange System Controls</ENT>
                            <ENT>0.21</ENT>
                            <ENT>0.36</ENT>
                            <ENT>12.1</ENT>
                            <ENT>29,800</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">D—Wastewater Controls</ENT>
                            <ENT>14.4</ENT>
                            <ENT>5.75</ENT>
                            <ENT>312</ENT>
                            <ENT>18,400</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total (A + B + C + D)</ENT>
                            <ENT>17.2</ENT>
                            <ENT>10.2</ENT>
                            <ENT>355</ENT>
                            <ENT>28,700</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        For the ample margin of safety analyses, we evaluated the cost and feasibility of available control technologies that could be applied to PEPO processes to reduce risks further, considering all of the health risks and other health information evaluated in the risk acceptability determination described above and the additional information that we can consider only in the ample margin of safety analysis (
                        <E T="03">i.e.,</E>
                         costs and economic impacts of controls, technological feasibility, uncertainties, and other relevant factors). We note that the EPA previously determined that the standards for the PEPO Production source category provide an ample 
                        <PRTPAGE P="106014"/>
                        margin of safety to protect public health (79 FR 17340, March 27, 2014), and that the most significant change since that determination was the revised 2016 IRIS inhalation URE for EtO. As such, we focused our ample margin of safety analysis on cancer risk for EtO since, even after application of controls needed to get risks to an acceptable level, EtO drives cancer risk and cancer incidence (
                        <E T="03">i.e.,</E>
                         98 percent of remaining cancer incidence of 0.08 is from EtO) for the PEPO Production source category.
                    </P>
                    <P>
                        For process vents, storage vessels, equipment leaks, and wastewater in the PEPO Production source category, we did not identify any other control options for EtO emissions beyond those proposed in this action to reduce risks to an acceptable level. Furthermore, the proposed EtO controls for process vents, storage vessels, equipment leaks, and wastewater to reduce risks to an acceptable level are far more stringent than other options we identified to control HAP generally (
                        <E T="03">i.e.,</E>
                         see sections IV.D and IV.C of this preamble). Therefore, we conclude that these controls to reduce EtO emissions from PEPO processes to reduce risks to an acceptable level would also provide an ample margin of safety to protect public health.
                    </P>
                    <P>
                        For EtO emissions from leaks in heat exchangers, we found that weekly monitoring is a cost-effective option to provide an ample margin of safety. Considering the incremental cost effectiveness from quarterly to monthly ($197,200 per ton of EtO emissions reductions) and from monthly to weekly ($1,734,200 per ton of EtO emissions reductions) are within the range of accepted values of cost effectiveness for EtO reductions,
                        <SU>36</SU>
                        <FTREF/>
                         we find it appropriate to propose the weekly option (which is required by the HON) to provide an ample margin of safety. For this reason, we are proposing weekly monitoring for leaks for heat exchange systems in EtO service using the Modified El Paso Method (see 40 CFR 63.1435(a) by reference to the HON (40 CFR 63.104(g)(6)). If the owner or operator finds a leak, we are proposing to require repair of the leak to reduce the concentration or mass emissions rate below the applicable leak action level as soon as practicable, but no later than 15 days after collecting the sample with no delay of repair allowed (see 40 CFR 63.1435(a) by reference to the HON (40 CFR 63.104(h)(6)). The document titled 
                        <E T="03">Analysis of Control Options for Heat Exchange Systems to Reduce Residual Risk of Ethylene Oxide in the PEPO Production Source Category,</E>
                         which is available in the docket for this action, provides additional information on this evaluated control option to reduce EtO risk from PEPO heat exchange systems. We solicit comments on the proposed control requirements to provide an ample margin of safety for the PEPO Production source category.
                    </P>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             See 89 FR 24110, April 5, 2024.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">5. Adverse Environmental Effects</HD>
                    <P>Based on our screening assessment of environmental risk presented in section IV.A.4 of this preamble, we did not identify any areas of concern with respect to environmental risk. Therefore, we have determined that HAP emissions from the PEPO Production source category do not result in an adverse environmental effect, and we are proposing that it is not necessary to set a more stringent standard to prevent, taking into consideration costs, energy, safety, and other relevant factors, an adverse environmental effect.</P>
                    <HD SOURCE="HD2">C. What are the results and proposed decisions based on our technology review?</HD>
                    <P>
                        In addition to the proposed EtO-specific requirements discussed in section IV.B.2 of this preamble, under CAA section 112(d)(6) we also evaluated developments in practices, processes, and control technologies for reducing HAP emissions from heat exchange systems, storage vessels, process vents, wastewater, and equipment leaks for processes subject to the PEPO NESHAP (see sections IV.C.1 through IV.C.5 of this preamble, respectively). We analyzed costs and emissions reductions for each emission source (
                        <E T="03">e.g.,</E>
                         process vents) and determined cost effectiveness (annualized cost/Mg or ton of emissions reduction) on a HAP basis. We also evaluated fenceline monitoring as a development in practices considered under CAA section 112(d)(6) for the purposes of managing fugitive emissions from sources subject to the PEPO NESHAP (see section IV.C.6 of this preamble).
                    </P>
                    <HD SOURCE="HD3">1. Standards for Heat Exchange Systems</HD>
                    <P>
                        Heat exchangers are devices or collections of devices used to transfer heat from process fluids to another process fluid (typically water) without intentional direct contact of the process fluid with the cooling fluid (
                        <E T="03">i.e.,</E>
                         non-contact heat exchanger). There are two types of heat exchange systems: closed-loop recirculation systems and once-through systems. Closed-loop recirculation systems use a cooling tower to cool the heated water leaving the heat exchanger and then return the newly cooled water to the heat exchanger for reuse. Once-through systems typically use surface freshwater (
                        <E T="03">e.g.,</E>
                         from a nearby river) as the influent cooling fluid to the heat exchangers, and the heated water leaving the system is then discharged from the facility. At times, the internal tubing material of a heat exchanger can corrode or crack, allowing some process fluids to mix or become entrained with the cooling water. Pollutants in the process fluids may subsequently be released from the cooling water into the atmosphere when the water is exposed to air (
                        <E T="03">e.g.,</E>
                         in a cooling tower for closed-loop systems or trenches/ponds in a once-through system).
                    </P>
                    <P>
                        The PEPO NESHAP at 40 CFR 63.1423 currently refers to the HON (40 CFR 63.101) to define a heat exchange system as “a device or collection of devices used to transfer heat from process fluids to water without intentional direct contact of the process fluid with the water (
                        <E T="03">i.e.,</E>
                         non-contact heat exchanger) and to transport and/or cool the water in a closed-loop recirculation system (cooling tower system) or a once-through system (
                        <E T="03">e.g.,</E>
                         river or pond water).” We are proposing to delete the reference to the HON definition and instead define a heat exchange system in the PEPO NESHAP so it refers to a PMPU (see section IV.E.4 of this preamble). The definition also clarifies that: (1) for closed-loop recirculation systems, the heat exchange system consists of a cooling tower, all PMPU heat exchangers that are in organic HAP service serviced by that cooling tower, and all water lines to and from these process unit heat exchangers; (2) for once-through systems, the heat exchange system consists of all heat exchangers that are in organic HAP service, servicing an individual PMPU and all water lines to and from these heat exchangers; (3) sample coolers or pump seal coolers are not considered heat exchangers for the purpose of this proposed definition and are not part of the heat exchange system; and (4) intentional direct contact with process fluids results in the formation of a wastewater. This definition also applies to heat exchange systems in EtO service as described in section IV.B.2.c of this preamble.
                    </P>
                    <P>
                        The PEPO NESHAP requirements for heat exchange systems at 40 CFR 63.1435, by reference to the HON (40 CFR 63.104), includes an LDAR program for owners or operators of certain heat exchange systems that do not meet one or more of the conditions in 40 CFR 63.104(a). The LDAR program specifies that owners or operators must monitor heat exchange systems for leaks of process fluids into cooling water and take actions to repair detected leaks 
                        <PRTPAGE P="106015"/>
                        within 45 days. Owners or operators may delay the repair of leaks if they meet the applicable criteria in 40 CFR 63.104. The PEPO NESHAP allows owners or operators to use any method listed in 40 CFR part 136 to sample cooling water for leaks for the HAP listed in table 4 to 40 CFR part 63, subpart F (for HON) that is also listed in table 4 to 40 CFR part 63, subpart PPP (recirculating systems) and table 9 to 40 CFR part 63, subpart G (for HON) that is also listed in table 4 to 40 CFR part 63, subpart PPP (once-through systems) (and other representative substances such as TOC or VOC that can indicate the presence of a leak can also be used). A leak in the heat exchange system is detected if the exit mean concentration of HAP (or other representative substance) in the cooling water is at least 1 ppmw or 10 percent greater than (using a one-sided statistical procedure at the 0.05 level of significance) the entrance mean concentration of HAP (or other representative substance) in the cooling water. Furthermore, the PEPO NESHAP allows owners or operators to monitor for leaks using a surrogate indicator (
                        <E T="03">e.g.,</E>
                         ion-specific electrode monitoring, pH, conductivity), provided that certain criteria in 40 CFR 63.104(c) are met. The PEPO NESHAP initially requires 6 months of monthly monitoring for existing heat exchange systems. Thereafter, the frequency can be reduced to quarterly. The leak monitoring frequencies are the same whether the owner or operator uses water sampling and analysis or surrogate monitoring to identify leaks.
                    </P>
                    <P>
                        As part of our technology review, we reviewed the criteria in 40 CFR 63.104 that exempt certain heat exchange systems from the LDAR requirements in the PEPO NESHAP to see if the exemptions were still reasonable to maintain. We identified two criteria in 40 CFR 63.104 dealing with once-through heat exchange systems meeting certain National Pollution Discharge Elimination System (NPDES) permit conditions (
                        <E T="03">i.e.,</E>
                         40 CFR 63.104(a)(3) and (4)) that warranted further assessment. Once-through heat exchange systems typically have systems open to the air (
                        <E T="03">e.g.,</E>
                         open sewer lines, trenches, and ponds) that are utilized to transport used cooling water to a discharge point (
                        <E T="03">e.g.,</E>
                         an outfall) of a facility. This cooling water can also be mixed with other sources of water (
                        <E T="03">e.g.,</E>
                         cooling water used in once-through heat exchange systems in non-PEPO processes, stormwater, treated wastewater, 
                        <E T="03">etc.</E>
                        ) in sewers, trenches, and ponds prior to discharge from the plant. If this point of discharge from the plant is into a “water of the United States,” the facility is required to have a NPDES permit and to meet certain pollutant discharge limits. In reviewing the requirements of 40 CFR 63.104(a)(3), we find that there is a clear disconnect between having a NPDES permit that meets certain allowable discharge limits (
                        <E T="03">i.e.,</E>
                         1 part per million by volume (ppmv) or less above influent concentration, or 10 percent or less above influent concentration, whichever is greater) at the discharge point of a facility (
                        <E T="03">e.g.,</E>
                         outfall) versus being able to adequately identify a leak from a once-through heat exchange system, given that these systems are open to the atmosphere prior to this discharge point and, therefore, any volatile HAP leaking from a once-through heat exchange system would likely be emitted to the atmosphere prior to the NPDES outfall. Similarly, while the requirements of 40 CFR 63.104(a)(4) allow facilities with once-through heat exchange systems that have certain requirements (
                        <E T="03">i.e.,</E>
                         the requirements of 40 CFR 63.104(a)(3) and (4)) incorporated into their NPDES permit to not comply with the requirements of 40 CFR 63.104(b) and 63.104(c), we find this exemption to be problematic. Specifically, the NPDES requirements at 40 CFR 63.104(a)(4) lack the specificity of where a sample must be taken to adequately find and quantify a leak from a once-through heat exchange system (
                        <E T="03">e.g.,</E>
                         just prior to the outfall from the plant versus from the exit of the once-through heat exchange system prior to being open to atmosphere), what concentration and/or mass emissions rate constitutes a leak that must be fixed, how quickly a leak must be fixed, what pollutants must be adequately accounted for, and what test method(s)/surrogates facilities are allowed. As such, we find 40 CFR 63.104(a)(4) to be inadequate in terms of being able to detect and repair leaks that are at least as equivalent to those that would be identified if once-through heat exchange systems were complying with 40 CFR 63.104(b) or (c) instead. Therefore, for purposes of demonstrating continuous compliance with the underlying MACT standard, we are proposing at 40 CFR 63.1435(a), by reference to 40 CFR 63.104(a)(4)(v), to remove the exemptions for once-through heat exchange systems meeting certain NPDES permit conditions at 40 CFR 63.104(a)(3) and (4) and instead to require that facilities comply with the requirements of 40 CFR 63.104(b) and 63.104(c).
                    </P>
                    <P>
                        Our technology review identified one development in LDAR practices and processes for heat exchange systems (
                        <E T="03">i.e.,</E>
                         broader than our review of heat exchange systems in EtO service discussed in section IV.B.2.c of this preamble): the use of the Modified El Paso Method 
                        <SU>37</SU>
                        <FTREF/>
                         to monitor for leaks. The Modified El Paso Method is included in the HON, MON, EMACT standards, the Petroleum Refinery Sector rule, and in the RACT/BACT/LAER clearinghouse database. TCEQ also requires the method for facilities complying with TCEQ's highly reactive volatile organic compound (HRVOC) rule (
                        <E T="03">i.e.,</E>
                         30 Texas Administrative Code Chapter 115, Subchapter H, Division 3). The Modified El Paso Method measures a larger number of compounds than the current methods required in the PEPO NESHAP and is more effective in identifying leaks. For LDAR programs applied to heat exchange systems, the compliance monitoring option, leak definition, and frequency of monitoring for leaks are all important considerations affecting emission reductions because they identify when there is a leak and when to take corrective actions to repair the leak. Therefore, we evaluated the Modified El Paso Method for use at PEPO facilities, including an assessment of appropriate leak definitions and monitoring frequencies.
                    </P>
                    <FTNT>
                        <P>
                            <SU>37</SU>
                             The Modified El Paso Method uses a dynamic or flow-through system for air stripping a sample of the water and analyzing the resultant off-gases for VOC using a flame ionization detector (FID) analyzer. The method is described in detail in appendix P of the TCEQ's Sampling Procedures Manual: 
                            <E T="03">The Air Stripping Method (Modified El Paso Method) for Determination of Volatile Organic Compound (VOC) Emissions from Water Sources.</E>
                             Appendix P is included in the docket for this rulemaking.
                        </P>
                    </FTNT>
                    <P>
                        To identify an appropriate Modified El Paso Method leak definition for facilities subject to the PEPO NESHAP, we identified five rules (
                        <E T="03">i.e.,</E>
                         TCEQ HRVOC rule, the HON, the MON, the EMACT standards, and the Petroleum Refinery Sector rule) that incorporate this monitoring method and have leak definitions corresponding to the use of this methodology. We also reviewed data submitted in response to a CAA section 114 request for PEPO production facilities. The TCEQ HRVOC rule, the HON, the MON, EMACT standards, and the Petroleum Refinery Sector rule have leak definitions of total strippable hydrocarbon concentration (as methane) in the stripping gas ranging from 3.1 ppmv to 6.2 ppmv. In addition, sources subject to the HON, the MON, EMACT standards, or the Petroleum Refinery Sector rule must repair a leak no later than 45 days after first identifying the leak and cannot delay the repair of leaks for more than 30 days where, during subsequent monitoring, owners or 
                        <PRTPAGE P="106016"/>
                        operators find a total strippable hydrocarbon concentration (as methane) in the stripping gas of 62 ppmv or higher. Taking into account the range of actionable leak definitions in use by other rules that require use of the Modified El Paso Method currently (
                        <E T="03">i.e.,</E>
                         3.1 ppmv to 6.2 ppmv of total strippable hydrocarbon (as methane) in the stripping gas), we chose to evaluate a leak definition at the upper end of identified actionable leak definitions in our analysis. Thus, we evaluated the Modified El Paso Method leak definition of 6.2 ppmv of total strippable hydrocarbon concentration (as methane) in the stripping gas for both new and existing heat exchange systems, along with not allowing delay of repair of leaks for more than 30 days where, during subsequent monitoring, a total strippable hydrocarbon concentration (as methane) in the stripping gas of 62 ppmv or higher is found.
                    </P>
                    <P>
                        We also considered more stringent monitoring frequencies. Both the Petroleum Refinery Sector rule, which includes monthly monitoring for existing sources under certain circumstances, and the TCEQ HRVOC rule, which includes continuous monitoring provisions for existing and new sources, have more stringent monitoring frequencies. However, the petroleum refinery rule analysis found the incremental HAP cost effectiveness to change from quarterly to monthly monitoring and monthly to continuous monitoring (at the same leak definition) of refinery heat exchange systems to be $40,000/ton and $500,000/ton, respectively. We conclude that these costs are not reasonable for PEPO facilities. Thus, we chose to evaluate quarterly monitoring for existing and new heat exchange systems (
                        <E T="03">i.e.,</E>
                         the base monitoring frequency currently in the rule). We also evaluated monthly monitoring to confirm the anticipated higher incremental HAP cost effectiveness.
                    </P>
                    <P>Based on this technology review, we identified the following control options for heat exchange systems as a development in practice that can be implemented at a reasonable cost: (1) quarterly monitoring for existing and new heat exchange systems (after an initial 6 months of monthly monitoring) with the Modified El Paso Method and a leak definition of 6.2 ppmv of total strippable hydrocarbon concentration (as methane) in the stripping gas, and (2) same as Control Option 1, except monthly monitoring with the Modified El Paso Method instead of quarterly monitoring.</P>
                    <P>
                        We then estimated the impacts of these control options assuming 24 PEPO facilities 
                        <SU>38</SU>
                        <FTREF/>
                         would be affected by requiring the use of the Modified El Paso Method. As part of our analysis, we assumed owners or operators conducting monitoring for three or more heat exchange systems would elect to purchase a stripping column and FID analyzer and perform in-house Modified El Paso monitoring because the total annualized costs for in-house Modified El Paso monitoring are less than the costs for contracted services. In addition, we assumed that owners or operators could repair leaks by plugging a specific heat exchanger tube, and if a heat exchanger is leaking to the extent that it needs to be replaced, then it is effectively at the end of its useful life. Therefore, we determined that the cost of replacing a heat exchanger is an operational cost that would be incurred by the facility as a result of routine maintenance and equipment replacement, and it is not attributable to the control option.
                    </P>
                    <FTNT>
                        <P>
                            <SU>38</SU>
                             We note that while there are 25 PEPO facilities, one PEPO facility is currently co-located with a HON facility. This facility is a small business that only receives and treats wastewater. Therefore, we do not expect this facility to have heat exchange systems on site.
                        </P>
                    </FTNT>
                    <P>
                        Table 6 of this preamble presents the nationwide impacts for requiring owners or operators at PEPO facilities to use the Modified El Paso Method quarterly or monthly (Control Options 1 and 2), and repair leaks of total strippable hydrocarbon concentration (as methane) in the stripping gas of 6.2 ppmv or greater. See the document titled 
                        <E T="03">Clean Air Act Section 112(d)(6) Technology Review for Heat Exchange Systems Located in the PEPO Production Source Category that are Associated with Processes Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this rulemaking, for details on the assumptions and methodologies used in this analysis.
                    </P>
                    <GPOTABLE COLS="8" OPTS="L2,p7,7/8,i1" CDEF="s50,10,10,10,10,10,10,10">
                        <TTITLE>Table 6—Nationwide Emissions Reductions and Cost Impacts of Control Options Considered for Heat Exchange Systems at PEPO Facilities</TTITLE>
                        <BOXHD>
                            <CHED H="1">Control option</CHED>
                            <CHED H="1">
                                Total
                                <LI>capital</LI>
                                <LI>investment</LI>
                                <LI>($)</LI>
                            </CHED>
                            <CHED H="1">
                                Total
                                <LI>annualized</LI>
                                <LI>costs w/o</LI>
                                <LI>credits</LI>
                                <LI>($/yr)</LI>
                            </CHED>
                            <CHED H="1">
                                Total
                                <LI>annualized</LI>
                                <LI>costs</LI>
                                <LI>w/credits</LI>
                                <LI>($/yr)</LI>
                            </CHED>
                            <CHED H="1">
                                Total HAP
                                <LI>emission</LI>
                                <LI>reductions</LI>
                                <LI>(tpy)</LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>HAP cost-</LI>
                                <LI>effectiveness</LI>
                                <LI>w/credits</LI>
                                <LI>($/ton)</LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>HAP cost-</LI>
                                <LI>effectiveness</LI>
                                <LI>w/o credits</LI>
                                <LI>($/ton)</LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>incremental</LI>
                                <LI>HAP cost-</LI>
                                <LI>effectiveness</LI>
                                <LI>w/credits</LI>
                                <LI>($/ton)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>54,700</ENT>
                            <ENT>30,700</ENT>
                            <ENT>10,400</ENT>
                            <ENT>17.4</ENT>
                            <ENT>600</ENT>
                            <ENT>1,800</ENT>
                            <ENT/>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>492,400</ENT>
                            <ENT>82,200</ENT>
                            <ENT>61,200</ENT>
                            <ENT>18.0</ENT>
                            <ENT>3,400</ENT>
                            <ENT>4,500</ENT>
                            <ENT>80,400</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        Based on the costs and emission reductions for the identified control options, we are proposing Control Option 1 to revise the PEPO NESHAP for heat exchange systems pursuant to CAA section 112(d)(6). We are not proposing Control Option 2 because it is not cost-effective given the high incremental total HAP cost effectiveness (
                        <E T="03">i.e.,</E>
                         $80,400/ton HAP) from Control Option 1. We are proposing Control Option 1 at 40 CFR 63.1435, by reference to the HON (40 CFR 63.104(g)(4)),
                        <SU>39</SU>
                        <FTREF/>
                         to specify quarterly monitoring for existing and new heat exchange systems (after an initial 6 months of monthly monitoring) using the Modified El Paso Method and a leak definition of 6.2 ppmv of total strippable hydrocarbon concentration (as methane) in the stripping gas. We are proposing to require owners and operators to repair the leak to reduce the concentration or mass emissions rate to below the leak action level as soon as practicable, but no later than 45 days after identifying the leak. We are also proposing, by reference to 40 CFR 63.104(j)(3), a delay of repair action level of total strippable hydrocarbon concentration (as methane) in the stripping gas of 62 ppmv, that if exceeded during leak monitoring, would require immediate repair (
                        <E T="03">i.e.,</E>
                         the leak found cannot be put on delay of repair and would be required to be repaired within 30 days of the monitoring event). This would apply to both monitoring heat exchange systems and individual 
                        <PRTPAGE P="106017"/>
                        heat exchangers by replacing the use of any 40 CFR part 136 water sampling method with the Modified El Paso Method and removing the option that allows for use of a surrogate indicator of leaks. We are also proposing, by reference to 40 CFR 63.104(h) and (i), that repair include re-monitoring at the monitoring location where a leak is identified to ensure that any leaks found are fixed. We are proposing that none of these requirements would apply to heat exchange systems that have a maximum cooling water flow rate of 10 gallons per minute or less because owners and operators of smaller heat exchange systems would be disproportionately affected and forced to repair leaks with a much lower potential HAP emissions rate than owners and operators of heat exchange systems with larger recirculation rate systems. Finally, we are proposing by reference to 40 CFR 63.104(l) that the leak monitoring requirements for heat exchange systems at 40 CFR 63.104(b) may be used in limited instances, instead of using the Modified El Paso Method, to monitor for leaks. We continue to maintain that the Modified El Paso Method is the preferred method to monitor for leaks in heat exchange systems and we are proposing that the requirements of 40 CFR 63.104(b) may only be used if 99 percent by weight or more of all the organic compounds that could potentially leak into the cooling water have a Henry's Law Constant less than 5.0E-6 atmospheres per mole per cubic meter (atm-m
                        <SU>3</SU>
                        /mol) at 25° Celsius. As noted in the proposal for the HON amendments (88 FR 25080), we selected this threshold based on a review of Henry's Law Constants for the HAP listed in table 4 to 40 CFR part 63, subpart F, as well as the water-soluble organic compounds listed in a recent alternative monitoring request from a MON facility.
                        <SU>40</SU>
                        <FTREF/>
                         Henry's Law Constants are available from the EPA at 
                        <E T="03">https://comptox.epa.gov/dashboard/.</E>
                         Examples of HAP that have a Henry's Law Constant less than 5.0E-6 atm-m
                        <SU>3</SU>
                        /mol at 25° Celsius are: aniline; 2-chloroacetophenone; diethylene glycol diethyl ether; diethylene glycol dimethyl ether; dimethyl sulfate; 2,4-dinitrotoluene; 1,4-dioxane; ethylene glycol monoethyl ether acetate; ethylene glycol monomethyl ether acetate; methanol; and toluidine. Many of these HAP also have very high boiling points, with most above 300 °F, which means they will generally stay in the cooling water and not be emitted to the atmosphere. We solicit comments on the proposed requirements related to heat exchange systems.
                    </P>
                    <FTNT>
                        <P>
                            <SU>39</SU>
                             We note that each of the HON citations mentioned in this paragraph of this preamble are also applicable to PEPO facilities pursuant to 40 CFR 63.1435. For these HON citations to properly apply to PEPO facilities, we are proposing substitution rule text at 40 CFR 63.1435(f) and (g).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>40</SU>
                             In May 2021, EPA Region 4 received a request from Eastman Chemical Company to perform an alternative method instead of the Modified El Paso Method to monitor for leaks in Eastman's Tennessee Operations heat exchange systems, which primarily have cooling water containing soluble HAP with a high boiling point. Eastman specifically identified two HAP (1,4-dioxane and methanol), which do not readily strip out of water using the Modified El Paso Method. Eastman's application for alternative monitoring included experimental data showing that the Modified El Paso Method would likely not identify a leak of these HAP in heat exchange system cooling water. Eastman conducted Modified El Paso Method monitoring under controlled scenarios to determine how much methanol and 1,4-dioxane would be detected. The scenarios included solutions of water and either methanol or 1,4-dioxane at concentrations of 1 ppmw, 20 ppmw, and 100 ppmw (as measured using water sampling methods allowed previously in the MON). The Modified El Paso Method did not detect any methanol or 1,4-dioxane from the 1 ppmw and 20 ppmw solutions (
                            <E T="03">i.e.,</E>
                             methanol and 1,4-dioxane did not strip out of the water in detectable amounts). The Modified El Paso Method detected very little HAP from the 100-ppmw solutions, with a maximum of only 0.17 percent of the 1,4-dioxane stripping out and being detected.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Standards for Storage Vessels</HD>
                    <P>Storage vessels are used to store liquid and gaseous feedstocks for use in a process, as well as to store liquid and gaseous products from a process. Most PEPO storage vessels are designed for operation at atmospheric or near atmospheric pressures; pressure vessels are used to store compressed gases and liquefied gases. Atmospheric storage vessels are typically cylindrical with a vertical orientation, and they are constructed with either a fixed roof or a floating roof. Some, generally small, atmospheric storage vessels are oriented horizontally. Pressure vessels are either spherical or horizontal cylinders.</P>
                    <P>
                        The HON storage vessel standards that PEPO affected sources are currently subject to, by reference to NESHAP subpart G at 40 CFR 63.119 through 63.123, require that owners and operators control emissions from storage vessels with capacities between 75 m
                        <SU>3</SU>
                         (inclusive) and 151 m
                        <SU>3</SU>
                         and a MTVP greater than or equal to 13.1 kPa, and storage vessels with capacities greater than or equal to 151 m
                        <SU>3</SU>
                         and a MTVP greater than or equal to 5.2 kPa. Storage vessels meeting these capacity and size criteria capacity are considered Group 1 storage vessels. Generally, the standards in the PEPO NESHAP for storage vessels refer to the provisions in the HON. As such, owners and operators of PEPO Group 1 storage vessels storing a liquid with a MTVP of total organic HAP less than 76.6 kPa must reduce emissions of organic HAP by 95 percent (or 90 percent if the storage vessel was installed on or before September 4, 1997) using a closed vent system and control device, or reduce organic HAP emissions either by utilizing an IFR or EFR, routing the emissions to a process or a fuel gas system, or through vapor balancing. Owners and operators of PEPO Group 1 storage vessels containing a liquid with a MTVP of total organic HAP greater than or equal to 76.6 kPa must reduce emissions of organic HAP by 95 percent (or 90 percent if the storage vessel was installed on or before September 4, 1997) utilizing a closed vent system and control device, or reduce organic HAP emissions by routing the emissions to a process or a fuel gas system, or using vapor balancing. In general, PEPO storage vessels that do not meet the MTVP and capacity thresholds described above are considered Group 2 storage vessels and owners or operators are not required to apply any additional emission controls provided they remain under Group 1 thresholds; however, Group 2 storage vessels are subject to certain monitoring, reporting, and recordkeeping requirements to ensure that they were correctly determined to be Group 2 storage vessels and that they remain in Group 2.
                    </P>
                    <P>
                        As part of our technology review for PEPO storage vessels (
                        <E T="03">i.e.,</E>
                         broader than our review of storage vessels in EtO service discussed in section IV.B.2.a of this preamble), we identified the following emission reduction options: (1) revising the capacity and MTVP thresholds of the PEPO NESHAP to reflect the HON existing source threshold which requires existing storage vessels between 38 m
                        <SU>3</SU>
                         (inclusive) and 151 m
                        <SU>3</SU>
                         with an MTVP greater than or equal to 6.9 kPa to reduce emissions of organic HAP by 95 percent utilizing a closed vent system and control device, or reduce organic HAP emissions either by utilizing an IFR, an EFR, by routing the emissions to a process or a fuel gas system, or using vapor balancing; (2) same as Control Option 1 plus requiring upgraded deck fittings 
                        <SU>41</SU>
                        <FTREF/>
                         and controls for guidepoles for all storage vessels equipped with an IFR as already required in 40 CR 63, subpart WW (NESHAP for Storage Vessels—Control Level (2); and (3) in addition to requirements specified in Control Options 1 and 2, requiring the conversion of EFRs to IFRs through use of geodesic domes and upgrades to deck fittings and guidepoles.
                    </P>
                    <FTNT>
                        <P>
                            <SU>41</SU>
                             Require all openings in an IFR (except those for automatic bleeder vents (vacuum breaker vents), rim space vents, leg sleeves, and deck drains) be equipped with a deck cover; and require the deck cover to be equipped with a gasket between the cover and the deck.
                        </P>
                    </FTNT>
                    <P>
                        We identified Control Option 1 as a technologically feasible development in practices, processes, and control 
                        <PRTPAGE P="106018"/>
                        technologies for storage vessels used at PEPO facilities because it reflects requirements for similar storage vessels that are located at chemical manufacturing facilities subject to the HON. Control Option 2 is an improvement in practices because these upgraded deck fittings and guidepole controls have been required by other regulatory agencies and other EPA regulatory action (
                        <E T="03">e.g.,</E>
                         Petroleum Refinery Sector rulemaking) since promulgation of the PEPO NESHAP. Finally, we consider Control Option 3 to be a development in control technology because we found that some storage vessels with EFRs have installed geodesic domes since promulgation of the PEPO NESHAP.
                    </P>
                    <P>
                        We used information about storage vessel capacity, design, and stored materials that industry provided to the EPA in response to our CAA section 114 request (see section II.C of this preamble) to evaluate the impacts of all three of the options presented. We did not identify any PEPO storage vessels from our CAA section 114 request that would be impacted by Control Option 1. Given that materials used in PEPO production have very low vapor pressures, the majority of PEPO Group 2 storage vessels do not meet the vapor pressure portion of the revised Control Option 1 applicability. Furthermore, our CAA section 114 request data shows zero Group 2 storage vessels fitted with an IFR or EFR, meaning no additional storage vessels would be affected by Control Option 2 or 3. To verify these findings, we conducted an air permit review alongside analysis of our CAA section 114 request data to identify any additional Group 2 storage vessels at PEPO facilities outside of the CAA section 114 respondents. We reviewed title V permits for the remaining 16 facilities subject to the PEPO NESHAP and determined that no additional Group 2 storage vessels would be affected by any of the aforementioned options. Based on these analyses, we estimate that applying any of the aforementioned options to the PEPO NESHAP would not result in cost impacts or emission reductions for PEPO facilities. See the document titled 
                        <E T="03">Clean Air Act Section 112(d)(6) Technology Review for Storage Vessels Located in the PEPO Production Source Category that are Associated with Processes Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this rulemaking, for details on the assumptions and methodologies used in this analysis.
                    </P>
                    <P>
                        We are proposing storage vessel Control Option 2 (which includes Control Option 1), pursuant to CAA section 112(d)(6), to revise the Group 1 storage capacity criterion for PEPO storage vessels at new and existing sources from between 75 m
                        <SU>3</SU>
                         (inclusive) and 151 m
                        <SU>3</SU>
                         to between 38 m
                        <SU>3</SU>
                         (inclusive) and 151 m
                        <SU>3</SU>
                         (see proposed table 3 to 40 CFR part 63, subpart PPP), and to require upgraded deck fittings and controls for guidepoles for all storage vessels equipped with an IFR as already required in 40 CFR part 63, subpart WW (see proposed 40 CFR 63.1432 which refers to the HON including 40 CFR 63.119(b)(5)(ix), (x), (xi), and (xii)). We note that the EPA recently finalized these same options for the HON, finding them to be cost effective for HON storage vessels (see 89 FR 42932, May 16, 2024). Given that the PEPO NESHAP directly references the HON storage vessel provisions (40 CFR part 63, subpart G), we believe it is reasonable for PEPO facilities to comply with these same final HON provisions. Although we did not find any PEPO storage vessels that would be affected by these proposed provisions, we believe it would be unnecessarily cumbersome to exclude these vessels by caveat in the storage vessel provisions of the PEPO NESHAP. Also, given that the EPA determined that Control Option 3 was not cost effective and did not propose this option for HON storage vessels, we are not proposing to revise the PEPO NESHAP to reflect the requirements of Control Option 3 pursuant to CAA section 112(d)(6). Materials used in PEPO production have very low vapor pressures so we anticipate that the cost effectiveness of Control Option 3 would be worse for PEPO storage vessels. We also anticipate that EFR storage vessels would not be considered for any new PEPO affected sources given we did not identify any existing EFR storage vessels subject to the PEPO NESHAP. We solicit comments on the proposed revisions for storage vessels.
                    </P>
                    <HD SOURCE="HD3">3. Standards for Process Vents</HD>
                    <P>
                        A process vent is a gas stream that is discharged during the operation of a particular unit operation (
                        <E T="03">e.g.,</E>
                         separation processes, purification processes, mixing processes, reaction processes). The gas stream(s) may be routed to other unit operations for additional processing (
                        <E T="03">e.g.,</E>
                         a gas stream from a reactor that is routed to a distillation column for separation of products), sent to one or more recovery devices, sent to a process vent header collection system (
                        <E T="03">e.g.,</E>
                         blowdown system) and APCD (
                        <E T="03">e.g.,</E>
                         flare, thermal oxidizer, carbon adsorber), and/or vented to the atmosphere. Process vents may be generated from continuous and/or batch operations, as well as from other intermittent types of operations (
                        <E T="03">e.g.,</E>
                         maintenance operations). If process vents are required to be controlled prior to discharge to the atmosphere to meet an applicable emissions standard, then they are typically collected and routed to an APCD through a closed vent system.
                    </P>
                    <P>The PEPO NESHAP specifies process vent control provisions for affected sources depending on the type of PEPO production process used: (1) polymerization of epoxides, or (2) polymerization of THF. Typically, PEPO processes that use epoxide reactants are batch processes, although some epoxide reactions are continuous, while production processes that use THF are continuous. For the PEPO production processes that use epoxides as a reactant, the NESHAP groups the process vent control provisions based on the function of the organic HAP in the production process and the resulting HAP emissions. Table 7 of this preamble shows the process vent emission standards of the PEPO NESHAP for each of these groups for existing and new affected sources.</P>
                    <GPOTABLE COLS="3" OPTS="L2,nj,p7,7/8,i1" CDEF="s50,xl100,r100">
                        <TTITLE>Table 7—Process Vent Emission Standards in the PEPO NESHAP for Affected Sources That Produce PEPO Using Epoxide Reactants</TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                Process vent
                                <LI>group</LI>
                            </CHED>
                            <CHED H="1">
                                Process vent standards for existing
                                <LI>affected sources</LI>
                            </CHED>
                            <CHED H="1">
                                Process vent standards for new
                                <LI>affected sources</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Epoxides emissions</ENT>
                            <ENT>
                                • 98-percent aggregate reduction of total epoxide emissions; 
                                <SU>1</SU>
                                <LI>• flare total epoxide emissions;</LI>
                                <LI>• maintain an outlet concentration of ≤20 ppmv of total epoxides or TOC; or</LI>
                                <LI>
                                    • maintain ≤1.69 × 10
                                    <E T="0731">−2</E>
                                     kilograms of epoxide emissions per megagram of product made
                                </LI>
                            </ENT>
                            <ENT>
                                • 99.9 percent aggregate reduction of total epoxide emissions; 
                                <SU>1</SU>
                                <LI>• maintain an outlet concentration ≤20 ppmv of total epoxides or TOC; or</LI>
                                <LI>
                                    • maintain ≤4.43 × 10
                                    <E T="0731">−3</E>
                                     kilograms of epoxide emissions per megagram of product made.
                                </LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="106019"/>
                            <ENT I="01">Nonepoxide organic HAP emissions from making or modifying the product</ENT>
                            <ENT>
                                <E T="03">Group 1 combination of process vents from batch unit operations:</E>
                                <LI>• 90-percent aggregate emission reduction; or</LI>
                                <LI>• flare emissions from all vents</LI>
                            </ENT>
                            <ENT>Same as existing affected sources.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>
                                <E T="03">Group 1 process vents from continuous unit operations:</E>
                                <LI>• 98-percent aggregate emission reduction; or</LI>
                                <LI>• flare emissions</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Nonepoxide organic HAP emissions from catalyst extraction</ENT>
                            <ENT>
                                • 90-percent aggregate emission reduction; or
                                <LI>• flare emissions from all vents</LI>
                            </ENT>
                            <ENT>Same as existing affected sources.</ENT>
                        </ROW>
                        <TNOTE>
                            <SU>1</SU>
                             The PEPO NESHAP allows the use of ECO as a means of reducing emissions by the required percentage (98 or 99.9 percent) or complying with the production-based limits (1.69 × 10
                            <E T="0731">−2</E>
                             or 4.43 × 10
                            <E T="0731">−3</E>
                            ). This pollution prevention technique reduces emissions by extending the time of reaction, thus leaving less unreacted epoxides to be emitted downstream. To demonstrate a percent efficiency, it is necessary to designate the basis, or the “uncontrolled” emissions, for assessing the percent reduction. The point where uncontrolled emissions are to be assessed, called the “onset” of the ECO, is defined in the PEPO NESHAP as the point when the epoxide concentration in the reactor liquid is equal to 25 percent of the concentration of epoxide in the liquid at the end of the epoxide feed.
                        </TNOTE>
                    </GPOTABLE>
                    <P>For the control requirements for nonepoxide organic HAP from making or modifying the product specified in table 7 of this preamble, owners or operators must determine whether the process vent is a Group 1 or Group 2 process vent. The PEPO NESHAP defines a “Group 1 combination of batch process vents” as a collection of process vents in a PMPU from batch unit operations that are associated with the use of a nonepoxide organic HAP to make or modify the product that has: (1) annual nonepoxide organic HAP emissions of 11,800 kg/yr (approximately 26,014 lb/yr) or greater, and (2) a cutoff flow rate that is greater than or equal to the annual average flow rate. The PEPO NESHAP defines a “Group 1 continuous process vent” as a process vent from a continuous unit operation that is associated with the use of a nonepoxide organic HAP to make or modify the product and that has: (1) a flow rate greater than or equal to 0.005 standard cubic meters per minute (scmm), (2) a total organic HAP concentration greater than or equal to 50 ppmv, and (3) a total resource effectiveness (TRE) index value less than or equal to 1.0. As discussed further below, the TRE index value is a measure of the supplemental total resource requirement per unit VOC (or HAP) reduction. The PEPO NESHAP defines a Group 2 process vent as a process vent that is associated with the use of a nonepoxide organic HAP to make or modify the product that is not classified as either a Group 1 combination of batch process vents or a Group 1 continuous process vent. In general, Group 2 process vents are not required to apply any additional emission controls; however, they are subject to certain monitoring, reporting, and recordkeeping requirements to ensure that they were correctly determined to be Group 2 and that they remain Group 2.</P>
                    <P>
                        The HON process vent standards that certain PEPO affected sources (
                        <E T="03">i.e.,</E>
                         those that produce PEPO using THF) are currently subject to require a Group 1/Group 2 determination:
                    </P>
                    <P>• A Group 1 process vent associated with a PMPU using THF is a process vent for which the vent stream flow rate is greater than or equal to 0.005 scmm, the total organic HAP concentration is greater than or equal to 50 ppmv, and the TRE index value is less than or equal to 1.0. Owners or operators of Group 1 process vents at PEPO processes that use THF are required to either: reduce emissions of organic HAP using a flare meeting 40 CFR 63.11(b); reduce emissions of total organic HAP or TOC by 98 weight percent or to an exit concentration of 20 ppmv, whichever is less stringent; or achieve and maintain a TRE index value greater than 1.0.</P>
                    <P>• A Group 2 process vent associated with a PMPU using THF is process vent for which the vent stream flow rate is less than 0.005 scmm, the total organic HAP concentration is less than 50 ppmv, or the TRE index value is greater than 1.0.</P>
                    <P>
                        As previously mentioned in this section of the preamble, the PEPO NESHAP contains a TRE index value threshold of 1.0 as part of the criteria used to determine whether owners or operators must control continuous process vents associated with nonepoxide organic HAP from making or modifying product and process vents associated with affected sources that produce PEPO using THF. In both of these process vent scenarios, the PEPO NESHAP requires owners or operators to calculate the TRE index using the procedures in the HON. The TRE index value accounts for all the resources which are expected to be used in VOC (or HAP) control by thermal oxidation and provides a dimensionless measure of resource burden based on cost effectiveness. Resources include supplemental natural gas, labor, and electricity. Additionally, if the off-gas contains halogenated compounds, resources will also include caustic and scrubbing and quench makeup water. For the PEPO NESHAP, owners or operators derive the TRE index value from the cost effectiveness associated with HAP control by a flare or thermal oxidation, and is a function of vent stream flowrate, vent stream net heating value, hourly emissions, and a set of coefficients. The EPA first introduced the TRE index value in an Agency document titled: 
                        <E T="03">Guideline Series for Control of Volatile Organic Compound (VOC) Emissions from Air Oxidation Processes in Synthetic Organic Chemical Manufacturing Industry (SOCMI)</E>
                         (see EPA-450/3-84-015, December 1984). The EPA incorporated the TRE concept into the original HON (see 59 FR 19468, April 22, 1994) and the original PEPO NESHAP rulemaking (see 64 FR 29420, June 1, 1999). The PEPO NESHAP uses the TRE index value as an alternative mode of compliance for process vent regulations. The TRE index value can also trigger monitoring, recordkeeping, and reporting requirements. For additional details regarding the TRE index value (including the equation and coefficients used to calculate the TRE index value for the PEPO NESHAP), see the document titled 
                        <E T="03">Clean Air Act Section 112(d)(6) Technology Review for Batch and Continuous Process Vents in the PEPO Production Source Category that are Associated with Processes Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <P>
                        Our technology review for PEPO process vents (
                        <E T="03">i.e.,</E>
                         broader than our review of process vents in EtO service discussed in section IV.B.2.a of this preamble) did not identify any control options associated with: (1) epoxide (
                        <E T="03">i.e.,</E>
                         EtO, propylene oxide, and 
                        <PRTPAGE P="106020"/>
                        epichlorohydrin) emissions resulting from the use of these chemicals as reactants, or (2) emissions of nonepoxide organic HAP resulting from their use in catalyst extraction. However, we identified the following emission reduction options as part of our technology review for continuous process vents associated with nonepoxide organic HAP from making or modifying product and process vents associated with affected sources that produce PEPO using THF: (1) remove the TRE concept in its entirety, remove the 50-ppmv and 0.005-scmm Group 1 process vent thresholds, and redefine a Group 1 process vent as any process vent that emits greater than or equal to 1.0 pound per hour (lb/hr) of total organic HAP; (2) the same requirements specified in Control Option 1, but redefine a Group 1 process vent as any process vent that emits greater than or equal to 0.10 lb/hr of total organic HAP; and (3) retain the TRE concept and the 50-ppmv and 0.005-scmm Group 1 process vent thresholds, but increase the TRE index value threshold from 1.0 to 5.0.
                    </P>
                    <P>
                        We identified Control Options 1 and 2 as developments in practices, processes, and control technologies for multiple reasons. First, we identified at least two chemical manufacturing NESHAP (
                        <E T="03">i.e.,</E>
                         EMACT standards and the HON) that do not use the TRE index value as criteria for determining whether a process vent should be controlled.
                        <SU>42</SU>
                        <FTREF/>
                         Second, based on the responses to our CAA section 114 request (see section II.C of this preamble), we observed that some facilities are voluntarily controlling continuous process vents that are not required to be controlled per the results of the TRE index value calculation. Of the 13 HON facilities that received the CAA section 114 request, at least three facilities confirmed they were voluntarily controlling some of their Group 2 process vents. We expect PEPO facilities will also voluntarily control some of their Group 2 process vents, because facilities responded in the CAA section 114 request that, pursuant to 40 CFR 63.113(h), many of their process vents are voluntarily designated as Group 1 process vents “so that TRE calculations are not required.” In other words, some facilities are likely electing to control certain process vents that have TRE index values greater than 1.0.
                        <SU>43</SU>
                        <FTREF/>
                         Third, based on the responses to our CAA section 114 request, we observed that facilities are routing multiple continuous process vents to a single APCD. This practice is significant because the current use of the TRE index value is only based on controlling a single process vent with a single APCD, which is an unrealistic scenario when compared to how chemical manufacturing facilities actually control their process vents. We believe that it is much more likely that a facility routes numerous process vents to the same APCD. Finally, we concluded that the TRE index is difficult to enforce because it is largely a theoretical characterization tool that incorporates numerous input values provided by owners or operators, and verifying the inputs without site-specific process knowledge can be problematic. We based our conclusion on a response to the CAA section 114 request received from one facility that provided over 300 pages of modeled runs that the facility used to help determine certain characteristics of their continuous process vents for use as inputs to TRE index value calculations (the facility had originally included these modeled runs with their Notification of Compliance Status report for the HON). Our review of this information identified numerous instances where the facility noted difficulties or uncertainties associated with modeling the process vent characteristics.
                    </P>
                    <FTNT>
                        <P>
                            <SU>42</SU>
                             The EPA recently removed the TRE index value from the HON (see 89 FR 42932, May 16, 2024). The EMACT standards never used the TRE index value.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>43</SU>
                             None of the nine PEPO facilities that received our CAA section 114 request reported having any Group 2 continuous process vents associated with processes subject to the PEPO NESHAP; and only one of these facilities designated eight of their process vents as Group 1 continuous process vents subject to the PEPO NESHAP. We note that facilities can voluntarily designate a Group 2 process vent as a Group 1 process vent and control it according to Group 1 requirements. In these instances, the owner or operator is not required to keep calculations supporting a TRE index value. Therefore, it is possible that some of these Group 1 process vents are Group 2 process vents designated as Group 1 process vents.
                        </P>
                    </FTNT>
                    <P>
                        We identified Control Option 3 as a development in practices, processes, and control technologies because we determined that another chemical manufacturing NESHAP (
                        <E T="03">i.e.,</E>
                         the MON) contains a TRE index value threshold criteria (
                        <E T="03">i.e.,</E>
                         less than or equal to 1.9) that is more stringent than the PEPO NESHAP TRE index value threshold criteria (
                        <E T="03">i.e.,</E>
                         less than or equal to 1.0). Additionally, we identified one State regulatory agency rule that uses a more stringent TRE index value threshold than the value specified in the PEPO NESHAP.
                        <SU>44</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>44</SU>
                             See Illinois Title 35: Subtitle B: Chapter I: Subchapter C: Parts 218 and 219 (
                            <E T="03">i.e.,</E>
                             Organic Material Emission Standards And Limitations For The Chicago Area Subpart V: Batch Operations And Air Oxidation Processes; and Organic Material Emission Standards And Limitations For The Metro East Area Subpart V: Batch Operations And Air Oxidation Processes). However, it is unlikely to be applicable to process vents in the PEPO Production source category because it applies specifically to air oxidation processes, which are not typically used in PEPO production.
                        </P>
                    </FTNT>
                    <P>To evaluate impacts of the three control options presented above, we used information for approximately 50 continuous process vents designated as Group 2 that was provided by nine of the 13 HON facilities that received the CAA section 114 request. We determined it was reasonable to use the CAA section 114 response data for HON Group 2 process vents to extrapolate impacts for certain continuous Group 2 process vents subject to the PEPO NESHAP given that PMPU sources subject to the PEPO NESHAP are similar to CMPU (chemical manufacturing process unit) sources that are subject to the HON. Additionally, there are 15 PEPO facilities co-located with HON facilities; therefore, we believe it is reasonable to assume that developments in practices, processes, and control technologies would be implemented across the entire facility, given the similarities between HON and PEPO process units. We also reviewed several air emissions permits issued by State regulatory agencies to validate our assumptions and estimates of the number of Group 2 process vents located at PEPO facilities. Although we were unable to determine the exact number of Group 2 process vents (both continuous and batch) that are located at each PEPO facility, we believe that, based on our air permit review, our Group 2 process vent estimates are reasonable. It is evident from our air permit review that some PEPO facilities have between one and six Group 2 process vents.</P>
                    <P>
                        We estimated that process vent Control Option 1 would impact four PEPO facilities; one facility would need to install a thermal oxidizer and three facilities would either use existing controls or are already voluntarily controlling their Group 2 process vents. We estimated that process vent Control Option 2 would impact eight PEPO facilities; five facilities would need to install a thermal oxidizer and three facilities would either use existing controls or are already voluntarily controlling their Group 2 process vents. For process vent Control Option 3, we estimated that four PEPO facilities would be impacted by this option with one PEPO facility needing to install a thermal oxidizer and three facilities using either existing controls or are already voluntarily controlling their Group 2 process vents (
                        <E T="03">i.e.,</E>
                         the same impacts as estimated for process vent 
                        <PRTPAGE P="106021"/>
                        Control Option 1). We then used information about the composition of process vent streams, net heating value, and volumetric and mass flow rate that industry provided to the EPA in response to the CAA section 114 request for HON Group 2 process vents to estimate the total capital investment and total annual cost of: (1) installing thermal oxidizers for reducing HAP emissions from certain PEPO Group 2 process vents, or (2) installing ductwork and a blower to route certain PEPO Group 2 process vents to an existing control device. For facilities that would need to install a thermal oxidizer, we used a total capital investment of $1,000,000 provided by commenters in the HON rulemaking (see 89 FR 42932, May 16, 2024). For total annual cost, we used the value the Agency determined for the HON rulemaking ($377,000 after adjusting for a higher interest rate and year 2022 dollars) for installing a new recuperative thermal oxidizer with 70-percent energy recovery following the procedures contained in the EPA Control Cost Manual.
                        <SU>45</SU>
                        <FTREF/>
                         For facilities that would not need to install a thermal oxidizer and would instead route Group 2 process vent emissions to an existing control device at the facility, we also estimated the average total capital investment and total annual cost values and emission reductions to install ductwork and a blower using the EPA Control Cost Manual.
                    </P>
                    <FTNT>
                        <P>
                            <SU>45</SU>
                             EPA, 2002. 
                            <E T="03">EPA Control Cost Manual,</E>
                             Sixth Edition. January 2002. Publication Number EPA/452/B-02-001.
                        </P>
                    </FTNT>
                    <P>Table 8 of this preamble presents the nationwide impacts for the three options considered for continuous process vents associated with nonepoxide organic HAP (from making or modifying product) and process vents associated with affected sources that produce PEPO using THF. We determined that Control Option 1 is cost effective; therefore, we are proposing, pursuant to CAA section 112(d)(6), to remove the TRE concept in its entirety from the PEPO NESHAP (see proposed 40 CFR 63.1425(c)(4) and (f)(7), 63.1428(h) and (i), 63.1429(b)(2), and 63.1430(e)(2), (f)(2) through (f)(5), and (j)). We are also proposing, pursuant to CAA section 112(d)(6), to remove the 50-ppmv and 0.005-scmm thresholds from the Group 1 definition for continuous process vents at 40 CFR 63.1423(b) associated with nonepoxide organic HAP and the Group 1 process vent applicability associated with a PMPU using THF, and instead require owners and operators of these process vents that emit greater than or equal to 1.0 lb/hr of total organic HAP to meet the current control standards in the PEPO NESHAP. We are also proposing to revise 40 CFR 63.1430(g)(3) to align to the proposed 1.0 lb/hr threshold. In this action, we are not proposing to revise the PEPO NESHAP to reflect the requirements of process vent Control Options 2 and 3 pursuant to CAA section 112(d)(6). We determined that process vent Control Option 2 is not cost effective, and while we believe Control Option 3 is cost effective, it would require retaining the TRE concept in the rule which, for the reasons explained above, we believe is not desirable. We solicit comments on the proposed revisions to the process vent requirements for the PEPO NESHAP.</P>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s25,12,12,12,12,12">
                        <TTITLE>
                            Table 8—Nationwide Emissions Reductions and Cost Impacts of Control Options Considered for Certain Process Vents 
                            <SU>1</SU>
                             at PEPO Facilities
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">Control option</CHED>
                            <CHED H="1">
                                Total capital
                                <LI>investment</LI>
                                <LI>($)</LI>
                            </CHED>
                            <CHED H="1">
                                Total
                                <LI>annualized</LI>
                                <LI>costs</LI>
                                <LI>($/yr)</LI>
                            </CHED>
                            <CHED H="1">
                                VOC
                                <LI>emission</LI>
                                <LI>reductions</LI>
                                <LI>(tpy)</LI>
                            </CHED>
                            <CHED H="1">
                                HAP
                                <LI>emission</LI>
                                <LI>reductions</LI>
                                <LI>(tpy)</LI>
                            </CHED>
                            <CHED H="1">
                                HAP cost-
                                <LI>effectiveness</LI>
                                <LI>($/ton)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>1,023,000</ENT>
                            <ENT>380,000</ENT>
                            <ENT>45</ENT>
                            <ENT>45</ENT>
                            <ENT>$8,500</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>3,040,000</ENT>
                            <ENT>1,135,000</ENT>
                            <ENT>34</ENT>
                            <ENT>21</ENT>
                            <ENT>53,700</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>1,023,000</ENT>
                            <ENT>380,000</ENT>
                            <ENT>37</ENT>
                            <ENT>37</ENT>
                            <ENT>10,200</ENT>
                        </ROW>
                        <TNOTE>
                            <SU>1</SU>
                             For continuous process vents associated with nonepoxide organic HAP (from making or modifying product) and process vents associated with affected sources that produce PEPO using THF.
                        </TNOTE>
                    </GPOTABLE>
                    <P>
                        As part of our technology review for the combination of batch process vents that are associated with the use of a nonepoxide organic HAP to make or modify the product, we identified the following emission reduction option: revise the PEPO NESHAP control threshold from 26,014 lb/yr to 10,000 lb/yr and remove the associated flow rate applicability threshold. We identified this option as a development in practices, processes, and control technologies based on our comparison of the batch process vent requirements in the NESHAP for Chemical Manufacturing Area Sources (CMAS) to those specified in the PEPO NESHAP. Also, as part of a recent technology review, the EPA updated the Group I Polymers and Resins (P&amp;R I) NESHAP (see 89 FR 42932, May 16, 2024) to reflect the applicability threshold used in the CMAS NESHAP. We note that the CMAS NESHAP regulates batch process vents from nine area source categories in the chemical manufacturing sector. Owners and operators of a CMAS CMPU with collective uncontrolled organic HAP emissions greater than or equal to 10,000 lb/yr from all batch process vents associated with an affected CMPU must meet emission limits for organic HAP emissions. The CMAS NESHAP defines GACT for batch process vents as 85-percent control for existing batch process units (and 90-percent control for new units) that have uncontrolled organic HAP emissions equal to or greater than 10,000 lb/yr. As discussed in the CMAS NESHAP rulemaking,
                        <SU>46</SU>
                        <FTREF/>
                         the EPA also used the applicability threshold of 10,000 lb/yr per batch process in the MON and this threshold indicates the size of a CMPU because the MON applies to major sources of HAP. The EPA used information from the baseline facility MON database and determined that costs to meet an 85-percent control requirement for existing CMAS CMPUs with uncontrolled organic HAP emissions equal to or greater than 10,000 lb/yr were reasonable ($8,700/ton). We note that the applicability threshold for uncontrolled organic HAP emissions of 10,000 lb/yr used in the CMAS NESHAP is more stringent than the applicability threshold of 26,014 lb/yr specified in the PEPO NESHAP for nonepoxide organic HAP emitted from Group 1 combination of batch process vents that are associated with the use of a nonepoxide organic HAP to make or modify the product.
                    </P>
                    <FTNT>
                        <P>
                            <SU>46</SU>
                             See 74 FR 56008, October 29, 2009.
                        </P>
                    </FTNT>
                    <P>
                        To evaluate impacts of the option presented for the combination of batch 
                        <PRTPAGE P="106022"/>
                        process vents that are associated with the use of a nonepoxide organic HAP to make or modify the product, we used information from the batch process vent impacts analysis for the CMAS final rule.
                        <SU>47</SU>
                        <FTREF/>
                         We selected the model plant for the 90-percent control option shown in table 3 of the CMAS NESHAP impacts analysis memorandum for sources subject to the PEPO NESHAP (instead of the 85-percent control option model plant shown in table 2 of the impacts analysis memorandum) to prevent backsliding of the current PEPO NESHAP requirements, which reflect MACT instead of the GACT standards of the CMAS NESHAP. We assumed that all facilities subject to the PEPO NESHAP, except for the nine that received our CAA section 114 request,
                        <SU>48</SU>
                        <FTREF/>
                         have batch process vents that would require control under the option evaluated (
                        <E T="03">i.e.,</E>
                         under the option to change the Group 1 combination of batch process vents threshold to 10,000 lb/yr). Additionally, we determined that one facility is a small business that is co-located with a HON facility, and already accounted for under the recent HON rulemaking (see 89 FR 42932, May 16, 2024). As a result, we estimated impacts to the remaining 15 PEPO facilities.
                    </P>
                    <FTNT>
                        <P>
                            <SU>47</SU>
                             RTI, 2009. 
                            <E T="03">Revised Impacts Analysis for Batch Process Vents Chemical Manufacturing Area Source NESHAP.</E>
                             October 14, 2009. EPA Docket No. EPA-HQ-OAR-2008-0334-0075.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>48</SU>
                             None of the nine PEPO facilities reported having any Group 2 combinations of batch process vents associated with processes subject to the PEPO NESHAP; however, five of the nine facilities reported having several Group 1 combinations of batch process vents subject to the PEPO NESHAP. We note that facilities can voluntarily designate a Group 2 process vent a Group 1 process vent and control it according to Group 1 requirements. In these instances, the owner or operator is not required to keep calculations supporting a TRE index value. Therefore, it is possible that some of these Group 1 process vents are Group 2 process vents designated as Group 1 process vents.
                        </P>
                    </FTNT>
                    <P>Table 9 of this preamble presents the nationwide impacts for the option considered for the combination of batch process vents that are associated with the use of a nonepoxide organic HAP to make or modify the product at PEPO facilities. We determined that this option is cost effective, and we are proposing, pursuant to CAA section 112(d)(6), to remove the Group 1 process vent thresholds of annual organic HAP emissions mass flow rate, cutoff flow rate, and the annual average batch vent flow rate from the definition of “Group 1 combination of batch process vents” specified in the PEPO NESHAP at 40 CFR 63.1423(b). We are also proposing to remove rule text associated with these process vent thresholds at 40 CFR 63.1428(c), (d), and (e). Instead, using the procedures specified in 40 CFR 63.1428(b), owners and operators of Group 1 combination of batch process vents that release a total of annual nonepoxide organic HAP emissions greater than or equal to 4,536 kg/yr (10,000 lb/yr) would be required at 40 CFR 63.1425(c) to reduce emissions of nonepoxide organic HAP from these process vents using a flare meeting the proposed operating and monitoring requirements for flares (see section IV.D.1 of this preamble); or reduce emissions of nonepoxide organic HAP by 90 percent by weight. We are also proposing to revise 40 CFR 63.1430(e)(1)(vii) to align to the proposed 4,536 kg/yr threshold. We solicit comments on the proposed revisions to the PEPO NESHAP for the combination of batch process vents that are associated with the use of a nonepoxide organic HAP to make or modify the product.</P>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s25,12C,12C,12C,12C,12C">
                        <TTITLE>Table 9—Nationwide Emissions Reductions and Cost Impacts of the Control Option Considered for the Combination of Batch Process Vents (That Are Associated With the Use of a Nonepoxide Organic HAP To Make or Modify the Product) at PEPO Facilities</TTITLE>
                        <BOXHD>
                            <CHED H="1">Control option</CHED>
                            <CHED H="1">
                                Total
                                <LI>capital</LI>
                                <LI>investment</LI>
                                <LI>($)</LI>
                            </CHED>
                            <CHED H="1">
                                Total
                                <LI>annualized</LI>
                                <LI>costs</LI>
                                <LI>($/yr)</LI>
                            </CHED>
                            <CHED H="1">
                                VOC
                                <LI>emission</LI>
                                <LI>reductions</LI>
                                <LI>(tpy)</LI>
                            </CHED>
                            <CHED H="1">
                                Organic HAP
                                <LI>emission</LI>
                                <LI>reductions</LI>
                                <LI>(tpy)</LI>
                            </CHED>
                            <CHED H="1">
                                Organic
                                <LI>HAP cost-</LI>
                                <LI>effectiveness</LI>
                                <LI>($/ton)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>778,950</ENT>
                            <ENT>625,050</ENT>
                            <ENT>87.8</ENT>
                            <ENT>87.8</ENT>
                            <ENT>7,120</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        For further details on our assumptions and methodologies used in these analyses, see the document titled 
                        <E T="03">Clean Air Act Section 112(d)(6) Technology Review for Batch and Continuous Process Vents in the PEPO Production Source Category that are Associated with Processes Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <HD SOURCE="HD3">4. Standards for Wastewater</HD>
                    <P>As previously mentioned in this preamble, HAP are emitted from wastewater collection, storage, and treatment systems that are uncovered or open to the atmosphere through volatilization of organic compounds at the liquid surface. Emissions occur by diffusive or convective means, or both. Diffusion occurs when organic concentrations at the water surface are much higher than ambient concentrations. The organics volatilize, or diffuse into the air, to reach equilibrium between aqueous and vapor phases. Convection occurs when air flows over the water surface, which reduces the concentration at the boundary layer between the liquid and air, thereby sweeping organic vapors from the water surface into the air. The rate of volatilization is related directly to the speed of the air flow over the water surface.</P>
                    <P>
                        The PEPO NESHAP defines wastewater to mean water that contains either: (1) an annual average concentration of compounds specified in table 4 to 40 CFR part 63, subpart PPP, of at least 5 ppmw and has an annual average flow rate of 0.02 liters per minute (lpm) or greater, or (2) an annual average concentration of compounds specified in table 4 to 40 CFR part 63, subpart PPP, of at least 10,000 ppmw at any flow rate. The PEPO NESHAP definition of wastewater also includes water discarded from a PMPU that is part of an affected source (see 40 CFR 63.1420(a) for the definition of an affected source). Wastewater can be process wastewater or maintenance wastewater. For process and maintenance wastewaters, and certain liquid streams in open systems within a PMPU, the PEPO NESHAP defines Group 1 wastewater streams at existing and new sources as having a total annual average concentration of compounds specified in table 4 to 40 CFR part 63, subpart PPP, that are also in table 9 to 40 CFR part 63, subpart G, greater than or equal to 10,000 ppmw at any flow rate, or greater than or equal to 1,000 ppmw with an annual average flow rate greater than or equal to 10 liters per minute. The HON wastewater standards that PEPO sources are currently subject to directly reference (with differences specified in 40 CFR 63.1433(a)) NESHAP subpart G at 40 
                        <PRTPAGE P="106023"/>
                        CFR 63.132 through 63.147, which provide owners and operators several control options for wastewater tanks, surface impoundments, containers, individual drain systems, and oil-water separators. NESHAP subpart G also specifies performance standards for treating wastewater streams using open or closed biological treatment systems or using a design steam stripper with vent control. For APCDs (
                        <E T="03">e.g.,</E>
                         thermal oxidizers) used to control emissions from collection system components, steam strippers, or closed biological treatment systems, NESHAP subpart G provides owners or operators several compliance options, including 95-percent destruction efficiency, a 20-ppmv outlet concentration, or temperature and residence time design specifications for enclosed combustion devices.
                    </P>
                    <P>The HON maintenance wastewater standards that PEPO sources are currently subject to directly reference (with exceptions specified in 40 CFR 63.1433(b)) NESHAP subpart F at 40 CFR 63.105, which requires owners or operators to prepare a description of the maintenance procedures for managing wastewaters generated from the emptying and purging of equipment during shutdowns, maintenance, and repair. For certain liquid streams in open systems within a PMPU, NESHAP subpart G requires drain, manhole, lift station, and trench components to be equipped with a tightly fitting solid cover, a cover with vent control, or water seals; pipes to have no visible gaps or other emissions interfaces; oil/water separators to be equipped with a fixed roof with vent control or a floating roof; and tanks to have a fixed roof (with vent control if the tank contents are sparged, are heated, or are treated using an exothermic reaction).</P>
                    <P>
                        As part of our CAA section 112(d)(6) technology review for PEPO wastewater streams (
                        <E T="03">i.e.,</E>
                         broader than our review of wastewater streams in EtO service discussed in section IV.B.2.d of this preamble), we evaluated tightening the PEPO wastewater Group 1 applicability thresholds. Specifically, we evaluated the option to require owners and operators to manage and treat existing wastewater streams with total annual average concentration of compounds specified in table 4 to 40 CFR part 63, subpart PPP (that are also in table 9 to NESHAP subpart G) greater than or equal to 1,000 ppmw at any flow rate, or greater than or equal to 10 ppmw at a flow rate of 10 lpm or greater.
                    </P>
                    <P>
                        Table 10 of this preamble presents the nationwide costs and impacts for the wastewater stream control option considered for PEPO facilities. For details on the assumptions and methodologies used in this analysis, see the document titled 
                        <E T="03">Clean Air Act Section 112(d)(6) Technology Review for Wastewater Streams Located in the PEPO Production Source Category that are Associated with Processes Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s25,12C,12C,12C,12C,12C">
                        <TTITLE>Table 10—Nationwide Emissions Reductions and Cost Impacts of the Control Option Considered for Wastewater Streams at PEPO Facilities</TTITLE>
                        <BOXHD>
                            <CHED H="1">Control option</CHED>
                            <CHED H="1">
                                Total
                                <LI>capital</LI>
                                <LI>investment</LI>
                                <LI>($)</LI>
                            </CHED>
                            <CHED H="1">
                                Total
                                <LI>annualized</LI>
                                <LI>costs</LI>
                                <LI>($/yr)</LI>
                            </CHED>
                            <CHED H="1">
                                VOC
                                <LI>emission</LI>
                                <LI>reductions</LI>
                                <LI>(tpy)</LI>
                            </CHED>
                            <CHED H="1">
                                Organic
                                <LI>HAP</LI>
                                <LI>emission</LI>
                                <LI>reductions</LI>
                                <LI>(tpy)</LI>
                            </CHED>
                            <CHED H="1">
                                Organic
                                <LI>HAP cost</LI>
                                <LI>effectiveness</LI>
                                <LI>($/ton)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>57,128,000</ENT>
                            <ENT>22,600,000</ENT>
                            <ENT>693</ENT>
                            <ENT>693</ENT>
                            <ENT>32,600</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        We determined that the option to revise wastewater stream Group 1 threshold applicability in the PEPO NESHAP (
                        <E T="03">i.e.,</E>
                         to require control of existing wastewater streams with total annual average concentration of table 4 to subpart PPP compounds (that are also in table 9 to NESHAP subpart G) greater than or equal to 1,000 ppmw at any flow rate, or greater than or equal to 10 ppmw at a flow rate of 10 lpm or greater) is not cost effective based on the costs and emission reductions presented. Therefore, we are not proposing to revise the PEPO NESHAP to reflect the requirements of this option pursuant to CAA section 112(d)(6).
                    </P>
                    <HD SOURCE="HD3">5. Standards for Equipment Leaks</HD>
                    <P>
                        As previously mentioned in this preamble, emissions of VOC and HAP from equipment leaks occur in the form of gases or liquids that escape to the atmosphere through many types of connection points (
                        <E T="03">e.g.,</E>
                         threaded fittings) or through the moving parts of certain types of process equipment during normal operation. Equipment regulated by the PEPO NESHAP includes agitators, compressors, connectors, instrumentation systems, OEL, PRDs, pumps, sampling collection systems, and valves that contain or contact material having 5 percent by weight or more of organic HAP, operate 300 hours per year or more, and are not in vacuum service.
                    </P>
                    <P>
                        The equipment leak standards that PEPO sources are currently subject to directly reference the provisions in the HON at 40 CFR part 63, subpart H, which require LDAR using monitoring with EPA Method 21 of appendix A-7 to 40 CFR part 60 at certain frequencies (
                        <E T="03">e.g.,</E>
                         monthly, quarterly, every 2 quarters, annually) and varying leak definitions (
                        <E T="03">e.g.,</E>
                         500 ppmv; 1,000 ppmv; 10,000 ppmv) depending on the type of component and service (
                        <E T="03">e.g.,</E>
                         in gas and vapor service or in light liquid service). The LDAR requirements for components in heavy liquid service include sensory monitoring (
                        <E T="03">e.g.,</E>
                         visual, audible, olfactory).
                    </P>
                    <P>
                        The practices, processes, and control technologies we considered during MACT development for equipment leaks at PEPO facilities included LDAR and equipment standards. To identify developments for the technology review, we evaluated responses to our CAA section 114 request, the RACT/BACT/LAER database, and other Federal regulations (
                        <E T="03">i.e.,</E>
                         the Petroleum Refinery Sector rule, HON, MON, and NSPS subpart VVb) and State regulations (
                        <E T="03">i.e.,</E>
                         the Texas fugitive emissions rules 
                        <SU>49</SU>
                        <FTREF/>
                         applicable to petrochemical processes). Also, the EPA conducted a general analysis in a 2011 equipment leaks study 
                        <SU>50</SU>
                        <FTREF/>
                         to identify the latest developments in practices, processes, and control technologies for equipment leaks at chemical manufacturing facilities and petroleum refineries, and to estimate the impacts of applying those practices, processes, and control technologies to model facilities. We used this 2011 equipment leaks analysis as a reference for conducting the technology review for equipment leaks at PEPO facilities.
                    </P>
                    <FTNT>
                        <P>
                            <SU>49</SU>
                             30 TAC 115, subchapters D and H, Division 3.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>50</SU>
                             Hancy. 2011. Memorandum from Hancy, C., RTI International, to Howard, J., EPA/OAQPS. 
                            <E T="03">Analysis of Emissions Reduction Techniques for Equipment Leaks.</E>
                             December 21, 2011. EPA Docket ID No. EPA-HQ-OAR-2010-0869.
                        </P>
                    </FTNT>
                    <P>
                        Our technology review for equipment leaks of HAP (
                        <E T="03">i.e.,</E>
                         broader than the EtO 
                        <PRTPAGE P="106024"/>
                        emissions discussed in section IV.B.2.b of this preamble) did not find any new control technologies for equipment leak emissions to evaluate. However, we did identify developments in LDAR practices and processes (
                        <E T="03">i.e.,</E>
                         lower leak definitions) for valves in gas and vapor service or in light liquid service, and pumps in light liquid service. We evaluated three control options to reduce HAP emissions from equipment leaks: (Control Option 1) lowering the leak definition for valves in light liquid service from 500 ppmv to 100 ppmv, (Control Option 2) same as Control Option 1, plus lowering the leak definition for valves in gas and vapor service from 500 ppmv to 100 ppmv, and (Control Option 3) same as Control Option 2, plus lowering the leak definition for pumps in light liquid service from 1,000 ppmv to 500 ppmv. For all other component and service types, we did not identify developments in LDAR practices and processes in the chemical sector.
                        <SU>51</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>51</SU>
                             We note that while other technologies such as optical gas imaging and sensor networks may be considered developments in monitoring for equipment leaks, the EPA did not evaluate those options further as we have insufficient information on how use of such monitoring technology compares to current EPA Method 21 practices for chemical sector sources.
                        </P>
                    </FTNT>
                    <P>
                        The EPA estimated emission reductions for the developments that we identified using component counts and emission factors. We derived the component counts using data provided to the EPA in response to our CAA section 114 request (see section II.C of this preamble) and we developed model component counts for 25 PEPO facilities. We then multiplied the number of nationwide PEPO processes 
                        <SU>52</SU>
                        <FTREF/>
                         by the model component counts to estimate the nationwide component counts. Subsequently, we calculated baseline emissions and emissions after implementation of the proposed controls for each component using these nationwide component counts and emission factors and leak frequencies for the chemical manufacturing industry obtained from the 2011 equipment leaks study.
                    </P>
                    <FTNT>
                        <P>
                            <SU>52</SU>
                             We used data provided to the EPA in response to our CAA section 114 request to estimate an average of two PMPUs per facility for the 16 PEPO facilities that did not receive the CAA section 114 request. Including the estimate for the 16 PEPO facilities that did not receive the CAA section 114 request with the 18 PMPUs that were reported in the CAA section 114 request, we estimate 50 PMPUs nationwide.
                        </P>
                    </FTNT>
                    <P>
                        The EPA then calculated the costs for the baseline and control options, which reflect the cost to implement an LDAR program for each component. Note that the difference between the costs for the baseline and control options is the incremental cost to comply with the control requirements. Furthermore, because the control options result in chemicals in process lines not leaking (
                        <E T="03">i.e.,</E>
                         not being lost), we present costs both with and without this consideration. To estimate savings in chemicals not being emitted (
                        <E T="03">i.e.,</E>
                         lost) due to the equipment leak control options, we applied a recovery credit of $900 per ton of VOC to the emission reductions in the analyses.
                    </P>
                    <P>
                        We calculated the VOC and HAP cost effectiveness by dividing the incremental annual costs by the emissions reductions. Table 11 of this preamble presents the nationwide costs and impacts for the suite of equipment leak control options considered for PEPO facilities. For details on the assumptions and methodologies used in this analysis, see the document titled 
                        <E T="03">Clean Air Act Section 112(d)(6) Technology Review for Equipment Leaks Located in the PEPO Production Source Category that are Associated with Processes Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <GPOTABLE COLS="8" OPTS="L2,p7,7/8,i1" CDEF="s25,10,10,10,10,12,12,12">
                        <TTITLE>Table 11—Nationwide Emissions Reductions and Cost Impacts of Control Options Considered for PEPO Equipment</TTITLE>
                        <BOXHD>
                            <CHED H="1">Control option</CHED>
                            <CHED H="1">
                                Total
                                <LI>capital</LI>
                                <LI>investment</LI>
                                <LI>($)</LI>
                            </CHED>
                            <CHED H="1">
                                Total
                                <LI>annualized</LI>
                                <LI>costs w/o</LI>
                                <LI>credits</LI>
                                <LI>($/yr)</LI>
                            </CHED>
                            <CHED H="1">
                                Total
                                <LI>annualized</LI>
                                <LI>costs</LI>
                                <LI>w/credits</LI>
                                <LI>($/yr)</LI>
                            </CHED>
                            <CHED H="1">
                                Total HAP
                                <LI>emission</LI>
                                <LI>reductions</LI>
                                <LI>(tpy)</LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>HAP cost</LI>
                                <LI>effectiveness</LI>
                                <LI>w/credits</LI>
                                <LI>($/ton)</LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>HAP cost</LI>
                                <LI>effectiveness</LI>
                                <LI>w/o credits</LI>
                                <LI>($/ton)</LI>
                            </CHED>
                            <CHED H="1">
                                Average
                                <LI>incremental</LI>
                                <LI>HAP cost</LI>
                                <LI>effectiveness</LI>
                                <LI>w/credits</LI>
                                <LI>($/ton)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>42,300</ENT>
                            <ENT>11,700</ENT>
                            <ENT>9,200</ENT>
                            <ENT>2.20</ENT>
                            <ENT>4,200</ENT>
                            <ENT>5,300</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>72,700</ENT>
                            <ENT>18,800</ENT>
                            <ENT>15,300</ENT>
                            <ENT>2.99</ENT>
                            <ENT>5,100</ENT>
                            <ENT>6,300</ENT>
                            <ENT>7,700</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>99,000</ENT>
                            <ENT>28,100</ENT>
                            <ENT>24,200</ENT>
                            <ENT>3.29</ENT>
                            <ENT>7,400</ENT>
                            <ENT>8,500</ENT>
                            <ENT>30,500</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>
                        Based on the costs and emission reductions for each of the options, we determined that Control Option 2 (which includes Control Option 1) is cost effective. Therefore, we are proposing, pursuant to CAA section 112(d)(6), to revise the PEPO NESHAP at 40 CFR 63.1434(a)(7) to use a leak definition of 100 ppmv for valves that are in either gas/vapor service or light liquid service. In this action, we are not proposing to revise the PEPO NESHAP to reflect the requirements of Control Option 3 pursuant to CAA section 112(d)(6), because we determined that Control Option 3 is not cost effective due to its high incremental HAP cost effectiveness (
                        <E T="03">i.e.,</E>
                         $30,500/ton of HAP) from Control Option 2. We solicit comments on the proposed revisions to the equipment leak requirements for the PEPO NESHAP.
                    </P>
                    <HD SOURCE="HD3">6. Standards for Fenceline Monitoring</HD>
                    <P>
                        Fenceline monitoring refers to the placement of monitors along the perimeter of a facility to measure pollutant concentrations. Coupled with requirements for root cause analysis and corrective action upon triggering an actionable level, this work practice standard is a development in practices considered under CAA section 112(d)(6) for the purposes of managing fugitive emissions. The measurement of pollutant concentrations and comparison to concentrations estimated from mass emissions via dispersion modeling is used to verify emission estimates from a facility's emissions inventory. If concentrations at the fenceline are greater than expected, potential causes may include underreported or unknown emissions, leaking equipment, or other issues, usually related to ground-level fugitive emissions. Fenceline monitoring also provides information on the location of these potential emissions sources because it provides complete spatial coverage of a facility. Further, when used with a mitigation strategy, such as root cause analysis and corrective action upon exceedance of an action level, fenceline monitoring can be effective in reducing emissions and reducing the uncertainty associated with emissions estimation and characterization. Finally, public reporting of fenceline monitoring data provides public transparency and greater visibility, leading to more focus and effort in reducing emissions.
                        <PRTPAGE P="106025"/>
                    </P>
                    <P>
                        The EPA has successfully applied fenceline monitoring to the petroleum refineries source category as a technique to manage and reduce benzene emissions from fugitive emissions sources such as storage vessels, wastewater treatment systems, and leaking equipment. In 2015, the EPA promulgated the RTR for the petroleum refineries source category and required that refineries install and operate fenceline monitors following EPA Methods 325A/B to monitor benzene emissions. Additionally, the 2015 rule required that refineries conduct a root cause analysis to identify sources of high fenceline monitoring readings (
                        <E T="03">i.e.,</E>
                         above an annual action level) and then develop a corrective action plan to address the sources and reduce emissions to a level that will bring fenceline monitoring concentrations below the action level.
                        <SU>53</SU>
                        <FTREF/>
                         To date, the EPA has received fenceline monitoring data for more than 5 years.
                        <SU>54</SU>
                        <FTREF/>
                         These data show that petroleum refinery fenceline concentrations have dropped by an average of 30 percent since the inception of the monitoring program requirements and illustrate that fenceline monitoring is an effective tool in reducing emissions and preserving emission reductions on an ongoing basis for these sources.
                    </P>
                    <FTNT>
                        <P>
                            <SU>53</SU>
                             40 CFR 63.658(f) through (h).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>54</SU>
                             Quarterly fenceline monitoring reports are available through the EPA's WebFIRE database at 
                            <E T="03">https://cfpub.epa.gov/webfire/.</E>
                             The EPA has also developed a dashboard to improve public access to this data. The dashboard is available at 
                            <E T="03">https://awsedap.epa.gov/public/extensions/Fenceline_Monitoring/Fenceline_Monitoring.html?sheet=MonitoringDashboard.</E>
                        </P>
                    </FTNT>
                    <P>
                        Additionally, in 2024, the EPA promulgated amendments to the HON (40 CFR part 63, subpart G) and the P&amp;R I NESHAP (40 CFR part 63, subpart U) that included work practice standards requiring owners and operators to conduct fenceline monitoring for any of six specific HAP (
                        <E T="03">i.e.,</E>
                         benzene; 1,3-butadiene; ethylene dichloride; vinyl chloride; EtO; and chloroprene) if their affected source uses, produces, stores, or emits any of them, and conduct root cause analysis and corrective action upon exceeding annual average concentration action levels established for each HAP. The final HON and P&amp;R I NESHAP amendments require owners and operators to conduct passive diffusive tube fenceline monitoring for benzene, 1,3-butadiene, chloroprene, and ethylene dichloride in accordance with EPA Methods 325A/B of 40 CFR part 63, appendix A, and to use canister sampling in accordance with EPA Method 327 of 40 CFR part 63, appendix A, for EtO and vinyl chloride.
                        <SU>55</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>55</SU>
                             In the same action (see 89 FR 42932, May 16, 2024), the EPA also finalized EPA Method 327 of 40 CFR part 63, appendix A, as a canister sampling and analysis method that provides procedures for measuring trace levels of targeted VOC (including organic HAP) in ambient air.
                        </P>
                    </FTNT>
                    <P>
                        Given the similarities between PMPUs subject to the PEPO NESHAP and CMPU sources that are subject to the HON, we evaluated the application of fenceline monitoring at PEPO facilities as a development in practices, processes, and control technologies pursuant to CAA section 112(d)(6). Like some CMPUs, PMPUs can be a significant source of EtO emissions from ground-level or near ground level fugitive sources such as storage vessels, wastewater treatment systems, and leaking equipment. On the other hand, we determined that PMPUs are not significant sources of emissions of benzene, 1,3-butadiene, chloroprene, ethylene dichloride, and vinyl chloride. In the risk modeling file, which uses data from the 2017 NEI,
                        <SU>56</SU>
                        <FTREF/>
                         we did not attribute any records of vinyl chloride or chloroprene emissions to PEPO processes, and only small amounts of 1,3-butadiene, benzene, and ethylene dichloride emissions are attributed to PEPO processes (none of these emissions is clearly from a PMPU). Any significant emissions of these HAP from PEPO facilities are attributed to non-source category emission sources from facilities that are subject to the HON fenceline monitoring requirements. Considering the available information, we conclude that, for the PEPO NESHAP, a fenceline monitoring requirement for EtO is appropriate, but a fenceline monitoring requirement for benzene, 1,3-butadiene, chloroprene, ethylene dichloride, and vinyl chloride would not lead to an appreciable reduction in emissions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>56</SU>
                             See appendix 1 of the document titled 
                            <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                             which is available in the docket for this rulemaking, for more details about development of the risk modeling file.
                        </P>
                    </FTNT>
                    <P>Based on this information, the EPA is proposing in this action to implement a fenceline monitoring program under CAA section 112(d)(6) to limit fugitive emissions of EtO. We are proposing at 40 CFR 63.1434(i), by reference to 40 CFR 63.184, to require fenceline monitoring at facilities in the PEPO Production source category that use, produce, store, or emit EtO. A brief summary of the proposed fenceline sampling requirements and our rationale for selecting the corrective action concentration levels are provided as follows. We solicit comments on the proposed standards for fenceline monitoring.</P>
                    <HD SOURCE="HD3">a. Developments in Monitoring Technology and Practices</HD>
                    <P>In developing the fenceline monitoring requirements for the Petroleum Refinery NESHAP, the HON, and the P&amp;R I NESHAP, the EPA identified two different methods for monitoring fugitive emissions: (1) passive diffusive tube monitoring networks, and (2) canister monitoring networks. Given the similarities between PMPUs subject to the PEPO NESHAP and CMPU sources that are subject to the HON, and the extent of co-location between PEPO and HON facilities (15 of the 25 PEPO facilities are co-located with HON facilities), we considered these monitoring methods as developments in practices under CAA section 112(d)(6) for purposes of managing fugitive EtO emission sources at PEPO production facilities.</P>
                    <P>
                        In the promulgated amendments to the HON, the EPA finalized a new EPA method (EPA Method 327 of 40 CFR part 63, appendix A) to monitor the concentration of EtO at facility fenceline locations. EPA Method 327 provides procedures for canister sampling and analysis for measuring trace levels of targeted VOC (including organic HAP) in air. The method draws upon the guidance in Method TO-15A 
                        <SU>57</SU>
                        <FTREF/>
                         for canister sampling and further develops this guidance into a robust method specific to fenceline monitoring, defining required data quality objectives, and incorporating existing best practices into the method. EPA Method 327 collects ambient air samples using specially prepared and pre-cleaned evacuated stainless-steel canisters. For analysis, the method specifies procedures for concentrating the target VOC (
                        <E T="03">i.e.,</E>
                         EtO) in a known volume of air drawn from the canister, desorbing the target VOC from the preconcentrator, and determining the concentration of the target VOC using a gas chromatograph-mass spectrometer (GC-MS). The EPA continues to investigate cost-effective monitoring methods and technologies that could offer improved sensitivity, improved time resolution, or increased time integration.
                    </P>
                    <FTNT>
                        <P>
                            <SU>57</SU>
                             
                            <E T="03">https://www.epa.gov/sites/default/files/2019-12/documents/to-15a_vocs.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        In this action, the EPA is proposing at 40 CFR 63.1434(i), by reference to 40 CFR 63.184(b)(2), to require fenceline monitoring of EtO concentrations for one 24-hour period every 5 days using canister sampling in accordance with 
                        <PRTPAGE P="106026"/>
                        EPA Method 327 of 40 CFR part 63, appendix A. This monitoring frequency is necessary to ensure that all onsite processes are monitored regularly while maintaining the cost effectiveness of implementing a canister monitoring network. A sampling frequency of every 5 days also ensures that the annual average concentration derived from the fenceline data are indicative of the actual average emissions from the site by reducing the possibility that sampling occurs only during emission spikes. Additionally, to accommodate continued advancements and improvements in monitoring technology, we are also proposing to amend the entry for 40 CFR 63.7(f) of table 1 to the PEPO NESHAP (applicability of the NESHAP general provisions) to clarify that an owner or operator can request to use another type of monitoring network to demonstrate compliance with the fenceline standards, provided they achieve adequate coverage and detection capabilities.
                    </P>
                    <HD SOURCE="HD3">b. Siting, Design, and Sampling Requirements for Fenceline Monitors</HD>
                    <P>The EPA is proposing at 40 CFR 63.1434(i), by reference to 40 CFR 63.184(b)(3), that owners or operators deploy monitors to measure fenceline concentrations of EtO at facilities subject to the PEPO NESHAP. A primary requirement for a fenceline monitoring system is that it provides adequate spatial coverage for determination of representative pollutant concentrations at the boundary of the facility. In an ideal scenario, owners or operators would place fenceline monitors so that any fugitive plume originating within the facility would have a high probability of intersecting one or more monitors, regardless of wind direction. Therefore, we are proposing that each facility would place eight canisters evenly spaced on the monitoring perimeter. The monitoring perimeter may be the facility fenceline or may be inside the facility fenceline, provided all sources of EtO are contained within the perimeter. The EPA is also proposing to require that facilities move the canister sampling locations with alternating sampling periods to ensure complete spatial coverage of the facility. For facilities with perimeters less than or equal to 5,000 meters, all eight sampling points would be monitored during each sampling period. For facilities with perimeters greater than 5,000 meters but less than or equal to 10,000 meters, 16 sampling points would be required; for facilities with perimeters greater than 10,000 meters, 24 sampling points would be required. For facilities with EtO emission sources that are not contained within one contiguous area, the EPA is proposing monitoring of these secondary areas as well, with the size of the secondary area dictating the number of canisters. While we recognize that EPA Method 325A contains an option for siting passive tubes by determining the geographic center of the facility and spacing the tubes based on measured angles from the center point, the EPA is not providing a similar approach to simplify the siting of the canisters.</P>
                    <P>
                        The EPA is proposing at 40 CFR 63.1434(i), by reference to 40 CFR 63.184(d), that for each 24-hour sampling period, the facility would determine a “delta c,” calculated as the lowest sample value for EtO subtracted from the highest sample value for EtO. This approach subtracts the estimated contribution from background emissions that do not originate from the facility. The owner or operator would average the delta c for the most recent year of samples (73 sampling periods) to calculate an annual average delta c on a rolling basis (
                        <E T="03">i.e.,</E>
                         calculate a new annual average delta c every 5 days using data from the most recent 73 sampling periods). The owner or operator would compare this rolling annual average delta c against the concentration action level for EtO.
                    </P>
                    <HD SOURCE="HD3">c. Action Levels and Rationale</HD>
                    <P>
                        As mentioned earlier in this preamble, the EPA is proposing to require facilities subject to the PEPO NESHAP to take corrective action to reduce fugitive emissions if monitored fenceline concentrations exceed the concentration action level on a rolling annual average basis.
                        <SU>58</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             Calculated every 5 days for EtO.
                        </P>
                    </FTNT>
                    <P>
                        Due to current limitations in method detection limits for EtO, we selected the proposed fenceline action level to be equal to three times the representative detection limit (RDL) for EtO, as this is the minimum concentration that can be measured with reasonable certainty. The RDL is based on the results of the best performing testing companies and laboratories using the most sensitive analytical procedures. The EPA used a multiplication factor of three to reduce the imprecision of the method until the imprecision in the sampling and analysis is similar to the precision of other EPA methods. For the 2024 final amendments to the HON and P&amp;R I NESHAP, the EPA determined an EtO RDL of 0.07 µg/m
                        <SU>3</SU>
                        , which resulted in an EtO action level of 0.2 µg/m
                        <SU>3</SU>
                        . Therefore, in this action the EPA is similarly proposing at 40 CFR 63.1434(i), by reference to 40 CFR 63.184(d)(3)(iv), an action level of 0.2 µg/m
                        <SU>3</SU>
                         for EtO. If the reported inventories are accurate, and considering the anticipated emissions reductions from controls we are proposing, our modeling of fenceline EtO concentrations indicates that all facilities should be able to meet the fenceline concentration action level. For further details of the analysis, see the document titled 
                        <E T="03">Clean Air Act Section 112(d)(6) Technology Review for Fenceline Monitoring Located at Facilities with PEPO Production Processes Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <HD SOURCE="HD3">d. Non-Source Category Emissions</HD>
                    <P>
                        This proposed approach also considers the possibility that offsite sources could contribute to modeled concentrations at a facility's fenceline. Additionally, non-PEPO sources could be located within facility property boundaries that also contribute to monitor readings. In this proposal, we are allowing the subtraction of offsite interfering sources (as they are not within the control of the owner or operator) through site-specific monitoring plans, but we are not providing this option for onsite, non-source category emissions. We based the action level on facility-wide emissions; therefore, we considered these non-source category sources in its development. Applying the fenceline standard to the whole facility will also limit emissions of EtO from all sources and provide more certainty in decisions being made as to whether the entire facility emissions align with what is expected from the EPA's analysis. It will also provide assurance to fenceline communities that emission reductions are achieved and maintained. This is important in the chemical sector, where there could be numerous source categories that can be co-located within a larger facility and have common tank farms, wastewater systems, heat exchangers, APCDs, fuel gas systems, 
                        <E T="03">etc.,</E>
                         that may be assigned or apportioned to various source categories.
                    </P>
                    <HD SOURCE="HD3">e. Corrective Action Requirements</HD>
                    <P>
                        The proposed fenceline monitoring provisions would require the initiation of root cause analysis upon the facility's annual average concentration exceeding the action level, as determined on a rolling average every sampling period. The root cause analysis is an assessment conducted through a process of investigation to determine the primary underlying cause and other contributing 
                        <PRTPAGE P="106027"/>
                        causes of an exceedance of the action level. The proposed provisions at 40 CFR 63.1434(i), by reference to 40 CFR 63.184(e)(1), would require an owner or operator to initiate a root cause analysis within 5 days of determining that an updated annual average concentration for EtO exceeds the action level. Owners or operators must conduct a root cause analysis following each sampling period in which the annual average EtO concentration remain above the action level, to determine whether the monitoring results and associated data indicate additional sources of emissions contributing to concentrations remaining above the action level. If the owner or operator cannot determine the root cause of the exceedance within 30 days of determining that there was an exceedance of an action level, the proposed revisions require use of real-time sampling techniques (
                        <E T="03">e.g.,</E>
                         mobile gas chromatographs) to determine the root cause of the exceedance.
                    </P>
                    <P>If the underlying causes of the action level exceedance are deemed to be from sources under the control of the owner or operator, we are proposing that the owner or operator take corrective action to address the underlying cause of the exceedance and to reduce concentrations below the action level as expeditiously as possible. We are proposing that owners or operators complete the root cause analysis and initial corrective action within 45 days after determining that there was an exceedance of the action level. If the owner or operator requires longer than 45 days to implement the corrective actions identified by the root cause analysis, the owner or operator would be required to submit a corrective action plan no later than 60 days after completion of the root cause analysis.</P>
                    <P>
                        After completion of the initial corrective action, if the delta c for each of the next three sampling periods for samples collected by EPA Method 327 
                        <SU>59</SU>
                        <FTREF/>
                         is below the action level, then the corrective action is assumed to have fixed the problem, and the owner and/or operator would have no obligation for additional corrective action. However, if the delta c for any of the three subsequent sampling periods after initial corrective action is over the action level, then the owner or operator would have to submit a corrective action plan and schedule for implementing design, operation, and maintenance changes to eliminate as quickly as possible and prevent recurrence of the primary cause and other contributing causes to the exceedance of the action level, to reduce annual average concentrations below the action level. The proposed provisions would require the owner or operator to include the implementation of real-time sampling techniques to locate the primary and other contributing causes of the exceedance in the corrective action plan. While the action level is based on annual average concentrations, once the action level is exceeded, each sampling period that exceeds the action level contributes to the delta c remaining above the action level. Following these high biweekly periods, owners or operators must investigate to determine the root cause and, if appropriate, to correct the root cause expeditiously to reduce the annual average delta c below the action level.
                    </P>
                    <FTNT>
                        <P>
                            <SU>59</SU>
                             The EPA is proposing that three sample periods must remain below the action level for samples taken by EPA Method 327 because this ensures that a sample will have been taken at every monitoring location at the site following the completion of the corrective action.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">f. Costs Associated With Fenceline Monitoring Requirements</HD>
                    <P>
                        Our cost estimate for implementing the same EtO fenceline monitoring work practice standard that is in the HON for the PEPO NESHAP follows the cost analysis already discussed in the document titled 
                        <E T="03">Clean Air Act Section 112(d)(6) Technology Review for Fenceline Monitoring located in the SOCMI Source Category that are Associated with Processes Subject to HON and for Fenceline Monitoring that are Associated with Processes Subject to Group I Polymers and Resins NESHAP</E>
                         (Docket Item No. EPA-HQ-OAR-2022-0730-0091). We estimated fenceline monitoring costs for eight canisters around the fenceline every 5 days. Table 12 of this preamble provides the estimated nationwide costs for fenceline monitoring as applied to facilities subject to the PEPO NESHAP. Note that 12 of the impacted facilities covered under the analysis have co-located sources subject to both the HON and the PEPO NESHAP and require EtO fenceline monitoring under both rules. For the purposes of this analysis, costs for these co-located facilities are included under the SOCMI source category for impacts to prevent costs being double counted. For further information, see the document titled 
                        <E T="03">Clean Air Act Section 112(d)(6) Technology Review for Fenceline Monitoring Located at Facilities with PEPO Production Processes Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="xs50,r100,12C,12C">
                        <TTITLE>Table 12—Nationwide Cost Impacts of Fenceline Monitoring for the PEPO NESHAP</TTITLE>
                        <BOXHD>
                            <CHED H="1">
                                No. of
                                <LI>facilities</LI>
                                <LI>impacted</LI>
                            </CHED>
                            <CHED H="1">Monitoring description</CHED>
                            <CHED H="1">
                                Total capital
                                <LI>investment</LI>
                                <LI>($)</LI>
                            </CHED>
                            <CHED H="1">
                                Total annualized costs
                                <LI>($/yr)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">10</ENT>
                            <ENT>Canisters only</ENT>
                            <ENT>88,720</ENT>
                            <ENT>4,453,600</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD3">g. Additional Requirements of the Fenceline Monitoring Program</HD>
                    <P>
                        The EPA is proposing, by reference to the HON at 40 CFR 63.182(e), that owners or operators report fenceline data on a quarterly basis. Each report would contain the results for each sample where the field portion of sampling is completed by the end of the quarter, as well as for associated field and method blanks (
                        <E T="03">i.e.,</E>
                         each report would contain data for at 18 canister sampling periods). Owners or operators would report these data electronically to the EPA within 45 days after the end of each quarterly period. See section IV.E.2 of this preamble for further discussion on electronic reporting and section IV.F of this preamble for further discussion on the compliance dates we are proposing.
                    </P>
                    <HD SOURCE="HD2">D. What actions are we taking pursuant to CAA sections 112(d)(2) and (3) and 112(h)?</HD>
                    <P>
                        In addition to the proposed actions discussed in section IV.B of this preamble to reduce risk from EtO emission sources (from PEPO processes) and our proposed actions discussed in section IV.C of this preamble based on our on technology review, we are proposing other requirements for the PEPO NESHAP, based on analyses 
                        <PRTPAGE P="106028"/>
                        performed pursuant to CAA sections 112(d)(2) and (3) and 112(h).
                        <E T="51">60 61</E>
                        <FTREF/>
                         We are proposing to: (1) add new monitoring and operational requirements for flares used to reduce emissions from PEPO production processes, (2) clarify regulatory provisions for vent control bypasses for closed vent systems containing bypass lines, (3) add work practice standards for startup and shutdown periods for maintenance vents and planned routine maintenance of storage vessels, (4) add new monitoring requirements for PEPO pressure vessels, (5) add new emission standards for PEPO surge control vessels and bottoms receivers, (6) add new emission standards for PEPO transfer operations, (7) add butylene oxide to the list of HAP presented in table 4 to subpart PPP, and (8) remove the 40 CFR 63.1420(d)(3) exemption for certain processes currently excluded from the affected source. See the following subsections for specific details regarding these proposed actions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>60</SU>
                             The EPA has authority under CAA section 112(d)(2) and (3) to set MACT standards for previously unregulated emission points. The EPA also retains the discretion to revise a MACT standard under the authority of CAA section 112(d)(2) and (3) (see 
                            <E T="03">Portland Cement Ass'n</E>
                             v. 
                            <E T="03">EPA,</E>
                             665 F.3d 177, 189 (D.C. Cir. 2011)), such as when it identifies an error in the original standard. See also 
                            <E T="03">Medical Waste Inst.</E>
                             v. 
                            <E T="03">EPA,</E>
                             645 F.3d 420, 426 (D.C. Cir. 2011) (upholding the EPA action establishing MACT floors, based on post-compliance data, when originally-established floors were improperly established).
                        </P>
                        <P>
                            <SU>61</SU>
                             The PEPO NESHAP requires that emission limits apply at all times (see 40 CFR 63.1420(h)).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. Flares</HD>
                    <P>The EPA is proposing under CAA section 112(d)(2) and (3) to amend the operating and monitoring requirements for flares, which are commonly used as APCDs in the PEPO Production source category, because we have determined that the current requirements for flares are not adequate to ensure the level of destruction efficiency needed to comply with the process vent, storage vessel, wastewater stream, and equipment leak MACT standards in the PEPO NESHAP. The requirements applicable to flares, which are used to control emissions from various emission sources, are set forth in the general provisions of 40 CFR part 63 and are cross-referenced in the PEPO NESHAP.</P>
                    <P>The general provisions of 40 CFR 63.11(b) specify that flares be: (1) steam-assisted, air-assisted, or non-assisted; (2) operated at all times when emissions may be vented to them; (3) designed for and operated with no visible emissions (except for periods not to exceed a total of 5 minutes during any 2 consecutive hours); and (4) operated with the presence of a pilot flame at all times. These general provisions also specify both the minimum heat content of gas combusted in the flare and the maximum exit velocity at the flare tip. The general provisions specify monitoring for the presence of the pilot flame and the operation of a flare with no visible emissions.</P>
                    <P>
                        In general, flares used as APCDs are expected to achieve 98-percent HAP destruction efficiencies when designed and operated according to the requirements in the general provisions. Studies on flare performance,
                        <SU>62</SU>
                        <FTREF/>
                         however, indicate that these general provision requirements are inadequate to ensure proper performance of flares at refineries and other petrochemical facilities, particularly when the flares are either steam- or air-assisted. In addition, over the last decade, flare minimization efforts at these facilities have led to an increasing number of flares operating at well below their design capacity, and while these efforts have resulted in reduced flaring of gases, situations of over-assisting with either steam or air have become exacerbated, leading to the degradation of flare combustion efficiency. Many PEPO facilities operate directly downstream from refineries and other petrochemical plants (
                        <E T="03">e.g.,</E>
                         ethylene and EtO production plants) and, consequently, they likely flare waste gas constituents that are similar to those of a refinery or petrochemical plant. Given that the flare dataset that formed the underlying basis of the new standards for refinery flares also included flares at petrochemical plants, we are proposing at 40 CFR 63.1426(a) and (e)(2)(i), 63.1429(a)(8), 63.1430(b)(1), and 63.1437(c), each by reference to proposed 40 CFR 63.1436, to apply the finalized suite of operational and monitoring requirements for refinery flares 
                        <SU>63</SU>
                        <FTREF/>
                         to those flares in the PEPO Production source category that control emissions from PEPO processes. Therefore, these proposed amendments at 40 CFR 63.1436 will ensure that continuous compliance with the CAA section 112(d)(2) and (3) standards is achieved for PEPO facilities that use flares as APCDs to meet the MACT standards at all times when controlling HAP emissions. We are also proposing to revise the entry for 40 CFR 63.11 of table 1 to the PEPO NESHAP to show that the provisions at 40 CFR 63.11(b) do not apply to flares because we are proposing to replace these provisions with new standards for flares used to comply with the MACT standards in the PEPO NESHAP.
                    </P>
                    <FTNT>
                        <P>
                            <SU>62</SU>
                             For a list of studies, refer to the technical report titled 
                            <E T="03">Parameters for Properly Designed and Operated Flares,</E>
                             in Docket Item No. EPA-HQ-OAR-2010-0682-0191.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>63</SU>
                             See 40 CFR 63.670 and 63.671 (originally finalized in 80 FR 75178 on December 1, 2015; and amended at 81 FR 45232 on July 13, 2016, 83 FR 60696 on November 26, 2018, 85 FR 6064 on February 4, 2020, and 89 FR 23860 on April 4, 2024).
                        </P>
                    </FTNT>
                    <P>
                        In 2012, the EPA compiled information and test data collected on flares and summarized its preliminary findings on operating parameters that affect flare combustion efficiency in a technical report titled 
                        <E T="03">Parameters for Properly Designed and Operated Flares,</E>
                         available in Docket Item No. EPA-HQ-OAR-2010-0682-0191.
                        <SU>64</SU>
                        <FTREF/>
                         The EPA submitted this report, along with a charge statement and a set of charge questions, to an external peer review panel.
                        <SU>65</SU>
                        <FTREF/>
                         The panel, consisting of individuals representing a variety of backgrounds and perspectives (
                        <E T="03">i.e.,</E>
                         industry, academia, environmental experts, and industrial flare consultants), concurred with the EPA's assessment that the following three primary factors affect flare performance: (1) the flow of the vent gas to the flare; (2) the amount of assist media (
                        <E T="03">e.g.,</E>
                         steam or air) added to the flare; and (3) the combustibility of the vent gas/assist media mixture in the combustion zone (
                        <E T="03">i.e.,</E>
                         the net heating value, lower flammability, and/or combustibles concentration) at the flare tip. In response to peer review comments, the EPA performed a validation and usability analysis on all available test data as well as a failure analysis on potential parameters discussed in the technical report as indicators of flare performance. The document titled 
                        <E T="03">Peer Review of Parameters for Properly Designed and Operated Flares,</E>
                         which is available in Docket Item No. EPA-HQ-OAR-2010-0682-0193, contains the peer review comments, and we have incorporated that document into the docket for this rulemaking. These analyses resulted in a change to the population of test data that the EPA evaluated, and they helped form the basis for the flare operating limits promulgated in the 2015 Petroleum Refinery Sector final rule at 40 CFR part 63, subpart CC (80 FR 75178).
                        <SU>66</SU>
                        <FTREF/>
                         In this 
                        <PRTPAGE P="106029"/>
                        action, we are also relying on the flare analyses discussed earlier in this preamble and proposing to apply the operating limits contained in the final rule for petroleum refineries to the flares used as APCDs in the PEPO Production source category (hereafter referred to as “PEPO flares”). The Agency believes, given the results from the various data analyses conducted for the Petroleum Refinery Sector rule, that the operating limits promulgated for flares used in the petroleum refinery sector are also appropriate and reasonable for PEPO flares to ensure that these flares meet the HAP destruction and removal efficiency at all times, consistent with the MACT standards established in the PEPO NESHAP in 1999 (64 FR 29420). Therefore, we are proposing at 40 CFR 63.1436 to replace all flare requirements throughout the PEPO NESHAP 
                        <SU>67</SU>
                        <FTREF/>
                         with the Petroleum Refinery Sector rule flare definitions and requirements in 40 CFR part 63, subpart CC, with certain clarifications and exemptions discussed in this section of the preamble, including, but not limited to, specifying that several definitions in 40 CFR part 63, subpart CC, that apply to petroleum refinery flares also apply to flares in the PEPO Production source category, adding a definition and requirements for pressure-assisted multi-point flares, and specifying additional requirements for when an owner or operator uses a gas chromatograph or mass spectrometer for compositional analysis.
                    </P>
                    <FTNT>
                        <P>
                            <SU>64</SU>
                             See section II.D. of this preamble, which addresses the incorporation by reference of certain docket files such as this one into the docket for this rulemaking.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>65</SU>
                             These documents can be found at 
                            <E T="03">https://www.epa.gov/stationary-sources-air-pollution/review-peer-review-parameters-properly-designed-and-operated-flares.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>66</SU>
                             See the document titled 
                            <E T="03">Flare Performance Data: Summary of Peer Review Comments and Additional Data Analysis for Steam-Assisted Flares</E>
                             in Docket Item No. EPA-HQ-OAR-2010-0682-0200 for a more detailed discussion of the data quality and analysis; the document titled 
                            <E T="03">
                                Petroleum 
                                <PRTPAGE/>
                                Refinery Sector Rule: Operating Limits for Flares
                            </E>
                             in Docket Item No. EPA-HQ-OAR-2010-0682-0206 for a more detailed discussion of the failure analysis, and the document titled 
                            <E T="03">Flare Control Option Impacts for Final Refinery Sector Rule</E>
                             in Docket Item No. EPA-HQ-OAR-2010-0682-0748 for additional analyses on flare performance standards based on public comments received on the proposed Petroleum Refinery Sector rule.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>67</SU>
                             Refer to proposed 40 CFR 63.1436(a)(1) through (25) for a list of provisions that would no longer apply.
                        </P>
                    </FTNT>
                    <P>
                        The remainder of this section of the preamble includes a discussion of requirements that we are proposing for PEPO flares, along with impacts and costs associated with these proposed revisions. Specifically, this action proposes to require that PEPO flares operate pilot flame systems continuously and that flares operate with no visible emissions (except for periods not to exceed a total of 5 minutes during any 2 consecutive hours) when the flare vent gas flow rate is below the smokeless capacity of the flare. In addition, this action proposes to consolidate measures related to flare tip velocity and proposes new operational and monitoring requirements related to the combustion zone gas. Further, this action proposes a work practice standard related to the visible emissions during periods when the flare is operated above its smokeless capacity (
                        <E T="03">e.g.,</E>
                         periods of emergency flaring). Currently, the MACT standards in the PEPO NESHAP cross-reference the general provisions at 40 CFR 63.11(b) for the operational requirements for flares used as APCD. This proposal eliminates cross-references to the general provisions and instead specifies all new operational and monitoring requirements that are intended to apply to flares used as APCDs in the PEPO NESHAP.
                    </P>
                    <HD SOURCE="HD3">a. Pilot Flames</HD>
                    <P>The PEPO NESHAP references the flare requirements in 40 CFR 63.11(b), which specify that a flare used as an APCD should operate with a pilot flame present at all times. The provisions at 40 CFR 63.1429(a)(2) also require a device (including but not limited to a thermocouple, ultraviolet beam sensor, or infrared sensor) capable of continuously detecting the presence of a pilot flame. Pilot flames are proven to improve flare flame stability, and even short durations of an extinguished flame could cause a significant reduction in flare destruction efficiency. In this proposal, we are proposing to remove the cross-reference to the general provisions for PEPO flares and the requirement at 40 CFR 63.1429(a)(2), and instead cross-reference 40 CFR part 63, subpart CC, to include in the PEPO NESHAP the existing provisions requiring that flares operate with a pilot flame at all times and that owners or operators continuously monitor for a pilot flame using a thermocouple or any other equivalent device. We are also proposing to add a continuous compliance provision that would consider each 15-minute block where there is at least 1 minute without a pilot flame present when regulated material is routed to the flare as a violation of the standard. Refer to 40 CFR 63.1436 and 63.670(b) and (g) for these proposed requirements. See section IV.D.1.e of this preamble for our rationale for proposing to use a 15-minute block averaging period for determining continuous compliance. We solicit comments on the proposed revisions for flare pilot flames.</P>
                    <HD SOURCE="HD3">b. Visible Emissions</HD>
                    <P>The PEPO NESHAP references 40 CFR 63.11(b), which specifies that a flare used as an APCD should operate with visible emissions for no more than 5 minutes in a 2-hour period. Owners or operators of these flares are required to conduct an initial performance demonstration for visible emissions using EPA Method 22 of appendix A-7 to 40 CFR part 60. We are proposing to remove the cross-reference to the general provisions for PEPO flares and instead cross-reference 40 CFR part 63, subpart CC, to include this same limitation on visible emissions. We are also proposing to clarify that owners or operators should conduct an initial 2-hour visible emissions demonstration the first time that regulated materials are routed to the flare.</P>
                    <P>With regard to continuous compliance with the visible emissions limitation, we are proposing daily visible emissions monitoring for PEPO flares whenever regulated material is routed to the flare and also visible emissions monitoring whenever owners or operators observe visible emissions from the flare. On days that the flare receives regulated material, we are proposing that owners or operators of PEPO flares monitor visible emissions at a minimum of once per day while the flare is receiving regulated material using an observation period of 5 minutes and EPA Method 22. Additionally, whenever regulated material is routed to a flare and there are visual emissions from the flare, we are proposing that owners or operators perform another 5-minute visible emissions observation using EPA Method 22, even if they have already performed the minimum required daily visible emission monitoring. For example, if an employee observes visible emissions, the owner or operator of the flare would perform a 5-minute EPA Method 22 observation to check for compliance upon initial observation or notification of such event. In addition, in lieu of daily visible emissions observations performed using EPA Method 22, we are proposing that owners and operators be allowed to use video surveillance cameras. We believe that video surveillance cameras would be at least as effective for the PEPO flares as the proposed daily 5-minute visible emissions observations using EPA Method 22.</P>
                    <P>
                        We are also proposing to extend the observation period for a PEPO flare to 2 hours whenever visible emissions are observed for greater than 1 continuous minute during any of the 5-minute observation periods. Refer to 40 CFR 63.1436 and 63.670(c) and (h) for these proposed requirements. We acknowledge that operating a flare near the incipient smoke point (the point at which black smoke begins to form within the flame) results in good combustion at the flare tip; however, smoking flares can contribute significantly to emissions of particulate matter that is 2.5 micrometers in diameter or smaller. Thus, while 
                        <PRTPAGE P="106030"/>
                        increasing the allowable period for visible emissions may be useful from an operational perspective, we do not believe the allowable period for visible emissions should be increased to more than 5 minutes in any 2-hour period. We solicit comments on the proposed allowable period for visible emissions from flares.
                    </P>
                    <P>
                        As discussed later in this section, we are proposing additional operational and monitoring requirements for PEPO flares that we expect will result in owners or operators of PMPUs installing equipment that can be used to fine-tune and control the amount of assist steam or air introduced at the flare tip, thereby maximizing the flare combustion efficiency. These monitoring and control systems will assist flare owners or operators in operating near the incipient smoke point without exceeding the visible emissions limit. While combustion efficiency may be highest at the incipient smoke point, it is not significantly higher than the combustion efficiency achieved by the proposed operating limits discussed in section IV.D.1.d of this preamble. As seen in the performance curves for flares, there is very limited improvement in flare performance beyond the performance achieved at the proposed operating limits (see document titled 
                        <E T="03">Petroleum Refinery Sector Rule: Operating Limits for Flares,</E>
                         available in Docket Item No. EPA-HQ-OAR-2010-0682-0206, which we have incorporated into the docket for this rulemaking). We solicit comments and data on appropriate periods of visible emissions that would encourage flare operation at the incipient smoke point.
                    </P>
                    <P>In addition, we are proposing that the owner or operator establish the smokeless capacity of each PEPO flare based on design specification of the flare and that the visible emissions limitation only apply when the flare vent gas flow rate is below its smokeless capacity. We are proposing a work practice standard that applies during emergency releases when the flow to a flare exceeds the smokeless capacity of the flare, based on comments the EPA received on the proposed Petroleum Refinery Sector rule. Refer to 40 CFR 63.1436 and 63.670(o) for these proposed provisions. In the Petroleum Refinery Sector final rule, the EPA explained that numerous comments on the proposal suggested that flares are not designed to meet the visible emissions requirements when operated beyond their smokeless capacity (80 FR 75178). According to commenters, flares are typically designed to operate in a smokeless manner at 20- to 30-percent of full hydraulic load. Thus, they claimed, flares have two different design capacities: (1) a “smokeless capacity” to handle normal operations and typical process variations, and (2) a “hydraulic load capacity” to handle very large volumes of gases discharged to the flare as a result of an emergency shutdown. According to commenters, these capacity considerations are inherent in all flare designs, and the issue of flares not meeting visible emissions requirements when beyond their smokeless capacity has not previously been an issue because flare operating limits did not apply during malfunction events.</P>
                    <P>For this proposed work practice standard, the NESHAP would require owners or operators to develop a flare management plan for PEPO flares that identifies procedures for limiting discharges to the flare as a result of process upsets or malfunctions that cause the flare to exceed its smokeless capacity. In addition, for any flare that exceeds both the smokeless design capacity and visible emissions limit, we are proposing that owners or operators conduct a specific root cause analysis and take corrective action to prevent the recurrence of a similarly caused event. We are proposing that if the root cause analysis indicates that the exceedance of the visible emissions limit is caused by operator error or poor maintenance, then the exceedance would be considered a violation of the work practice standard. We are also proposing that a second event that occurs within a rolling 3-year period from the same root cause on the same equipment would be considered a violation of the standard. Finally, we are proposing that a third visible emissions limit exceedance occurring from the same flare in a rolling 3-year period would be a violation of the work practice standard, regardless of the cause.</P>
                    <P>
                        In several of the EPA's previous impact analyses (for petroleum refinery flares and ethylene production flares),
                        <SU>68</SU>
                        <FTREF/>
                         the EPA established the number of events in a given time period that would be the “backstop” (
                        <E T="03">i.e.,</E>
                         a violation of the standard). In each of these analyses, the EPA evaluated four different timing alternatives (two events in 5 years; two events in 3 years; two events in 5 years; and three events in 3 years) based on the number of existing flares evaluated over a 20-year period, and ultimately concluded that three events in 3 years would be “achievable” for the average of the best performing flares. We see no reason why this would be any different for PEPO flares. Even if a best-performing flare “typically” only has one event every 7 years, the fact that these events are random by nature (unpredictable, not under the direct control of the owner or operator) makes it difficult to use a 5-year time span. Based on this analysis, three events in 3 years would appear to be “achievable” for the average of the best performing flares.
                    </P>
                    <FTNT>
                        <P>
                            <SU>68</SU>
                             See EPA-HQ-OAR-2010-0682-0793, EPA-HQ-OAR-2010-0682-0794, and EPA-HQ-OAR-2017-0357-0017.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">c. Flare Tip Velocity</HD>
                    <P>
                        This proposed action consolidates provisions related to flare tip velocity for PEPO flares. The PEPO NESHAP references the flare provisions in 40 CFR 63.11(b), which specify maximum flare tip velocities based on flare type (non-assisted, steam-assisted, or air-assisted) and the net heating value of the flare vent gas. Based on data provided to the EPA in response to our CAA section 114 request (see section II.C of this preamble), four of the nine flares that PEPO facilities reported using as APCDs are either steam- or air-assisted (see the document titled 
                        <E T="03">Control Option Impacts for Flares in the PEPO Production Source Category that Control Emissions from Processes Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this rulemaking). Maximum flare tip velocities are required to ensure that the flame does not “lift off” the flare (
                        <E T="03">i.e.,</E>
                         a condition where a flame separates from the tip of the flare and there is space between the flare tip and the bottom of the flame), which could cause flame instability and/or potentially result in a portion of the flare gas being released without proper combustion. We are proposing to remove the cross-reference to the general provisions for PEPO flares and instead to cross-reference 40 CFR part 63, subpart CC, to consolidate the provisions for maximum flare tip velocity into the PEPO NESHAP as a single equation, irrespective of flare type (
                        <E T="03">i.e.,</E>
                         steam-assisted, air-assisted, or non-assisted). Refer to 40 CFR 63.1436 and 63.670(d), (i), and (k) for these proposed provisions.
                    </P>
                    <P>
                        Based on analysis conducted for the Petroleum Refinery Sector rule, the EPA identified test runs of air-assisted flares with high tip velocities that had high combustion efficiencies (see the document titled 
                        <E T="03">Petroleum Refinery Sector Rule: Evaluation of Flare Tip Velocity Requirements</E>
                         in Docket Item No. EPA-HQ-OAR-2010-0682-0212). These test runs exceeded the maximum flare tip velocity limits for air-assisted flares using the linear equation in 40 CFR 63.11(b)(8). When the EPA compared these test runs to the test runs for non-assisted and steam-assisted 
                        <PRTPAGE P="106031"/>
                        flares, we determined that air-assisted flares appeared to have the same operating envelope as the non-assisted and steam-assisted flares. Therefore, for air-assisted PEPO flares, we are proposing the use of the same equation that non-assisted and steam-assisted flares currently use to establish the flare tip velocity operating limit. We are also proposing that the owner or operator determine the flare tip velocity on a 15-minute block average basis. See section IV.D.1.e of this preamble for our rationale for proposing to use a 15-minute block averaging period for determining continuous compliance.
                    </P>
                    <P>Finally, we are proposing to exclude the provision for the special flare tip velocity equation in the general provisions at 40 CFR 63.11(b)(6)(i)(A) for non-assisted PEPO flares used to control gases with hydrogen content greater than 8 percent. This equation, which was developed based on limited data from a chemical manufacturer, has very limited applicability for flares used as APCDs in the PEPO Production source category because it only provides an alternative for non-assisted flares that are used to control gases with large quantities of hydrogen. Available data indicates that there are 18 flares in the PEPO Production source category; approximately 45 percent of these flares are either steam-assisted or air-assisted and 55 percent are non-assisted flares. Instead, we are proposing compliance alternatives that we believe provide a better way for PEPO flares combusting gases with high hydrogen content to comply with the rule while ensuring proper destruction performance of the flare (see section IV.D.1.d of this preamble for the proposed compliance alternatives). Therefore, for non-assisted PEPO flares used as APCDs for gases with hydrogen content greater than 8 percent, we are proposing to exclude this special flare tip velocity equation as a compliance alternative. We request comment on the need to include this equation in the PEPO NESHAP.</P>
                    <HD SOURCE="HD3">d. Net Heating Value of the Combustion Zone Gas</HD>
                    <P>
                        The current provisions for flares in 40 CFR 63.11(b) specify that the flare vent gas meet a minimum net heating value of 200 British thermal units per standard cubic foot (Btu/scf) for non-assisted flares and 300 Btu/scf for air- and steam-assisted flares. The PEPO NESHAP references these provisions, but neither the general provisions nor the PEPO NESHAP includes specific requirements for monitoring the net heating value of the flare vent gas. Moreover, recent flare testing results indicate that meeting a minimum net heating value limit alone does not address instances when the flare may be over-assisted because it only considers the net heating value of the gas being combusted in the flare and does not consider other parameters (
                        <E T="03">e.g.,</E>
                         absence of assist media). However, many industrial flares use steam or air as an assist medium to protect the flare tip, promote turbulence for the mixing, induce air into the flame, and operate with no visible emissions. Using excessive steam or air results in dilution and cooling of flared gases and can lead to operating a flare outside its stable flame envelope, reducing the destruction efficiency of the flare. In extreme cases, over-steaming or excess aeration can snuff out a flame and allow regulated material to be released into the atmosphere without complete combustion. As previously noted in section IV.D.1.c of this preamble, because available data indicate that about half of all PEPO flares are either steam- or air-assisted, it is critical that we ensure that the determination of flare combustion efficiency account for assist media in some form. Recent flare test data have shown that the best way to account for situations of over-assisting is to consider the gas mixture properties at the flare tip in the combustion zone when evaluating the ability to combust efficiently. As discussed in the introduction to this preamble section, the external peer review panel concurred with our assessment that the combustion zone properties at the flare tip are critical parameters to know in determining whether a flare will achieve good combustion. The general provisions, however, solely rely on the net heating value of the flare vent gas, and we have determined that that information is not sufficient for determining flare combustion efficiency of PEPO flares.
                    </P>
                    <P>
                        In this proposal, in lieu of requiring compliance with the operating limits for net heating value of the flare vent gas specified in the general provisions, we are proposing to cross-reference 40 CFR part 63, subpart CC, to include in the PEPO NESHAP a single minimum operating limit for the net heating value in the combustion zone gas (NHVcz) of 270 Btu/scf during any 15-minute period for steam-assisted, air-assisted, and non-assisted PEPO flares. Refer to 40 CFR 63.1436 and 63.670(l) and (m) for these proposed provisions. The Agency believes, given the results from the various data analyses conducted for the Petroleum Refinery Sector rule, that this NHVcz operating limit promulgated for flares in the Petroleum Refinery Sector source category is also appropriate and reasonable and will ensure PEPO flares meet the HAP destruction efficiencies in the standard at all times when operated in concert with the other proposed flare provisions such as the pilot flame, visible emissions, and flare tip velocity requirements. See the documents titled 
                        <E T="03">Petroleum Refinery Sector Rule: Operating Limits for Flares</E>
                         and 
                        <E T="03">Flare Control Option Impacts for Final Refinery Sector Rule</E>
                         in Docket Item Nos. EPA-HQ-OAR-2010-0682-0206 and EPA-HQ-OAR-2010-0682-0748, respectively). In addition, we are proposing that owners or operators may use a corrected heat content of 1,212 Btu/scf for hydrogen, instead of 274 Btu/scf, to demonstrate compliance with the NHVcz operating limit for PEPO flares; however, owners or operators who intend to use the corrected hydrogen heat content must have a system capable of monitoring for the hydrogen content in the flare vent gas. The EPA determined the 1,212 Btu/scf value based on a comparison between the lower flammability limit and net heating value of hydrogen compared to light organic compounds and we have used this value in several consent decrees issued by the EPA. Based on analyses conducted for the Petroleum Refinery Sector rule (see the document titled 
                        <E T="03">Flare Control Option Impacts for Final Refinery Sector</E>
                         in Docket Item No. EPA-HQ-OAR-2010-0682-0748), the EPA determined that using a 1,212 Btu/scf value for hydrogen greatly improves the correlation between combustion efficiency and the combustion zone net heating value over the entire array of data.
                    </P>
                    <P>
                        Furthermore, in addition to the NHVcz operating limit, we are proposing a net heating value dilution parameter (NHVdil) for certain PEPO flares that operate with perimeter assist air. Refer to 40 CFR 63.1436 and 63.670(f) and (n) for these proposed provisions. For air-assisted flares, use of too much perimeter assist air can lead to poor flare performance. Furthermore, based on our analysis of the air-assisted flare datasets (see the document titled 
                        <E T="03">Petroleum Refinery Sector Rule: Operating Limits for Flares</E>
                         in Docket Item No. EPA-HQ-OAR-2010-0682-0206), we determined that a NHVdil of 22 Btu/scf is necessary to ensure that there is enough combustible material available to adequately burn the gas and pass through the flammability region and also ensure that degradation of flare performance from excess aeration does not occur. We found that including the flow rate of perimeter assist air in the calculation of the NHVcz does not 
                        <PRTPAGE P="106032"/>
                        identify all instances of excess aeration and could (in some instances) even allow facilities to send very dilute vent gases to the flare that would not combust (
                        <E T="03">i.e.,</E>
                         vent gases below their lower flammability limit could be sent to flare). Instead, the data suggest that the diameter of the flare tip, in concert with the amount of perimeter assist air (and other parameters used to determine NHVcz), provide the inputs necessary to calculate whether this type of flare is over-assisted. This dilution parameter is consistent with the combustion theory that the more time the gas spends in the flammability region above the flare tip, the more likely it will combust. Also, because both the volume of the combustion zone (represented by the diameter) and how quickly this gas is diluted to a point below the flammability region (represented by perimeter assist air flow rate) characterize this time duration, it is logical that we propose such a parameter.
                    </P>
                    <P>We also found that some assist steam lines are purposely designed to entrain air into the lower or upper steam at the flare tip; and for flare tips with an effective tip diameter of 9 inches or more, there are no flare tip steam induction designs that can entrain enough assist air to cause a flare operator to have a deviation from the NHVdil operating limit without first deviating from the NHVcz operating limit. Therefore, we are proposing to allow owners or operators of PEPO flares that only use perimeter assist air entrained in lower and upper steam at the flare tip and that have a flare tip diameter of 9 inches or greater to comply only with the NHVcz operating limit. Steam-assisted flares with perimeter assist air and an effective tip diameter of less than 9 inches would remain subject to the requirement to account for the amount of assist air intentionally entrained within the calculation of NHVdil. However, we recognize that owners or operators cannot directly measure this assist air, but the quantity of air entrained is dependent on the assist steam rate and the design of the steam tube's air entrainment system. Therefore, we are proposing provisions to specify that owners or operators of these smaller diameter steam-assisted PEPO flares use the steam flow rate and the maximum design air-to-steam ratio of the steam tube's air entrainment system for determining the flow rate of this assist air. Using the maximum design ratio will tend to over-estimate the assist air flow rate, which is conservative with respect to ensuring compliance with the NHVdil operating limit.</P>
                    <P>Finally, we are proposing that owners or operators record and calculate 15-minute block average values for these parameters. Section IV.D.1.e of this preamble provides our rationale for selecting a 15-minute block averaging period. We solicit comments on the proposed revisions related to NHVcz.</P>
                    <HD SOURCE="HD3">e. Data Averaging Periods for Flare Gas Operating Limits</HD>
                    <P>
                        Except for the visible emissions operating limits described in section IV.D.1.b of this preamble, we are proposing to use a 15-minute block averaging period for each proposed flare operating parameter (
                        <E T="03">i.e.,</E>
                         presence of a pilot flame, flare tip velocity, and NHVcz) to ensure that PEPO flares operate within the appropriate operating conditions. We consider a 15-minute averaging time to be the most appropriate for assessing proper flare performance because flare vent gas flow rates and composition can change significantly over short periods of time. Furthermore, because destruction efficiency can fall precipitously when a flare is controlling vent gases below (or outside) the proposed operating limits, short time periods where the operating limits are not met could seriously decrease the overall performance of the flare. Refer to the Petroleum Refinery Sector rule preambles (79 FR 36880 and 80 FR 75178) for further details supporting why we believe a 15-minute averaging period is appropriate.
                    </P>
                    <P>
                        Given the short averaging times for the operating limits, we are proposing calculation methodologies to enable owners or operators to use “feed forward” calculations to ensure compliance with the operating limits on a 15-minute block average for PEPO flares. Specifically, we propose using the results of the compositional analysis determined just prior to a 15-minute block period for the next 15-minute block average. Owners or operators of PEPO flares will then know the vent gas properties for the upcoming 15-minute block period and can adjust assist gas flow rates relative to vent gas flow rates to comply with the proposed operating limits. In other words, “feed forward” means that owners or operators would use the net heating value in the vent gas (NHVvg) going into the flare in one 15-minute period to adjust the assist media (
                        <E T="03">i.e.,</E>
                         steam or air) and/or the supplemental gas in the next 15-minute period, as necessary, to calculate an NHVcz limit of 270 Btu/scf or greater using the proposed equation. We recognize that when a subsequent measurement value is determined, the instantaneous NHVcz based on that compositional analysis and the flow rates that exist at the time may not be above 270 Btu/scf. We are proposing that this is not a violation of the operating limit. Rather, we are proposing that the owner or operator is only required to make operational adjustments based on that information to achieve, at a minimum, the net heating value limit for the subsequent 15-minute block average. We are, however, proposing that failure to adjust the assist media or supplemental natural gas using the NHVvg from the previous period in the equation provided for calculating an NHVcz limit of 270 Btu/scf would be a violation of the operating limit. Alternatively, because the owner or operator could directly measure the NHVvg on a more frequent basis, such as with a calorimeter (and optional hydrogen analyzer), the process control system is able to adjust more quickly, and the owner or operator can adjust the assist media or supplemental natural gas more quickly. In this manner, the owner or operator is not limited by relying on NHVvg data that may not represent the current conditions. We are, therefore, also proposing that the owner or operator may opt to use the NHVvg in such instances from the same period to comply with the operating limit. For examples of “feed forward” calculations, see attachment 3 of the document titled 
                        <E T="03">Flare Control Option Impacts for Final Refinery Sector Rule</E>
                         in Docket Item No. EPA-HQ-OAR-2010-0682-0748.
                    </P>
                    <P>We are also proposing to clarify that when determining compliance with the flare tip velocity and combustion zone operating limits specified in 40 CFR 63.670(d) and (e), the initial 15-minute block period starts with the 15-minute block that includes a full 15 minutes of the flaring event. In other words, we are proposing to clarify that the owner or operator demonstrate compliance with the velocity and NHVcz requirements starting with the block that contains the fifteenth minute of a flaring event; and the owner or operator is not required to demonstrate compliance for the previous 15-minute block in which the event started and contained only a fraction of flow. We solicit comments on these proposed revisions.</P>
                    <HD SOURCE="HD3">f. Flares in Dedicated Service</HD>
                    <P>
                        In lieu of the requirement that owners or operators continuously monitor the composition of the vent gas and the NHVvg, we are proposing an alternative monitoring approach for PEPO flares in dedicated service where the flare vent gas has consistent composition and flow. We believe that these flares do not 
                        <PRTPAGE P="106033"/>
                        need to have the same type of ongoing monitoring requirements as those with more variable waste streams. Thus, we are proposing an option that owners or operators can use to demonstrate compliance with the operating requirements for PEPO flares that are in dedicated service to a specific emission source, such as a transfer rack operation consistently loading the same material. We are proposing that owners or operators submit an application to the Administrator to allow the use of this alternative compliance option. We are proposing that the application include a description of the system, characterization of the vent gases that could be routed to the flare based on a minimum of 7 grab samples (14 daily grab samples for continuously operated flares), and specification of the net heating value that will be used for all flaring events (based on the minimum net heating value of the grab samples). In other words, for PEPO flares that are in dedicated service, we are proposing that owners or operators could use the minimum NHVvg determined from the grab samples in the equation at 40 CFR 63.670(m)(1) for all flaring events to determine NHVcz. We are also proposing to allow engineering estimates to characterize the amount of gas flared and the amount of assist gas introduced into the system. For example, we believe that the use of fan curves to estimate air assist rates would be acceptable. We propose that flare owners or operators would use the net heating value determined from the initial sampling phase and measured or estimated flare vent gas and assist gas flow rates, if applicable, to demonstrate compliance with the standards. Refer to 40 CFR 63.1436 and 63.670(j)(6) for these proposed provisions. Finally, for owners and operators that must comply with the continuous monitoring requirements, we are proposing additional clarifications and requirements at 40 CFR 63.1436 when using a gas chromatograph or mass spectrometer for compositional analysis. We solicit comments on the proposed revisions related to flares in dedicated service.
                    </P>
                    <HD SOURCE="HD3">g. Impacts of the Proposed Flare Operating and Monitoring Requirements</HD>
                    <P>
                        The EPA expects that the requirements for flares used as APCDs in the PEPO Production source category discussed in this section will affect all flares at PEPO processes. As previously mentioned, based on facility responses to our CAA section 114 request (see section II.C of this preamble), we estimate that there are 18 flares of traditional elevated flare tip designs (
                        <E T="03">e.g.,</E>
                         steam-assisted, air-assisted, and non-assisted flare tips). The EPA estimated the costs for each flare for a given facility, considering current monitoring systems already installed on each individual flare. Given that the same type of equipment is used for flares in the PEPO Production source category and for the petroleum refinery sector, we estimated the costs for any additional monitoring systems needed based on installed costs received from petroleum refineries and, if installed costs were unavailable, we based the cost estimates on vendor-purchased equipment. The EPA estimated the baseline emissions and the emission reductions achieved by the proposed rule based on current vent gas and steam flow data submitted by industry representatives. We note that the requirements for PEPO flares that we are proposing will ensure compliance with the MACT standards in the PEPO NESHAP when flares are used as an APCD. Because we are not changing the underlying MACT standards in the PEPO NESHAP, we did not include any of the estimated excess emissions from flares in the summary of total estimated emissions reductions for this action. However, we estimate that the proposed operational and monitoring requirements have the potential to reduce excess emissions from PEPO flares by approximately 75 tpy of HAP and 281 tpy of VOC (
                        <E T="03">i.e.,</E>
                         non-methane, non-ethane total hydrocarbons). According to the emissions inventory file we used to assess residual risk (see section IV.C.1 of this preamble), there are 10 individual HAP compounds included in the emissions inventory for PEPO flares, including propylene oxide, EtO, toluene, glycol ethers, and hexane. For more detail on the impact estimates, see the document titled 
                        <E T="03">Control Option Impacts for Flares in the PEPO Production Source Category that Control Emissions from Processes Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <HD SOURCE="HD3">2. Closed Vent System Containing Bypass Lines</HD>
                    <P>
                        For a closed vent system containing bypass lines that can divert the stream away from the APCD to the atmosphere, the PEPO NESHAP requires the owner or operator to either: (1) install, maintain, and operate a continuous parametric monitoring system for flow on the bypass line that is capable of detecting whether a vent stream flow is present at least once every 15 minutes, or (2) secure the bypass line valve in the non-diverting position with a car-seal or a lock-and-key type configuration. Under option 2, the PEPO NESHAP also requires owners or operators to inspect the seal or closure mechanism at least once per month to verify the valve is maintained in the non-diverting position (see 40 CFR 63.1429(c)(2) for more details). To expressly prohibit bypassing an APCD at affected sources, as implied by option 2, we are proposing that an owner or operator may not bypass the APCD at any time and that a bypass is a violation (see proposed 40 CFR 63.1429(c)(3)), and owners and operators must estimate, maintain records, and report the quantity of organic HAP released (see proposed 40 CFR 63.1430(d)(6) and (h)(7)). These proposed requirements are also being proposed at 40 CFR 63.1425(f), by reference to 40 CFR 63.114(d)(2) and (3) and 63.118(a)(5) and (f)(7), for process vents in a PMPU that use THF to produce one or more PEPO products. We are proposing these revisions to ensure continuous compliance with the MACT standards, consistent with 
                        <E T="03">Sierra Club</E>
                         v. 
                        <E T="03">EPA,</E>
                         551 F.3d 1019 (D.C. Cir. 2008) (where the Court determined that standards under CAA section 112(d) must provide for compliance at all times), because bypassing an APCD could result in a release of regulated organic HAP to the atmosphere that would be required to be controlled under the existing MACT standards in the PEPO NESHAP. We are also proposing that the use of a cap, blind flange, plug, or second valve on open-ended valves or lines (following the requirements specified in 40 CFR 60.482-6(a)(2), (b), and (c) or following requirements codified in another regulation that are the same as 40 CFR 60.482-6(a)(2), (b), and (c)) is sufficient to prevent a bypass. We solicit comments on these proposed revisions.
                    </P>
                    <HD SOURCE="HD3">3. Maintenance Activities</HD>
                    <P>
                        In the 2014 final rule (79 FR 17340, March 27, 2014), we removed the exemption from emissions standards for periods of SSM in accordance with a decision of the United States Court of Appeals for the District of Columbia Circuit, 
                        <E T="03">Sierra Club</E>
                         v. 
                        <E T="03">EPA,</E>
                         551 F.3d 1019 (D.C. Cir. 2008), 
                        <E T="03">cert. denied,</E>
                         130 S. Ct. 1735 (U.S. 2010). This decision stated that the EPA must have standards in place at all times, even during periods of SSM. As a result, the process vent and storage vessel provisions (as well as other provisions) in the PEPO NESHAP apply at all times. Although the EPA eliminated the SSM exemption from the PEPO NESHAP in 2014, we recognize that owners or operators periodically discharge vent streams during certain maintenance activities, such as those that require equipment openings, and we consider maintenance 
                        <PRTPAGE P="106034"/>
                        activities a separate class of startup and shutdown emissions because there must be a point in time when the equipment can be opened, and any remaining emissions vented to the atmosphere. We also acknowledge that it would require a significant effort to identify and characterize each of these potential release points (
                        <E T="03">e.g.,</E>
                         for permitting purposes). Therefore, we are proposing to establish MACT standards for maintenance activities (
                        <E T="03">i.e.,</E>
                         equipment openings, storage vessel degassing, and periods of planned routine maintenance of the emission control system for the vent on a fixed roof tank at a new or existing affected source). CAA section 112(h)(1) states that the Administrator may prescribe a work practice standard or other requirements, consistent with the provisions of CAA section 112(d) or (f), in those cases where, in the judgment of the Administrator, it is not feasible to enforce an emission standard. We are proposing work practices instead of numeric emission limits for maintenance activities because it is “not feasible to prescribe or enforce an emission standard” for these emissions. Emissions from maintenance activities are not “emitted through a conveyance designed and constructed to emit or capture such pollutant” (see CAA section 112(h)(2)(A)) and it is not possible to characterize each of these potential release points.
                    </P>
                    <HD SOURCE="HD3">a. Equipment Openings (Excluding Storage Vessel Degassing)</HD>
                    <P>To determine what MACT standards should be established for equipment openings, we reviewed State permit conditions and determined that the air emissions permits for the best performers specify that owners or operators meet certain conditions before they open equipment to the atmosphere. The conditions include thresholds regarding the lower explosive limit (LEL) and the amount of gas that may be emitted. Based on our review of these permits, we have determined that a work practice standard that allows opening process equipment to the atmosphere during maintenance events only after meeting certain conditions (as specified in this section IV.D.3.a of the preamble) represents the MACT floor level of control for equipment openings at new and existing affected sources. Therefore, we are proposing a work practice standard at 40 CFR 63.1425(h)(1)(i) to specify that, prior to opening process equipment to the atmosphere during maintenance events, owners or operators must first drain the equipment before purging to a closed vent system so that the concentration of the vapor in the equipment served by the maintenance vent is less than or equal to 10 percent of the LEL. For those situations where owners or operators cannot demonstrate 10-percent LEL, we are proposing at 40 CFR 63.1425(h)(1)(ii) that owners or operators may open and vent the equipment to the atmosphere if the pressure is less than or equal to 5 pounds per square inch gauge (psig), provided that owners or operators do not actively purge the equipment to the atmosphere until meeting the LEL criterion. We are proposing this 5-psig threshold to acknowledge that a certain minimum pressure must exist for the flare header system (or other similar control system) to operate properly. We are also proposing at 40 CFR 63.1425(h)(1)(iii) that owners or operators can open equipment when the amount of VOC contained in the equipment is less than 50 pounds. These proposed work practice standards are also being proposed at 40 CFR 63.1425(f), by reference to 40 CFR 63.113(k), for maintenance vents in a PMPU that use THF to produce one or more PEPO products.</P>
                    <P>
                        We acknowledge that installing a blind flange to prepare equipment for maintenance may be necessary and that by doing so, the owner or operator may not be able to meet the proposed maintenance vent conditions mentioned earlier in this section (
                        <E T="03">e.g.,</E>
                         a valve used to isolate the equipment will not seat fully, so organic material may continually leak into the isolated equipment). To limit the emissions during the blind flange installation, we are proposing at 40 CFR 63.1425(h)(1)(iv) depressurizing the equipment to 2 psig or less prior to equipment opening and maintaining pressure of the equipment where purge gas enters the equipment at or below 2 psig during the blind flange installation. The low allowable pressure limit will reduce the amount of process gas released during the initial equipment opening, and the ongoing 2 psig pressure requirement will limit the purge gas rate. Together, these proposed provisions will limit the emissions during blind flange installation and will result in comparable emissions allowed under the proposed maintenance vent conditions mentioned earlier in this section. We expect these situations to be rare and expect that the owner or operator would remedy the situation as soon as practical (
                        <E T="03">e.g.,</E>
                         replace the isolation valve or valve seat during the next turnaround in the example provided earlier in this paragraph). Therefore, we are only proposing that owners or operators use this alternative maintenance vent limit under those situations where the proposed primary limits (
                        <E T="03">i.e.,</E>
                         the concentration of the vapor in the equipment served by the maintenance vent is less than or equal to 10 percent of the LEL, pressure is less than or equal to 5 psig, or VOC is less than 50 pounds) are not achievable and blinding of the equipment is necessary. We did not identify any additional options beyond those identified here (
                        <E T="03">i.e.,</E>
                         beyond-the-floor options) for controlling emissions from equipment openings.
                    </P>
                    <P>
                        To demonstrate compliance with the proposed equipment opening work practice standards, we are proposing at 40 CFR 63.1430(a) that owners and operators must keep standard site procedures used to deinventory equipment for safety purposes (
                        <E T="03">e.g.,</E>
                         hot work or vessel entry procedures), as well the following additional records (as applicable):
                    </P>
                    <P>• The concentration of the vapor at the time of the vessel opening exceeds 10 percent of its LEL, identification of the maintenance vent, the process units or equipment associated with the maintenance vent, the date of maintenance vent opening, and the concentration of the vapor at the time of the vessel opening;</P>
                    <P>• Either the vessel pressure at the time of the vessel opening exceeds 5 psig or the concentration of the vapor at the time of the active purging was initiated exceeds 10 percent of its LEL, identification of the maintenance vent, the process units or equipment associated with the maintenance vent, the date of maintenance vent opening, the pressure of the vessel or equipment at the time of discharge to the atmosphere and, if applicable, the concentration of the vapors in the equipment when active purging was initiated;</P>
                    <P>• Records of the estimating procedures used to determine the total quantity of VOC in the equipment and the type and size limits of equipment that contain less than 50 pounds of VOC at the time of maintenance vent opening;</P>
                    <P>
                        • For each maintenance vent opening that contains greater than 50 pounds of VOC for which the deinventory procedures are not followed or for which the equipment opened exceeds the type and size limits established in the records, records that identify the maintenance vent, the process units or equipment associated with the maintenance vent, the date of maintenance vent opening, and records used to estimate the total quantity of VOC in the equipment at the time the 
                        <PRTPAGE P="106035"/>
                        maintenance vent was opened to the atmosphere; and
                    </P>
                    <P>• Identification of the maintenance vent, the process units or equipment associated with the maintenance vent, records documenting actions taken to comply with other applicable alternatives and why utilization of this alternative was required, the date of maintenance vent opening, the equipment pressure and concentration of the vapors in the equipment at the time of discharge, an indication of whether active purging was performed and the pressure of the equipment during the installation or removal of the blind if active purging was used, the duration the maintenance vent was open during the blind installation or removal process, and records used to estimate the total quantity of VOC in the equipment at the time the maintenance vent was opened to the atmosphere for each applicable maintenance vent opening.</P>
                    <P>
                        For any maintenance vent release exceeding the proposed applicable limits (
                        <E T="03">e.g.,</E>
                         the maintenance vent release is greater than 10 percent of the LEL), we are proposing that the owner or operator include in the next periodic report: (1) identification of the maintenance vent and the equipment served by the maintenance vent; (2) the date and time the maintenance vent was opened to the atmosphere; (3) the LEL in percent, vessel pressure in psig, or mass in pounds of VOC in the equipment, as applicable, at the start of atmospheric venting, and if the 5 psig vessel pressure option was used and active purging was initiated while the concentration of the vapor was 10 percent or greater of its LEL, also include the concentration of the vapors at the time active purging was initiated; and (4) an estimate of the mass in pounds of organic HAP released during the entire atmospheric venting event.
                    </P>
                    <P>
                        We solicit comments on the proposed revisions related to maintenance activities. For additional details and discussion, see the document titled 
                        <E T="03">Review of Regulatory Alternatives for Certain Vent Streams in the PEPO Production Source Category that are Associated with Processes Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <HD SOURCE="HD3">b. Storage Vessel Degassing</HD>
                    <P>
                        The PEPO NESHAP does not currently contain a standard specific to storage vessel degassing when storage vessels are using control devices to comply with the requirements in 40 CFR 63.119(a)(2) (via reference by 40 CFR 63.1432). We acknowledge that storage vessel degassing is similar to maintenance vents (
                        <E T="03">e.g.,</E>
                         equipment openings) and that there must be a point in time when the owner or operator can open the storage vessel and vent any remaining gas into the atmosphere. Therefore, to determine what MACT standards should be established for storage vessel degassing operations, we reviewed available data to determine how the best performers are controlling storage vessel degassing emissions.
                    </P>
                    <P>
                        We identified three regulations that address emissions from storage vessel degassing: two in Texas and one in California. The Texas Administrative Code 
                        <SU>69</SU>
                        <FTREF/>
                         specifies degassing provisions and TCEQ implements those provisions through operating permit conditions.
                        <SU>70</SU>
                        <FTREF/>
                         In California, the South Coast Air Quality Management District (SCAQMD) specifies degassing requirements in their Rule 1149.
                        <SU>71</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>69</SU>
                             See 30 Texas Administrative Code Chapter 115, Subchapter F, Division 3, available at 
                            <E T="03">https://texreg.sos.state.tx.us/public/readtac%24ext.ViewTAC?tac_view=5&amp;ti=30&amp;pt=1&amp;ch=115&amp;sch=F&amp;div=3&amp;rl=Y.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>70</SU>
                             See 
                            <E T="03">https://www.tceq.texas.gov/assets/public/permitting/air/Guidance/NewSourceReview/mss/chem-mssdraftconditions.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>71</SU>
                             
                            <E T="03">See http://www.aqmd.gov/docs/default-source/rule-book/reg-xi/rule-1149.pdf.</E>
                        </P>
                    </FTNT>
                    <P>The Texas Administrative Code requirements are the least stringent and require control of degassing emissions until the vapor space concentration is less than 35,000 ppmv as methane or 50 percent of the LEL. The TCEQ permit conditions require control of degassing emissions until the vapor space concentration is less than 10 percent of the LEL or until the VOC concentration is less than 10,000 ppmv, and SCAQMD Rule 1149 requires control of degassing emissions until the vapor space concentration is less than 5,000 ppmv as methane. The EPA considers the TCEQ permit conditions to be equivalent to SCAQMD Rule 1149 control requirements because 5,000 ppmv as methane equals 10 percent of the LEL for methane.</P>
                    <P>Currently, 8 of the 25 existing PEPO facilities are located in Texas and subject to the TCEQ permit conditions; however, no PEPO facilities are located in California and subject to the SCAQMD rule. Therefore, the TCEQ permit conditions relying on storage vessel degassing until 10 percent of the LEL is achieved reflect what the best performers have implemented for storage vessel degassing.</P>
                    <P>We reviewed TCEQ operating permit condition 6 (applicable to floating roof storage vessels) and permit condition 7 (applicable to fixed roof storage vessels) for key information that we could implement to form the basis of a standard for storage vessel degassing. The TCEQ operating permit conditions require control of degassing emissions for floating roof and fixed roof storage vessels until the vapor space concentration is less than 10 percent of the LEL and the owner or operator has removed all the standing liquid from the vessel to the extent practicable. The permit conditions also specify that facilities have the option of degassing a storage vessel until reaching a VOC concentration of 10,000 ppmv.</P>
                    <P>We do not consider the 10,000 ppmv concentration cutoff option in the TCEQ permit conditions to be equivalent to or as stringent as the compliance option to meet 10 percent of the LEL. Therefore, we are not proposing the 10,000 ppmv concentration as a compliance option. We also do not expect that the best performers would use this concentration for compliance because the TCEQ permit conditions allow facilities to calibrate their LEL monitor using methane.</P>
                    <P>
                        Based on review of this information, we are proposing that the TCEQ requirements to reduce the vapor space concentration to less than 10 percent of the LEL and to remove all the standing liquid from the vessel to the extent practicable reflect the MACT floor for both new and existing PEPO sources. We did not identify any additional options beyond this (
                        <E T="03">i.e.,</E>
                         beyond-the-floor options) for controlling emissions from storage vessel degassing. Therefore, we are proposing these requirements at 40 CFR 63.1432(a) by reference to 40 CFR 63.119(a)(6). However, because we recognize that in some cases (
                        <E T="03">e.g.,</E>
                         use of an inert blanket) the storage vessel atmosphere would not have an LEL, the EPA is also proposing an organic HAP concentration cutoff of 5,000 ppmv (measured as methane) as an equivalent alternative to reducing the vapor space concentration to less than 10 percent of the LEL. These are considered equivalent because 5,000 ppmv as methane equals 10 percent of the LEL for methane.
                    </P>
                    <P>
                        Additionally, in petitions for reconsideration that the EPA recently received on the MON, EMACT standards, Petroleum Refinery Sector rule, and OLD NESHAP, petitioners asserted that it is necessary to make connections to a temporary control device to control the degassing emissions from floating roof storage vessels, which may require opening the storage vessel to make these connections. Therefore, we are proposing that owners or operators may open a floating roof storage vessel prior to degassing to set up equipment (
                        <E T="03">i.e.,</E>
                         make connections to a temporary 
                        <PRTPAGE P="106036"/>
                        control device), but owners or operators must use this approach in a limited manner and must not actively purge the storage vessel while making connections.
                    </P>
                    <P>
                        We estimated the emissions reductions that would result from this proposed change to the PEPO NESHAP by evaluating the population of storage vessels that are subject to control under 40 CFR 63.119(a)(2) (by reference in 40 CFR 63.1432) and not located in Texas. Storage vessels regulated by the PEPO NESHAP in Texas are already subject to the degassing requirements; therefore, those PEPO facilities would not achieve additional emissions reductions. Additionally, the PEPO facility that is owned by a small business also has processes subject to the HON, and the impacts of such degassing requirements on the facility were already accounted for under the recent HON rulemaking (see 89 FR 42932). Based on a review of facility responses to our CAA section 114 request (see section II.C of this preamble), owners or operators degas most storage vessels an average of once every 11 years. Using this average, and the population of PEPO storage vessels that are not in Texas (15 vessels) based on the assumption of one Group 1 storage vessel per non-Texas facility, we estimated that one storage vessel degassing event would be newly subject to control each year. Controlling PEPO storage vessel degassing would reduce HAP emissions by 0.87 tpy. See the document titled 
                        <E T="03">Degassing Cost and Emissions Impacts for Storage Vessels Located in the PEPO Production Source Category that are Associated with Processes Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this rulemaking, for details on the assumptions and methodologies used in this analysis.
                    </P>
                    <HD SOURCE="HD3">c. Planned Routine Maintenance for Storage Vessel Control Devices</HD>
                    <P>
                        Although the PEPO NESHAP currently allows owners and operators to disconnect the fixed roof storage vessel vent from the closed vent system and control device, fuel gas system, or process equipment for up to 240 hours per year during planned, routine maintenance (see 40 CFR 63.119(e)(3) through (5) (by reference in 40 CFR 63.1432)), we are proposing at 40 CFR 64.1432(a) by reference to 40 CFR 63.119(e)(7) that owners and operators would not be allowed to fill the storage vessel during these periods (such that the vessel would emit HAP to the atmosphere for a limited amount of time due to breathing losses only). Our proposal is based on our review of other chemical sector NESHAP (HON, P&amp;R I NESHAP, and Group II Polymers and Resins (P&amp;R II) NESHAP (89 FR 42932, May 16, 2024)) where we have determined that a work practice standard that allows owners and operators up to 240 hours per year during planned routine maintenance of the emission control system, provided that there are no working losses from the vessel, represents the MACT floor level of control for fixed roof storage vessel vents at new and existing affected sources. We expect PEPO sources are using these same types of practices to limit emissions, so we are proposing that this work practice represents the MACT floor level of control for fixed roof storage vessel vents at new and existing sources. However, if these processes are currently uncontrolled, the cost effectiveness of this work practice ($2,250 per ton of HAP reduced), minimal energy requirements, and limited non-air quality health and environmental impacts would likely result in the EPA establishing beyond-the-floor requirements based on the same practice. These proposed requirements ensure that a CAA section 112 standard is in place at all times, given that all working loss emissions from fixed roof storage vessels would be controlled during these periods of planned routine maintenance of the emission control system, thus satisfying 
                        <E T="03">Sierra Club</E>
                         v. 
                        <E T="03">EPA,</E>
                         551 F.3d 1019 (D.C. Cir. 2008).
                    </P>
                    <P>
                        We estimated the emissions reductions that would result from this proposed change to the PEPO NESHAP. We assumed that owners and operators would install a secondary control device system (to control emissions from vessels during periods of planned routine maintenance of the primary control device) and that owners and operators would choose activated carbon canisters as the method of control. Based on the facility responses to our CAA section 114 request (see section II.C of this preamble), we identified one facility that operates one Group 1 fixed roof storage vessel subject to controls according to table 3 to the PEPO NESHAP. We were also able to determine from an air permit review that another PEPO facility (
                        <E T="03">i.e.,</E>
                         one that did not receive our CAA section 114 request) does not have any Group 1 storage vessels subject to controls according to table 3 to the PEPO NESHAP. Furthermore, we determined that one facility is a small business that is co-located with a HON facility, and already accounted for under the recent HON rulemaking (see 89 FR 42932). Using all of this information, we then extrapolated and estimated that the total number of Group 1 fixed roof storage vessels subject to the PEPO NESHAP nationwide is 15, assuming one vessel per facility. We then estimated that the highest amount of HAP emissions that would be expected to occur from a PEPO fixed roof storage vessel during the 240 hours of planned routine maintenance would be 262 pounds, if the emissions are not controlled. This emissions estimate includes 19.3 pounds of breathing losses and 243 pounds of working losses. We based these emissions on the average vessel capacity and average vapor pressure material stored in a vessel reported (for all HON and PEPO fixed roof storage vessels) in response to our CAA section 114 request, and we estimated using the emission estimation procedures from chapter 7 of the EPA's Compilation of Air Pollutant Emission Factors.
                        <SU>72</SU>
                        <FTREF/>
                         We assumed that activated carbon canisters would achieve a 95 percent reduction in HAP emissions, which would reduce emissions per vessel by 230 pounds of HAP per year of working loss emissions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>72</SU>
                             
                            <E T="03">Compilation of Air Pollutant Emission Factors. Volume 1: Stationary Point and Area Sources.</E>
                             AP-42, Fifth Edition. Chapter 7: Liquid Storage Tanks. OAQPS, Research Triangle Park, NC.
                        </P>
                    </FTNT>
                    <P>As a beyond-the-floor control option, we considered requiring owners and operators to also control breathing losses from storage vessels during periods of planned routine maintenance of the emission control system. However, we concluded that this option would not be cost effective because we estimated it would cost $28,360 per ton of HAP reduced.</P>
                    <P>
                        See the document titled 
                        <E T="03">Cost and Emissions Impacts for 240-Hour Planned Routine Maintenance Work Practice Standard on Storage Vessels Located in the PEPO Production Source Category that are Associated with Processes Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this rulemaking, for details on the assumptions and methodologies used in this analysis.
                    </P>
                    <HD SOURCE="HD3">4. Pressure Vessels</HD>
                    <P>
                        We are proposing to establish separate MACT standards for pressure vessels that are associated with processes subject to the PEPO NESHAP. The rule does not currently regulate HAP emissions from pressure vessels. The EPA is proposing to define “pressure vessel” at 40 CFR 63.1423(a) (by reference to 40 CFR 63.101) to mean “a storage vessel that is used to store liquids or gases and is designed not to vent to the atmosphere as a result of compression of the vapor headspace in the pressure vessel during filling of the 
                        <PRTPAGE P="106037"/>
                        pressure vessel to its design capacity.” To eliminate any ambiguity in applicability or control requirements, the EPA is also proposing at 40 CFR 63.1423(b) to remove the exemption for “pressure vessels designed to operate in excess of 204.9 kilopascals and without emissions to the atmosphere” from the definition of storage vessel. This longstanding exemption is ambiguous with respect to what “without emissions to the atmosphere” means. For example, most pressure vessels have relief devices that allow for venting when pressure exceeds setpoints. In many cases, these vents are routed to control devices; however, control devices are not completely effective (
                        <E T="03">e.g.,</E>
                         they may achieve only 98-percent control), and therefore pressure vessels are sources of emissions to the atmosphere, even if they are controlled. There are also instances where other components in pressure systems may allow for fugitive releases because of leaks from fittings or cooling systems. All of these events arguably are “emissions to the atmosphere,” and it is likely that even if the PEPO NESHAP maintained this exemption, owners and operators of pressure vessels would still have uncertainty regarding whether or not they were subject to substantive requirements. Therefore, the proposed revisions remove the ambiguity associated with the exemption and set new MACT standards intended to limit emissions to the atmosphere from pressure vessels at new and existing affected sources. We are also clarifying in the definition of PMPU at 40 CFR 63.1423(b) that the collection of equipment that is part of a PMPU includes pressure vessels.
                    </P>
                    <P>
                        We are proposing LDAR requirements at 40 CFR 63.1432(a) by reference to 40 CFR 63.119(a)(7) that are based on similar no-detectable emission requirements required for closed vent systems in most chemical sector NESHAP. These proposed requirements, which apply to each point on the pressure vessel through which total organic HAP could potentially be emitted,
                        <SU>73</SU>
                        <FTREF/>
                         are consistent with CAA section 112(d) controls and reflect the MACT floor at new and existing affected sources. We did not identify any additional options beyond this (
                        <E T="03">i.e.,</E>
                         beyond-the-floor options) for controlling emissions from pressure vessels. As such, these proposed requirements impose a standard that requires no detectable emissions at all times (
                        <E T="03">i.e.,</E>
                         the proposed standard would require owners and operators to meet a leak definition of 500 ppmv at each point on the pressure vessel where total organic HAP could potentially be emitted); require initial and annual leak monitoring using EPA Method 21 of 40 CFR part 60, appendix A-7; and require routing organic HAP through a closed vent system to a control device (
                        <E T="03">i.e.,</E>
                         no releases to the atmosphere through any points on the pressure vessel). These proposed LDAR requirements exclude connectors in EtO service, gas/vapor or light liquid valves in EtO service, and light liquid pumps in EtO service because those would be subject to more stringent LDAR requirements under the proposed EtO equipment leak standards.
                    </P>
                    <FTNT>
                        <P>
                            <SU>73</SU>
                             Except for connectors in EtO service, gas/vapor or light liquid valves in EtO service, light liquid pumps in EtO service, and except for equipment that meet the unsafe-to-monitor or difficult-to-monitor criteria specified in 40 CFR 63.168(h) and (i) (for valves in gas/vapor service and in light liquid service) and in 40 CFR 63.174(f) and (h) (for connectors in gas/vapor service and in light liquid service).
                        </P>
                    </FTNT>
                    <P>
                        We estimated the emissions reductions that would result from this proposed change to the PEPO NESHAP. Based on facility responses to our CAA section 114 request (see section II.C of this preamble) and an air permit review of PEPO facilities, we estimated that there are 15 pressure vessels located at PEPO facilities. Using information from a 2012 analysis that identified developments for storage vessels at chemical manufacturing facilities and petroleum refineries,
                        <SU>74</SU>
                        <FTREF/>
                         we estimate a total HAP emission reduction of 1.5 tpy for all affected pressure vessels associated with processes subject to the PEPO NESHAP. See the document titled 
                        <E T="03">Cost and Emissions Impacts for Pressure Vessels Located in the PEPO Production Source Category that are Associated with Processes Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this rulemaking, for details on the assumptions and methodologies used in this analysis. We solicit comments on the proposed revisions for pressure vessels.
                    </P>
                    <FTNT>
                        <P>
                            <SU>74</SU>
                             Randall, 2012. Memorandum from Randall, D., RTI International, to Parsons, N., EPA/OAQPS. 
                            <E T="03">Survey of Control Technology for Storage Vessels and Analysis of Impacts for Storage Vessel Control Options.</E>
                             January 20, 2012. EPA Docket No. EPA-HQ-OAR-2010-0871.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">5. Surge Control Vessels and Bottoms Receivers</HD>
                    <P>The PEPO NESHAP, via reference to 40 CFR part 63, subpart H, defines a surge control vessel to mean feed drums, recycle drums, and intermediate vessels. PMPUs use surge control vessels when in-process storage, mixing, or management of flow rates or volumes is needed to assist in manufacturing of a product. The PEPO NESHAP defines a bottoms receiver, via reference to 40 CFR part 63, subpart H, as a tank that collects distillation bottoms before the stream is sent to storage or for further downstream processing.</P>
                    <P>
                        The PEPO NESHAP does not consider surge control vessels and bottoms receivers to be storage vessels because they are covered by the equipment leak provisions. Although these emissions sources are regulated under the equipment leak provisions (
                        <E T="03">i.e.,</E>
                         40 CFR 63.1434 by reference to NESHAP subpart H), the equipment leak requirements refer to the storage vessel requirements in NESHAP subpart G. Owners and operators of surge control vessels and bottoms receivers are required to comply with the HON storage vessel requirements in 40 CFR part 63, subpart G (
                        <E T="03">i.e.,</E>
                         use a floating roof or route emissions to a closed vent system and control to achieve 95-percent control), provided the surge control vessel or bottoms receiver meets certain capacity and vapor pressure requirements. For PEPO surge control vessels and bottoms receivers at existing sources, storage vessel control requirements apply if the capacity is between 75 m
                        <SU>3</SU>
                         (inclusive) and 151 m
                        <SU>3</SU>
                         and the MTVP is greater than or equal to 13.1 kPa, or the capacity is greater than or equal to 151 m
                        <SU>3</SU>
                         and the MTVP is greater than or equal to 5.2 kPa. For PEPO surge control vessels and bottoms receivers at new sources, storage vessel control requirements apply if the capacity is between 38 m
                        <SU>3</SU>
                         (inclusive) and 151 m
                        <SU>3</SU>
                         and the MTVP is greater than or equal to 13.1 kPa, or the capacity is greater than or equal to 151 m
                        <SU>3</SU>
                         and the MTVP is greater than or equal to 0.7 kPa. The PEPO NESHAP excludes all other surge control vessels and bottoms receivers from emissions control requirements.
                    </P>
                    <P>
                        We are proposing at 40 CFR 63.1423(b) to remove surge control vessels and bottoms receivers from the list of equipment included in the definition of equipment leak, and we are proposing at 40 CFR 63.1434(a)(8) to require that owners and operators of all surge control vessels and bottoms receivers shall reduce emissions of organic HAP consistent with the process vent control requirements at 40 CFR 63.1425 through 63.1431, as applicable. The proposed requirements for surge control vessels and bottoms receivers also represent the level of control found to be cost-effective for process vents under the technology review in section IV.C.3 of this preamble and, therefore, the level of control we are proposing for process vents. Emissions from surge control vessels and bottoms receivers are characteristic of process vents, not emissions from storage vessels. These 
                        <PRTPAGE P="106038"/>
                        vessels operate at process temperatures, rather than ambient storage temperatures; typically do not undergo level changes that larger storage vessels undergo; and are most often operated under pressure with and without intake or discharge of non-condensable gases. The size of these vessels is also typically not correlated with emissions, as are storage vessels. We solicit comments on the proposed revisions for surge control vessels and bottoms receivers.
                    </P>
                    <HD SOURCE="HD3">6. Transfer Racks</HD>
                    <P>We are proposing to establish MACT standards for transfer racks that are associated with processes subject to the PEPO NESHAP. The EPA considers transfer racks to be part of the collection of equipment that comprise a PMPU, as defined in the PEPO NESHAP; however, the rule does not currently regulate HAP emissions from transfer racks.</P>
                    <P>
                        Because the equipment used in transfer racks at PEPO production facilities is similar to the equipment used at HON facilities, we are proposing to define a “transfer rack” based on a similar definition used in the HON (40 CFR 63.101). We are proposing to define “transfer rack” at 40 CFR 63.1423(b) to mean the collection of loading arms and loading hoses, at a single loading rack, that are assigned to a PMPU according to the procedures specified in 40 CFR 63.1420(f)(1) through (5) (where the term “transfer rack” is substituted for “storage vessel”) and are used to fill tank trucks and/or railcars with organic liquids that contain one or more organic HAP. A transfer rack also includes the associated pumps, meters, shutoff valves, relief valves, and other piping and valves. We are also proposing at 40 CFR 63.1423(a) (by reference to 40 CFR 63.101) to define a “loading rack” to mean “a single system used to fill tank trucks and railcars at a single geographic site. Loading equipment and operations that are physically separate (
                        <E T="03">i.e.,</E>
                         do not share common piping, valves, and other equipment) are considered to be separate loading racks.” The HON definition of transfer rack explicitly excludes racks, arms, or hoses that only transfer liquids containing organic HAP as impurities or that use vapor balancing during all loading operations. We note that the PEPO NESHAP already provides these exclusions at 40 CFR 63.1420(c)(10) and (11).
                    </P>
                    <P>Loading losses are the primary source of evaporative emissions from rail tank car or tank truck operations. Loading losses occur as the liquid entering the tank during loading displaces the organic vapors from the tank headspace into the atmosphere. These organic vapors are a combination of vapors: (1) formed in the empty tank by evaporation of residual product from previous loads, (2) transferred to the tank by vapor balance systems during product unloading, and (3) generated in the tank during loading of new product.</P>
                    <P>
                        Based on data provided to the EPA in response to our CAA section 114 request (see section II.C of this preamble), we identified 17 transfer racks located at 6 of the 25 PEPO facilities.
                        <SU>75</SU>
                        <FTREF/>
                         We also identified another transfer rack at a seventh facility based on our review of the facility operating permit. One of the 25 PEPO facilities is a small business and is only subject to the PEPO NESHAP because it receives and treats wastewater from another PEPO facility; therefore, we do not expect this small business facility to have a transfer rack on site that would be associated with a PMPU. For the remaining 17 facilities, we used CAA section 114 request data to estimate averages of 2 PMPUs per facility and 1 transfer rack per PMPU. Based on these assumptions, we estimated that there are 34 transfer racks associated with the 17 facilities (17 facilities × 2 PMPUs/facility × 1 transfer rack/PMPU = 34 transfer racks). Therefore, we estimated a nationwide total of 52 transfer racks in the PEPO Production source category that are associated with processes subject to the PEPO NESHAP.
                    </P>
                    <FTNT>
                        <P>
                            <SU>75</SU>
                             As of March 1, 2024, there were 25 facilities that are major sources of HAP emissions in operation that are subject to the PEPO NESHAP. The list of facilities located in the United States that are part of the PEPO Production source category with processes subject to the PEPO NESHAP is presented in the document titled 
                            <E T="03">List of Facilities Subject to the PEPO NESHAP,</E>
                             which is available in the docket for this action.
                        </P>
                    </FTNT>
                    <P>
                        We reviewed available data to determine how the best performers are controlling emissions from PEPO transfer racks. Given that 14 of the 25 PEPO facilities are located in either Louisiana or Texas, we evaluated the transfer rack provisions contained in the administrative code for these two States. The Texas provisions 
                        <SU>76</SU>
                        <FTREF/>
                         for transfer racks provisions apply to materials containing VOC having a true vapor pressure greater than or equal to 0.5 pounds per square inch absolute (psia) (3.45 kPa) under actual storage conditions, and the Louisiana provisions 
                        <SU>77</SU>
                        <FTREF/>
                         apply to materials containing VOC with a true vapor pressure of 1.5 psia (10.3 kPa) or greater at loading conditions. In each of these rules, owners and operators are required to use a vapor balance system or reduce emissions by 90 percent during loading operations (at a transfer rack). We also reviewed the transfer rack requirements in the HON because one PEPO facility said (in response to our CAA section 114 request) that they voluntarily comply with the HON for their PEPO transfer racks. The HON regulates transfer operations at 40 CFR 63.126 through 63.130. The HON requires owners and operators of each HON transfer rack that annually loads greater than or equal to 0.65 million liters of liquid products that contain organic HAP with a rack weighted average vapor pressure greater than or equal to 10.3 kPa to equip each transfer rack with a vapor collection system and control device to reduce total organic HAP emissions by 98 percent by weight or to an exit concentration of 20 ppmv. The HON also allows multiple other options to control emissions from applicable transfer racks, including use of a flare or collecting emissions for use in the process, a fuel gas system, or a vapor balance system.
                    </P>
                    <FTNT>
                        <P>
                            <SU>76</SU>
                             See 30 Texas Administrative Code Chapter 115, Subchapter C, Division 1, available at 
                            <E T="03">https://www.tceq.texas.gov/permitting/air/rules/state/115/r5211hp.html.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>77</SU>
                             See Louisiana Administrative Code 33:III.2107, Chapter 21, available at 
                            <E T="03">https://www.deq.louisiana.gov/resources/category/regulations-lac-title-33.</E>
                        </P>
                    </FTNT>
                    <P>
                        For the purpose of addressing regulatory gaps, we are proposing in this action that the requirements to use a vapor balance system or reduce emissions by 90 percent during loading operations (at a transfer rack) are consistent with CAA section 112(d) controls and reflect the MACT floor for transfer racks at existing PEPO sources. We also propose that the transfer rack requirements in the HON (
                        <E T="03">i.e.,</E>
                         reduce emissions by 98 percent by weight or to an exit concentration of 20 ppmv during loading operations at a transfer rack) are consistent with CAA section 112(d) controls and reflect the MACT floor for transfer racks at new PEPO sources and beyond-the-floor control for transfer racks at existing PEPO sources.
                    </P>
                    <P>
                        We consider the vapor pressure applicability threshold in the Texas transfer rack provisions to be more stringent than the vapor pressure applicability thresholds contained in the HON and the Louisiana provisions. Therefore, we are proposing the vapor pressure applicability threshold specified in the Texas transfer rack provisions in addition to the HON transfer rack requirements. In summary, we are proposing at 40 CFR 63.1434(j), by reference to 40 CFR 63.126 through 63.130, that owners and operators of PEPO transfer racks that load materials with an MTVP greater than or equal to 0.5 psia (3.45 kPa) under actual storage conditions (
                        <E T="03">i.e.,</E>
                         Group 1 transfer racks as defined in 40 CFR 63.1423(b)) must comply with the HON requirements at 40 CFR 63.126 through 63.130, if the 
                        <PRTPAGE P="106039"/>
                        material contains organic HAP as defined by 40 CFR 63.1423(b). To accommodate these proposed requirements, we are also proposing to remove the exemption of the terms “transfer” and “transferred” in the definition of “maximum true vapor pressure” at 40 CFR 63.1423(b). We anticipate that these proposed requirements achieve any additional emission reductions because we believe that transfer racks operating at PEPO sources load materials with very low true vapor pressures (
                        <E T="03">i.e.,</E>
                         less than 0.3 psia based on data provided to the EPA in response to our CAA section 114 request) or are using vapor balancing as a control option. As a beyond-the-floor control option, we explored controlling the organic HAP emissions from PEPO transfer racks with add-on controls (
                        <E T="03">i.e.,</E>
                         thermal oxidizers) and we determined that, although feasible, such add-on controls were unreasonably expensive, given that organic HAP emissions from PEPO transfer racks are expected to be small due to their low true vapor pressures (
                        <E T="03">e.g.,</E>
                         all but one of the PEPO transfer racks in the modeling file are reported as each emitting less than about 380 pounds of organic HAP per year). Therefore, we concluded that the control of organic HAP using a thermal oxidizer would not be reasonable. For example, the EPA estimated a cost of approximately $1,700,000 per ton of HAP emissions reduced for use of a thermal oxidizer. We solicit comments on the proposed standards for transfer racks.
                    </P>
                    <HD SOURCE="HD3">7. Butylene Oxide</HD>
                    <P>
                        In this action, we are proposing to add butylene oxide (also known as 1,2-epoxybutane) to the definition of “epoxide” in 40 CFR 63.1423(b) and to the list of HAP presented in table 4 to the PEPO NESHAP. In a 1997 document supporting the establishment of the PEPO Production source category titled 
                        <E T="03">Polyether Polyols Production Industry Characterization,</E>
                         which is available in the docket for this action (Docket ID No. EPA-HQ-OAR-2023-0282), the EPA established two subcategories for the purpose of analyzing MACT floors and regulatory alternatives: (1) PEPO made from polymerization of epoxides (
                        <E T="03">i.e.,</E>
                         EtO, propylene oxide, butylene oxide), and (2) PEPO made from the polymerization of THF. While the EPA recognized in this supporting documentation that butylene oxide is an epoxide used as a reactant to make PEPO, the EPA incorrectly stated that butylene oxide was not a HAP; therefore, the EPA did not include this compound in the epoxide definition or table 4 to subpart PPP.
                    </P>
                    <P>
                        Because most PEPO process units make a variety of products, including copolymers made from more than one type of epoxide, we have determined that any process unit using butylene oxide is likely to also use other epoxides (
                        <E T="03">i.e.,</E>
                         EtO or propylene oxide); as such, gas streams from the process are already required to be monitored and controlled according to the PEPO NESHAP. For example, one facility reports EtO, propylene oxide, and 1,2-epoxybutane from the same PEPO reactor in the 2017 NEI. Therefore, we conclude that this proposed action will not result in the control of processes that are not already subject to the epoxide emissions standards specified in the PEPO NESHAP and that impacts will be minimal. We solicit comments on the proposed inclusion of butylene oxide.
                    </P>
                    <HD SOURCE="HD3">8. 40 CFR 63.1420(d)(3) Exemption</HD>
                    <P>The PEPO NESHAP (40 CFR 63.1420(d)(3)) exempts from the definition of affected source reactions or processing that occur after completion of epoxide polymerization and all catalyst removal steps, if any. In this action, the EPA is proposing at 40 CFR 63.1420(d)(4) to remove the exemption in 40 CFR 63.1420(d)(3) and to require capture and control of emissions from these currently unregulated steps in the PEPO production process (which may include, but are not limited to, solvent removal, purification, drying, and solids handling operations).</P>
                    <P>
                        The reactions or processing that occur after completion of epoxide polymerization and catalyst removal steps are included in the PEPO Production source category. The EPA is proposing to expand the definition of the affected source because HAP emissions are possible from these steps 
                        <SU>78</SU>
                        <FTREF/>
                         and are thus a regulatory gap that the EPA is required to address. Additionally, because the EPA concludes that the current MACT standards for process vents are appropriate for sources associated with reactions or processing that occur after completion of epoxide polymerization and catalyst removal steps,
                        <SU>79</SU>
                        <FTREF/>
                         the EPA is proposing that it is not necessary to evaluate alternative MACT limits for these currently unregulated steps beyond subjecting them to the previously established MACT limits for process vents. We solicit comments on the proposed removal of the exemption in 40 CFR 63.1420(d)(3).
                    </P>
                    <FTNT>
                        <P>
                            <SU>78</SU>
                             For example, a facility reports EtO emissions from a dryer and a solids handling system that are not considered part of the affected source subject to the PEPO NESHAP because they occur after epoxide polymerization and catalyst removal steps.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>79</SU>
                             For example, the facility reporting EtO emissions from a dryer and a solids handling system has used a flare to control emissions from the dryer and a baghouse to control emissions from the vent collection system associated with the solids handling system.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">E. What other actions are we proposing?</HD>
                    <P>In addition to the proposed actions related to CAA sections 112(d)(2), (3), and (6), 112(h), and 112(f) discussed in sections IV.B through IV.D of this preamble, we are proposing to address selected issues raised in the petition for reconsideration (see section II.A.2 of this preamble). In addition, we are proposing changes to the PEPO NESHAP recordkeeping and reporting requirements to require the use of electronic reporting of certain reports, and we are proposing other technical amendments and definition revisions to improve the clarity and enforceability of certain provisions in the PEPO NESHAP. Our rationale and proposed changes related to all these issues are discussed as follows.</P>
                    <HD SOURCE="HD3">1. Reconsideration Issues</HD>
                    <P>The EPA discusses certain issues raised in the petition for reconsideration (see section II.A.2 of this preamble) related to affirmative defense and PRDs as described in this section IV.E.1 of the preamble.</P>
                    <HD SOURCE="HD3">a. Affirmative Defense</HD>
                    <P>
                        As part of the 2014 PEPO NESHAP RTR rulemaking (see 59 FR 17340, March 27, 2014), the EPA included the ability to assert an affirmative defense to civil penalties for violations caused by malfunctions (see 40 CFR 63.1420(i)) to create a system that incorporated some flexibility, recognizing that there is a tension inherent in many types of air regulations to ensure adequate compliance while simultaneously recognizing that, despite the most diligent of efforts, owners or operators may violate emission standards under circumstances entirely beyond the control of the source. Although the EPA recognized that its case-by-case enforcement discretion provides sufficient flexibility in these circumstances, we included the affirmative defense provision to provide a more formalized approach and more regulatory clarity. See 
                        <E T="03">Weyerhaeuser Co.</E>
                         v. 
                        <E T="03">Costle,</E>
                         590 F.2d 1011, 1057-58 (D.C. Cir. 1978) (holding that an informal case-by-case enforcement discretion approach is adequate); but see 
                        <E T="03">Marathon Oil Co.</E>
                         v. 
                        <E T="03">EPA,</E>
                         564 F.2d 1253, 1272-73 (9th Cir. 1977) (requiring a more formalized approach to consideration of “upsets beyond the control of the permit holder.”). Under the EPA's regulatory affirmative defense provisions, if a source could demonstrate in a judicial 
                        <PRTPAGE P="106040"/>
                        or administrative proceeding that it had met the requirements of the affirmative defense in the regulation, civil penalties would not be assessed. However, the petitioners argued that the EPA should remove the affirmative defense provisions in the PEPO NESHAP because the court vacated the affirmative defense in one of the EPA's other CAA section 112 regulations. 
                        <E T="03">NRDC</E>
                         v. 
                        <E T="03">EPA,</E>
                         749 F.3d 1055 (D.C. Cir. 2014) (vacating affirmative defense provisions in the CAA section 112 rule establishing emission standards for Portland cement kilns). The court found that the EPA lacked authority to establish an affirmative defense for private civil suits and held that under the CAA, the authority to determine civil penalty amounts in such cases lies exclusively with the courts, not the EPA. Specifically, the court found: “As the language of the statute makes clear, the courts determine, on a case-by-case basis, whether civil penalties are `appropriate.' ” See 
                        <E T="03">NRDC,</E>
                         749 F.3d at 1063 (“[U]nder this statute, deciding whether penalties are `appropriate' in a given private civil suit is a job for the courts, not EPA.”).
                        <SU>80</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>80</SU>
                             The court's reasoning in 
                            <E T="03">NRDC</E>
                             focuses on civil judicial actions. The court noted that “EPA's ability to determine whether penalties should be assessed for CAA violations extends only to administrative penalties, not to civil penalties imposed by a court.” 
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        In light of 
                        <E T="03">NRDC</E>
                         (and as requested by the petitioners), the EPA published a separate proposal (89 FR 52425, June 24, 2024) to remove regulatory affirmative defense provisions from three NSPS and 15 NESHAP (including the PEPO NESHAP). The public comment period for that proposal closed on August 8, 2024, and in this proposal, the EPA is not reopening the comment period or otherwise seeking additional public comments on this issue. The EPA will take separate final action on this issue, including responding to public comments submitted on the June 24, 2024, proposal. That final action will constitute the EPA's response to the petition for reconsideration on the affirmative defense provision promulgated in the 2014 final rule (79 FR 17340, March 27, 2014). Consequently, it is not necessary for the EPA to further address this issue in this proposed rulemaking.
                    </P>
                    <HD SOURCE="HD3">b. PRDs</HD>
                    <P>
                        The petitioners stated that, although the PEPO NESHAP RTR proposal (77 FR 1268, January 9, 2012) required facilities to install electronic indicators and alarms to ensure compliance with the proposed prohibition of pressure releases to the atmosphere from PRDs in organic HAP service, the EPA made these types of equipment optional in the final rule (79 FR 17340, March 27, 2014), allowing sources to use “a device or system that is capable of identifying and recording the time and duration of each pressure release (
                        <E T="03">e.g.,</E>
                         rupture disk indicators, magnetic sensors, motion detectors on the pressure relief valve stem, flow monitors, and pressure monitors) in lieu of prescribing that PRDs be equipped with release indicators and alarms.” The petitioners contended that it was not feasible to comment on the EPA's change to allow other indicators of atmospheric releases from PRDs. Additionally, the petitioners argued that the EPA did not provide the public an opportunity to comment when it narrowed the applicability of the PRD release prohibition in the final rule to PRDs “in organic HAP service,” and that, at a minimum, the EPA must narrow the applicability to only PRDs “in HAP service” to affect all HAP. Finally, the petitioners asserted that the EPA did not adequately justify giving PEPO facilities 3 years to comply with the PRD requirements in the PEPO NESHAP.
                    </P>
                    <P>
                        The PEPO NESHAP codifies the PRD requirements at 40 CFR 63.1434(c). We are not proposing to make any changes to the PRD requirements at 40 CFR 63.1434(c) as we believe the 2014 final rule (79 FR 17340, March 27, 2014) reached appropriate conclusions regarding each of these issues; however, we request comment on these requirements. We note that neither the proposed nor final rule was specific to a particular type of release indicator, and both the proposed and final rules anticipated use of a device capable of immediately notifying the facility of a release. Additionally, both the proposal and the final rule specified requirements for PRDs “in organic HAP service,” and we disagree with the petitioners that we should expand the scope of the PRD requirements because the PEPO production process includes reacting organic chemicals together to make an organic chemical product. Also, we believe other changes we made to the PRD requirements between proposal and final were for clarification and were a reasonable outgrowth of public comments. Finally, we stated in the preamble to the final rule (see 79 FR 17345) that time to comply with the PRD requirements is needed for facilities to “research equipment and vendors, purchase, install, test and properly operate any necessary equipment.” Even so, the petitioners' argument that the EPA did not adequately justify giving PEPO facilities 3 years to comply with the PRD requirements is no longer relevant, given that all new and existing sources have been complying with the PRD requirements for over 7 years (
                        <E T="03">i.e.,</E>
                         since March 27, 2017).
                    </P>
                    <HD SOURCE="HD3">2. Electronic Reporting</HD>
                    <P>
                        As part of the 2014 PEPO NESHAP RTR rulemaking (see 59 FR 17340, March 27, 2014), the EPA began requiring owners or operators of PEPO facilities to submit electronic copies of certain required performance test reports. The proposed rule amendments in this action would require owners and operators of PEPO processes to submit electronic copies of required performance test reports using new procedures. In lieu of requiring owners and operators to submit the results of performance tests “by direct computer-to-computer electronic transfer via EPA-provided software” (see 40 CFR 63.1439(e)(9)(i)), we are proposing at 40 CFR 63.1426(b)(6) and 63.1439(e)(9)(iii) that owners and operators must submit the results of the performance test following the procedures specified in 40 CFR 63.9(k), which requires use of the EPA's Central Data Exchange (CDX) using the Compliance and Emissions Data Reporting Interface (CEDRI). The proposed rule amendments would also require owners or operators to submit flare management plans and periodic reports (including fenceline monitoring reports) through the EPA's CDX using CEDRI (see proposed 40 CFR 63.1436(b), 63.1439(e)(6), and 63.1434(i)). A description of the electronic data submission process is provided in the document titled 
                        <E T="03">Electronic Reporting Requirements for New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP) Rules,</E>
                         available in the docket for this action.
                    </P>
                    <P>
                        The proposed rule would require that performance test results collected using test methods that are supported by the EPA's Electronic Reporting Tool (ERT) as listed on the ERT website 
                        <SU>81</SU>
                        <FTREF/>
                         at the time of the test be submitted in the format generated through the use of the ERT or an electronic file consistent with the XML schema on the ERT website, and other performance test results be submitted in portable document format (PDF) using the attachment module of the ERT. Flare management plans would be uploaded as a PDF file.
                    </P>
                    <FTNT>
                        <P>
                            <SU>81</SU>
                             
                            <E T="03">https://www.epa.gov/electronic-reporting-air-emissions/electronic-reporting-tool-ert.</E>
                        </P>
                    </FTNT>
                    <P>
                        For periodic reports (including fenceline monitoring reports), the proposed rule would require that 
                        <PRTPAGE P="106041"/>
                        owners and operators use an appropriate spreadsheet template to submit information to CEDRI. A draft version of the proposed templates for these reports is included in the docket for this action.
                        <SU>82</SU>
                        <FTREF/>
                         The EPA specifically requests comment on the content, layout, and overall design of the templates. We are proposing that owners and operators begin using the templates for periodic reports other than fenceline reports 3 years after the final rule is published in the 
                        <E T="04">Federal Register</E>
                        <E T="03">,</E>
                         or after the reporting template for the subpart has been available on the CEDRI website for 1 year, whichever date is later. Owners and operators would begin using the templates for fenceline monitoring reports starting when the first fenceline monitoring report is due.
                    </P>
                    <FTNT>
                        <P>
                            <SU>82</SU>
                             See Part_63_Subpart_PPP_63.1439(e)(6)_Periodic_Report.xlsx, which is available in the docket for this action.
                        </P>
                    </FTNT>
                    <P>Additionally, the EPA has identified two broad circumstances in which electronic reporting extensions may be provided. These circumstances are: (1) outages of the EPA's CDX or CEDRI which preclude an owner or operator from accessing the system and submitting required reports, and (2) force majeure events, which are defined as events that will be or have been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevent an owner or operator from complying with the requirement to submit a report electronically. Examples of force majeure events are acts of nature, acts of war or terrorism, or equipment failure or safety hazards beyond the control of the facility. The EPA is providing these potential extensions for submitting electronic copies of required performance test reports, flare management plans, and periodic reports (including fenceline monitoring reports) to protect owners and operators from noncompliance in cases where they cannot successfully submit a report by the reporting deadline for reasons outside of their control. In both circumstances, the decision to accept the claim of needing additional time to report is within the discretion of the Administrator, and reporting should occur as soon as possible. These potential extensions were recently added to 40 CFR part 63, subpart A, General Provisions at 40 CFR 63.9(k) and we are proposing to amend the entry for 40 CFR 63.9(k) of table 1 to the PEPO NESHAP (Applicability of General Provisions to Subpart PPP Affected Sources) to remove the constraint that 40 CFR 63.9(k) applies “only as specified in Sec. 63.9(j)” such that 40 CFR 63.9(k) would apply for any notifications or reports required by the PEPO NESHAP to be submitted electronically.</P>
                    <P>
                        The electronic submittal of the reports addressed in this proposed rulemaking will increase the usefulness of the data contained in those reports, is in keeping with current trends in data availability and transparency, will further assist in the protection of public health and the environment, will improve compliance by facilitating the ability of regulated facilities to demonstrate compliance with requirements and by facilitating the ability of delegated State, local, Tribal, and territorial air agencies and the EPA to assess and determine compliance, and will ultimately reduce burden on regulated facilities, delegated air agencies, and the EPA.
                        <SU>83</SU>
                        <FTREF/>
                         Electronic reporting also eliminates paper-based, manual processes, thereby saving time and resources, simplifying data entry, eliminating redundancies, minimizing data reporting errors, and providing data quickly and accurately to the affected facilities, air agencies, the EPA, and the public. Moreover, electronic reporting is consistent with the EPA's plan 
                        <SU>84</SU>
                        <FTREF/>
                         to implement Executive Order 13563 and is in keeping with the EPA's Agency-wide policy 
                        <SU>85</SU>
                        <FTREF/>
                         developed in response to the White House's Digital Government Strategy.
                        <SU>86</SU>
                        <FTREF/>
                         For more information on the benefits of electronic reporting, see the document titled 
                        <E T="03">Electronic Reporting Requirements for New Source Performance Standards (NSPS) and National Emission Standards for Hazardous Air Pollutants (NESHAP) Rules,</E>
                         referenced earlier in this section.
                    </P>
                    <FTNT>
                        <P>
                            <SU>83</SU>
                             We are proposing at 40 CFR 63.1421(c)(5) that the approval to an alternative to any electronic reporting to the EPA proposed for the PEPO NESHAP cannot be delegated to State, local, or Tribal agencies.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>84</SU>
                             EPA's Final Plan for Periodic Retrospective Reviews, August 2011. Available at: 
                            <E T="03">https://www.regulations.gov/document?D=EPA-HQ-OA-2011-0156-0154.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>85</SU>
                             E-Reporting Policy Statement for EPA Regulations, September 2013. Available at: 
                            <E T="03">https://www.epa.gov/sites/production/files/2016-03/documents/epa-ereporting-policy-statement-2013-09-30.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>86</SU>
                             Digital Government: Building a 21st Century Platform to Better Serve the American People, May 2012. Available at: 
                            <E T="03">https://obamawhitehouse.archives.gov/sites/default/files/omb/egov/digital-government/digital-government.html.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Performance Testing</HD>
                    <P>The EPA is proposing at 40 CFR 63.1437(a) performance testing once every 5 years to demonstrate compliance with emission limits for certain process vents (if you route emissions to a control device other than a flare). We determined that periodic emission testing should be required to help ensure continuous compliance. Repeat performance tests are already required by permitting authorities for some facilities. Further, requiring periodic repeat performance tests will help to ensure that control systems are properly maintained over time, thereby reducing the potential for acute emissions episodes. Currently, facilities conduct a one-time performance test or design evaluation and then monitor operating parameters. A design evaluation (in lieu of performance testing) is currently allowed for control techniques that receive less than 10 tpy of uncontrolled organic HAP emissions from one or more PMPU. However, we are proposing to remove the design evaluation option at 40 CFR 63.1426(b)(6) and (7) and (f), and require ongoing performance tests for owners and operators using a combustion, recovery, or recapture device to comply with an epoxide or organic HAP percent reduction efficiency requirement in 40 CFR 63.1425(b)(1)(i), (b)(2)(ii), (c)(1)(ii), (c)(3)(ii), or (d)(2); an epoxide concentration limitation in 40 CFR 63.1425(b)(1)(ii) or (b)(2)(iii); or an annual epoxide emission limitation in 40 CFR 63.1425(b)(1)(iii) or (b)(2)(iv). We are proposing that the ongoing performance tests be conducted at a minimum frequency of once every 5 years to supplement the parameter monitoring and to ensure that emission controls continue to operate as demonstrated during the initial performance test. Currently 40 CFR 63.1437(a) also requires the owner or operator to record the necessary process information to document operating conditions during the test. We are proposing to clarify that this includes an explanation to support that the operating conditions during each test represent the entire range of normal operation, including conditions for maximum emissions, even if such emissions are not expected during maximum production.</P>
                    <P>
                        In addition, we are proposing to eliminate the option in 40 CFR 63.1427(a)(2)(ii) that exempts owners or operators using ECO as a control technique from directly measuring the concentration of unreacted epoxide when determining the batch cycle percent epoxide emission reduction. Currently, the rule requires comparing the epoxide concentration obtained through direct measurement for one product from each product class with the concentration determined using 
                        <PRTPAGE P="106042"/>
                        process knowledge, reaction kinetics, and engineering knowledge. Owners and operators are exempt at 40 CFR 63.1427(a)(2)(ii) from this direct measurement comparison if uncontrolled epoxide emissions before the end of the ECO are less than 10 tpy. However, we are proposing to remove this exemption and to require that owners and operators conduct the comparison of epoxide concentration using direct measurement for one product from each product class even if uncontrolled epoxide emissions before the end of the ECO are less than 10 tpy.
                    </P>
                    <P>We solicit comments on the proposed revisions to the performance testing and ECO direct measurement requirements.</P>
                    <HD SOURCE="HD3">4. Certain Definitions That Refer to the HON</HD>
                    <P>
                        We note that in an effort to remove redundancy and improve consistency, the EPA recently finalized moving all of the definitions from NESHAP subparts G and H (
                        <E T="03">i.e.,</E>
                         40 CFR 63.111 and 40 CFR 63.161, respectively) into the definition section of NESHAP subpart F (
                        <E T="03">i.e.,</E>
                         40 CFR 63.101) (see 89 FR 42932, May 16, 2024). Given that the PEPO NESHAP directly references these provisions for certain definitions (see 40 CFR 63.1423), we are proposing to revise the phrasing used in 40 CFR 63.1423(a) to refer to NESHAP subpart F in instances where a definition in the PEPO NESHAP points to either NESHAP subpart G or H.
                    </P>
                    <P>We are also proposing editorial changes that clarify references in the PEPO NESHAP definitions at 40 CFR 63.1423(b) to properly reference the correct HON citation for “continuous recorder,” “maximum true vapor pressure,” “residual,” and “waste management unit.”</P>
                    <P>
                        We are proposing to delete “heat exchange system” from the list of terms in 40 CFR 63.1423(a) that refer to subpart F for their definition. We are proposing to define “heat exchange system” at 40 CFR 63.1423(b) so the definition refers to PMPUs instead of CMPUs. We are proposing “heat exchange system” to mean a device or collection of devices used to transfer heat from process fluids to water without intentional direct contact of the process fluid with the water (
                        <E T="03">i.e.,</E>
                         non-contact heat exchanger) and to transport and/or cool the water in a closed-loop recirculation system (cooling tower system) or a once-through system (
                        <E T="03">e.g.,</E>
                         river or pond water). For closed-loop recirculation systems, the heat exchange system consists of a cooling tower, all PMPU heat exchangers that are in organic HAP service and serviced by that cooling tower, and all water lines to and from these process unit heat exchangers. For once-through systems, the heat exchange system consists of all heat exchangers that are in organic HAP service servicing an individual PMPU and all water lines to and from these heat exchangers. Sample coolers or pump seal coolers are not considered heat exchangers for the purpose of this definition and are not part of the heat exchange system. Intentional direct contact with process fluids results in the formation of a wastewater. We are also proposing to revise the definition of “in organic HAP service” to include a heat exchange system, to be consistent with the use of “in organic HAP service” in the definition of “heat exchange system.”
                    </P>
                    <HD SOURCE="HD3">5. Monitoring for Adsorbers That Cannot Be Regenerated and Regenerative Adsorbers That Are Regenerated Offsite</HD>
                    <P>
                        We are proposing to add monitoring requirements at 40 CFR 63.1429(a)(9) for adsorbers that cannot be regenerated and regenerative adsorbers that are regenerated offsite because the PEPO NESHAP does not currently include specific monitoring requirements for this type of APCD and it is possible that owners and operators may use this type of APCD to control emissions from PEPO sources. We are proposing that owners and operators of this type of APCD use dual adsorbent beds in series. We are proposing to prescribe a dual-bed system because the use of a single bed does not ensure continuous compliance unless the bed is replaced significantly before breakthrough.
                        <SU>87</SU>
                        <FTREF/>
                         The proposed monitoring requirements for non-regenerative adsorbers fulfill the EPA's obligation to establish monitoring requirements to ensure continuous compliance with the emission limits (
                        <E T="03">e.g.,</E>
                         98-percent control or a 20-ppmv TOC outlet concentration) when owners or operators are using these types of control devices to comply with the standards. A dual-bed system will allow one bed to be saturated before it is replaced and, therefore, makes efficient use of the adsorber bed without exceeding the emission limits.
                    </P>
                    <FTNT>
                        <P>
                            <SU>87</SU>
                             We are proposing to define the term “breakthrough” at 40 CFR 63.1423(a) (by reference to 40 CFR 63.101) to mean the time when the level of HAP or TOC detected is at the highest concentration allowed to be discharged from an adsorber system.
                        </P>
                    </FTNT>
                    <P>Similar to regenerative adsorbers, to monitor performance deterioration, we are proposing measurements of HAP or TOC using a portable analyzer or chromatographic analysis for non-regenerative absorbers. We are proposing that owners or operators obtain these measurements at the outlet of the first adsorber bed in series using a sampling port, and that they obtain measurements monthly (if the bed has at least 2 months of the bed design life remaining), weekly (if the bed has between 2 months and 2 weeks of bed design life remaining), or daily (when the bed has less than 2 weeks of bed design life remaining). Also, we propose to require that owners and operators establish an average adsorber bed life from a design evaluation as well as conduct monitoring no later than 3 days after a bed is put into service as the first bed in series to confirm that it is functioning properly.</P>
                    <P>We did not identify any carbon adsorbers in the risk modeling file. To validate this finding, we conducted an air permit review alongside analysis of our CAA section 114 request data and confirmed that PEPO facilities do not currently use carbon adsorbers to control HAP emissions from PEPO sources. Therefore, we do not anticipate any cost associated with adding these proposed monitoring and operation requirements to the PEPO NESHAP for non-regenerative adsorbers and adsorbers with beds that are regenerated off-site. Additionally, the EPA acknowledges that these proposed requirements could be considered under CAA section 112(d)(6) because of the specification to have two adsorber beds in series, instead of as a proposed change to the monitoring requirements. However, our rationale for why a second bed is needed would not be any different if we described these proposed changes under CAA section 112(d)(6) instead of as a monitoring change. As previously mentioned, we are proposing these changes because the current PEPO NESHAP does not contain monitoring requirements for non-regenerative adsorbers, and it is possible that owners and operators may use this type of APCD to control emissions from PEPO sources.</P>
                    <HD SOURCE="HD3">6. Listing of 1-Bromopropane (1-BP) as a HAP</HD>
                    <P>
                        On January 5, 2022, the EPA published in the 
                        <E T="04">Federal Register</E>
                         (87 FR 393) a final rule amending the list of HAP under the CAA to add 1-bromopropane in response to public petitions previously granted by the EPA. For the PEPO Production source category, we conclude that the inclusion of 1-BP as an organic HAP will not have any effect on the MACT standards. First, 1-BP is not an epoxide, nor is it THF. Furthermore, we have no information showing that 1-BP is used, produced, or emitted to make or modify the PEPO product. Accordingly, we are proposing 
                        <PRTPAGE P="106043"/>
                        that no further action is required related to 1-BP. We solicit comments on this approach, and should new information submitted to the EPA show that 1-BP is emitted from this source category, the EPA will consider this information in the context of developing any MACT standards that may be needed to address emissions of 1-BP. We also note that in several instances in the PEPO NESHAP, facilities can comply with a TOC concentration standard (
                        <E T="03">e.g.,</E>
                         20 ppmv), which could adequately regulate emissions of 1-BP if it is emitted from this source category.
                    </P>
                    <HD SOURCE="HD3">7. Other Editorial Changes</HD>
                    <P>The EPA is proposing additional changes that address technical and editorial corrections for the PEPO NESHAP and overlap with the P&amp;R I NESHAP as detailed here:</P>
                    <P>• The EPA is proposing to replace “elastomer” with “polyether polyol” in 40 CFR 63.1420(e)(3) to correct a typographical error, given that the PEPO NESHAP applies to PMPUs and does not use the term “elastomer” anywhere else in the rule.</P>
                    <P>• The EPA is proposing to delete “parts per million by volume” in 40 CFR 63.1425(f)(7)(iv) because “ppmv” is defined previously in the rule.</P>
                    <P>• The EPA is proposing at 40 CFR 63.1426(b)(4) and (5) to allow owners and operators of emission sources controlled by a boiler or process heater burning hazardous waste to comply with the provisions of 40 CFR part 63, subpart EEE, rather than complying with the performance test provisions in the PEPO NESHAP.</P>
                    <P>• The EPA is proposing to clarify at 40 CFR 63.1426(c)(2) that performance tests and compliance determinations must be conducted according to the schedule and procedures in 40 CFR 63.1437.</P>
                    <P>• The EPA is proposing to remove the exemption at 40 CFR 63.1426(d)(1) that allows owners and operators to be exempt from determining uncontrolled organic HAP emissions for process vents in a PMPU if all process vents subject to the emission reduction requirements of 40 CFR 63.1425(b), (c)(1), or (d)(2) are controlled at all times using a combustion, recovery, or recapture device, or ECO. Based on our review of historical documents, it is not clear why this exemption is needed. Instead, we are proposing that owners and operators must determine uncontrolled emissions for each process vent at a PMPU that is complying with the process vent control requirements in 40 CFR 63.1425(b)(1)(i), (b)(1)(iii), (b)(2)(ii), (b)(2)(iv), (c)(1)(ii), or (d)(2) using a combustion, recovery, recapture device, or ECO.</P>
                    <P>• The EPA is proposing to correct a reference error in 40 CFR 63.1430(c), (d)(1), (d)(1)(i), and (k) such that the paragraphs point to not only table 5 to 40 CFR part 63, subpart PPP, but also table 6 to 40 CFR part 63, subpart PPP.</P>
                    <P>• The EPA is proposing to add at 40 CFR 63.1439(d)(11) requirements to maintain records of excursions. The EPA is proposing to require that sources keep records of this information to ensure that there is adequate information to allow the EPA to determine the severity of any failure to meet a standard, and to provide data that may document how the source met the general duty to minimize emissions when the source has failed to meet an applicable standard.</P>
                    <P>• The EPA is proposing to clarify at 40 CFR 63.1439(e)(6)(i) that all Periodic Reports must contain the company name and address (including county), as well as the beginning and ending dates of the reporting period.</P>
                    <P>• The EPA is proposing to clarify at 40 CFR 63.1439(e)(6)(iii)(B) that for each excursion reported in a Periodic Report, the owner or operator must include the start date and time, duration, cause, a list of the affected sources or equipment, an estimate of the quantity of each regulated pollutant emitted over any emission limit, a description of the method used to estimate the emissions, actions taken to minimize emissions, and any corrective action taken.</P>
                    <P>• The EPA is proposing to clarify at 40 CFR 63.1439(e)(6)(iii)(C) that for periods when monitoring data were not collected, the Periodic Report must include start date, start time, and duration of each period when monitoring data were not collected.</P>
                    <P>
                        • The EPA is proposing to clarify at 40 CFR 63.1439(e)(6)(ix)(C)(
                        <E T="03">2</E>
                        ) that for PRDs in organic HAP service, Periodic Reports must include “start date, start time, and duration in minutes of the pressure release” instead of “date, time, and duration of the pressure release.”
                    </P>
                    <P>
                        • The EPA is proposing to insert the missing word “releases” at 40 CFR 63.1439(e)(6)(ix)(C)(
                        <E T="03">5</E>
                        ) to clarify that we mean “pressure releases,” not “pressure.”
                    </P>
                    <P>• The EPA is proposing to remove the entry for 40 CFR 63.6(e) of table 1 to the PEPO NESHAP because it is unnecessary given that there are already entries in the table for all subparagraphs associated with 40 CFR 63.6(e). We are also proposing to change “yes” to “no” for the entry for 40 CFR 63.6(e)(2) because this provision has no requirement and is “[Reserved].”</P>
                    <P>• The EPA is proposing to add an entry for 40 CFR 63.7(a)(4) into table 1 to the PEPO NESHAP because it is missing and is applicable.</P>
                    <P>• The EPA is proposing to revise the entries for 40 CFR 63.10(b)(2) and (d)(5) of table 1 to the PEPO NESHAP to specify where the recordkeeping and reporting requirements are in the PEPO NESHAP.</P>
                    <P>• The EPA is proposing to edit the title of table 2 to the PEPO NESHAP to include “and Group 1 Polymers and Resins” because the content in the table contains provisions related the P&amp;R I NESHAP.</P>
                    <P>• The EPA is proposing to correct several explanations in table 2 to the PEPO NESHAP to refer to the correct paragraph(s) for certain requirements being proposed in this action.</P>
                    <P>• In reviewing cross-references between the PEPO NESHAP and P&amp;R I NESHAP, the EPA noticed that, even though the rule text exists, the EPA inadvertently removed the “(iii)” for paragraph 40 CFR 63.506(e)(6)(iii) in its recent final rulemaking (see 89 FR 42932, May 16, 2024) and is proposing to correct this typographical error by adding the “(iii)” back into the P&amp;R I NESHAP. This proposed edit does not change any rule text within 40 CFR 63.506(e)(6)(iii).</P>
                    <HD SOURCE="HD2">F. What compliance dates are we proposing?</HD>
                    <P>The proposed amendments in this rulemaking for adoption under CAA sections 112(d)(2) and (3) and 112(h) (see section IV.D of this preamble) and CAA section 112(d)(6) (see section IV.C of this preamble) are subject to the compliance deadlines outlined in the CAA under section 112(i). The proposed amendments in this rulemaking for adoption under CAA section 112(f) (see section IV.B of this preamble) are subject to the compliance deadlines outlined in the CAA under section 112(f)(4).</P>
                    <P>
                        For all the requirements we are proposing under CAA sections 112(d)(2), (3), and (6), and 112(h) (except for the fenceline monitoring requirements), we are proposing at 40 CFR 63.1422(h) that existing affected sources and affected sources that were new sources under the current PEPO NESHAP (
                        <E T="03">i.e.,</E>
                         they commenced construction or reconstruction after September 4, 1997, and on or before December 27, 2024 must comply with all of the amendments no later than 3 years after the effective date of the final rule or upon startup, whichever is later. For existing sources, CAA section 112(i) provides that the compliance date shall be as expeditious as practicable, but no later than 3 years after the effective date of the standard. (“Section 112(i)(3)'s 
                        <PRTPAGE P="106044"/>
                        three-year maximum compliance period applies generally to any emission standard . . . promulgated under [section 112].” 
                        <E T="03">Association of Battery Recyclers</E>
                         v. 
                        <E T="03">EPA,</E>
                         716 F.3d 667, 672 (D.C. Cir. 2013)). In determining what compliance period is as expeditious as practicable, we consider the amount of time needed to plan and construct projects and to change operating procedures. As provided in CAA section 112(i) and 5 U.S.C. 801(3), all new affected sources that commenced construction or reconstruction after December 27, 2024 would be required to comply with these requirements upon the effective date of the final rule or upon startup, whichever is later. The EPA anticipates that the effective date of the final rule will be the publication date of the final rule.
                    </P>
                    <P>
                        For fenceline monitoring, we are proposing at 40 CFR 63.1422(n) that owners and operators of all existing affected sources and all affected sources that were new under the current rule (
                        <E T="03">i.e.,</E>
                         sources that commenced construction or reconstruction after September 4, 1997, and on or before December 27, 2024) must begin fenceline monitoring 2 years after the effective date of the final rule and, starting 3 years after the effective date of the final rule, must perform root cause analysis and apply corrective action requirements upon exceedance of the annual average concentration action level.
                    </P>
                    <P>
                        For all of the requirements we are proposing under CAA section 112(f), we are proposing at 40 CFR 63.1422(m) a compliance date of 2 years after the effective date of the final rule or upon startup, whichever is later, for all existing affected sources and for all affected sources that were new sources under the current PEPO NESHAP (
                        <E T="03">i.e.,</E>
                         they commenced construction or reconstruction after September 4, 1997, and on or before December 27, 2024), to comply with the proposed EtO requirements. For all new affected sources that commence construction or reconstruction after December 27, 2024, we are proposing that owners or operators comply with the EtO requirements upon the effective date of the final rule or upon startup, whichever is later.
                    </P>
                    <HD SOURCE="HD3">1. Rationale for Proposed Compliance Dates of Proposed CAA Sections 112(d)(2) and (3) and 112(h) Amendments</HD>
                    <P>We are proposing new operating and monitoring requirements under CAA sections 112(d)(2) and (3) for PEPO flares. We anticipate that these provisions would require the installation of new flare monitoring equipment, and we project that most PMPUs would install new control systems to monitor and adjust assist gas (air or steam) addition rates. Similar to the addition of new control equipment, these new monitoring requirements for flares would require engineering evaluations, solicitation and review of vendor quotes, contracting and installation of the equipment, and operator training. Installation of new monitoring and control equipment on flares will require the flare to be taken out of service. Depending on the configuration of the flares and flare header system, taking the flare out of service may also require a significant portion of the PMPU to be shut down. Therefore, for all existing affected sources, and all new affected sources under the current PEPO NESHAP that commenced construction or reconstruction after September 4, 1997, and on or before December 27, 2024, we are proposing that it is necessary to provide 3 years after the effective date of the final rule (or upon startup, whichever is later) for owners or operators to comply with the new operating and monitoring requirements for flares. For all new affected sources that commence construction or reconstruction after December 27, 2024, we are proposing that owners or operators comply with the new operating and monitoring requirements for flares upon the effective date of the final rule or upon startup, whichever is later.</P>
                    <P>Under CAA sections 112(d)(2) and (3), we are proposing new vent control requirements for bypasses. These requirements would typically require the addition of piping and potentially new control requirements. As owners or operators would most likely route these bypass emissions to a flare, we are proposing for all existing affected sources, and new affected sources under the current PEPO NESHAP that commenced construction or reconstruction after September 4, 1997, and on or before December 27, 2024, to provide 3 years after the effective date of the final rule (or upon startup, whichever is later) to allow for owners or operators to coordinate these bypass modifications with the installation of the new monitoring equipment for the flares. For all new affected sources that commence construction or reconstruction after December 27, 2024, we are proposing that owners or operators comply with the new vent control requirements for bypasses upon the effective date of the final rule or upon startup, whichever is later.</P>
                    <P>We are also proposing to establish work practice standards in the PEPO NESHAP for maintenance activities. We anticipate that sources will need time to: review and update their standard operating procedures for maintenance activities; identify the most appropriate preventive measures or control approaches; design, install, and test the control systems; and install necessary process instrumentation and safety systems if so required. Therefore, for all existing affected sources, and all new affected sources under the current PEPO NESHAP that commenced construction or reconstruction after September 4, 1997, and on or before December 27, 2024, we are proposing a compliance date of 3 years after the effective date of the final rule (or upon startup, whichever is later) for owners or operators to comply with the work practice standards for maintenance activities. For all new affected sources that commence construction or reconstruction after December 27, 2024, we are proposing that owners or operators comply with the work practice standards for maintenance activities upon the effective date of the final rule or upon startup, whichever is later.</P>
                    <P>
                        Other amendments we are proposing under CAA sections 112(d)(2) and (3) include LDAR requirements for pressure vessels, process vent control requirements for certain surge control vessels and bottoms receivers, control requirements for certain transfer racks, the addition of butylene oxide to the definition of “epoxide” in 40 CFR 63.1423(b) and to the list of HAP presented in table 4 to the PEPO NESHAP, and the removal of the exemption in 40 CFR 63.1420(d)(3) for reactions or processing that occur after completion of epoxide polymerization and all catalyst removal steps. We anticipate that any of these proposed provisions may require additional time to plan, purchase, and install equipment for emissions control; however, even if additional time is not needed, the EPA recognizes the confusion that multiple different compliance dates for individual requirements would create and the additional burden such an assortment of dates would impose. Therefore, for all existing affected sources, and all new affected sources under the current rules that commenced construction or reconstruction after September 4, 1997, and on or before December 27, 2024, we are proposing a compliance date of 3 years after the effective date of the final rule (or upon startup, whichever is later) for owners or operators to comply with these other proposed amendments. For all new 
                        <PRTPAGE P="106045"/>
                        affected sources that commence construction or reconstruction after December 27, 2024, we are proposing that owners or operators comply with these other proposed amendments upon the effective date of the final rule or upon startup, whichever is later.
                    </P>
                    <HD SOURCE="HD3">2. Rationale for Proposed Compliance Dates of Proposed CAA Section 112(d)(6) Amendments</HD>
                    <P>As a result of our technology review for PEPO heat exchange systems, we are proposing to replace the existing leak definition and monitoring method with a new leak definition and monitoring method. We project that some owners and operators would require engineering evaluations, solicitation and review of vendor quotes, contracting and installation of monitoring equipment, and operator training. In addition, facilities will need time to read and understand the amended rule requirements and to update standard operating procedures. Therefore, we are proposing that all existing affected sources, and all new affected sources under the current rule that commenced construction or reconstruction after September 4, 1997, and on or before December 27, 2024, must comply with the new monitoring requirements for heat exchange systems no later than 3 years after the effective date of the final rule (or upon startup, whichever is later). For all new affected sources that commence construction or reconstruction after December 27, 2024, we are proposing that owners or operators comply with the new monitoring requirements for heat exchange systems upon the effective date of the final rule or upon startup, whichever is later.</P>
                    <P>Under our technology review for PEPO storage vessels under CAA section 112(d)(6), we are revising the PEPO NESHAP to reflect more stringent storage vessel capacity and MTVP thresholds. Although we did not find any PEPO storage vessels that would be affected by these proposed provisions, we believe it would be unnecessarily cumbersome to impose different compliance dates for these new storage vessel requirements. The EPA recognizes the confusion that multiple different compliance dates for individual requirements would create and the additional burden that such an assortment of dates would impose. Therefore, we are proposing that all existing affected sources, and all new affected sources under the current rules that commenced construction or reconstruction after September 4, 1997, and on or before December 27, 2024, must comply with the new storage vessel requirements no later than 3 years after the effective date of the final rule (or upon startup, whichever is later). For all new affected sources that commence construction or reconstruction after December 27, 2024, we are proposing that owners or operators comply with the new storage vessel requirements upon the effective date of the final rule or upon startup, whichever is later.</P>
                    <P>We are also proposing, pursuant to CAA section 112(d)(6), to remove the 50-ppmv and 0.005-scmm Group 1 process vent thresholds from the definition of “Group 1 continuous process vent” for continuous process vents associated with nonepoxide organic HAP and the Group 1 process vent applicability associated with a PMPU using THF, and to instead require owners and operators of these process vents that emit greater than or equal to 1.0 lb/hr of total organic HAP to meet the current control standards in the PEPO NESHAP. Additionally, as a result of our technology review for PEPO Group 1 combination of batch process vents, we are proposing that owners and operators of batch process vents that release a total of annual organic HAP emissions greater than or equal to 4,536 kg/yr (10,000 lb/yr) from all batch process vents combined reduce emissions of organic HAP from these process vents using a flare meeting the proposed operating and monitoring requirements for flares; or reduce emissions of organic HAP or TOC by 90-percent by weight. We project that some owners and operators will need to install new control equipment and/or new hard-piping or ductwork for certain process vents because of the proposed applicability revisions. The addition of new control equipment would require engineering design, solicitation, and review of vendor quotes, and contracting and installation of the equipment, which would need to be timed with process unit outage and operator training. Therefore, we are proposing that all existing affected sources, and all new affected sources under the current rules that commenced construction or reconstruction after September 4, 1997, and on or before December 27, 2024, must comply with the new process vent requirements no later than 3 years after the effective date of the final rule (or upon startup, whichever is later). For all new affected sources that commence construction or reconstruction after December 27, 2024 we are proposing that owners or operators comply with the new process vent requirements upon the effective date of the final rule or upon startup, whichever is later.</P>
                    <P>Compliance dates for the fenceline monitoring provisions proposed under CAA section 112(d)(6) consider the amount of time that it will take owners and operators to develop their siting plans and secure the capabilities to conduct the monitoring and analyze the results. For fenceline monitoring, the compliance timeline also must consider the timeline for controls addressing EtO emissions to be installed and operational before monitoring can begin to develop the annual average concentration baseline. After a year, if the annual average concentration exceeds the action level, root cause analysis and application of corrective measures can take place. Therefore, we are proposing that owners and operators of all existing sources and all new affected sources under the current rule that commenced construction or reconstruction after September 4, 1997, and on or before December 27, 2024 must begin fenceline monitoring 2 years after the effective date of the final rule. The 2-year period provides owners and operators with time to: read and assess the new fenceline monitoring requirements; prepare sampling and analysis plans; develop and submit site-specific monitoring plans; identify representative, accessible, and secure monitoring locations for offsite monitors and obtain permission from the property owner to both place and routinely access the monitors; make any necessary physical improvements to fenceline areas to accommodate site monitors, including construction of access roads, physical fencing, and potential drainage improvements; and obtain approval of any necessary capital expenditures. We are also proposing that owners and operators of such sources perform root cause analysis and apply corrective action requirements upon exceedance of an annual average concentration action level starting 3 years after the effective date of the final rule.</P>
                    <P>For all new affected sources that commence construction or reconstruction after December 27, 2024, we are proposing that owners or operators begin fenceline monitoring upon the effective date of the final rule or upon startup, whichever is later. We are also proposing to require quarterly reporting of fenceline results beginning 1 year after monitoring begins for such sources.</P>
                    <HD SOURCE="HD3">3. Rationale for Proposed Compliance Dates of Proposed CAA Section 112(f) Amendments</HD>
                    <P>
                        As previously mentioned in this preamble, we are proposing, under CAA 
                        <PRTPAGE P="106046"/>
                        section 112(f), new provisions considering results of the risk assessments to address emissions of EtO from equipment leaks, heat exchange systems, process vents, storage vessels, and wastewater at PEPO processes. CAA section 112(f)(4) prescribes the compliance date for emission standards issued under CAA section 112(f). 
                        <E T="03">Ass'n of Battery Recyclers</E>
                         v. 
                        <E T="03">EPA,</E>
                         716 F.3d 667, 672 (D.C. Cir. 2013) (“[S]ection 112(f)(4)'s two-year maximum applies more specifically to standards `under this subsection,' 
                        <E T="03">i.e.,</E>
                         section 112(f).”). For existing sources, the earliest compliance date for CAA section 112(f) standards is 90 days after the effective date. However, the compliance period can be extended up to 2 years after the effective date if the EPA finds that more time is needed for the installation of controls and that steps will be taken during the period of the waiver to assure that the health of persons will be protected from imminent endangerment. 42 U.S.C. 7412(f)(4)(B). The EPA anticipates that the proposed provisions will require additional time to plan, purchase, and install equipment for EtO control. For example, for PEPO process vents in EtO service, if the affected source cannot demonstrate 99.9-percent control of EtO emissions, or reduce EtO emissions to less than 1 ppmv (from each process vent) or 5 lb/yr (for all combined process vents), then the owner or operator would need to install a new control system, such as a scrubber with piping, ductwork, feed tanks, 
                        <E T="03">etc.</E>
                         Similarly, this same scenario (
                        <E T="03">i.e.,</E>
                         installation of a new control system) may be necessary for storage vessels in order to reduce EtO emissions by greater than or equal to 99.9 percent by weight or to a concentration of less than 1 ppmv. Likewise, a new steam stripper may be needed to control wastewater with a total annual average concentration of EtO greater than or equal to 1 ppmw. Additional permits may be required for this new emission control equipment (
                        <E T="03">e.g.,</E>
                         New Source Review and/or title V permit modifications). In other words, the EPA anticipates that facilities will need sufficient time to properly engineer the project, obtain capital authorization and funding, procure the equipment, obtain permits, and construct and start up the equipment. Therefore, in the absence of any determination by the EPA that a PEPO affected source is presenting imminent endangerment, we are proposing a compliance date of 2 years after the effective date of the final rule or upon startup, whichever is later, for all existing affected sources, and all new affected sources under the current rule that commenced construction or reconstruction after September 4, 1997, and on or before December 27, 2024 to comply with the proposed EtO requirements. For all new affected sources that commence construction or reconstruction after December 27, 2024, we are proposing that owners or operators comply with the EtO requirements upon the effective date of the final rule or upon startup, whichever is later.
                    </P>
                    <HD SOURCE="HD3">4. Rationale for Proposed Compliance Dates of Other Proposed Amendments</HD>
                    <P>We are proposing electronic reporting requirements (see section IV.E.2 of this preamble) and we anticipate that facilities would need some time to successfully accomplish these reporting revisions, including time to read and understand the amended rule requirements, to make any necessary adjustments (including adjusting standard operating procedures), and to convert reporting mechanisms and install necessary hardware and software. We are also proposing to add control device operational and monitoring requirements for adsorbers that cannot be regenerated and regenerative adsorbers that are regenerated offsite (including a requirement to use dual adsorbent beds in series) (see section IV.E.5. of this preamble). We anticipate that facilities would need some time to purchase and install a second adsorber bed. As previously mentioned, the EPA recognizes the confusion that multiple different compliance dates for individual requirements would create and the additional burden that such an assortment of dates would impose. From our assessment of the timeframe needed for compliance with both the new proposed electronic reporting requirements for flare management plans, compliance reports, and performance evaluation reports, and the new proposed adsorber requirements, the EPA considers a period of 3 years after the effective date of the final rule to be the most expeditious compliance period practicable. Thus, we are proposing that all existing affected sources, and all new affected sources under the current rule that commenced construction or reconstruction after September 4, 1997, and on or before December 27, 2024 be in compliance with these revised requirements upon initial startup or within 3 years of the effective date of the final rule, whichever is later. For all new affected sources that commence construction or reconstruction after December 27, 2024, we are proposing that owners or operators comply with these revised requirements upon the effective date of the final rule or upon startup, whichever is later. However, we are proposing to provide 60 days after the effective date of the final rule (or upon startup, whichever is later) for owners or operators of all affected sources to comply with the requirement to submit performance test reports electronically according to the proposed procedures specified in 40 CFR 63.1439(e)(9)(iii).</P>
                    <HD SOURCE="HD1">V. Summary of Cost, Environmental, and Economic Impacts</HD>
                    <HD SOURCE="HD2">A. What are the affected sources?</HD>
                    <P>
                        There are 25 facilities subject to the PEPO NESHAP. The list of facilities is available in the document titled 
                        <E T="03">List of Facilities Subject to the PEPO NESHAP,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <HD SOURCE="HD2">B. What are the air quality impacts?</HD>
                    <P>This proposed action would reduce HAP and VOC emissions from PEPO emission sources. We estimate that the proposed amendments to the NESHAP, excluding the proposed EtO emission standards, would reduce overall VOC and HAP emissions from the PEPO Production source category by approximately 164 and 157 tpy, respectively. Additionally, the proposed EtO emission standards are expected to reduce EtO emissions by approximately 14 tpy. We note that these emissions reductions do not consider the potential excess emissions reductions from flares that could result from the proposed monitoring requirements; we estimate flare excess emissions reductions of 75 tpy HAP and 281 tpy VOC.</P>
                    <P>
                        Considering secondary impacts (
                        <E T="03">e.g.,</E>
                         emission increases associated with supplemental fuel or additional electricity), the EPA estimates that the proposed action would result in additional emissions of 155 tpy of carbon monoxide (CO), 242,000 tpy of carbon dioxide (CO
                        <E T="52">2</E>
                        ), 188 tpy of nitrogen oxides (NO
                        <E T="52">X</E>
                        ) (including 4 tpy of nitrous oxide), 14 tpy of particulate matter, 1.0 tpy of sulfur dioxide (SO
                        <E T="52">2</E>
                        ), and a reduction of 996 tpy of methane emissions. More information about the estimated emission reductions and secondary impacts of this proposed action for the PEPO NESHAP can be found in the Economic Impact Analysis (EIA) accompanying this proposal and in documents referenced in sections IV.B through IV.D of this preamble.
                    </P>
                    <HD SOURCE="HD2">C. What are the cost impacts?</HD>
                    <P>
                        The EPA estimates that this proposed action would cumulatively cost (in 2022 dollars) approximately $31.0 million in total capital costs and $18.7 million per year in total annualized costs (including 
                        <PRTPAGE P="106047"/>
                        product recovery), based on our analysis of the proposed action described in sections IV.B through IV.D of this preamble. The present value (PV) of the estimated costs of this proposed rule, discounted at a 2 percent rate over the 2026 to 2040 period, is estimated at $236 million with an estimated equivalent annualized value (EAV) of $18.4 million without product recovery. With product recovery, the PV is estimated at $235 million with an estimated EAV of $18.3 million. The overall difference caused by product recovery is relatively minor, at less than a 0.43 percent decrease in both the PV and EAV.
                    </P>
                    <P>Although the EPA does not factor in cost when setting a MACT floor level of control, we estimated the cost of the standards proposed pursuant to CAA sections 112(d)(2) and (3) and 112(h) to include in the cumulative costs of the proposed action.</P>
                    <P>Table 13 of this preamble summarizes the results of the impact estimates for flares in the PEPO Production source category that control emissions from PEPO processes.</P>
                    <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,12,12">
                        <TTITLE>Table 13—Nationwide Cost Impacts for Flares in the PEPO Production Source Category That Control Emissions From PEPO Processes</TTITLE>
                        <BOXHD>
                            <CHED H="1">Control description</CHED>
                            <CHED H="1">
                                Total capital
                                <LI>investment</LI>
                                <LI>(million $)</LI>
                            </CHED>
                            <CHED H="1">
                                Total annualized
                                <LI>costs</LI>
                                <LI>(million $/yr)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Flare Operational and Monitoring Requirements</ENT>
                            <ENT>11.5</ENT>
                            <ENT>2.82</ENT>
                        </ROW>
                        <ROW RUL="n,s">
                            <ENT I="01">Work Practice Standards for Flares Operating Above Their Smokeless Capacity</ENT>
                            <ENT>0.20</ENT>
                            <ENT>0.05</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Total</ENT>
                            <ENT>11.7</ENT>
                            <ENT>2.88</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>For the proposed equipment opening work practice standard, discussed in section IV.D.3.a, we expect that all PEPO facilities already have standard procedures in place when performing equipment openings (at the very least for safety reasons), with the exception of one facility, which is a small business that is co-located with a HON facility and is already accounted for under the recent HON rulemaking (see 89 FR 42932). As such, the only costs incurred are for recordkeeping after each non-conforming event. We estimated the annual costs to be $11,000 per year.</P>
                    <P>We estimated the annual cost of the proposed storage vessel degassing work practice standard, discussed in section IV.D.3.b, to be $7,100.</P>
                    <P>
                        For the proposed requirement to control working emissions from storage vessels during routine maintenance, discussed in section IV.D.3.c, we determined that the total capital cost of a 55-gallon activated carbon drum with two connections, including piping and ductwork, is approximately $1,500, based on vendor quotes. Following the guidelines of the EPA Control Cost Manual,
                        <SU>88</SU>
                        <FTREF/>
                         we estimated that the annual cost per PMPU is $259. Thus, we estimated the nationwide capital cost for removal of the 240-hour exemption provisions (except for vessel breathing losses) for the PEPO NESHAP would be $22,500 and the annualized costs would be $3,900.
                    </P>
                    <FTNT>
                        <P>
                            <SU>88</SU>
                             EPA Air Pollution Control Cost Manual—Section 3: VOC Controls; Section 3.1: VOC Recapture Controls, Carbon Adsorbers Calculation Spreadsheet. Retrieved from 
                            <E T="03">https://www.epa.gov/economic-and-cost-analysis-air-pollution-regulations/cost-reports-and-guidance-air-pollution.</E>
                             October 2018.
                        </P>
                    </FTNT>
                    <P>We estimate that the nationwide capital cost for the proposed pressure vessel LDAR requirements discussed in section IV.D.4 would be about $3,800 and the annualized capital costs would be $3,500.</P>
                    <P>We anticipate that the following proposed changes would impose minimal costs: prohibiting bypasses of the APCD (discussed in section IV.D.2); setting MACT standards for transfer racks (discussed in section IV.D.6); inclusion of butylene oxide in the definition of epoxide and the list of HAP in table 4 to the PEPO NESHAP (discussed in section IV.D.7).</P>
                    <HD SOURCE="HD2">D. What are the economic impacts?</HD>
                    <P>
                        The EPA conducted an EIA for this proposal, in a document titled 
                        <E T="03">Economic Impact Analysis,</E>
                         which is available in the docket for this action. The EIA contains two parts. The EPA calculated the economic impacts of the proposal on small entities as the percentage of total annualized costs incurred by affected ultimate parent owners to their revenues. This ratio provides a measure of the direct economic impact to ultimate parent owners of PEPO facilities while presuming no impact on consumers. We estimate that the only small business impacted by the proposal will incur total annualized costs of 0.68 percent of its revenue both with and without product recovery. The Regulatory Flexibility Act (RFA) section later in this preamble and the EIA for this proposed rulemaking provide more explanation of these economic impacts.
                    </P>
                    <HD SOURCE="HD2">E. What are the benefits?</HD>
                    <P>The emissions controls required by these rules are expected to reduce emissions of a number of HAP. The proposed amendments to the PEPO NESHAP, excluding the EtO emission standards and the new flare requirements, would reduce HAP emissions from PEPO sources by approximately 157 tpy. The proposed EtO emission standards are projected to reduce EtO emissions from PEPO processes by approximately 14 tpy. We also estimate that the proposed amendments to the NESHAP will reduce excess emissions of HAP from flares in the PEPO Production source category by an additional 75 tpy.</P>
                    <P>Quantifying and monetizing the economic value of reducing the risk of cancer and non-cancer effects is made difficult by the lack of a central estimate of cancer and non-cancer risk and the lack of estimates of the value of an avoided case of cancer (fatal and non-fatal) and morbidity effects. Due to methodology and data limitations, we did not attempt to monetize the health benefits of reductions in HAP emissions in this analysis. With regard to emissions changes, the EPA is unable to assess the total costs, benefits, and distributional consequences of these actions at the community/neighborhood level.</P>
                    <P>
                        EtO is used in the production of PEPO. Health effects from acute (short-term) exposure to EtO in humans consist mainly of central nervous system depression and irritation of the eyes and mucous membranes. Chronic (long-term) exposure to EtO in humans can cause irritation of the eyes, skin, nose, throat, and lungs, and damage to the brain and nervous system. There is also some evidence linking EtO 
                        <PRTPAGE P="106048"/>
                        exposure to reproductive effects.
                        <SU>89</SU>
                        <FTREF/>
                         The International Agency for Research on Cancer has classified EtO as a known human carcinogen.
                        <SU>90</SU>
                        <FTREF/>
                         The EPA's IRIS characterized EtO as “carcinogenic to humans” by the inhalation route of exposure based on the total weight of evidence (U.S. EPA, 2016), in accordance with the EPA's Guidelines for Carcinogen Risk Assessment.
                        <SU>91</SU>
                        <FTREF/>
                         The EPA concluded that there was strong, but less than conclusive on its own, epidemiological evidence of lymphohematopoietic cancers and breast cancer in EtO-exposed workers (U.S. EPA, 2016). People living near PEPO production facilities that emit EtO may have an increased risk of developing lymphoid cancers and, for females, breast cancer.
                        <SU>92</SU>
                        <FTREF/>
                         We conclude that reducing EtO emissions from PEPO production facilities will significantly reduce the cancer risk for exposed populations (see sections IV.A.1 and IV.B.3 of this preamble).
                    </P>
                    <FTNT>
                        <P>
                            <SU>89</SU>
                             ATSDR. 
                            <E T="03">Toxicological Profile for Ethylene Oxide.</E>
                             U.S. Department of Health and Human Services. 2022. Available at 
                            <E T="03">https://www.atsdr.cdc.gov/toxprofiles/tp137.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>90</SU>
                             International Agency for Research on Cancer. 
                            <E T="03">Chemical Agents and Related Occupations. Volume 100F, A Review of Human Carcinogens.</E>
                             2012. Available at 
                            <E T="03">https://publications.iarc.fr/Book-And-Report-Series/Iarc-Monographs-On-The-Identification-Of-Carcinogenic-Hazards-To-Humans/Chemical-Agents-And-Related-Occupations-2012.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>91</SU>
                             U.S. EPA. 
                            <E T="03">Guidelines for Carcinogen Risk Assessment.</E>
                             2005. Available at 
                            <E T="03">https://www.epa.gov/risk/guidelines-carcinogen-risk-assessment.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>92</SU>
                             U.S. EPA. 
                            <E T="03">Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide. Integrated Risk Information System (IRIS) on Ethylene Oxide.</E>
                             National Center for Environmental Assessment, Washington DC. 2016.
                        </P>
                    </FTNT>
                    <P>
                        The emission controls installed to comply with these proposed rules are also expected to reduce VOC emissions which, in conjunction with NO
                        <E T="52">X</E>
                         and in the presence of sunlight, form ground-level ozone (O
                        <E T="52">3</E>
                        ). To assess O
                        <E T="52">3</E>
                        -related human health impacts, the EPA consults the 
                        <E T="03">Integrated Science Assessment for Ozone</E>
                         (Ozone ISA) 
                        <SU>93</SU>
                        <FTREF/>
                         as summarized in the 
                        <E T="03">Technical Support Document for the Final Revised Cross State Air Pollution Rule Update.</E>
                        <SU>94</SU>
                        <FTREF/>
                         In brief, the Ozone ISA found short-term (less than 1 month) exposures to ozone to be causally related to respiratory effects, a “likely to be causal” relationship with metabolic effects, and a “suggestive of, but not sufficient to infer, a causal relationship” for central nervous system effects, cardiovascular effects, and total mortality. The Ozone ISA reported that long-term exposures (1 month or longer) to ozone are “likely to be causal” for respiratory effects including respiratory mortality, and a “suggestive of, but not sufficient to infer, a causal relationship” for cardiovascular effects, reproductive effects, central nervous system effects, metabolic effects, and total mortality.
                    </P>
                    <FTNT>
                        <P>
                            <SU>93</SU>
                             U.S. EPA (2020). 
                            <E T="03">Integrated Science Assessment for Ozone and Related Photochemical Oxidants.</E>
                             U.S. EPA. Washington, DC. Office of Research and Development. EPA/600/R-20/012. Available at: 
                            <E T="03">https://www.epa.gov/isa/integrated-science-assessment-isa-ozone-and-related-photochemical-oxidants.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>94</SU>
                             U.S. EPA. 2021. 
                            <E T="03">Technical Support Document (TSD) for the Final Revised Cross-State Air Pollution Rule Update for the 2008 Ozone Season NAAQS Estimating PM</E>
                            <E T="52">2.5</E>
                            <E T="03">- and Ozone-Attributable Health Benefits. https://www.epa.gov/sites/default/files/2021-03/documents/estimating_pm2.5-_and_ozone-attributable_health_benefits_tsd.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">F. What analysis of environmental justice did we conduct?</HD>
                    <P>
                        For purposes of analyzing regulatory impacts, the EPA relies upon its June 2016 
                        <E T="03">Technical Guidance for Assessing Environmental Justice in Regulatory Analysis,</E>
                         which provides recommendations that encourage analysts to conduct the highest quality analysis feasible, recognizing that data limitations, time, resource constraints, and analytical challenges will vary by media and circumstance. The Technical Guidance states that a regulatory action may involve potential EJ concerns if it could: (1) create new disproportionate impacts on communities with EJ concerns; (2) exacerbate existing disproportionate impacts on communities with EJ concerns; or (3) present opportunities to address existing disproportionate impacts on communities with EJ concerns through this action under development.
                    </P>
                    <P>
                        The EPA's EJ technical guidance states that “[t]he analysis of potential EJ concerns for regulatory actions should address three questions: (A) Are there potential EJ concerns associated with environmental stressors affected by the regulatory action for population groups of concern in the baseline? (B) Are there potential EJ concerns associated with environmental stressors affected by the regulatory action for population groups of concern for the regulatory option(s) under consideration? (C) For the regulatory option(s) under consideration, are potential EJ concerns created or mitigated compared to the baseline?” 
                        <SU>95</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>95</SU>
                             
                            <E T="03">Technical Guidance for Assessing Environmental Justice in Regulatory Analysis,</E>
                             U.S. EPA, June 2016. Quote is from Section 3—Key Analytic Considerations, page 11.
                        </P>
                    </FTNT>
                    <P>The EJ analysis is presented for the purpose of providing the public with as full as possible an understanding of the potential impacts of this proposed action. The EPA notes that analysis of such impacts is distinct from the determinations proposed in this action under CAA section 112, which are based solely on the statutory factors the EPA is required to consider under that section.</P>
                    <HD SOURCE="HD3">1. PEPO Production Source Category Demographics</HD>
                    <P>
                        For the PEPO Production source category, the EPA examined the potential for the 23 PEPO facilities (for which the EPA had HAP emissions inventories for emissions from the PEPO category) 
                        <SU>96</SU>
                        <FTREF/>
                         to pose concerns to communities living in proximity to facilities, both in the baseline and under the control option proposed in this proposed action. Specifically, to examine the potential for EJ concerns, the EPA conducted three different demographic analyses of the populations living within 10 km and 50 km of the PEPO facilities: a proximity analysis; a baseline cancer risk-based analysis (
                        <E T="03">i.e.,</E>
                         before implementation of any controls required by this proposed action); and a post-control cancer risk-based analysis (
                        <E T="03">i.e.,</E>
                         after implementation of the controls proposed to be required by this proposed action). In this preamble, we focus on the results from the demographic analyses using a 10 km radius because this area captures the majority of the population with higher cancer risks due to HAP emissions from PEPO facilities. Specifically, 100 percent of the population with baseline cancer risks greater than or equal to 50-in-1 million from PEPO Production source category emissions lives within 10 km of the PEPO facilities. The methodology and detailed results of the demographic analyses, including the demographic analyses for populations living within 50 km of facilities, are presented in the document titled 
                        <E T="03">Analysis of Demographic Factors for Populations Living Near Polyether Polyols (PEPO) Production Facilities—Source Category Analysis of Proposed Amendments,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <FTNT>
                        <P>
                            <SU>96</SU>
                             Note that there are 25 facilities identified as subject to the PEPO NESHAP. However, one of these facilities has a PEPO source still under construction and another facility did not have sufficient information to parse out the source category records. Therefore, only 23 facilities were included for the PEPO Production source category analyses.
                        </P>
                    </FTNT>
                    <P>
                        For all three demographic analyses, the affected populations (
                        <E T="03">i.e.,</E>
                         those living within 10 km of the facilities) are compared to the national population. The total population, population percentages, and population count for each demographic group for the entire U.S. population are shown in the column titled “Nationwide Average for 
                        <PRTPAGE P="106049"/>
                        Reference” in tables 14 through 16 of this preamble. These national data are provided as a frame of reference to compare the results of the proximity analysis, the baseline cancer risk-based analysis, and the post-control cancer risk-based analysis.
                    </P>
                    <P>Detailed results of the PEPO Production source category demographic analyses are located in subsections a (proximity analysis), b (baseline risk-based analysis), and c (post-control risk-based analysis) of this section V.F.1 of the preamble. The following paragraphs briefly summarize the results of these demographic analyses.</P>
                    <P>The results of the proximity analysis indicate that a total of 1.4 million people live within 10 km of the 23 PEPO facilities analyzed. The percent of the population living within 10 km of the PEPO facilities is above the corresponding national average for the following demographic groups: Black, Hispanic or Latino, people living below the poverty level, people living below two times the poverty level, people over the age of 25 without a high school diploma, and people that are age 0 to 17. The results of the proximity analysis indicate that the proportion of other demographic groups living within 10 km of PEPO facilities is similar to or below the national average. The baseline cancer risk-based demographic analysis, which focuses on populations that have higher cancer risks, suggests that disparities exist for the same demographic groups as seen in the proximity analysis.</P>
                    <P>The post-control risk-based demographic analysis shows that the controls proposed to be required by this proposed action would notably reduce the number of people who are exposed to cancer risks resulting from PEPO Production source category emissions at all risk levels. At greater than or equal to a cancer risk of 1-in-1 million, the number of individuals exposed would decrease from 834,000 to 592,000. The demographic composition of those individuals exposed to cancer risk greater than or equal to 1-in-1 million post-control is similar to the demographic composition of the individuals exposed to a cancer risk of 1-in-1 million at baseline. At greater than or equal to a cancer risk of 50-in-1 million, the number of individuals exposed would decrease from 28,000 to 1,600. The demographic composition of those individuals exposed to cancer risk greater than or equal to 50-in-1 million post-control is above the corresponding national average for the following demographic groups: Black, Hispanic or Latino, age 0-17, people living below the poverty level, people living below two times the poverty level, and those over 25 without a high school education. After control is implemented, the number of people who are exposed to cancer risks greater than 100-in-1 million resulting from PEPO Production source category emissions would decrease from 3,300 to zero. Therefore, there are no disparities among demographic groups at this risk level. The actions of this proposed rulemaking would improve human health of current and future populations that live near these facilities. For more details see the remainder of this section V.F of the preamble.</P>
                    <HD SOURCE="HD3">a. Proximity Analysis</HD>
                    <P>The column titled “Proximity Analysis for Population Living Within 10 km of PEPO Facilities” in tables 14 through 16 of this preamble shows the share and count of people for each of the demographic categories for the total population living within 10 km (~6.2 miles) of PEPO facilities. These are the results of the proximity analysis and are repeated in tables 14 through 16 of this preamble for easy comparison to the risk-based analyses discussed later in this preamble.</P>
                    <P>Approximately 1.4 million people live within 10 km of the 23 PEPO facilities assessed. The results of the proximity demographic analysis indicate that the percentages of the population that is Black (13 percent, 192,000 people), Hispanic or Latino (22 percent, 320,000 people) are higher than the national average (12 percent and 19 percent, respectively). The percentages of people living below the poverty level (14 percent, 196,000 people) and below 2 times the poverty level (31 percent, 446,000 people) are also higher than the national average (14 percent and 31 percent, respectively). In addition, the percentage of people over the age of 25 without a high school diploma (14 percent, 197,000 people) is higher than the national average (12 percent). The proximity analysis indicates that the proportion of other demographic groups living within 10 km of PEPO facilities is similar to or below the national average.</P>
                    <HD SOURCE="HD3">b. Baseline Risk-Based Demographics</HD>
                    <P>The baseline risk-based demographic analysis results are shown in the “baseline” column of tables 14 through 16 of this preamble. This analysis focused on the populations living within 10 km (~6.2 miles) of the PEPO facilities with estimated cancer risks greater than or equal to 1-in-1 million resulting from PEPO Production source category emissions (table 14 of this preamble), greater than or equal to 50-in-1 million (table 15 of this preamble), and greater than 100-in-1 million (table 16 of this preamble). The risk analysis indicated that emissions from the source category, prior to the controls proposed to be required in this action, expose 834,000 people living near 18 facilities to a cancer risk greater than or equal to 1-in-1 million, 28,000 people living near 10 facilities to a cancer risk greater than or equal to 50-in-1 million, and 3,300 people living near 6 facilities to a cancer risk greater than 100-in-1 million.</P>
                    <P>In the baseline, there are 834,000 people living around 18 PEPO facilities with a cancer risk greater than or equal to 1-in-1 million resulting from PEPO Production source category emissions. The 18 PEPO facilities are located across 7 States, but more than two-thirds (14 facilities) of the facilities are located in Texas, West Virginia, and Louisiana. Ninety-seven percent of the people with risks greater than or equal to 1-in-1 million live around these 14 PEPO facilities in Texas, West Virginia, and Louisiana. The overall percent of the baseline population with estimated cancer risks greater than or equal to 1-in-1 million who are Black (15 percent, 129,000 people) is above the average percentage of the national population that is Black (12 percent). Around five PEPO facilities located in Louisiana, the percent of the population with cancer risks greater than or equal to 1-in-1 million resulting from PEPO baseline source category emissions that is Black is more than two times the national average (greater than 24 percent). These five PEPO facilities account for about half of the Black population living within 10 km of PEPO facilities with risks greater than or equal to 1-in-1 million resulting from PEPO Production source category baseline emissions.</P>
                    <P>
                        The overall percent of the population with cancer risks greater than or equal to 1-in-1 million resulting from PEPO Production source category baseline emissions that is Hispanic or Latino (26 percent, 218,000 people) is higher than that in the baseline proximity analysis (22 percent, 320,000 people) and well above the national average (19 percent). Around three PEPO facilities located in Texas, the percent of the population that is Hispanic or Latino with cancer risks greater than or equal to 1-in-1 million resulting from PEPO baseline source category emissions is more than two times the national average. These three PEPO facilities account for over half of the Hispanic or Latino population living within 10 km of PEPO facilities with risks greater than or equal to 1-in-1 million resulting from PEPO Production source category baseline emissions. The 
                        <PRTPAGE P="106050"/>
                        percent of the population that is linguistically isolated with baseline cancer risks greater than or equal to 1-in-1 million is more than twice the national average for one of these three Texas facilities. The percent of the population that is American Indian or Alaskan Native or Other and Multiracial with risks greater than or equal to 1-in-1 million resulting from PEPO Production source category baseline emissions is below the national average for all facilities.
                    </P>
                    <P>The percent of the population living below the poverty level and below two times the poverty level with cancer risks greater than or equal to 1-in-1 million resulting from PEPO baseline source category emissions (15 percent and 34 percent, respectively) is above the national average (13 percent and 30 percent, respectively). Around three facilities located in West Virginia, the percent of the population living below the poverty level and below two times the poverty level within 10 km of PEPO facilities with risks greater than or equal to 1-in-1 million resulting from PEPO Production source category baseline emissions is about 10 percent higher than the national average. The percent of the population over 25 years old without a high school diploma with cancer risks greater than or equal to 1-in-1 million resulting from PEPO Production source category baseline emissions (15 percent, 128,000 people) is greater than the national average (12 percent).</P>
                    <P>In the baseline, there are about 28,000 people living around 10 PEPO facilities with a cancer risk greater than or equal to 50-in-1 million resulting from PEPO Production source category baseline emissions. These 10 PEPO facilities are located across 4 States (Louisiana, Texas, West Virginia, and Kentucky). Sixty percent of the people with risks greater than or equal to 50-in-1 million resulting from PEPO Production source category baseline emissions live within 10 km of one facility, which is located in Louisiana. The overall percent of the population that is Black with baseline cancer risk greater than or equal to 50-in-1 million resulting from PEPO Production source category emissions (10 percent, 2,800 people) is below the national average (12 percent). However, around four PEPO facilities located in Louisiana and West Virginia, the percent of the population with cancer risks greater than or equal to 50-in-1 million resulting from PEPO baseline source category emissions that is Black is more than two times the national average (greater than 24 percent).</P>
                    <P>
                        The overall percent of the population that is Hispanic or Latino with baseline cancer risk greater than or equal to 50-in-1 million resulting from PEPO Production source category emissions (10 percent, 2,700 people) is below the national average (19 percent). However, around two PEPO facilities located in Texas, the percent of the population with cancer risks greater than or equal to 50-in-1 million resulting from PEPO baseline source category emissions that is Hispanic or Latino is more than two times the national average (
                        <E T="03">i.e.,</E>
                         greater than 38 percent). The population near these two facilities in Texas accounts for about 77 percent of the number of Latino/Hispanic people with risks greater than or equal to 50-in-1 million resulting from the PEPO Production source category emissions. The percent of the population that is American Indian or Alaskan Native with risks greater than or equal to 50-in-1 million resulting from PEPO Production source category baseline emissions is below the national average for all facilities. The percent of the population that is Other or Multiracial with risks greater than or equal to 50-in-1 million resulting from PEPO Production source category baseline emissions is below the national average for all but one facility located in West Virginia.
                    </P>
                    <P>The percentage of the population with cancer risks resulting from PEPO Production source category baseline emissions greater than or equal to 50-in-1 million that are below the poverty level (14 percent), below two times the poverty level (35 percent), and over 25 years old without a high school diploma (16 percent) are above the respective national averages. Around four facilities located in West Virginia, the percentages of the population living below the poverty level and below two times the poverty level within 10 km of PEPO facilities with risks greater than or equal to 50-in-1 million resulting from PEPO Production source category baseline emissions are about 10 percent higher than the national average.</P>
                    <P>In the baseline, there are 3,300 people living around 6 PEPO facilities with a cancer risk resulting from PEPO Production source category baseline emissions greater than 100-in-1 million. These six PEPO facilities are located in Texas, West Virginia and Louisiana. The percent of the population that is Black with cancer risk greater than 100-in-1 million resulting from PEPO Production source category baseline emissions (14 percent, 500 people) is above the national average (12 percent). Around two facilities in West Virginia, the percentage of the Black population with cancer risks greater than 100-in-1 million resulting from PEPO Production source category emissions is over two times the national average.</P>
                    <P>The percentage of the population that is Hispanic/Latino with risks greater than 100-in-1 million resulting from PEPO Production source category emissions (21 percent, 700 people) is above the national average (19 percent). The share of the Hispanic and Latino population with cancer risks greater than 100-in-1 million resulting from PEPO Production source category emissions is driven by one facility in Texas where the percent of the population that is Hispanic/Latino is over three times the national average. The percent of the population that is American Indian or Alaskan Native with risks greater than 100-in-1 million resulting from PEPO Production source category baseline emissions is well below the national average for all facilities.</P>
                    <P>The percentages of the population with cancer risks greater than 100-in-1 million resulting from PEPO Production source category baseline emissions that are below the poverty level (26 percent, 900 people), below 2 times the poverty level (46 percent, 1,500 people), and over 25 without a high school diploma (30 percent, 1,000 people) are above the respective national averages.</P>
                    <P>Around four facilities located in West Virginia and Louisiana, the percent of the population with cancer risks greater than 100-in-1 million resulting from PEPO Production source category baseline emissions that are below the poverty level is two to four times the national average. In addition, for two of these facilities located in West Virginia, the population with cancer risks greater than 100-in-1 million resulting from PEPO Production source category baseline emissions that are below two times the poverty level is two times the national average.</P>
                    <P>
                        In summary, the baseline risk-based demographic analysis, which focuses on populations that are expected to have higher cancer risks resulting from PEPO Production source category emissions, suggests that Blacks and Hispanic or Latino individuals are disproportionately overrepresented at cancer risk levels of greater than or equal to 1-in-1 million and greater than 100-in-1 million. In addition, the baseline risk-based demographic analysis suggests that populations living below the poverty level and living below two times the poverty level are disproportionately overrepresented at all cancer risk levels. This disproportionate overrepresentation is the greatest in the population with cancer risks greater than 100-in-1 million.
                        <PRTPAGE P="106051"/>
                    </P>
                    <HD SOURCE="HD3">c. Post-Control Risk-Based Demographics</HD>
                    <P>This analysis focused on the populations living within 10 km (~6.2 miles) of the facilities with estimated cancer risks greater than or equal to 1-in-1 million (table 14 of this preamble), greater than or equal to 50-in-1 million (table 15 of this preamble), and greater than 100-in-1 million (table 16 of this preamble) resulting from PEPO Production source category emissions after implementation of the proposed controls (“post-control”). The results of the post-control risk-based demographics analysis are in the column titled “Post-Control” of tables 14 through 16 of this preamble. In this analysis, we evaluated how the projected EtO emission reductions of the proposed standards for PEPO processes described in this action affect the distribution of risks. This evaluation makes it possible to characterize the post-control risks and to evaluate whether the proposed action would create or mitigate potential EJ concerns as compared to the baseline.</P>
                    <P>The risk analysis indicated that the number of people within 10 km of a facility exposed to risks greater than or equal to 1-in-1 million resulting from PEPO Production source category emissions (table 14 of this preamble) would be reduced from approximately 834,000 people in the baseline to 592,000 people after implementation of the PEPO controls in this proposal. The populations with a cancer risk greater than or equal to 1-in-1 million resulting from PEPO Production source category emissions are located around 18 facilities in the baseline and 16 facilities for post-control.</P>
                    <P>The post-control population living within 10 km of a facility with estimated cancer risks greater than or equal to 1-in-1 million resulting from PEPO Production source category emissions (table 14 of this preamble) has similar demographic percentages to the baseline population with risks greater than or equal to 1-in-1 million. However, the number of individuals with risks greater than or equal to 1-in-1 million resulting from PEPO Production source category emissions would be reduced in each demographic.</P>
                    <P>The percentage of the population with risks greater than or equal to 1-in-1 million resulting from PEPO Production source category emissions that is Black is 3 percent higher in the post-control population (18 percent) than in the baseline population (15 percent). However, the number of Black individuals with risks at or above 1-in-1 million would be reduced by almost 25,000 people from 129,000 in the baseline to 105,000 in the post-control scenario.</P>
                    <P>Similarly, the percentage of the population with risks greater than or equal to 1-in-1 million resulting from PEPO Production source category post-control emissions that is Hispanic/Latino would still be above the national average (25 percent versus 19 percent), but the number of Hispanic/Latino individuals with risks at or above 1-in-1 million would be reduced by about 70,000 people from 218,000 in the baseline to 148,000 in the post-control scenario.</P>
                    <P>The percent of the population that is American Indian or Alaskan Native with risks greater than or equal to 1-in-1 million resulting from PEPO Production source category emissions (0.2 percent) is below the national average (0.6 percent) in the post-control analysis and populations around all facilities are below the national average. The number of American Indians or Alaskan Natives with risks greater than or equal to 1-in-1 million resulting from PEPO Production source category emissions would be reduced from 2,100 in the baseline to 1,200 in the post-control scenario.</P>
                    <P>The percentages of the population with risks greater than or equal to 1-in-1 million resulting from PEPO Production source category emissions below the poverty level (15 percent) and below two times the poverty level (34 percent) are the same in the post-control scenario as in the baseline. However, the number of individuals with risks greater than or equal to 1-in-1 million resulting from PEPO Production source category emissions that are below the poverty level would be reduced by about 35,000 (from 125,000 to 91,000) and those below 2 times the poverty level is reduced by about 78,000 (from 281,000 to 203,000). The percent of individuals over 25 years old without a high school diploma is 1 percent higher in the post-control scenario (16 percent) than in the baseline (15 percent), but the number of individuals with risks greater than or equal to 1-in-1 million resulting from PEPO Production source category emissions would be reduced by almost 35,000, from 128,000 to 93,000. The percentage of the population that is in linguistic isolation with risks greater than or equal to 1-in-1 million resulting from PEPO Production source category emissions is the same in the post-control scenario (5 percent), but the number of individuals would be reduced by almost 11,000 compared to the baseline, from 38,000 to 27,000.</P>
                    <P>The risk analysis indicated that the number of people living within 10 km of a facility and exposed to risks greater than or equal to 50-in-1 million resulting from PEPO Production source category emissions (table 15 of this preamble) would be reduced significantly, from 28,000 people in the baseline to 1,600 people after implementation of the controls in this proposal. This represents more than a 90 percent reduction in the number of individuals with risk greater than or equal to 50-in-1 million when compared to the baseline. The populations living within 10 km of a facility and with a cancer risk greater than or equal to 50-in-1 million resulting from PEPO Production source category emissions are located around four facilities in the post-control scenario, six fewer facilities than in the baseline. These four facilities are located in Louisiana, Texas, and West Virginia (two facilities). The communities within 10 km of two of those facilities (in Louisiana and Texas) comprise over 80 percent of the population with risks greater than or equal to 50-in-1 million resulting from PEPO Production source category post-control emissions.</P>
                    <P>The number of individuals with risks greater than or equal to 50-in-1 million would be reduced significantly for each demographic category in the post-control scenario. The percentage of the population with risks greater than or equal to 50-in-1 million resulting from PEPO Production source category emissions that is Black would increase from 10 percent in the baseline to 17 percent in the post-control scenario, which is above the national average (12 percent). However, the number of Black individuals with risks at or above 50-in-1 million would be reduced from 2,800 in the baseline to 300 post-control. Similarly, the percentage of the population with risks greater than or equal to 50-in-1 million resulting from PEPO Production source category emissions that is Hispanic/Latino would increase from 10 percent in the baseline to 25 percent post-control, but the number of Hispanic/Latino individuals with risks at or above 50-in-1 million would be reduced from 2,700 in the baseline to 400 post-control. The number of American Indians or Alaskan Natives with risks greater than or equal to 50-in-1 million resulting from PEPO Production source category emissions would be reduced from about 100 in the baseline to zero post-control.</P>
                    <P>
                        The percentages of the population with risks greater than or equal to 50-in-1 million resulting from PEPO Production source category post-control emissions whose income is below the poverty level (22 percent) and below two times the poverty level (42 percent) 
                        <PRTPAGE P="106052"/>
                        would be higher than from the baseline (14 percent and 35 percent, respectively). However, the number of individuals with risks greater than or equal to 50-in-1 million resulting from PEPO Production source category emissions that are below the poverty level would be reduced from by about 3,700 people (from 4,100 to 400) and those below two times the poverty level would be reduced by about 9,200 people (from 9,900 to 700). The number of individuals with risks greater than or equal to 50-in-1 million resulting from PEPO Production source category emissions that are over 25 years old without a high school diploma or are linguistically isolated would also be greatly reduced post-control.
                    </P>
                    <P>The risk analysis indicated that the number of people living within 10 km of a facility with risks greater than 100-in-1 million resulting from PEPO Production source category emissions (table 16 of this preamble) would be reduced from 3,300 individuals in the baseline to zero individuals after application of the PEPO controls in this proposal. Therefore, for the post-control risk-based demographic results, there would be no “greater than 100-in-1 million” demographic results to discuss.</P>
                    <P>In summary, as shown in the post-control risk-based demographic analysis, the controls proposed to be required by this proposal would significantly reduce the number of people expected to have cancer risks greater than or equal to 1-in-1 million, greater than or equal to 50-in-1 million, and greater than 100-in-1 million resulting from PEPO Production source category emissions. Although the number of individuals with risks greater than or equal to 1-in-1 million would be reduced in the post-control scenario (reduced from 834,000 people to 592,000 people), populations of Black individuals, Hispanic/Latino individuals, those living below the poverty level and two times the poverty level, and those over 25 without a high school diploma would remain disproportionately represented. Similarly, the number of individuals with risks greater than or equal to 50-in-1 million would be reduced significantly in the post-control scenario (reduced from 28,000 to 1,600), but the population of Black individuals, Hispanic/Latino individuals, those living below the poverty level and two times the poverty level, and those over 25 without a high school diploma would remain disproportionately represented. Post-control, there would be no individuals with risks greater than 100-in-1 million resulting from PEPO Production source category emissions (reduced from 3,300 people to 0 people).</P>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,10,18,10,10">
                        <TTITLE>
                            Table 14—Source Category: Comparison of Baseline and Post-Control Demographics of Populations With Cancer Risk Greater Than or Equal to 1-in-1 Million Resulting From PEPO NESHAP Source Category Emissions Living Within 10 
                            <E T="01">km</E>
                             of Facilities to the National Average and Proximity Demographics
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">Demographic group</CHED>
                            <CHED H="1">Nationwide average for reference</CHED>
                            <CHED H="1">Proximity analysis for total population living within 10 km of PEPO facilities</CHED>
                            <CHED H="1">
                                Cancer risk ≥1-in-1
                                <LI>million within 10 km of PEPO facilities</LI>
                            </CHED>
                            <CHED H="2">Baseline</CHED>
                            <CHED H="2">Post-control</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Total Population</ENT>
                            <ENT>330M</ENT>
                            <ENT>1.4M</ENT>
                            <ENT>834K</ENT>
                            <ENT>592K</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Number of Facilities</ENT>
                            <ENT/>
                            <ENT>23</ENT>
                            <ENT>18</ENT>
                            <ENT>16</ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Race and Ethnicity by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">White</ENT>
                            <ENT>
                                60%
                                <LI>[196M]</LI>
                            </ENT>
                            <ENT>
                                59%
                                <LI>[847K]</LI>
                            </ENT>
                            <ENT>
                                54%
                                <LI>[450K]</LI>
                            </ENT>
                            <ENT>
                                53%
                                <LI>[313K]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Black</ENT>
                            <ENT>
                                12%
                                <LI>[40M]</LI>
                            </ENT>
                            <ENT>
                                13%
                                <LI>[192K]</LI>
                            </ENT>
                            <ENT>
                                15%
                                <LI>[129K]</LI>
                            </ENT>
                            <ENT>
                                18%
                                <LI>[105K]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">American Indian and Alaskan Native</ENT>
                            <ENT>
                                0.6%
                                <LI>[2.1M]</LI>
                            </ENT>
                            <ENT>
                                0.2%
                                <LI>[3.3K]</LI>
                            </ENT>
                            <ENT>
                                0.3%
                                <LI>[2.1K]</LI>
                            </ENT>
                            <ENT>
                                0.2%
                                <LI>[1.2K]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Hispanic or Latino (white and nonwhite)</ENT>
                            <ENT>
                                19%
                                <LI>[63M]</LI>
                            </ENT>
                            <ENT>
                                22%
                                <LI>[320K]</LI>
                            </ENT>
                            <ENT>
                                26%
                                <LI>[218K]</LI>
                            </ENT>
                            <ENT>
                                25%
                                <LI>[148K]</LI>
                            </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Other and Multiracial</ENT>
                            <ENT>
                                9%
                                <LI>[29M]</LI>
                            </ENT>
                            <ENT>
                                5%
                                <LI>[68K]</LI>
                            </ENT>
                            <ENT>
                                4%
                                <LI>[34K]</LI>
                            </ENT>
                            <ENT>
                                4%
                                <LI>[26K]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Age by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Age 0 to 17 years</ENT>
                            <ENT>
                                22%
                                <LI>[74M]</LI>
                            </ENT>
                            <ENT>
                                24%
                                <LI>[345K]</LI>
                            </ENT>
                            <ENT>
                                24%
                                <LI>[204K]</LI>
                            </ENT>
                            <ENT>
                                25%
                                <LI>[147K]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Age 18 to 64 years</ENT>
                            <ENT>
                                62%
                                <LI>[203M]</LI>
                            </ENT>
                            <ENT>
                                61%
                                <LI>[876K]</LI>
                            </ENT>
                            <ENT>
                                61%
                                <LI>[511K]</LI>
                            </ENT>
                            <ENT>
                                61%
                                <LI>[363K]</LI>
                            </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Age ≥65 years</ENT>
                            <ENT>
                                16%
                                <LI>[53M]</LI>
                            </ENT>
                            <ENT>
                                15%
                                <LI>[210K]</LI>
                            </ENT>
                            <ENT>
                                14%
                                <LI>[118K]</LI>
                            </ENT>
                            <ENT>
                                14%
                                <LI>[83K]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Income by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Below Poverty Level</ENT>
                            <ENT>
                                13%
                                <LI>[42M]</LI>
                            </ENT>
                            <ENT>
                                14%
                                <LI>[196K]</LI>
                            </ENT>
                            <ENT>
                                15%
                                <LI>[125K]</LI>
                            </ENT>
                            <ENT>
                                15%
                                <LI>[91K]</LI>
                            </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Below 2x Poverty Level</ENT>
                            <ENT>
                                30%
                                <LI>[100M]</LI>
                            </ENT>
                            <ENT>
                                31%
                                <LI>[446K]</LI>
                            </ENT>
                            <ENT>
                                34%
                                <LI>[281K]</LI>
                            </ENT>
                            <ENT>
                                34%
                                <LI>[203K]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Education by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00" RUL="s">
                            <ENT I="01">Over 25 and without a High School Diploma</ENT>
                            <ENT>
                                12%
                                <LI>[38M]</LI>
                            </ENT>
                            <ENT>
                                14%
                                <LI>[197K]</LI>
                            </ENT>
                            <ENT>
                                15%
                                <LI>[128K]</LI>
                            </ENT>
                            <ENT>
                                16%
                                <LI>[93K]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <PRTPAGE P="106053"/>
                            <ENT I="21">
                                <E T="02">Linguistically Isolated by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Linguistically Isolated</ENT>
                            <ENT>
                                5%
                                <LI>[17M]</LI>
                            </ENT>
                            <ENT>
                                4%
                                <LI>[59K]</LI>
                            </ENT>
                            <ENT>
                                5%
                                <LI>[38K]</LI>
                            </ENT>
                            <ENT>
                                5%
                                <LI>[27K]</LI>
                            </ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Notes:</E>
                        </TNOTE>
                        <TNOTE>• Nationwide population and demographic percentages are based on Census' 2016-2020 American Community Survey (ACS) 5-year block group averages. Total population count is based on 2020 Decennial Census block population.</TNOTE>
                        <TNOTE>• To avoid double counting, the “Hispanic or Latino” category is treated as a distinct demographic category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.</TNOTE>
                        <TNOTE>• The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR was located at a user assigned receptor at an individual residence and not at a census block centroid, we were unable to estimate population and demographics for that facility.</TNOTE>
                        <TNOTE>• The sum of individual populations with a demographic category may not add up to total due to rounding. K = Thousands, M = Millions.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,10,18,10,10">
                        <TTITLE>
                            Table 15—Source Category: Comparison of Baseline and Post-Control Demographics of Populations With Cancer Risk Greater Than or Equal to 50-in-1 Million Resulting From PEPO NESHAP Source Category Emissions Living Within 10 
                            <E T="01">km</E>
                             of Facilities to the National Average and Proximity Demographics
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">Demographic group</CHED>
                            <CHED H="1">Nationwide average for reference</CHED>
                            <CHED H="1">Proximity analysis for total population living within 10 km of PEPO facilities</CHED>
                            <CHED H="1">
                                Cancer risk ≥50-in-1
                                <LI>million within 10 km of PEPO facilities</LI>
                            </CHED>
                            <CHED H="2">Baseline</CHED>
                            <CHED H="2">Post-control</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Total Population</ENT>
                            <ENT>330M</ENT>
                            <ENT>1.4M</ENT>
                            <ENT>28K</ENT>
                            <ENT>1.6K</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Number of Facilities</ENT>
                            <ENT/>
                            <ENT>23</ENT>
                            <ENT>10</ENT>
                            <ENT>4</ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Race and Ethnicity by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">White</ENT>
                            <ENT>
                                60%
                                <LI>[196M]</LI>
                            </ENT>
                            <ENT>
                                59%
                                <LI>[847K]</LI>
                            </ENT>
                            <ENT>
                                77%
                                <LI>[22K]</LI>
                            </ENT>
                            <ENT>
                                56%
                                <LI>[900]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Black</ENT>
                            <ENT>
                                12%
                                <LI>[40M]</LI>
                            </ENT>
                            <ENT>
                                13%
                                <LI>[192K]</LI>
                            </ENT>
                            <ENT>
                                10%
                                <LI>[2.8K]</LI>
                            </ENT>
                            <ENT>
                                17%
                                <LI>[300]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">American Indian and Alaskan Native</ENT>
                            <ENT>
                                0.6%
                                <LI>[2.1M]</LI>
                            </ENT>
                            <ENT>
                                0.2%
                                <LI>[3.3K]</LI>
                            </ENT>
                            <ENT>
                                0.3%
                                <LI>[&lt;100]</LI>
                            </ENT>
                            <ENT>
                                0.0%
                                <LI>[0]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Hispanic or Latino (white and nonwhite)</ENT>
                            <ENT>
                                19%
                                <LI>[63M]</LI>
                            </ENT>
                            <ENT>
                                22%
                                <LI>[320K]</LI>
                            </ENT>
                            <ENT>
                                10%
                                <LI>[2.7K]</LI>
                            </ENT>
                            <ENT>
                                25%
                                <LI>[400]</LI>
                            </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Other and Multiracial</ENT>
                            <ENT>
                                9%
                                <LI>[29M]</LI>
                            </ENT>
                            <ENT>
                                5%
                                <LI>[68K]</LI>
                            </ENT>
                            <ENT>
                                3%
                                <LI>[900]</LI>
                            </ENT>
                            <ENT>
                                3%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Age by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Age 0 to 17 years</ENT>
                            <ENT>
                                22%
                                <LI>[74M]</LI>
                            </ENT>
                            <ENT>
                                24%
                                <LI>[345K]</LI>
                            </ENT>
                            <ENT>
                                23%
                                <LI>[6.4K]</LI>
                            </ENT>
                            <ENT>
                                29%
                                <LI>[500]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Age 18 to 64 years</ENT>
                            <ENT>
                                62%
                                <LI>[203M]</LI>
                            </ENT>
                            <ENT>
                                61%
                                <LI>[876K]</LI>
                            </ENT>
                            <ENT>
                                57%
                                <LI>[16.3K]</LI>
                            </ENT>
                            <ENT>
                                57%
                                <LI>[900]</LI>
                            </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Age ≥65 years</ENT>
                            <ENT>
                                16%
                                <LI>[53M]</LI>
                            </ENT>
                            <ENT>
                                15%
                                <LI>[210K]</LI>
                            </ENT>
                            <ENT>
                                20%
                                <LI>[5.7K]</LI>
                            </ENT>
                            <ENT>
                                15%
                                <LI>[200]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Income by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Below Poverty Level</ENT>
                            <ENT>
                                13%
                                <LI>[42M]</LI>
                            </ENT>
                            <ENT>
                                14%
                                <LI>[196K]</LI>
                            </ENT>
                            <ENT>
                                14%
                                <LI>[4.1K]</LI>
                            </ENT>
                            <ENT>
                                22%
                                <LI>[300]</LI>
                            </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Below 2x Poverty Level</ENT>
                            <ENT>
                                30%
                                <LI>[100M]</LI>
                            </ENT>
                            <ENT>
                                31%
                                <LI>[446K]</LI>
                            </ENT>
                            <ENT>
                                35%
                                <LI>[9.9K]</LI>
                            </ENT>
                            <ENT>
                                42%
                                <LI>[700]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Education by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00" RUL="s">
                            <ENT I="01">Over 25 and without a High School Diploma</ENT>
                            <ENT>
                                12%
                                <LI>[38M]</LI>
                            </ENT>
                            <ENT>
                                14%
                                <LI>[197K]</LI>
                            </ENT>
                            <ENT>
                                16%
                                <LI>[4.4K]</LI>
                            </ENT>
                            <ENT>
                                32%
                                <LI>[500]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <PRTPAGE P="106054"/>
                            <ENT I="21">
                                <E T="02">Linguistically Isolated by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Linguistically Isolated</ENT>
                            <ENT>
                                5%
                                <LI>[17M]</LI>
                            </ENT>
                            <ENT>
                                4%
                                <LI>[59K]</LI>
                            </ENT>
                            <ENT>
                                2%
                                <LI>[500]</LI>
                            </ENT>
                            <ENT>
                                1%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Notes:</E>
                        </TNOTE>
                        <TNOTE>• Nationwide population and demographic percentages are based on Census' 2016-2020 ACS 5-year block group averages. Total population count is based on 2020 Decennial Census block population.</TNOTE>
                        <TNOTE>• To avoid double counting, the “Hispanic or Latino” category is treated as a distinct demographic category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.</TNOTE>
                        <TNOTE>• The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR was located at a user assigned receptor at an individual residence and not at a census block centroid, we were unable to estimate population and demographics for that facility.</TNOTE>
                        <TNOTE>• The sum of individual populations with a demographic category may not add up to total due to rounding. K = Thousands, M = Millions.</TNOTE>
                        <TNOTE>• When the population being characterized is very small, the demographic distributions provided by the Census can be subject to a high level of uncertainty. To avoid implying a level of precision that is not supported by the data, when the population of an individual demographic is less than 100, we have indicated it on the demographic tables as &lt;100.</TNOTE>
                    </GPOTABLE>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,10,18,10,10">
                        <TTITLE>Table 16—Source Category: Comparison of Baseline and Post-Control Demographics of Populations With Cancer Risk Greater Than 100-in-1 Million Resulting From PEPO NESHAP Source Category Emissions Living Within 10 km of Facilities to the National Average and Proximity Demographics</TTITLE>
                        <BOXHD>
                            <CHED H="1">Demographic group</CHED>
                            <CHED H="1">Nationwide average for reference</CHED>
                            <CHED H="1">Proximity analysis for total population living within 10 km of PEPO facilities</CHED>
                            <CHED H="1">
                                Cancer risk &gt;100-in-1 
                                <LI>million within 10 km of PEPO facilities</LI>
                            </CHED>
                            <CHED H="2">Baseline</CHED>
                            <CHED H="2">Post-control</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Total Population</ENT>
                            <ENT>330M</ENT>
                            <ENT>1.4M</ENT>
                            <ENT>3.3K</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Number of Facilities</ENT>
                            <ENT/>
                            <ENT>23</ENT>
                            <ENT>6</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Race and Ethnicity by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">White</ENT>
                            <ENT>
                                60%
                                <LI>[196M]</LI>
                            </ENT>
                            <ENT>
                                59%
                                <LI>[847K]</LI>
                            </ENT>
                            <ENT>
                                61%
                                <LI>[2K]</LI>
                            </ENT>
                            <ENT>
                                100%
                                <LI>[0]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Black</ENT>
                            <ENT>
                                12%
                                <LI>[40M]</LI>
                            </ENT>
                            <ENT>
                                13%
                                <LI>[192K]</LI>
                            </ENT>
                            <ENT>
                                14%
                                <LI>[500]</LI>
                            </ENT>
                            <ENT>
                                0%
                                <LI>[0]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">American Indian and Alaskan Native</ENT>
                            <ENT>
                                0.6%
                                <LI>[2.1M]</LI>
                            </ENT>
                            <ENT>
                                0.2%
                                <LI>[3.3K]</LI>
                            </ENT>
                            <ENT>
                                0.0%
                                <LI>[0]</LI>
                            </ENT>
                            <ENT>
                                0.0%
                                <LI>[0]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Hispanic or Latino (white and nonwhite)</ENT>
                            <ENT>
                                19%
                                <LI>[63M]</LI>
                            </ENT>
                            <ENT>
                                22%
                                <LI>[320K]</LI>
                            </ENT>
                            <ENT>
                                21%
                                <LI>[700]</LI>
                            </ENT>
                            <ENT>
                                0%
                                <LI>[0]</LI>
                            </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Other and Multiracial</ENT>
                            <ENT>
                                9%
                                <LI>[29M]</LI>
                            </ENT>
                            <ENT>
                                5%
                                <LI>[68K]</LI>
                            </ENT>
                            <ENT>
                                5%
                                <LI>[100]</LI>
                            </ENT>
                            <ENT>
                                0%
                                <LI>[0]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Age By Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Age 0 to 17 years</ENT>
                            <ENT>
                                22%
                                <LI>[74M]</LI>
                            </ENT>
                            <ENT>
                                24%
                                <LI>[345K]</LI>
                            </ENT>
                            <ENT>
                                25%
                                <LI>[800]</LI>
                            </ENT>
                            <ENT>
                                0%
                                <LI>[0]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Age 18 to 64 years</ENT>
                            <ENT>
                                62%
                                <LI>[203M]</LI>
                            </ENT>
                            <ENT>
                                61%
                                <LI>[876K]</LI>
                            </ENT>
                            <ENT>
                                58%
                                <LI>[1.9K]</LI>
                            </ENT>
                            <ENT>
                                0%
                                <LI>[0]</LI>
                            </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Age ≥65 years</ENT>
                            <ENT>
                                16%
                                <LI>[53M]</LI>
                            </ENT>
                            <ENT>
                                15%
                                <LI>[210K]</LI>
                            </ENT>
                            <ENT>
                                17%
                                <LI>[600]</LI>
                            </ENT>
                            <ENT>
                                0%
                                <LI>[0]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Income by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Below Poverty Level</ENT>
                            <ENT>
                                13%
                                <LI>[42M]</LI>
                            </ENT>
                            <ENT>
                                14%
                                <LI>[196K]</LI>
                            </ENT>
                            <ENT>
                                26%
                                <LI>[900]</LI>
                            </ENT>
                            <ENT>
                                0%
                                <LI>[0]</LI>
                            </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Below 2x Poverty Level</ENT>
                            <ENT>
                                30%
                                <LI>[100M]</LI>
                            </ENT>
                            <ENT>
                                31%
                                <LI>[446K]</LI>
                            </ENT>
                            <ENT>
                                46%
                                <LI>[1.5k]</LI>
                            </ENT>
                            <ENT>
                                0%
                                <LI>[0]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Education by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00" RUL="s">
                            <ENT I="01">Over 25 and without a High School Diploma</ENT>
                            <ENT>
                                12%
                                <LI>[38M]</LI>
                            </ENT>
                            <ENT>
                                14%
                                <LI>[197K]</LI>
                            </ENT>
                            <ENT>
                                30%
                                <LI>[1k]</LI>
                            </ENT>
                            <ENT>
                                0%
                                <LI>[0]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <PRTPAGE P="106055"/>
                            <ENT I="21">
                                <E T="02">Linguistically Isolated by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Linguistically Isolated</ENT>
                            <ENT>
                                5%
                                <LI>[17M]</LI>
                            </ENT>
                            <ENT>
                                4%
                                <LI>[59K]</LI>
                            </ENT>
                            <ENT>
                                1%
                                <LI>[&lt;100]</LI>
                            </ENT>
                            <ENT>
                                0%
                                <LI>[0]</LI>
                            </ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Notes:</E>
                        </TNOTE>
                        <TNOTE>• Nationwide population and demographic percentages are based on Census' 2016-2020 ACS 5-year block group averages. Total population count is based on 2020 Decennial Census block population.</TNOTE>
                        <TNOTE>• To avoid double counting, the “Hispanic or Latino” category is treated as a distinct demographic category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.</TNOTE>
                        <TNOTE>• The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR was located at a user assigned receptor at an individual residence and not at a census block centroid, we were unable to estimate population and demographics for that facility.</TNOTE>
                        <TNOTE>• The sum of individual populations with a demographic category may not add up to total due to rounding. K = Thousands, M = Millions.</TNOTE>
                    </GPOTABLE>
                    <HD SOURCE="HD3">2. PEPO Production Whole-Facility Demographics</HD>
                    <P>
                        As described in section III.B.7 of this preamble, we assessed the facility-wide (or “whole-facility”) risks for 25 PEPO facilities in order to compare the PEPO Production source category risk to the whole-facility risks, accounting for HAP emissions from the entire major source and not just those resulting from PEPO Production source category emissions at the major source as discussed in the previous section (V.F.1). The whole-facility risk analysis includes all sources of HAP emissions at each facility as reported in the NEI (described in section III.B of this preamble). Since PEPO facilities tend to include HAP emissions sources from many source categories, the EPA conducted a whole-facility demographic analysis focused on post-control risks. This whole-facility demographic analysis characterizes the remaining risks that communities would face after implementation of the controls proposed to be required in this proposal (
                        <E T="03">i.e.,</E>
                         post-control).
                    </P>
                    <P>
                        The whole-facility demographic analysis is an assessment of individual demographic groups in the total population living within 10 km (~6.2 miles) and 50 km (~31 miles) of the facilities. In this preamble, we focus on the results from the demographic analyses using a 10 km radius because this area captures the majority of the population with higher cancer risks due to HAP emissions from PEPO facilities. Specifically, 100 percent of the population with baseline cancer risks greater than or equal to 50-in-1 million from PEPO Production source category emissions lives within 10 km of the PEPO facilities. The results of the whole-facility demographic analysis for populations living within 50 km are included in the document titled 
                        <E T="03">Analysis of Demographic Factors for Populations Living Near Polyether Polyols (PEPO) Production Facilities—Whole Facility Analysis of Proposed Amendments,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <P>The whole-facility demographic analysis post-control results are shown in table 17 of this preamble. This analysis focused on the populations living within 10 km of the PEPO facilities with estimated whole-facility post-control cancer risks greater than or equal to 1-in-1 million, greater than or equal to 50-in-1 million, and greater than 100-in-1 million. The risk analysis indicated that all emissions from the PEPO facilities, after the reductions proposed to be imposed by the proposed rule, would expose a total of about 1 million people living around 22 facilities to a cancer risk greater than or equal to 1-in-1 million, 13,000 people living around 12 facilities to a cancer risk greater than or equal to 50-in-1 million, and about 200 people living around 1 facility to a cancer risk greater than 100-in-1 million.</P>
                    <P>When the PEPO whole-facility populations are compared to the PEPO Production source category populations in the post-control scenarios, we see 400,000 additional people with risks greater than or equal to 1-in-1 million, 11,000 additional people with risks greater than or equal to 50-in-1 million, and 200 additional people with risks greater than 100-in-1 million.</P>
                    <P>The demographic distribution of the whole-facility population with post-control cancer risks greater than or equal to 1-in-1 million is similar to the distribution of the source category population with post-control cancer risks greater than or equal to 1-in-1 million. Therefore, the whole-facility population with post-control cancer risks greater than or equal to 1-in-1 million has disproportionately high representation from Blacks, Hispanics and Latinos, people living below the poverty level, people living below two times the poverty level, and those over 25 without a high school education.</P>
                    <P>The population with post-control cancer risks greater than or equal to 50-in-1 million in the whole-facility analysis has a much different demographic distribution than the source category population with post-control cancer risks greater than or equal to 50-in-1 million. The percent of the population that is Black with risks greater than or equal to 50-in-1 million is lower for the whole-facility post-control analysis (9 percent) versus the category post-control analysis (17 percent) and is therefore below the national average (12 percent). The lower representation of the Black population is reflected in slightly higher (1 to 2 percent) greater representation of the other races/ethnicities. As such, the Hispanic and Latino population is still disproportionately represented at 27 percent, which is well above the national average of 19 percent. The percentage of the population with risks greater than or equal to 50-in-1 million that is below the poverty level (8 percent) and below two times the poverty level (21 percent) is about half that for the whole-facility post-control population than for the category post-control population. This means that the whole-facility population is below the national average for both poverty demographics.</P>
                    <P>
                        Based on results from the whole-facility emissions analysis, there would be about 200 people with post-control risks greater than 100-in-1 million. Earlier in this preamble, we showed that 
                        <PRTPAGE P="106056"/>
                        the PEPO Production source category emissions analysis indicated that there would be no people with post-control risks greater than 100-in-1 million. The increased cancer risk for most of these 200 people is driven by EtO emissions from non-PEPO processes (HON, MON, and R&amp;D Testing) co-located at PEPO facilities.
                    </P>
                    <P>The percent of the population in the whole-facility analysis with post-control risks greater than 100-in-1 million that is Black (26 percent, &lt;100 people) is more than double the national average (12 percent). In addition, the percentages of the population in the whole-facility analysis with a post-control risk greater than 100-in-1 million that are below the poverty level (21 percent, &lt;100 people), below 2 times the poverty level (44 percent, &lt;100 people), and over 25 years old without a high school diploma (25 percent, &lt;100 people) are all above the national average (13 percent, 30 percent and 12 percent, respectively).</P>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,12,12,12,12">
                        <TTITLE>
                            Table 17—Whole Facility: Whole-Facility Post-Control Demographics for PEPO Production Facilities by Risk Level for Populations Living Within 10 
                            <E T="01">km</E>
                             of Facilities
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">Demographic group</CHED>
                            <CHED H="1">Nationwide</CHED>
                            <CHED H="1">Post-control cancer risk for populations within 10 km of PEPO facilities</CHED>
                            <CHED H="2">
                                ≥1-in-1
                                <LI>million</LI>
                            </CHED>
                            <CHED H="2">
                                ≥50-in-1
                                <LI>million</LI>
                            </CHED>
                            <CHED H="2">
                                &gt;100-in-1
                                <LI>million</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Total Population</ENT>
                            <ENT>329,824,950</ENT>
                            <ENT>1M</ENT>
                            <ENT>13K</ENT>
                            <ENT>200</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Number of Facilities</ENT>
                            <ENT/>
                            <ENT>22</ENT>
                            <ENT>12</ENT>
                            <ENT>1</ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Race and Ethnicity by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">White</ENT>
                            <ENT>
                                60%
                                <LI>[196M]</LI>
                            </ENT>
                            <ENT>
                                52%
                                <LI>[520K]</LI>
                            </ENT>
                            <ENT>
                                59%
                                <LI>[7.6K]</LI>
                            </ENT>
                            <ENT>
                                61%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Black</ENT>
                            <ENT>
                                12%
                                <LI>[40M]</LI>
                            </ENT>
                            <ENT>
                                15%
                                <LI>[149K]</LI>
                            </ENT>
                            <ENT>
                                9%
                                <LI>[1.2K]</LI>
                            </ENT>
                            <ENT>
                                26%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">American Indian and Alaskan Native</ENT>
                            <ENT>
                                0.6%
                                <LI>[2.1M]</LI>
                            </ENT>
                            <ENT>
                                0.2%
                                <LI>[2K]</LI>
                            </ENT>
                            <ENT>
                                0.6%
                                <LI>[&lt;100]</LI>
                            </ENT>
                            <ENT>
                                0.0%
                                <LI>[0]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Hispanic or Latino (white and nonwhite)</ENT>
                            <ENT>
                                19%
                                <LI>[63M]</LI>
                            </ENT>
                            <ENT>
                                28%
                                <LI>[282K]</LI>
                            </ENT>
                            <ENT>
                                27%
                                <LI>[3.5K]</LI>
                            </ENT>
                            <ENT>
                                10%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Other and Multiracial</ENT>
                            <ENT>
                                9%
                                <LI>[29M]</LI>
                            </ENT>
                            <ENT>
                                5%
                                <LI>[49K]</LI>
                            </ENT>
                            <ENT>
                                4%
                                <LI>[500]</LI>
                            </ENT>
                            <ENT>
                                3%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Age By Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Age 0 to 17 years</ENT>
                            <ENT>
                                22%
                                <LI>[74M]</LI>
                            </ENT>
                            <ENT>
                                25%
                                <LI>[249K]</LI>
                            </ENT>
                            <ENT>
                                21%
                                <LI>[2.7K]</LI>
                            </ENT>
                            <ENT>
                                13%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Age 18 to 64 years</ENT>
                            <ENT>
                                62%
                                <LI>[203M]</LI>
                            </ENT>
                            <ENT>
                                62%
                                <LI>[616K]</LI>
                            </ENT>
                            <ENT>
                                62%
                                <LI>[7.9K]</LI>
                            </ENT>
                            <ENT>
                                58%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Age ≥65 years</ENT>
                            <ENT>
                                16%
                                <LI>[53M]</LI>
                            </ENT>
                            <ENT>
                                14%
                                <LI>[135K]</LI>
                            </ENT>
                            <ENT>
                                17%
                                <LI>[2.2K]</LI>
                            </ENT>
                            <ENT>
                                29%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Income by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Below Poverty Level</ENT>
                            <ENT>
                                13%
                                <LI>[42M]</LI>
                            </ENT>
                            <ENT>
                                14%
                                <LI>[144K]</LI>
                            </ENT>
                            <ENT>
                                8%
                                <LI>[1.1K]</LI>
                            </ENT>
                            <ENT>
                                21%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Below 2x Poverty Level</ENT>
                            <ENT>
                                30%
                                <LI>[100M]</LI>
                            </ENT>
                            <ENT>
                                32%
                                <LI>[320K]</LI>
                            </ENT>
                            <ENT>
                                21%
                                <LI>[2.7K]</LI>
                            </ENT>
                            <ENT>
                                44%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Education by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00" RUL="s">
                            <ENT I="01">Over 25 and without a High School Diploma</ENT>
                            <ENT>
                                12%
                                <LI>[38M]</LI>
                            </ENT>
                            <ENT>
                                15%
                                <LI>[150K]</LI>
                            </ENT>
                            <ENT>
                                16%
                                <LI>[2K]</LI>
                            </ENT>
                            <ENT>
                                25%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Linguistically Isolated by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Linguistically Isolated</ENT>
                            <ENT>
                                5%
                                <LI>[17M]</LI>
                            </ENT>
                            <ENT>
                                5%
                                <LI>[53K]</LI>
                            </ENT>
                            <ENT>
                                2%
                                <LI>[300]</LI>
                            </ENT>
                            <ENT>
                                2%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Notes:</E>
                        </TNOTE>
                        <TNOTE>• Nationwide population and demographic percentages are based on Census' 2016-2020 ACS 5-year block group averages. Total population count is based on 2020 Decennial Census block population.</TNOTE>
                        <TNOTE>• To avoid double counting, the “Hispanic or Latino” category is treated as a distinct demographic category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.</TNOTE>
                        <TNOTE>• The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR was located at a user assigned receptor at an individual residence and not at a census block centroid, we were unable to estimate population and demographics for that facility.</TNOTE>
                        <TNOTE>• The sum of individual populations with a demographic category may not add up to total due to rounding.</TNOTE>
                        <TNOTE>
                            • As indicated in the table there is only one facility with an MIR above 100-in-1 million in the whole-facility post-control analysis (75 people). However, emissions of two other facilities (located next to each other) impact one census block and yield additional population above 100-in-1 million (78 people). Thus, 75 + 78 = 153 people with risks greater than 100-in-1 million. In addition, not shown in the table, is a facility where the MIR was located at a cluster of residences with a user assigned receptor and was not located at a census block centroid. Population data are only provided by the Census Bureau at census blocks, therefore, the number of people living at the households was estimated manually and demographic data were not available. We estimate that there are an additional 60 people exposed to risks greater than 100-in-1 million living around this facility, bringing the total to about 200 people for whole-facility risks.
                            <PRTPAGE P="106057"/>
                        </TNOTE>
                        <TNOTE>• When the population being characterized is very small, the demographic distributions provided by the Census can be subject to a high level of uncertainty. To avoid implying a level of precision that is not supported by the data, when the population of an individual demographic is less than 100, we have indicated it on the demographic tables as &lt;100.</TNOTE>
                    </GPOTABLE>
                    <HD SOURCE="HD3">3. PEPO Production Community Demographics</HD>
                    <P>As described in section III.B.8 of this preamble, we assessed the community-based risks for 25 PEPO facilities in order to compare the PEPO Production source category risk to the community risks. The community risks include HAP emissions from all major stationary sources within 10 km of the PEPO facilities as reported in the NEI (described in section III.B of this preamble). The discussion of the community risk analysis is focused on post-control risks. This community demographic analysis characterizes the remaining risks that communities would face after implementation of the controls proposed to be required in this proposal.</P>
                    <P>
                        The community demographic analysis is an assessment of individual demographic groups in the total population living within 10 km (~6.2 miles) of the PEPO facilities. The community risk assessment and demographics were only conducted at the 10 km radius because, based on PEPO category emissions, this distance includes 100 percent of the population with cancer risks greater than or equal to 50-in-1 million. The full results of the community demographic analysis are in the document titled 
                        <E T="03">Analysis of Demographic Factors for Populations Living Near Polyether Polyols (PEPO) Production Facilities—Community-Based Assessment,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <P>The community demographic analysis post-control results are shown in table 18 of this preamble. This analysis focused on the populations living within 10 km of the PEPO facilities with estimated community post-control cancer risks greater than or equal to 1-in-1 million, greater than or equal to 50-in-1 million, and greater than 100-in-1 million. The risk analysis indicated that all emissions from all facilities within 10 km of the PEPO facilities, after the reductions proposed to be imposed by the proposed rule, would expose a total of about 1.1 million people living around 25 facilities to a cancer risk greater than or equal to 1-in-1 million, 66,000 people living around 20 facilities to a cancer risk greater than or equal to 50-in-1 million, and about 500 people living around 8 facilities to a cancer risk greater than 100-in-1 million.</P>
                    <P>When the PEPO community populations are compared to the PEPO Production source category populations in the post-control scenarios, we see 500,000 additional people with risks greater than or equal to 1-in-1 million, 64,000 additional people with risks greater than or equal to 50-in-1 million, and 500 additional people with risks greater than 100-in-1 million.</P>
                    <P>The demographic distribution of the community population with cancer risks greater than or equal to 1-in-1 million is very similar to the category population and the whole-facility population with cancer risks greater than or equal to 1-in-1 million in the post-control scenario. Therefore, the community population with post-control cancer risks greater than or equal to 1-in-1 million has disproportionately high representation from Blacks, Hispanics and Latinos, people living below the poverty level, people living below two times the poverty level, and those over 25 without a high school education.</P>
                    <P>The population with cancer risks greater than or equal to 50-in-1 million in the community analysis has a much different demographic distribution than the source category population with cancer risks greater than or equal to 50-in-1 million in the post-control scenario. The percent of the population that is Black with risks greater than or equal to 50-in-1 million is lower for the community post-control analysis (7 percent) versus the category post-control analysis (17 percent). The lower representation of the Black population is reflected in greater representation of the other races/ethnicities. In particular, the percent of the population that is Hispanic or Latino is considerably disproportionately represented at 33 percent, which is significantly above the national average of 19 percent. The percentage of the population with risks greater than or equal to 50-in-1 million that is below the poverty level, below two times the poverty level, or over 25 years old without a high school diploma is about half that for the community post-control population than for the category post-control population.</P>
                    <P>Based on results from the community emissions analysis, there are about 500 people with post-control risks greater than 100-in-1 million. The PEPO Production source category emissions analysis indicated that there are no people with post-control risks greater than 100-in-1 million. The increased cancer risk for most of these 500 people is driven largely by EtO emissions from non-PEPO processes (HON, MON, and R&amp;D Testing) at PEPO facilities and other facilities within 10 km of PEPO facilities.</P>
                    <P>The percent of the population in the community analysis with post-control risks greater than 100-in-1 million that is Black (16 percent, &lt;100 people) is above the national average (12 percent). The percent of the population in the community analysis with a post-control risk greater than 100-in-1 million that is below the poverty level (12 percent, &lt;100 people) and below 2 times the poverty level (26 percent, 100 people) is below the national average (13 percent and 30 percent, respectively). The percent of the population in the community analysis with a post-control risk greater than 100-in-1 million that is over 25 years old without a high school diploma (16 percent, &lt;100 people) is above the national average (12 percent).</P>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,12,12,12,12">
                        <TTITLE>Table 18—Community: Community Post-Control Demographics for PEPO Facilities by Risk Level for Populations Living Within 10 km of Facilities</TTITLE>
                        <BOXHD>
                            <CHED H="1">Demographic group</CHED>
                            <CHED H="1">Nationwide</CHED>
                            <CHED H="1">Post-control cancer risk for populations within 10 km of PEPO facilities</CHED>
                            <CHED H="2">
                                ≥1-in-1 
                                <LI>million</LI>
                            </CHED>
                            <CHED H="2">
                                ≥50-in-1 
                                <LI>million</LI>
                            </CHED>
                            <CHED H="2">
                                &gt;100-in-1 
                                <LI>million</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Total Population</ENT>
                            <ENT>329,824,950</ENT>
                            <ENT>1.1M</ENT>
                            <ENT>66K</ENT>
                            <ENT>500</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Number of Facilities</ENT>
                            <ENT/>
                            <ENT>25</ENT>
                            <ENT>20</ENT>
                            <ENT>8</ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <PRTPAGE P="106058"/>
                            <ENT I="21">
                                <E T="02">Race and Ethnicity by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">White</ENT>
                            <ENT>
                                60%
                                <LI>[196M]</LI>
                            </ENT>
                            <ENT>
                                53%
                                <LI>[611K]</LI>
                            </ENT>
                            <ENT>
                                53%
                                <LI>[35K]</LI>
                            </ENT>
                            <ENT>
                                64%
                                <LI>[300]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Black</ENT>
                            <ENT>
                                12%
                                <LI>[40M]</LI>
                            </ENT>
                            <ENT>
                                15%
                                <LI>[169K]</LI>
                            </ENT>
                            <ENT>
                                7%
                                <LI>[4.8K]</LI>
                            </ENT>
                            <ENT>
                                16%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">American Indian and Alaskan Native</ENT>
                            <ENT>
                                0.6%
                                <LI>[2.1M]</LI>
                            </ENT>
                            <ENT>
                                0.2%
                                <LI>[2.6K]</LI>
                            </ENT>
                            <ENT>
                                0.3%
                                <LI>[200]</LI>
                            </ENT>
                            <ENT>
                                0.0%
                                <LI>[0]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Hispanic or Latino (white and nonwhite)</ENT>
                            <ENT>
                                19%
                                <LI>[63M]</LI>
                            </ENT>
                            <ENT>
                                27%
                                <LI>[306K]</LI>
                            </ENT>
                            <ENT>
                                33%
                                <LI>[22K]</LI>
                            </ENT>
                            <ENT>
                                19%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Other and Multiracial</ENT>
                            <ENT>
                                9%
                                <LI>[29M]</LI>
                            </ENT>
                            <ENT>
                                5%
                                <LI>[55K]</LI>
                            </ENT>
                            <ENT>
                                6%
                                <LI>[4.2K]</LI>
                            </ENT>
                            <ENT>
                                2%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Age By Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Age 0 to 17 years</ENT>
                            <ENT>
                                22%
                                <LI>[74M]</LI>
                            </ENT>
                            <ENT>
                                25%
                                <LI>[283K]</LI>
                            </ENT>
                            <ENT>
                                25%
                                <LI>[16K]</LI>
                            </ENT>
                            <ENT>
                                22%
                                <LI>[100]</LI>
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Age 18 to 64 years</ENT>
                            <ENT>
                                62%
                                <LI>[203M]</LI>
                            </ENT>
                            <ENT>
                                62%
                                <LI>[705K]</LI>
                            </ENT>
                            <ENT>
                                61%
                                <LI>[41K]</LI>
                            </ENT>
                            <ENT>
                                57%
                                <LI>[300]</LI>
                            </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Age ≥65 years</ENT>
                            <ENT>
                                16%
                                <LI>[53M]</LI>
                            </ENT>
                            <ENT>
                                14%
                                <LI>[156K]</LI>
                            </ENT>
                            <ENT>
                                14%
                                <LI>[9.4K]</LI>
                            </ENT>
                            <ENT>
                                21%
                                <LI>[100]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Income by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Below Poverty Level</ENT>
                            <ENT>
                                13%
                                <LI>[42M]</LI>
                            </ENT>
                            <ENT>
                                15%
                                <LI>[175K]</LI>
                            </ENT>
                            <ENT>
                                10%
                                <LI>[6.3K]</LI>
                            </ENT>
                            <ENT>
                                12%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">Below 2x Poverty Level</ENT>
                            <ENT>
                                30%
                                <LI>[100M]</LI>
                            </ENT>
                            <ENT>
                                34%
                                <LI>[384K]</LI>
                            </ENT>
                            <ENT>
                                23%
                                <LI>[15K]</LI>
                            </ENT>
                            <ENT>
                                26%
                                <LI>[100]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Education by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00" RUL="s">
                            <ENT I="01">Over 25 and without a High School Diploma</ENT>
                            <ENT>
                                12%
                                <LI>[38M]</LI>
                            </ENT>
                            <ENT>
                                16%
                                <LI>[183K]</LI>
                            </ENT>
                            <ENT>
                                14%
                                <LI>[9K]</LI>
                            </ENT>
                            <ENT>
                                16%
                                <LI>[100]</LI>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="04" RUL="s">
                            <ENT I="21">
                                <E T="02">Linguistically Isolated by Percent [Number of People]</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Linguistically Isolated</ENT>
                            <ENT>
                                5%
                                <LI>[17M]</LI>
                            </ENT>
                            <ENT>
                                5%
                                <LI>[57K]</LI>
                            </ENT>
                            <ENT>
                                4%
                                <LI>[2.7K]</LI>
                            </ENT>
                            <ENT>
                                1%
                                <LI>[&lt;100]</LI>
                            </ENT>
                        </ROW>
                        <TNOTE>
                            <E T="02">Notes:</E>
                        </TNOTE>
                        <TNOTE>• Nationwide population and demographic percentages are based on Census' 2016-2020 ACS 5-year block group averages. Total population count is based on 2020 Decennial Census block population.</TNOTE>
                        <TNOTE>• To avoid double counting, the “Hispanic or Latino” category is treated as a distinct demographic category. A person who identifies as Hispanic or Latino is counted as Hispanic or Latino, regardless of race.</TNOTE>
                        <TNOTE>• The number of facilities represents facilities with a cancer MIR above level indicated. When the MIR was located at a user assigned receptor at an individual residence and not at a census block centroid, we were unable to estimate population and demographics for that facility.</TNOTE>
                        <TNOTE>• The sum of individual populations with a demographic category may not add up to total due to rounding.</TNOTE>
                        <TNOTE>• Not shown in the table is a facility where the MIR was located at a cluster of residences with a user assigned receptor and was not located at a census block centroid. Population data are only provided by the Census Bureau at census blocks, therefore, the number of people living at the households was estimated manually and demographic data were not available. We estimate that there are an additional 60 people exposed to risks greater than 100-in-1 million living around this facility, bringing the total to about 600 people for Community risks.</TNOTE>
                        <TNOTE>• When the population being characterized is very small, the demographic distributions provided by the Census can be subject to a high level of uncertainty. To avoid implying a level of precision that is not supported by the data, when the population of an individual demographic is less than 100, we have indicated it on the demographic tables as &lt;100.</TNOTE>
                    </GPOTABLE>
                    <HD SOURCE="HD2">G. What analysis of children's environmental health did we conduct?</HD>
                    <P>
                        This action proposes to address risk from EtO. In addition, the EPA's Policy on Children's Health 
                        <SU>97</SU>
                        <FTREF/>
                         also applies to this action. Accordingly, we have evaluated the environmental health or safety effects of EtO emissions and exposures on children.
                    </P>
                    <FTNT>
                        <P>
                            <SU>97</SU>
                             Children's Health Policy. Available at: 
                            <E T="03">https://www.epa.gov/children/childrens-health-policy-and-plan.</E>
                        </P>
                    </FTNT>
                    <P>
                        Because EtO is mutagenic (
                        <E T="03">i.e.,</E>
                         it can damage deoxyribonucleic acid, DNA), children are expected to be more susceptible to its harmful effects. To take this into account, as part of the risk assessment in support of this rulemaking, the EPA followed its guidelines 
                        <SU>98</SU>
                        <FTREF/>
                         and applied age-dependent adjustment factors (ADAF) for childhood exposures (from birth up to 16 years of age). With the ADAF applied to account for greater susceptibility of children, the adjusted EtO inhalation 
                        <PRTPAGE P="106059"/>
                        URE is 5 × 10
                        <E T="51">−3</E>
                         per µg/m
                        <SU>3</SU>
                        . We note that, because EtO is mutagenic, emission reductions proposed in this action would be particularly beneficial to children. The results of the risk assessment are contained in sections IV.A and IV.B of this preamble and further documented in the risk report, 
                        <E T="03">Residual Risk Assessment for the Polyether Polyols (PEPO) Production Source Category in Support of the 2024 Risk and Technology Review Proposed Rule,</E>
                         which is available in the docket for this rulemaking.
                    </P>
                    <FTNT>
                        <P>
                            <SU>98</SU>
                             U.S. EPA. 2005. 
                            <E T="03">Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens.</E>
                             U.S. EPA, Washington, DC, EPA/630/R-03/003F. 
                            <E T="03">https://www.epa.gov/sites/default/files/2013-09/documents/childrens_supplement_final.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">VI. Request for Comments</HD>
                    <P>We solicit comments on this proposed action. In addition to general comments on this proposed action, we are also interested in additional data that may improve the risk assessments and other analyses. We are specifically interested in receiving any information regarding developments in practices, processes, and control technologies that reduce emissions. We are also interested in receiving information on costs, emissions, and product recovery, and we request comment on how to address the non-monetized costs and benefits of the proposed rule. We request comment on data and approaches to monetize the health benefits of reducing exposure to EtO and other HAP emitted from PEPO sources.</P>
                    <HD SOURCE="HD1">VII. Submitting Data Corrections</HD>
                    <P>
                        The site-specific emissions profiles used in the source category risk and demographic analyses and instructions are available for download on the project website at 
                        <E T="03">https://www.epa.gov/stationary-sources-air-pollution/polyether-polyols-production-national-emission-standards-hazardous.</E>
                         The data files include detailed information for each HAP emissions release point for the facilities in the source category.
                    </P>
                    <P>If you believe that the data are not representative or are inaccurate, please identify the data in question, provide your reason for concern, and provide any “improved” data that you have, if available. When you submit data, we request that you provide documentation of the basis for the revised values to support your suggested changes. To submit comments on the data downloaded from the project website, complete the following steps:</P>
                    <P>1. Within this downloaded file, enter suggested revisions to the data fields appropriate for that information.</P>
                    <P>
                        2. Gather documentation for any suggested emissions revisions (
                        <E T="03">e.g.,</E>
                         performance test reports, material balance calculations).
                    </P>
                    <P>
                        3. Send the entire downloaded file with suggested revisions and all accompanying documentation to Docket ID No. EPA-HQ-OAR-2023-0282 (through the method described in the 
                        <E T="02">ADDRESSES</E>
                         section of this preamble).
                    </P>
                    <P>5. If you are providing comments on a single facility or multiple facilities, you need only submit one file for all facilities. The file should contain all suggested changes for all sources at that facility (or facilities).</P>
                    <HD SOURCE="HD1">VIII. Statutory and Executive Order Reviews</HD>
                    <P>
                        Additional information about these statutes and Executive orders can be found at 
                        <E T="03">https://www.epa.gov/laws-regulations/laws-and-executive-orders.</E>
                    </P>
                    <HD SOURCE="HD2">A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094: Modernizing Regulatory Review</HD>
                    <P>This action is not a significant regulatory action as defined in Executive Order 12866, as amended by Executive Order 14094, and was therefore not subject to a requirement for Executive Order 12866 review.</P>
                    <HD SOURCE="HD2">B. Paperwork Reduction Act (PRA)</HD>
                    <P>The information collection activities in this proposed rule have been submitted for approval to the OMB under the PRA. The information collection request (ICR) document that the EPA prepared has been assigned EPA ICR number 1811.13. You can find a copy of the ICR in the docket for this rulemaking, and it is briefly summarized here.</P>
                    <P>In this action, the EPA is proposing to add new monitoring and operational requirements for flares, add work practice standards for startup and shutdown periods for maintenance vents and planned routine maintenance of storage vessels, clarify regulatory provisions for vent control bypasses, add new monitoring requirements for PEPO pressure vessels, add new emission standards for PEPO surge control vessels and bottoms receivers, and add new emission standards for PEPO transfer operations. The EPA is also proposing to require control of EtO emissions from process vents, storage vessels, equipment leaks, heat exchange systems, and wastewater in EtO service. In addition, the EPA is proposing amendments to the PEPO NESHAP that add requirements for electronic reporting of periodic reports and performance test results, add requirements for fenceline monitoring, and make other minor clarifications and corrections. This information will be collected to ensure compliance with the PEPO NESHAP.</P>
                    <P>
                        <E T="03">Respondents/affected entities:</E>
                         Owners or operators of PEPO production facilities.
                    </P>
                    <P>
                        <E T="03">Respondent's obligation to respond:</E>
                         Mandatory (40 CFR part 63, subpart PPP).
                    </P>
                    <P>
                        <E T="03">Estimated number of respondents:</E>
                         27 (assumes 2 new respondents over the next 3 years).
                    </P>
                    <P>
                        <E T="03">Frequency of response:</E>
                         Initially, semiannually, and annually.
                    </P>
                    <P>
                        <E T="03">Total estimated burden:</E>
                         12,000 hours (per year). Burden is defined at 5 CFR 1320.3(b).
                    </P>
                    <P>
                        <E T="03">Total estimated cost:</E>
                         Average annual cost is $12,800,000 (per year) which includes $11,600,000 annualized capital or operation &amp; maintenance costs.
                    </P>
                    <P>An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.</P>
                    <P>
                        Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this rulemaking. The EPA will respond to any ICR-related comments in the final rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs using the interface at 
                        <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. OMB must receive comments no later than January 27, 2025.
                    </P>
                    <HD SOURCE="HD2">C. Regulatory Flexibility Act (RFA)</HD>
                    <P>
                        I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. We identified that one of the 25 facilities in the PEPO Production source category affected by this proposed action is a small business. This facility is subject to the PEPO NESHAP because it receives and treats wastewater from a PEPO production facility. The EIA conducted for this proposal (see 
                        <E T="03">Economic Impact Analysis,</E>
                         which is available in the docket for this action) showed that this small business will not incur total annualized costs greater than one percent of its revenue.
                    </P>
                    <HD SOURCE="HD2">D. Unfunded Mandates Reform Act (UMRA)</HD>
                    <P>
                        This action does not contain an unfunded mandate of $100 million or 
                        <PRTPAGE P="106060"/>
                        more (adjusted for inflation) as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The costs involved in this action are estimated not to exceed $176 million in 2022$ ($100 million in 1995$ adjusted for inflation using the gross domestic product implicit price deflator) or more in any one year.
                    </P>
                    <HD SOURCE="HD2">E. Executive Order 13132: Federalism</HD>
                    <P>This action does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the National Government and the Sstates, or on the distribution of power and responsibilities among the various levels of government.</P>
                    <HD SOURCE="HD2">F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments</HD>
                    <P>This action does not have Tribal implications as specified in Executive Order 13175. None of the facilities that have been identified as being affected by this action are owned or operated by Tribal governments or are located within Tribal lands. Thus, Executive Order 13175 does not apply to this action.</P>
                    <HD SOURCE="HD2">G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks</HD>
                    <P>
                        Executive Order 13045 directs Federal agencies to include an evaluation of the health and safety effects of the planned regulation on children in Federal health and safety standards and explain why the regulation is preferable to potentially effective and reasonably feasible alternatives. While the environmental health or safety risks addressed by this action present a disproportionate risk to children because EtO is mutagenic (
                        <E T="03">i.e.,</E>
                         EtO can damage DNA), this action is not subject to Executive Order 13045 because it is not a significant regulatory action under section 3(f)(1) of Executive Order 12866. However, the EPA's 
                        <E T="03">Policy on Children's Health</E>
                         applies to this action. Information on how the Policy was applied is available in section V.G of this preamble.
                    </P>
                    <HD SOURCE="HD2">H. Executive Order 13211: Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use</HD>
                    <P>This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.</P>
                    <HD SOURCE="HD2">I. National Technology Transfer and Advancement Act (NTTAA) and 1 CFR Part 51</HD>
                    <P>This proposed action involves technical standards. Therefore, the EPA conducted searches for the PEPO NESHAP through the Enhanced National Standards Systems Network Database managed by the American National Standards Institute (ANSI). We also conducted a review of voluntary consensus standards (VCS) organizations and accessed and searched their databases. We conducted searches for EPA Methods 1, 1A, 2, 2A, 2C, 2D, 2F, 2G, 3B, 4, 18, 21, 22, and 25A of 40 CFR part 60, appendix A, and EPA Methods 301 and 320 of 40 CFR part 63, appendix A. During the EPA's VCS search, if the title or abstract (if provided) of the VCS described technical sampling and analytical procedures that are similar to the EPA's reference method, the EPA ordered a copy of the standard and reviewed it as a potential equivalent method. We reviewed all potential standards to determine the practicality of the VCS for this rulemaking. This review requires significant method validation data that meet the requirements of EPA Method 301 for accepting alternative methods or scientific, engineering, and policy equivalence to procedures in the EPA reference methods. The EPA may reconsider determinations of impracticality when additional information is available for particular VCS.</P>
                    <P>We did not identify any applicable VCS for EPA Methods 1A, 2A, 2D, 2F, 2G, 21, and 22. However, the EPA is proposing amendments to 40 CFR 63.14 to incorporate by reference the following three VCS: ANSI/ASME PTC 19.10-1981—Part 10, “Flue and Exhaust Gas Analyses” as an acceptable alternative to EPA Method 3B (manual portion only); ASTM D6420-18, “Standard Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry” as an acceptable alternative to EPA Method 18; and ASTM D6348-12e1, “Determination of Gaseous Compounds by Extractive Direct Interface Fourier Transform (FTIR) Spectroscopy” as an acceptable alternative to EPA Method 320.</P>
                    <P>
                        ANSI/ASME PTC 19.10-1981—Part 10, “Flue and Exhaust Gas Analyses” quantitatively determines the gaseous constituents of exhausts including oxygen, CO
                        <E T="52">2</E>
                        , CO, nitrogen, SO
                        <E T="52">2</E>
                        , sulfur trioxide, nitric oxide, nitrogen dioxide, hydrogen sulfide, and hydrocarbons. This method incorporates both manual and instrumental methodologies for the determination of oxygen content. The manual method segment of the oxygen determination is performed through the absorption of oxygen. This method is available at the ANSI, 1899 L Street NW, 11th Floor, Washington, DC 20036 and the American Society of Mechanical Engineers (ASME), Three Park Avenue, New York, NY 10016-5990; telephone number: 1-800-843-5990; and email address: 
                        <E T="03">customercare@asme.org.</E>
                         See 
                        <E T="03">https://wwww.ansi.org</E>
                         and 
                        <E T="03">https://www.asme.org.</E>
                         The standard is available to everyone at a cost determined by ANSI/ASME ($88). ANSI/ASME also offer memberships or subscriptions for reduced costs. The cost of obtaining these methods is not a significant financial burden, making the methods reasonably available.
                    </P>
                    <P>ASTM D6420-18, “Standard Test Method for Determination of Gaseous Organic Compounds by Direct Interface Gas Chromatography-Mass Spectrometry” uses a direct interface gas chromatograph/mass spectrometer to measure 36 VOC and provide an on-site analysis of extracted, unconditioned, and unsaturated (at the instrument) gas samples from stationary sources. In this action, the EPA is proposing ASTM D6420-18 as an alternative to EPA Method 18 with the following caveats:</P>
                    <P>• The target compounds are known and are listed in ASTM D6420-18 as measurable.</P>
                    <P>• ASTM D6420-18 is not used for methane and ethane because the atomic mass is less than 35.</P>
                    <P>• ASTM D6420-18 is never specified as a total VOC method.</P>
                    <P>
                        ASTM D6348-12e1, “Standard Test Method for Determination of Gaseous Compounds by Extractive Direct Interface Fourier Transform (FTIR) Spectroscopy” is an extractive FTIR spectroscopy-based field test method and is used to quantify gas phase concentrations of multiple target compounds in emissions streams from stationary sources. When using ASTM D6348-12e1, the EPA proposes the following conditions: (1) The test plan preparation and implementation in the Annexes to ASTM D6348-03 sections Al through A8 are mandatory; and (2) in Annex A5 (Analyte Spiking Technique) to ASTM D6348-103, the owner or operator must determine the percent (%) R for each target analyte (Equation A5.5). For the test data to be acceptable for a compound, %R must be 70% ≥ R ≤ 130%. If the %R value does not meet this criterion for a target compound, the test data is not acceptable for that compound and the owner or operator must repeat the test for that analyte (
                        <E T="03">i.e.,</E>
                          
                        <PRTPAGE P="106061"/>
                        the sampling and/or analytical procedure should be adjusted before a retest). We are proposing that owners or operators must report the %R value for each compound in the test report, and all field measurements must be corrected with the calculated %R value for that compound by using the following equation:
                    </P>
                    <P>Reported Results = Measured Concentration in Stack/%R × 100.</P>
                    <P>
                        ASTM D6420-18 and ASTM D6348-12e1 are available at ASTM International, 1850 M Street NW, Suite 1030, Washington, DC 20036. See 
                        <E T="03">https://www.astm.org/.</E>
                         These standards are available to everyone at a cost determined by the ASTM ($63 and $83, respectively). The ASTM also offers memberships or subscriptions that allow unlimited access to their methods. The cost of obtaining these methods is not a significant financial burden, making the methods reasonably available to stakeholders.
                    </P>
                    <P>
                        The search identified 11 VCS that were potentially applicable for this rulemaking in lieu of EPA reference methods. After reviewing the available standards, the EPA determined that the 11 candidate VCS (ASTM D3154-00 (2006), ASTM D3464-96 (2007), ASTM 3796-90 (2004), ISO 10780:1994, ASME B133.9-1994 (2001), ANSI/ASME PTC 19-10-198-Part 10, NIOSH Method 2010 “Amines, Aliphatic,” ASTM D6060-96 (2009), ISO 14965:2000(E), EN 12619 (1999), ASTM D4855-97 (2002)) identified for measuring emissions of pollutants or their surrogates subject to emission standards in the rule would not be practical due to lack of equivalency, documentation, and validation data, and due to other important technical and policy considerations. The EPA documented the search and review results in the memorandum, 
                        <E T="03">Voluntary Consensus Standard Results for National Emission Standards for Hazardous Air Pollutants: Polyether Polyols Production Industry Residual Risk and Technology Review,</E>
                         which is available in the docket for this action. The EPA welcomes comments on this aspect of the proposed rulemaking and, specifically, invites the public to identify potentially applicable VCS and to explain why such standards should be used in this regulation.
                    </P>
                    <P>Under 40 CFR 63.7(f) and 63.8(f), subpart A—General Provisions, a source may apply to the EPA for permission to use alternative test methods or alternative monitoring requirements in place of any required testing methods, performance specifications, or procedures in the final rule or any amendments.</P>
                    <HD SOURCE="HD2">J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations and Executive Order 14096: Revitalizing Our Nation's Commitment to Environmental Justice for All</HD>
                    <P>The EPA believes that the human health or environmental conditions that exist prior to this action result in or have the potential to result in disproportionate and adverse human health or environmental effects on communities with EJ concerns. For the PEPO NESHAP, a total of approximately 1.5 million people live within 10 km of the 25 PEPO facilities that were assessed for risk. Based on the whole-facility proximity analysis summarized in section V.F of this preamble, the percentages of the population that are Black (13 percent versus 12 percent) and Hispanic or Latino (22 percent versus 19 percent) are higher than the national averages. In addition, the percentages of the population that are below the poverty level (14 percent versus 12 percent), below two times the poverty level (32 percent versus 30 percent), and over 25 years of age without a high school diploma (14 percent versus 12 percent) are higher than the national averages. The proportions of other demographic groups living within 10 km of PEPO facilities are lower than the national average. The EPA also conducted a risk assessment of possible cancer risks and other adverse health effects and found that prior to this proposed regulation, cancer risks for the PEPO Production source category were above acceptable levels for a number of areas in which these demographic groups live. See section V.F of this preamble for an analysis that characterizes populations living in proximity to facilities and risks prior to the proposed regulation.</P>
                    <P>
                        The EPA believes that this proposed action is likely to reduce existing disproportionate and adverse effects on communities with EJ concerns. This action would establish standards for EtO emission sources at PEPO processes (
                        <E T="03">i.e.,</E>
                         process vents, storage vessels, heat exchange systems, equipment leaks, and wastewater). This action proposes to require fenceline monitoring for EtO, which drives cancer risks for PEPO production sources, and proposes to address flare combustion efficiency. The EPA is also proposing that fenceline monitoring data be reported electronically to the EPA so that it can be made public and provide fenceline communities with greater access to information about potential emissions impacts.
                    </P>
                    <P>As a result of these proposed changes, we expect zero people to be exposed to risk levels above 100-in-1 million due to emissions from the source category. See sections IV.A and IV.B of this preamble for more information about the control requirements of the regulation and the resulting reduction in cancer risks. Also, see section V.F of this preamble for an analysis that characterizes populations living in proximity to facilities after implementation of the proposed regulation (post-control).</P>
                    <P>
                        The information supporting this Executive order review is contained in section V.F of this preamble, as well as in the technical reports, 
                        <E T="03">Analysis of Demographic Factors for Populations Living Near Polyether Polyols (PEPO) Production Facilities—Source Category Analysis of Proposed Amendments, Analysis of Demographic Factors for Populations Living Near Polyether Polyols (PEPO) Production Facilities—Whole Facility Analysis of Proposed Amendments,</E>
                         and 
                        <E T="03">Analysis of Demographic Factors for Populations Living Near Polyether Polyols (PEPO) Production Facilities—Community-Based Assessment,</E>
                         which are available in the docket for this action.
                    </P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects in 40 CFR Part 63</HD>
                        <P>Environmental protection, Administrative practice and procedures, Air pollution control, Hazardous substances, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements.</P>
                    </LSTSUB>
                    <SIG>
                        <NAME>Michael S. Regan,</NAME>
                        <TITLE>Administrator.</TITLE>
                    </SIG>
                </SUPLINF>
                <FRDOC>[FR Doc. 2024-29466 Filed 12-26-24; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 6560-50-P</BILCOD>
            </PRORULE>
        </PRORULES>
    </NEWPART>
    <VOL>89</VOL>
    <NO>248</NO>
    <DATE>Friday, December 27, 2024</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="106063"/>
            <PARTNO>Part V</PARTNO>
            <AGENCY TYPE="P">Department of Health and Human Services</AGENCY>
            <SUBAGY>Food and Drug Administration</SUBAGY>
            <HRULE/>
            <CFR>21 CFR Part 101</CFR>
            <TITLE>Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”; Final Rule</TITLE>
        </PTITLE>
        <RULES>
            <RULE>
                <PREAMB>
                    <PRTPAGE P="106064"/>
                    <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                    <SUBAGY>Food and Drug Administration</SUBAGY>
                    <CFR>21 CFR Part 101</CFR>
                    <DEPDOC>[Docket No. FDA-2016-D-2335]</DEPDOC>
                    <RIN>RIN 0910-AI13</RIN>
                    <SUBJECT>Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Food and Drug Administration, HHS.</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Final rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>The Food and Drug Administration (FDA or we) is issuing this final rule updating the definition for the implied nutrient content claim “healthy” to be consistent with current nutrition science and Federal dietary guidance, especially the Dietary Guidelines for Americans (Dietary Guidelines), regarding how consumers can maintain healthy dietary practices. This final rule revises the requirements for when the term “healthy” can be used as an implied nutrient content claim in the labeling of human food products to help consumers identify foods that are particularly useful as the foundation of a nutritious diet that is consistent with dietary recommendations.</P>
                    </SUM>
                    <DATES>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>This rule is effective February 25, 2025. The compliance date of this final rule is February 25, 2028.</P>
                    </DATES>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>
                            For access to the docket to read background documents or comments received, go to 
                            <E T="03">https://www.regulations.gov</E>
                             and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>
                            <E T="03">With regard to the final rule:</E>
                             Vincent de Jesus, Office of Nutrition and Food Labeling (HFS-803), Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD, 20740, 240-402-1450; Denise See or Barbara Little, Office of Policy, Regulations, and Information (HFS-024), Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
                        </P>
                        <P>
                            <E T="03">With regard to the information collection:</E>
                             Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
                            <E T="03">PRAStaff@fda.hhs.gov.</E>
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <HD SOURCE="HD1">Table of Contents</HD>
                    <EXTRACT>
                        <FP SOURCE="FP-2">I. Executive Summary</FP>
                        <FP SOURCE="FP1-2">A. Purpose of the Final Rule</FP>
                        <FP SOURCE="FP1-2">B. Summary of the Major Provisions of the Final Rule</FP>
                        <FP SOURCE="FP1-2">C. Legal Authority</FP>
                        <FP SOURCE="FP1-2">D. Costs and Benefits</FP>
                        <FP SOURCE="FP-2">II. Table of Abbreviations/Commonly Used Acronyms in This Document</FP>
                        <FP SOURCE="FP-2">III. Background</FP>
                        <FP SOURCE="FP1-2">A. Need for the Regulation/History of This Rulemaking</FP>
                        <FP SOURCE="FP1-2">B. Summary of Comments to the Proposed Rule</FP>
                        <FP SOURCE="FP1-2">C. General Overview of the Final Rule</FP>
                        <FP SOURCE="FP-2">IV. Legal Authority</FP>
                        <FP SOURCE="FP-2">V. Comments on the Proposed Rule and FDA Response</FP>
                        <FP SOURCE="FP1-2">A. Introduction</FP>
                        <FP SOURCE="FP1-2">B. General Comments</FP>
                        <FP SOURCE="FP1-2">C. Food Group Equivalents</FP>
                        <FP SOURCE="FP1-2">D. Nutrients to Limit</FP>
                        <FP SOURCE="FP1-2">
                            E. Combination Foods (
                            <E T="03">i.e.,</E>
                             Mixed Products, Main Dish Products, and Meal Products)
                        </FP>
                        <FP SOURCE="FP1-2">F. Beverages</FP>
                        <FP SOURCE="FP1-2">G. The Term “Healthy” and Related Terms or Derivatives of “Healthy”</FP>
                        <FP SOURCE="FP1-2">H. Nutritional Context</FP>
                        <FP SOURCE="FP1-2">I. Records Requirements</FP>
                        <FP SOURCE="FP1-2">J. Effective and Compliance Dates</FP>
                        <FP SOURCE="FP1-2">K. Legal Comments</FP>
                        <FP SOURCE="FP1-2">L. Miscellaneous Comments</FP>
                        <FP SOURCE="FP-2">VI. Economic Analysis of Impacts</FP>
                        <FP SOURCE="FP1-2">A. Introduction</FP>
                        <FP SOURCE="FP1-2">B. Overview of Benefits, Costs, and Transfers</FP>
                        <FP SOURCE="FP-2">VII. Analysis of Environmental Impact</FP>
                        <FP SOURCE="FP-2">VIII. Paperwork Reduction Act of 1995</FP>
                        <FP SOURCE="FP-2">IX. Federalism</FP>
                        <FP SOURCE="FP-2">X. Consultation and Coordination With Indian Tribal Governments</FP>
                        <FP SOURCE="FP-2">XI. References</FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">I. Executive Summary</HD>
                    <HD SOURCE="HD2">A. Purpose of the Final Rule</HD>
                    <P>This final rule updates the requirements for when the term “healthy” can be used as an implied nutrient content claim in the labeling of human food products to help consumers identify foods that can serve as the foundation of a nutritious diet that is consistent with current dietary recommendations. Consumers rely on food labels when navigating the marketplace to make informed choices about the foods they purchase for themselves and their families. FDA plays an important role in ensuring that the labels or labeling of food for human consumption, including claims on labels or labeling that market a food, are accurate, truthful, and not misleading. One such claim that FDA has regulated is the term “healthy” on product labels. Since 1994, we have recognized that when a manufacturer uses labeling that describes a product as “healthy” in the nutritional context, it is making an implicit claim about the level of nutrients in the product. In particular, such a claim implies that the nutrient content of the food may help consumers maintain healthy dietary practices. Given that nutrition science has evolved since the 1990s, this final rule updates the definition of “healthy” to be consistent with current nutrition science and Federal dietary guidance to help ensure that consumers have access to more complete, accurate, and up-to-date information on food labels. This final rule is also consistent with the longstanding purpose of this implied nutrient content claim to indicate that the nutrient levels of a food may help consumers maintain healthy dietary practices and furthers FDA's goals in accordance with its statutory mandate to prevent misleading labeling and reduce consumer confusion that can result from the use of inconsistent definitions for nutrient content claims.</P>
                    <P>
                        In addition, updating the “healthy” nutrient content claim is one initiative action listed in the White House National Strategy on Hunger, Nutrition, and Health under the pillar of empowering all consumers to make and have access to healthy choices (Ref. 6). FDA, as part of this whole-of-government approach, broadly seeks to help reduce the burden of diet-related chronic diseases. Doing so will advance health equity, because diet-related chronic diseases are experienced disproportionately by certain racial and ethnic minority groups and those with lower socioeconomic status. For further discussion regarding the scope of the problem Americans face from diet-related chronic diseases, please see the proposed rule, 87 FR 59168 at 59170. We are committed to accomplishing these goals, in part, by prioritizing nutrition initiatives that can help improve dietary patterns in the United States. An important aspect of reducing the burden of diet-related chronic diseases, as well as advancing health equity, is helping consumers access nutrition information that allows them to identify healthier choices. As discussed further in section V. (“Comments on the Proposed Rule and FDA Response”), nutrient content claims, such as “healthy,” as well as other claims made on labels or in the labeling of foods act as quick signals on food packages. These statements may help consumers, particularly those with lower nutrition or health literacy, quickly and easily identify foods that can be the foundation of a healthy dietary pattern. Additionally, as discussed further in section V. (“Comments on the Proposed Rule and 
                        <PRTPAGE P="106065"/>
                        FDA Response”), our review of the products available in the current marketplace demonstrates that the updated “healthy” criteria allow affordable, accessible, and culturally preferred 
                        <SU>1</SU>
                        <FTREF/>
                         nutrient-dense foods within different food groups and subgroups to bear the “healthy” claim, including frozen, canned, dried, and other shelf-stable products. This final rule is one part of FDA's broader commitment to help reduce diet-related chronic diseases and also to advance health equity by helping consumers to identify foods that can be the foundation of a healthy dietary pattern. While there has been consistency in many of the recommendations in Federal dietary guidelines and the underlying nutrition science on which they are based, we intend to remain aligned with the most current nutrition science reflected in Federal dietary guidelines and will continue to update our regulations and policies, as appropriate.
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             The term “culturally preferred foods” is used here to describe safe and nutritious foods that meet the diverse tastes and needs of customers based on their cultural identity (Ref. 46).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. Summary of the Major Provisions of the Final Rule</HD>
                    <P>This final rule updating the definition of “healthy” includes provisions that:</P>
                    <P>• Establish parameters for use of the term “healthy” or derivative terms “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness” as an implied nutrient content claim on the label or in labeling of a food that suggests that a food, because of its nutrient content, may help consumers maintain healthy dietary practices, where there is also implied or explicit information about the nutrition content of the food on the label or in the labeling (§ 101.65(d)(1) and (3)) (21 CFR 101.65(d)(1) and (3))).</P>
                    <P>• Establish a framework based on food groups and nutrients to limit (NTL) for the “healthy” claim.</P>
                    <P>
                        • Establish that “food group,” for the purposes of the “healthy” claim, refers to the groups of foods recommended in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         (for adults and children 2 years of age and older), which are vegetables, fruits, dairy, grains, protein foods, as well as oils (§ 101.65(d)(2)).
                    </P>
                    <P>
                        ○ The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         does not categorize oils as a “food group,” but they emphasize that oils are one of the six core elements of a healthy dietary pattern, along with vegetables, fruits, grains, dairy, and protein foods, and recommend daily intake objectives for oils, similar to the food groups. Therefore, we include oils as a food group for purposes of this rule.
                    </P>
                    <P>
                        ○ For purposes of this rule, when we refer to foods as recommended or encouraged by the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         we are referring to only those foods that are recommended or encouraged for adults and children 2 years of age or older because that is the population for which the claim is intended.
                    </P>
                    <P>• Establish food group equivalents (FGEs) that identify qualifying amounts of foods from each food group based on nutritional content (§ 101.65(d)(2)).</P>
                    <P>• An FGE contains the following: (§ 101.65(d)(2))</P>
                    <FP SOURCE="FP-1">○ Vegetable—1/2 cup equivalent (c-eq)</FP>
                    <FP SOURCE="FP-1">○ Fruit—1/2 cup equivalent</FP>
                    <FP SOURCE="FP-1">○ Grains—3/4 ounce (oz) equivalent whole grain</FP>
                    <FP SOURCE="FP-1">○ Dairy—2/3 cup equivalent</FP>
                    <FP SOURCE="FP-1">○ Protein foods:</FP>
                    <FP SOURCE="FP-1">
                        ▪ Game meat—1
                        <FR>1/2</FR>
                         oz equivalent
                    </FP>
                    <FP SOURCE="FP-1">▪ Seafood—1 oz equivalent</FP>
                    <FP SOURCE="FP-1">▪ Egg—1 oz equivalent</FP>
                    <FP SOURCE="FP-1">▪ Beans, peas, or lentils—1 oz equivalent</FP>
                    <FP SOURCE="FP-1">▪ Nuts and seeds, or soy products—1 oz equivalent</FP>
                    <P>• Require that, to bear a claim subject to this rule, individual food products, mixed products, main dishes, and meals must meet FGEs and specific limits for added sugars, saturated fat, and sodium based on a percentage of the Daily Value (DV) for these nutrients. To bear a claim that is subject to this rule:</P>
                    <P>○ An individual food that has a reference amount customarily consumed (RACC, used to determine serving size), greater than 50 grams (g) or greater than 3 tablespoons (Tbsp) and meets the following conditions per RACC; or an individual food that has a RACC of 50 g or less or 3 Tbsp or less and meets the following conditions per 50 g of food: (§ 101.65(d)(3)(ii)(A) and (B))</P>
                    <GPH SPAN="3" DEEP="576">
                        <PRTPAGE P="106066"/>
                        <GID>ER27DE24.002</GID>
                    </GPH>
                    <P>○ A mixed product that meets the following conditions per RACC (§ 101.65(d)(3)(iii)):</P>
                    <GPH SPAN="3" DEEP="103">
                        <PRTPAGE P="106067"/>
                        <GID>ER27DE24.003</GID>
                    </GPH>
                    <P>○ A main dish product as defined in § 101.13(m) (21 CFR 101.13(m)) that meets the following conditions per labeled serving: (§ 101.65(d)(3)(iv))</P>
                    <GPH SPAN="3" DEEP="116">
                        <GID>ER27DE24.004</GID>
                    </GPH>
                    <P>○ A meal product as defined in § 101.13(l) that meets the following conditions per labeled serving: (§ 101.65(d)(3)(v))</P>
                    <GPH SPAN="3" DEEP="115">
                        <GID>ER27DE24.005</GID>
                    </GPH>
                    <P>
                        • Provide that individual foods or mixed products that are comprised of one or more of the following foods encouraged by the Dietary Guidelines, with no other added ingredients except for water: vegetable; fruit; whole grains; fat-free and low-fat dairy; lean meat, seafood, eggs, beans, peas, lentils, nuts and seeds, automatically qualify (
                        <E T="03">i.e.,</E>
                         without having to meet the FGE and nutrients to limit (NTL) requirements) for the “healthy” claim because of their nutrient profile and positive contribution to an overall healthy diet. § 101.65(d)(3)(i))
                    </P>
                    <P>• Provide that all water, tea, and coffee with less than 5 calories per RACC and per labeled serving automatically qualify for the “healthy” claim. (§ 101.65(d)(3)(vi))</P>
                    <P>• Require the establishment and maintenance of certain records for foods bearing the “healthy” claim where the FGE contained in the product is not apparent from the label of the food. The records must be kept for a period of at least 2 years after introduction or delivery for introduction of the food into interstate commerce. During an inspection, such records must be provided to FDA upon request for official review and photocopying or other means of reproduction. (§ 101.65(d)(4))</P>
                    <HD SOURCE="HD2">C. Legal Authority</HD>
                    <P>We are issuing this final rule to update the definition of the implied nutrient content claim “healthy” consistent with our authority in sections 201(n), 403(a), 403(r), and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) (21 U.S.C. 321(n), 343(a), 343(r), and 371(a)). We are also relying on our authority under sections 403(r), 403(a), 201(n) and 701(a) of the FD&amp;C Act for certain records requirements.</P>
                    <HD SOURCE="HD2">D. Costs and Benefits</HD>
                    <P>
                        In the current marketplace, about 5 percent of all packaged foods are labeled as “healthy.” Because nutrition science has evolved over time, updating the definition of the implied nutrient content claim “healthy” to more closely align with nutrition science underpinning the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         will better inform consumers who are selecting those products to choose a more healthful diet, which may result in lower incidence of diet-related chronic diseases, including cardiovascular disease (CVD) and type 2 diabetes. Quantifiable benefits of the rule are the estimated reduction over time in all-cause mortality stemming 
                        <PRTPAGE P="106068"/>
                        from consumers that rely upon the “healthy” implied nutrient content claim selecting and consuming more healthful foods. Discounted at 3 percent over 20 years, the mean present value of benefits is estimated at $686 million, or $46 million annualized. This is calculated through the inverse association between a Healthy Eating Index score and all-cause mortality (Ref. 44). Quantifiable costs to manufacturers associated with updating the “healthy” claim are reformulating, labeling, and recordkeeping. Discounted at 3 percent over 20 years, the mean present value of costs is estimated at $403 million, or $27 million annualized. Potential costs of rebranding certain foods are discussed qualitatively. Net benefits are estimated at $283 million, or $19 million annualized.
                    </P>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="106069"/>
                        <GID>ER27DE24.006</GID>
                    </GPH>
                    <PRTPAGE P="106070"/>
                    <HD SOURCE="HD1">III. Background</HD>
                    <HD SOURCE="HD2">A. Need for the Regulation/History of This Rulemaking</HD>
                    <P>
                        In the 
                        <E T="04">Federal Register</E>
                         of May 10, 1994 (59 FR 24232), we published a final rule (the 1994 rule or original rule) entitled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy’ ” amending § 101.65(d) to define the term “healthy” as an implied nutrient content claim under section 403(r) of the FD&amp;C Act. The definition established in 1994 (original definition) was linked to certain requirements in the Nutrition Facts label at § 101.9 (21 CFR 101.9) and serving size regulations at § 101.12 (21 CFR 101.12) that were in effect in 1994. The 1994 rule established parameters for use of the implied nutrient content claim “healthy” or related terms (such as “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness”) on the label or in the labeling of a food that is useful in creating a diet that is consistent with dietary recommendations, if the food meets certain nutrient conditions. Under the 1994 rule, these conditions included specific criteria for nutrients that must be met for the food to bear such claims. These criteria included limits on total fat, saturated fat, cholesterol, and sodium, and minimum amounts (10% of DV) of nutrients whose consumption is encouraged, such as vitamin A, vitamin C, calcium, iron, protein, and dietary fiber. Under the 1994 rule, foods must meet all limits and contain the minimum amount of at least one nutrient to encourage (NTE) to bear the “healthy” claim. The required nutrient criteria varied for certain food groups (
                        <E T="03">e.g.,</E>
                         different criteria for seafood, game meat, and raw fruits and vegetables). The 1994 rule also linked the claim with an explicit or implicit claim or statement about a nutrient (
                        <E T="03">e.g.,</E>
                         “healthy, contains 3 grams of fat”).
                    </P>
                    <P>Nutrition science and Federal dietary guidance have evolved since 1994. Since that time, FDA has issued final rules updating the Nutrition Facts label and serving size information for packaged foods to reflect new scientific information. This includes the final rules “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (81 FR 33742, “NFL Final Rule”), and “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments” (81 FR 34000, “Serving Size Final Rule”) which were published on May 27, 2016. These rules (codified primarily at part 101 (21 CFR part 101)) included changes to the nutrients that must be declared on the Nutrition Facts label. For example, the Nutrition Facts label must now include a declaration of the amount of added sugars in a serving of a product, based on our conclusion that evidence regarding dietary patterns and health outcomes supports a mandatory declaration of added sugars (§ 101.9(c)(1)(iii)). The updates also included changes to the DV of certain individual nutrients to reflect changes in recommended intake levels based on current nutrition science. The Nutrition Facts label declaration requirements and DVs for individual nutrients significantly inform the regulations for nutrient content claims, such as “healthy.” The NFL Final Rule and the Serving Size Final Rule reflect the nutrition science in the Dietary Guidelines, other consensus reports, national survey intake data, and research regarding consumer use and understanding of the food label.</P>
                    <P>
                        As the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         explains, current nutrition science focuses “on consuming a healthy dietary pattern” (Ref. 1). Current nutrition science emphasizes nutrient-dense foods, such as fruits, vegetables, and whole grains, as core elements of a healthy dietary pattern. “Nutrient-dense” foods and beverages are defined as foods and beverages that provide vitamins, minerals, and other health-promoting components and have little or no added sugars, saturated fat, and sodium (Ref. 1). These foods, which contain a variety of important nutrients, work synergistically as part of a dietary pattern to help improve health (Ref. 1). A number of these nutrient-dense foods were not able to bear the “healthy” claim under the 1994 rule (
                        <E T="03">e.g.,</E>
                         salmon due to fat amounts). Further, the 1994 rule permitted manufacturers to use the claim “healthy” on some foods that, based on updated nutrition science and Federal dietary guidance, contain levels of nutrients that would not help consumers maintain healthy dietary practices (
                        <E T="03">e.g.,</E>
                         certain foods that are high in added sugars). We have long recognized the need to update the definition for the implied nutrient content claim “healthy” to be consistent with current nutrition science and Federal dietary guidance. Consequently, in the 
                        <E T="04">Federal Register</E>
                         of September 29, 2022 (87 FR 59168), we issued a proposed rule to amend the definition of “healthy” to ensure that foods bearing the claim are foods that may help consumers maintain healthy dietary practices, consistent with current nutrition science and Federal dietary guidance; in other words, nutrient-dense foods that are foundational to a healthy dietary pattern. The preamble to the proposed rule discussed, in some detail, the reasons why we felt it necessary to update the definition of “healthy” as an implied nutrient content claim (see 87 FR 59168 at 59169 through 59173).
                    </P>
                    <P>
                        When FDA first defined healthy in 1994 (59 FR 24232), we concluded that “the fundamental purpose of a `healthy' claim is to highlight those foods that, based on their nutrient levels, are particularly useful in constructing a diet that conforms to current dietary guidelines” (59 FR 24232 at 24233). Under this framework, which is continued under this rule, foods that do not qualify for use of the claim are not deemed to be “unhealthy” or unable to provide any nutritional benefits to consumers. Nor does the healthy definition, as established in this rule, represent a determination by FDA that consumers should only choose foods that qualify for the “healthy” claim or completely avoid choosing foods that do not qualify for the “healthy” claim. The current 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         (Ref. 1) focuses on the importance of a healthy dietary pattern as a whole and its role in promoting health, reducing risk of chronic diseases, and meeting nutrient needs. Although nearly all foods can be incorporated into a healthy dietary pattern to some extent, current nutrition science emphasizes nutrient-dense foods, such as fruits, vegetables, and whole grains, as core elements of a healthy dietary pattern (Ref. 1). Moreover, foods that meet the requirements for “healthy” as defined in this rule are foods that, because of their overall nutrition profiles, can be the “foundation” or “building blocks” of a healthy dietary pattern recommended by the Dietary Guidelines.
                    </P>
                    <P>
                        Foods that do not meet the requirements defined in this rule to bear the “healthy” claim could, however, have beneficial nutritional attributes and these nutritional attributes can be communicated to consumers in many different ways. For example, use of other nutrient content claims, such as “low” (
                        <E T="03">e.g.,</E>
                         “low saturated fat” in § 101.62(c) (21 CFR 101.62(c))) or “high” (§ 101.54(b) (21 CFR 101.54(b))) can inform consumers interested in intake of specific nutrients. In addition, a food label can include health claims, which are different than nutrient content claims in that they show how a food or food component may reduce the risk of a disease or health-related condition. Other claims (
                        <E T="03">e.g.,</E>
                         structure/
                        <PRTPAGE P="106071"/>
                        function claims) can describe, for example, the role of a nutrient intended to affect the normal structure or function of the body. Additionally, dietary guidance statements are a type of voluntary labeling statement that can be used on labels that represent or suggest that an individual food or food group may contribute to or help maintain a nutritious dietary pattern. Dietary guidance statements provide manufacturers with a broad range of messages beyond characterizing the nutrient content of the food (compared with nutrient content claims such as “healthy”) and can communicate to consumers that a food or food group may contribute to or help maintain a nutritious dietary pattern. Different nutrition labeling claims communicate different meanings to consumers, and there are different criteria for their use. However, certain statements may be considered more than one type of claim, depending on the context in which they are used and taken together with the labels or labeling as a whole. As such, that a food may qualify for another type of claim does not automatically make the food eligible for the “healthy” claim, just as that a food qualifies for the “healthy” claim does not mean a food will meet the requirements for other claims. The criteria for each of the different claims must be met to use that specific claim and manufacturers are free to use any applicable claims for which they qualify and make truthful and non-misleading statements on food labels or labeling.
                    </P>
                    <HD SOURCE="HD2">B. Summary of Comments to the Proposed Rule</HD>
                    <P>We received approximately 400 comments on the proposed rule, each containing one or more comments on one or more provisions of the rule. We received comments from industry; trade organizations; consulting firms; law firms; academia; public health organizations; public advocacy groups; consumers; consumer groups; Congress, State, and local Governments; and other organizations. In section V. (“Comments on the Proposed Rule and FDA Response”), we summarize these comments, respond to them, and explain any revisions we made to the proposed rule. The topics addressed most frequently in the comments include:</P>
                    <P>• Many comments support the proposed rule on the grounds that it would help consumers make better, healthier choices, and generally improve the nutritional knowledge of the average consumer in the United States.</P>
                    <P>• Similarly, numerous comments support the proposed rule on the grounds that it could help combat the high rate of obesity and diet-related chronic diseases and illnesses in the Unites States.</P>
                    <P>• Although many comments support updating the “healthy” definition and acknowledge the need for consistency with current nutrition science and Federal dietary recommendations, particularly the Dietary Guidelines, a number of comments request changes to provide more flexibility and, according to the comments, increase the number of foods that could qualify for the “healthy” claim. Such comments range in scope, from small increases in the allowable nutrient levels to the addition of entire new sets of criteria.</P>
                    <P>• Many comments request that we simplify and streamline the criteria for combination foods (mixed products, meals, and main dishes) to allow more flexibility in formulations and recipes for combination foods recommended by the Dietary Guidelines.</P>
                    <P>• Several comments suggest entirely different, alternative frameworks for the definition of “healthy” such as changes to the FGE criteria, permitting NTE as part of the criteria, and changes that would allow products with a small RACC to use the claim.</P>
                    <P>• Other comments recommend changes, including both higher or lower limits, to the nutrient limits for added sugars, saturated fat, and sodium.</P>
                    <P>• Some comments also address other topics in the proposed rule, including some for which we specifically requested comments and information. For example, some comments discuss exemptions from the FGE criteria and/or nutrient limits for certain foods, such as fish/seafood, certain plant-based proteins or plant-based beverages, tart fruits, and beverages other than plain water, such as coffee and tea. Other comments discuss bottled water containing other ingredients, such as flavors.</P>
                    <HD SOURCE="HD2">C. General Overview of the Final Rule</HD>
                    <P>We provide a detailed overview of the final rule above in section I.B (“Summary of the Major Provisions of the Final Rule”). In support of our consideration of the comments received on the proposed rule, we conducted reviews of databases of products available in the current marketplace to determine what foods in the marketplace would meet certain FGE and NTL criteria in the proposed rule (Ref. 2). As a result of comments received and, in some cases, also supported by the marketplace review we conducted to evaluate those comments, we have made several changes to the proposed criteria to provide additional flexibility, which will result in more foods qualifying to bear the “healthy” claim while still aligning with current nutrition science and Federal dietary guidelines. Such changes include, but are not limited to, the following:</P>
                    <P>• The rule applies the “healthy” criteria to individual foods with a RACC of 50 g or less or 3 Tbsp or less on a per 50 g basis instead of a per RACC basis (§ 101.65(d)(3)(ii)(A) and (B)). This results in foods consumed in small amounts that are recommended for healthy dietary patterns qualifying for the claim.</P>
                    <P>• The rule expands the proposed exemption for raw, whole fruits and vegetables to provide that an individual food or mixed product that is comprised of one or more of the foods encouraged by the Dietary Guidelines, with no other added ingredients except for water, automatically qualifies for the “healthy” claim without meeting the specified criteria because of its nutrient profile and total contribution to an overall healthy diet. Such foods are vegetables; fruits; whole grains; fat-free and low-fat dairy; and lean meat, seafood, eggs, beans, peas, lentils, nuts, and seeds (§ 101.65(d)(3)(i)).</P>
                    <P>• The rule makes several changes to the FGE criteria from what we proposed, including:</P>
                    <P>
                        ○ The FGE for dairy is 
                        <FR>2/3</FR>
                         c-eq instead of 
                        <FR>3/4</FR>
                         c-eq.
                    </P>
                    <P>
                        ○ For combination foods (mixed products, main dishes, and meals), the rule provides additional flexibility in the proportions required for FGEs. For mixed products, the proposed rule would have required 
                        <FR>1/2</FR>
                         FGEs from each of the two food groups. The final rule requires that each food group component should have no less than 
                        <FR>1/4</FR>
                         FGE and that the combined amount of two or more different groups be equal to one total FGE (
                        <E T="03">e.g.,</E>
                          
                        <FR>1/4</FR>
                         FGE from one food group and 
                        <FR>3/4</FR>
                         FGE from the second food group) (§ 101.65(d)(3)(iii)). For main dish products and meal products, the proposed rule would have required exactly 1 FGE each of two or three different food groups, respectively. The final rule requires that each food group component have no less than 
                        <FR>1/2</FR>
                         FGE to comprise the total of 2 FGEs for main dish products and 3 FGEs for meal products (§ 101.65(d)(3)(iv)-(v)). This increased flexibility for FGE requirements will result in more products, such as plant-based patties, being able to meet the FGE requirements for combination foods while still containing meaningful amounts of the different food groups.
                        <PRTPAGE P="106072"/>
                    </P>
                    <P>○ Vegetable and fruit powders that are produced by drying whole vegetables and fruits and grinding into powder form have similar nutrient content to whole vegetables and fruits, and they may be considered in calculation of the vegetable and fruit FGEs for the “healthy” claim.</P>
                    <P>• The rule makes a number of changes to the nutrient to limit criteria from what we proposed, including:</P>
                    <P>○ The rule provides more flexibility for sodium in mixed products by increasing the limit from ≤10% DV to ≤15% DV per RACC (§ 101.65(d)(3)(iii)).</P>
                    <P>○ The rule provides more flexibility for added sugars in whole grain products by increasing the limit from ≤5% DV to ≤10% DV for the grains group (§ 101.65(d)(3)(ii)).</P>
                    <P>○ The rule finalizes an added sugars limit for individual fruits, vegetables, and protein foods of ≤2% of the DV in consideration of the addition of small amounts of added sugars through seasonings and recipes, as well as for the functional attributes of sugars (§ 101.65(d)(3)(ii)).</P>
                    <P>○ The rule excludes the inherent saturated fat in seafood from the saturated fat limit for seafood products and lowers the saturated fat limit for seafood products to ≤5% DV, to provide more flexibility for seafood, which has a fat profile that is predominantly beneficial unsaturated fats but has amounts of naturally occurring saturated fat that can vary across and within different types of seafood (§ 101.65(d)(3)(ii)). This approach is consistent with the proposed approach for nut and seed products.</P>
                    <P>
                        ○ For combination foods (mixed products, main dishes, and meals), the rule streamlines the NTL criteria so that there is one limit each for saturated fat, sodium, and added sugars for mixed products, for main dishes, and for meals (
                        <E T="03">i.e.,</E>
                         limits do not vary based on food groups within each category) (§ 101.65(d)(3)(iii)-(v)).
                    </P>
                    <P>• The rule expands the exemption for plain and plain, carbonated water to include all water, tea, and coffee with less than 5 calories per RACC and per labeled serving (§ 101.65(d)(3)(vi)). The exemption includes carbonated or noncarbonated water, coffee, and tea, containing non-caloric ingredients such as flavors, no- or low-calorie sweeteners, vitamins, and minerals.</P>
                    <HD SOURCE="HD1">IV. Legal Authority</HD>
                    <P>We are issuing this rule to update the definition of the implied nutrient content claim “healthy” consistent with our authority in sections 201(n), 403(a), 403(r), and 701(a) of the FD&amp;C Act. These sections authorize FDA to adopt regulations that prohibit labeling that is false or misleading in that it fails to reveal facts that are material in light of the representations that are made with respect to consequences that may result from consuming the food or uses terms to characterize the level of any nutrient in a food that has not been defined by regulation by FDA.</P>
                    <P>Congress passed the Nutrition Labeling and Education Act (NLEA) of 1990 (Pub. L. 101-535), with three basic objectives: (1) to make available nutrition information that can help consumers in selecting foods that can lead to healthier diets; (2) to eliminate consumer confusion by establishing definitions for nutrient content claims that are consistent with the terms defined by the Secretary of HHS; and (3) to encourage product innovation through the development and marketing of nutritionally improved foods (58 FR 2302, January 6, 1993). The NLEA created section 403(r)(1)(A) of the FD&amp;C Act, which provides specifications for a claim made in the label or labeling of the food which expressly or by implication characterizes the level of any nutrient which is of the type required by section 403(q)(1) or (2) of the FD&amp;C Act to be in the label or labeling of the food. The statute permits the use of these label and labeling claims that expressly or by implication characterize the level of any nutrient in a food, but only if the claims are made in accordance with FDA's authorizing regulations (section 403(r)(1)(A) and (r)(2)(A) of the FD&amp;C Act). Such claims are referred to as “nutrient content claims.”</P>
                    <P>Nutrient content claims can either be claims that expressly characterize the level of a nutrient (express claims, such as “low fat”) or claims that by implication characterize the level of any nutrient (implied claims, like the “healthy” claim or “high in oat bran”). Nutrient content claims are typically based per RACC. This allows nutrient content claims on foods to be considered consistently across products and product sizes. In rulemaking to implement section 403(r)(1)(A) and 403(r)(2) of the FD&amp;C Act shortly after the enactment of the NLEA, we determined that a claim that states that a food, because of its nutrient content, may be useful in maintaining healthy dietary practices is a claim that characterizes the levels of nutrients in a food (“Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms,” 58 FR 2302 at 2374 to 2375, January 6, 1993). That rulemaking resulted in regulations defining “implied nutrient content claims” as including claims that imply that a food, because of its nutrient content, may help consumers maintain healthy dietary practices. As the preamble explained, “[t]he claims are essentially saying that the levels of nutrients in the food are such that the food will contribute to good health” (58 FR 2302 at 2375).</P>
                    <P>FDA issued another regulation in 1994, in which we defined “healthy” when the term is used as an implied nutrient content claim (59 FR 24232, May 10, 1994). The preamble to the 1994 final rule explained that the statute requires that FDA define terms by regulation before they are used as nutritional claims in food labeling; more specifically, under the terms of section 403(r)(1)(A) and 403(r)(2) of the FD&amp;C Act, a nutrient content claim would misbrand a food unless it is made in accordance with a definition of the Secretary of HHS (and, by delegation, FDA) or with one of the other provisions in section 403(r)(2) of the FD&amp;C Act (59 FR 24232 at 24234). The preamble explained that FDA had already determined that, when used in the nutritional labeling context, the term “healthy” is making an implied claim about the levels of the nutrients in the food; that is, that these levels are such that the food would be useful in achieving a total diet that conforms to current dietary recommendations (56 FR 60421 at 60423, November 27, 1991). Accordingly, FDA established a definition for “healthy” when it is used in a nutritional context.</P>
                    <P>This rulemaking updates the definition of “healthy” when used as an implied nutrient content claim, based on current nutrition science and Federal dietary guidance. The updates also reflect the science underlying the changes made to the Nutrition Facts label in the 2016 update to that labeling requirement. As explained in section III. (“Background”), our updated criteria for “healthy” incorporate both food group and NTL requirements. These changes are intended to ensure that foods bearing the implied nutrient content claim “healthy” are nutrient-dense foods that may help consumers maintain healthy dietary practices, based on current nutrition science and Federal dietary guidance. The fundamental purpose of this rulemaking furthers the Congressional objectives underlying the NLEA of providing nutrition information to consumers to help in selecting foods that can lead to healthier diets and reducing consumer confusion potentially caused by the use of inconsistent definitions for nutrient content claims.</P>
                    <P>
                        The revised definition of “healthy” is consistent with the framework 
                        <PRTPAGE P="106073"/>
                        established by the statute and regulations as informed by current science. The statutory language describes nutrient content claims as claims in the label or labeling of a food that expressly or by implication characterize the level of any nutrient in a food (section 403(r)(1)(A) of the FD&amp;C Act). FDA regulations define “implied nutrient content claims,” in part, as claims that imply that a food, because of its nutrient content, may help consumers maintain healthy dietary practices. The statute's reference to characterizing the level of any nutrient and the regulation's reference to maintaining healthy dietary practices incorporate a scientific component because both the characterization and the assessment of healthy dietary practices involve an evaluation of the impact of diet on health. As science evolves over time, the understanding of how nutrient levels should be characterized and appropriate measures for maintaining healthy dietary practices may also evolve. Thus, it is appropriate and consistent with the regulatory framework for FDA to update definitions related to implied nutrient content claims based on current science.
                    </P>
                    <P>
                        The term “healthy” can be an implied nutrient content claim because it suggests that the food, because of its nutrient content, may help consumers maintain healthy dietary practices. The 1994 definition of the claim discussed levels for nine different individual nutrients: fat, saturated fat, cholesterol, vitamin A, vitamin C, calcium, iron, protein, and fiber (§ 101.65(d)(2)(i)). As discussed elsewhere in this document, in recent years the Dietary Guidelines have shifted to recommending healthy dietary patterns and the consumption of food groups in certain quantities to achieve adequate nutrient intake, based on the understanding that each food group contributes an array of important nutrients to the diet (
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                        ). The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         reflects the current scientific understanding that nutrients are not consumed in isolation and focuses its recommendations on consuming a variety of nutrient-dense foods, across all food groups, as part of a healthy dietary pattern. Specifically, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         states that because foods provide an array of nutrients and other components that have health benefits, nutritional needs should be met primarily through eating a variety of nutrient-dense foods. Additionally, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommends increasing intakes of certain food groups and subgroups to shift intakes of underconsumed dietary components closer to recommendations.
                    </P>
                    <P>
                        As we have long explained, the “healthy” claim thus “characterizes the level of [some] nutrient[s] in a food” by implicitly stating that the food contains nutrients at levels or in combinations that help consumers maintain healthy dietary practices. Our 1994 definition sought to ensure that the use of that claim would help consumers who choose to maintain such dietary practices, would not be misleading, and would reduce consumer confusion. That definition did so by tying the use of the claim to circumstances in which the claim accorded with then-accepted scientific and medical understandings. As the underlying science has developed—in ways reflected in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                        —the definition of the claim must be updated to ensure that our regulation continues to serve its original functions.
                    </P>
                    <P>The final rule's definition of “healthy” includes food groups that provide a number of different nutrients. It thus reflects the conclusion that the use of the term “implicitly” characterizes the overall nutrient content of the food, rather than focusing on one individual nutrient in isolation, as with an express nutrient content claim. Each food group that is included in the food group requirement for the updated definition of the “healthy” claim represents the inclusion of multiple important nutrients. The use of food groups better accounts for how all these nutrients contribute, and may work synergistically, to create a healthy dietary pattern and improve health outcomes. It thus better accounts for how the use of the “healthy” claim implicitly characterizes the level of nutrients in a food—as containing nutrients in sufficient levels and combinations that contribute to healthy dietary patterns, which can lead to better health outcomes. By requiring products to contain a certain amount of a food group, the final rule will help ensure foods bearing the “healthy” claim contain a variety of important beneficial nutrients and, therefore, help Americans meet recommended nutrient intakes and maintain healthy dietary patterns.</P>
                    <P>
                        In addition to section 403(r)(2) of the FD&amp;C Act, we are issuing this rule under section 701(a) of the FD&amp;C Act, which states that we may issue regulations for the efficient enforcement of the FD&amp;C Act and has been interpreted to apply to “effectuate a congressional objective expressed elsewhere in the Act” (
                        <E T="03">Association of American Physicians and Surgeons, Inc.</E>
                         v. 
                        <E T="03">FDA,</E>
                         226 F. Supp. 2d 204 (D.D.C. 2002) (citing 
                        <E T="03">Pharm. Mfrs. Ass'n.</E>
                         v. 
                        <E T="03">FDA,</E>
                         484 F. Sup. 1179, 1183 (D. Del. 1980)).
                    </P>
                    <P>
                        We are also relying on our authority under sections 403(r), 403(a), 201(n), and 701(a) of the FD&amp;C Act, to finalize records requirements designed to ensure that the use of the “healthy” claim is accurate, truthful, and not misleading, based on information known only to the manufacturer, and to facilitate efficient and effective action to enforce the requirements when necessary. Our authority to establish records requirements has been upheld under other provisions of the FD&amp;C Act where FDA has found such records to be necessary (
                        <E T="03">National Confectioners Assoc.</E>
                         v. 
                        <E T="03">Califano,</E>
                         569 F.2d 690, 693-94 (D.C. Cir. 1978)). The recordkeeping applies only to foods voluntarily bearing the “healthy” claim for which an adequate analytical method to determine FGE is not available or the amount cannot be discerned from the label alone. The records will allow us to verify that the product meets the requirements to bear the claim and that use of the nutrient content claim “healthy” is truthful and not misleading. Thus, the records requirements will help in the efficient enforcement of the FD&amp;C Act (see discussion in section V.I (“Records Requirements”) for more information).
                    </P>
                    <P>
                        The authority granted to FDA under sections 701(a), 403(r), 403(a)(1), and 201(n) of the FD&amp;C Act not only includes authority to establish records requirements, but also includes access to such records. Without access to such records, FDA would not know whether the food meets the proposed requirements to bear the “healthy” claim consistent with section 403(r) of the FD&amp;C Act, and whether the use of the claim is truthful and not misleading under sections 403(a)(1) and 201(n) of the FD&amp;C Act. The introduction or delivery for introduction into interstate commerce of a misbranded food is a prohibited act under section 301(a) of the FD&amp;C Act (21 U.S.C. 331(a)). Thus, to determine whether a food that is voluntarily bearing a “healthy” nutrient content claim is misbranded and the manufacturer has committed a prohibited act, we must have access to the manufacturer's records that we are requiring be kept under § 101.65(d)(4). Failure to make and keep records and provide the records to FDA, as described in § 101.65(d)(4), would result in the food bearing the “healthy” claim being misbranded under sections 403(r) and 403(a)(1) of the FD&amp;C Act.
                        <PRTPAGE P="106074"/>
                    </P>
                    <HD SOURCE="HD1">V. Comments on the Proposed Rule and FDA Response</HD>
                    <HD SOURCE="HD2">A. Introduction</HD>
                    <P>
                        We received approximately 400 comments on the proposed rule. We received comments from consumers; consumer groups; academia; trade organizations; industry (
                        <E T="03">e.g.,</E>
                         food manufacturers); public health organizations; public advocacy groups; Congress, State, and local government agencies; and other organizations. In the remainder of this section, we summarize these comments, respond to them, and explain any revisions we made to the proposed rule. Where we did not receive comments and do not have additional discussion in this final rule, we finalized the proposed provisions without change.
                    </P>
                    <P>We have numbered each comment to help distinguish between different comments. We have grouped similar comments together under the same number, and, in some cases, we have separated different issues discussed in the same comment and designated them as distinct comments for purposes of our responses. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comment's value, importance, or the order in which comments were received.</P>
                    <HD SOURCE="HD2">B. General Comments</HD>
                    <P>Many comments make general remarks supporting or opposing the proposed rule without focusing on a particular proposed provision.</P>
                    <P>
                        (Comment 1) The majority of the comments express general support for updating the “healthy” implied nutrient content claim to make it consistent with current nutrition science and Federal dietary guidance, including the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         noting the claim has not been updated since the 1990s. Numerous comments note that the proposed rule would help consumers make better, healthier choices for purchasing and consuming food, generally improve the nutritional knowledge of the average U.S. consumer, and give consumers information that could help combat the high rate of obesity and diet related chronic diseases and illnesses in the United States.
                    </P>
                    <P>
                        (Response 1) We agree with the comments that support updating the “healthy” implied nutrient content claim. Nutrition science has evolved since the 1990s when FDA first established a definition for the implied nutrient content claim “healthy,” and the purpose of this rule is to update the definition to be consistent with current nutrition science and Federal dietary guidance, such as the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         to help ensure that consumers have access to more complete, accurate, and up-to-date information in the labeling of human food products. As more fully discussed in section III. (“Background”), the fundamental purpose of a “healthy” claim is to highlight those foods that, based on their nutrient levels, are particularly useful in constructing a diet that is consistent with current dietary guidelines. The current 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         focuses on the importance of a healthy dietary pattern as a whole and its role in promoting health, reducing risk of chronic diseases, and meeting nutrient needs (Ref. 1). Therefore, foods that qualify for “healthy” are those foods that are particularly useful in helping consumers with creating healthy dietary patterns. As discussed, with this framework, we emphasize that foods that do not qualify for use of the claim are not necessarily “unhealthy” or unable to provide any nutritional benefits to consumers. Foods that meet the requirements for the “healthy” claim are foods that, because of their overall nutrition profiles, can be a “foundation” for a healthy dietary pattern recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         Foods that do not meet the requirements could, however, have attributes that are beneficial. As more fully discussed above in section III. (“Background”), these beneficial attributes can be communicated to consumers in other ways. We reiterate that an inability to meet the requirements for use of the claim “healthy” does not necessarily make a food unhealthy and that manufacturers can communicate the nutritional qualities of their foods through other applicable label claims and any truthful and non-misleading statements they want to include.
                    </P>
                    <P>(Comment 2) Some comments recommend the term “healthy” continue to evolve as science around nutrition changes and ask us to clarify our intentions to update the claim in the future, as needed.</P>
                    <P>
                        (Response 2) Although the Dietary Guidelines are published every 5 years to reflect current nutrition science, and some of its specific recommendations have evolved as scientific knowledge has grown, many of its foundational recommendations have remained consistent over time (
                        <E T="03">e.g.,</E>
                         recommending increased consumption of fruits, vegetables, and whole grains, and diets low in saturated fat and sodium). As discussed in the proposed rule (87 FR 59168 at 59170), advancements in nutrition science have provided a greater understanding of, and focus on, the importance of healthy dietary patterns, and how dietary components act synergistically to affect health. The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         has a particular focus on the importance of dietary patterns as a whole, with recommendations to help Americans make choices from across and within all food groups within calorie needs to add up to an overall healthy dietary pattern (Ref. 1). The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         also includes recommendations to limit daily intake of added sugars, saturated fat, and sodium, and emphasizes “shifts,” or replacement of less healthy food choices with nutrient-dense foods, as methods for consumers to achieve a healthy dietary pattern. The scientific evidence discussed in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         and the Scientific Report of the 2020 Dietary Guidelines Advisory Committee (2020 DGAC report), and the recommendations based on that nutrition science, have informed this rulemaking and are the primary basis for the criteria that we have established for the “healthy” nutrient content claim. While there has been consistency in many of the recommendations in Federal dietary guidelines and the underlying nutrition science on which they are based, we intend to remain aligned with the most current nutrition science reflected in Federal dietary guidelines and will update our regulations and policies, as appropriate. However, we note that the updated definition of “healthy” is designed to be flexible and to accommodate possible changes in updated recommendations, as discussed further below in this section. For example, instead of tying the nutrient limits to absolute values, the criteria are provided as percentages of the DV.
                    </P>
                    <P>(Comment 3) Some comments ask FDA to clarify that our work to update the “healthy” definition does not signal that other foods do not have a role to play in a healthy dietary pattern or something broader, such as whether a food is “good” or “bad” or “some other broader policy recommendation.” Some comments assert that allowing some foods to be labeled as “healthy” could lead consumers to infer all other foods are unhealthy, even if such foods have beneficial components, which could limit options for low-income and vulnerable populations.</P>
                    <P>
                        Several comments assert that “healthy” diets vary across cultures, ages, and disease states and suggest that, for example, a healthy diet for an individual recovering from an eating 
                        <PRTPAGE P="106075"/>
                        disorder is vastly different from a healthy diet for someone who has heart failure. The comments argue that allowing foods to be labeled as “healthy” implies that foods without those labels are “unhealthy” and could exacerbate eating disorders and possibly trigger relapse or otherwise prevent recovery. Some comments claim that FDA is incorrectly indicating that “healthy” is the same for everyone and suggest that our focus should instead be on giving people the tools to evaluate the specific nutrients that are in food and that we should consider removing the “healthy” claim altogether and refocus labeling efforts on clear and concise labeling that is sensitive to multiple cultures, disease states, and ages.
                    </P>
                    <P>
                        (Response 3) In this rule, we are updating the criteria for the “healthy” nutrient content claim so that it aligns with current nutrition science and Federal dietary guidance. The fundamental purpose of a “healthy” claim is to highlight those foods that, based on their nutrient levels, are particularly useful in creating a diet that is consistent with current dietary guidelines. As discussed, with this framework, we emphasize that foods that do not qualify for use of the claim or do not use the claim are not necessarily “unhealthy” or unable to provide any nutritional benefits to consumers. Foods that meet the requirements for the “healthy” claim are foods that, because of their overall nutrition profiles, are useful as a foundation for a healthy dietary pattern recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         The scientific evidence that informs the Dietary Guidelines is representative of the U.S. population, including people who are healthy, people at risk for diet-related chronic conditions and diseases (
                        <E T="03">e.g.,</E>
                         CVD, type 2 diabetes, and obesity), and some people who are living with one or more of these diet-related chronic illnesses (Ref. 1). The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         states that a “fundamental premise of the 
                        <E T="03">2020-2025 Dietary Guidelines</E>
                         is that nearly everyone, no matter their health status, can benefit from shifting food and beverage choices to better support healthy dietary patterns” and explains that it is essential that medical organizations and health professionals adapt the Dietary Guidelines to meet the specific needs of their patients (Ref. 1). For consumers who would like to evaluate the specific nutrients that are in a food or beverage, the Nutrition Facts label is an available tool. The comments did not provide, and we are not aware of, evidence that a food labeled “healthy” for the narrow purpose of making a voluntary nutrient content claim could adversely impact those with eating disorders. We plan to undertake consumer education efforts related to the “healthy” claim, which we expect to include highlighting the importance of choosing a variety of nutrient-dense foods within and across different food groups and subgroups.
                    </P>
                    <P>(Comment 4) Some comments argue that the proposed rule would not cause a “significant” change in consumer behavior or diet, warning that a “healthy” claim on processed and packaged products could discourage consumers from buying whole fruits and vegetables. However, such comments also note that an update to the “healthy” definition would make food products labeled with the claim align with current nutrition standards and lead to more healthy products being sold. The comments also assert that packaged food products are “essential” for communities that cannot afford exclusively fresh foods, and state that the new definition would help customers identify healthier options.</P>
                    <P>(Response 4) Nutrient content claims such as “healthy” are intended to provide consumers with information to help them quickly and easily identify foods that can be the foundation of a healthy dietary pattern. We agree that the updated “healthy” claim, which focuses on food groups and NTL, will better align with current nutrition science and support consumers, including those who frequently purchase packaged foods, in identifying healthier options. We disagree that the updated healthy claim could discourage consumers from buying whole fruits and vegetables. Both processed and packaged foods as well as fresh, whole foods, such as fruits and vegetables will be able to qualify for the “healthy” claim. Foods that qualify for the healthy claim that are not packaged can have the claim communicated to consumers through signage and other materials in the store. Therefore, through use of the “healthy” claim, consumers will have additional information on foods throughout the grocery store that can help make more informed decisions.</P>
                    <P>(Comment 5) Some comments oppose the proposed definition of “healthy,” asserting that the term “healthy” is not easily definable, will be used inconsistently, can quickly become outdated, and is a subjective term that can be applied differently for different people. Some comments assert that this change would allow food manufacturers to incorrectly label what the comments consider unhealthy foods as “healthy,” thus allowing manufacturers to mislead and deceive consumers. Some comments oppose the rule by asserting that government control over food labeling and promulgation of rules about what can be called “healthy” is unnecessary.</P>
                    <P>
                        (Response 5) The rule establishes updated criteria for the narrow use of the term “healthy” as a voluntary nutrient content claim. As discussed in section IV. (“Legal Authority”), Congress passed the NLEA with three basic objectives: (1) to make available nutrition information that can help consumers select foods that can lead to healthier diets; (2) to eliminate consumer confusion by establishing definitions for nutrient content claims that are consistent with the terms defined by the Secretary of HHS; and (3) to encourage product innovation through the development and marketing of nutritionally improved foods. The NLEA created section 403(r)(1)(A) of the FD&amp;C Act, which provides specifications for a claim made in the label or labeling of the food which expressly or by implication characterizes the level of any nutrient which is of the type required by section 403(q)(1) or (2) of the FD&amp;C Act to be in the label or labeling of the food. The statute permits the use of these label and labeling claims that expressly or by implication characterize the level of any nutrient in a food, but only if the claims are made in accordance with FDA's authorizing regulations (section 403(r)(1)(A) and (r)(2)(A) of the FD&amp;C Act). Hence, establishing a definition of “healthy,” when used as a nutrient content claim, is necessary for such claims to be lawfully made and is partially intended to serve the very purpose these general comments opposing the rule use to argue against it, namely, to avoid consumer confusion and misleading claims. The fundamental purpose of this rulemaking furthers the Congressional objectives underlying the NLEA of providing nutrition information to consumers to help in selecting foods that can lead to healthier diets and reducing consumer confusion potentially caused by the use of inconsistent definitions for nutrient content claims. Further, under section 403(r)(1)(A) and (r)(2) of the FD&amp;C Act, use of the “healthy” nutrient content claim would misbrand a food unless it is made in accordance with the regulatory definition we are establishing in this rule.
                        <PRTPAGE P="106076"/>
                    </P>
                    <HD SOURCE="HD2">C. Food Group Equivalents</HD>
                    <HD SOURCE="HD3">1. General Comments</HD>
                    <P>(Comment 6) Numerous comments support using food groups as criteria in the definition of the claim “healthy,” stating that the change from focusing on individual nutrients better reflects the Dietary Guidelines, ensures that more nutrient-dense foods are included in the “healthy” definition, increases flexibility for certain products, avoids shifting nutrient guidelines, and is clearer to consumers. The comments mention that use of the food group criteria will enhance the messaging around the importance of creating healthy eating habits as opposed to a framework that targets individual foods. Some comments also provide that basing the “healthy” definition on food groups rather than individual nutrients is more consistent with evolving nutrition science that emphasizes dietary patterns. One comment mentions that requiring products to meet food-based criteria may help minimize or avoid unintended consequences of a focus solely on individual nutrients.</P>
                    <P>Some comments oppose use of food groups as criteria in the definition of the claim “healthy,” as opposed to individual nutrients, claiming the FGEs are too complex and difficult to calculate, that there is too much variance in nutrients within certain food groups, and the healthfulness of foods should be based on different individual nutrients. One comment claims that FDA has not adequately justified the move from only considering nutrients to also including food groups in the definition of the “healthy” claim.</P>
                    <P>
                        (Response 6) We agree that the food group approach is in alignment with the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         which places an emphasis on a healthy dietary pattern as a whole, rather than on individual nutrients or foods in isolation. The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         states that because foods provide an array of nutrients and other components that have health benefits, nutritional needs should be met primarily through a variety of nutrient-dense foods. The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         provides that a healthy dietary pattern consists of nutrient-dense forms of foods and beverages, in recommended amounts, across all food groups and recommends increasing intakes of certain food groups and subgroups to move intakes of underconsumed dietary components closer to recommendations.
                    </P>
                    <P>
                        We disagree that the FGE approach is too complex and note that there are several currently available resources that can help with calculation. As discussed further herein, the food groups and the FGE amounts are based on information contained in the 
                        <E T="03">Dietary Guidelines, 2020-2025;</E>
                         as such, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         is a helpful resource in determining the amounts of foods necessary to meet FGEs. The USDA Food Patterns Equivalents Database (FPED) also provides information about cup- and ounce-equivalents of different foods and beverages to assist with calculations (Ref. 3). Additionally, FDA recognizes the importance of time for industry to determine the FGE amounts in their products, and we have set the rule's compliance date as being 3 years from the rule's effective date. We intend to provide additional resources for manufacturers to help determine FGE amounts before the compliance date. The additional resources may include guidance documents for industry, information on the FDA website, FAQs, direct communications in response to questions, or online webinars.
                    </P>
                    <P>(Comment 7) Many comments support using food groups as criteria in the definition of the claim “healthy,” but ask that the rule maintain a level of reliance on individual beneficial nutrients or include requirements for beneficial nutrients as an alternative to ensure that important nutrients are not missed by the rule focusing too heavily on food groups. Some comments support the food group approach, but request that the updated “healthy” criteria permit a food to qualify if it meets both the NTL and either the food groups to encourage or the original NTE criteria.</P>
                    <P>
                        (Response 7) We discussed in section III. (“Background”) that the purpose of a “healthy” claim is to highlight those foods that, based on their nutrient levels, are particularly useful in creating a diet that is consistent with current dietary guidelines. The current 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         (Ref. 1) focuses on the importance of a healthy dietary pattern as a whole and its role in promoting health, reducing risk of chronic diseases, and meeting nutrient needs. Therefore, based on current dietary recommendations and nutrition science, foods that qualify for “healthy” are those foods that are particularly useful in helping consumers create healthy dietary patterns. As described by the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         a healthy dietary pattern “consists of nutrient-dense forms of foods and beverages across all food groups, in recommended amounts, and within calorie limits.” The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         also describes that “[c]ommon characteristics of dietary patterns associated with positive health outcomes include relatively higher intake of vegetables, fruits, legumes, whole grains, low- or non-fat dairy, lean meats and poultry, seafood, nuts, and unsaturated vegetable oils, and relatively lower consumption of red and processed meats, sugar-sweetened foods and beverages, and refined grains.” (Ref. 1). The original definition for the “healthy” nutrient content claim was based solely on individual nutrients, both minimum amounts and specific limits. This approach is inconsistent with current nutrition science regarding healthy dietary patterns and their effect on health and development of chronic disease. Foods that contain certain NTE, such as certain individual vitamins, minerals, or fiber, can be beneficial to consumers. However, highlighting those foods as “healthy” would not necessarily help consumers in the overall construction of healthy dietary patterns, in which nutrient-dense foods from across all of the recommended food groups and subgroups provide an array of nutrients and ensure overall nutrient adequacy from the diet. Including requirements for minimum amounts of foods from the recommended food groups better reflects the overall nutrient content of foods and how nutrients in the food groups and subgroups may work together as part of a healthy dietary pattern. Thus, we decline to include individual NTE criteria in the final rule.
                    </P>
                    <P>(Comment 8) Some comments assert that FDA's proposed FGE is sometimes larger than the serving size of the product itself, particularly for products with small serving sizes that would be unable to qualify as “healthy” because they could not provide an FGE per RACC. Examples of types of foods discussed in the comments include certain whole grain bread products, certain snack foods, natural cheeses, and many yogurts. The comments state that these smaller RACC products would be excluded from making “healthy” claims solely based on their serving size. The comments request that FDA modify the criteria for products with small RACCs to require a smaller contribution to the FGEs. The comments suggest various different modifications to the criteria, including lowering the required FGE amounts, adjusting the criteria for the claim to incrementally increase based on food size, and adopting a category with criteria for foods with small RACCs.</P>
                    <P>
                        (Response 8) In the proposed rule (87 FR 59168 at 59177), we determined the FGEs based on the cup- and ounce-equivalents and recommended daily food group amounts developed for the 
                        <PRTPAGE P="106077"/>
                        Healthy U.S.-Style Dietary Pattern for ages 2 and older in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         (Ref. 1). The proposed thresholds for the FGEs were set so that foods that bear the claim “healthy” contain enough of the food group that they could help consumers achieve the recommended daily food group amounts. Foods that do not contain the minimum FGE amount for their food group would not meet the requirements and not be eligible to bear the claim. As many comments point out, however, there are many foods that are included in the food groups recommended by the Dietary Guidelines, and fit into healthful dietary patterns, that are in forms whose RACCs are smaller than the minimum FGE requirement. After evaluating nutrient-dense foods with small RACCs across the recommended food groups and subgroups, we have determined that many of these foods with RACCs smaller than the proposed FGEs could qualify for use of the claim “healthy” if their RACC sizes were similar to those of typical individual foods and if they met all the other requirements for the use of the claim (Ref. 2).
                    </P>
                    <P>FDA has previously addressed challenges related to foods with small RACCs in its nutrition labeling regulations. For example, in the context of eligibility for “low” nutrient content claims, FDA provided different criteria for eligibility to use the “low fat” claim based on the RACC of the individual food (§ 101.62(b)(2)). In the context of the low-fat claim, FDA applies different criteria based on RACC size to ensure that a food does not qualify for a “low fat” claim solely because it is consumed in small amounts.</P>
                    <P>For the proposed “healthy” definition, the reverse situation is present in that certain foods recommended for healthful dietary patterns would be unable to meet the FGE criteria for the claim due to being typically consumed in small amounts. Because we do not intend to exclude foods consumed in small amounts that are recommended for healthful dietary patterns, the final rule applies the “healthy” criteria to individual foods with a RACC of 50 g or less or 3 Tbsp or less on a per 50 g basis instead of a per RACC basis (§ 101.65(d)(3)(ii)(B)).</P>
                    <P>In the context of the “low fat” claim, FDA defined small RACC foods as “individual foods that have a RACC of 30 g or less or 2 Tbsp or less.” For the purposes of the “healthy” claim, to most appropriately include the variety of foods recommended by the Dietary Guidelines for healthful dietary patterns, which was supported by our review of food products in the current marketplace (Ref. 2), we are defining small RACC foods as foods with a RACC of 50 g or less or 3 Tbsp or less.</P>
                    <P>This change to the criteria for small RACC foods acknowledges that there have been a number of changes to individual RACC sizes since nutrient content claim criteria for foods with small RACC sizes, such as for the “low fat” claim (§ 101.62(b)(2)), were implemented. As an example, medium weight cereals initially had a RACC size of 30 g, which would fall under the small RACC description included in other nutrient content claims such as the “low fat” claim. In 2016, FDA updated the RACC size for medium weight cereals to 40 g (§ 101.12(b)). Thus, medium weight whole grain cereals are no longer considered a food with small RACC under the nutrient content claim of “low fat.” If we were to define small RACCs as “individual foods that have a RACC of 30 g or less or 2 Tbsp or less” for purposes of the “healthy” claim, medium weight whole grain cereals would not be considered to have a small RACC size, would have the “healthy” criteria applied on a per RACC basis (40 g), and would not meet the whole grain FGEs. However, medium weight nutrient-dense whole grain cereals, which are recommended as part of a healthy dietary pattern, will meet the whole grain FGE criterion for the “healthy” claim on a 50 g basis. As demonstrated when we reviewed the current marketplace (Ref. 2) in our data analysis, whole grain cereals are just one of many nutrient-dense foods recommended as part of a healthy dietary pattern that would not meet the FGE criteria on a 30 g basis but would meet them on a 50 g basis. Therefore, to ensure that nutrient-dense foods that are recommended for healthful dietary patterns are able to qualify for the “healthy” claim, the final rule applies the “healthy” criteria to individual foods with a RACC of 50 g or less or 3 Tbsp or less on a per 50 g basis instead of a per RACC basis (§ 101.65(d)(3)(ii)(B).</P>
                    <P>We have also made other changes that will result in more nutrient-dense foods with serving sizes that are smaller than the proposed FGE requirements being able to qualify for the “healthy” claim. For example, we have expanded the proposed exemption for raw, whole fruits and vegetables (see Response 9) and lowered the FGE requirement for dairy (see Response 29). We did not receive comments that the proposed FGE requirements were too restrictive for other food groups and subgroups, aside from concerns regarding products with small RACC sizes and the dairy FGE requirement. Therefore, we are finalizing the FGE requirements as proposed for the other food groups and subgroups.</P>
                    <P>(Comment 9) Many comments support the exemption in the proposed rule that would allow any raw, whole fruits and vegetables, including any whose RACC size might be smaller than the fruit and vegetable FGE requirements, to qualify for the “healthy” claim. Some comments note, however, that other fruit and vegetable options, such as frozen fruits and vegetables or chopped fruits and vegetables (without added ingredients), would not meet the proposed automatic qualification for raw, whole fruits and vegetables. Some comments mention that, while fresh or raw avocados would qualify under the exemption as proposed, frozen avocados would not. The comments request that the exemption for raw, whole fruits and vegetables be expanded to include other forms, such as frozen and chopped fruits and vegetables.</P>
                    <P>Some comments note that other food groups recommended by the Dietary Guidelines also include many similar, single-ingredient foods that align with recommendations in the guidelines but would not qualify for the “healthy” claim under the proposed rule. The comments assert that the FGE and NTL criteria are not necessary for these types of products because they are nutrient-dense foods encouraged by the Dietary Guidelines. The comments request that we expand the exemption for raw, whole fruits and vegetables to other single-ingredient nutrient-dense foods recommended by the Dietary Guidelines or include an additional category for nutrient-dense whole foods recommended by the Dietary Guidelines to ensure that these types of foods can also qualify for the “healthy” claim without needing to meet the FGE and NTL criteria.</P>
                    <P>
                        (Response 9) We do not intend to exclude nutrient-dense single-ingredient foods that are foods encouraged by the Dietary Guidelines from qualifying for the updated “healthy” definition. We agree that it is not necessary for such foods to meet additional criteria because they are nutrient-dense foods encouraged by the Dietary Guidelines that can help consumers maintain healthy dietary practices by serving as a foundation for a healthy dietary pattern. Therefore, we have revised the rule to expand the exemption for raw, whole fruits and vegetables to include individual foods or mixed products that are comprised of one or more of the following nutrient-dense foods encouraged by the Dietary Guidelines (for adults and children 2 years of age and older), with no other added 
                        <PRTPAGE P="106078"/>
                        ingredients except for water: vegetables; fruits; whole grains; fat-free and low-fat dairy; and lean game meat, seafood, eggs, beans, peas, lentils, nuts, and seeds (§ 101.65(d)(3)(i)). Individual foods and mixed products that contain these nutrient-dense foods encouraged by the Dietary Guidelines and do not contain any added ingredients, besides water, will automatically qualify for the “healthy” claim because of their nutrient profile and positive contribution to an overall healthy diet. Such products do not need to meet the FGE and NTL requirements for individual foods or mixed foods. For example, foods such as fish and lean game meats, skim milk, brown rice, and the many other single-ingredient nutrient-dense foods encouraged by the Dietary Guidelines can use the “healthy” nutrient content claim without having to meet the FGE and NTL requirements.
                    </P>
                    <P>
                        For similar reasons to those discussed above, we are also expanding the exemption so that it will not be limited to “raw, whole” versions of foods encouraged by the Dietary Guidelines, but rather will include other forms of these foods, including a variety of shelf-stable and/or economical forms of foods. For example, frozen or sliced fruits and vegetables, 100% whole grain flours, dried beans, peas, and lentils, frozen seafood, chopped nuts, and certain nut butters (
                        <E T="03">i.e.,</E>
                         only containing nuts), with no added ingredients other than water, automatically qualify without needing to meet the FGE and nutrient to limit requirements. Additionally, as a result of the expansion of this exemption, single-ingredient foods encouraged by the Dietary Guidelines that have small RACC sizes (
                        <E T="03">e.g.,</E>
                         frozen avocado pieces) will now qualify even if their RACCs are smaller than the FGE amounts for their respective food groups or subgroups.
                    </P>
                    <P>
                        Certain mixed products are also eligible for the exemption. A mixed product that contains multiple single-ingredient foods encouraged by the Dietary Guidelines (without additional ingredients besides water) but does not meet the FGE requirements for a mixed product to qualify for “healthy” (
                        <E T="03">i.e.,</E>
                         contain 1 total FGE) will fall under the expanded exemption and will automatically qualify for the claim (§ 101.65(d)(3)(i)). We have determined that these types of products (
                        <E T="03">i.e.,</E>
                         mixed products that contain only nutrient-dense foods that are encouraged by the Dietary Guidelines without added ingredients besides water) can also serve as part of a foundation for a healthy dietary pattern because of their nutrient profile and positive contribution to an overall healthy diet. Many of these types of products, regardless of whether they are individual foods or mixed products, would also meet the FGE and NTL criteria for individual foods or mixed products; however, this exemption allows manufacturers to more easily determine and verify compliance with the updated “healthy” criteria, particularly for mixed products. For example, a product that contains two ingredients that are each a food encouraged by the Dietary Guidelines—such as a frozen mix of a vegetable and a whole grain, or a blend of 100% juices that contains 80% fruit juice and 20% vegetable juice—and does not contain additional ingredients besides water, will automatically qualify under the expanded exemption in § 101.65(d)(3)(i). We are finalizing the expanded exemption under § 101.65(d)(3)(i) as: an individual food or mixed product that is comprised of one or more of the following foods that are the foundation of a healthy dietary pattern, with no other added ingredients except for water: (1) vegetable; (2) fruit; (3) whole grains; (4) fat-free and low-fat dairy; and (5) lean meat, seafood, eggs, beans, peas, lentils, nuts, and seeds. Additionally, because the standard information required on the food label, such as the list of ingredients for such a product, provides sufficient information to verify that the food meets the “healthy” criteria, records will not be required to demonstrate compliance with the FGE requirements for products that qualify for the automatic exemption in § 101.65(d)(3)(i) and (d)(4).
                    </P>
                    <P>
                        We are not expanding the exemption to main dishes or meals because those products serve different roles in the diet. Main dish products, defined by our regulations at § 101.13(m), are larger in size (weighing at least 6 oz per labeled serving) than individual foods and mixed products, and are intended to make a major contribution to a meal (
                        <E T="03">i.e.,</E>
                         contain most of the components of a meal). A main dish product might include, for example, a frozen entrée that is intended to be eaten with additional items to form a full meal. Because of their size and the larger contribution that they make to the overall diet, we are requiring in § 101.65(d)(iv) that main dish products contain at least two total FGEs per labeled serving with a minimum of a 
                        <FR>1/2</FR>
                         FGE for each of the two food groups, and that they meet NTL criteria (see Section V.E “Combination Foods” for further discussion of requirements for mixed products, main dishes, and meals). Meal products, defined at § 101.13(l), are larger in size (weighing at least 10 oz per labeled serving) than main dish products and are intended to provide all food for a single eating occasion (
                        <E T="03">i.e.,</E>
                         a complete meal). An example of a meal is a frozen dinner that includes an entrée, vegetable side, and dessert. Because of their size and the larger contribution that they make to the overall diet, we are requiring in § 101.65(d)(v) that meal products contain at least three total FGEs per labeled serving with a minimum of a 
                        <FR>1/2</FR>
                         FGE for each of the three food groups. It is important that main dishes and meals contain a minimum amount of different food groups (
                        <E T="03">i.e.,</E>
                         meet the FGE criteria) because their size and larger contribution in the diet means that it is particularly important for them to contain an array of nutrients and to help consumers achieve the recommended daily food group amounts and meet nutritional needs, and therefore we are not including main dishes and meals in the expanded exemption.
                    </P>
                    <P>
                        For simplicity, throughout the rule we will refer to this exemption as the “single-ingredient exemption” and will generally refer to these nutrient-dense foods that are encouraged by the Dietary Guidelines with no added ingredients, except for water, as “single-ingredient foods encouraged by the Dietary Guidelines.” We again note, however, that these single-ingredient foods encouraged by the Dietary Guidelines and the single-ingredient exemption, also include individual foods and mixed products that contain multiple single-ingredient foods with no added ingredients, except for water (
                        <E T="03">e.g.,</E>
                         a frozen mix of a vegetable and a whole grain, or a blend of 100% juices that contains 80% fruit juice and 20% vegetable juice).
                    </P>
                    <P>(Comment 10) Some comments also recommend that herbs and spices be able to qualify for the “healthy” claim. These comments assert that herbs and spices can reduce consumption of added sugars, sodium, and saturated fat by making nutrient-dense foods more palatable without adding calories. Additionally, the comments state that herbs and spices increase the consumption of nutrient-dense foods such as vegetables, fruits, and healthy grains. Some comments assert that spices meet the definition of vegetable products, but provide that given their small RACC, spices would not be able to meet the proposed FGE criteria.</P>
                    <P>
                        (Response 10) We agree that herbs and spices can play an important role in the diet by replacing seasonings and ingredients that contribute sodium, saturated fat, and added sugars to the diet. They can also help increase the palatability of nutrient-dense foods. However, because of their primary use 
                        <PRTPAGE P="106079"/>
                        as a flavoring for foods, they are typically consumed in such small quantities that they generally do not contribute a meaningful amount of nutrients to the diet. The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         mentions that spices and herbs can help flavor foods when reducing added sugars, saturated fat, and sodium, and that they can also contribute to the enjoyment of nutrient-dense foods (Ref. 1). Some herbs are included as examples in the vegetable food group in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         (
                        <E T="03">e.g.,</E>
                         cilantro, basil, and chives). Foods or ingredients that are considered to be part of the vegetable food group can also contribute toward the FGE requirement for vegetables in different forms, such as dried forms (see Response 44).
                    </P>
                    <P>(Comment 11) Some comments suggest that FDA allow foods with small RACCs to satisfy their FGE requirement by having a component from a recommended food group as the first ingredient on the ingredient declaration. The comments suggest this “first ingredient” approach both for foods with small RACCs and as an alternative to the FGE requirement, not limited to foods with small RACCs. In the “first ingredient” approach, there would be no absolute amount of a food group required; the approach would require only that the component from a qualifying food group would be the ingredient of the greatest weight in a food.</P>
                    <P>(Response 11) We decline to adopt the “first ingredient” approach suggested by the comments. The regulations regarding ingredient declaration require only that ingredients be listed in descending order of predominance by weight (21 CFR 101.4(a)). A descending order by weight does not, however, provide any indication of a significant or meaningful amount of an ingredient. Being listed first in the ingredient declaration only indicates that a food has proportionally more of that ingredient compared to each of the other ingredients individually. For example, a food could contain 10 different ingredients, and, although the first ingredient may weigh more than each of the other nine ingredients individually, the total sum of the other nine ingredients could proportionally outweigh the first ingredient. The overall food in that case would not be likely to have a significant amount of the first ingredient from a recommended food group and therefore would not meaningfully contribute to the recommended daily food group amounts. Therefore, using the first ingredient in an ingredient list to determine FGEs would not be a reliable way to help consumers identify foods that can help them meet recommended food group amounts, nor would it effectively address challenges related to the qualification of foods with small RACCs. As discussed in Response 8, the rule includes criteria specific to small RACC foods.</P>
                    <P>(Comment 12) Many comments request that FDA provide more guidance on what counts as an FGE and how to calculate the FGE contribution of a food. The comments note that the proposed FGE amounts are in volume, and that the volume of a food will vary considerably based on the form of the food. Some comments ask that FDA provide a standard methodology, calculator, and/or database that manufacturers could use to determine FGEs for their products.</P>
                    <P>
                        (Response 12) We determined FGE amounts based on the cup- and ounce-equivalents developed for the Healthy U.S.-Style Dietary Pattern for ages 2 and older in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         (Ref. 1). The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         provides information on the many types of foods that are contained in each food group in the food patterns (see Ref. 1, Appendix A3-2, footnote b) and descriptions of how much of those foods are needed to meet a cup- or ounce-equivalent (see Ref. 1, Appendix A3-2, footnote c). Additionally, there are other resources available, such as the FPED, which provides further information about cup- and ounce-equivalents of different foods and beverages (Ref. 3). FDA understands that, depending on the type and form of an individual food, manufacturers may benefit from additional information on how to determine the amount necessary to meet the FGE amounts required for their foods to be eligible for the “healthy” claim. The final rule sets a compliance date that is 3 years from the effective date, and we intend to provide additional resources to help manufacturers comply with the final rule before the end of the compliance period. The additional resources may take the form of guidance documents for industry, information on the FDA website, FAQs, direct communications in response to questions, or online webinars, as discussed in Response 6.
                    </P>
                    <P>(Comment 13) Many comments request that FDA make clear that the list we provided for FGEs in the preamble to the proposed rule is not exhaustive.</P>
                    <P>(Response 13) The marketplace for food products is wide in scope and continually evolving and therefore cannot be comprehensively covered by the examples of FGEs described in this rule. Thus, the list of examples of FGEs we provided in the proposed rule and in the final rule is not an exhaustive list.</P>
                    <HD SOURCE="HD3">2. FGEs Based on Four Eating Occasions Per Day</HD>
                    <P>
                        (Comment 14) Some comments express concern with the assumption in the proposed rule that the typical American dietary pattern consists of three meals and one snack per day (
                        <E T="03">i.e.,</E>
                         four eating occasions). The comments assert that the dietary habits of Americans have shifted over the past several years from a primarily meal-based diet to one that includes more snacking or “ready to eat” meals. The comments suggest that FGEs should not be based on a consumption pattern of four eating occasions per day. Another comment notes that the recommendations in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         were based on the assumption that Americans consume three meals per day and two snacks.
                    </P>
                    <P>Some comments question the equal division among the four eating occasions. For example, some comments suggest that snacks should be weighed differently than meals due to size. One comment recommends that meals carry three times the ounce equivalent (oz-eq) as a snack for the nutrient recommended daily allowance.</P>
                    <P>
                        (Response 14) Our review of consumption patterns indicates that the typical American dietary pattern consists of three meals and one snack per day, 
                        <E T="03">i.e.,</E>
                         four eating occasions (not including beverage-only eating occasions) (Ref. 2). These data signify that individuals have four opportunities in a day to meet the recommended daily food group amounts in the Healthy U.S.-Style Dietary Pattern, and thereby satisfy their nutritional needs. The food group amounts recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         (
                        <E T="03">e.g.,</E>
                         2 c-eq/day of fruit) are total recommended amounts for the day, not for individual foods, meals, or snacks. The recommended daily amounts of food groups provided by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         are not dependent on number of eating occasions. In determining the food group requirements for “healthy,” the total daily amount of food groups are divided across the number of eating occasions as determined by the data from national consumption surveys. National consumption data over the last several decades, (
                        <E T="03">i.e.,</E>
                         the USDA Continuing Survey of Food Intakes by Individuals 1989-91 and Diet and Health Knowledge Survey 1989-91 (CSFII/DHKS 1989-1991) through the 2015-2016 National Health and Nutrition Examination Survey 
                        <PRTPAGE P="106080"/>
                        (NHANES)) (Refs. 2, 36, and 37) demonstrate that the highest percentage of the U.S. population ages 4 and older reported four eating occasions per day. Note that we excluded beverage-only eating occasions from our analysis of the 2015-2016 NHANES data to focus only on eating occasions that provided consumers with a meaningful opportunity to consume foods from all the recommended food groups.
                    </P>
                    <P>While some comments question the equal division among the four eating occasions, we decline to change this method for the final rule. For this rule, we analyzed the most current national consumption data, the 2017-March 2020 NHANES (Refs. 2 and 38), and determined that the median number of eating occasions (meals plus snacks) per day continues to be four eating occasions (not including beverage-only eating occasions) (Refs. 2 and 38). The data from NHANES 2017-2020 describe both the number of meals eaten per day and the number of snacks eaten per day. The data demonstrate that the highest percentage of people reported eating three meals per day. The highest percentage of people also reported eating one snack per day. Analysis of the combined eating occasion data show that the highest percentage of people reported having four eating occasions per day (meals plus snacks). We note that a study cited in the comments examined the same NHANES data that we used in our analysis. However, the study considered reports of beverage-only occasions whereas we excluded beverage-only occasions. Therefore, total number of eating occasions are different.</P>
                    <P>
                        The typical sizes of meals and snacks may differ but are not weighted differently when dividing the recommended daily food group amounts to determine the FGE amounts. This is because the meals and the snack are all eating occasions that provide consumers with an equal opportunity to consume foods from the recommended food groups. For example, the recommended daily amount for fruit is 2 cups per day, and consumers have the opportunity to consume fruit at all three meals and at a snack. Therefore, it is reasonable to divide the recommended daily amount for fruit among the four eating occasions equally, which results in an FGE amount of 
                        <FR>1/2</FR>
                         c-eq of fruit (2 c-eq divided by four eating occasions). We further note that this method is consistent with FDA's method in previous labeling rulemakings and relies on the same rationale (see final rules on general requirements for health claims and nutrient content claims in food labeling, 58 FR 2478 at 2495 and 58 FR 2302 at 2379-2380).
                    </P>
                    <HD SOURCE="HD3">3. FGEs for Vegetables</HD>
                    <P>
                        (Comment 15) Some comments request that FDA provide more guidance on how to convert various forms of fruit and vegetable groups into a 
                        <FR>1/2</FR>
                         c-eq vegetables per RACC that we proposed as the FGE amount for vegetables, taking into consideration the changes in density that occur from processing steps such as chopping, pureeing, grating, and cooking. The comments also ask that FDA provide guidance on how to convert dried fruits and vegetables, including those in powdered forms, into the whole equivalent “single strength” form for purposes of determining the food group contribution.
                    </P>
                    <P>
                        (Response 15) We are aware that the examples of FGEs described in the proposed rule did not represent all possible forms of foods, including different forms of vegetable products, such as chopped, dried, or grated vegetables. However, as noted in the proposed rule, the FGEs are based on the cup- and ounce-equivalents developed for the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         (Ref. 1). The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         and the FPED (Ref. 3), which is used to develop the Healthy Dietary Patterns for the guidelines, provide detailed information about cup- and ounce-equivalents of different foods and beverages and are resources that can help manufacturers determine the appropriate FGE amounts. For example, the FPED describes that sliced, diced, or chopped raw vegetables are given the same cup weight and the cup weights are typically the average weights of different cuts. The FPED provides the example of raw carrots which are assigned a 125-gram cup weight, which is an average of one cup of sliced (122 g) and chopped (128 g) carrots (Ref. 3). We note that, as explained in Response 44, vegetable powders may be considered in the calculation of vegetable FGEs, which represents a change from the proposed rule.
                    </P>
                    <P>(Comment 16) Some comments support FDA's approach to include FGEs in the proposed “healthy” criteria on the basis that it would encourage increased consumption of fruits and vegetables but assert that the proposed approach to FGEs may limit products that can meet the requirements because they do not provide the required amount of FGEs. The comments assert that FDA should allow products to count “partial FGEs,” which could allow additional products to meet the FGE requirement for vegetables.</P>
                    <P>
                        (Response 16) As explained in Response 8, we do not intend to exclude foods consumed in small amounts that are recommended for healthful dietary patterns, including various vegetable products. Thus, we revised the rule at § 101.65(d)(3)(ii)(B) to provide methods for addressing the qualification of foods with small RACCs. We also revised the rule, at § 101.65(d)(i), to include a single-ingredient exemption, which expands the exemption for raw, whole fruits and vegetables to other nutrient-dense forms of fruits and vegetables (as well as to foods in other food groups). The expanded exemption will result in more fruit and vegetable products (
                        <E T="03">i.e.,</E>
                         single-ingredient fruits and vegetables without added ingredients besides water) qualifying for “healthy,” regardless of their RACC size (
                        <E T="03">e.g.,</E>
                         chopped or frozen fruits and vegetables). This single-ingredient exemption is discussed in Response 9.
                    </P>
                    <P>(Comment 17) Some comments urge FDA to consolidate the food groups for fruits and vegetables. The comments assert that combining the fruit and vegetable food groups would avoid “arbitrary distinctions” for products that contain a mixture of fruits and vegetables, and that a product that contains meaningful amounts of fruits, vegetables, or fruits and vegetables together should be treated the same, regardless of the precise contribution to the fruit group versus the vegetable group. One comment requests that FDA combine the fruit and vegetable groups for children ages 1-3 to provide flexibility for foods that contain meaningful amounts of fruits and vegetables collectively.</P>
                    <P>
                        (Response 17) We decline to combine the fruit and vegetable food groups in this final rule. Fruits and vegetables are considered different food groups in the Dietary Guidelines and have separate daily recommended intake amounts. As noted on the MyPlate website (
                        <E T="03">https://www.myplate.gov/</E>
                        ), while botanically, most vegetables are considered fruits, the two groups are separated for nutritional and culinary purposes, meaning distinctions are made based on nutrient content, use in meals, and taste (
                        <E T="03">e.g.,</E>
                         fruits are generally considered sweet or tart, while vegetables are not). Each food group provides a particular array of nutrients, and the recommended intake amounts of the different food groups reflect dietary patterns that are associated with positive health outcomes (Ref. 1). Healthy dietary patterns include intakes of foods from across the different food groups recommended by the Dietary Guidelines, including the fruit and vegetable food groups. Thus, vegetables 
                        <PRTPAGE P="106081"/>
                        and fruits are distinct food groups that contribute their own nutrients and have separate recommended amounts for healthy dietary patterns. This distinction is applicable to foods directed at all ages, including foods intended for consumption by children over 2 years of age. As discussed in the Dietary Guidelines, individuals in all life stages are encouraged to consume foods from across all food groups to meet nutrient intake needs. Finally, the comments suggesting combining the vegetable and fruit group FGEs did not provide information on the benefits of combining the two food groups nor the effects such an action would have on the ability to construct healthy dietary patterns, and thus we have no basis on which to make such a change.
                    </P>
                    <P>Considering the conventional distinction between fruits and vegetables in diets and food preparation purposes, the differences in nutrient contributions from the two food groups, and consistency with the Dietary Guidelines, we do not agree that the vegetable and fruit food groups should be combined. The rule, therefore, retains the framework of the vegetable food group and fruit food group as two distinct food groups. However, we have modified the criteria in other ways to provide additional flexibility for mixed products, for example, with the expanded single-ingredient exemption for nutrient-dense foods encouraged by the Dietary Guidelines (see Response 9, § 101.65(d)(3)(i)), and for mixed products, main dishes, and meals, for example, through added flexibility in the proportions required for FGE requirements (see Response 106, § 101.65(d)(3)(iii)-(v)). These modifications should help address the comments' concerns relating to the requirements for mixed products containing a mix of fruits and vegetables. For example, mixed products, such as a frozen mix of fruit and vegetables or a blend of 100% juices that contains 80% fruit juice and 20% vegetable juice, that do not contain additional ingredients besides water, will automatically qualify to bear the claim under the expanded single-ingredient exemption.</P>
                    <HD SOURCE="HD3">4. FGEs for Fruits</HD>
                    <P>
                        (Comment 18) Some comments request that FDA provide more guidance on how to convert various forms of fruit and vegetable groups into a 
                        <FR>1/2</FR>
                         cup, taking into consideration the changes in density that occur from processing steps such as chopping, pureeing, grating, and cooking. One comment notes that moisture and solid levels vary among fruits and vegetables, and the conversion of 1 cup fresh or cooked fruits or vegetables to 
                        <FR>1/2</FR>
                         cup dried fruits and vegetables may not accurately reflect all types of fruits and vegetables. The comment requests that FDA allow food companies flexibility to use reasonable options for determining FGEs of their products when converting between dried and rehydrated forms of fruits and vegetables.
                    </P>
                    <P>(Response 18) We recognize that additional information on FGEs may be helpful and we respond to the comments requesting options for determining FGEs for different forms of fruit products, such as dried and rehydrated fruits (with regard to both vegetables and fruits) above in section V.C.3 (“FGEs for Vegetables”). We also provide information about available resources to support the determination of FGE amounts in Response 6 and 12.</P>
                    <P>
                        (Comment 19) A number of comments do not support a “healthy” claim being on 100% fruit juice. One comment provides that, although 100% fruit juice in small amounts may offer a way for people to obtain important nutrients and contribute to dietary recommendations for fruit intake, 100% fruit juice is likely to be overconsumed because of its high palatability and accessibility. The comment says that the presence of a “healthy” claim may promote excess consumption of 100% fruit juice, which could contribute large amounts of unnecessary calories and sugar to the diet. Some comments note that the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         provides that whole fruit is the preferred way to meet the recommended fruit intake amounts.
                    </P>
                    <P>
                        (Response 19) We disagree that 100% juice should not be able to qualify to bear the “healthy” claim. The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         states that foods in the fruit food group include both whole fruits and 100% juice, and the Healthy U.S.-Style Dietary Pattern for ages 2 and older includes 100% juice as a food that contributes to the healthy dietary pattern. As discussed in the 2020 DGAC report, 100% juice is a nutrient-dense food that does not contribute energy through added sugars and contributes to meeting nutrient and food group needs (Ref. 8). The comments suggesting that 100% fruit juices being labeled as “healthy” may promote excess consumption do not provide evidence that would contradict or cause us to question the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         As discussed elsewhere, the purpose of this rule is to help consumers identify foods that are particularly useful in creating a diet that is consistent with dietary recommendations. Based on the contributions of 100% juice, including both fruit and vegetable juice, to healthy dietary patterns as presented in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         and Healthy U.S.-Style Dietary Pattern for ages 2 and older, we are including 100% fruit and vegetable juice among foods that are eligible to bear the “healthy” claim (Ref. 1). Additionally, we include in this rule a single-ingredient exemption for nutrient-dense foods that are encouraged by the Dietary Guidelines with no added ingredients, except for water (see Response 9).
                    </P>
                    <P>(Comment 20) Some comments do not support fruit puree and fruit paste being able to qualify for the “healthy” claim because, according to the comments, they often do not contain fiber-containing parts of the whole fruit and are seldom consumed independently. For example, if the whole fruit or vegetable is not used in making the purees or pastes, such as if the skin is removed from apples before making applesauce, then the purees could have lower fiber content than the whole fruit or vegetable.</P>
                    <P>
                        (Response 20) As stated in the proposed rule (87 FR 59168 at 59184), FDA considers concentrated fruit and vegetable purees and pastes to be fruits and vegetables for the purpose of calculating FGEs because these products are essentially fruits and vegetables that have been processed to change the physical form of the fruit or vegetable and to remove moisture. While removal of the skin of fruits and vegetables for concentrated fruit and vegetable purees and pastes may affect total fiber content compared with whole, intact fruits and vegetables, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         includes purees, such as applesauce, in the food groups for fruits without qualification related specifically to fiber content. Fruits and vegetables provide a wide array of nutrients and are consumed in a wide variety of forms. Some forms of fruits and vegetables are consumed without skins, even when the skins are edible, such as in canned and frozen varieties. Even with the removal of fruits and vegetable skins, the overall nutrient profiles of purees and pastes remain within the range of the varied available forms of fruits and vegetables. For the development of the Healthy U.S.-Style Dietary Pattern, the FPED also included applesauce puree with a c-eq of 245 g. Similarly, pastes, such as tomato paste, are included in the food group for vegetables and the FPED provides a c-eq of 120 g. Fruit and vegetable purees and pastes are foods that are included in the fruit and vegetable food groups in the Dietary Guidelines. Thus, under the final rule, fruit and vegetable purees and paste are eligible to bear a “healthy” 
                        <PRTPAGE P="106082"/>
                        claim as individual vegetable foods, if they meet the applicable FGE and NTL criteria (see § 101.65(d)(3)(ii)). Furthermore, fruit and vegetable pastes and purees that contain no other ingredients, except for the addition of water, would be included under the single-ingredient exemption (see Response 9, § 101.65(d)(3)(i)). In addition, although fruit pastes and purees can be used as ingredients in foods such as yogurts and bakery products, the mere presence of pastes and purees in those products does not enable such products to qualify for use of the claim. Food products, such as bakery products containing fruit pastes and purees, would continue to be evaluated based on the overall criteria set forth for their food category. Likewise, packaged products of fruit pastes and purees would be evaluated on the criteria set forth for fruit products, regardless of any potential use as ingredients in other food products.
                    </P>
                    <HD SOURCE="HD3">5. FGE for Grains and Whole Grains</HD>
                    <P>
                        (Comment 21) Many comments support the general approach to grain products (
                        <E T="03">i.e.,</E>
                         that grain products must contain a 
                        <FR>3/4</FR>
                         oz-eq of whole grains to bear the “healthy” claim) and mention that the approach supports consumers in achieving the Dietary Guidelines recommendation that at least half of total grains consumed be whole grains. However, some comments assert that grain products should have to meet additional criteria to qualify for the “healthy” claim, such as being required to be nearly 100% whole grain and minimally processed.
                    </P>
                    <P>
                        (Response 21) We developed the FGEs to help consumers identify foods that can help them meet the recommended daily food group amounts as described in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         and the Healthy U.S.-Style Dietary Pattern. Whole grains are grains that have the entire grain kernel, which includes the bran, germ, and endosperm, while refined grains have been processed to remove the bran and germ. Some refined grains are enriched. Enriched grain products are refined grains that have specific nutrients added back to replace losses of the nutrients that occur during processing (Ref. 4). Setting the FGE for grain products at 
                        <FR>3/4</FR>
                         oz-eq of whole grains helps consumers identify foods that can help them meet the recommended 3 oz-eq of whole grains per day. Although some comments suggest that grain products labeled “healthy” should be entirely whole grains and/or minimally processed, we find that those conditions are unnecessary if the food contains an FGE of whole grains. A food that contains a full FGE of whole grains, but is not 100% whole grain or is processed, still contributes to meeting the recommended daily amount of 3 oz-eq of whole grains per day, which supports the primary objective of the FGEs. Therefore, we decline to require proportions of overall whole grains or processing limitations to whole grain foods beyond the criteria set in the definition. We note that the 
                        <E T="03">Dietary Guidelines 2020-2025</E>
                         recommends that any refined grains that consumers choose be enriched grains.
                    </P>
                    <P>
                        (Comment 22) Some comments request that we adjust the proposed FGE requirement for whole grains to align with the recommendations in the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         which is 8 g of whole grains per 1 oz-eq (
                        <E T="03">i.e.,</E>
                         if half of the grains are whole grains). One comment provides that the 
                        <E T="03">Dietary Guidelines</E>
                         recommends 6 ounce-equivalents of grain foods per day, with at least half of those being whole grains. According to the comment, under the proposed rule, foods with 8 g whole grain per oz-eq that meet the nutrient limits for saturated fat, added sugars, and sodium would not qualify for the “healthy” claim. The comment suggests that FDA align the whole grain threshold with the recommendations in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         of 8 g per oz-eq. The comment also recommends that the requirements for the whole grain criteria be provided in grams present per reference amount.
                    </P>
                    <P>
                        (Response 22) Although the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         provides individuals with multiple strategies to facilitate shifts in eating habits, the primary objective of the food group recommendations is to help consumers meet the recommended 3 oz-eq of whole grains per day. Both the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         and the FPED explain that a 1 oz-eq of whole grains is 16 g of whole grains. The comments suggest that the criteria should align with one of the strategies to facilitate shifts in eating habits discussed in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         to choose foods whose grain components are comprised of at least 50% whole grains, which would be 8 g per oz-eq. However, the FGE requirement for whole grains included in the updated “healthy” criteria is based on the Dietary Guidelines' recommended amount of 3 oz-eq of whole grains per day. To determine the amount of FGE required for a food to bear the “healthy” claim, the recommended daily food group amounts are divided among the four eating occasions typically consumed. Consequently, the rule sets the FGE for grains at 
                        <FR>3/4</FR>
                         oz-eq of whole grains (see § 101.65(d)(2)), which would be calculated as 12 g of whole grains per RACC (16 g of whole grains multiplied by 
                        <FR>3/4</FR>
                        ). Therefore, we are not lowering the amount of whole grains needed to qualify, as the goal of this FGE is to help consumers identify foods that can help them reach the 3 oz-eq per day recommended for whole grains. The strategies discussed in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         to help people consume more whole grains can be helpful, however, and can be communicated to consumers in many ways, both on food labels and through communications and education outside of labeling.
                    </P>
                    <P>Additionally, we decline to shift to using gram amounts as the basis for compliance with the FGE requirements, as suggested by the comment. As discussed in Response 33, the concepts of cup and ounce equivalents incorporate the calculation of the specific gram weights of individual foods. The use of oz-eq for the whole grain FGE allows for the calculation of gram amounts for individual foods. FGEs in cup- and ounce-equivalents allow for the calculation of specific amounts of FGEs in foods, including in grams, that exist in a wide variety of forms and that could be measured in different measurement units.</P>
                    <P>(Comment 23) Some comments on the whole grain FGEs request that we provide additional guidance and examples on how to calculate the FGEs. The comments also indicate that the FGE calculations could potentially exclude a wide variety of foods which are inherently whole grain, such as whole wheat flour, and foods made from whole grains, such as whole wheat bagels.</P>
                    <P>(Response 23) We discuss some examples of resources for the determination of FGE amounts in Response 12. As noted in Response 12, the final rule sets a compliance date that is 3 years from the effective date, and we intend to provide additional resources to help manufacturers comply with the final rule before the end of the compliance period. Additionally, because of the single-ingredient exemption that we are providing (§ 101.65(d)(3)(i)), single-ingredient whole grains that meet the criteria for the single-ingredient exemption would automatically qualify for the claim without having to meet FGE or NTL criteria.</P>
                    <P>
                        (Comment 24) Several comments assert that refined grain foods with an inherent or fortified nutrient to encourage should be able to bear a “healthy” claim as they can be part of a healthy dietary pattern and are encouraged by the 
                        <E T="03">
                            Dietary Guidelines, 
                            <PRTPAGE P="106083"/>
                            2020-2025.
                        </E>
                         The comments mention that the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         does not require that all grains are whole, but instead encourages people to “make half their grains whole” and to choose enriched grain products when consuming refined grains. The comments provide that enrichment and fortification of grains improves intake of several nutrients, including nutrients such as iron and folate, which are critical for women of childbearing age.
                    </P>
                    <P>Some comments note that although FDA's food group approach to “healthy” labeling is conceptually reasonable and may work well for some food groups, the approach raises concerns when applied to the grain group. The comments urge FDA to ensure that the “healthy” criteria do not unintentionally discourage consumption of other grain foods recommended by the Dietary Guidelines, including enriched grains, asserting that less than 8% of Americans consume the minimum recommendation for whole grain foods and that fiber is an underconsumed food component. The comments ask that the “healthy” labeling distinguish staple grain foods from “indulgent grain products” that should be consumed less often.</P>
                    <P>
                        Another comment asserts that the “healthy” nutrient content claim should allow refined or enriched grains to use the healthy claim if they provide a good or excellent source of fiber and meet the added sugar, saturated fat, and sodium limits. According to the comment, the main concern cited in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         regarding refined grains is that they commonly contain added sugar, sodium, and saturated fat. The comment states that if a product meets the criteria for added sugars, sodium, and saturated fat and contains one or more components of public health concern (
                        <E T="03">i.e.,</E>
                         those that are underconsumed in the U.S. population) at meaningful levels, that product should be included in a healthy eating pattern.
                    </P>
                    <P>
                        (Response 24) As previously stated, the purpose of the “healthy” claim is to highlight those foods that are particularly useful in creating a diet that is consistent with current dietary guidelines. For grains consumption, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         states that healthy dietary patterns include whole grains and limit the intake of refined grains. While refined grains can be included in a healthy diet, the objective identified in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         is to meet the recommended daily amount of grain foods intake mostly through whole grains. Most Americans already meet the recommendations for overall grain intake in their diets. However, 98% do not meet the whole grain intake recommendations, and 74% consume more refined grains than recommended (Ref. 1). The “healthy” claim can help consumers identify the whole grain foods that are characteristic of a healthy dietary pattern so that they may shift grain consumption from predominantly refined grains to more whole grains. Although we recognize that some refined grain foods are staple foods for some groups and may contain important nutrients such as iron or fiber, they are not among the core elements included in healthy dietary patterns. For this reason, the FGEs for grain foods in the rule are set to a specific amount of whole grains, not refined grains (§ 101.65(d)(2)). Additionally, a food that contains a full FGE of whole grains, but is not 100% whole grain (
                        <E T="03">i.e.,</E>
                         also contains refined grains), could still meet the FGE criteria to qualify for the “healthy” claim. Even though the food is not 100% whole grain, it would still contribute to meeting the recommended daily amount of 3 oz-eq of whole grains, which supports the primary objective of the FGEs. While certain foods containing refined or enriched grains may not contain any whole grains, they could contain full FGEs from other food groups, such as vegetables. Based on the entire composition of the food product and the presence of other food group components, these products may also be able to qualify for the “healthy” claim.
                    </P>
                    <P>(Comment 25) A number of comments mention that the proposed rule would disqualify many grain foods, including the majority of ready-to-eat cereals on the market, from using the term “healthy.” The comments note that research shows ready-to-eat cereal is one of the most affordable, accessible, and nutrient-dense breakfast choices a person can make.</P>
                    <P>
                        (Response 25) As discussed in the previous response, whole grains are core elements of a healthy dietary pattern; accordingly, the rule sets the grain FGE with whole grain requirements and does not include requirements for refined grains. Ready-to-eat cereals that are comprised primarily of refined grains instead of whole grains may not be able to meet the FGE for whole grains in the rule and qualify for use of the “healthy” claim. However, there are many cereals on the market that are made with whole grains, and our review of the current food marketplace showed that many of these cereals contain the rule's required FGE amount of whole grains (Ref. 2). Furthermore, while there are cereals made with whole grains that do not currently meet the FGE for whole grains in the rule, some have levels of whole grain that are close to the 
                        <FR>3/4</FR>
                         oz-eq FGE amount, and manufacturers could choose to reformulate the product to meet the rule's FGE requirement, should they want the product to qualify for the “healthy” claim.
                    </P>
                    <P>Ready-to-eat cereals currently made with refined grains, and those with whole grains in amounts that do not meet the required FGE amount, can still play a role in the diets of consumers. Foods that do not qualify for use of the claim are not necessarily “unhealthy” or unable to provide any nutritional benefits to consumers. As previously discussed, the purpose of the “healthy” claim is to highlight those foods that are particularly useful in creating a diet that is consistent with current dietary guidelines. Ready-to-eat cereals, especially those without or with low levels of added sugars, sodium, and saturated fat, can provide numerous nutrients, such as iron or folate, and manufacturers can continue to communicate those nutritional attributes in many different ways.</P>
                    <P>
                        (Comment 26) One comment requests lowering the proposed 
                        <FR>3/4</FR>
                         oz-eq of whole grain per RACC requirement for products with a RACC of 15 g or less to 0.375 oz-eq per RACC. The comment expresses that many of its products that mainly contain whole grains would be unable to qualify as “healthy” under the proposed rule because, given their small RACC, they would not be able to meet the 
                        <FR>3/4</FR>
                         ounce-equivalent of whole grain.
                    </P>
                    <P>
                        (Response 26) As discussed earlier, we acknowledge that certain foods recommended by current nutrition science and Federal dietary guidance would be unable to meet the proposed criteria for the healthy claim due to being typically consumed in small amounts. Therefore, the rule now applies the “healthy” criteria to individual foods with a RACC of 50 g or less or 3 Tbsp or less on a per 50 g basis instead of a per RACC basis (see § 101.65(d)(3)(ii)). Applying the “healthy” criteria to grain products that have RACCs of 15 g on a 50 g basis, results in foods of this RACC size to meet the FGE of 
                        <FR>3/4</FR>
                         oz-eq of whole grains. For example, a grain food with a RACC of 15 g that contained 0.375 oz-eq of whole grains, which would be equal to 6 g of whole grains, can qualify on a per 50 g basis. The calculated amount of whole grains in that food would be 20 g of whole grains per 50 g (50 g divided by 15 g and then multiplied by 6 g and then rounded up to 20 g). This food qualifies for the FGE of 
                        <FR>3/4</FR>
                         oz-eq (12 g). Therefore, lowering the FGE amount, as suggested in the comment, is unnecessary, and the 
                        <PRTPAGE P="106084"/>
                        concern raised by the comment is addressed by the fact that foods of that RACC size can now meet the whole grain FGE on a per 50 g basis. As such, we decline to lower the FGE amount. The final rule retains the FGE requirement for grains of 
                        <FR>3/4</FR>
                         oz eq whole grains (§ 101.65(d)(3)(ii)(B)).
                    </P>
                    <P>(Comment 27) Some comments express that FDA's sole focus on whole grains as the criteria for grain products to qualify for the “healthy” claim is overly simplistic and would not address the Dietary Guidelines recommendations of a balanced diet. The comments request that FDA provide updated educational resources for consumers on choosing all types of grains, including enriched refined grains without solid fats or sugars, to meet Dietary Guidelines recommendations.</P>
                    <P>
                        (Response 27) The objective of the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         is to encourage consumption of those foods and food groups that are common in healthy dietary patterns, and the “healthy” claim can help consumers identify foods that are particularly useful in helping them achieve a diet consistent with current dietary recommendations. We explained earlier why the criteria for the “healthy” claim will focus on whole grains and not refined grains, as whole grains are core elements of healthy dietary patterns. For the same reasons, we intend to focus our educational efforts on consumption of whole grains. We have, however, expressed throughout this rule that foods that are unable to qualify for the “healthy” claim are not “unhealthy” and can still be incorporated as part of a healthy dietary pattern. We plan to also incorporate this messaging in consumer education efforts related to the “healthy” claim.
                    </P>
                    <P>(Comment 28) One comment asserts that the labeling of grain foods is confusing in part due to misleading advertising and encourages FDA to improve the labeling of whole grains to improve transparency for consumers. The comment asks that whole grain products that meet the criteria for the “healthy” labeling claim be required to disclose the percentage of both whole and refined grains.</P>
                    <P>
                        (Response 28) We have determined that setting the FGE for grain products at 
                        <FR>3/4</FR>
                         oz-eq of whole grains helps consumers identify foods that can help them meet the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommended 3 oz-eq of whole grains per day. A food that contains a full FGE of whole grains, but is not 100% whole grain, still contributes to meeting the recommended daily amount of 3 oz-eq, which supports the primary objective of the FGEs. For these reasons, we decline to require additional information about grain content or any other qualifying criteria as part of the “healthy” claim. However, if manufacturers choose to do so, they may use other claims and truthful and non-misleading statements about the nutritional qualities of their foods in addition to the use of the “healthy” claim. For example, a food that bears a “healthy” claim could also make claims about whole grain or fiber content, provided that the food meets all applicable requirements for such claims.
                    </P>
                    <HD SOURCE="HD3">6. FGE for Dairy</HD>
                    <P>
                        (Comment 29) Some comments disagree with the proposed 
                        <FR>3/4</FR>
                         c-eq per RACC for the dairy group to qualify for the “healthy” claim, stating that it is confusing to consumers and places an unnecessary burden on industry. The comments assert that the 
                        <FR>3/4</FR>
                         c-eq for dairy is less actionable for consumers because it does not equate to a recommended serving as provided in the 
                        <E T="03">Dietary Guidelines.</E>
                    </P>
                    <P>
                        Some comments urge FDA to adopt an FGE of 
                        <FR>1/2</FR>
                         c-eq dairy for natural cheese. The comments note that few cheeses would qualify for the “healthy” nutrient content claim under the proposed “healthy” definition. A number of comments assert that using the proposed 
                        <FR>3/4</FR>
                         c-eq for dairy would cause many cheeses, including fat-free or low-fat forms, to be unable to bear the “healthy” claim, based solely on the amount of serving equivalents set by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         and the defined RACCs. The comments also state that it may be difficult to determine whether a cheese is eligible for a healthy claim, because cheeses have varying weights and densities.
                    </P>
                    <P>
                        (Response 29) In response to these comments, we reviewed the current marketplace related to the RACC sizes of different dairy products and the amounts of FGEs contained in those foods (Ref. 2). This review showed that the comments were correct that a number of dairy foods, including some cheeses and many yogurts, would not meet the proposed FGE of 
                        <FR>3/4</FR>
                         c-eq of dairy. However, the amount of dairy in many of those products was close to meeting the FGE amounts (ranging from about 0.69 to 0.71 c-eq per RACC). Dairy products, including milk, yogurt, and cheese, especially in fat-free and low-fat forms, are included in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         as core elements of healthy dietary patterns. Although the proposed FGE threshold was set to help consumers identify foods that could help them meet the recommended daily amount of dairy, we do not intend to exclude nutrient-dense foods that are recommended for healthful dietary patterns. We have already addressed the issue of foods with small RACCs in Response 8 and the methods provided for addressing small RACC foods will result in many dairy foods with small RACCs, such as natural cheeses, being able to meet the FGE amounts. However, there are some other dairy foods that do not have small RACCs and that still would not meet the FGE amounts. Therefore, we have revised the FGE threshold for dairy in the rule to 
                        <FR>2/3</FR>
                         c-eq per RACC (see § 101.65(d)(2)). Examples of 
                        <FR>2/3</FR>
                         c-eq of dairy are 
                        <FR>2/3</FR>
                         cup fat-free or low-fat milk, yogurt, or lactose-free versions of these products, or fortified soy beverage or yogurt alternatives; and 1 oz natural cheese or 
                        <FR>2/3</FR>
                         oz processed cheese.
                    </P>
                    <P>
                        As discussed, the FGE threshold was set to help consumers identify foods that could help them meet the recommended daily amount of dairy, which is 3 c-eq per day. With an FGE set at 
                        <FR>2/3</FR>
                         c-eq and an opportunity for consumption at four eating occasions per day, the daily amount achieved would be 2 
                        <FR>2/3</FR>
                         c-eq of dairy per day (
                        <FR>2/3</FR>
                         c-eq multiplied by four), and the total amount consumed would be close to the recommended 3 c-eq daily intake. Setting the FGE at a lower level will result in more dairy foods being able to meet requirements for the “healthy” claim, which could provide more dairy options labeled as “healthy” for consumers to choose from. Dairy products are underconsumed in the United States, with 90% of consumers not meeting the daily recommendation currently (Ref. 1). The adjustment to the dairy FGE is similar to how adjustments were made to some FGEs in the proposed rule, such as the vegetable food group, which is also underconsumed. Because vegetables are underconsumed with 90% of consumers not meeting the vegetable intake recommendation, the FGE amount was slightly rounded down to 
                        <FR>1/2</FR>
                         c-eq. Setting the FGE requirements for underconsumed food groups at a slightly lower amount makes it easier for foods in those groups to qualify for the claim and allows for more foods on the market to be labeled “healthy.” More nutrient-dense dairy options being able to be labeled as “healthy” may help consumers in identifying and choosing nutrient-dense dairy options that can help them meet the daily recommendation.
                    </P>
                    <P>
                        Although some comments suggest setting the FGE threshold at even lower amounts than 
                        <FR>2/3</FR>
                         c-eq, such as 
                        <FR>1/2</FR>
                         c-eq, amounts lower than 
                        <FR>2/3</FR>
                         c-eq would make meeting the daily recommended amount 
                        <PRTPAGE P="106085"/>
                        for dairy difficult. Requiring a minimum of 
                        <FR>2/3</FR>
                         c-eq for the dairy FGE to meet the FGE requirement for the “healthy” claim would enable consumers to identify dairy products that would help them approach meeting the daily recommended amounts for dairy and result in many nutrient-dense dairy options qualifying for the “healthy” claim. We note that the FGE amounts are criteria for manufacturers to use when determining if a product qualifies for the “healthy” claim. The presence of a “healthy” claim on a product that meets the criteria will simply help consumers to identify foundational foods for building healthy dietary patterns. To support this goal, we intend to engage in consumer education efforts related to the “healthy” claim.
                    </P>
                    <P>(Comment 30) One comment notes that there are disparities in dairy consumption related to race and ethnicity, with non-Hispanic Black and Asian children and adults consuming the least amount of dairy. The comment also mentions that lactose intolerance is significantly more prevalent among Black and Hispanic Americans than in non-Hispanic white populations, and that natural cheeses such as cheddar, mozzarella, and Monterey Jack are “virtually lactose-free” dairy options upon which individuals with lactose intolerance rely. According to the comment, limiting the labeling of cheese as a “healthy” food could further widen the disparity gap in dairy consumption. The comment asserts that dairy consumption needs to be encouraged across age, race, and ethnic groups to achieve the daily dairy recommendation as a part of healthy eating patterns to help advance health equity. Some comments note that plant-based dairy foods are alternative dairy sources for those with lactose intolerance.</P>
                    <P>
                        (Response 30) The criteria for foods to bear the “healthy” claim are intended to help consumers identify foods that are foundational to a healthy dietary pattern. As noted in Response 29, we have lowered the FGE amount for dairy to 
                        <FR>2/3</FR>
                         c-eq, which will result in more dairy foods being able to meet the FGE requirements for the “healthy” claim and may result in more dairy options labeled as “healthy” for consumers to choose from (
                        <E T="03">e.g.,</E>
                         more yogurts). There are other options in the dairy group for individuals who are lactose intolerant that could qualify for “healthy,” such as certain lactose-free versions of dairy products or certain dairy products that are naturally lactose-free. Also, fortified soy milk, and plant-based dairy alternatives with similar nutrient composition as dairy are included in the dairy food group for the purposes of the “healthy” claim, which can provide alternatives to individuals who are lactose-intolerant. The 
                        <E T="03">Dietary Guidelines, 2015-2020</E>
                         discusses that key nutrient contributions from dairy foods include calcium, protein, vitamin A, vitamin D, magnesium, phosphorous, potassium, riboflavin, vitamin B12, zinc, choline, and selenium (Ref. 4). As we noted earlier in this rule, while not all dairy foods may qualify for use of the claim, the use of the “healthy” claim on some foods is not intended to signal that all other foods are “unhealthy,” including foods consumed by certain subgroups of the population (see section III.A (“Need for the Regulation/History of This Rulemaking”). Other foods are still available for consumption and manufacturers can communicate truthful and non-misleading information about lactose-free foods or information that encourages culturally appropriate consumption of dairy foods on the food label outside of use of the “healthy” claim.
                    </P>
                    <P>(Comment 31) Some comments assert that ambiguity in the determination of the FGEs of certain dairy foods, including yogurt, could lead to inconsistency in manufacturer calculations of FGEs and confusion among consumers. A number of comments request that FDA provide a list, examples, or maintain a database for manufacturers to use in calculating the amount of FGEs delivered by each food.</P>
                    <P>(Response 31) The comments on the dairy FGEs echoed the requests in the comments across the food groups for guidance in determining the FGE amounts for foods in this group. We provide a general discussion on available resources to support determination of FGE amounts in Response 12. For example, fluid milks and yogurts are calculated at 245 g for a one c-eq in the FPED database (Ref. 3). As noted in Response 12, the final rule sets a compliance date that is 3 years from the effective date, and we intend to provide additional resources to help manufacturers comply with the final rule before the end of the compliance period.</P>
                    <P>(Comment 32) Some comments request guidance regarding what dairy alternatives might be considered “healthy.” Some comments note that, according to the Dietary Guidelines, alternative beverages such as almond, rice, coconut, or hemp milks are not nutritionally equivalent to milk and are therefore not included in the dairy foods group. The comments note that dairy foods contribute nutrients such as calcium, vitamin D, and potassium to the American diet. One comment provides that, according to the Dietary Guidelines, only fortified soy products are nutritionally similar to dairy products and can serve as a replacement to dairy products. However, other comments support the inclusion of plant-based dairy alternatives in the dairy group. The comments mention that many people do not consume dairy products for a variety of reasons, such as allergy, intolerance, cultural practices, or preference. Many comments that support inclusion of plant-based dairy alternatives in the dairy group request that FDA set forth specific nutritional criteria that plant-based dairy alternatives must meet to qualify for the “healthy” claim. One comment asserts that if FDA permits nutritional comparisons between plant-based and traditional dairy products through the use of the term “healthy,” then FDA should require the plant-based products to bear the imitation labeling outlined in § 101.3(e) (21 CFR 101.3(e)).</P>
                    <P>
                        (Response 32) In the proposed rule (87 FR 59168 at 59187), we determined that including fortified plant-based dairy alternatives among the food options in the dairy group can help consumers identify foods that can help them increase their dairy group intake and meet the dairy group daily intake recommendations. We specifically limited plant-based milk alternatives and plant-based yogurt alternatives that could qualify for the claim to those products whose overall nutritional content is similar to dairy foods (
                        <E T="03">e.g.,</E>
                         provide similar amounts of protein, calcium, potassium, vitamin D, and other nutrients) and are used as alternatives to milk and yogurt. We discussed in the proposed rule that, when the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         published, fortified soy beverages and yogurts were the only alternatives that were nutritionally comparable to dairy, and the composition data evaluated by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         demonstrated that the nutrient content in fortified soy beverages and yogurts is similar to that of dairy. Plant-based dairy alternatives are formulated foods, with evolving compositions and formulations. It is possible that plant-based dairy alternatives from sources other than soy, such as almond milk or oat milk, may be produced with nutritional profiles similar to dairy. If plant-based dairy alternatives are formulated with nutritional profiles similar to that of dairy, then it would be appropriate for those products to be considered among the food options in the dairy group. Although not mentioned in the proposed rule, in 
                        <PRTPAGE P="106086"/>
                        addition to plant-based milk and yogurt alternatives, plant-based cheese alternatives are also available on the market. Currently, these plant-based cheese alternatives do not have similar nutrient composition to cheese. However, as with plant-based milk and yogurt alternatives, it is possible that in the future plant-based cheese alternatives may be produced with nutritional profiles similar to that of dairy. If those food products were to become available, they would be considered under the criteria for the dairy group to qualify for use of the “healthy” claim. We reiterate that, for purposes of this rule, it is only those plant-based dairy alternatives that have similar nutrition composition to dairy that will be included in the dairy group for purposes of qualifying for the “healthy” claim. For example, soy-based yogurt alternatives would need to have similar nutrient composition to traditional milk-based yogurt. Plant-based milk alternatives would, likewise, need to have similar nutrient composition to milk to be considered under the criteria for dairy foods in this rule. While nutrient profiles can vary among different dairy foods, the 
                        <E T="03">Dietary Guidelines, 2015-2020</E>
                         discusses that key nutrient contributions from dairy foods include calcium, protein, vitamin A, vitamin D, magnesium, phosphorous, potassium, riboflavin, vitamin B12, zinc, choline, and selenium (Ref. 4). We note that FDA has also published a draft guidance on the labeling of plant-based milk alternatives, and we requested comment on nutrient profiles of plant-based milk alternatives (Ref. 5). Requiring plant-based products to bear imitation labeling as outlined in § 101.3(e) is outside the scope of this rule.
                    </P>
                    <P>(Comment 33) Some comments question the use of FGEs, cup- and ounce-equivalents for the criteria for dairy foods. One comment notes that FDA has departed from the use of a defined gram-basis, the RACC, or labeled serving size as the basis for the “healthy” claim, without explanation. The comment urges FDA to consider a basis that is specific to certain types of dairy foods or the RACC.</P>
                    <P>
                        (Response 33) The claim “healthy' is a nutrient content claim and the criteria are applied on a per RACC basis, as is typically the case with nutrient content claims. The NTL criteria in the “healthy” definition are based on grams or milligrams per RACC, similar to other claims, but are reflected as percentages of the DV to allow flexibility in the future if there are changes in the DV for these nutrients. The FGE criteria introduced in the “healthy” definition are applied on a cup- and ounce-equivalent per RACC basis to be consistent with how food group recommendations are provided for in relation to dietary patterns. The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         provides food group recommendations in cup- and ounce-equivalents, such as 3 c-eq of dairy per day for a reference 2,000-calorie diet. The daily recommended amounts of the food groups are spread out throughout the day across an individual's eating occasions. Therefore, the amounts per eating occasion are also in cup- and ounce-equivalents. The concept of equivalents, however, incorporates the calculation of the specific gram weights of individual foods. In the example used earlier in this section for fluid milk and yogurt, 245 g is a one c-eq, as calculated in the FPED database. Calculating the FGE of 
                        <FR>2/3</FR>
                         c-eq results in an FGE amount of approximately 163 g for milk and yogurt. The use of cup- and ounce-equivalents allows for the calculation of specific amounts of foods that exist in a wide variety of forms.
                    </P>
                    <P>(Comment 34) One comment asserts that FDA is providing plant-based dairy alternative products a competitive advantage because manufacturers of these products may choose between two different FGEs (protein foods or dairy).</P>
                    <P>(Response 34) As discussed in Response 35, there are some foods, namely beans, peas, and lentils, that may be considered under either the protein or the vegetable food group for calculation of FGEs. However, plant-based dairy products that are labeled and marketed as dairy alternatives will be evaluated against the criteria for the dairy food group for the purposes of the “healthy” claim, as discussed in Response 32. Therefore, manufacturers of plant-based dairy alternative products are not able to choose between two different food groups for the calculation of FGEs.</P>
                    <HD SOURCE="HD3">7. FGEs for Protein Foods</HD>
                    <P>(Comment 35) One comment says that dry beans, dry peas, lentils, and chickpeas, known as pulses, are rich sources of protein, potassium, and dietary fiber, and provide other important minerals, such as magnesium, choline, and iron, and minimal amounts of added sugar, saturated fat, and sodium to the diet. The comment supports FDA's proposal to permit beans, peas, and lentils to be categorized as either a vegetable or a protein under the rule because the nutrient content is similar to other foods in both the protein and vegetable groups. The comment asserts that pulses are emerging in a variety of new forms, including flours, powders, spreads, purees, pastas, and proteins, and can be used in a wide variety of applications, such as pastas, plant-based entrees, baked goods, and beverages. The comment asserts that these varying forms contain the same nutritional benefits of pulses in their whole form and maintains that FDA should provide flexibility to allow for innovative pulse products to qualify as “healthy.”</P>
                    <P>
                        Other comments request that other sources of protein, including protein powders, isolates, and concentrates from whey, soy, and pea, be included in the protein foods group. The comments note that the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         includes soy flour, soy protein isolate, and soy concentrate in the protein group and provides that soy includes tofu, tempeh, and products made from soy flour, soy protein isolate, and soy concentrate. The comments assert that all plant-based proteins should be considered part of the protein foods group.
                    </P>
                    <P>
                        (Response 35) In the proposed rule (87 FR 59168 at 59185), we stated that for individual foods, the nutrient content of beans, peas, and lentils is similar to foods in both the protein foods group and in the vegetable group and may be counted under either food group. Similarly, for combination foods, we proposed that beans, peas, and lentils could be counted as either a protein food or as a vegetable in a combination food (87 FR 59168 at 59191). Our position has not changed on beans, peas, and lentils and these foods can be considered under either of those food groups to qualify for the claim in this final rule. For consideration as vegetables, the FGEs for beans, peas, and lentils is 
                        <FR>1/2</FR>
                         c-eq per RACC and for consideration as protein foods, the FGE is 1 oz-eq per RACC, consistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         (§ 101.65(d)(3)(ii)).
                    </P>
                    <P>
                        The daily recommendation for protein foods in the Healthy U.S.-Style Dietary Pattern at the 2,000-calorie level is 5
                        <FR>1/2</FR>
                         oz-eq. For all the food groups, we calculated the FGE by dividing the daily amount by four eating occasions (5
                        <FR>1/2</FR>
                         oz equivalents of protein foods divided by four is 1
                        <FR>3/8</FR>
                         oz-eq). For the beans, peas, and lentils sub-category of protein foods, we set the FGE at 1 oz-eq, which is lower than 1
                        <FR>3/8</FR>
                         oz-eq. We proposed rounding down to 1 oz-eq to increase the number of products containing these subgroups that would be eligible to bear the claim, consistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         which encourages consumption of such products (87 FR 59168 at 59188). The rule maintains the 1 oz-eq FGE for beans, peas, and lentils as it provides 
                        <PRTPAGE P="106087"/>
                        sufficient flexibility for a variety of options of nutrient-dense protein foods, including pulses, to be eligible for the claim, which may help consumers identify foods that help them meet the daily recommended amount of protein foods. We decline to include protein isolates and concentrates when calculating what meets the FGE requirement for the protein group. The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommends following a healthy dietary pattern with a focus on meeting food group needs by consuming a variety of nutrient-dense foods and beverages and staying within calorie needs. Although the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         includes soy protein isolates and concentrates among examples of foods in the protein foods group, these components will not count toward meeting the FGEs for the protein foods group in the rule. The food group approach to the “healthy” claim represents a shift from focusing on individual nutrients to nutrient-dense foods. Nutrients that are extracted from foods, such as isolates and concentrates, are not whole, nutrient-dense foods but rather, individual nutrients such as those included in the original definition for the “healthy” claim. Because of the shift in the framework toward foods rather than individual nutrients, counting isolated or concentrated protein toward the protein FGEs would not be consistent with the “healthy” claim's focus on nutrient-dense foods that serve as the foundation of healthy dietary patterns. The presence of extracted components, such as isolates or concentrates, and information about any potential benefits, however, may be useful to consumers and manufacturers may communicate this information in other ways, (
                        <E T="03">e.g.,</E>
                         nutrient content claims, health claims, and other truthful and non-misleading statements on the label).
                    </P>
                    <P>(Comment 36) One comment asks that FDA provide additional guidance about converting all forms of pulses into c-eq as a vegetable or into ounce equivalents as protein. The comment mentions that the proposed rule does not include information regarding how to account for changes in volume from processing such as milling, grinding, chopping, pureeing, dehydrating, and cooking, and asks FDA to provide calculation guidance to help in determining compliance with the FGE criteria.</P>
                    <P>(Response 36) We provide information about available resources to support determination of FGE amounts in Response 12. For example, the FPED provides c-eq for beans and provides amounts for different forms such as cooked, uncooked (dry), and canned (Ref. 3). For varieties of a food that are cut pieces of the whole form, as with beans that are chopped, sliced, or ground, the total amount of food in a c-eq of whole food and the cut food would be the same. As noted in Response 12, the final rule sets a compliance date that is 3 years from the effective date, and we intend to provide additional resources to help manufacturers comply with the final rule before the end of the compliance period.</P>
                    <P>(Comment 37) One comment requests additional clarity regarding plant-based foods, including how ingredients like chickpea powder or legume powder would be treated and whether pea milk, almond milk, and other plant-based milks, whether fortified or not, would be considered protein foods.</P>
                    <P>
                        (Response 37) Powders of protein products, such as chickpea powders or legume powders, can be included in FGE calculations provided that the powders are essentially the dried/dehydrated and ground forms of the original, whole food. Powders that have ingredients added to them or components of the food removed from them (other than water) would not be considered a form of the original food for the purposes of the “healthy” claim. The FPED provides an example for legumes, specifically soy flour, which has a 1 oz-eq of 
                        <FR>1/2</FR>
                         oz (~14 g) (Ref. 3). Plant-based milk alternatives, such as pea milk or almond milk, would be evaluated against the criteria for the dairy food group and not the protein foods group and are discussed in the dairy section V.C.6 (“FGEs for Dairy”).
                    </P>
                    <P>(Comment 38) A number of comments seek clarification as to whether coconut is considered a nut. One comment mentions that coconut is currently classified as a tree nut under the Food Allergen Labeling and Consumer Protection Act and provides that the saturated fat of a coconut is inherent to the coconut, as is the case with nuts. Other comments note that they are excluding coconut from their discussion of nuts and seeds (and would not support exclusion of saturated fat content of coconut from the overall saturated fat limit, as was proposed for nuts and seeds) because coconut is unusually rich in saturated fat.</P>
                    <P>
                        (Response 38) While a coconut is botanically a fruit (specifically, a fibrous one-seeded drupe), the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         does not include coconuts in the nut or the fruit category. In addition, the FPED database used in the modeling of the U.S. Food Patterns describes the “Nuts and Seeds” category as “Peanuts, tree nuts, and seeds; excludes coconut” (Ref. 3). Instead, the FPED considers coconuts to be solid fats, listing coconuts with other examples of solid fats as “Coconut meat, raw—Raw coconut meat containing 33.5 grams of fat per 100 grams.” Because coconut meat contains total fat amounts of over 33 g per 100 g and most of the fat is saturated (29.7 g per 100 g) (Ref. 7), we have determined that coconuts will not be counted as contributing toward the protein foods group (
                        <E T="03">i.e.,</E>
                         will not be considered a nut) or the fruit food group, consistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                    </P>
                    <P>
                        (Comment 39) Many comments request that FDA enable protein foods with small serving sizes to meet the definition of “healthy.” One comment notes that there are a number of nutrient-dense pulse products, such as hummus and roasted chickpeas, that would fall into the “individual foods” category but have small RACC serving sizes. The comment asserts that even though these foods provide important nutrients like dietary fiber and protein while providing minimal amounts of added sugar, saturated fat, and sodium, it is mathematically impossible for these small serving sizes to provide the minimum amounts of food groups required by the proposed rule criteria. The comment requests that FDA create a pathway for nutrient-dense foods with small RACCs and serving sizes to meet the definition of “healthy.” The comment mentions this could be achieved by allowing products with small RACCs and serving sizes that meet the maximum limits for added sugar, saturated fat, and sodium, to meet the “healthy” definition if their first listed ingredient is an NTE. The comment mentions another approach would be to require a smaller amount of FGE for these smaller sized products, such as 
                        <FR>1/4</FR>
                         FGE.
                    </P>
                    <P>
                        (Response 39) As discussed in Response 8, we do not intend to exclude nutrient-dense foods consumed in small amounts that are recommended for healthful dietary patterns, including certain protein foods. The final rule includes criteria specific to foods with small RACC sizes in § 101.65(d)(3)(iii)(B). Under the small RACC criteria, foods with a small RACC size (≤50 g) need to meet the criteria per 50 g, which will result in many foods with small RACC sizes being able to meet the FGE amounts. Additionally, with the expanded exemption for single-ingredient foods in § 101.65(d)(3)(i), as further discussed in Response 9, many foods with both larger RACC sizes and small RACC sizes, such as roasted chickpeas, will automatically qualify for the claim, as long as no other ingredients except for water are added.
                        <PRTPAGE P="106088"/>
                    </P>
                    <P>The comments also mention hummus as a food with a small RACC that may not be able to qualify for the claim. Hummus, which has a RACC of 2 Tbsp, is a mixed product with a number of ingredients. Mixed products, such as hummus, would need to meet the applicable FGE amounts in addition to the NTL criteria to qualify for the claim, as discussed in section V.E.2 (“Mixed Products”).</P>
                    <P>(Comment 40) One comment supports FDA's inclusion of soy foods and soy milk in the rule but requests that we align the rule with FDA's authorized health claims and qualified health claims under 21 CFR 101.14. The comment notes that many soy foods are not eligible for the proposed “healthy” claim even though they are eligible for FDA authorized health claims and qualified health claims.</P>
                    <P>(Response 40) Foods and food components that are the subjects of health claims that FDA has authorized or for which it considers the exercise of enforcement discretion have an evidence-based relationship of risk reduction with a disease or health-related condition and the language in the health claim communicates this specific relationship. Although many foods that are the subjects of health claims do meet the requirements of the “healthy” nutrient content claim, not all foods that are the subject of a health claim are core elements of a healthy dietary pattern, and therefore would not necessarily qualify to bear the “healthy” claim (see section III. (“Background”) for further discussion of differences between different nutrition labeling claims).</P>
                    <P>
                        Whether and how a soy food qualifies for “healthy” depends on the food's specific nutrient profile and role in the diet. Some soy foods, such as soybeans, qualify under the single-ingredient exemption (see Response 9). Other foods made from soybeans would be subject to the FGE amounts and NTL criteria for dairy (
                        <E T="03">e.g.,</E>
                         soy milk) or for nuts, seeds, and soy products (
                        <E T="03">e.g.,</E>
                         tofu) to qualify for the “healthy” claim.
                    </P>
                    <HD SOURCE="HD3">8. FGEs for Oils</HD>
                    <P>
                        (Comment 41) A number of comments express support for FDA's proposal to include oils, which includes 100% oils, certain oil-based spreads 
                        <E T="03">(i.e.,</E>
                         those whose fat content comes solely from oil), and certain oil-based dressings (
                        <E T="03">i.e.,</E>
                         those containing at least 30% oil and made from oils that meet the “healthy” definition) as a food group, viewing this as consistent with current nutrition science. The comments note that the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         does not categorize oils as a “food group” but emphasizes that oils are one of the six core elements of a healthy dietary pattern and recommends daily intake objectives for oils like the food groups.
                    </P>
                    <P>Some comments do not support including “oils” as a food group. The comments express that allowing oils to be labeled as healthy may unintentionally communicate to consumers that oils are healthy in any amount and could lead to consumer confusion and overconsumption.</P>
                    <P>(Response 41) Healthy dietary patterns include foods such as vegetable oils with unsaturated fats and are lower in foods high in saturated fats, such as butter, shortening, lard, or coconut oil (Ref. 1). Strategies to shift intakes toward achieving a healthy dietary pattern include cooking with vegetable oils instead of fats like butter. Therefore, to reflect these shifts, as discussed in the Dietary Guidelines, we conclude it is appropriate for certain oils and oil-based products to qualify for the “healthy” claim. We are not, however, establishing an FGE for oils in foods made with these oils and oil-based products. We disagree with and are not aware of any information in the comments or elsewhere supporting the argument that including oils as a food group for the purposes of this rule may lead to consumer confusion and overconsumption. We note that we do intend to address oil consumption in our consumer education efforts related to the “healthy” claim.</P>
                    <P>(Comment 42) Some comments do not support allowing oil-based spreads and oil-based dressings to qualify to use the “healthy” claim due to concerns that many of these products contain ultra-processed or highly processed oil or other ingredients.</P>
                    <P>(Response 42) Oils are characteristic components of healthy dietary patterns, and this determination reflects that current dietary recommendations encourage a shift from use and consumption of saturated fats, such as in butter and many salad dressings, to spreads and dressings made predominantly of unsaturated oils. The oils in these foods may be processed to a greater degree than fats such as butter or lard; however, healthy dietary patterns which include unsaturated oils rather than fats high in saturated fats are associated with positive health outcomes (Ref. 1).</P>
                    <P>(Comment 43) One comment recommends that the requirement for oil-based dressing to have at least 30% oil be lowered to a level of 10% oil.</P>
                    <P>
                        (Response 43) The replacement of oils for solid fats in the diet is a key reason for the inclusion of oils as core elements of healthy dietary patterns. Shifts from solid fats to unsaturated oils are important strategies for constructing healthy dietary patterns. Therefore, 100% oils and oil-based dressings and spreads that meet specific requirements can qualify for the “healthy” claim. Foods that are described as “oil-based” for the purposes of the “healthy” claim are not intended to identify foods that simply have oils as an ingredient. Rather, the foods identified as oil-based are intended to be foods where oil is a primary component. At ≥30%, oils would typically make up the largest component in the food, with the exception of water. Lowering the oil requirement to ≥10%, however, would not ensure that the food is an oil-based dressing with oils as the largest component, except for any water present. As discussed in the proposed rule, we did not set qualifying FGEs for the oils group, but instead, limit use of the claim to the oils themselves, oil-based dressings, and oil-based spreads, provided they meet the specified criteria. We decline to lower the minimum amount of required oil in oil-based dressings in the rule to 10% oil, consistent with the purpose of the claim and the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                    </P>
                    <HD SOURCE="HD3">9. FGEs for Fruit and Vegetable Powders</HD>
                    <P>(Comment 44) In the proposed rule, we did not consider vegetable or fruit powders to be vegetables or fruits, respectively, for the purpose of calculating FGEs. Some comments support this approach. One comment asserts that vegetable powders should not qualify as vegetables for purposes of the rule because vegetable powders may be produced or used in a way that modifies the whole vegetable to an extent that removes some essential characteristics that are beneficial when consuming the whole vegetable, which could impact the nutrient content. The comment notes that diets high in vegetables and fruits are beneficial, in part, because the vegetables and fruits displace other less healthy foods, and states that it is unlikely that foods made with vegetable powders would have the same effect. The comment expresses concern that allowing a product with no recognizable vegetable in it to bear the “healthy” claim would send the wrong message to consumers. Another comment agrees with the exclusion of vegetable and fruit powders on the basis that they are often used to create ultra-processed snack foods such as vegetable sticks, puffs, and other snack foods that the comment describes as high in fat and salt and low in dietary fiber.</P>
                    <P>
                        Other comments recommend that fruit and vegetable powders, or certain fruit and vegetable powders (
                        <E T="03">e.g.,</E>
                         those with 
                        <PRTPAGE P="106089"/>
                        similar nutrient composition as whole fruits and vegetables), be able to contribute to FGEs. For example, some comments ask that FDA allow fruit and vegetable powders that are not derived from juice to contribute to the fruit and vegetable food groups and ask that FDA provide guidance for calculating FGE contributions from fruit and vegetable powders. Several comments provide information or data demonstrating that different fruit and vegetable powders have similar nutrient composition as whole fruits and vegetables. For example, one comment provides an assessment of fresh, dried, and powdered legumes to support the inclusion of powdered fruits, vegetables, and legumes under the “healthy” definition. The comment relies on data from the USDA Standard Food Database to demonstrate that the nutritional composition of whole chickpeas, black beans, and navy beans are substantially similar to the powdered forms. The comment provides that chickpea flour, meal, and grits contain more protein and higher dietary fiber levels than a whole, raw chickpea, and mentions that USDA reports similar results for black beans and navy beans. The comments also note that FDA has recognized in its guidance, 
                        <E T="03">Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals,</E>
                         that fruit and vegetable powders that are not made from juices “are essentially whole fruits and vegetables that have been processed to change the physical form of the fruit or vegetable to remove moisture.”
                    </P>
                    <P>One comment supports the inclusion of dried juice powder if 100% juice counts toward the FGEs but provides no data or information to support their recommendation.</P>
                    <P>(Response 44) In the proposed rule (87 FR 59168 at 59185), we stated that we would consider concentrated vegetable and fruit purees and pastes to be vegetables and fruits for the purpose of calculating FGEs because these products are essentially whole vegetables and fruits that have been processed to change the physical form of the vegetable to remove moisture. We did not include vegetable and fruit powders for the purpose of calculating FGEs because of the potential for these products to be produced or used in a way that modifies the vegetable or fruit to an extent that removes some essential characteristics that are beneficial when consuming the whole vegetable or fruit, which could impact nutrient content. However, we asked for comment regarding whether vegetable and fruit powders should be included for the purposes of FGE calculations, and in particular, any data regarding whether vegetable powders have similar or different nutrient content, or similar or different roles in a healthy dietary pattern, compared to whole vegetables. Comments to the proposed rule describe methods of vegetable and fruit powder production which are essentially only changes to the form and removal of moisture, and thus are similar to the production of purees and pastes. Information provided in the comments shows that the nutrient content of dried and ground powders is similar to the nutrient content of whole, fresh (or dried) varieties of vegetables and fruits. Comments did not provide any information about the processing of powders made from juices or the nutritional composition of powders made from juices.</P>
                    <P>We disagree that labeling foods with vegetable or fruit powders as “healthy” will send the “wrong message” to consumers. Foods that qualify for the “healthy” claim through the use of vegetable and fruit powders, including processed foods, will meet the minimum FGE requirements of either vegetables or fruits and will not exceed the NTL amounts. Therefore, foods that contain vegetable and fruit powders and bear the “healthy” claim will be nutrient-dense foods. Nutrient-dense whole vegetable and fruits in powdered form, or products that contain them, can also displace other ingredients or foods in the diet that are not nutrient-dense.</P>
                    <P>For this reason, we conclude that vegetable and fruit powders that are produced by drying whole vegetables and fruits and grinding into powder form may be considered in calculation of the vegetable and fruit FGEs. We are aware that some powders made from 100% juice could be less nutrient dense, such as juice powders made with carrier agents or drying aids like maltodextrins (see Food Labeling; Declaration of Ingredients; Common or Usual Name for Nonstandardized Foods; Diluted Juice Beverages Final Rule (58 FR 2897 at 2917, January 6, 1993)). Therefore, powders made through methods with ingredients that are added or taken away, such as powders made from 100% juice or juice concentrate with the addition of maltodextrin, may not be considered in the calculation of vegetable and fruit FGEs. We also address powders of protein products, such as chickpea powders or legume powders, in Response 37. We state that those powders can be included in FGE calculations provided that the powders are essentially the dried/dehydrated and ground forms of the original, whole food. These specific foods (beans, peas, lentils, soy, etc.) can also be considered under the vegetable group as vegetable powders.</P>
                    <HD SOURCE="HD3">10. Other Comments on Food Groups</HD>
                    <P>(Comment 45) Some comments discuss the health benefits associated with plant-based foods marketed as alternatives for other types of foods and recommend that FDA create a separate food group for such plant-based foods and beverages.</P>
                    <P>
                        (Response 45) There are a number of plant-based foods marketed as alternatives for other types of foods, 
                        <E T="03">e.g.,</E>
                         soy-based milk alternatives or bean-based patties marketed as hamburger alternatives. As discussed in the section V.C.6 (“FGE for Dairy”), plant-based milk alternatives are subject to the criteria for the dairy food group. Other plant-based alternatives to animal-derived foods, though, vary widely in scope, and are not all similar in content, use, or nutrition. These plant-based alternatives to animal-derived food products are being modeled after many different types of animal-derived foods, including hamburgers, chicken nuggets, hot dogs, ground beef, or fish. The components of plant-based alternatives to animal-derived foods are broad and range from vegetables and fruits, to grains, and to other protein sources, such as beans and nuts. Because of the wide variation among products, it would not be appropriate to consider all plant-based foods marketed as alternatives for other types of food under the same criteria. These products should be considered based on the criteria for their individual ingredients. For example, plant-based alternatives to animal-derived foods that are primarily bean-based would be considered under the protein foods or vegetable food groups. Plant-based alternatives to animal-derived food products also could be considered under the criteria for the categories of combination foods if the products meet the requirements (
                        <E T="03">e.g.,</E>
                         a plant-based patty made of beans and grain ingredients that meets the “healthy” criteria for a mixed product). Therefore, we do not agree that a separate food group with a different set of criteria should be created for all plant-based foods and beverages marketed as alternatives to other types of food. This approach would be inconsistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         which does not have a separate food group for such plant-based foods and beverages. We are also aware of ongoing efforts in the innovation of meat-alternative products with novel protein ingredients from a variety of sources beyond plant-based 
                        <PRTPAGE P="106090"/>
                        proteins. Novel ingredients derived from alternative sources, like mycoprotein and algae, may not fit into the categories of food groups established by the Dietary Guidelines. As efforts toward innovation move forward, we intend to monitor the marketplace and will address issues related to use of “healthy” on such products in the future, if necessary.
                    </P>
                    <P>(Comment 46) One comment recommends adding food groups to encourage, instead of NTE, which, according to the comment, would include groups that have nutritional value, for which current intakes are minimal, or that are linked to decreased chronic disease risk. The comment mentions fruits, vegetables, whole grains, and the subgroup beans, peas, and lentils as candidates for the food groups to encourage. The comment asserts that food groups and subgroups to which “automatic healthy status” has been granted should be given a special designation, beyond “healthy,” “to distinguish them from foods that were not granted automatic status and to emphasize their prioritization in healthy dietary patterns.”</P>
                    <P>
                        (Response 46) We agree with the inclusion of food group requirements instead of requirements for NTE in the definition of “healthy,” as further discussed in section V.D.6 (“Nutrients to Encourage”). As described by the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         a healthy dietary pattern “consists of nutrient-dense forms of foods and beverages across all food groups, in recommended amounts, and within calorie limits.” The criteria established for the definition may vary for individual foods from different food groups and there are foods which fall under the rule's single-ingredient exemption (see Response 9). However, all foods that are able to bear the “healthy” claim are foods that are particularly useful in helping consumers to create healthy dietary patterns, which is the purpose of the claim. Therefore, we disagree that certain foods that qualify for the claim should be given any special designations above other qualifying foods.
                    </P>
                    <P>(Comment 47) One comment notes that the proposed rule does not include provisions for communicating how many servings or FGEs of fruits, vegetables, dairy, protein foods, or grains to incorporate into a daily pattern, and does not include a mention of staying within caloric requirements, both of which are recommendations of the Dietary Guidelines. The comment provides that, even if an individual were to only purchase and consume foods labeled “healthy,” they may not achieve a healthy pattern if these foods are not consumed in the appropriate portions for each food group and within calorie limits. The comment suggests that additional on-pack communications, in addition to the term “healthy,” could help consumers identify how these foods fit into a healthy pattern.</P>
                    <P>
                        (Response 47) The purpose of a “healthy” claim is to serve as a quick signal to highlight foods that, based on their nutrient levels, are particularly useful in building healthy dietary patterns. While we agree that consumer education is an important part of implementing the “healthy” final rule, we have determined that it would not be appropriate to require educational information about the “healthy” claim or how to achieve healthy dietary patterns on food labels due to the limited space available and other label requirements. Information and education on healthy dietary patterns are readily available to consumers through various resources, including the Dietary Guidelines and related resources, such as the MyPlate education initiative at 
                        <E T="03">MyPlate.gov</E>
                        . Further, we plan to undertake consumer education efforts related to the “healthy” claim, which could include highlighting the importance of staying within daily calorie limit recommendations and choosing a variety of nutrient-dense foods within and across different food groups and subgroups—two concepts that are an integral part of the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         Additionally, the Nutrition Facts label includes information about how certain nutrients fit into the total daily diet. For these reasons, we decline to require additional information on labels about “healthy” and healthy dietary patterns, although manufacturers are free to include additional truthful and non-misleading information voluntarily.
                    </P>
                    <P>
                        (Comment 48) Some comments note that the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recognizes that dietary supplements are useful for individuals who cannot otherwise adequately obtain their nutrient needs or have different nutritional needs. The comments ask that FDA exempt dietary supplements from the “healthy” nutrient content claim requirements.
                    </P>
                    <P>One comment asserts that dietary supplements are outside the scope of the “healthy” implied nutrient content claim rule because, according to the comment, dietary supplements are, by definition, intended to supplement the diet and are not represented as conventional foods. The comment requests that if dietary supplements are not exempted from the “healthy” implied nutrient content claim criteria, then FDA either exercise enforcement discretion related to dietary supplements or establish parameters that would permit dietary supplements to bear the “healthy” claim. Another comment seeks clarification as to whether a dietary supplement that does not meet the “healthy” claim criteria may still bear the word “healthy” as part of a claim related to a products' ability to maintain a healthy structure or function or an otherwise lawful dietary supplement claim.</P>
                    <P>(Response 48) The proposed rule did not exclude dietary supplements from our definition (87 FR 59168 at 59176). However, as explained in the proposed rule, current nutrition science reflects the view that “good nutrition does not come from intake of individual nutrients (as dietary supplements often provide) but rather from foods with their mix of various nutrients working together in combination” (id.). Consistent with this scientific understanding, the “healthy” claim is intended to highlight those foods that are particularly useful in constructing healthy dietary patterns, which includes food choices from across the different food groups, and we have included FGE requirements to update the claim definition to focus on such foods. Because this is the intent of the claim, we decline to exempt dietary supplements from the “healthy” criteria. However, dietary supplements may bear nutrient content claims, including “healthy,” if they meet applicable criteria. Under some circumstances, a dietary supplement product may use the term “healthy” as part of a structure/function claim, without being subject to the requirements of the “healthy” nutrient content claim (see Response 123).</P>
                    <P>
                        (Comment 49) Some comments request that medical foods and foods for special dietary use (FSDU) be exempted from the requirements of the “healthy” claim. One comment states that, historically, both medical foods and FSDU have not been subject to the “healthy” claim criteria. According to the comment, medical foods are exempt from nutrient content claim requirements in § 101.13(q)(4)(ii). The comment also mentions that § 101.65(b)(6) specifically exempts claims for foods for special dietary use from implied nutrient content claim requirements when the claim identifies the special diet of which the food is intended to be a part; the comment asks FDA to maintain this exemption. The comment provides that medical foods 
                        <PRTPAGE P="106091"/>
                        and FSDUs are not intended as conventional foods for use as part of a healthy dietary pattern, but instead, are intended to supplement the diet or meet specific nutrition requirements in specific populations. The comment asserts that medical foods and FSDUs should thus not be subject to the “healthy” claim criteria but instead should be allowed to use the term “healthy” in a nutritional context, provided that the claim is not otherwise false and misleading.
                    </P>
                    <P>(Response 49) Medical foods, as defined by section 5 of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), are exempt from nutrient content claim regulations and therefore not subject to this rule (§ 101.13(q)(4)(ii)). Our regulations also exempt certain label statements from FDA nutrient content claim requirements under § 101.13, and this rule does not alter these exemptions. For example, a label statement on a food that complies with a specific provision of 21 CFR part 105 solely to note that a product has special dietary usefulness relative to a physical, physiological, pathological, or other condition, where the claim identifies the special diet of which the food is intended to be a part, is exempt from the requirements in § 101.13 (§ 101.65(b)(6)). However, FDA regulations do not include a general exemption from applicable nutrient content claim labeling requirements for all foods for special dietary uses. Therefore, foods for special dietary uses are subject to the rule if manufacturers choose to include a “healthy” nutrient content claim on a label, unless they meet a specific exemption from the requirements of § 101.13. It would be inconsistent with current nutrition science and dietary recommendations on building healthy dietary patterns for a food for a special dietary use that does not meet the requirements of the “healthy” claim to bear such claim in a label statement not subject to an exemption.</P>
                    <HD SOURCE="HD2">D. Nutrients to Limit</HD>
                    <HD SOURCE="HD3">1. General Comments</HD>
                    <P>(Comment 50) Many comments express general support for having NTL as part of the “healthy” framework. These comments assert that nutrient limits combined with FGE requirements better reflect the overall nutrient content of a food, including how nutrients may work together to help build a healthy dietary pattern across different food groups and subgroups, and that the rule's framework is therefore more consistent with the Dietary Guidelines than the original definition. However, some comments suggest that the rule's limits for single “avoidance nutrients” contradicts the approach of relying on food groups as a replacement for single favorable nutrients. Other comments acknowledge that chemically altered and highly processed foods high in sugar, sodium, and saturated fats should not be considered “healthy” due to their association with increased risks related to obesity and diet-related chronic diseases.</P>
                    <P>
                        (Response 50) We agree that having limits for saturated fat, added sugars, and sodium as part of the “healthy” claim criteria is supported by current nutrition science and Dietary Guideline recommendations. Current intake of saturated fat, sodium, and added sugars exceed recommended amounts for a majority of people in the United States. The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         includes four over-arching guidelines, including: (1) a guideline to focus on meeting food group needs with nutrient-dense foods and beverages, while staying within calorie limits (where nutrient-dense foods and beverages are described as containing vitamins, minerals, and other health-promoting compounds and containing little added sugars, saturated fat, and sodium) and (2) a guideline to limit foods and beverages higher in saturated fat, sodium, and added sugars. Therefore, the updated “healthy” framework, consisting of minimum requirements for food groups as well as limits for saturated fat, sodium, and added sugars, is consistent with current nutrition science and key recommendations in the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                    </P>
                    <P>
                        We disagree that having limits for saturated fat, added sugars, and sodium as part of the “healthy” criteria contradicts having minimum requirements for food groups (
                        <E T="03">i.e.,</E>
                         FGE criteria) as a replacement for minimum requirements for individual beneficial nutrients. Food group requirements better reflect the array of nutrients that are contained in a food rather than one individual beneficial nutrient in isolation. Including limits for saturated fat, sodium, and added sugars, as well as food group criteria, in the framework for the updated “healthy” definition better characterizes the overall nutrient content of foods, and as mentioned is consistent with current nutrition science and the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         For further discussion of these topics, see section V.C (“Food Group Equivalents”) and section V.D.6 (“Nutrients to Encourage”).
                    </P>
                    <P>(Comment 51) Some comments support the different limits for saturated fat, sodium, and added sugars, or recommend limits that are more restrictive, noting that intakes of these nutrients are associated with adverse health outcomes and that for a majority of Americans, intakes of these nutrients exceed recommended amounts. However, many comments raise concerns that the proposed limits are too restrictive. For example, some comments assert that the proposed limits on saturated fat, sodium, and added sugars would “arbitrarily” disqualify many foods from using the “healthy” claim. Some comments contend that the proposed limits are so low that, besides whole foods or single ingredient foods or commodity foods, few products would meet the proposed criteria. For example, some comments note that healthier packaged foods and prepared foods often used by consumers would be excluded from bearing a “healthy” claim due to their “judicious” amounts of saturated fat, sodium, and added sugars. Another comment argues that the proposed criteria would force manufacturers of meals and main dishes that currently qualify for “healthy” to drastically reformulate their products.</P>
                    <P>
                        (Response 51) Based on data and information received in comments, current nutrition science, and the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         and supported by our review of the products available in the marketplace (Ref. 2), we have made adjustments to some requirements, including to some of the NTL criteria, which result in more nutrient-dense foods that are recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         being able to qualify for the “healthy” claim. Those adjustments are described in the following sections on saturated fat, sodium, and added sugars.
                    </P>
                    <P>
                        (Comment 52) Some comments support adjusting NTL based on food groups and subgroups, asserting that “some degree of variation by food group or subgroup is necessary to account for the intrinsic differences in nutrient content of different food groups and each food group's contribution to a healthy diet.” One comment supports the proposed approach to consider characteristics of the different food groups instead of a “one-size-fits-all algorithm” for updating the “healthy” definition, stating that the proposed approach is consistent with the principles underpinning the Dietary Guidelines that promote choosing healthy foods from different food groups, which work together synergistically within healthy eating patterns. In contrast, other comments argue that criteria should vary based on RACC size, rather than by food groups, to account for the range of RACC sizes in the individual/mixed foods category and their contribution to a dietary 
                        <PRTPAGE P="106092"/>
                        pattern, arguing that there is little variation in the proposed limits based on food groups (
                        <E T="03">e.g.,</E>
                         0-5% DV for added sugars across food groups), but considerable variation in RACC sizes in some food groups (
                        <E T="03">e.g.,</E>
                         5 g to 110 g in the grains food group). Other comments support having different criteria (
                        <E T="03">e.g.,</E>
                         for NTL and food group contributions) for products with smaller RACCs. The comments note that small RACC foods contribute meaningfully to the diet, but, in many cases, the proposed food group requirements are not mathematically possible for smaller RACC individual/mixed foods because the RACC size is smaller than the minimum FGE requirement.
                    </P>
                    <P>
                        (Response 52) We agree that taking into consideration the characteristics of the different food groups, rather than using a “one-size-fits-all” approach, aligns with the framework of the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         and its emphasis that healthy dietary patterns are formed by choosing nutrient-dense foods across different food groups, which vary in the nutrients they provide and can work together to improve health. Different food groups consist of foods that vary in their nutrient content and setting the same limit for all food groups could result in foods with unnecessary excess saturated fat, sodium, or added sugars being able to bear the “healthy” claim or result in the unnecessary addition of NTL (
                        <E T="03">e.g.,</E>
                         saturated fat or added sugars) to products in some food groups. For example, increasing the saturated fat limit across all food groups could result in the unnecessary addition of saturated fat for products in food groups such as vegetables, which are generally not sources of saturated fat, or result in the addition of added sugars to fruit products, which are generally already naturally sweet.
                    </P>
                    <P>
                        Therefore, we have maintained the proposed approach of adjusting NTLs across food groups and subgroups for individual foods (§ 101.65(d)(3)(iii)) based on considerations such as different nutrient profiles of the different food groups and subgroups; the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommendations for different food groups (
                        <E T="03">e.g.,</E>
                         consuming fat-free and low-fat dairy) and for saturated fat, sodium, and added sugars; and current intakes of different food groups/subgroups and NTL; and our marketplace review of nutrient-dense foods (Ref. 2). We have, however, modified the NTL criteria for combination foods (
                        <E T="03">i.e.,</E>
                         mixed products, main dishes, and meals) so that the limits for saturated fat, added sugars, and sodium are streamlined and are not dependent on the food groups that make up the combination foods (§ 101.65(d)(3)(iii), (iv) and (v)) (as further discussed in section V.E (“Combination Foods”). We also have included criteria specifically for foods with smaller RACCs (≤50 g) (§ 101.65(d)(3)(iii)) based on comments to the proposed rule that demonstrate that some nutrient-dense foods with smaller RACCs are not able to qualify based on the proposed criteria, which were also supported by our marketplace review of nutrient-dense foods across different food groups and categories (Ref. 2). The changes to the NTL criteria for individual foods, as well as the rationale for those changes, are discussed below in the individual NTL sections for saturated fat, sodium, and added sugars.
                    </P>
                    <P>
                        (Comment 53) Some comments support considering the “food matrix” (
                        <E T="03">e.g.,</E>
                         nutrient and non-nutrient components of foods, as well as physical structure and form) as part of the “healthy” definition, and say that, without taking the food matrix into consideration, the proposed NTL could discourage the consumption of certain foods that contain beneficial nutrients but do not qualify for the claim (
                        <E T="03">e.g.,</E>
                         full-fat dairy).
                    </P>
                    <P>
                        (Response 53) The description of nutrient-dense foods in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         (
                        <E T="03">e.g.,</E>
                         containing little or no added sugars, saturated fat, and sodium) does not change based on food matrix components such as physical structure and food form. Therefore, while we do adjust NTL based on unique considerations for the different food groups, including some components of the food matrix (such as overall nutrient profile), we decline to adjust NTL criteria based on other components of the food matrix such as physical structure, food form, and non-nutrient components because they do not characterize the nutrient levels of a food.
                    </P>
                    <P>
                        (Comment 54) Some comments believe that the approach used for calculating the criteria for NTL should be the same approach used for calculating FGE criteria. For example, some comments argue that the criteria for the NTL, such as added sugars, should be calculated by dividing the DV by four eating occasions—analogous to the approach used for calculating FGE criteria—arguing that there is more room for intake of added sugars, for example, in the daily diet (
                        <E T="03">i.e.,</E>
                         without reaching the daily limit of 50 g for added sugars) than what would result with the proposed limits.
                    </P>
                    <P>
                        (Response 54) We decline to use the same approach for setting NTL as for calculating FGE criteria. FGE requirements are the 
                        <E T="03">minimum</E>
                         amounts of a food from a particular recommended food group that must be contained in a product for it to bear the “healthy” claim, and they are intended to help consumers identify foods that can help them reach recommendations for food groups to meet nutritional needs.
                    </P>
                    <P>
                        In contrast to FGE criteria, NTL criteria are the 
                        <E T="03">maximum</E>
                         amounts of saturated fat, added sugars, and sodium, that foods which bear the “healthy” claim can contain, based on recommendations to limit intake of these nutrients. For the NTL, the goal is to stay below, rather than achieve, the limit in order to avoid excess intake of saturated fat, added sugars, and sodium. Consumers eat a variety of foods throughout the day. This may include multiple foods, which may or may not meet the “healthy” criteria, at different eating occasions that provide saturated fat, added sugars, and sodium. Foods that do not qualify for the “healthy” claim that are consumed throughout the day also serve as sources of saturated fat, sodium, and added sugars, and may contain higher amounts of these nutrients (
                        <E T="03">e.g.,</E>
                         if they do not meet the “healthy” NTL criteria). Consequently, it is not appropriate to calculate the baseline amounts for the NTL using the assumption that all foods consumed in a day are foods that qualify for “healthy,” and it is not appropriate to use the same approach for calculating the maximum amount of added sugars, saturated fat, or sodium as is used for calculating the minimum amount of FGEs (
                        <E T="03">e.g.,</E>
                         dividing the DV by four) in order for a food to qualify for “healthy.” This approach would be unlikely to help consumers identify foods that are particularly useful for building a healthy dietary pattern recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         and could result in consumers exceeding the recommended daily limits for these NTL. We therefore decline to change the approach for calculating the baseline amounts for the NTL (
                        <E T="03">e.g.,</E>
                         by dividing the DVs for the NTL by four eating occasions) as suggested in the comments. We have, however, modified the proposed adjustments for NTL for some food groups and discuss these modifications in the saturated fat, sodium, and added sugars sections below.
                    </P>
                    <P>
                        (Comment 55) Some comments encourage FDA to set consistent limits for saturated fat, added sugars, and sodium (
                        <E T="03">i.e.,</E>
                         the same percent DV limit for all three nutrients). For example, one comment suggests that the proposed baseline limits do not reflect the definition of nutrient density in the 
                        <PRTPAGE P="106093"/>
                        Dietary Guidelines where all three nutrients are “equally addressed.” The comment suggests that consumers could interpret a higher limit for one nutrient as indicating that the one nutrient is less of a public health concern and offered alternative approaches for consideration, such as ≤5% DV for saturated fat, added sugars, and sodium; 8% DV for saturated fat, added sugars, and sodium; or 10% DV for saturated fat, added sugars, and sodium.
                    </P>
                    <P>(Response 55) While we agree that the concepts of limiting saturated fat, sodium, and added sugars are all part of the definition of nutrient-dense foods in the Dietary Guidelines, we disagree that the definition implies that the limits for saturated fat, sodium, and added sugars must be the same in a nutrient-dense food. There are many factors that we considered when determining the limits for saturated fat, added sugars, and sodium, such as dietary recommendations and current scientific evidence for each, intake of each in the United States, inherent amounts of each in different foods, their respective functions in foods, and our marketplace review of nutrient-dense foods in the food supply (Ref. 2). These factors vary depending on the nutrient and the food group.</P>
                    <P>In setting the criteria for NTL, we proposed baseline values for each nutrient and adjusted the values, as warranted. Different food groups and subgroups each contain foods that provide a variety of nutrients, including important nutrients that are underconsumed, and some naturally contain higher amounts of nutrients that should be limited. For example, dairy foods provide vitamin D and calcium; however, they also may contain saturated fat. In contrast, fruits and vegetables contain minimal or no saturated fat. Using the same saturated fat criteria across all food groups could result in the exclusion of foods that provide important nutrients and that are recommended by the Dietary Guidelines. However, increasing the saturated fat limit across all food groups could result in the unnecessary addition of saturated fat for foods in food groups such as vegetables, which are generally not sources of saturated fat. Therefore, we decline to use the same percentages to set the saturated fat, added sugars, and sodium limits. See below for further discussion of the individual limits that we have determined for saturated fat, added sugars, and sodium.</P>
                    <HD SOURCE="HD3">2. Saturated Fat</HD>
                    <P>
                        (Comment 56) Several comments express support for the proposed limits on saturated fat, including the baseline of ≤5% of the DV per RACC and proposed adjustments for different food groups (
                        <E T="03">i.e.,</E>
                         ≤10% of the DV per RACC for dairy products, game meats, seafood, and eggs). The comments support aligning the baseline level with the existing “low in saturated fat” nutrient content claim, and also support adjusting the limits for certain food groups to allow for naturally-occurring saturated fat in nutrient-dense foods recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         (
                        <E T="03">e.g.,</E>
                         low-fat dairy products, lean proteins, eggs, nuts, seeds, seafood, and certain oils), while “limiting the addition of saturated fats to other recommended foods, such as frozen vegetables in a butter sauce.” In contrast, some comments express concern with the proposed saturated fat limits for individual foods of ≤5%, ≤10%, and ≤20% DV (depending on food group), asserting that the proposed saturated fat criteria are too strict. Some comments support the following alternative limits which they assert are largely in agreement with our proposed saturated fat limits but are based on RACC size rather than by food group: 5% DV per RACC for individual foods with a RACC ≤30 grams, 10% DV for individual/mixed foods per RACC with a RACC &gt;30 grams, 15% DV per serving for main dishes, and 20% DV per serving for meals. The comments argue that the alternative limits would allow for inclusion of foods with intrinsic saturated fat (
                        <E T="03">e.g.,</E>
                         protein foods, dairy, seafood, and avocado), while “retaining a reasonable cap on overall saturated fat intake.” Another comment states that the strict proposed saturated fat limits could deprive children of sufficient saturated fat, which is necessary for proper growth and brain development.
                    </P>
                    <P>
                        (Response 56) In the proposed rule (87 FR 59168 at 59178), we discuss that consensus reports, as well as the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         recommend limiting saturated fat intake to no more than 10% of calories per day, based on risk of CVD. The baseline limit for saturated fat (≤5% DV per RACC) is consistent with the low saturated fat nutrient content claim (§ 101.62(c)(2)). The limits are further consistent with the limits for most of the individual foods in the original definition for “healthy,” and our marketplace review of nutrient-dense foods (Ref. 2), as well as comments that we received to the proposed rule, which did not suggest that the proposed saturated fat limits overall were too restrictive. As further discussed in Response 52, we have maintained the approach of adjusting limits for saturated fat, sodium, and added sugars for individual foods based on considerations for the different food groups and subgroups. Using a baseline limit of ≤5% DV for individual foods and adjusting the limit (
                        <E T="03">e.g.,</E>
                         increasing the limit to ≤10% DV for some food groups and subgroups (
                        <E T="03">e.g.,</E>
                         dairy) results in a variety of nutrient-dense foods recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         across food groups being able to qualify for the “healthy” claim, including those with some inherent saturated fat (
                        <E T="03">e.g.,</E>
                         low-fat dairy). As discussed in Response 52, having the same saturated fat limit across different food groups could result in foods with unnecessary excess saturated fat being able to bear the “healthy” claim or result in the unnecessary addition of saturated fat to products in some food groups that are generally not sources of saturated fat (
                        <E T="03">e.g.,</E>
                         fruits and vegetables). Therefore, we decline to change the baseline limit of ≤5% DV for saturated fat for individual foods, and we decline to adjust the limit based solely on RACC size for individual foods without incorporating food group adjustments. We have, however, adjusted the saturated fat criteria for some food groups and subgroups such that more nutrient-dense foods encouraged by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         that contain inherent or intrinsic saturated fat will now qualify for the claim, as discussed below. We have also modified the saturated fat limits for combination foods (
                        <E T="03">i.e.,</E>
                         mixed products, main dishes, and meals) so that the limits are streamlined and are not dependent on the food groups that make up the combination foods, as further discussed in section V.E (“Combination Foods”). In addition, we have modified the proposed criteria to include different criteria for smaller RACC foods, described in detail in Response 8. Categories based on RACC size are also incorporated in the criteria for main dishes and meals (weighing at least 6 oz and 10 oz per labeled serving, respectively).
                    </P>
                    <P>
                        Further, we disagree that the saturated fat limits for the “healthy” claim would deprive children of sufficient saturated fat for proper growth and development, as current saturated fat intakes in this population exceed recommendations. For example, data from the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         demonstrate that 82-88% of children (ages 2-13 years) in the United States exceed the recommended daily limit for saturated fat.
                    </P>
                    <P>
                        (Comment 57) Some comments agree with the proposal to limit saturated fat in general but express concern regarding the higher limit for dairy, game meats, eggs, oils and oil-based spreads and 
                        <PRTPAGE P="106094"/>
                        dressings, and/or seafood. For example, some comments express concern that higher limits are allowed for foods that represent high sources of saturated fat in the diet, such as dairy and meat.
                    </P>
                    <P>
                        (Response 57) The proposed rule discusses our rationale for the proposed adjustments to the baseline saturated fat limit across the different food groups and subgroups (87 FR 59168 at 59178). Generally, adjustments were made based on specific considerations of the different food groups and subgroups, as further discussed in Response 52, to ensure that nutrient-dense foods across all food groups and subgroups could qualify for the “healthy” claim. This approach aligns with the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         approach for healthy dietary patterns, 
                        <E T="03">i.e.,</E>
                         incorporating a variety of nutrient-dense foods across all of the food groups and subgroups (Ref. 1). For example, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         discusses that dairy is one of the core elements of a healthy dietary pattern and states that most individuals would benefit by increasing intake of dairy in fat-free or low-fat forms, whether from milk (including lactose-free milk), yogurt, and cheese, or from fortified soy beverages or soy yogurt. The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         also identifies protein foods, including lean meats, poultry, eggs, and seafood, as one of the core elements of a healthy dietary pattern. When selecting protein foods, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommends shifting to nutrient-dense options, specifically lean and options that are low in saturated fat and shifting to add variety to the intake of protein foods. The Healthy U.S.-Style Dietary Pattern, as an example, includes daily amounts of lean protein and fat-free or low-fat dairy, because of the nutrients that these food groups provide (Ref. 1). Similarly, the adjustments to the saturated fat limits result in nutrient-dense forms of protein foods and dairy, for example, qualifying for the claim, thereby including a variety of foods that provide important nutrients to the diet while also limiting the amount of saturated fat that these foods contribute to the overall daily intake of saturated fat. These saturated fat criteria can help consumers identify products that can help them make shifts within the protein and dairy food groups. For example, one suggested shift in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         is “[w]hen cooking and purchasing meals, select lean meat and lower fat cheese in place of high-fat meats and regular cheese . . .” (Ref. 1).
                    </P>
                    <P>
                        The adjustments in the saturated fat criteria are consistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         For example, for dairy, the saturated fat limit of ≤10% DV per RACC (or per 50 g for RACCs ≤50 g or ≤3 Tbsp) will result in fat-free and low-fat dairy products qualifying to bear the claim, which are more nutrient-dense forms of dairy recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         but not dairy products with higher amounts of saturated fat (
                        <E T="03">e.g.,</E>
                         2% or full-fat milk). Fat-free and low-fat dairy products provide the same nutrients, but contain less saturated fat, than higher fat options such as 2% and full-fat milk and cheese. The saturated fat criteria will limit the contributions of qualifying foods to daily saturated fat intake, while still resulting in a variety of nutrient-dense forms across food groups, including dairy, game meats, eggs, seafood, and oils and oil-based spreads and dressings being able to meet the “healthy” definition, consistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         Therefore, we are finalizing the proposed saturated fat limit of ≤10% DV for game meats and eggs (see section V.D.5 (“Nutrients Not Included”) for discussion of comments on eggs and dietary cholesterol) and provide further discussion below of comments on nuts and seeds, soy products, seafood, dairy, and for oils and oil-based dressings and spreads.
                    </P>
                    <P>
                        (Comment 58) Some comments raise concerns that the saturated fat limits are inconsistent across different food groups and subgroups, asserting that plant-based foods, such as those in the beans, peas, lentils, and soy products subgroup, should have at least the same saturated fat limit (
                        <E T="03">i.e.,</E>
                         ≤10% DV instead of ≤5% DV), or a higher limit, than animal-based foods on the grounds that: plant-based foods have beneficial nutrients that are lacking in animal-based foods (
                        <E T="03">e.g.,</E>
                         dietary fiber); certain plant-based products, such as some soy-based foods, “have a healthier fat profile overall” (
                        <E T="03">e.g.,</E>
                         higher amounts of unsaturated fats) than animal-based foods; plant-based foods also provide “important nutrients,” which is used as a basis in the proposed rule for animal-based foods having a higher saturated fat limit; and the reasons for the different saturated fat limits for animal- and plant-based foods are not consistent with nutrition science or Federal dietary recommendations. Some comments agree with the rationale in the proposed rule that many foods in the beans, peas, lentils, and soy products group are generally lower in saturated fat; however, the comments point out that some foods do contain saturated fat naturally. For example, some comments point out that soybeans contain higher amounts of saturated fat (2.88 g per 100 g) than most other legumes (except for peanuts), but their fatty acid profile is predominantly unsaturated fats (
                        <E T="03">e.g.,</E>
                         60% polyunsaturated fat and 15% saturated fat), similar to the fatty acid profile of nuts. In comparison, peanuts contain 6.28 g of saturated fat per 100 g, but they are placed in the nuts and seeds subgroup and their saturated fat is excluded from the saturated fat limit. Other comments discuss certain soy-based products (
                        <E T="03">e.g.,</E>
                         plant-based patties, some tofu products) that would not be able to qualify due to their saturated fat content. Overall, these comments recommend: (1) excluding the naturally occurring saturated fat contained in soybeans from the saturated fat limit for soy products, similar to the nuts and seeds subgroup, because of their similar fatty acid profiles (
                        <E T="03">i.e.,</E>
                         predominantly unsaturated fats) or (2) increasing the saturated fat limit for the beans, peas, lentils, and soy products subgroup to ≤10% DV to be consistent with other protein subgroups.
                    </P>
                    <P>
                        (Response 58) Because the protein foods group is diverse and contains varying amounts of saturated fat and different nutrients, we proposed adjustments to the baseline saturated fat limit for some protein foods subgroups (proposed § 101.65(d)(3)(ii)). For example, for game meat and seafood, the proposed saturated fat limits were increased from the ≤5% DV per RACC baseline limit to ≤10% DV per RACC (similar to the &lt;2 g per RACC saturated fat limit for the “extra lean” nutrient content claim for game meat or seafood products). For nuts and seeds, we proposed that the saturated fat content inherent in nuts and seeds would not contribute to the 5% DV per RACC saturated fat limit for that subgroup. We explained the rationale for this exclusion. First, unsalted nuts and seeds are nutrient-dense foods and, while they contain saturated fat, they have a fat profile makeup of predominantly unsaturated fats. Second, scientific evidence, including the scientific evidence supporting multiple FDA-qualified health claims, demonstrate that replacing other sources of saturated fat in the diet with nuts has beneficial effects on risk of coronary heart disease, including nuts with higher saturated fat. Third, more than half of Americans do not meet the recommendation for nuts, seeds, and soy products, and the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommends consuming nuts without differentiating among types (even though the saturated fat content of nuts is variable). And fourth, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommends reducing saturated fat by substituting certain ingredients with 
                        <PRTPAGE P="106095"/>
                        sources of unsaturated fats, for example using nuts and seeds in a dish instead of cheese.
                    </P>
                    <P>
                        For beans, peas, lentils, and soy products, we proposed the baseline limit for saturated fat of ≤5% DV per RACC because these foods generally have low amounts of naturally occurring saturated fat. We also noted that the protein foods subgroups used in the proposed rule were slightly different than the protein subgroups in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         due to consideration of animal sources of protein for which labeling is regulated by USDA's Food Safety and Inspection Service (
                        <E T="03">e.g.,</E>
                         meat and poultry products, egg products, and catfish), and specific variation needed in FGE requirements and NTL across protein foods subgroups. For example, we proposed a subgroup for game meats and a subgroup for eggs instead of the meats, poultry, and eggs subgroup from the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         In addition, we grouped “beans, peas, lentils and soy products” together as a subgroup and “nuts and seeds” as another subgroup. In contrast, the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         which categorizes foods into food groups and subgroups based on similar nutrient profiles of different foods, groups “beans, peas, and lentils” together as one subgroup and “nuts, seeds, and soy products” as another subgroup (Ref. 1). The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         also explains that generally foods made from processed soybeans (
                        <E T="03">e.g.,</E>
                         tofu, tempeh, and products made from soy flour) are part of the nuts, seeds, and soy products subgroup, while soybeans and edamame (soybean in the pod) are part of the beans, peas, and lentils subgroup.
                    </P>
                    <P>
                        After considering the comments received on this topic and the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         categorization of protein foods subgroups, which is based on groupings of protein foods with similar nutrient profiles, we modified the following proposed protein foods subgroups: “beans, peas, lentils, and soy products” and “nuts and seeds.” The final rule includes soy products with nuts and seeds (instead of with beans, peas, and lentils) in the “nuts, seeds, and soy products” subgroup and the proposed rule's subgroup of “beans, peas, lentils, and soy products” is now the “beans, peas, and lentils” subgroup in the final rule, which is in alignment with the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         subgroups. The saturated fat that is naturally occurring in foods in the nuts, seeds, and soy products subgroup will be excluded from the saturated fat limit of ≤5% DV per RACC (or per 50 g for RACCs ≤50 g or ≤3 Tbsp) for nuts, seeds, and soy products. The rationale for the exclusion of inherent saturated fat in nuts, seeds, and soy products is similar to the rationale discussed in the proposed rule, and above, for the exclusion of inherent saturated fat in nuts and seeds and is based on scientific evidence and the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         and supported by our marketplace review (Ref. 2). Nuts, seeds, and soybeans (from which soy products are derived) generally have a fatty acid profile that is predominantly unsaturated fats, and there are multiple health claims based on scientific evidence supporting the beneficial relationship of fatty acids contained in these foods (
                        <E T="03">e.g.,</E>
                         substitution of unsaturated fats for saturated fats) and/or these foods (
                        <E T="03">e.g.,</E>
                         nuts, including nuts with relatively higher amounts of saturated fat) and reduced risk of coronary heart disease. Moreover, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         does not differentiate between specific nuts or soy products based on saturated fat, whereas they do differentiate between foods in other food groups based on saturated fat (
                        <E T="03">i.e.,</E>
                         lean or low-fat meats and fat-free and low-fat dairy). In addition, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         discusses specific strategies for making shifts to reduce saturated fat intake by replacing it with unsaturated fat. We note that even the nuts that are the highest in saturated fat have fat profiles that are predominantly unsaturated fat (
                        <E T="03">e.g.,</E>
                         Brazil nuts contain ~24% saturated fat and ~74% unsaturated fat) (Ref. 7). Our review of the products available in the current marketplace demonstrates that, if inherent saturated fat were not excluded, a majority of nut and seed products, without added sources of saturated fat, would not be able to meet the saturated fat limit even if it was increased to ≤10% DV (per 50 g due to their small RACC) (Ref. 2). Similar to nuts and seeds, soybeans also have fat profiles that are predominantly unsaturated fat (
                        <E T="03">e.g.,</E>
                         soybeans, mature seeds, raw contains ~14.5% saturated fat and ~66% unsaturated fat) (Ref. 7), and therefore, the same rationale applies. However, as we do not consider coconut to be part of the nuts, seeds, and soy products subgroup, the inherent saturated fat in coconut is not excluded from the saturated fat limit. See Response 38 for discussion of why coconut is not considered part of the nuts, seeds, and soy products subgroup.
                    </P>
                    <P>
                        Foods such as soybeans and edamame are considered part of the beans, peas, and lentils subgroup, consistent with the Dietary Guidelines. These foods (without added ingredients), including different forms, such as frozen edamame, would qualify for the exemption for single-ingredient foods that are encouraged by the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         Soy products that contain other sources of saturated fat, for example, a soy-based vegetable patty that contains added vegetable oil, would be subject to the saturated fat limit for the nuts, seeds, and soy products subgroup; however, the saturated fat inherent in soybeans would not contribute to the limit. As discussed in the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         one strategy for reducing intake of saturated fat from protein foods is to replace processed or high-fat meats with beans, peas, and lentils. Shifts such as these are encouraged in part because of the lower saturated fat content of beans, peas, and lentils. Increasing the saturated fat limit for individual foods in the beans, peas, and lentils subgroup (
                        <E T="03">e.g.,</E>
                         from ≤5% DV to ≤10% DV, as requested in some comments), which are generally lower in inherent saturated fat, would not reflect the recommended shifts in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         for the protein foods group and for lowering saturated fat intake, and could result in foods in this subgroup with unnecessary excess saturated fat qualifying to bear the “healthy” claim. Further, our marketplace review demonstrates that a number and variety of nutrient-dense foods within the different protein foods subgroups, including the beans, peas, and lentils subgroup and the nuts, seeds, and soy products subgroup, are able to meet the saturated fat limits for the different protein foods subgroups (Ref. 2). For example, nutrient-dense soy products with naturally occurring saturated fat, such as different types of tofu, meet a saturated fat limit for nuts, seeds, and soy products of ≤5% DV, excluding the saturated fat inherent in nuts, seeds, and soybeans. Therefore, we decline to increase the saturated fat limit for the beans, peas, and lentils subgroup (see below for further discussion of comments on the saturated fat limit for nuts, seeds, and soy products).
                    </P>
                    <P>
                        Other changes that we have made to the final rule will result in more flexibility for products in the beans, peas, and lentils subgroup to qualify for the “healthy” claim. As discussed earlier, we have expanded the exemption for raw, whole fruits and vegetables to include single-ingredient foods recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         in other food groups and in other forms (
                        <E T="03">e.g.,</E>
                         frozen edamame, unsalted roasted soybeans (soy nuts), and whole soybean flour). See below and Response 9 for further 
                        <PRTPAGE P="106096"/>
                        discussion of the expanded exemption. In addition, we have modified the saturated fat limits for combination foods (
                        <E T="03">i.e.,</E>
                         mixed products, main dishes, and meals), which varied in the proposed rule depending on the food group components, to a consistent amount regardless of the food groups or subgroups contained in the mixed product, main dish, or meal (see section V.E (“Combination Foods”) for further discussion). This provides more flexibility, compared to the proposed rule, for mixed products (
                        <E T="03">e.g.,</E>
                         plant-based patties), main dishes, and meals made with components from food groups and subgroups such as fruits; vegetables; grains; beans, peas, and lentils; and nuts, seeds, and soy products to meet the saturated fat limits for “healthy.” The saturated fat inherent in nuts, seeds, and soy products would be excluded from the saturated fat limit for mixed products, main dishes, and meals. This will result in mixed products, main dishes, and meals that are made with nutrient-dense foods encouraged by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         meeting the saturated fat criteria for “healthy.” For these reasons, we decline to increase the saturated fat limit for the beans, peas, and lentils subgroup. Further discussions of comments on nuts, seeds, and soy products, and on oils are below, and we did not receive comments on saturated fat and other plant-based food groups (
                        <E T="03">i.e.,</E>
                         fruits, vegetables, and grains). Therefore, we are finalizing the proposed saturated fat limits of ≤5% DV for fruits, vegetables, and grains.
                    </P>
                    <P>
                        (Comment 59) We specifically asked for comment in the proposed rule on whether all nuts, regardless of saturated fat, should qualify for the “healthy” claim and whether the saturated fat content contained in nuts and seeds should not contribute to the saturated fat limit for nut and seed products. Many comments support the proposed approach—that the saturated fat contained in nuts and seeds should not contribute towards the saturated fat limit for nut and seed products—agreeing with the rationale detailed in the proposed rule. In contrast, one comment expresses concern with allowing foods with higher amounts of saturated fat, such as nuts, to qualify because of the Dietary Guidelines daily limit for saturated fat of 10% of calories. The comment requests that further education be done for products containing nuts and seeds, 
                        <E T="03">i.e.,</E>
                         language paired with a healthy icon label to help consumers understand healthy dietary patterns and saturated fat (“certain “healthy” nuts should be consumed in moderation due to their higher saturated fat content”). Another comment encourages FDA to eliminate the exemption for saturated fat from nuts, noting that the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         does not make reference to source of saturated fat with the recommendation to limit saturated fat intake, and that eliminating the exemption would encourage consumers to limit the consumption of nuts that are high in saturated fat. The comment uses the example that there are several dairy products that meet the current requirement of 1 g of saturated fat per RACC and serving, and that these current requirements that exist for dairy products should also apply to nuts.
                    </P>
                    <P>
                        (Response 59) In the preamble to the proposed rule (87 FR 59168 at 59178-59179), we proposed that the saturated fat inherent in nuts and seeds would not count towards the saturated fat limit for nut and seed products of ≤5% DV per RACC. We agree with comments supporting this proposal because, while nuts and seeds contain saturated fat, they have a fat profile makeup of predominantly monounsaturated and polyunsaturated fats, and numerous studies have demonstrated that replacing other sources of saturated fat in the diet with nuts has beneficial effects on CVD risk, including nuts with relatively higher amounts of saturated fat. FDA also has qualified health claims characterizing these relationships, and the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommends consuming nuts without differentiating among types. For these reasons, we are finalizing our proposal that the saturated fat inherent in nuts and seeds does not count towards the saturated fat limit for nuts and seed products.
                    </P>
                    <P>
                        The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommends reducing intake of saturated fat by substituting certain ingredients with sources of unsaturated fats, including using nuts and seeds in a dish instead of cheese. In addition to the multiple qualified health claims on nuts, there are also health claims based on the scientific evidence for the substitution of unsaturated fats for saturated fats. For example, as discussed above, we have authorized a health claim for the substitution of unsaturated fats for saturated fats and reduced risk of heart disease. The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         further recommends consuming nuts without differentiating among types, 
                        <E T="03">i.e.,</E>
                         does not specify that only lower saturated fat nuts should be consumed or that nuts with higher amounts of saturated fat should be limited. In contrast, different types of dairy products are encouraged in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         when describing strategies for the dairy group and when describing strategies for reducing saturated fat in general. For example, one strategy that is discussed is to choose fat-free or low-fat milk instead of 2% or whole milk. The “healthy” criteria for the dairy food group and for the nuts, seeds, and soy products subgroup align with the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         because fat-free and low-fat dairy, as well as nuts and seeds (without differentiating among types), can qualify for the “healthy” claim. The fatty acid profile of nuts, seeds, and soybeans, which consists of predominantly unsaturated fats, is different than the fatty acid profile of dairy, which consists of predominantly saturated fats, and the comment did not provide any rationale for why the requirements for nuts should be the same for dairy, particularly since nuts are included in the protein foods group and not the dairy food group. Based on the reasons described above, we disagree that the exemption for saturated fat inherent in nuts and seeds should be eliminated. Further, for reasons described above, we disagree that current saturated fat requirements for dairy should apply to nuts or that some nuts should not be able to qualify for the “healthy” claim. As discussed above, the final rule excludes naturally occurring saturated fat inherent in nuts, seeds, and soybeans from the saturated fat limit for the nuts, seeds, and soy products subgroup. Any saturated fat that is added to products in the nuts, seeds, and soy products subgroup that is not inherent in nuts, seeds, and soybeans will count towards the saturated fat limit (see below for further discussion of the saturated fat limit for the nuts, seeds, and soy products subgroup).
                    </P>
                    <P>
                        We agree that consumer education is an important part of implementing the “healthy” final rule and intend to consider the issue of potential excess consumption of foods labeled as “healthy” in our education efforts to support implementation of the rule. However, we disagree that specific statements such as “certain `healthy' nuts should be consumed in moderation due to their higher saturated fat content” on the label accompanying the “healthy” claim is the best approach. The updated “healthy” definition includes criteria for saturated fat, sodium, and added sugars, but provides exclusions for inherent saturated fat contained in food groups and subgroups (
                        <E T="03">e.g.,</E>
                         nuts, seeds, and soy products) in which the fat profiles are made up of predominantly unsaturated fats. These exclusions are supported by scientific 
                        <PRTPAGE P="106097"/>
                        evidence discussed above and result in nutrient-dense foods that are encouraged by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         qualifying for the claim. Because these foods can be particularly useful in building a healthy dietary pattern, which aligns with the purpose of the updated “healthy” claim, it is not necessary to include additional language accompanying the “healthy” claim about the saturated fat content of nuts.
                    </P>
                    <P>
                        (Comment 60) Another comment requests that FDA consider whether the saturated fat criterion for nuts and seeds could increase the use of nuts as a source of saturated fat in combination foods that may not have previously included nuts, which could pose issues for individuals with nut allergies (
                        <E T="03">e.g.,</E>
                         who may not be aware of changes to products to include nuts).
                    </P>
                    <P>
                        (Response 60) FDA takes several measures to protect those with food allergies and other food hypersensitivities. These measures include establishing regulatory requirements (
                        <E T="03">e.g.,</E>
                         allergen labeling); providing guidance to the food industry, consumers, and other stakeholders on best ways to assess and manage allergen hazards in food; conducting surveillance; and taking regulatory actions when appropriate. For certain foods or substances that cause allergies or other hypersensitivity reactions, there are more specific labeling requirements. Under section 403(w)(1) of the FD&amp;C Act, food labels must identify the food source of all major food allergens used to make the food. While it is possible that some manufacturers may choose to reformulate products in ways that increase the use of nuts to meet the “healthy” criteria, FDA cannot predict whether this rule will result in an overall increase in the use of nuts in products that previously did not include them, and we do not have any evidence that there will be a significant change in the foods available to consumers with food allergies. If there are changes made to ingredients that include the addition of major food allergens (
                        <E T="03">e.g.,</E>
                         nuts and fish), these ingredients still must be declared on the food label in accordance with sections 403(i) and 403(w) of the FD&amp;C Act. It is important that consumers with food allergies always read labels to identify foods that they are allergic to, which can also help them recognize any changes in the formulation of a product.
                    </P>
                    <P>
                        (Comment 61) Some comments recommend that we increase the limit for saturated fat from added oils in peanut butter (≤5% of the DV for nuts and seeds in the protein food subgroup in proposed § 101.65(d)(3)(ii)) to make it consistent with the proposed limit for some of the other protein food subgroups (
                        <E T="03">i.e.,</E>
                         ≤10% of the DV), noting that oils may sometimes be added to peanut butter for stability and ease of spreading. The comments highlight the nutrient content of nuts and seeds (
                        <E T="03">e.g.,</E>
                         sources of unsaturated fats), including peanut butter, and the health benefits associated with their consumption. Further, several comments assert that peanut butter is an economical way for people to consume important nutrients and protein. One comment states that it would be unfortunate if peanut butter were excluded from the final rule.
                    </P>
                    <P>
                        (Response 61) As discussed above, we described the rationale for adjusting the saturated fat baseline limit for different protein subgroups in the proposed rule (87 FR 59168 at 59178-59179). For example, for game meats and seafood, the proposed saturated fat limit was increased from ≤5% DV per RACC to ≤10% DV per RACC (similar to the &lt;2 g per RACC saturated fat limit for the “extra lean” nutrient content claim for game meat or seafood products) because using the ≤5% DV baseline limit would prevent nutrient-dense foods in these subgroups from being able to bear the “healthy” claim due to their inherent saturated fat. In contrast, for the nuts and seeds subgroup, the proposed adjustment to the baseline saturated fat limit was to exclude the inherent saturated fat in nuts and seeds from counting towards the ≤5% DV per RACC saturated fat limit. This adjustment was proposed so that all nuts, which contain fat profiles that are predominantly unsaturated fats, could qualify for the “healthy” claim, consistent with scientific evidence and the 
                        <E T="03">Dietary Guidelines,</E>
                         as described above.
                    </P>
                    <P>
                        We agree that nut butters can be an economical way for people to consume protein and certain nutrients. Our review of the products available in the current marketplace demonstrates that many nut butters meet the proposed saturated fat criteria for nuts and seeds, including all nut butters that contain only nuts or only nuts and salt (Ref. 2). Therefore, we disagree that peanut butter would be unable to bear the “healthy” claim with a saturated fat limit of ≤5% DV (excluding the saturated fat inherent in nuts). As noted in some comments, oils may be added to some peanut butters for stability and ease of spreading. However, as mentioned, there are also nut butters that do not contain added oils. Many of the nut butters that do not meet the limit for saturated fat to bear the claim contain palm oil or fully hydrogenated vegetable oils, which have relatively higher amounts of saturated fat compared with other oils. Increasing the baseline saturated fat limit to ≤10% DV, in addition to providing an exclusion for saturated fat inherent in nuts and seeds, could result in additional saturated fat, including from oils that are higher in saturated fat such as palm oil, in products that already contain inherent saturated fat. The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         states that “[t]he fat in some tropical plants, such as coconut oil, palm kernel oil, and palm oil, are not included in the oils category because they contain a higher percentage of saturated fat than do other oils” (Ref. 1). Further, increasing the saturated fat limit to ≤10% DV (which could result in additional saturated fat in nut butters, for example from oils with higher amounts of saturated fat), would not be consistent with our basis for proposing a saturated fat limit for 100% oils of 20% of total fat—to align with the National Academies (
                        <E T="03">i.e.,</E>
                         DRI macronutrient report description of dietary fats low in saturated fatty acids), the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         and other labeling claims. Many nut butters, including peanut butter, are able to qualify for the claim with a saturated fat limit of ≤5% DV while excluding the saturated fat inherent in nuts.
                    </P>
                    <P>For the reasons discussed above, we decline to further adjust the proposed saturated fat limit for nuts and seeds and are therefore finalizing the limit for the nuts, seeds, and soy products subgroup at ≤5% DV per RACC or per 50 g for RACCs ≤50 g or ≤3 Tbsp, with the exclusion of inherent saturated fat in nuts, seeds, and soy products (§ 101.65(d)(3)(iii)).</P>
                    <P>
                        (Comment 62) Some comments assert that the saturated fat criteria for seafood are too stringent, despite seafood having a favorable fatty acid profile (
                        <E T="03">i.e.,</E>
                         good sources of unsaturated fats) and providing other important nutrients (
                        <E T="03">e.g.,</E>
                         calcium, potassium, and vitamin D). For example, some comments said that certain higher fat species of fish (
                        <E T="03">e.g.,</E>
                         king salmon and halibut) would be disqualified with a ≤10% DV per RACC saturated fat limit, despite being high in nutrients such as beneficial fats. Similarly, some comments assert that certain higher fat fish that contain predominantly unsaturated fat, are higher in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) than other fish, and are recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         would be excluded from bearing the “healthy” claim. Some comments note that the proposed saturated fat limit for seafood represents a regression of standard to pre-2016 (referring to the FDA enforcement discretion guidance that was issued for foods that are not low in 
                        <PRTPAGE P="106098"/>
                        total fat but have a fat profile consisting of predominantly mono- and polyunsaturated fats and is discussed further in our response below). Another comment expresses concern regarding the proposed approach for allowing more “nutrient flexibility” for some food categories but not others—such as nuts and seeds, but not seafood—despite their similar fatty acid profiles with high mono- and polyunsaturated fat content, arguing that it is arbitrary and unjustified. Some comments, therefore, request that we either increase the saturated fat limit for seafood (
                        <E T="03">e.g.,</E>
                         from ≤10% DV to ≤15% DV), use a framework similar to our 2016 guidance (
                        <E T="03">i.e.,</E>
                         for foods that contain amounts of combined mono- and polyunsaturated fats that are greater than their saturated fat amount), or provide an exemption for saturated fat contained in seafood, similar to the exemption for saturated fat contained in nuts and seeds, because they all have similar fatty acid profiles. Other comments request that we expand the exemption for raw, whole fruits and vegetable to other single ingredient foods, to ensure that nutrient-dense foods recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         such as seafood, can qualify for the claim.
                    </P>
                    <P>
                        (Response 62) As discussed in the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         the seafood subgroup, which includes fish and shellfish, provides beneficial unsaturated fatty acids, such as EPA and DHA, as well as other important nutrients (
                        <E T="03">e.g.,</E>
                         calcium, vitamins D and B
                        <E T="52">12</E>
                        , and heme iron). Despite the beneficial fatty acid and nutrient profiles of seafood, almost 90% of the U.S. population do not meet recommendations for seafood (Ref. 1). The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         encourages seafood choices that are higher in beneficial unsaturated fatty acids (
                        <E T="03">e.g.,</E>
                         EPA and DHA), and does not distinguish between seafood based on saturated fat amounts, in contrast to dairy and meat (
                        <E T="03">i.e.,</E>
                         fat-free or low-fat dairy, and lean or low-fat meat).
                    </P>
                    <P>
                        In 2016, we issued a guidance on the use of the term “healthy,” in part to advise food manufacturers of our intent to exercise enforcement discretion relative to foods that are not low in total fat but have a fat profile makeup of predominantly mono- and polyunsaturated fats. We explained in the guidance that the focus of the most recent dietary fat recommendations has shifted away from limiting total fat intake to encouraging intakes of mono and polyunsaturated fats and that foods that use the term `healthy' on their labels that are not low in total fat should have a fat profile makeup of predominantly mono and polyunsaturated fats (
                        <E T="03">i.e.,</E>
                         sum of monounsaturated fats and polyunsaturated fats are greater than the total saturated fat content of food). We advised manufacturers that we intended to exercise enforcement discretion with respect to the requirement at that time that any food bearing the nutrient content claim “healthy” meet the low fat criterion (§ 101.65(d)(2)(i)), provided that the amounts of monounsaturated and polyunsaturated fats in the product constituted the majority of the fat content, if certain conditions were met (Notice of Availability for a Final Guidance “Use of the Term `Healthy' in the Labeling of Human Food Products: Guidance for Industry” September 28, 2016, 81 FR 66527). This exercise of enforcement discretion was important because the fat that is contained in these products is mostly the types that are encouraged by current dietary recommendations (
                        <E T="03">i.e.,</E>
                         unsaturated fats).
                    </P>
                    <P>
                        We agree with the comments recommending that we expand the proposed exclusion for inherent saturated fat in nuts and seeds to seafood because seafood has fat profiles consisting of predominantly unsaturated fats similar to nuts and seeds and contains EPA and DHA as well as other important nutrients. The final rule, therefore, excludes the inherent saturated fat contained in seafood from the saturated fat limit for the seafood subgroup in § 101.65(d)(3)(iii), similar to the nuts, seeds, and soy products subgroup. Our marketplace review demonstrates that saturated fat amounts not only vary between types of seafood (
                        <E T="03">e.g.,</E>
                         different types of fish and shellfish), but also within species (
                        <E T="03">e.g.,</E>
                         different species of salmon) (Ref. 2). While single-ingredient seafood automatically qualifies for the “healthy” claim under the single-ingredient exemption (see Response 9), a saturated fat limit for the seafood subgroup of ≤10% DV could exclude products containing certain species of higher fat fish/seafood (
                        <E T="03">e.g.,</E>
                         certain species of salmon) that are sources of beneficial unsaturated fatty acids and recommended by the 
                        <E T="03">Dietary Guidelines,</E>
                         from qualifying for the “healthy” claim if the products contain other ingredients (
                        <E T="03">e.g.,</E>
                         sauce or seasoning). Further, the saturated fat limits for combination foods (
                        <E T="03">i.e.,</E>
                         mixed products, main dishes, and meals) could restrict rather than encourage seafood from being incorporated into combination foods (see section V.E (“Combinations Foods”) for further discussion on the saturated fat limits for combination foods). Excluding individual foods that contain higher fat fish that are sources of unsaturated fatty acids (
                        <E T="03">e.g.,</E>
                         EPA and DHA), but are not single-ingredient products, or causing manufacturers to avoid using certain seafood ingredients in combination foods, is not consistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         which specifically encourages consumption of fish that is higher in EPA and DHA (and lower in methylmercury) and does not distinguish between types of seafood based on saturated fat amounts.
                    </P>
                    <P>
                        The basis for the exclusion of inherent saturated fat in seafood is similar to that for the exclusion of inherent saturated fat in nuts, seeds, and soy products. The fatty acid profile of seafood is similar to nuts, seeds, and soybeans in that it is predominantly unsaturated fats and there is strong evidence that substituting unsaturated fats for saturated fat can lower the risk of CVD (for further discussion of this evidence, see Response 63). Further, there are health claims based on the evidence supporting the substitution of unsaturated fats for saturated fats and risk of coronary heart disease. For example, we have authorized a health claim for the substitution of unsaturated fats for saturated fats and reduced risk of heart disease. In addition, as previously noted, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         does not emphasize or differentiate between certain seafood based on saturated fat, whereas it does for other food groups and subgroups (
                        <E T="03">i.e.,</E>
                         lean or low-fat meats and fat-free or low-fat dairy). Instead, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         encourages consumption of seafood, such as salmon, that is higher in the unsaturated fats EPA and DHA (and lower in methylmercury). Even fish with relatively higher amounts of saturated fat have fat profiles that are predominantly unsaturated fats (
                        <E T="03">e.g.,</E>
                         salmon, chinook, raw contains ~30% saturated fat and ~69% unsaturated fat) (Ref. 7). The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         also discusses specific strategies for reducing saturated fat intake by replacing it with unsaturated fat and for adding variety to protein subgroup intakes—such as consuming seafood more often or replacing foods that are higher in saturated fat (
                        <E T="03">e.g.,</E>
                         high-fat meats or regular cheese) with sources of unsaturated fat. Therefore, to ensure that nutrient-dense seafood products with a fatty acid profile of predominantly unsaturated fats are not excluded from bearing the “healthy” claim, we are excluding the inherent saturated fat in seafood from the saturated fat limit in § 101.65(d)(3)(ii) for the seafood subgroup.
                        <PRTPAGE P="106099"/>
                    </P>
                    <P>
                        In the proposed rule, we proposed an adjustment to the baseline saturated fat limit for seafood (
                        <E T="03">i.e.,</E>
                         increasing the baseline saturated fat limit from ≤5% DV per RACC to ≤10% DV per RACC) to be consistent with the saturated fat limit for the “extra lean” nutrient content claim for seafood or game meat products (§ 101.62(e)(4)), as was used in the original criteria for “healthy,” and because using the baseline saturated fat limit would prevent nutrient-dense foods in this food group from being able to bear the “healthy” claim even though they contain important beneficial nutrients such as unsaturated fatty acids (
                        <E T="03">e.g.,</E>
                         EPA and DHA) and can help consumers build a healthy dietary pattern as recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         Because the inherent saturated fat in seafood will now be excluded from the saturated fat limit for the seafood subgroup, we have determined that the baseline saturated fat limit of ≤5% (with the exclusion of inherent saturated fat in seafood), rather than the proposed limit of ≤10% DV, will result in nutrient-dense seafood products qualifying for the “healthy” claim without resulting in the addition of unnecessary saturated fat to products that already contain inherent saturated fat. This approach is consistent with the saturated fat criteria for the nuts, seeds, and soy products subgroup. Moreover, the single ingredient exemption, discussed in Response 9, includes higher fat species of fish that are sources of beneficial unsaturated fatty acids such as EPA and DHA, among other nutrient-dense foods.
                    </P>
                    <P>
                        (Comment 63) Some comments contend that few dairy foods, other than non-fat and low-fat, unflavored, milk and yogurt, could bear the “healthy” claim despite dairy being good or excellent sources of three of the four nutrients of public health concern (
                        <E T="03">i.e.,</E>
                         calcium, vitamin D, and potassium). Some comments support having higher saturated fat limits for foods such as dairy, or express opposition to any limit on saturated fat, asserting that FDA lacks credible evidence that saturated fats are harmful. Some comments object to FDA's interpretation of the effect of saturated fat on cardiovascular health and obesity, arguing that full-fat dairy products have “neutral and positive attributes.” Other comments recommend that we exclude milkfat from the saturated fat limit for the dairy food group when it is inherently present in a product (such as cheese), due to emerging science on benefits of milkfat, arguing that full-fat and reduced-fat dairy products (
                        <E T="03">e.g.,</E>
                         2% milk) should also be able to make “healthy” claims. Some comments state that all nutrition science should be considered, not just the science reflected in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         and the updated Nutrition Facts label, and reference groups outside of the United States that have either provided exemptions for certain dairy products (
                        <E T="03">e.g.,</E>
                         2% milk, whole milk, and yogurt and cheese if they contain certain amounts of nutrients) from front-of-pack labeling requirements (Health Canada) or have changed their dietary recommendations to include dairy at all fat levels for the general population (Australian Heart Foundation). Further, some comments note that the 2025 Dietary Guidelines Advisory Committee is addressing a question on food sources of saturated fat, and that future iterations of the Dietary Guidelines may create additional food source-specific guidelines on saturated fat; therefore, they argue that flexibility should be provided for dairy products (
                        <E T="03">e.g.,</E>
                         exempting milkfat from the saturated fat limit) to reduce delays in adjusting to the next Dietary Guidelines.
                    </P>
                    <P>
                        (Response 63) In the proposed rule (87 FR 59168 at 59172), we described the need to update the “healthy” definition so the claim would again accurately represent levels of nutrients in a food that may help consumers maintain healthy dietary practices, consistent with current nutrition science and Federal dietary guidance, as reflected in the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         More closely aligning the “healthy” definition with the nutrition science underpinning the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         will better inform consumers and help them identify foods that are particularly useful in building a healthy dietary pattern. The Dietary Guidelines, which are updated every 5 years to reflect current nutrition science, are the foundation of Federal dietary guidance and are intended to inform policymakers when implementing federal policies and programs related to food, nutrition, and health. The Dietary Guidelines, as well as consensus reports from authoritative bodies, and their nutrition science underpinning, help FDA to shape regulations on nutrition-related claims and other information that is on a food label.
                    </P>
                    <P>
                        When developing regulations for nutrition-related claims and nutrition labeling, we review and consider many sources of scientific evidence, information, and dietary recommendations that may be relevant (
                        <E T="03">e.g.,</E>
                         conclusions of other expert or international bodies), and findings or research that represent consensus of experts in the field or an entire body of scientific literature are generally more informative than individual studies. We have closely aligned the updated criteria with nutrition science underpinning federal dietary guidance, particularly the Dietary Guidelines, while also considering other sources of scientific evidence and information, for example, consensus reports from authoritative bodies; FDA health claims and the scientific evidence on which they are based; our marketplace review of nutrient-dense foods; public comments to the proposed rule, including studies and data submitted in comments; and U.S. consumption patterns for saturated fat, added sugars, sodium, and recommended food groups and subgroups.
                    </P>
                    <P>
                        Nutrient-dense foods are described in the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         as providing important nutrients (
                        <E T="03">e.g.,</E>
                         vitamins and minerals), while providing little or no saturated fat, added sugars, and sodium (Ref. 1). Fat-free and low-fat dairy products are considered to be more nutrient-dense forms of dairy because they provide the same important nutrients (
                        <E T="03">e.g.,</E>
                         calcium, vitamin D, and potassium), but contain less saturated fat than higher fat options such as 2% and full-fat milk and cheese (Ref. 1). As discussed above, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         states that it would be beneficial for most consumers to increase consumption of dairy in fat-free or low-fat forms and includes strategies to increase dairy intake, such as drinking fat-free or low-fat milk with meals or incorporating unsweetened fat-free or low-fat yogurt into meals or snacks. In the proposed rule, we proposed a saturated fat limit for the dairy group of ≤10% DV per RACC, an increase from the baseline saturated fat limit of ≤5% DV per RACC, so that fat-free and low-fat dairy products—more nutrient-dense forms of dairy recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                        —could meet the saturated fat limit. Our review of the products available in the marketplace, in response to these comments, demonstrates that nutrient-dense forms of dairy, including fat-free and low-fat milk and yogurt, can meet the proposed ≤10% DV per RACC saturated fat limit (Ref. 2). Our marketplace review also indicates that many cheeses currently in the marketplace do not meet the proposed ≤10% DV per RACC saturated fat limit (
                        <E T="03">e.g.,</E>
                         because fat-free and low-fat cheese products make up a low percentage of the overall cheese market) (Ref. 2). However, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         emphasizes that most individuals would benefit by increasing intake of fat-free or low-fat 
                        <PRTPAGE P="106100"/>
                        cheese (as well as other types of dairy such as fat-free or low-fat milk and yogurt), and we have determined that a saturated fat limit of ≤10% DV per RACC or per 50 g for RACCs ≤50 g or ≤3 Tbsp for the dairy food group will help consumers identify dairy products in more nutrient-dense forms (
                        <E T="03">i.e.,</E>
                         fat-free and low-fat), consistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         and that these nutrient-dense dairy foods that qualify for the “healthy” claim can serve as a foundation for a healthy dietary pattern. Therefore, we decline to increase the saturated fat limit for dairy foods above ≤10% DV per RACC. We emphasize that dairy products that exceed the saturated fat limit can still be part of a healthy dietary pattern and their nutritional attributes can be conveyed with other labeling claims or other truthful and non-misleading statements in labeling.
                    </P>
                    <P>
                        The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         provides the following recommendation for limiting saturated fat: “For those 2 years and older, intake of saturated fat should be limited to less than 10 percent of calories per day by replacing them with unsaturated fats, particularly polyunsaturated fats” (Ref. 1). The recommended limit for saturated fat in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         is based on the totality of the scientific evidence, including rigorous systematic reviews, examined by the 2020 DGAC for the relationship between saturated fat, particularly the replacement of saturated fat with unsaturated fats, and cardiovascular disease and blood cholesterol. For example, the 2020 DGAC review found that reducing intake of saturated fat in adults by substituting it with unsaturated fats, particularly polyunsaturated fat, lowers the incidence of CVD (Ref. 8). Specifically, the 2020 DGAC concluded in their report that: (1) there was strong evidence that replacing saturated fat intake with polyunsaturated fatty acids reduces CHD events and CVD mortality in adults and (2) there was strong and consistent evidence that replacing saturated with unsaturated fats, particularly polyunsaturated fats, in the diet reduces low-density lipoprotein (LDL) cholesterol in adults. The 2020 DGAC report emphasizes that shifts from saturated fat to unsaturated fats are best within the context of a healthy dietary pattern, which includes higher intake of fatty fish, nuts and seeds, and low-fat dairy (as well as other recommended food groups) (Ref. 8).
                    </P>
                    <P>
                        As discussed in detail above, the inherent saturated fat in seafood and in nuts, seeds, and soybeans are excluded from the saturated fat limits for the seafood subgroup and the nuts, seeds, and soy products subgroup because their fat profiles are predominantly unsaturated fats. Based on the evidence for unsaturated fats, particularly the substitution of unsaturated fats for saturated fat, there are Federal dietary recommendations and health claims for the substitution of unsaturated fats for saturated fat in the diet and for foods with fatty acid profiles that are predominantly unsaturated fats. Further, in contrast to what it does for dairy, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         does not distinguish between or encourage different types of seafood based on saturated fat content, but rather encourages seafood choices that are higher in unsaturated fats, 
                        <E T="03">i.e.,</E>
                         EPA and DHA (and lower in methylmercury), and also does not distinguish between or encourage different types of nuts, seeds, and soy products based on saturated fat content. In contrast to the fat profiles of nuts, seeds, and soy products, and seafood, which are predominantly unsaturated fat, the fat profiles of full-fat dairy foods are predominantly saturated fat (
                        <E T="03">e.g.,</E>
                         milk, whole, 3.25% milkfat, with added vitamin D contains ~67% saturated fat and 25% unsaturated fat; yogurt, plain, whole milk contains ~54% saturated fat and ~22% unsaturated fat) (Ref. 7). One of the characteristics of a healthy dietary pattern, as described in the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         includes relatively higher amounts of low- or non-fat dairy. In addition, as mentioned previously, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         encourages shifts to more nutrient-dense forms of dairy, 
                        <E T="03">i.e.,</E>
                         fat-free and low-fat dairy.
                    </P>
                    <P>We are aware of relatively recent studies on the effects of different sources of saturated fat, such as dairy. The 2020 DGAC review focused on types of dietary fats rather than sources; however, the committee recognized the growing body of research on specific fatty acids, sources of fats (explicitly sources of saturated fat), and the food matrix in their report. As noted in some comments, the 2025 DGAC is currently examining a question on food sources of saturated fat and risk of cardiovascular disease. It would be premature to speculate about what the findings will be from the 2025 DGAC review related to food sources of saturated fat, or what future iterations of the Dietary Guidelines might include on this topic. Further, we are unaware of recommendations from other U.S. Federal entities, or consensus reports from authoritative bodies that include recommendations for the general U.S. population, that encourage full-fat dairy for the general U.S. population.</P>
                    <P>
                        Based on these considerations, we decline to exempt the saturated fat inherent in dairy foods from the saturated fat limit for the “healthy” definition. We will continue to stay abreast of research in this area, including any future consensus reports or recommendations from federal bodies, such as the 
                        <E T="03">Dietary Guidelines.</E>
                         For discussion of comments expressing opposition to any limit on saturated fat for the “healthy” criteria, see section (a) below (basing the saturated fat limit on a ratio approach versus the % DV).
                    </P>
                    <P>(Comment 64) Some comments support the proposed saturated fat limit of ≤20% of total fat for 100% oils, oil-based spreads, and oil-based dressings, asserting that this limit is consistent with what is used by the National Academies, grounded in the scientific literature, and ensures that oils, spreads, and dressings can be a part of a healthy dietary pattern because they are lower in saturated fat and higher in unsaturated fatty acids. One comment notes that FDA struck the right balance in determining which products should be considered “healthy” with respect to the “oils and fats” group. In contrast, some comments argue that the saturated fat limit of ≤20% of total fat poses a food design problem for oil-based spreads. Two comments assert that 25% of total fat is the lower limit for saturated fat in order for spreads to maintain their solid nature, and that a limit of 20% of total fat would only allow sprays and liquid margarine products to qualify. Further, these comments recommend that spreads be given the option of qualifying as a small RACC food and qualifying based on the actual amount of saturated fat per serving rather than the saturated fat oil component. One comment notes that a saturated fat limit of 25% of total fat is 5% lower than most spreads in the market. Another comment recommends increasing the limit to 33% of total fat asserting that this would be consistent with the World Health Organization's (WHO) recommendations for total fat and saturated fat of no more than 30% of caloric intake and 10% of caloric intake, respectively.</P>
                    <P>
                        (Response 64) In the proposed rule (87 FR 59168 at 59189), we explained that we proposed a saturated fat limit for oils of 20% of total fat to ensure that only oils with a fat profile of predominantly monounsaturated and polyunsaturated fats, as recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         meet the criteria for “healthy.” We discussed in the proposed rule that a saturated fat limit of ≤20% of total fat for the oils group is also consistent with both the percentage used in the National 
                        <PRTPAGE P="106101"/>
                        Academies DRI macronutrient report to describe dietary fats low in saturated fatty acids (Ref. 9) and the saturated fat requirement for determining the type of foods, for example vegetable oils, spreads, and shortenings, that are eligible to bear the health claim for “Substitution of Saturated Fat in the Diet with Unsaturated Fatty Acids and Reduced Risk of Heart Disease” (Ref. 13). Further, it aligns with the recommendations and strategies in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         for the substitution of saturated fat with unsaturated fat, including specific shifts that are encouraged related to oils (
                        <E T="03">e.g.,</E>
                         using oils that are higher in unsaturated fat instead of fats high in saturated fat, such as butter, shortening, lard, or coconut or palm oils). As noted above, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         does not include coconut oil, palm kernel oil, or palm oil in the oils category because they contain a higher percentage of saturated fat compared to other oils.
                    </P>
                    <P>We agree with comments that a saturated fat limit of ≤20% of total fat is supported by a body of scientific evidence, including evidence demonstrating reductions in LDL-cholesterol when plant-derived oils are substituted for fats or oils higher in saturated fat. We recognize that saturated fat is used in oil-based spreads for certain functions such as stability and texture. However, we disagree that 25% of total fat is the lower limit for saturated fat in order for oil-based spreads to maintain their solid nature, as our marketplace review demonstrates that there are oil-based spreads currently in the marketplace that contain saturated fat in amounts that are ≤20% of total fat (Ref. 2). Therefore, we also disagree that a saturated fat limit of ≤20% of total fat would only result in sprays and liquid margarine products qualifying. Increasing the limit for oil-based spreads, for example to ≤25% or ≤33% of total fat as requested in some comments, would result in use of the “healthy” claim on oil-based spreads with higher amounts of saturated fat which would be inconsistent with the claim's objective of helping consumers to identify products that are particularly useful for creating a healthy diet consistent with dietary recommendations. We note that the WHO recommended limits of ≤30% of total calories from total fat and ≤10% of total calories from saturated fat are based on percentages of total caloric intake and are not on a per product basis. Therefore, we disagree that the WHO recommendations for total fat and saturated fat as a percentage of total calorie intake warrant a saturated fat limit of 33% of total fat for oil-based spreads in this rule regarding the “healthy” claim.</P>
                    <P>For the reasons discussed above, we decline to increase the saturated fat limit for oil-based spreads and are finalizing the saturated fat limit of ≤20% of total fat for 100% oils, oil-based dressings, and oil-based spreads. While oil-based spreads are a small RACC food, the saturated fat limit for the oils food group, including 100% oil, oil-based dressings, and oil-based spreads, is based on a percentage of total fat rather than the amount of saturated fat per serving, for the reasons discussed above.</P>
                    <HD SOURCE="HD3">a. Request for Comment on Limits Based on Ratio of Saturated Fat to Total Fat (Alternative Approach)</HD>
                    <P>In the preamble to the proposed rule, we explained that we were also considering alternatives to the proposed limits on saturated fat, including an approach using a ratio of saturated fat to total fat, such as a ratio based on current DVs for saturated fat and total fat, which are based on 10% and 35% of daily calorie intake, respectively (87 FR 59168 at 59179). We explained that the intent of this approach would be to apply a single ratio across all food groups, thereby reducing the variation in the proposed limits, while still providing some flexibility for foods that supply monounsaturated and polyunsaturated fats (see 87 FR 59168 at 59179). We invited comment on this approach.</P>
                    <P>
                        (Comment 65) Some comments argue that a ratio of unsaturated fat to saturated fat is a more favorable approach than the proposed approach for saturated fat limits based on percent DV, asserting that current Dietary Guidelines focus “on the type of fat, rather than the amount of fat or specific subtypes of fat.” Similarly, some comments argue that a ratio-based approach (
                        <E T="03">e.g.,</E>
                         a ratio of saturated fat to total fat of &lt;1:3.5 derived from the DVs for saturated fat and total fat) would ensure that foods such as fish products, which contain high levels of mono- and polyunsaturated fats, are able to bear the “healthy” claim, as well as other foods like cooked soybeans, cooked edamame, dried chickpeas, and boiled or canned potatoes. In contrast, numerous comments express support for the current proposal of using a limit of saturated fat alone, and not for the alternative approach of using a ratio of saturated fat to total fat, reasoning that the current proposed approach is simpler and aligns better with the Dietary Guidelines, which do not focus on achieving a particular ratio of saturated fat. The comments argue that a ratio approach is also not generally used in other dietary guidance and that any type of ratio-based approach that would place emphasis on overall fat content is not consistent with Federal policy recommendations and could create confusion for consumers. However, one comment indicates support for a ratio approach if the Dietary Guidelines were updated to include a recommended ratio of saturated to total fat. Some comments also discuss that an alternative approach like a ratio of saturated fat to total fat would be harder to understand and possibly misleading—specifically, it could allow manufacturers to manipulate their ratios and achieve “healthy” claims on products with high saturated fat. Similarly, other comments express opposition to the use of a ratio for saturated fat to total fat on the grounds that it could encourage manipulation of dairy foods to decrease the ratio, it would not contribute to greater consumer understanding of “healthy” diets, and it could lead to a greater intake of saturated fats. In addition, one comment says that a ratio approach would exclude foods with small amounts of saturated fat (
                        <E T="03">e.g.,</E>
                         1 gram) if those foods did not contain at least a certain amount of total fat (
                        <E T="03">e.g.,</E>
                         3.5 grams).
                    </P>
                    <P>
                        (Response 65) We agree that the Dietary Guidelines focus on types of fat, rather than the amount of total fat or specific subtypes of fat. However, this does not support a ratio approach for saturated fat. In fact, this supports the proposed approach for saturated fat as a percentage of the DV, as the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         provides a recommended daily limit amount for saturated fat, but does not provide recommendations for specific ratio amounts (
                        <E T="03">e.g.,</E>
                         ratio of saturated fat to total fat or ratio of unsaturated fat to saturated fat). Therefore, we agree that the approach of a saturated fat limit based on the percent DV, and not on a ratio, is more consistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025'</E>
                        s recommended quantitative limit for saturated fat. We also note that removal of the total fat limit as part of the “healthy” criteria also supports the shift to focus on the types of fat rather than total fat, as we discuss in the proposed rule (87 FR 59168 at 59178-59179). We agree that using saturated fat limits based on the percent DV is simpler than using limits based on a ratio and emphasize that a ratio approach does not distinguish between products that have low amounts of saturated fat and low amounts of other fat versus products that have high amounts of 
                        <PRTPAGE P="106102"/>
                        saturated fat and high amounts of other fat. Therefore, we share the concern that a ratio approach could allow manipulation of fats to allow for more saturated fat in a product by increasing other fat sources in the product, which goes against the intent of having a saturated fat limit. In addition, a ratio approach could result in manipulation to add more fat sources in order for a product that contains even a small amount of saturated fat to qualify (
                        <E T="03">e.g.,</E>
                         if the product contained a small amount of saturated fat, but not enough total fat to meet the specified ratio).
                    </P>
                    <P>We note one exception in the “healthy” criteria, for oils and oil-based spreads and dressings, where the limit for saturated fat is based on a percentage of total fat. The composition of oils is unique (primarily made up of fatty acids) compared to the other food groups, and we proposed a limit for saturated fat of ≤20% total fat for this category. See Response 64 for further discussion about the saturated fat limit for oils and oil-based dressings and spreads.</P>
                    <P>
                        Regarding seafood, we have adjusted the proposed criteria to provide more flexibility for nutrient-dense foods that are recommended by the Dietary Guidelines (see Response 62 for discussion of saturated fat and seafood). For example, all varieties of fish, including fish that is high in mono- and polyunsaturated fats but also contains saturated fat, can qualify for the “healthy” claim based on the single-ingredient exemption. A majority of other examples provided in comments in support of a ratio can also meet the updated definition (
                        <E T="03">e.g.,</E>
                         cooked soybeans, cooked edamame, dried chickpeas). See Response 58 on saturated fat and beans, peas, lentils, and soy products and Response 9 for the expanded exemption for single-ingredient nutrient-dense foods.
                    </P>
                    <P>(Comment 66) One comment states that saturated fat, as a single amount or a ratio, should not be included as a nutrient to limit as it could result in reduced intake of nutrient-dense foods. The comment asserts that limiting saturated fat as a class, or single nutrient, is too simplistic, noting for example that it does not take into consideration individual saturated fatty acids that can have different effects. Another comment recommends that careful consideration be given when grouping all saturated fatty acids under the general term “saturates” because not all saturates have the same physiological effects.</P>
                    <P>
                        (Response 66) We disagree that saturated fat should not be included as a nutrient to limit and that including it as a nutrient to limit would prevent nutrient-dense foods from bearing the “healthy” claim. As discussed in the proposed rule (87 FR 59168 at 59178), several consensus reports reviewing the scientific evidence related to saturated fat intake, as well as the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         include recommendations to limit saturated fat based on CVD risk. Further, dietary recommendations continue to recognize the well-established relationship between consumption of saturated fat and effects on blood cholesterol (87 FR 59168 at 59178). Despite these recommendations, 76% of males and 71% of female adults (ages 19-30 years) in the United States exceed recommended limits for saturated fat (Ref. 8). It is important, therefore, to continue to include a limit for saturated fat as part of the “healthy” definition, while still ensuring that there are nutrient-dense foods containing some inherent saturated fat that can qualify. The updated “healthy” criteria framework includes adjustments and exemptions to ensure that nutrient-dense foods recommended by the Dietary Guidelines can qualify for the claim. In the proposed rule, we made adjustments to the baseline saturated fat limit for some food groups and subgroups, such as increasing the saturated fat limit to ≤10% per RACC for dairy products to ensure that low-fat dairy could qualify, as recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         and excluding the inherent saturated fat in nuts and seeds from the saturated fat limit for that subgroup. Further, as discussed above, we have expanded the exemption for raw, whole fruits and vegetables to single-ingredient foods recommended by the Dietary Guidelines and made adjustments to the proposed criteria so that the inherent saturated fat in soybeans and seafood are excluded from the saturated fat limit for their respective subgroups. As a result, a variety of nutrient-dense foods can qualify for the updated “healthy” claim, particularly when compared to the original “healthy” definition.
                    </P>
                    <P>
                        We further disagree that the saturated fat limit is too simplistic and does not take into consideration individual saturated fatty acids that can have different effects. The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         provides a quantitative intake recommendation for saturated fat, which relates to intake of all saturated fatty acids. The comments did not provide details on a suggested alternative grouping or provide data or information to support the rationale for an alternative grouping for saturated fat, and therefore FDA does not have a basis on which to consider alternative groupings. For these reasons, we decline to change the classification of the saturated fat group and all individual saturated fatty acids are included within the saturated fat group for the purposes of the “healthy” nutrient content claim criteria.
                    </P>
                    <P>(Comment 67) One comment asserts that the Dietary Reference Intake (DRI) values for saturated fat, on which the DV is based, were issued in the early 2000s and that methodology for developing evidence-based guidance has evolved since that time. The comment also states that DRIs are predicated on essentiality, and it is unclear if saturated fat is an essential nutrient given that humans can synthesize saturated fatty acids de novo. Therefore, the comment asserts that the approach used to establish a saturated fat DV may not be appropriate and supports a ratio approach instead.</P>
                    <P>(Response 67) While DRIs are one consideration when determining DVs, DVs do not have to be solely or directly based on DRI values. For example, there is not a DRI value for saturated fat, and the DVs for macronutrients—total fat, total carbohydrate, and protein—are not solely based on DRI values. We also note that the DRI framework has been expanded to now include chronic disease risk reduction (Refs. 10 and 11), therefore a DRI value does not need to be based on essentiality.</P>
                    <P>
                        In the proposed rule (87 FR 59168 at 59178), and the NFL Final Rule (81 FR 33742), we provide examples of consensus reports, as well as the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         which have reviewed the scientific evidence related to saturated fat intake, and recommended saturated fat intakes of no more than 10% of calories based on CVD risk. In 2016, we reaffirmed in the NFL Final Rule that the 20 g DV, which is 10% of calories for a 2,000 calorie reference intake level, is consistent with scientific evidence based on CVD risk for the general population (81 FR 33742 at 33786). Therefore, the DV for saturated fat is not related to whether or not saturated fat is an essential nutrient. Similarly, the recommendations in consensus reports, as well as in the Dietary Guidelines, to limit daily intake of saturated fat are not based on whether saturated fat is essential, but rather on the scientific evidence for saturated fat as it relates to CVD risk. The 2020 DGAC Report explains that humans do not have dietary requirements for saturated fats because they “synthesize them from other dietary substrates”; intake of saturated fat is associated with risk of CVD; and the Committee recommends “saturated fat intake be 
                        <PRTPAGE P="106103"/>
                        limited to less than of 10 percent of total energy intake, as recommended by the 
                        <E T="03">2015-2020 Dietary Guidelines for Americans</E>
                        ” (Ref 8). While we agree that methodology for developing evidence-based guidance has evolved since the early 2000s, we disagree that the DV is based on methodology from that time, as the 2020 DGAC, for example, used current methodologies to evaluate the body of evidence for saturated fat and CVD risk.
                    </P>
                    <P>Basing nutrient limits for the use of the “healthy” claim on a percentage of the DV for saturated fat, added sugars, and sodium, instead of on gram amounts (the approach used in the original “healthy” criteria), allows for flexibility and helps ensure longevity if DVs are updated in the future. If the DV for saturated fat were to change in the future, it would be reflected in the “healthy” criteria because the limits for the NTL are based on the % DV.</P>
                    <P>
                        Lastly, when we asked for comment on an alternative ratio approach, the example that we provided in the proposed rule (
                        <E T="03">i.e.,</E>
                         a ratio based on current DVs for saturated fat and total fat) was based on DVs, including the DV for saturated fat. The comment did not provide input specifically on that example nor did it suggest, or provide information or evidence for, an alternative ratio amount that would not be based on DVs. For the reasons described above, we do not have a basis to change to a ratio approach and will maintain the overall approach of basing the saturated fat limit on a percentage of the DV rather than on a ratio (with the exception of the oils group as discussed above).
                    </P>
                    <HD SOURCE="HD3">3. Sodium</HD>
                    <P>
                        (Comment 68) Many comments agree that sodium should be included as a nutrient to limit in the “healthy” claim. Some comments agree that the proposed ≤10% of the DV per RACC baseline limits for individual foods, including fruit, vegetable, grain, and dairy products and protein foods, are an appropriate step towards curtailing sodium consumption. These comments note that most sodium consumed in the United States comes from salt added during commercial food processing and preparation and that sodium consumption in the United States far exceeds the recommended daily intake limit—average intake (ages 1 and older) is 3,393 mg/day and the recommended daily limit from the current 
                        <E T="03">Dietary Guidelines, 2020-20205</E>
                         is 2,300 mg/day for most ages. A few comments argue that the sodium limits should be more restrictive, for example, that the baseline limit should be lowered to ≤5% DV. Other comments agreed with a ≤10% DV limit instead of a ≤5% DV limit based on the functional role that sodium plays in many foods, asserting that a sodium limit of ≤5% DV is not feasible or practical at this time. One comment acknowledges that, while lower sodium limits would be preferable, aiming to lower daily intake to 2,300 mg is a more realistic goal; however, it also notes that foods that exceed the voluntary sodium reduction targets should not be eligible for the “healthy” claim.
                    </P>
                    <P>(Response 68) In the proposed rule (87 FR 59168 at 59179), we explained that a lower sodium limit for the updated “healthy” definition should be feasible due to reductions in sodium in certain foods in response to consumer support for policies to limit sodium content in manufactured foods and technological progress since the original definition was issued in 1994. For example, in 2021, FDA published short-term (2.5 year) voluntary sodium reduction targets for the food industry, as part of a gradual, iterative approach to help reduce sodium in the food supply and support reducing sodium intakes over time (Ref. 12). In 2024, we issued new, voluntary targets for sodium reduction in foods in a draft guidance that serve as Phase II of the Agency's ongoing work. The new targets build on the final, voluntary sodium reduction goals issued in 2021, now referred to as Phase I (Ref. 47). When determining the proposed sodium limit for the “healthy” claim, we considered the many functions of sodium in food, including taste, texture, microbial safety, and stability. The sodium limit of ≤10% DV (currently ≤230 mg for adults and children 4 years of age and older) is ~50% less than the sodium limit in the original criteria for “healthy” (480 mg or ~20% DV). As noted, we proposed a lower limit (≤10% DV) than the limit in the original criteria because of the technological advances and progress that have been made since 1994 in reducing sodium in foods. We are concerned that a limit of ≤5% of the DV for sodium would not be practical at this time. Having limits that are too restrictive would prevent a variety of nutrient-dense foods across foods groups and subgroups from being able to qualify for the “healthy” claim.</P>
                    <P>
                        Compared to the sodium limit in the original definition (480 mg per RACC or per 50 g for RACCs ≤30 g for individual foods), the lower limit of ≤10% DV (currently 230 mg) per RACC (or per 50 g for RACCs ≤50 g or ≤3 Tbsp) will allow the updated “healthy” claim to help consumers identify more nutrient-dense foods that can help them achieve a healthy dietary pattern, which is consistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         Further, our marketplace review of nutrient-dense foods demonstrates that a ≤10% DV limit permits a variety of nutrient-dense foods to qualify across food groups and subgroups, while allowing some sodium for processing, preservation, or taste (
                        <E T="03">e.g.,</E>
                         low sodium canned vegetables) (Ref. 2). For the reasons discussed above, we decline to lower the baseline limit for sodium to ≤5% DV per RACC. See the discussion in Response 69 for a comparison of the sodium reduction targets and the criteria for the “healthy” nutrient content claim.
                    </P>
                    <P>
                        (Comment 69) Some comments raise concerns that the proposed limits for sodium are too restrictive and would exclude products encouraged by the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         including whole grain tortillas and most nutrient-dense low/reduced sodium canned products (
                        <E T="03">e.g.,</E>
                         canned vegetables). The comments assert that the proposed limits are significantly lower (25-50%) than the original “healthy” criteria and suggest that food products could contain more sodium and still align with the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         Some comments state that the proposed limits undermine the functional purposes of sodium. The comments also assert that sodium is crucial to ensuring the flavor of foods that are promoted by the rule and the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         reasoning that compliance with the ≤10% DV limit would result in a lack in taste that would discourage consumption of such products, even if they bear the “healthy” claim.
                    </P>
                    <P>Some comments assert that the proposed sodium limits would not encourage reformulation and that there is more room to accommodate greater amounts of sodium, suggesting different options as alternative sodium criteria across food categories, for example:</P>
                    <P>1. Individual foods: 0-10% DV per RACC or per 50 g for foods with small RACCs; mixed products: 460 mg (20% DV) per RACC and labeled serving or per 50 g for foods with small RACCs; main dishes: 600 mg or less per labeled serving; and meals: 600 mg or less per labeled serving; or</P>
                    <P>2. Individual or mixed foods, small RACC (RACC ≤30 g/2 Tbsp): 10% DV per RACC; individual or mixed foods, RACC &gt;30 g/2 Tbsp: 20% DV per RACC; main dishes: 25% DV per serving; and meals: 30% DV per serving.</P>
                    <P>
                        The comments argue that the alternative criteria would allow more options in the marketplace to be labeled as “healthy,” including foods that are encouraged by the Dietary Guidelines 
                        <PRTPAGE P="106104"/>
                        and MyPlate, and those that are affordable, accessible, and culturally relevant choices, that do not meet the proposed sodium criteria (
                        <E T="03">e.g.,</E>
                         canned vegetables, 100% whole grain tortillas, some Special Supplemental Nutrition Program for Women, Infants and Children (WIC) eligible cereals, and reduced sodium/light soups). A few comments advocate for increasing the sodium limit to ≤15% DV for individual foods because it would provide additional enticements for reformulation efforts to lower the sodium levels for foods. One comment, in support of keeping the sodium limits for the original “healthy” definition, notes that when the sodium limit for the original “healthy” definition of 600 mg is applied to a main dish weighing 270 g (222 mg sodium/100 g), it is well below the category target mean of 270 mg/100 g for the “frozen meals” category from the short-term sodium reduction targets. In contrast, another comment advocates for a sodium limit lower than the proposed limit for meals (30% DV) because meals lower in sodium are more consistent with the 2016 draft long-term voluntary sodium reduction goals, for example, a typical 9 oz. (255 g) frozen meal had a target mean of 460 mg (180 mg/100 g) compared with the proposed sodium limit of 690 mg (30% DV) for meals.
                    </P>
                    <P>
                        (Response 69) Based on evidence showing a beneficial effect of reducing sodium intake on risk of CVD and hypertension, including on systolic and diastolic blood pressure, the National Academies established the following Chronic Disease Risk Reduction Intake (CDRR) values: 1,200 mg/day, ages 1 through 3; 1,500 mg/day, ages 4 through 8; 1,800 mg/day, ages 9 through 13; and 2,300 mg/day, ages 14 and above (Ref. 11). Data from the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         demonstrates that 90% of the U.S. population exceeds recommended limits for sodium intake (Ref. 1). In the United States, most sodium consumed comes from salt added during commercial processing and preparation of foods (including foods that are prepared in restaurants). The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         notes that the nutrient-dense choices in the Healthy U.S.-Style Dietary Pattern contribute approximately 60-100% of the CDRR (for different ages across calorie levels). As a result, there is very little room for food choices that are high in sodium in a healthy dietary pattern that meets the daily recommended limit for sodium, for most calorie levels and at most ages. To reduce sodium intake, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommends implementing multiple strategies, for example, consuming foods with less sodium in all food groups, by using food labels to choose products with no-salt-added, less sodium, or reduced sodium.
                    </P>
                    <P>We explained in the proposed rule (87 FR 59168 at 59179) that we expect that it is feasible to lower the sodium limit for the new “healthy” criteria, as compared to the original definition, due to reductions in sodium in certain foods and food categories, in response to consumer support for policies to limit sodium content in manufactured foods (Refs. 17 and 18) and technological progress since the original definition of “healthy” was finalized in 1994. We disagree that the proposed sodium limits do not take into consideration the function of sodium in foods. As mentioned above, when determining the limits for the “healthy” claim, we considered the many functions of sodium in food, including taste, texture, microbial safety, and stability. We proposed a limit for sodium of ≤10% per RACC to allow for these considerations. Furthermore, as we stated in the proposed rule, while a baseline limit for sodium of ≤5% of the DV per RACC would be consistent with the proposed saturated fat and added sugar baseline limits, we were concerned that a limit of ≤5% of the DV per RACC for sodium would not be practical.</P>
                    <P>Lowering the “healthy” sodium limit to ≤10% DV also aligns with recent FDA initiatives related to sodium reduction in foods. For example, these include our 2021 final guidance with voluntary targets for reducing sodium in foods (Phase I targets) (Ref. 12), our 2024 draft guidance with voluntary targets for reducing sodium in foods (Phase II targets) (Ref. 47), our 2023 proposed rule to permit safe and suitable salt substitutes to reduce sodium in standardized foods (Ref. 15), and our 2020 enforcement discretion guidance related to use of an alternate name for potassium chloride in food labeling (“potassium salt”) (85 FR 82332, December 18, 2020). Technological progress and efforts such as these, as well as our marketplace review of nutrient-dense foods, support lowering the sodium limits for the updated “healthy” definition compared to the limits in the original “healthy” definition that were issued in 1994.</P>
                    <P>
                        As referenced in some comments to the “healthy” proposed rule, the 2021 final guidance included 2.5-year voluntary targets for commercially processed, packaged, and prepared food. While the sodium reduction targets and “healthy” criteria are complementary to one another and support the same overarching goal—reducing intake of sodium in the United States—the purpose, approach, and rationale for the limits for the updated “healthy” criteria are different than those for the sodium reduction targets. The 2021 final guidance for industry provides voluntary 2.5 year sodium reduction targets, with target mean and upper bound concentrations for 163 categories of food that are commercially processed, packaged, and prepared. The 2024 draft guidance for industry contains 3-year voluntary sodium reduction targets for 163 categories of food that aim to help reduce Americans' average sodium intake to about 2,750 mg/day. The “healthy” claim, and underlying criteria, seeks to help consumers identify foundational foods that can help them build a healthy dietary pattern, which would consist of intake of less than 2,300 mg of sodium per day, consistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                    </P>
                    <P>
                        We decline to adopt the recommendations in some comments that suggest alternative sodium limits. Setting a sodium limit of 20% DV for individual foods would not be consistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         as it would not help consumers identify foods that are particularly useful in creating healthy dietary patterns because they are nutrient-dense, 
                        <E T="03">e.g.,</E>
                         containing little or no sodium. Instead, products that contain 20% DV of sodium per serving would be considered to be high in sodium based on our regulations. Our nutrient content claims regulations at § 101.54(b) allow for the use of claims indicating that a food is an “excellent source of,” “high,” or “rich in” a nutrient if it contains 20% or more of the DV per RACC. According to current nutrition science and Federal dietary guidance, consumers should strive to limit sodium in their diets as part of building healthy dietary patterns rather than to get enough of it. Therefore, it would not be appropriate or consistent with current dietary recommendations to set a sodium limit for the use of the “healthy” claim that is equal to the amount required for the use of claims indicating that a food is “an excellent source of,” “high in,” or “rich in,” a nutrient.
                    </P>
                    <P>
                        The intent of the updated sodium limits for the “healthy” claim is to ensure both a sufficient number and variety of nutrient-dense foods, across different food groups and subgroups recommended by the 
                        <E T="03">Dietary Guidelines, 2020-20205,</E>
                         can bear the “healthy” claim, while also being rigorous enough to distinguish foods that are particularly useful in building a healthy dietary pattern. The sodium 
                        <PRTPAGE P="106105"/>
                        limits may also result in industry innovation, which can increase the availability of lower sodium nutrient-dense foods in the marketplace and help consumers build healthier dietary patterns.
                    </P>
                    <P>
                        Our marketplace review demonstrates that a sodium limit of ≤10% DV, combined with other permitted exemptions (see Response 9), results in a variety of nutrient-dense individual foods across all food groups qualifying for “healthy” (including nutrient-dense foods included in the Dietary Guidelines and MyPlate website) without resulting in foods that contain unnecessary excess sodium to bear the claim (Ref. 2). For example, it shows that different forms of food products across food groups, including affordable, accessible, and culturally relevant nutrient-dense foods could qualify to bear the “healthy” claim because they can meet a sodium limit of ≤10% DV, such as canned, dried, frozen, and other shelf-stable or packaged products (
                        <E T="03">e.g.,</E>
                         options for canned vegetables and 100% whole grain tortillas) and also accommodates some of the functional purposes of sodium.
                    </P>
                    <P>Accordingly, we have determined that a baseline sodium limit of ≤10% DV per RACC (or per 50 g for RACCs ≤50 g or ≤3 Tbsp) for individual foods results in a variety of nutrient-dense foods across recommended food groups qualifying for the “healthy” claim while ensuring that foods that can qualify for “healthy” do not contain unnecessary excess sodium, and we therefore decline to increase the sodium limit. See Response 8 for further discussion of criteria for small RACC foods. Also see section V.E (“Combination Foods”) for discussion of specific criteria for combination products, including mixed products, main dishes, and meals.</P>
                    <P>
                        (Comment 70) Some comments supporting the alternative criteria described in the previous comment summary suggest that such alternative criteria would help consumers adapt to a stepwise reduction of sodium. Similarly, some comments suggest that a stepwise approach imposes flexible sodium limits on a product-by-product basis, while accounting for products' contributions to healthy dietary patterns. For example, some comments recommend that the small RACC (≤30 g) individual and mixed food category have their own limit (
                        <E T="03">e.g.,</E>
                         ≤10% DV) on the grounds that these changes would reflect the smaller consumption of these foods in a diet. Some comments suggest that the most effective approach to lower sodium in foods is to use a stepwise, gradual reduction of sodium in line with FDA's 2021 voluntary sodium reduction targets guidance, reasoning that the guidance “involves a level of precision with respect to sodium targets for specific products within a category/RACC that the `healthy' sodium criteria would not be able to reach.” One comment asserts that the “healthy” sodium limits are not consistent with and are “unusually dramatic” compared with other federal dietary policy and references a USDA proposed rule from February 2023, “Children's Nutrition Program: Revisions to Meal Patterns Consistent With the 2020 Dietary Guidelines for Americans” (88 FR 8050, February 7, 2023) in which the USDA proposed a gradual reduction in school meal sodium limits.
                    </P>
                    <P>
                        (Response 70) We agree that there should be a stepwise approach across food categories (
                        <E T="03">i.e.,</E>
                         gradual or incremental increases in sodium for individual foods with a smaller RACC, individual foods with larger RACCs, mixed products, main dishes, and meals). As discussed in Response 8, we have decided to modify the criteria by providing specific criteria for foods with smaller RACCs as recommended in many comments. In addition, in section V.E (“Combination Foods”) we discuss our incremental or stepwise approach for setting the NTL for mixed products, main dishes, and meals.
                    </P>
                    <P>In the previous response, we described the differences in the specific aims, approaches, and rationales for the voluntary sodium reduction targets and the sodium limits for the updated “healthy” definition. Accordingly, while these two efforts align in their support of the role of lower sodium foods in healthy dietary patterns, we disagree that the limits for sodium for foods that bear the “healthy” nutrient content claim should match the sodium reduction targets that are for 163 categories of food commercially processed, packaged, and prepared by industry.</P>
                    <P>
                        Similarly, there are differences in the specific aims, approaches, and rationales between the sodium limits in the 2023 USDA child nutrition meal patterns proposed rule, and the recently issued 2024 final rule, and the sodium limits for the updated definition for the voluntary “healthy” nutrient content claim. As an example of one of the key differences, the sodium limits in the USDA final rule apply, on average, to school meals offered during a particular school week (89 FR 31962). The sodium limits for “healthy” are based on a per RACC or per labeled serving basis, whereas the USDA sodium limits for school meals apply, on average, to lunches and breakfasts offered during a school week and do not apply per meal or per menu item. For example, under the USDA final rule, specific products are not held to specific sodium limits, but meals need to fit in the overall weekly limit. As a result, meals, menu items, or products with higher sodium can be offered if they are balanced out with products with lower sodium throughout the school week. In contrast, the “healthy” claim, when voluntarily used on a food label or in food labeling, is intended to help consumers identify foods that are particularly useful, because of their nutrient levels, for serving as a foundation for a healthy dietary pattern. While there were multiple proposed sodium reduction dates in the USDA proposed rule, the USDA final rule has a single sodium reduction for both school lunch and breakfast, to occur in school year 2027-2028. The USDA final rule gives schools and the school food industry an endpoint to work toward in the near-term, while still providing time to gradually reduce sodium prior to implementation. We disagree that the “healthy” proposed sodium limit of ≤690 mg per labeled serving for meals is unusually restrictive compared to the sodium limits in the USDA final rule for school meals (see section V.E (“Combination Foods”) for more information on sodium limits for mixed products, main dishes, and meals). Further, as noted in their final rule, USDA used FDA's sodium reduction targets from the 2021 final guidance (now being referred to as Phase I) to inform the proposed weekly sodium limits for the school lunch and breakfast programs. As discussed in Response 69 and above, there are differences in the specific aims, approaches, and rationales for the FDA voluntary sodium reduction targets and the sodium limits for the updated “healthy” definition—which seeks to help consumers identify foundational foods that can help them build a healthy dietary pattern consistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         (
                        <E T="03">e.g.,</E>
                         consisting of sodium intake of less than 2,300 mg per day). Similarly, while the sodium limits for school meals and the sodium limits for the “healthy” claim both support the role of lower sodium foods in healthy dietary patterns, these efforts have different purposes and considerations, and they use different approaches. 
                    </P>
                    <P>
                        (Comment 71) Other comments reference “Food Labeling; Nutrient Content Claims, Definition of Sodium Levels for the Term `Healthy' ” (70 FR 56828, September 29, 2005) (“2005 sodium final rule”), specifically the decision to eliminate the “second tier” 
                        <PRTPAGE P="106106"/>
                        (more restrictive) sodium limits, corresponding to ~15% of the DV, from the 1994 “healthy” definition, based in part on concerns from industry regarding the feasibility of reformulating products to meet reduced sodium limits. 
                    </P>
                    <P>(Response 71) The intent of the two-tiered sodium levels established by the 1994 final rule was to encourage industry to be innovative and further lower sodium levels in foods bearing the claim “healthy.” In 2005, we decided to retain the higher “first-tier” sodium limits, in part, because of the challenges related to the feasibility at that time of meeting the lower limits, including technological barriers to reducing sodium in foods that were in the marketplace at that time. In the 2005 sodium final rule (70 FR 56828 at 56834), we stated that we had anticipated that phasing in the lower second-tier sodium level requirement for the term “healthy” would allow the food industry time to develop technically and commercially viable alternatives to salt. We said at that time that, although it is unfortunate that no viable alternative has been found, we understand the manufacturing difficulties that are presented by the absence of a suitable substitute for salt and has taken them into consideration in deciding how to regulate the sodium content of foods bearing the “healthy” claim. We also stated that: “[w]hen FDA issued the 1994 final rule providing for a phased-in second-tier sodium level . . . [we] had anticipated that with the passage of time, there would be sufficient technological progress to make it feasible to implement this lower sodium level requirement for foods labeled as `healthy' ” (70 FR 56828 at 56836). Since 2005, there have been some substantial sodium reduction efforts, including technological advances such as development and usage of safe and suitable salt substitutes to help manufacturers reduce sodium in foods. Taking into account the compliance date for this final rule for updating the “healthy” definition, over 30 years will have passed since the original “healthy” definition was issued and over 20 years will have passed since the 2005 sodium final rule on defining sodium levels for the “healthy” claim. While we have provided some flexibility for mixed products (compared to the proposed rule) and for meals (compared to the original “healthy” definition), (see discussion of combination foods in section V.E), the lower sodium limits for individual foods and main dishes, compared with the original “healthy” definition, are consistent with the progress that has been made over this time. Additionally, we expect that progress in these areas will continue going forward, consistent with sodium reduction efforts such as those described above.</P>
                    <P>(Comment 72) Some comments raise concerns that the proposed sodium limits of ≤10% DV are too restrictive for certain food groups, subgroups, or types of products. In, brief, the comments identified the following products as possibly not being able to meet the proposed sodium limits:</P>
                    <P>
                        • Many frozen foods (
                        <E T="03">e.g.,</E>
                         seafood products), including frozen foods that meet the original “healthy” criteria (
                        <E T="03">e.g.,</E>
                         frozen vegetables in a tomato sauce).
                    </P>
                    <P>
                        • Canned foods (
                        <E T="03">e.g.,</E>
                         vegetables).
                    </P>
                    <P>• Some fresh seafood, without added ingredients, that typically have a sodium content above the proposed limit.</P>
                    <P>• Soup, including reduced sodium/light soups. One comment points out that soups have a RACC of 245 g or approximately 8 ounces, larger than the RACC for main dishes, which must weigh a minimum of 6 ounces; however, soups qualify as an individual/mixed product with a proposed limit of ≤10% DV, while main dishes have a proposed sodium limit of ≤20% DV.</P>
                    <P>
                        • Many plant-based products, such as those made with soy (
                        <E T="03">e.g.,</E>
                         plant-based patties).
                    </P>
                    <P>• Liquid oil-based dressings.</P>
                    <P>• Many whole grain products, including bread and tortillas.</P>
                    <P>• Cheeses.</P>
                    <P>
                        One comment argues that four eating occasions per day allows for consumption of 25% DV for sodium at each occasion and that the proposed limits only allow “healthy” grain products to contain 10% DV for sodium. Other comments discuss the different functions of sodium in foods and note that the feasibility of lowering sodium in certain products is challenging (
                        <E T="03">e.g.,</E>
                         soups and cheeses). Specifically, one comment suggests that FDA allow “formulation flexibility” related to standards of identity, 
                        <E T="03">e.g.,</E>
                         for cheeses that are required by their standards of identity to use salt, so that more cheese products can qualify for the “healthy” claim. The comment asserts that permitting the use of salt alternatives in standardized cheeses will allow further innovation by the dairy industry and allow more cheeses to qualify for the “healthy” claim while meeting standards of identity. The comment further recommends that FDA issue enforcement discretion or a direct-to-final rule, simultaneously with the “healthy” final rule, to allow the use of salt alternatives in standardized cheeses.
                    </P>
                    <P>
                        Many comments request more flexibility in the sodium limits for specific food groups, subgroups, or products, so that more of products listed above can bear the healthy claim, noting that a moderate amount of sodium increases palatability of foods that provide important nutrients, such as seafood (
                        <E T="03">e.g.,</E>
                         frozen fish) and dairy (
                        <E T="03">e.g.,</E>
                         cheese). In contrast, one comment concurs with the proposed limit on sodium for the dairy food group. For frozen foods, comments highlight the importance of availability of affordable, frozen products to low-income families. Some comments suggest increasing the limits for both sodium and added sugars to ≤20% DV for grain products.
                    </P>
                    <P>
                        (Response 72) As explained above, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         suggests that consumers use food labels to choose products with no-salt-added, less sodium, or reduced sodium. The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         describes nutrient-dense foods and beverages as products that provide vitamins, minerals, and other health-promoting components, while having little or no saturated fat, sodium, and added sugars. Along with our consideration of the Dietary Guidelines, we used our marketplace review to demonstrate whether nutrient-dense foods across food groups could meet the ≤10% DV sodium limit for individual foods, including products mentioned in comments such as whole grain breads, tortillas, and English muffins; frozen and fresh seafood; reduced/light sodium soups; reduced sodium/low sodium canned vegetables, frozen vegetable blends in sauces, and plant-based patties (Ref. 2).
                    </P>
                    <P>
                        <E T="03">Frozen vegetable blends and plant-based patties.</E>
                         Certain frozen vegetable blends in sauces could qualify as a mixed product depending on the individual components of the food (
                        <E T="03">i.e.,</E>
                         if they meet the FGE requirements for mixed products). We have provided more flexibility for sodium in mixed products by increasing the limit from ≤10% DV to ≤15% DV per RACC (or per 50 g for RACCs ≤50 g or ≤3 Tbsp), which is discussed in section V.E.2 (“Mixed Product”). The higher sodium limit for mixed products could also provide more flexibility for products mentioned in the comments, for example plant-based patties, such as those made with soy, depending on the individual components of the product. There are other vegetable blends with sauces and plant-based patties that will not qualify for the “healthy” claim because their sodium amount exceeds the ≤15% DV limit for mixed products, or because 
                        <PRTPAGE P="106107"/>
                        they do not meet the minimum FGEs for a mixed product and their sodium exceeds the ≤10% DV limit for individual foods.
                    </P>
                    <P>
                        <E T="03">Canned vegetables.</E>
                         For canned vegetables, amounts of sodium vary widely, including in reduced-sodium canned vegetables. An individual food labeled as “low sodium” would need to contain 140 mg or less per RACC (or per 50 g for foods with RACC ≤30 g) (§ 101.61(b)(4) (21 CFR 101.61(b)(4))). Therefore, all “low sodium” foods, including all “low sodium” canned vegetables would meet the 10% DV sodium limit, which is currently 230 mg. For a food labeled as “reduced sodium,” the food needs to contain at least 25% less sodium per RACC than an appropriate reference food (see § 101.61(b)(6)). Therefore, the amount of sodium can vary for reduced-sodium canned vegetables depending on the sodium amount in the reference food (which is also similar for foods labeled as “light”), and these products could still contain higher amounts of sodium. Our marketplace review demonstrates that many canned vegetables, including low-sodium canned vegetables and some reduced-sodium vegetables, can meet a ≤10% DV sodium limit (Ref. 2). Canned vegetable products that meet the “healthy” claim are products that are particularly useful, because of their nutrient content (including sodium amounts), in helping consumers identify foods that can be the foundation of a healthy dietary pattern. Canned vegetable products that have sodium in excess of 10% DV are not necessarily unhealthy (
                        <E T="03">e.g.,</E>
                         they can still be part of a healthy dietary pattern) and their beneficial nutritional attributes can be communicated in other ways that are not false or misleading. Therefore, we have decided to finalize the ≤10% DV per RACC (or per 50 g for RACCs ≤50 g or ≤3 Tbsp) sodium limit for individual foods for the vegetable food group and for the beans, peas, and lentils subgroup.
                    </P>
                    <P>
                        <E T="03">Seafood.</E>
                         The expanded exception for whole, raw fruits and vegetables to other forms (
                        <E T="03">e.g.,</E>
                         frozen) and to other foods recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         in other food groups (
                        <E T="03">e.g.,</E>
                         seafood), will result in fresh and frozen seafood without added ingredients qualifying for the “healthy” claim without being subject to FGE or NTL requirements, including the sodium limit (see Response 9). Our marketplace review indicates that there are additional seafood products, 
                        <E T="03">i.e.,</E>
                         besides single-ingredient seafood (including some frozen seafood products), that can also meet the ≤10% DV limit (Ref. 2). Seafood products that qualify for the “healthy” claim are products that are particularly useful, because of their nutrient levels (including sodium amounts), for helping consumers identify foods that are foundational for a healthy dietary pattern. As emphasized in the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         there is little room in most healthy dietary patterns for excess sodium. Therefore, we have decided to finalize the sodium limit of ≤10% DV per RACC (or per 50 g for RACCs ≤50 g or ≤3 Tbsp) for individual foods for the seafood group. Seafood products that are not able to meet the sodium limit are not necessarily unhealthy and can still be included as part of a healthy dietary pattern. Further, their beneficial nutritional attributes can be communicated with other label statements and claims, provided they are not false or misleading.
                    </P>
                    <P>
                        <E T="03">Soup.</E>
                         For soup, sodium content varies widely, with most soups containing a high amount of sodium (≥20% DV). A majority of soups do not meet the sodium limits for the original “healthy” claim. While some dry soup mixes can meet the updated sodium limits for “healthy,” most “wet soups” cannot. Wet soups are those that contain liquid (
                        <E T="03">i.e.,</E>
                         they exclude dry soup mixes). Our marketplace review of wet soups, including reduced sodium and light soups, demonstrates that over 70% of wet soups contain a high amount, at least 460 mg (≥20% DV), of sodium per RACC, with numerous containing ≥1,000 mg of sodium per RACC (Ref. 2). As mentioned above, an individual food labeled as “low sodium” would need to contain 140 mg or less per RACC (or per 50 g for foods with RACC ≤30 g) (§ 101.61(b)(4)). Low-sodium foods, including low-sodium soups, would therefore meet the ≤10% DV sodium limit for individual foods, which is currently 230 mg. We note that there are also some soups with no added salt, which only contain small amounts of sodium, that also meet the sodium limit for individual foods. As mentioned above, foods labeled as “reduced sodium” contain at least 25% less sodium per RACC than an appropriate reference food (§ 101.61(b)(6)). The nutrient content claim “light” may be used on a food if the sodium is reduced by 50% or more compared to the reference food, and other requirements are met (
                        <E T="03">e.g.,</E>
                         the reference food contains ≤40 calories and ≤3 g of fat per RACC) (21 CFR 101.56). Because the amount of sodium varies for reduced sodium and light soups depending on the sodium amount in the reference food, these products could still contain higher amounts of sodium. As previously mentioned, we have increased the sodium limit for mixed products to ≤15% DV per RACC (or per 50 g for RACCs ≤50 g or ≤3 Tbsp). This change will provide more flexibility for products, such as certain soups, to meet the sodium limit for mixed products compared to the proposed limit of ≤10% DV. Based on their ingredients, it is possible that certain soups could meet the FGE requirements for a main dish and in those cases the sodium limit would be ≤20% DV per labeled serving. We recognize, however, that most soups currently in the marketplace will exceed the sodium limits for individual foods, mixed products, and main dishes and that sodium reduction in soups can be challenging. As discussed, foods that qualify to bear the “healthy” claim are foods that, because of their nutrient levels (including amounts of sodium), are particularly useful in building healthy dietary patterns. Soups that cannot bear the “healthy” claim are not necessarily unhealthy, nor does the absence of a “healthy” claim indicate that these soups are unable to provide any nutritional benefits. Soups, such as reduced sodium or light soups, can be part of a healthy dietary pattern, and their beneficial attributes can be conveyed to consumers in other ways that are not false or misleading (
                        <E T="03">e.g.,</E>
                         other nutrient content claims).
                    </P>
                    <P>
                        <E T="03">Oil-based dressings oil-based spreads, and 100% oils.</E>
                         In the proposed rule, we proposed lowering the baseline sodium limit to ≤5% DV for oil-based dressings and oil-based spreads because of their small RACC sizes. However, as previously discussed, we have now provided different criteria for smaller RACC foods (
                        <E T="03">i.e.,</E>
                         qualifying on a 50-gram basis instead of per RACC for foods with RACCs ≤50 g or ≤3 Tbsp). As a result, and as supported by our marketplace review (Ref. 2), it is not necessary to reduce the sodium limit to ≤5% DV for oil-based dressings and oil-based spreads due to their small RACC since their criteria will be based on 50 grams. Therefore, the final rule has a sodium limit of ≤10% DV per 50 g for oil-based dressings and oil-based spreads. In addition, we are finalizing the proposed sodium limit of 0% DV for 100% oils.
                    </P>
                    <P>
                        <E T="03">Grain products.</E>
                         Nutrient-dense forms of whole grains, including whole grain bread and cereal products, can qualify for the claim. Several comments grouped their comments about sodium together with added sugars (
                        <E T="03">e.g.,</E>
                         asserting that the proposed added sugar and sodium limits for grain products would prevent a vast majority of whole grain breads, buns, tortillas, and cereals 
                        <PRTPAGE P="106108"/>
                        from qualifying from “healthy”). In those cases, it is difficult to distinguish between the specific concerns with the sodium limits versus the specific concerns with the added sugars limits for some of the example products mentioned in the comments. However, we disagree that a ≤10% DV sodium limit would prevent a “vast majority” of whole grain bread products from qualifying, as our marketplace review shows that there are many whole grain bread products (including several English muffin products) that already meet a ≤10% DV limit (Ref. 2). We note that we have provided more flexibility for the added sugars limit for whole grain products by increasing the limit from ≤5% DV to ≤10% DV for the grains group, which is discussed in section V.D.4 (“Added Sugars”). We further disagree that 100% whole grain tortillas would be unable to qualify for the updated “healthy” claim as indicated in some comments. Our marketplace review demonstrates that some 100% whole grain tortillas are currently able to meet the sodium limit for the updated “healthy” criteria (Ref. 2). We also note that most tortillas are not able to qualify for the original “healthy” definition (
                        <E T="03">e.g.,</E>
                         do not contain 10% of a specified beneficial nutrient, with the exception of those with added fiber). The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         points out that the grains that are typically consumed in the United States are forms with higher amounts of sodium and lists tortillas as one of the examples. They discuss that shifts to more nutrient-dense forms of grains will help in building healthy dietary patterns. Therefore, the sodium limit of ≤10% DV (or per 50 g for RACCs ≤50 g or ≤3 Tbsp) for individual foods results in nutrient-dense options in the grains group qualifying for the claim, and can consequently help consumers identify foods that are particularly useful for building a healthy dietary pattern that is consistent with current nutrition science and Federal dietary guidance. Therefore, we have decided to finalize the ≤10% DV per RACC (or per 50 g for RACCs ≤50 g or ≤3 Tbsp) sodium limit for the grains group.
                    </P>
                    <P>
                        We also disagree with the comments asserting that the sodium limit for grains will impact consumers' ability to access whole grain products. Setting a sodium limit of 20% DV for individual foods, as suggested by some comments, would not be consistent with the Dietary Guidelines as it would not help consumers identify whole grain foods that are nutrient-dense, 
                        <E T="03">e.g.,</E>
                         containing little or no sodium. As noted above, products that contain 20% DV or more of sodium per serving would be considered high in sodium. We note that the “healthy” criteria do not prevent products that cannot qualify to bear the claim from being sold, and, as stated previously, the absence of a “healthy” claim on a food does not mean that the food is “unhealthy.” Foods that do not qualify for the “healthy” nutrient content claim can still be part of a healthy dietary pattern. In contrast, foods that can bear the “healthy” claim are foods that, because of their nutrient content, including amounts of sodium, are particularly useful in building a healthy dietary pattern.
                    </P>
                    <P>
                        <E T="03">Dairy.</E>
                         We acknowledge the different functions of sodium in foods, and, as discussed in the proposed rule and above, the functions of sodium were a consideration when allowing additional flexibilities for the proposed baseline limits for sodium compared to those for saturated fat and added sugars. We also understand that sodium reduction can be more challenging for certain foods, such as cheeses, and that sodium varies widely across different cheese products. Our marketplace review of nutrient-dense foods demonstrates that there are numerous foods that meet a ≤10% DV sodium limit in the dairy food group, including different nutrient-dense milk and yogurt products (Ref. 2). The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         notes that dairy is usually consumed in forms that contain higher amounts of sodium, such as cheese (
                        <E T="03">e.g.,</E>
                         cheese in mixed dishes, including sandwiches, pizza, and pasta dishes). While some cheeses can meet a ≤10% DV sodium limit per RACC, or per 50 g for RACCs ≤50 g, most cheeses will not meet a ≤10% DV sodium limit and 10% DV saturated fat limit per RACC, or per 50 g for RACCs ≤50 g or ≤3 Tbsp. We agree that allowing more flexibility for manufacturers to use salt substitutes in standardized foods would help reduce sodium content of standardized foods, including standardized cheeses and related cheese products. As noted above, in 2023 we issued a proposed rule, “Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods” (Ref. 15). In the proposed rule, we propose to amend our standard of identity regulations that specify salt (sodium chloride) as a required or optional ingredient to permit the use of salt substitutes in standardized foods.
                    </P>
                    <P>We agree that allowing salt substitutes in standardized foods would provide food manufacturers with new flexibility to use salt substitutes and would support further innovation by food manufacturers that could lead to a greater number of products that can meet the sodium limits for the “healthy” claim, including dairy, grain, and canned vegetable products.</P>
                    <P>Therefore, we have decided to finalize the sodium limit of ≤10% DV per RACC (or per 50 g for RACCs ≤50 g or ≤3 Tbsp) for individual foods for the dairy food group.</P>
                    <P>
                        <E T="03">Other.</E>
                         We also disagree with the rationale that having four eating occasions per day equates to 25% DV for sodium at each eating occasion, which supports a sodium limit of 20% DV for individual foods, such as grain products. The sodium limits in the “healthy” definition are intended to ensure that the foods that bear the claim are those that can help consumers stay below the daily limit of sodium. Consumers do not eat a diet composed entirely of foods that qualify as individual foods for the “healthy” claim, and multiple foods containing sodium could be eaten at one eating occasion. Therefore, basing the sodium limit on this type of calculation could result in foods bearing the “healthy” claim that would not help consumers stay beneath the daily sodium limit.
                    </P>
                    <P>We did not receive comments that the proposed sodium limits of ≤10% DV were too restrictive for fruits, game meats, eggs, and nuts and seeds (see “Frozen vegetable blends and plant-based patties” section above for discussion of soy products), and are finalizing a sodium limit of ≤10% DV per RACC (or per 50 g for RACCs ≤50 g or ≤3 Tbsp) for fruits, game meats, eggs, and nuts, seeds, and soy products.</P>
                    <P>
                        (Comment 73) One comment recommends that FDA evaluate the possibility of incorporating the ratio of sodium to potassium as an alternative criterion that would apply to products that exceed the proposed limit of 230 mg sodium per RACC. Another comment requests that we either adopt higher sodium limits in general—individual or mixed foods, small RACC (RACC ≤30g/2 Tbsp): ≥10% DV per RACC; individual or mixed foods with RACC &gt;30g/2 Tbsp: ≥20% DV per RACC; main dishes: ≥25% DV per serving; and meals: ≥30% DV per serving, or adopt these higher sodium limits for food products that contain at least as much potassium as sodium (
                        <E T="03">i.e.,</E>
                         a ratio of 1:1 or &lt;1) and allow NTE as an alternative option to FGEs. The comment discusses the importance of potassium in cardiovascular and bone health; the low intake of potassium in the United States; the relationship of potassium and sodium on blood pressure; the 2019 National Academies report on Dietary Reference Intakes (DRI) for Sodium and Potassium; FDA actions related to potassium labeling, 
                        <PRTPAGE P="106109"/>
                        including potassium salt; and that public health efforts to reduce sodium intake may also inadvertently reduce potassium intake.
                    </P>
                    <P>
                        (Response 73) We previously explained why including sodium as one of the NTL for the updated “healthy” definition is consistent with dietary recommendations, and the underlying scientific evidence on which they are based, which support the relationship between sodium and blood pressure and risk of CVD. The 2020 DGAC Report mentions the relationship between sodium and potassium and the association with blood pressure and CVD (Ref. 8). However, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         does not discuss potassium in relation to sodium recommendations, nor does it include a specific recommendation for potassium (besides the inclusion of the DRI values in Appendix 1) or recommendations for a specific ratio of sodium to potassium (Ref.1). Other organizations and consensus reports from authoritative bodies have also not adopted a sodium-to-potassium ratio recommendation instead of, or in addition to, individual recommendations for sodium limits (and individual potassium limits in some cases). For example, the 2019 National Academies DRI report for sodium and potassium concluded that there was insufficient evidence to characterize the relationship between the ratio of sodium to potassium and health outcomes (Ref. 11). Therefore, the National Academies DRI authoring committee was unable to establish the sodium and potassium DRIs based on a ratio and unable to assess the behavioral implications of recommending a ratio (Ref. 11). The National Academies DRI committee expressed concern in the DRI report that establishing a DRI value as a sodium-to-potassium ratio might lead to the misimpression that using a potassium supplement to modify the ratio would be beneficial, which has not yet been evaluated. They noted that further investigation into the interactions of sodium and potassium is needed.
                    </P>
                    <P>
                        We agree that potassium is an underconsumed nutrient and that it is important for health, including because (among other things) of its role in lowering blood pressure, as we discussed in the NFL Final Rule in support of the mandatory declaration of potassium on the label (81 FR 33742). We also agree that use of potassium chloride can help lower sodium in the food supply and that the substitution of potassium chloride for sodium chloride can have beneficial impacts on public health by reducing intake of sodium, which is overconsumed, and increasing intake of potassium, which is underconsumed. Recent efforts, such as our 2020 final guidance on naming of potassium chloride in food labeling and our 2023 proposed rule to permit salt substitutes in standardized foods, support the use of salt substitutes like potassium salts in foods to help reduce sodium in the food supply (Refs. 14 and 15). We agree that use of potassium salts is one tool that could be used to reduce sodium in foods that could then potentially bear the “healthy” claim. However, we disagree that our positions and actions about potassium and the use of potassium chloride as a salt substitute in foods is reason to include potassium as part of the sodium limit for the updated “healthy” definition, or reason to include NTE as part of the updated definition (see section V.D.6 (“Nutrients to Encourage”) for discussion of NTE). The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         notes that if individuals consume healthy dietary patterns, they can meet recommendations for potassium, calcium, and dietary fiber, and that consumers should be encouraged to make shifts to increase intakes of vegetables, fruits, beans, whole grains, and dairy to increase intakes of potassium, calcium, and dietary fiber closer to recommendations. The approach for the updated “healthy” definition, which incorporates food group requirements (
                        <E T="03">i.e.,</E>
                         minimums) and includes multiple flexibilities for underconsumed food groups and subgroups (
                        <E T="03">e.g.,</E>
                         adjustments to FGE requirements for vegetable and dairy products and adjustments to NTL for whole grain, seafood, and dairy products), is intended to help consumers identify foods that are particularly useful in building healthier dietary patterns—which help them get closer to or meet recommended intakes of food groups and subgroups and, as a result, achieve adequate intake of beneficial nutrients, including potassium.
                    </P>
                    <P>The comment stating that reducing sodium-containing foods may also inadvertently reduce potassium-containing foods did not provide any data besides referencing shared food sources that are commonly consumed. In fact, the comment included a report that suggested a potential strategy to prevent an inadvertent reduction in potassium intake is the use of potassium salts to partially replace sodium in foods. The report summarized a modeling study showing that the substitution of sodium with potassium salts in the top sources of sodium resulted in an estimated decrease of sodium intake of 9% with an accompanying increase in potassium intake of 16% (Ref. 16). The use of potassium salt in the food supply has increased in recent years, and we anticipate that its usage may continue to increase. Additionally, because potassium is required on the Nutrition Facts label (§ 101.9(c)(8)), consumers can use that label to determine and compare amounts of potassium in different foods.</P>
                    <P>
                        Similar to the discussion in section V.D.2 (“Saturated Fat”) related to a ratio approach for saturated fat, a ratio approach for sodium (
                        <E T="03">e.g.,</E>
                         using a ratio of sodium to potassium for products that exceed the proposed limit of 230 mg sodium per RACC, as recommended in the comment) would add complexity to the “healthy” definition and does not distinguish between products that have low amounts of sodium and low amounts of potassium versus products that have high amounts of sodium and high amounts of potassium. Similarly, having higher sodium limits for products that contain a certain amount of potassium (as requested in the comment) would also result in foods that are high in sodium qualifying for “healthy,” which is not in alignment with the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         For the reasons discussed above, we decline to include a ratio of sodium to potassium as an alternative to the sodium limit or adopt higher sodium limits for foods that contain at least as much potassium as sodium in the food and allow NTE. We also decline to adopt the specific sodium limits for individual/mixed products with small RACCs, individual/mixed products with RACC &gt;30 g/2 Tbsp, and main dishes that were mentioned in the comment that requested higher sodium limits in general. The sodium limit for small RACC foods in the updated “healthy” definition is similar to the sodium limit suggested in the comment for individual foods and mixed products with small RACCs (except it will be applied to foods with a RACC ≤50 g or ≤3 Tbsp and determined on a 50 g basis) and the “healthy” sodium limit for meals is the same as that suggested in the comment for meals (≤30% DV per serving). We have also increased the sodium limit for mixed products (≤15% DV per RACC or per 50 g for RACCs ≤50 g or ≤3 Tbsp) and oil-based dressings and spreads (≤10% DV per 50 g) (see section V.C (“Food Group Equivalents”) for individual foods and section V.E. (“Combination Foods”). Our rationale for not adopting the sodium limits suggested in the comment for individual foods with RACCs ≥30 g (20% DV per RACC) and main dishes (25% DV per 
                        <PRTPAGE P="106110"/>
                        serving) is also discussed in sections V.C (“Food Group Equivalents”) and V.E (“Combination Foods”).
                    </P>
                    <HD SOURCE="HD3">4. Added Sugars</HD>
                    <P>(Comment 74) Many comments support added sugars limits for products bearing a “healthy” claim, citing national and international recommendations to limit added sugars and research on the association between added sugars consumption and increased risk of weight gain and chronic diseases. The comments also note that added sugars are overconsumed in the United States, accounting for almost 270 calories, or more than 13% of total calories per day in the United States population (Ref. 1). However, some comments question the need for an added sugars limit, suggesting that sugar has been “unduly vilified.” The comments state that, in the NFL Final Rule, FDA “conceded that the scientific evidence does not establish an independent relationship between added sugars and a disease” and further assert that the scientific evidence linking added sugars to chronic illness remains inconclusive. The comments suggest that limiting “healthy” foods to those with no more than 5% of the DV for added sugars is not supported by scientific or marketplace evidence or by a regulatory rationale because we have not established a “low” added sugars nutrient content claim.</P>
                    <P>
                        (Response 74) As discussed in the proposed rule (87 FR 59168 at 59178), the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommends choosing nutrient-dense foods across and within food groups while limiting foods and beverages higher in added sugars. Vegetables, fruits, whole grains, seafood, eggs, beans, peas, and lentils, unsalted nuts and seeds, fat-free and low-fat dairy products, and lean meats and poultry—when prepared with no or little added sugars, saturated fat, and sodium—are identified as nutrient-dense foods (Ref. 1). As noted in some comments, limiting added sugars intake is also supported by a number of other national and international health and health professional organizations. The proposed NTL criteria for added sugars help to ensure that foods bearing the “healthy” claim are the nutrient-dense foods that are particularly useful in creating a healthy dietary pattern, as described in the Dietary Guidelines, and do not contain excess added sugars, which can have negative health implications.
                    </P>
                    <P>Although we stated in the NFL Final Rule that there is not an independent association between added sugars and risk of disease (81 FR 33742 at 33844), there was nevertheless ample scientific justification for requiring the mandatory declaration of added sugars. That determination was based on evidence related to healthy dietary patterns and a reduced risk of chronic disease as well as on evidence showing that consumption of higher amounts of added sugars makes it difficult to meet nutrient needs within calorie limits. More specifically, we required the mandatory declaration of added sugars on the Nutrition Facts label due, in part, to strong evidence showing that dietary patterns characterized, in part, by lower intakes of sugar-sweetened foods and beverages are associated with a decreased risk of CVD (Ref. 19). In addition, Americans continue to overconsume added sugars (Ref. 8), which can make it difficult to meet nutrient needs within calorie limits. Thus, consumption of added sugars, in excess, has direct implications on whether individuals can consume a healthy dietary pattern, which is associated with reduced risk of diet related disease, without exceeding the amount of calories they need. Given that the purpose of the “healthy” nutrient content claim is to help consumers identify foods that are particularly useful in helping them create a healthy dietary pattern, it is important that foods bearing the “healthy” claim not contribute amounts of added sugars to the diet that would make it difficult to construct a healthy dietary pattern within calorie limits.</P>
                    <P>
                        We disagree that the proposed baseline limit of ≤5% of DV per RACC for added sugars in individual foods (currently ≤2.5 g for adults and children 4 years of age and older) is arbitrary. While there is no “low added sugars” nutrient content claim, we have established requirements for the use of “low in” claims for other nutrients consistent with the 5% DV limit, making this criterion generally consistent with other “low in” nutrient content claims. We have also reviewed a variety of nutrient-dense products across different food groups and subgroups that are recommended by the Dietary Guidelines available in the marketplace to compare their added sugar levels with the proposed limits (Ref. 2). We are finalizing added sugars limits for “healthy” based on considerations for specific food groups and subgroups recommended by the 
                        <E T="03">Dietary Guidelines for Americans, 2020-2025</E>
                         and supported by our marketplace review.
                    </P>
                    <P>(Comment 75) Some comments argue that the proposed added sugars limits are inconsistent with the Dietary Guidelines recommendation to consume less than 10% of calories per day from added sugars. The comments note that the Dietary Guidelines recommend shifts toward choosing foods and beverages with less added sugars, but our proposal allows no added sugars for some food categories. The comments suggest that there is room within a healthy dietary pattern that includes no more than 50 g added sugars to accommodate slightly higher amounts of added sugars. The comments argue that, with limits of 10-20% of the added sugars DV in certain categories, and four eating occasions per day, consumers would consume only a portion of the Daily Reference Value for added sugars, and it would also leave room in a dietary pattern to consume other foods that may not meet the “healthy” definition.</P>
                    <P>
                        (Response 75) We disagree with comments suggesting that the proposed added sugars limits are inconsistent with the Dietary Guidelines. Since the Dietary Guidelines were first issued in 1980, the Dietary Guidelines have included recommendations to limit intake of sugars. Since the 
                        <E T="03">Dietary Guidelines for Americans, 2015-2020,</E>
                         a recommendation has been included in the Dietary Guidelines to limit intake of added sugars to less than 10% of calories per day (Refs. 20-26, 4, and 1).
                    </P>
                    <P>
                        We also disagree that it would be appropriate to apply the quantitative intake recommendation for added sugars from the Dietary Guidelines to individual food products because the recommended limit from the Dietary Guidelines is meant to be applied across the diet for the entire day rather than to individual foods that make up the diet. As previously noted in section III. (“Background”), the “healthy” claim is used to identify foods that have nutrient content that makes them foundational foods for a healthy dietary pattern. Furthermore, the recommendation in the Dietary Guidelines is a limit not to be exceeded rather than an amount to achieve in the diet. An added sugars limit of ≤10% of the DV for individual food products across all food categories would not help consumers to identify the most nutrient-dense forms of many foods recommended by the Dietary Guidelines and would be inconsistent with the recommendation to consume 
                        <E T="03">less than</E>
                         10% of calories from added sugars per day.
                    </P>
                    <P>
                        (Comment 76) Some comments support the ≤5% DV per RACC baseline limit for added sugars, with adjustments to the added sugars limits for certain food categories. The comments suggest that “healthy” claims on foods loaded with added sugars confuse consumers 
                        <PRTPAGE P="106111"/>
                        and are out of step with the Dietary Guidelines' advice to limit added sugars to achieve a healthy dietary pattern. Some comments say that the adoption of stricter limits on added sugars for products making “healthy” claims will help restore consumer confidence in the integrity of the claim and prevent misleading “healthy” claims on products like sugary granola bars, frozen meals, shakes, cereals, and other foods and beverages with excess added sugars.
                    </P>
                    <P>
                        Other comments raise concerns that nutrient-dense foods recommended by the Dietary Guidelines (
                        <E T="03">e.g.,</E>
                         whole grain cereals, fruit and vegetable products, and nuts) would not be able to meet the “healthy” criteria due to the added sugars requirements. Comments note that sugars are added to nutrient-dense foods for several reasons, including palatability, food preservation, and functional attributes (
                        <E T="03">e.g.,</E>
                         viscosity, water activity, texture, bulk, and browning). The comments say that establishing a limit of 0% of calories from added sugars for some categories could eliminate some nutrient-dense products from qualifying as “healthy” and be counterproductive to the goal of improving the nutritional quality of Americans' diets. The comments suggest that strict limits for added sugars could discourage reformulation, and even cause manufacturers to make products that are less healthy because the “healthy” limits are not attainable.
                    </P>
                    <P>Some comments also raise concerns that the proposed added sugars limits lack consistency across product categories, with some product categories having minimal amounts of either 0% or 2% of the DV for added sugars. They indicate that the lack of consistency in added sugars limits across food categories could confuse consumers.</P>
                    <P>Many comments suggest higher limits for added sugars. The comments recommend a baseline limit of at least 5% DV and up to 20% of the DV for added sugars for individual foods and mixed products to accommodate development of more and better product options that consumers would incorporate into their diets. Some comments support a 30% DV added sugars limit for meals, 25% DV for main dishes, and proportionally smaller amounts for individual foods/mixed products.</P>
                    <P>(Response 76) In setting added sugars limits for individual foods, we considered several factors, including variability in the need for added sugars based on how certain products are typically consumed, whether the food category is underconsumed, as well as availability of foods in the marketplace with varying amounts of added sugars. As discussed in the proposed rule (87 FR 59168 at 59178), applying the same added sugars limit across all food groups could result in unnecessary addition of sugars to foods. For example, nutrient-dense foods, such as eggs, nuts, fruits, and vegetables, are often not consumed with the addition of sugar, so setting a limit for these foods that is consistent with foods from other food groups that more commonly have sugars added to increase palatability, such as whole grain cereals and fat-free and low-fat dairy, could result in foods with unnecessary excess added sugars qualifying for the “healthy” claim” or the unnecessary addition of added sugars to protein foods, fruits, and vegetables. We disagree that consumers would be confused by varying added sugars limits across food groups. The “healthy” nutrient content claim acts as a quick signal to consumers that a food, because of its nutrient composition, is particularly useful in creating a healthy dietary pattern. The added sugars limits for different food categories are geared towards manufacturers so they can determine whether their products qualify to bear the claim. Therefore, we decline to set one added sugars limit for individual food products across food categories and are finalizing our approach of setting nutrient limits based on considerations for different food categories.</P>
                    <P>
                        We also disagree that the added sugars limit for individual foods and mixed products should be set at 20% or more of the DV for added sugars. Our nutrient content claim regulations allow for the use of claims indicating that a food is an “excellent source of,” “high,” or “rich in” a nutrient if it contains 20% or more of the DV per RACC (§ 101.54(b)). As discussed, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommends choosing nutrient-dense foods while limiting foods and beverages higher in added sugars. Therefore, it would not be appropriate to set an added sugars limit for the use of the “healthy” claim that is equal to or greater than the level required for the use of claims indicating that a food is “an excellent source of,” “high in,” or “rich in,” a nutrient, as that limit would result in foods bearing the “healthy” claim that are not particularly useful in creating a diet that is consistent with current dietary recommendations.
                    </P>
                    <P>
                        As for the comments expressing concern that some nutrient-dense foods recommended by Federal dietary recommendations would not meet added sugars limits, we have adjusted some of the added sugars limits which results in more nutrient-dense foods encouraged by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         being able to bear the claim. As further discussed below, we are increasing the added sugars limit for fruits, vegetables, and protein foods as well as for grains. We have also adjusted added sugars limits for mixed products, meals, and main dishes to provide more flexibility for recipes and the formulation of such foods (see section V.E (“Combination Foods”). These changes will permit manufacturers to formulate foods with some added ingredients, such as seasonings and sauces containing small amounts of added sugars, and still qualify for the “healthy” claim. Our review (Ref. 2) of products available in the marketplace and their added sugars content provided additional support for these changes.
                    </P>
                    <P>
                        (Comment 77) Some comments note that foods made from recipes on the USDA MyPlate Kitchen website (Ref. 27), which provides recipes intended to help Americans put the recommendations of the Dietary Guidelines into practice, contain levels of added sugars that are greater than the proposed limits for the “healthy” claim. Other comments assert that the proposed added sugars limits for “healthy” are inconsistent with USDA's recent proposed rule to revise the school nutrition standards. The comments say that USDA's proposed rule includes added sugars limits that provide significantly more flexibility than FDA's proposed “healthy” criteria, and in some cases 4-5 times the amount of added sugars permitted in our proposal. One comment also refers to a 2021 analysis of the most cost-effective way to follow a dietary pattern consistent with the 
                        <E T="03">Dietary Guidelines for Americans, 2020-2025</E>
                         that was conducted by the USDA Center for Nutrition Policy and Promotion. The analysis of USDA's Thrifty Food Plan (TFP) gives examples of higher nutrient density, lower cost foods (Ref. 28). The comment states that many of the food sources identified in the TFP report would not meet the proposed “healthy” criteria.
                    </P>
                    <P>
                        (Response 77) Most of the recipes provided on the MyPlate website are for mixed products, meals, and main dishes, which have higher added sugars limits than individual foods. While all MyPlate recipes contain nutrient-dense ingredients and the finished product can be a part of a healthy diet, some recipes are for foods, such as desserts (
                        <E T="03">e.g.,</E>
                         recipes for apple crisps, chocolate squash cake, and banana cupcakes), that are not foundational to a healthy dietary pattern. Therefore, we disagree that all foods in recipes on the MyPlate website should be able to meet the added sugars 
                        <PRTPAGE P="106112"/>
                        limits for the “healthy” nutrient content claim (Ref. 27).
                    </P>
                    <P>We also disagree that limits we set for use of the healthy claim should be consistent with added sugars limits in the recently issued USDA rule that revises meal patterns for the Child Nutrition Programs. The “Child Nutrition Programs: Meal Patterns Consistent With the 2020-2025 Dietary Guidelines for Americans” rule (89 FR 31962) updates standards in an effort to further improve the nutritional quality of school meals.</P>
                    <P>
                        It would not be appropriate to align requirements for the “healthy” claim with those of USDA programs, such as the National School Lunch Program (NSLP) and WIC, as they serve different purposes. The “healthy” rule provides criteria for use of a voluntary nutrient content claim suggesting that a food, because of its nutritional content, is particularly useful in building a healthy dietary pattern. However, NSLP requirements are designed to provide age-appropriate meals to specific age/grade groups and set minimum standards for school meals that schools must follow to receive cash subsidies and USDA foods for reimbursable meals served at the school. The NSLP requires five meal components, each with daily and weekly minimums, and the current requirements provide limits for calories, saturated fat, and sodium. In addition, new added sugars limits for school meals will be gradually phased in over the next several years. Considerations, such as food and labor costs, student participation, and plate waste, are taken into account when developing the meal patterns for the NSLP. The WIC food packages provide supplemental foods designed to meet the special nutrient needs of low-income pregnant, breastfeeding, and non-breastfeeding postpartum women, infants and children up to 5 years of age who are at nutritional risk. Because these programs serve a subset of the U.S. population
                        <E T="03">—i.e.,</E>
                         students (NSLP) or persons with specific nutritional needs (WIC)—it would not be appropriate to base requirements for the “healthy” nutrient content claim, which is applicable to the general U.S. population and based on a healthy dietary pattern (
                        <E T="03">i.e.,</E>
                         total diet), on USDA requirements for these programs.
                    </P>
                    <P>
                        The purpose of USDA's TFP is more closely aligned with the purpose of the “healthy” nutrient content claim in that it is made up of specific amounts of various food categories that together comprise a practical, cost-effective diet that meets dietary guidance. Furthermore, the TFP Market Basket for a reference family of four is also based on recommended food group and subgroup amounts in the 
                        <E T="03">Dietary Guidelines for Americans, 2020-2025</E>
                         Healthy U.S.-Style Dietary Pattern and FNDDS data that we used for our marketplace review (Ref. 2). However, there are important differences. The modeling categories used in the 2021 USDA Center for Nutrition Policy and Promotion analysis referenced in comments were designed to prioritize higher nutrient-density foods (
                        <E T="03">i.e.,</E>
                         those with less added sugars, saturated fat, and/or sodium) and consider prices while allowing for food diversity in the Market Basket. Cost is an important factor in determining the TFP Market Basket, and while we have given consideration to whether nutrient limits would exclude low-cost, nutrient-dense foods, selecting nutrient limits for the “healthy” claim that help consumers identify foods that are foundational to a healthy dietary pattern is our primary consideration. We also note that the examples provided of foods that are deemed to be in the “higher nutrient-density” category are placed in that category based on whether they contain 21.2g/100g of total sugars rather than being based on their added sugars content. Furthermore, several examples of nutrient-dense whole grain cereals that are part of the TFP provided in the comment would be above the 20% or more DV per RACC (the level at which FDA permits “high” claims under our nutrient content claim regulations), which is not consistent with setting a limit that ensures that the “healthy” claim identifies foods that are particularly useful in constructing a healthy dietary pattern. While the limits for added sugars may exclude some foods from the TFP from bearing the “healthy” claim, the flexibilities we are providing in the rule with the “single-ingredient exemption” (see Response 9), as well as adjustments to the added sugars limit for grains, fruits, vegetables, and protein foods, as discussed below, will result in more nutrient-dense products included in the TFP being able to bear the “healthy” claim, consistent with the purpose of the claim.
                    </P>
                    <HD SOURCE="HD3">a. Added Sugars Limits for Food Groups and Certain Food Products</HD>
                    <P>
                        (Comment 78) Some comments support the proposed limit of 0% of the added sugars DV (0 grams) for vegetable, fruit, and protein products, while others say the proposed limits for those food groups are too restrictive. The comments that oppose the proposed limit say that it would not allow for the addition of small amounts of sugars to these foods in recipes and by seasonings and other ingredients. The comments also note that sugars may be added when formulating recipes to align with culinary flavor profiles. In addition, some comments assert that small amounts of sugar (1-2 g per serving) may be added to certain canned beans, peas, and lentils (
                        <E T="03">e.g.,</E>
                         kidney beans) to enhance the texture or palatability due to the bitter taste. The comments provide examples of foods, such as bagged salads with dressings, frozen fruit and grain bowls, frozen vegetable burgers, and canned vegetables that could not bear the healthy claim due to the proposed added sugars limits. Some comments argue that, by setting a 0% DV added sugars limit for fruit, vegetables, and protein food groups, FDA is creating a barrier to innovation in these categories. The comments suggest that a 0% DV limit for added sugars in the fruit, vegetables, and protein groups is inconsistent with food pattern modeling used to develop the 
                        <E T="03">Dietary Guidelines for Americans, 2020-2025</E>
                         because the nutrient-dense reference foods for fruit, whole grains, nuts, and dairy all had low amounts of added sugars and were able to be combined within the “Healthy US Dietary Pattern.” Further, some comments state that consumers should not be misled to believe that recommended foods, such as nuts and seeds, must contain zero added sugars to be “healthy,” asserting that this is not consistent with Federal dietary policy.
                    </P>
                    <P>Some comments also note that recipes in MyPlate Kitchen containing fruits and vegetables have between 5-10% of the DV for added sugars. The comments refer to the proposed added sugars allowance for oil-based dressings of ≤2% of the DV to improve palatability of vegetables, but note that vegetables, as an individual food product, would not be able to contain any added sugars. Further, the comments assert that FDA provided no explanation to support its conclusion that whole grain or dairy-based foods are “healthy” when containing ≤5% DV added sugars, but fruits, vegetables, and nut and seed-based products are not.</P>
                    <P>
                        Other comments state that products such as nuts and seeds are often consumed as components of mixed products and express concern regarding the proposed 0% DV limit for added sugars for certain protein foods, including nuts and seeds. The comments urge FDA to revise the added sugars limit for protein foods to ≤5% DV to accommodate nuts and seeds, which are commonly consumed as a snack food. The comments state that the ≤5% DV baseline limit, in conjunction with the 0% DV limit on nuts and seeds, would force producers to either exclude 
                        <PRTPAGE P="106113"/>
                        nuts and seeds from products or make other fundamental alterations. The comments express concern that some nutrient-dense protein foods, like peanut butter, which may contain small amounts of added sugars for palatability, could be excluded as a result of the strict 0% DV added sugars restriction. The comments note that nut butters are a nutritious, sustainable, shelf-stable, and economical source of protein. Some comments recommend that the added sugars limit for nuts and seeds should be ≤5% of the DV for added sugars, consistent with the proposed limits for dairy products because dairy products are also sweetened to increase palatability.
                    </P>
                    <P>The comments suggest that that such stringent added sugars limits for fruits, vegetables, and protein foods could have unintended consequences. The comments suggest that the proposed 0% DV limit for these foods could promote increased use of ingredients such as polyols and other low or no calorie sweeteners, stating that a growing proportion of people are trying to avoid these types of ingredients. Furthermore, they argue that the proposed limits for these recommended foods could discourage their consumption or confuse consumers about the relative health value of these foods.</P>
                    <P>(Response 78) We disagree that the proposed added sugars limit for fruits, vegetables, and protein foods would discourage their consumption since these foods are often consumed in their natural state without the addition of any sugars. For many years, dietary recommendations, including the Dietary Guidelines, have consistently recommended fruits, vegetables, and certain protein foods and limiting the consumption of sugar, so we also disagree that the proposed added sugars limit would be confusing to consumers. However, we recognize that small amounts of added sugars that are added to recommended foods through recipes and seasonings can enhance the flavor of fruits, vegetables, and protein foods and can have functional properties that go beyond palatability. Small amounts of sugars may also be added to fruits and vegetables for flavor standardization because of the variability in sugar content due to growing conditions. We are increasing the added sugars limit for fruits, vegetables, and protein foods to provide some flexibility for products containing foods from these food groups that are foundational to a healthy dietary pattern.</P>
                    <P>
                        We conducted a review of the products available in the marketplace to determine how much added sugars are typically included in individual fruit, vegetable, and protein foods, such as canned and frozen fruits and vegetables, and nut products, including different types of nut butters (Ref. 2). While we agree that requiring fruits, vegetables, and protein foods to contain no added sugars to qualify for the “healthy” claim would prevent some individual food products from these categories from bearing the claim, we disagree that a limit of 5% of the DV is appropriate. Many individual food products in these categories contain no added sugars and setting a limit of 5% of the DV per RACC could result in foods that contain more added sugars than necessary bearing the “healthy” claim, when the “healthy” limits are intended to help consumers identify foods that are particularly useful in achieving a healthy dietary pattern. Small amounts of added sugars contributed by different foods in the diet add up over the course of the day and can make it difficult for an individual to meet nutrient needs without exceeding the amount of calories they need in a day for weight maintenance (81 FR 33742 at 33759). We looked at the added sugars content of specific fruit, vegetable, and protein food products mentioned in comments (
                        <E T="03">e.g.,</E>
                         nut butters and fish with seasonings) and found that there are products of this type currently in the marketplace with less than or equal to 5% of the DV for added sugars.
                    </P>
                    <P>
                        Furthermore, many of the MyPlate kitchen recipes incorporating fruits and vegetables with amounts of added sugars of 5-10% of the DV are mixed products, meals, and main dishes rather than individual foods. As previously mentioned, we are increasing the added sugars limits for mixed products, meals, and main dishes to provide more flexibility in the formulation of those products. Based on our consideration of the different purposes and functions of added sugars in different foods, including texture, flavor standardization; use in seasonings, sauces, and other ingredients in the formulation of recipes; consistency with the 
                        <E T="03">Dietary Guidelines, 2020-2025;</E>
                         and our marketplace review of nutrient-dense foods, we are finalizing an added sugars limit for individual fruits, vegetables, and protein foods of ≤2% of the DV (currently ≤1 g for adults and children 4 years of age and older) per RACC (or per 50 g for foods with RACCs 50 g or less or 3 Tbsp or less), which will provide for the addition of small amounts of added sugars without resulting in products that contain unnecessary amounts of added sugars being able to bear the “healthy” claim.
                    </P>
                    <P>
                        Many products mentioned in comments, such as frozen fruit and grain bowls, frozen vegetable grain bowls, frozen plant-based patties, and some fresh, bagged salads with dressing and toppings, could be considered mixed products or main dishes, depending on their formulation. Products that only contain enough of one of the recommended food groups to bear the claim (
                        <E T="03">e.g.,</E>
                         a bag of salad with only salad dressing) would be considered to be individual foods. The increased added sugars limit for individual fruits, vegetables, and protein foods, as well as the increased limit for grains (discussed below), provide more flexibility for the types of products mentioned in comments that contain small amounts of added sugars but can still be foundational to a healthy dietary pattern. The increased added sugars limit also decreases the likelihood that manufacturers will add polyols and low- and no-calorie sweeteners to fruits, vegetables, and protein foods.
                    </P>
                    <P>(Comment 79) One comment provides that, while the DGAC Report recommended a limit for added sugars in foods, there was acknowledgement that foods containing small amounts of added sugars can be part of a healthy diet. The comment supports FDA's proposal that 100% juices eligible to bear the “healthy” claim contain 0% added sugars, but also advocates that juice drinks containing a small amount of added sugars should be considered “healthy.”</P>
                    <P>
                        (Response 79) We disagree that, in general, juice drinks containing small amounts of added sugars should qualify to bear the “healthy” claim. The Dietary Guidelines consider juice drinks to be sugar-sweetened beverages. Sugar-sweetened beverages are one of the major sources of added sugars in the typical U.S. diet, contributing approximately 24% of added sugars to the diets of adults and children 1 year and older (Ref. 1 Figure 1-10). The Dietary Guidelines includes 100% fruit juices, but not juice drinks containing added sugars, in the fruit group. Furthermore, the 
                        <E T="03">Dietary Guidelines for Americans, 2020-2025</E>
                         says that when juices are consumed, they should be 100% juice or 100% juice diluted with water (without added sugars). Juice drinks often contain juices from fruits that are naturally sweet, and therefore, allowing juice drinks to contain added sugars could result in juice drinks with unnecessary excess sugars qualifying to bear the “healthy” claim. In addition, as stated above, small amounts of added sugars contributed by different foods in the diet add up over the course of the day and can make it difficult for an individual to meet nutrient needs 
                        <PRTPAGE P="106114"/>
                        without exceeding the amount of calories they need in a day for weight maintenance (81 FR 33742 at 33759). For these reasons, we decline to revise the rule so that juice drinks containing even small amounts of added sugars could qualify for the “healthy” claim.
                    </P>
                    <P>
                        (Comment 80) A number of comments raise concerns that the added sugars limit of zero g for the fruit group would prevent tart fruit products, (
                        <E T="03">e.g.,</E>
                         dried cranberries, dried tart cherries, and cranberry juice drinks), and, in particular, cranberries and tart cherries, from bearing the “healthy” claim. The comments explain that cranberries and tart cherries have a lower natural sugar content than most other fruits, necessitating added sugars for palatability. The comments assert that the proposal unfairly disadvantages tart fruit products and would discourage Americans from consuming these nutrient-dense fruits. The comments also posit that the added sugars limit, in conjunction with the proposed FGE criteria, would mislead consumers to believe that such products are unhealthy because they do not bear a “healthy” claim. One comment argues that, from a First Amendment perspective, FDA has ignored a number of less restrictive means to achieve its goals, including the comment's proposed modified criteria for lower sugar fruits such as cranberries. The comments also express concern over the financial impact on cranberry and tart cherry farmers if such products are not eligible to bear the “healthy” claim due to their added sugars content.
                    </P>
                    <P>The comments note that products that compete with cranberry and tart cherry products in the marketplace, such as raisins and dried apples, have a similar or higher total sugar content and would be permitted to make the claim. The comments state that the added sugars in dried cranberries and tart cherries do not result in more total calories than comparable foods. They assert that the body's response to sugars does not depend on whether they are naturally present or added to foods. The comments also note that reduced sugar dried cranberries have less sugar and more fiber compared to other dried fruits.</P>
                    <P>The comments assert that cranberry and tart cherry products are nutritious and contain bioactive components. The comments explain that such products are high in nutrients, such as vitamins A and C as well as in copper and flavanoids. The comments highlight that USDA currently promotes consumption of cranberry products, despite their added sugar content, and raise concerns that the proposed added sugars limit undercuts the nutritional contribution that dried cranberries, cranberry juice, and tart cherry products make to healthy dietary patterns.</P>
                    <P>Some comments advocate for a framework that would allow cranberry products, including sweetened dried cranberries, that meet fruit FGE criteria and sodium and saturated fat limits, but contain added sugars for palatability in an amount that does not exceed the total sugar content of similar fruit products, to bear the “healthy” claim. The comments similarly support either an exemption for tart cherries from the added sugars limit or say that the added and natural sugar limits should be standardized for all fruits without exception. The comments ask that, if we do not change our position on the added sugars limits for tart fruits, we delay implementation of the final rule for 5 years to give the industry time to use its inventory of previously printed labels and work to procure new labeling as well as to conduct research regarding added sugars in tart cherries.</P>
                    <P>Some comments also oppose the exclusion of cranberry and tart cherry juice products from using the “healthy” claim simply because they do not meet fruit equivalent requirements and contain added sugars. The comments provide information about the health benefits of 27% cranberry juice drink and argue that consumers need to consume less cranberry content compared to the content of other fruit juices to receive the healthful benefits from polyphenol bioactives contained in cranberries. The comments also note that FDA issued a letter of enforcement discretion for a qualified health claim regarding the relationship between cranberry juice beverages containing at least 27% cranberry juice (8 fluid oz) and risk reduction of recurrent urinary tract infections in healthy women. The comments suggest that if we proceed with the proposed definition of “healthy,” it could lead consumers to switch to apple juice, orange juice, or grape juice from cranberry juice.</P>
                    <P>
                        (Response 80) We agree that cranberries and tart cherries are examples of naturally tart fruits to which manufacturers often add sugar to increase palatability. The comments and our review of products in the marketplace demonstrate that many cranberry and tart cherry products provide amounts of total sugars that are less than or equivalent to comparable fruit products. We recognize that cranberry and tart cherry products, because of their nutrient composition, are particularly useful in building a healthy dietary pattern (although the qualified health claim and any other health benefits not directly related to nutrient content mentioned by the comments are not relevant here). Therefore, we intend to consider the exercise of our enforcement discretion for the added sugars limit for cranberry and tart cherry products that meet fruit FGE criteria and meet the nutrient limits for sodium and saturated fat, but contain added sugars for palatability in an amount that is no greater than the amount of total sugars in comparable products with endogenous (inherent) sugars but no added sugars (
                        <E T="03">e.g.,</E>
                         unsweetened raisins, 100% grape juice). We consider a “comparable product” to be one that is in the same food category (
                        <E T="03">e.g.,</E>
                         fruit), that is in the same form (
                        <E T="03">e.g.,</E>
                         dried), and that has the same usage (
                        <E T="03">e.g.,</E>
                         snack). For example, we consider unsweetened raisins to be comparable to sweetened dried cranberries and sweetened dried cherries and unsweetened 100% grape juice to be comparable to a sweetened 27% cranberry juice drink.
                    </P>
                    <P>
                        Additionally, we intend to exercise enforcement discretion for the inclusion of the added sugars contribution from cranberry and tart cherry ingredients in mixed products that meet the FGE criteria and the nutrient limits for sodium and saturated fat, but the cranberry and tart cherry ingredients contain added sugars for palatability in an amount that is no greater than the amount of total sugars in comparable products, as previously described. For example, under this enforcement discretion policy, the added sugars contributed by dried cranberries in a trail mix that meets the FGE criteria and nutrient limits for mixed products would not count towards the added sugars limit for the product when the added sugars in the dried cranberries are in an amount that is no greater the amount of total sugars in a comparable product with endogenous sugars (
                        <E T="03">e.g.,</E>
                         raisins).
                    </P>
                    <P>
                        At this time, we do not intend to exercise enforcement discretion for other tart fruit products. Based on the information that we have received in response to the requirement for mandatory declaration of added sugars on the Nutrition Facts label and the proposed added sugars limits for the use of the “healthy” implied nutrient content claim, cranberry and tart cherry products are uniquely impacted by the added sugars labeling requirements. They are at a competitive disadvantage in the marketplace compared to other comparable foods that naturally have the same amount of total sugars (
                        <E T="03">e.g.,</E>
                         raisins, grape juice).
                    </P>
                    <P>
                        We are not aware that there are other tart fruits that are at a competitive 
                        <PRTPAGE P="106115"/>
                        disadvantage because products made with those fruits require sugars for palatability at an amount that is comparable to other fruit products with natural sugars. Furthermore, many products made with other tart fruits (
                        <E T="03">e.g.,</E>
                         lemonade and limeade) are made with far less juice or fruit and more sugar and water than cranberry and tart cherry products.
                    </P>
                    <P>For the reasons previously mentioned, we are only providing enforcement discretion for cranberry and tart cherry products at this time, but could consider remedies for other tart fruit products if we become aware of additional information demonstrating that they are similarly situated. As with any intent to exercise enforcement discretion, FDA may update the exercise of enforcement discretion, consistent with FDA's good guidance practices (21 U.S.C. 371(h), 21 CFR 10.115).</P>
                    <P>
                        (Comment 81) Many comments express concern that the proposed limit on added sugars for grains would prevent many whole grain foods from bearing a “healthy” claim and generally make it difficult for consumers to make healthy dietary choices. The comments say that added sugars are used to make nutrient-dense foods, including whole grains, more palatable. They suggest that the addition of moderate amounts of added sugars can increase consumption of whole grains, which are currently underconsumed in the United States, and promote more healthful dietary patterns. The comments suggest increasing the added sugars limit for grains (
                        <E T="03">e.g.,</E>
                         to 10%, 20% or 25% of the DV for added sugars).
                    </P>
                    <P>The comments say that more than 95% of the major ready-to-eat breakfast cereal products on the market and most whole grain breads will not qualify due to the added sugars criteria. The comments note that, among the general population, ready-to-eat cereal eaters have higher intakes of several nutrients, including the nutrients of public health concern, such as calcium, vitamin D, and fiber, than those who do not eat ready-to-eat cereal. In addition, the comments cite data from the National Health and Nutrition Examination Survey 2017-2018, which they say shows that ready-to-eat cereal is the number one contributor of fiber in children's diets and ready-to-eat cereal is a top source of whole grain for all Americans 2 years of age and older. The comments note that ready-to-eat cereal is an affordable and accessible choice because it is a shelf-stable food that can be found in small stores in big cities, large supermarkets, and online. The comments cite data showing that the intake of nutrients of public health concern was significantly higher among low-income ready-to-eat cereal eaters compared to low-income non-eaters. Some comments argue that the proposed ≤5% DV added sugars limit for breakfast cereal is too low and suggest that consumers will add more sugars on their own if limits are set too low. Some comments recommend increasing cereal products' added sugars limits from 5% of the DV to 10% of the DV to reflect their delivery of whole grains and essential nutrients and their typical consumption as a main dish.</P>
                    <P>
                        (Response 81) Most Americans meet recommendations for total grain intakes, but 98 percent fall below recommendations for whole grains and 74% exceed limits for refined grains (Ref. 1). The 
                        <E T="03">Dietary Guidelines for Americans, 2020-2025</E>
                         recommends that grain-based foods in nutrient-dense forms limit the additions of added sugars, saturated fat, and sodium. It also notes that that limited amounts of added sugars can be used to make some grain-based foods more palatable while staying within calorie and nutrient limits, but most grains should be eaten in their most nutrient-dense forms.
                    </P>
                    <P>In response to these comments, we conducted a review of the products available in the marketplace to look more closely at the added sugars content of whole grain products, such as ready-to-eat cereals, hot cereals, whole grain breads, and whole grain crackers (Ref. 2). Our marketplace review of the added sugars content of whole grain breads and crackers showed that there are many whole grain breads and crackers that contain ≤5% of the DV for added sugars, including whole grain options for breads, pita bread, English muffins, hotdog and hamburger rolls, naan, flatbreads, pizza crusts, tortillas, and crackers, and therefore, would qualify to use of the “healthy” claim. While we did not find that 95% of ready-to-eat cereals would be ineligible for the “healthy” claim based on the proposed added sugars limit, the proposed added sugars limit does significantly limit the number of whole grain cereal products, as well as the variety of whole grain foods that would qualify for the claim. There is a wide distribution in terms of the added sugars content of whole grain breakfast cereals (ranging from 0 g/serving to 22 g/serving). Increasing the added sugars limit from ≤5% of the DV for added sugars to ≤10% of the DV for added sugars would result in more, and a wider variety of, whole grain cereals, which are encouraged in the Dietary Guidelines as sources of important nutrients, as well as a wider variety of whole grain foods being able to bear the claim.</P>
                    <P>
                        However, increasing the added sugars limit to ≥10% of the DV for added sugars would not reflect the Dietary Guidelines recommended shifts towards nutrient dense forms of all grains, including ready-to-eat breakfast cereals, that are recommended in the Dietary Guidelines, and could result in whole grain foods, such as breads and crackers, with excess added sugars, qualifying to bear the “healthy” claim. We recognize that ready-to-eat cereals can be an important source of nutrients to the diet because most are fortified. However, the 
                        <E T="03">Dietary Guidelines for Americans, 2020-2025</E>
                         notes that grains are generally consumed in forms with higher amounts of sodium and added sugars (
                        <E T="03">e.g.,</E>
                         grain-based desserts, many ready-to-eat breakfast cereals) rather than the nutrient-dense forms and recommend shifting to more nutrient-dense forms of grains, such as ready-to-eat breakfast cereals with less sugar to help meet healthy dietary patterns.
                    </P>
                    <P>
                        After further consideration of the added sugars limit for grain products and the comments received on this topic, we find, based in part on the recommendations in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         for whole grains that suggest that limited amounts of added sugars can be included to increase palatability and the availability of nutrient-dense whole grain cereals in the marketplace, that increasing the added sugars limit from ≤5% of the DV to ≤10% of the DV would result in more nutrient-dense whole grain products encouraged by the Dietary Guidelines, such as whole grain cereals with less sugar, being able to bear the claim, and would allow manufacturers to use the “healthy” claim on a wider variety of whole grain products, which are underconsumed in the United States. Therefore, we are finalizing an added sugars limit of ≤10% of the DV per RACC for added sugars (currently ≤5 g for adults and children 4 years of age and older) for whole grains.
                    </P>
                    <P>
                        With respect to comments that suggest that consumers will add more sugars on their own if the added sugars limits for the “healthy” claim are too low and that the added sugars limits need to be increased to 10% of the DV for added sugars because cereal products are typically consumed as a main dish, the “healthy” claim is a voluntary nutrient content claim that does not prescribe how or when a consumer would consume a food or what they would add to their food. Regardless of what the added sugars limit is for products bearing the claim, consumers may choose to add sugars to their food, and they may choose to consume cereal alone or with other foods as part of a 
                        <PRTPAGE P="106116"/>
                        snack or meal. Main dishes must contain foods from at least two qualifying food groups with no less than 
                        <FR>1/2</FR>
                         FGE from either of the two food groups and a total of two FGEs. If a cereal product meets the FGE requirements and other requirements for the use of the “healthy” claim as a main dish, it could also qualify based on the added sugars limit for main dishes (≤15% of the DV for added sugars), which is higher than the limit for individual foods, which are now able to contain ≤10% of the DV for added sugars.
                    </P>
                    <P>(Comment 82) Specifically referring to dairy, some comments support the proposed added sugars limit for dairy of ≤5% of the DV. The comments say that dairy products should not be permitted to have higher limits because dairy products are often sweetened. The comments also say that, although sugars are often added to dairy products, many dairy products do not contain added sugars and do not need them for palatability. The comments recommend against allowing any flavored milk to bear the “healthy” claim, citing data from the School Nutrition and Meal Cost Study showing the main source of added sugars in both school breakfasts and school lunches was flavored fat-free milk. The USDA School Nutrition and Meal Cost Study is a nationally representative assessment of the school meal programs (Ref. 40). The comments say that encouraging children to drink beverages with no added sugars is a goal of the Dietary Guidelines, which would be supported by only allowing the “healthy” label to be used on unflavored rather than flavored milk.</P>
                    <P>Conversely, other comments urge FDA to consider allowing a reasonable increase in sugar content because a moderate amount of sugar increases palatability of dairy foods that provide essential nutrients. The comments suggest a 10% added sugars limit for dairy products, because they assert that the addition of added sugars is necessary to increase the palatability of dairy and encourage consumption of nutrient-dense dairy products. The comments argue that flavored milks and yogurts are a nutrient-dense source of vitamins, minerals, and protein and that flavored varieties of dairy products encourage more consumption of these foods across the population that is underconsuming dairy. The comments note that companies have already been working to reformulate their products to include lower sugar options following the publication of the NFL Final Rule; however, if the added sugars limit for products to qualify for the “healthy” claim is set too low, the comments state that further reformulation will be impractical and undesired by consumers, and therefore, companies will be less likely to undertake reformulation.</P>
                    <P>
                        The comments also argue that, according to the 
                        <E T="03">Dietary Guidelines 2020-2025,</E>
                         nearly two-thirds of all energy from added sugars in the average American diet is coming from sugar-sweetened beverages, sweetened coffees and teas, desserts and sweet snacks, and candies and sugars. In contrast, dairy foods contribute only 4% of total added sugars to the average American diet, and yogurt contributes less than 2%. The comments argue that beverages make up a large proportion of a child's caloric intake and, therefore, the current Dietary Guidelines recommend that beverages also need to be evaluated in light of both overall calories and available nutrient content. The comments suggest that milk can help fulfill these two elements while other beverages cannot.
                    </P>
                    <P>Other comments suggest that FDA has not provided adequate scientific rationale to support or justify the proposed added sugar limit for dairy foods at 5% of the DV/RACC. The comments assert that the proposed limits for dairy would encourage the use of alternative, non-nutritive sweeteners that have not been proven to aid in weight management in the long term. The comments recommend increasing the added sugars limit to at least 10% DV per c-eq for dairy products.</P>
                    <P>Many comments urge FDA to increase the added sugars limit for yogurts, stating that a certain amount of sweetness is needed to offset the naturally tart taste of yogurt. One comment says that, according to their analysis of Nielson Label Insight data, the proposed added sugars limit would prevent 72% of yogurts, including low-fat and fat free yogurts from bearing the “healthy” claim. The comment argues that disqualification of most low-fat and fat-free yogurts with moderate amounts of added sugar from bearing the “healthy” claim will further jeopardize Americans' consumption of dairy foods and may engender a false perception that yogurts are not healthy. Another comment asserts that the science does not support limiting intake of core foods that contain added sugars, such as flavored yogurt and milk. The comment points to a recent study showing that yogurt consumers had higher diet quality and higher percent of the population meeting recommended intakes for calcium, magnesium, and potassium than non-consumers (Ref. 29). The comments say that such a low limit for added sugars would force more yogurt manufacturers to sweeten their yogurts with low and no calorie sweeteners.</P>
                    <P>
                        (Response 82) The definition of nutrient-dense foods and beverages provided in the 
                        <E T="03">Dietary Guidelines for Americans 2020-2025</E>
                         includes fat-free and low-fat dairy products, when prepared with no or little added sugars, saturated fat, and sodium (Ref. 1). The 
                        <E T="03">Dietary Guidelines for Americans, 2020-2025</E>
                         note that most Americans are not consuming enough dairy and suggest that strategies to increase dairy intake include drinking fat-free or low-fat milk or a fortified soy beverage with meals or incorporating unsweetened fat-free or low-fat yogurt into breakfast or snacks. There is no mention of flavored milks, flavored yogurts, or other flavored dairy products or plant-based dairy alternatives as recommended foods. Further, the 
                        <E T="03">Dietary Guidelines for Americans, 2020-2025</E>
                         recommend that beverages that contain no added sugars should be the primary choice for children and adolescents. It notes that consuming beverages with no added sugars is particularly important for young children ages 2 through 8, when only a small number of calories remains for other uses after meeting food group and nutrient needs with nutrient-dense choices. Unsweetened fat-free and low-fat milk, including low-lactose or lactose free options or fortified soy beverages are among the beverages recommended for children and adolescents in the Dietary Guidelines.
                    </P>
                    <P>We disagree that the study cited in the comment is sufficient to determine that science does not support limiting intake of added sugars from dairy products such as yogurt and flavored milk. As discussed previously, the Dietary Guidelines, as well as consensus reports from authoritative bodies, and their nutrition science underpinning, help FDA to shape regulations on nutrition-related claims and other information that is on a food label. We rely on these sources of information because the reflect expert review and recommendations based on the body of nutrition evidence rather than findings from one individual study, which may not reflect the larger body of evidence.</P>
                    <P>
                        While we are including dairy products with small amounts of added sugars added to increase their palatability in the foods that qualify for the “healthy” claim, including dairy products with significant amounts of added sugars would not be consistent with the 
                        <E T="03">Dietary Guidelines for Americans, 2020-2025,</E>
                         which recommends consumption of the most nutrient-dense forms of foods and specifically encourages consumption of 
                        <PRTPAGE P="106117"/>
                        unsweetened fat-free and low-fat dairy products (
                        <E T="03">e.g.,</E>
                         milk and yogurt) as nutrient-dense options in the dairy group. In response to the comments, we conducted a marketplace review to look at added sugars content of dairy products, including milk products, yogurts, and plant-based dairy alternatives (Ref. 2). Unlike the grains group, where relatively few products in certain product categories, such as ready-to-eat cereals, would meet the proposed added sugars limit, we found that the majority of dairy products (approximately 73%) contained 0 g of added sugars per serving and most unflavored dairy products across all dairy product categories, as well as approximately 32% of yogurts and 9% of flavored milks, could meet the proposed limit of ≤5% of the DV for added sugars. Given that there are many dairy products currently on the market that could meet the proposed added sugars limit, including a significant number of yogurts and even some flavored milk products, and in keeping with the recommendations and strategies for reducing consumption of added sugars discussed in the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         including the specific recommendation encouraging consumption of unsweetened dairy products, as well as the purpose of the “healthy” nutrient content claim, we are finalizing the added sugars limit of ≤5% of the DV per RACC (currently ≤2.5 g/RACC for adults and children 4 years of age and older) for dairy products.
                    </P>
                    <P>(Comment 83) Some comments express concern about the application of the proposed added sugars limit to plant-based dairy alternatives. The comments say that, to approximate the natural sweetness of dairy or to feed the microbes responsible for creating yogurt, sugar is sometimes required in modest amounts to create alternative dairy products with similar culinary attributes to conventional dairy products. The comments also say that the enzymatic hydrolysis process used to create some oat milk products breaks down starches naturally occurring in oats into sugars. Some comments support added sugars limits for plant-based dairy alternatives that are consistent with those of cow's milk dairy products. Some comments suggested that higher levels of added sugars are necessary in plant-based dairy alternatives in comparison to other dairy products while others suggested that the same added sugars limits should be applied for dairy and plant-based dairy alternatives. The comments also argue that plant-based dairy alternatives, such as oat beverages, must declare sugars created through enzymatic hydrolysis as added sugars on the Nutrition Facts label, and, therefore, the proposed added sugars limits would prevent such products from bearing the “healthy” claim, while cow's milk products that contain added sugars could bear the claim. Some comments suggest that, in the case of alternative dairy products containing sugars solely as a result of enzymatic or microbial activity and no other added sugar, such products should be eligible to bear a “healthy” claim if they contain less sugar than 1 cup of unsweetened cow's milk, contribute significant nutrients of value, and do not exceed the saturated fat and sodium limits per RACC for dairy.</P>
                    <P>(Response 83) With respect to sugars added to plant-based milk alternative products through enzymatic hydrolysis, we said in our guidance regarding declaration on the Nutrition Facts label (Ref. 30) that, for the added sugars declaration on the label, we consider sugars created through the hydrolysis of starch or other complex carbohydrates inherent to grains, such as oats or rice, to be the same as sugars created through the hydrolysis of starch in the production of ingredients, such as maltodextrins, because in both cases, sugars are created through controlled hydrolysis. Because the hydrolysis process is controlled, manufacturers can determine the amount of sugars created and present in the final product. We said that we considered the sugars created through controlled hydrolysis in the production of plant-based beverages to provide empty calories to the diet. Although many plant-based beverages created through controlled hydrolysis contain sugars created through that process (that are considered added sugars for the purposes of the Nutrition Facts label) in amounts similar to the total sugars content of unflavored cow's milk, we are aware that there are such products in the marketplace that are unsweetened, contain no added sugars, and therefore do not contribute empty calories from added sugars to the diet. We do not have data or information about whether and how much added sugars may be necessary in plant-based dairy alternatives to approximate the taste of dairy, to feed microbes in the creation of plant-based yogurt alternatives, or to break down starches into sugars, and the comments that argued for this adjustment did not provide such data or information. Therefore, we do not have a basis to set a different added sugars limit for plant-based dairy alternatives, and so we also decline to provide an exemption from the added sugars limit for the sugars created through controlled enzymatic hydrolysis in the creation of plant-based beverages.</P>
                    <P>
                        (Comment 84) One comment urges us to permit liquid oil-based dressings containing up to 6% of the DV (3 g) of added sugars per RACC rather than the proposed limit of ≤2% (currently ≤1 g for adults and children 4 years of age and older). The comments say that the sugars in oil-based dressings play a role in making nutritious leafy greens and other vegetables in salads tastier. The comments also note that the 
                        <E T="03">Dietary Guidelines for Americans, 2020-2025</E>
                         states that a limited amount of added sugars can be included as part of an overall healthy eating pattern that includes healthy choices from each of the food groups.
                    </P>
                    <P>
                        (Response 84) The comment did not provide any data or other information to support changing the added sugars limit for oil-based dressings from 2% of the DV for added sugars to 6% of the DV for added sugars. There are many ingredients in oil-based dressings that can enhance the flavor of foods (
                        <E T="03">e.g.,</E>
                         the oil itself, herbs, and other seasonings) besides sugar. We reviewed products available in the marketplace and found that approximately 26% of oil-based dressings can meet the added sugars limit of 2% of the DV per 50 g. The 
                        <E T="03">Dietary Guidelines for Americans, 2020-2025</E>
                         recommends limiting added sugars to no more than 10% of calories per day. As discussed in the NFL Final Rule, small amounts of added sugars add up throughout the course of the day (81 FR 33742 at 33759). Because oil-based dressings can contain multiple ingredients that can enhance the flavor of foods such as leafy green vegetables, there are many such products in the marketplace that meet the added sugars limit. Further, we are not aware of any data or information that would support a different limit that is greater than ≤2% of the DV for added sugars. Therefore, we decline to change the added sugars limit for oil-based dressings and are finalizing the added sugars limits of 0% of the added sugars DV per RACC (or per 50 g if 50 g or less or 3 Tbsp or less) for 100% oil and oil-based spreads and ≤2% of the DV per RACC (or per 50 g if 50 g or less or 3 Tbsp or less) for oil-based dressings.
                    </P>
                    <HD SOURCE="HD3">b. Low- and No-Calorie Sweeteners</HD>
                    <P>
                        In the proposed rule (87 FR 59168 at 59180), we noted that we do not consider high-intensity (low- and no-calorie) sweeteners to be added sugars. Although we used the term “high intensity sweeteners” to describe sweeteners other than sugars and syrups 
                        <PRTPAGE P="106118"/>
                        that are added to foods for sweetening purposes in the proposed rule, high intensity sweeteners are a subset of sweeteners that are many times sweeter than table sugar (sucrose). The comments discuss sweeteners that provide less calories than sucrose more broadly. Therefore, for the purpose of this final rule, we will refer to all sweeteners (
                        <E T="03">e.g.,</E>
                         “high intensity sweeteners,” “nonnutritive sweeteners,” “sugars metabolized differently than traditional sugars,” “zero calorie sweeteners,” sugar alcohols, etc.) that provide less calories than sucrose as “low- and no- calorie sweeteners” throughout rather than “high intensity sweeteners.”
                    </P>
                    <P>
                        (Comment 85) Some comments agree with FDA's position in the proposed rule that low-and no-calorie sweeteners are not a factor in determining whether a product meets the requirements for the use of the “healthy” claim and support foods qualifying for the “healthy” claim that contain these ingredients. The comments note that the 
                        <E T="03">Dietary Guidelines for Americans, 2020-2025</E>
                         emphasize that a healthy dietary pattern is one that is flexible and allows individuals the ability to adjust the recommendations to meet their personal preferences, cultural traditions, and budgetary restrictions. The comments state that allowing products containing low-and no-calorie sweeteners to bear the “healthy” claim will allow companies to offer a variety of healthy foods that appeal to consumers and help the reduce the amount of added sugars in their diets. The comments also state that science has determined the safety of low- and no-calorie sweeteners.
                    </P>
                    <P>Many comments opposing a “healthy” claim on products containing low- and no-calorie sweeteners express concern about the safety of low- and no-calorie sweeteners, including specific products such as aspartame, saccharin, sucralose, and acesulfame. They also question the validity of studies professing the safety of low- and no-calorie sweeteners, arguing that while sweeteners may have neutral effects on physical health, low- and no-calorie sweeteners can negatively impact health. They discuss individual studies on the impact on the microbiome, the association with neurophysiological symptoms such as headaches, migraines, and irritability, and suggest that low- and no-calorie sweeteners are addictive and foster cravings that lead to the overconsumption of foods that are associated with metabolic diseases. Similarly, the comments argue that these sweeteners are metabolically active and lead to a number of complications including glucose intolerance.</P>
                    <P>The comments express particular concern about the use of low- and no-calorie sweeteners in products marketed to children. The comments refer to a citizen petition from the Sugar Association (FDA-2020-P-1478) regarding the labeling of products containing low- and no-calorie sweeteners, including requests related to the labeling of these sweeteners in foods and beverages consumed by children, which are outside the scope of this rule. The comments discuss statements from health professional organizations such as the American Academy of Pediatrics (Ref. 31) and the American Heart Association (Ref. 32) suggesting that the long-term safety of low- and no-calorie sweeteners in children has not been established.</P>
                    <P>(Response 85) As explained in the preamble to the proposed rule, since 1994, we have recognized that labeling that describes a food product as “healthy” in a nutritional context is making an implicit claim of the level of nutrients in the product. This implied claim can be used to identify foods that are particularly useful in creating a diet that is consistent with current dietary recommendations. Based on current nutrition science and Federal dietary guidelines, we have included the NTL that further this goal—added sugars, saturated fat, and sodium. We agree that the ability of foods using the “healthy” claim to contain low- and no-calorie sweeteners can give manufacturers more flexibility in formulating foods to meet the requirements for the use of the claim and can provide consumers with more options to meet their needs and preferences.</P>
                    <P>Further, we note that significant scientific evidence has shown that low- and no-calorie sweeteners are safe for consumption. Under the FD&amp;C Act, such evidence is required to establish the safety of any substance intentionally added to food, whether it is a food additive requiring pre-market approval or is excepted from the definition of a food additive because it is generally recognized as safe (GRAS) under the conditions of its intended use. For every food additive petition for a low- or no-calorie sweetener, FDA assesses its safety under its intended conditions of use. When GRAS notices have been submitted for a low- or no-calorie sweeteners, FDA conducted an initial evaluation to determine whether to file it as a GRAS notice for evaluation of whether the notified substance (a low- or no-calorie sweetener in this case) is GRAS under the conditions of its intended use (see 21 CFR 170.265(a)(1)). FDA also stays abreast of published literature and is aware that there are some new studies regarding consumptions of sweeteners by children and adolescents, but notes these studies have methodological challenges and are not conclusive. Based on the evaluation of existing evidence, including studies on the association of consumption of sweeteners in children and adolescents on various health outcomes, FDA has determined that the uses of sweeteners that are authorized by regulation are safe, and FDA had no questions regarding notifiers' GRAS conclusions for a variety of sweeteners. For more information about FDA's position on low- and no-calorie sweeteners, see FDA's published information about food additive petitions and GRAS notices (Ref. 33).</P>
                    <P>Thus, to the extent that comments argue that low- and no-calorie sweeteners should not be permitted in foods bearing the “healthy” claim based on their health effects and their perceived impact on maintaining healthy dietary practices, based on the FDA determinations of safety, we do not have a basis for concluding that products bearing the “healthy” claim should not contain low- or no-calorie sweeteners due to any perceived impact on consumers' ability to maintain healthy dietary practices. We intend to continue to monitor the use of low- and no-calorie sweeteners and evidence related to their impact on health and, as appropriate, will update the nutrient content claim “healthy” as nutrition science evolves.</P>
                    <P>
                        (Comment 86) Some comments note the language in the Dietary Guidelines regarding the lack of certainty about the effectiveness of replacing added sugars with low- and no-calorie sweeteners as a long-term weight management strategy and refer to guidance issued by the WHO on the use of non-sugar sweeteners that was based on a systematic review and meta-analysis on the health effects of non-sugar sweeteners conducted by the WHO (Refs. 1, 34, and 41). The comments claim that the guidance states that “there is no clear consensus on whether non-sugar sweeteners are effective for long-term weight loss or maintenance, or if they are linked to other long-term health effects at intakes within the Acceptable Range.” The comments call for more studies on the long-term effects of low- and no-calorie sweeteners before it can be determined whether they contribute to a healthy dietary pattern. They also recommend that FDA monitor the marketplace to determine if manufacturers reformulate products 
                        <PRTPAGE P="106119"/>
                        with low- and no-calorie sweeteners to meet the “healthy” criteria.
                    </P>
                    <P>(Response 86) Our determination that products containing low- and no-calorie sweeteners may use the “healthy” claim is not based on their association with weight loss or weight maintenance. Products may contain low- and no-calorie sweeteners for a variety of reasons, including to replace sugars, which can cause dental caries and impact blood glucose levels. We previously discussed that we have determined that low- and no-calorie sweeteners evaluated by FDA are safe, and we do not have a basis to exclude products containing low-and no-calorie sweeteners from bearing the claim. However, we do intend to monitor the use of low- and no-calorie sweeteners and evidence related to their impact on health.</P>
                    <P>(Comment 87) Some comments recommend that sugars, such as D-tagatose and isomaltulose, are metabolized differently than traditional sugars, and should be excluded from the definition of added sugars for the purpose of the “healthy” claim. One comment notes that many foods in which traditional sugars are replaced with isomaltulose may bear a health claim about the reduction in risk of dental caries, and it could be confusing to consumers if such a product could not bear the “healthy” claim yet another food containing a similar amount of traditional sugar that does promote dental caries could bear the “healthy” claim.</P>
                    <P>(Response 87) We disagree with comments asserting that FDA should not consider D-tagatose and isomaltulose as added sugars for the purpose of the “healthy” nutrient content claim. We concluded in the NFL Final Rule that because D-tagatose and isomaltulose are chemically sugars, and other substances are included or excluded from the definition of sugars and added sugars based on whether they are free, mono-, or disaccharides rather than on their physiological effects. Including D-tagatose and isomaltulose in the declaration of added sugars is consistent with how we have characterized other sugars (81 FR 33742 at 33837).</P>
                    <P>With respect to the comment suggesting that consumers would be confused if a product containing traditional sugars can bear a “healthy” claim yet a product bearing the health claim related to isomaltulose and a reduced risk of dental caries is not able to bear the claim, we disagree. As discussed in section V.H (“Nutritional Context”), the “healthy” nutrient content claim is different from a health claim. The “healthy” nutrient content claim suggests that a food, because of its nutrient content, is particularly helpful in building a healthy dietary pattern, whereas a health claim discusses the relationship between a substance and a disease or health related condition. The fact that a food may bear a health claim about a specific relationship between a substance and a disease or health related condition does not mean that the food is particularly useful in building a healthy dietary pattern consistent with dietary recommendations. As such, products containing D-tagatose or isomaltulose must meet the added sugars limit to bear the “healthy” claim.</P>
                    <P>(Comment 88) Some comments suggest that American consumers would be unlikely to trust a “healthy” label on products that include low- and no-calorie sweeteners and request that the definition of “healthy” include a required disclosure that products contain low- and no-calorie sweeteners on the front of the label.</P>
                    <P>(Response 88) As for the comments claiming that consumers will not trust products containing low- and no-calorie sweeteners bearing a “healthy” claim, we do not have evidence to suggest that this outcome is possible or likely. We do note, however, that the criteria for a “healthy” claim are based on the foods' contribution of nutrients to a healthy dietary pattern that help consumers in maintaining healthy dietary practices. Therefore, we decline to change our position on low- and no-calorie sweeteners.</P>
                    <P>(Comment 89) Some comments suggest that restrictive added sugars limits could incentivize the increased use of low- and no-calorie sweeteners in fruits, vegetables, protein food groups (including the nuts and seed subgroup) and express opposition to nutrition policy that would expand broad use of these ingredients. Likewise, the comments express concern with the growing number of new products containing low- and no-calorie sweeteners and suggest that the proposed rule could result in the increased use of low- and no-calorie sweeteners and other highly processed ingredients, instead of natural products such as honey.</P>
                    <P>Similarly, some comments assert that an allowance for low- and no-calorie sweeteners would lead consumers away from choosing products with naturally occurring sugars. These comments argue that allowing sweetener-enriched products to bear the “healthy” claim would lead to increased use of “highly processed” low- and no-calorie sweeteners, which would negatively impact the sugar industry.</P>
                    <P>Some comments also oppose including any products with low- and no-calorie sweeteners in the “healthy” definition on the grounds they would train consumers' palates to expect unhealthy food more often that could lead to overconsumption. They say that a main driver of excessive food intake is the desire to experience reward, even when calorically satiated, and sweet taste, whether caloric or not, is highly rewarding. The comments also argue that children are particularly sensitive to the rewarding effects of sweet taste, asserting that taste preferences are formed at an early age.</P>
                    <P>
                        (Response 89) We do not know whether and how manufacturers may voluntarily reformulate their products to meet the requirements for the use of the “healthy” claim, and we also do not have evidence regarding how consumers will respond to any such changes in the marketplace. “Healthy” is a voluntary nutrient content claim that is used to identify foods that are foundational to a healthy dietary pattern, and products containing low- and no-calorie sweeteners would be an even smaller subset of the foods in the market that qualify to bear the “healthy” claim. Consumers are motivated by a variety of factors when choosing foods to purchase and consume (
                        <E T="03">e.g.,</E>
                         taste, appearance, mouthfeel, etc.). We are not aware of any evidence that the ability of products bearing the “healthy” claim to contain low- and no-calorie sweeteners would lead consumers away from choosing products with naturally occurring sugars.
                    </P>
                    <P>The added sugars limits are set to help consumers to identify foods that are particularly useful in helping the build healthy dietary patterns—nutrient-dense foods with limited amounts of added sugars. However, as discussed above, we have increased the added sugars limits for many individual food groups and subgroups, as well as for mixed products, main dishes, and meals (see section V.E (“Combination Foods”)), which will result in more nutrient-dense products sweetened with some traditional sugars being able bear the claim. (See Response 78 for additional discussion about the added sugars limit and low- and no-calorie sweeteners in the fruits, vegetables, and protein food groups.)</P>
                    <P>
                        Thus, the final rule does not prevent the use of low- and no-calorie sweeteners in products bearing the “healthy” claim. However, we intend to continue to monitor the use of low- and no-calorie sweeteners and the evidence related to their impact on health.
                        <PRTPAGE P="106120"/>
                    </P>
                    <HD SOURCE="HD3">5. Nutrients Not Included</HD>
                    <HD SOURCE="HD3">a. Total Fat</HD>
                    <P>
                        (Comment 90) Some comments support FDA's proposal that total fat not be included in the “healthy” criteria and confirmed our assertion that this approach would be consistent with current nutrition science, the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         and the updated Nutrition Facts label. One comment also notes that not having a total fat limit is consistent with FDA's 2016 enforcement discretion guidance for the “healthy” nutrient content claim, relative to foods that are not low in total fat but have a fat profile consisting predominantly of mono- and polyunsaturated fat. Some comments discuss the adverse consequences of having a total fat limit in the original definition, such as the exclusion of foods that are high in unsaturated fats. The comments noted that, by not having a total fat limit, the rule would allow the claim on foods (
                        <E T="03">e.g.,</E>
                         fish, avocados, nuts and seeds, and certain oils) that are sources of mono- and polyunsaturated fats, which are important components of healthy dietary patterns.
                    </P>
                    <P>
                        (Response 90) We agree that not including a total fat limit, while maintaining a saturated fat limit, is consistent with current nutrition science, the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         and the updated Nutrition Facts label. This approach will also result in foods that are sources of unsaturated fats being able qualify for the claim.
                    </P>
                    <HD SOURCE="HD3">b. Trans Fat</HD>
                    <P>
                        (Comment 91) Several comments agree with our proposal to not include 
                        <E T="03">trans</E>
                         fat limits as part of the updated criteria for the “healthy” nutrient content claim, noting that the primary dietary source of industrially-produced 
                        <E T="03">trans</E>
                         fat, PHOs, are no longer considered to be GRAS and have largely been removed from the food supply and the saturated fat limits should adequately address other sources of 
                        <E T="03">trans</E>
                         fat aside from PHOs (
                        <E T="03">e.g., trans</E>
                         fat from ruminant products). One comment states that the science does not support an additional limit for 
                        <E T="03">trans</E>
                         fat on top of the saturated fat limit. In contrast, another comment recommends having a 
                        <E T="03">trans</E>
                         fat limit as part of the updated criteria for the claim; the comment mentions that studies have shown a positive association between 
                        <E T="03">trans</E>
                         fat intake and CVD risk and expresses the view that 
                        <E T="03">trans</E>
                         fat provides little to no nutritional benefit.
                    </P>
                    <P>
                        (Response 91) We agree that 
                        <E T="03">trans</E>
                         fat has adverse effects on CVD risk; however, the comment does not provide any data or information showing that the proposed saturated fat limits would not adequately address products in the marketplace containing 
                        <E T="03">trans</E>
                         fat, particularly since PHOs are no longer considered GRAS and have largely been removed from the food supply. We note that, in the 
                        <E T="04">Federal Register</E>
                         of December 14, 2023 (88 FR 86580), FDA published a notice confirming the effective date of a direct final rule amending our regulations to no longer provide for the use of PHOs in food given our determination that PHOs are no longer GRAS. The rule also revokes prior sanctions (
                        <E T="03">i.e.,</E>
                         pre-1958 authorization of certain uses) for the use of PHOs in margarine, shortening, and bread, rolls, and buns based on our conclusion that these uses of PHOs may be injurious to health. Therefore, we decline to change our approach for 
                        <E T="03">trans</E>
                         fat, and the final rule does not include a limit for 
                        <E T="03">trans</E>
                         fat as part of the updated “healthy” criteria.
                    </P>
                    <P>
                        (Comment 92) One comment requested that FDA require any amount of 
                        <E T="03">trans</E>
                         fat to be listed on food labels.
                    </P>
                    <P>
                        (Response 92) The amount of 
                        <E T="03">trans</E>
                         fat required for the declaration of 
                        <E T="03">trans</E>
                         fat on food labels is outside of the scope of this rule. We note, however, that the NFL Final Rule and our label regulation at § 101.9(c)(2)(ii) does require disclosure of 
                        <E T="03">trans</E>
                         fat as part of the Nutrition Facts label.
                    </P>
                    <HD SOURCE="HD3">c. Dietary Cholesterol</HD>
                    <P>
                        (Comment 93) In the proposed rule (87 FR 59168 at 59181), we tentatively concluded that it was unnecessary to include limits for dietary cholesterol as part of the updated “healthy” criteria because, similar to our approach with 
                        <E T="03">trans</E>
                         fat, dietary cholesterol would already be sufficiently limited by the proposed limits for saturated fat. We invited comment on our proposed approach, including any data showing that the saturated fat limit would not adequately limit dietary cholesterol or any data indicating that foods with both lower amounts of saturated fat and higher amounts of dietary cholesterol (
                        <E T="03">i.e.,</E>
                         seafood and eggs) should not be able to qualify for the “healthy” claim.
                    </P>
                    <P>Several comments agree that we should not include a limit for dietary cholesterol for the “healthy” claim, noting that limits on dietary cholesterol would be redundant given the limits for saturated fat, and that dietary cholesterol limits would also deter consumption of nutrient-dense foods, particularly eggs and other protein products. One comment explains that replacing saturated fat with unsaturated fat is more important for lowering LDL-cholesterol and that scientific evidence does not support limiting dietary cholesterol to lower LDL-cholesterol. The comment agrees that the saturated fat limits would adequately address dietary cholesterol because dietary cholesterol and saturated fat are often found in the same foods, noting that the exceptions of eggs and shellfish are nutrient-dense foods that can be incorporated into a healthy dietary pattern.</P>
                    <P>
                        (Response 93) We agree that the saturated fat limits adequately address dietary cholesterol. As noted in the proposed rule (87 FR 59168 at 59181), the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         does not make any recommendations regarding intake of dietary cholesterol, but the National Academies recommend that dietary cholesterol consumption be as low as possible without compromising the nutritional adequacy of the diet. We also noted in the proposed rule that the 2020 DGAC Report stated that it is difficult to assess the independent effects of dietary cholesterol on blood lipids and CVD because dietary cholesterol is found in sources that are also typically sources of saturated fat. A dietary pattern that is low in saturated fat is typically low in dietary cholesterol. Thus, the saturated fat limits for the definition of the “healthy” claim will adequately address dietary cholesterol because of their common food sources.
                    </P>
                    <P>
                        (Comment 94) Two comments support the inclusion of a dietary cholesterol limit, noting that studies show an adverse association with dietary cholesterol and blood cholesterol or cardiovascular health. One of these comments states that the proposed rule ignores the role of cholesterol on cardiovascular health by not including a dietary cholesterol limit. The comment also notes that an average-sized egg contains 186 milligrams of cholesterol and that some sub-groups of the population (
                        <E T="03">i.e.,</E>
                         those with high cholesterol, diabetes, or cardiovascular disease) are advised to limit their intake of cholesterol to less than 200 mg/day.
                    </P>
                    <P>
                        (Response 94) As explained in the previous response and discussed in the 2020 DGAC Report, it is difficult to assess the independent effects of dietary cholesterol on blood lipids and CVD because dietary cholesterol is found in sources that are also typically sources of saturated fat (Ref. 8). In the proposed rule, we explained that we expect that the saturated fat limits would sufficiently limit most foods that contain more than 60 mg of cholesterol, with a few exceptions such as eggs and some shellfish (87 FR 59168 at 59181). In the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         eggs and seafood (which includes fish and shellfish) are listed as examples of 
                        <PRTPAGE P="106121"/>
                        nutrient-dense foods and are identified in the Key Recommendations as examples of one of the core elements—protein foods—in a healthy dietary pattern. While some sub-groups of the population who are considered at-risk for certain chronic diseases (
                        <E T="03">e.g.,</E>
                         those with high blood cholesterol) or who have certain chronic diseases (
                        <E T="03">e.g.,</E>
                         those with CVD) may aim to lower their intake of dietary cholesterol, the “healthy” claim is intended to help the general population identify foods that are particularly useful in helping them build a healthy dietary pattern. Individuals with specific health conditions or concerns can use the Nutrition Facts label to identify foods that contain higher amounts of dietary cholesterol. For these reasons, and the reasons discussed in the previous response, we decline to change our approach for dietary cholesterol and a limit for dietary cholesterol is not included as part of the updated criteria.
                    </P>
                    <P>(Comment 95) One comment discusses the importance of consumer education and data monitoring related to dietary cholesterol. The comment explains the importance of providing information to help consumers interpret how to use the “healthy” claim, particularly in the context of amounts of foods consumed, so that foods such as eggs, as well as other foods labeled as “healthy,” are not overconsumed. The comment also recommends that FDA monitor the impact of the updated “healthy” claim on dietary cholesterol intake.</P>
                    <P>Other comments ask that we perform data monitoring to evaluate the impact of the updated “healthy” claim on the presence of different nutrients or ingredients in the marketplace or on the dietary intake of different nutrients or ingredients.</P>
                    <P>
                        (Response 95) We agree that excessive consumption of foods labeled as “healthy” is an important topic and that consumer education may help consumers use the “healthy” claim to help build healthy dietary patterns. We plan to undertake consumer education efforts, which could address, for example, the importance of both staying within calorie limits and choosing a variety of nutrient-dense foods within and across different food groups and subgroups—two concepts that are an integral part of the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         We also plan to monitor and evaluate the impacts of the updated “healthy” definition after its implementation.
                    </P>
                    <HD SOURCE="HD3">d. Other Comments on Nutrients Not Included</HD>
                    <P>(Comment 96) One comment recommends that we consider an absolute calorie limit—such as 200 calories, 400 calories, and 600 calories per labeled serving or RACC (whichever is larger) for individual foods, main dishes, and meals, respectively—as part of the “healthy” criteria to discourage the consumption and development of high calorie foods.</P>
                    <P>
                        (Response 96) We included FGE criteria and NTL criteria in the updated definition for the “healthy” nutrient content claim to help consumers identify foods that are particularly useful in building a healthy dietary pattern, which are nutrient-dense foods. Nutrient-dense foods are described in the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         as providing vitamins, minerals, and other health-promoting components while having little or no added sugars, saturated fat, and sodium (Ref. 1). Because nutrient-dense foods contain little or no excess calories, and/or are prepared with little or no excess calories, from added sugars or saturated fat, they tend to have a higher amount of nutrients per calorie. While we did not include a specific calorie limit in the proposed criteria, calories are taken into consideration indirectly in the “healthy” definition by including criteria for NTL for saturated fat and added sugars (which provide calories) as well as FGE criteria. FGE criteria were determined based on a 2,000 calorie diet; therefore, the amount of nutrient-dense foods needed to meet the FGEs are based on recommended nutrient amounts within that calorie limit. The comment did not provide any data or information demonstrating why an absolute calorie limit would be necessary or that the FGE and NTL criteria were not sufficient in limiting calories, nor did it explain how calorie limits were calculated or determined. Therefore, we decline to include a limit for calories on top of the FGE and NTL criteria.
                    </P>
                    <P>(Comment 97) One comment requests that we exempt foods that qualify for the “healthy” claim from § 101.13(h), which requires a disclosure statement for foods with certain levels of cholesterol. The comment says that, without an exemption, foods might give consumers mixed messages about dietary cholesterol.</P>
                    <P>
                        (Response 97) Disclosure statements are required when “a food that bears a nutrient content claim contains a nutrient at a level which increases to persons in the general population the risk of a disease or health-related condition which is diet related” (see section 403(r)(2)(B) of the FD&amp;C Act). The nutrients that require disclosure statements include total fat, saturated fat, cholesterol, and sodium (§ 101.13(h)). These nutrients are also included as NTL in the original definition of “healthy” (§ 101.65(d)). As discussed earlier in this section, total fat and dietary cholesterol are no longer included as NTL in the definition. The 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         does not include a key recommendation for intake of total fat or dietary cholesterol (see Response 93) (Ref. 1). Thus, disclosure statements for total fat or cholesterol are not required for use of the claim “healthy.” The saturated fat limits we are finalizing will help ensure that foods with higher amounts of total fat that use a “healthy” claim are predominantly comprised of unsaturated fats, and that cholesterol-containing foods are limited. There are situations where foods that qualify for the claim may contain saturated fat in amounts that exceed the disclosure level for saturated fat. The updated “healthy” definition provides exclusions for inherent saturated fat contained in certain food groups and subgroups (
                        <E T="03">e.g.,</E>
                         nuts, seeds, and soy products and seafood) that have fat profiles that are predominantly made up of unsaturated fat. As discussed in the saturated fat section above, these exclusions are supported by current nutrition science and result in nutrient-dense foods that are encouraged by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         being able to qualify for the claim. Because these foods, which may contain saturated fat that exceeds the disclosure level, are nutrient-dense foods encouraged by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         and are foundational for healthy dietary patterns, we conclude that disclosure statements highlighting these levels of saturated fat are unnecessary and foods that bear the “healthy” claim are exempt from the requirement for disclosure statements for saturated fat in § 101.13(h).
                    </P>
                    <P>(Comment 98) Several comments discuss certain ingredients or chemicals, besides nutrients, that can be present in foods and whether they should be considered as part of the criteria for the “healthy” claim. Some comments argue that the proposed rule's focus on sodium, saturated fats, and added sugars leaves open the possibility for products to bear “healthy” labels despite containing “unhealthy” compounds not covered by the rule.</P>
                    <P>
                        (Response 98) As explained in the preamble to the proposed rule (87 FR 59168 at 59169), since 1994, we have recognized that labeling that describes a 
                        <PRTPAGE P="106122"/>
                        food product as “healthy” in a nutritional context is making an implicit claim of the level of nutrients of the product. The presence or absence of ingredients other than nutrients in a food product (
                        <E T="03">e.g.,</E>
                         preservatives, colorings, contaminants (including toxic elements), pesticides, oxalate) is outside of the scope of the “healthy” nutrient content claim. Similarly, information about the production method of a food (
                        <E T="03">e.g.,</E>
                         genetically engineered or organic) is beyond the scope of the “healthy” nutrient content claim as it does not characterize the level of nutrients in a food.
                    </P>
                    <HD SOURCE="HD3">7. Nutrients To Encourage</HD>
                    <P>
                        (Comment 99) Some comments support eliminating the NTE (
                        <E T="03">i.e.,</E>
                         nutrients that are underconsumed and whose low intake in the general population or in individual subpopulations raise public health concern) requirement. The comments assert that the NTE requirement has allowed food manufacturers to fortify non-nutrient-dense foods for the sole purpose of qualifying as “healthy” without improving the healthfulness of the products. The comments provide that the “healthy” claim should not appear on heavily processed, non-nutrient-dense foods that have been fortified to meet the claim's criteria. Many comments say the food group-based approach we proposed by FDA, noting that it is consistent with dietary recommendations for healthy dietary patterns and may minimize the unintended consequences of focusing solely on individual nutrients. Other comments support the shift away from the NTE requirement by noting that certain foods would not qualify as “healthy” if there were NTE requirements, despite evidence in support of the health benefits of these foods (
                        <E T="03">e.g.,</E>
                         mushrooms).
                    </P>
                    <P>Other comments oppose the exclusion of the NTE criteria from the rule. The comments assert that nutrients, such as vitamins, minerals, fiber, and protein, should continue to be part of the “healthy” nutrient claim criteria. One comment supports FDA's food group-based approach as an effective way to encourage consumers to eat a variety of foods as part of a balanced diet, but believes it is still important to retain some additional nutrient requirements for certain food categories to help ensure that these foods provide a similar nutrient profile to comparable foods, including for plant-based alternatives to dairy products.</P>
                    <P>
                        (Response 99) The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         (Ref. 1) focuses on the importance of a healthy dietary pattern as a whole and its role in promoting health, reducing risk of chronic diseases, and meeting nutrient needs. The original definition for the “healthy” nutrient content claim was based solely on individual nutrients, including a minimum amount of a beneficial nutrient and specific allowable limits for other nutrients, and is inconsistent with current nutrition understanding of healthy dietary patterns and their effect on health and development of chronic disease. Foods that contain certain NTE, such as vitamins, minerals, or fiber, can be beneficial to consumers. However, requiring that foods contain a certain amount of individual NTE in order to qualify for the “healthy” claim would not necessarily help consumers identify foods that are particularly useful, based on their overall nutrient profile, for building healthy dietary patterns. Additionally, as we explained in the proposed rule, including criteria for NTE could spur fortification to allow foods that are low in saturated fat, sodium, and added sugars to qualify for the “healthy” claim, despite these foods not contributing to a meaningful amount of a food group (87 FR 59168 at 59176). Including requirements for specific amounts of foods from across all of the recommended food groups better reflects how nutrients work together and make up the food groups and subgroups that are part of a healthy dietary pattern. We conclude that the criteria of the “healthy” claim should include FGE requirements instead of requirements for individual NTE in the definition. Furthermore, we decline to revise the definition to include any requirements for NTE in addition to the FGE requirements, considering that consumption of the recommended amounts of food across all of the recommended food groups enables consumers to create healthy dietary patterns and achieve nutrient adequacy. For more on how we are ensuring that alternative dairy foods provide the same nutrient profile as traditional dairy in order to qualify in the dairy food group to bear the “healthy” claim, please see Response 32.
                    </P>
                    <P>(Comment 100) One comment suggests that, if FDA decides to keep the NTE requirement, we should require foods to meet the nutrition criteria without fortification. The comment suggests that FDA would also need to create exemptions for certain fruits, vegetables, and nuts that do not meet the NTE requirement.</P>
                    <P>
                        (Response 100) As discussed in the previous response, we decline to retain or add any requirements for NTE in place of or in addition to FGE requirements. Instead, the “healthy” definition includes criteria of FGEs for the food groups encouraged by the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         Therefore, considerations regarding fortification or exemptions based on NTE are not necessary.
                    </P>
                    <P>(Comment 101) Some comments assert that both inherent and fortified nutrients should be allowed. One comment provides that the body does not discern whether a nutrient comes from an intrinsic or fortified source and that nutrients from either an intrinsic or fortified source contribute equally toward the overall nutrient intake. The comments mention that the Dietary Guidelines recognize that, in some cases, fortified foods may be useful in providing one or more nutrients that otherwise may be consumed in less than recommended amounts. The comments contend that, because manufacturers are already subject to FDA's existing fortification policy, exclusion of the NTE criteria is unnecessary. A number of comments mention that the Dietary Guidelines make reference to the value of choosing fortified foods to help meet nutrient needs for certain vitamins and minerals. One comment cites as an example the Dietary Guidelines' reference to Vitamin D being harder to acquire through natural sources from the diet alone, thus requiring the consumption of foods and beverages fortified with Vitamin D in order to achieve nutrient adequacy. Another comment mentions that, given “healthy” is a nutrient content claim, the inclusion of positive nutrients and food groups is prudent.</P>
                    <P>
                        (Response 101) As previously stated, we decline to amend the definition to include any requirements for NTE in addition to the FGEs. FGE criteria based on the consumption of food across all of the recommended food groups will help consumers in identifying foods that are particularly useful in constructing healthy dietary patterns. Because requirements for NTE are not included in the definition, we do not need to address issues related to inherent or fortified nutrients. The presence of individual nutrients in a food, and knowledge about the benefits, however, may be useful to consumers, and, as previously discussed, manufacturers may communicate such information in many different ways. While highlighting foods with significant levels of a nutrient may be useful to some consumers, we reiterate that helping consumers identify nutrient-dense foods from the recommended food groups, which better reflects the overall nutrient content of foods, can better help consumers in creating healthy dietary patterns to maintain healthy dietary 
                        <PRTPAGE P="106123"/>
                        practices, which is the primary purpose of the “healthy” claim.
                    </P>
                    <P>(Comment 102) Some comments recommend a first ingredient approach combined with a NTE requirement as an alternative option to the proposed FGE requirements, such that the FGE criteria would be considered to be met if a food's first ingredient (or for foods other than beverages, the second ingredient if the first ingredient is water or broth) is in one of the food groups to encourage and a NTE requirement is met. Other comments recommend that, as an alternative option to food group requirements, FDA allow a food to qualify for the “healthy” claim if, in addition to meeting the NTL criteria for sodium, saturated fat, and added sugars, the food also meets NTE thresholds of nutrients such as dietary fiber, protein, vitamin D, calcium, potassium, or iron. The comments distill this recommendation as allowing foods to qualify for healthy if they meet both: (1) NTL criteria and (2) either the minimum amount for an inherent or fortified positive nutrient or the food group criteria. Another comment recommends an alternative approach of including a target of 10% DV for nutrients identified by the Dietary Guidelines as being at risk of underconsumption as a way to qualify for the “healthy” claim. Another comment recommends an approach involving a scaled percentage DV of NTE for different food groups, regardless of FGE content.</P>
                    <P>(Response 102) We decline to adopt a first ingredient approach to determine FGEs because, as discussed in Response 11, it is not a reliable way to help consumers identify foods that can help them meet recommended food group amounts. As discussed in Response 99, we conclude that the criteria for the “healthy” claim should include FGE requirements instead of requirements for individual NTE in the definition because requiring foods to contain a certain amount of individual nutrients to qualify for the “healthy” claim would not necessarily help consumers identify foods that are particularly useful for building healthy dietary patterns. Furthermore, combining an NTE requirement with a “first ingredient” approach would not be more effective than an FGE requirement. Because a “first ingredient” approach would lead to uncertainty about the specific amount of a food group in a product, such an approach combined with the presence of a single NTE in the product would not help consumers identify foods that are particularly useful for building healthy dietary patterns.</P>
                    <P>(Comment 103) The comments assert that, with the proposed limitations on saturated fat, sodium, and added sugars, the exclusion of NTE criteria would lead to underconsumption of nutrients that are necessary for healthy dietary patterns. The comments recommend that FDA include NTE criteria for nutrients identified as dietary components of public health concern by the Dietary Guidelines, including calcium, dietary fiber, potassium, and vitamin D. One comment contends that the proposed rule would exclude many foods that are nutrient-dense, for example, foods containing meaningful amounts of NTE, based solely on their nominal added sugars content; foods having slightly less than the precise amounts of food groups required by the proposal; or foods containing slightly more sodium than the proposal would require.</P>
                    <P>
                        (Response 103) We disagree that excluding NTE criteria would lead to underconsumption of nutrients of public health concern. As discussed above, and per the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         if a healthy dietary pattern is consumed, 
                        <E T="03">i.e.,</E>
                         a diet that meets the recommended daily amount of food from across the recommended food groups, the intake of nutrients of public health concern such as calcium, dietary fiber, potassium can meet the daily requirements (Ref. 1). The requirements for vitamin D can be met as well, except in specific cases, such as situations where climate and sunlight exposure become an issue. A “healthy” claim can help consumers identify the foods that are particularly useful in constructing healthy dietary patterns and thus meeting nutrient requirements, including nutrients of public health concern. It is for this reason that the “healthy” claim definition includes requirements for FGEs. We recognize, though, that, for some specific individuals and situations, nutrients in dietary supplements and/or fortified foods could be useful, and those benefits can continue to be communicated to consumers through various truthful and non-misleading label statements.
                    </P>
                    <P>(Comment 104) One comment notes the health benefits of antioxidants and omega fatty acids and recommends that FDA devise a system that reflects the relationship of a specific foods' overall essential nutrient content in relation to the caloric space that the food takes up in a person's daily diet.</P>
                    <P>
                        (Response 104) As discussed previously, the original definition for “healthy” reflected an individual nutrient-centric approach, but nutrition science and dietary recommendations have evolved since the time the original definition was developed. The construction of overall healthy dietary patterns, and not the identification of foods with specific individual nutrient amounts, is most associated with promoting health and reducing chronic disease risk in the general public (Ref. 1). For the reasons previously discussed, we conclude that the criteria of the “healthy” claim should include FGE requirements, along with nutrient limits, instead of requirements for individual NTE in the definition. FGE requirements better reflect the overall nutrient content of a food and the array of nutrients that are contained in the different food groups, including examples mentioned in the comment. Further, we made other adjustments to the criteria to support the use of the “healthy” claim on certain nutrient-dense foods from the recommended food groups. For example, we have made adjustments to exclude the inherent saturated fat in nuts, seeds, and soy products, and seafood from the saturated fat criteria, because their fat profile is predominantly unsaturated fat (
                        <E T="03">e.g.,</E>
                         omega-3 and omega-6 fatty acids), and an adjustment so that nutrient-dense single-ingredient foods encouraged by the 
                        <E T="03">Dietary Guidelines</E>
                         can automatically qualify for the claim. The presence and benefits of individual nutrients can still be communicated in many different ways and through many different types of truthful and non-misleading statements on the label.
                    </P>
                    <HD SOURCE="HD2">E. Combination Foods (i.e., Mixed Products, Main Dish Products, and Meal Products)</HD>
                    <HD SOURCE="HD3">1. General Comments</HD>
                    <P>(Comment 105) Many comments object to FDA's proposed requirement that at least one FGE from one, two, or three different food groups must be present in every individual product/mixed product, main dish, or meal, respectively. The comments note that the proposed framework is not reflective of the practical realities of recipe design and that recipes do not always contain a full FGE from one, two, or three food groups. They request that FDA instead allow for aggregation of any volume or fractions of defined food groups to contribute to the total FGE requirements for mixed products, main dishes, and meals. The comments mention that permitting aggregation of any volume or fractions of defined food groups in meeting FGEs in combination foods will allow for more flexibility in recipes while still promoting intake of underconsumed food groups.</P>
                    <P>
                        One comment mentions that pasta products can be made with a variety of nutrient-dense ingredients, such as 
                        <PRTPAGE P="106124"/>
                        vegetables and legumes, and that, under the proposed requirements, such pasta products would require either one full FGE of grains or vegetables, or 
                        <FR>1/2</FR>
                         FGE of grains and 
                        <FR>1/2</FR>
                         FGE of vegetables. The comment requests that FDA revise the FGE requirements so that an individual food or mixed product would qualify if it contains a total of 1 FGE from one or more different food groups, so that, for example, products containing 
                        <FR>1/3</FR>
                         FGE vegetable and 
                        <FR>2/3</FR>
                         grain, or 
                        <FR>1/4</FR>
                         FGE vegetable and 
                        <FR>3/4</FR>
                         FGE grain could qualify. According to the comment, this would better reflect the overall food group contribution of, for example, a pasta product that contains a meaningful contribution to both the whole grains and vegetable food groups.
                    </P>
                    <P>
                        (Response 105) As described in the proposed rule, combination foods are foods that contain a meaningful amount of more than one food group. The proposed rule required that a mixed product needed to contain at least 
                        <FR>1/2</FR>
                         FGE each of two different foods groups per RACC to meet the FGE criteria (87 FR 59168 at 59190). The requirement that mixed products contain 
                        <FR>1/2</FR>
                         FGE from two different food groups effectively provides one total FGE, similar to individual foods, since mixed products are similar in size to an individual food. As the comments note, however, the components of mixed products are not always divided into exactly 
                        <FR>1/2</FR>
                         FGE of different food groups. For example, a mixed food may have 
                        <FR>2/3</FR>
                         FGE of one food group and 
                        <FR>1/3</FR>
                         FGE of a different food group. Although the proportions would not be exactly 
                        <FR>1/2</FR>
                         FGE for each food group, the total amount of FGE would still be one FGE. We recognize that requiring at least 
                        <FR>1/2</FR>
                         FGE from two different food groups could restrict formulations of foods that could otherwise contribute meaningful FGE amounts to the diet and manufacturers could potentially be limited in the types of healthful food offerings they could provide to consumers. For this reason, we have revised the criteria for mixed products at § 101.65(d)(iv). The final rule allows for two or more food groups to contribute to the 1 FGE total for mixed products; the food groups contributing to the 1 FGE (“qualifying food groups”) must be present in amounts of at least 
                        <FR>1/4</FR>
                         FGE. We are setting this threshold because setting the level lower than 
                        <FR>1/4</FR>
                         FGE would not provide meaningful amounts of the required food groups in mixed products and therefore not be as effective in helping consumers meet the daily recommended amounts for the food groups. Similarly, for main dish products and meal products, we conclude that flexibility should be provided by allowing varying proportions of the FGE amounts required for the food. We acknowledge that main dish products might not contain at least 1 FGE each of two different food groups and that meal products might not contain at least 1 FGE each of three different food groups. Rather, the foods may have less of one food group and more of another and still be nutrient-dense. With these changes, the total amount of FGE required for main dish products and meal products would still be the same as proposed, but the required minimum contributions of each of the individual components FGEs is reduced. Although a minimum of one full FGE from each qualifying food group component will not be required, the rule will require the product to have no less than 
                        <FR>1/2</FR>
                         FGE from each of the two qualifying food group components for main dishes, or each of three qualifying food group components for meals, so that the product provides a meaningful amount of the respective food groups (see § 101.65(d)(iv) and (v)). For example, a main dish could contain 
                        <FR>1/2</FR>
                         FGE of vegetables and 1 
                        <FR>1/2</FR>
                         FGE of whole grains, totaling two full FGEs. As another example, a meal product could contain 
                        <FR>1/2</FR>
                         FGE of dairy, 
                        <FR>3/4</FR>
                         FGE of protein foods, and 1 
                        <FR>3/4</FR>
                         FGE of whole grains, combining for 3 full FGEs.
                    </P>
                    <P>
                        Pasta products, which are most commonly made of wheat, would typically fall under the individual foods criteria for grain products. The comments, however, discuss pasta products that might be made from both grain ingredients and vegetable ingredients. With the updated FGE criteria for mixed products, these type of pasta products could qualify for use of the “healthy” claim as a mixed product if the product contained a total of one full FGE from whole grain and vegetable ingredients, with a minimum FGE amount for the qualifying food groups of 
                        <FR>1/4</FR>
                         FGE. For example, the whole grain ingredients could contribute 
                        <FR>3/4</FR>
                         of the whole grain FGE and the vegetable ingredients could contribute 
                        <FR>1/4</FR>
                         of the vegetable FGE. The adjustments in the required minimum FGE amounts provides flexibility in the qualification of combination foods while also providing consumers with meaningful amounts of food groups recommended for building healthy dietary patterns.
                    </P>
                    <P>(Comment 106) In the proposed rule, we proposed specific NTL criteria for combination foods, and many comments address these proposed limits for sodium, added sugars, and saturated fat.</P>
                    <P>Some comments express that the proposed criteria for combination foods are difficult to follow. Some comments request that FDA provide more examples of these types of products to help with understanding the final criteria.</P>
                    <P>
                        Some comments note that, while they agree that nutritious dietary patterns should contain less sodium and added sugars and more whole foods, the rule for combination foods products places limits on added sugars, sodium, and saturated fat, without providing a scientific rationale regarding why some products have different limits than others (
                        <E T="03">i.e.,</E>
                         depending on the food groups contained in the product). The comments request more information about the rationale for the distinction and request that FDA standardize the requirements for added sugars, sodium, and saturated fat among combination foods that contain different food groups.
                    </P>
                    <P>One comment suggests an alternative framework and several comments refer to and express support for this alternative framework. The alternative framework would combine FDA's proposed individual foods and mixed products food categories into one category, and further delineate the combined individual/mixed food category by RACC size to include a small RACC subcategory, as defined in § 101.13, as individual foods with RACCs that are 30 g or less or 2 Tbsp or less. The alternative framework would retain the original food categories of main dishes and meals. The comment requests that the limits for sodium, added sugars, and saturated fat increase in a stepwise manner based on RACC/serving size that correlate to specific food categories and do not vary based on food groups. The comment suggests the following limits for sodium:</P>
                    <P>• 10% DV sodium per RACC for the individual and mixed food category with small RACCs;</P>
                    <P>• 20% DV sodium per RACC for individual and mixed foods with a RACC &gt;30g;</P>
                    <P>• 25% DV sodium per serving for main dishes; and</P>
                    <P>• 30% DV sodium per serving for meals.</P>
                    <P>With respect to added sugars, the comment questions why there is not a sliding scale for added sugars limits based on the proportional RACC/serving size. The comment recommends the same percentage limits for added sugars as it does for sodium limits. The comment also suggests a stepwise increase in saturated fat limits, as follows:</P>
                    <P>
                        • 5% DV saturated fat per RACC for the individual and mixed food category with small RACCs;
                        <PRTPAGE P="106125"/>
                    </P>
                    <P>• 10% DV saturated fat per RACC for individual and mixed foods with a RACC &gt;30g;</P>
                    <P>• 15% DV saturated fat per serving for main dishes; and</P>
                    <P>• 20% DV saturated fat per serving for meals.</P>
                    <P>(Response 106) We calculated the proposed NTL criteria for combination foods based on the criteria for the individual component food groups. For mixed products, we calculated the limits by finding the average of the NTL criteria for their component food groups (87 FR 59168 at 59191). For main dishes and meal products, we calculated the NTL criteria by adding together the nutrient limits for the two or three individual food groups, respectively, that make up the food product (id. at 59192 to 59193). For example, for a whole grain vegetable lasagna main dish, the sodium limit as proposed would be ≤20% DV (≤10% DV for whole grains plus ≤10% DV for vegetables). We explained in the proposed rule that, because there is variation in the saturated fat limits for different subgroups of protein foods, the proposed saturated limit for combination products containing protein varied depending on the type of protein in the product. Similarly, because there was variation in the proposed added sugars limits for different food groups, the proposed added sugars limits for combination products also varied depending on the food groups (or subgroups) in the product.</P>
                    <P>
                        Due to the different proposed limits for the individual food groups and subgroups, however, the resulting criteria for all of the possibilities of combination foods were numerous and complicated. Additionally, as some comments explain, combination foods are not typically formulated by only adding the foods from two or three different food groups together, but, rather, are formulated to include foods from the different food groups along with other ingredients (
                        <E T="03">e.g.,</E>
                         sauces and seasonings). To simplify and streamline the criteria and also to provide some flexibility in formulations and recipes for combination foods, the final rule, at § 101.65(d)(3)(iii) through (v), revises the NTL criteria for combination foods.
                    </P>
                    <P>
                        <E T="03">Sodium.</E>
                         We agree with comments that support an incremental or stepwise approach for the NTL across food categories. In the proposed rule, the sodium limits for most individual foods and for mixed products, which typically have RACCs similar in size to individual foods, were set at the baseline limit of ≤10% of the DV (currently ≤230 mg for adults and children 4 years of age and older) per RACC (87 FR at 59192). In determining the baseline sodium limit, we considered many factors, such as the effects of sodium on health and chronic disease as well as the many functions of sodium in food, including taste, texture, microbial safety, and stability (see section V.D.3 for further discussion of sodium limits for individual foods). As mentioned previously, some comments provide information that explain that combination foods, such as mixed products, are not necessarily formulated by just adding foods from two different food groups together, such as a vegetable and a grain product. Rather, recipes and formulations can include foods from different food groups along with other ingredients to create particular taste profiles, flavors, etc. Additional components to the recipes could include ingredients such as seasonings and sauces and some additional sodium is often present in the formulations of mixed products in the additional ingredients, such as a sauce or seasonings. For this reason, we determine that it is reasonable for mixed products to have a sodium limit that is incrementally higher (≤15% DV per RACC) than the sodium limit for individual foods. Providing additional flexibility to the sodium limit for mixed products could also allow manufacturers to provide a greater variety of healthful options to consumers. However, considering the health effects of sodium consumption and the recommended total sodium limits in the diet, we conclude that mixed products should not exceed 15% of the DV for sodium (currently ≤345 mg for adults and children 4 years of age and older) per RACC (or per 50 g for RACCs ≤50 g or ≤3 Tbsp). The ≤15% DV mixed product sodium limit at § 101.65(d)(3)(iv) increases the mixed product sodium limit from what we proposed by 50% without bringing the limit up to those of larger combination foods (
                        <E T="03">i.e.,</E>
                         main dish products and meal products).
                    </P>
                    <P>
                        For main dish and meal products, we proposed sodium limits of ≤20% and ≤30% of the DV per labeled serving, respectively (87 FR at 59192 and 59193), and we are finalizing these limits at § 101.65(d)(3)(v) and (vi). These limits reflect the stepwise increase in size and number of food group components of these larger food products. At ≤30% of the DV per labeled serving, a meal product, which contains FGEs from at least three different food groups, will have three times the allowable sodium limit of an individual food. As previously discussed, main dish products are required to contain FGEs from two different food groups. To scale the sodium limit proportionate to the FGE requirements, the sodium limit is set at ≤20% of the DV per labeled serving for main dish products. This limit is twice the amount of the limit for an individual food. It is also 
                        <FR>2/3</FR>
                         the value of the meal products limit, which is appropriate due to the number of food group components required of main dishes compared to meal products. We conclude that the range of values from ≤10% to ≤30% of the DV for sodium, across the categories of foods (
                        <E T="03">i.e.,</E>
                         individual foods, mixed products, main dishes, and meals), appropriately reflects the increasing sizes and number of food group components in each food category, while still helping consumers identify foods across different food categories that can serve as a foundation for healthy dietary patterns and help stay below the daily recommended limit for sodium. Increasing the limits beyond those finalized in this rule, for example limits higher than ≤10% for individual foods, ≤15% for mixed products, and ≤20% for main dishes, as requested in some comments, would not help consumers in identifying foods that can help them build healthy dietary patterns by staying below the daily recommended limit for sodium.
                    </P>
                    <P>
                        <E T="03">Added Sugars.</E>
                         We are revising the limits for added sugars in the rule to be ≤10% of the DV per RACC (or per 50 g for RACCs ≤50 g) for all mixed products, regardless of their food group components (see § 101.65(d)(3)(iii)). Setting the limit at ≤10% DV simplifies and provides one standard value for all mixed products. Similar to the limits for sodium for combination foods, we agree that added sugars limits should incrementally increase across the different types of combination food products. Further, based on the comments that we received to the proposed rule and supported by our review of products available in the marketplace (Ref. 2), we find that it is reasonable to accommodate added sugars content that is higher than the range that we had proposed for mixed products, main dishes, and meals. Even though certain individual food group components may not contain many added sugars, some additional added sugars may be included in developing recipes and formulations for combination foods. While the proposed sodium limits for main dish and meal products were a single value for their individual categories (≤20% and ≤30% of the DV per RACC), the proposed limits for added sugars for these categories varied depending on the 
                        <PRTPAGE P="106126"/>
                        specific food groups that contributed to the FGEs. (See 87 FR 59168 at 59192 to 59193.) For both main dishes and meal products, the added sugars limits ranged from 0% of the DV to ≤10% of the DV depending on the food group components (id.). To simplify the requirements, we revised the rule to provide a single added sugars limit value for each combination food category that incrementally increases across the combination food categories in a way that reflects their sizes and number of food group components (see § 101.65(d)(3)(iii)-(v)). Additionally, the rule increases the added sugars limits above the highest proposed levels for each of the combination food categories, which may allow for flexibility in formulations and recipes for combination foods.
                    </P>
                    <P>For main dish products, we are setting the added sugars limit incrementally higher than mixed products at ≤15% of the DV per labeled serving (see § 101.65(d)(3)(v)). The rule's limit of ≤15% DV added sugars for main dish products is an increase from the highest proposed added sugars limit for mixed products of ≤10% of the DV, which may provide for flexibility in formulations and recipes of healthy main dish options that manufacturers can provide to consumers while still helping consumers to identify foods that help them stay within the daily recommended intake limit for added sugars. Likewise, the rule increases the proposed limit for added sugars for meal products to ≤20% of the DV per labeled serving (see § 101.65(d)(3)(v)). Meal products must have one more food group component than main dishes and are larger products that constitute the entirety of a meal. Thus, the increase to ≤20% of the DV represents an incremental increase of added sugars from the ≤15% of the DV limit for main dish products. As with the other combination foods, increasing the added sugars limit for meals may result in manufacturers' being able to provide a wider variety of healthy food product options to consumers while still helping consumers identify foods that can help them build healthy dietary patterns by staying within daily recommended intake limits.</P>
                    <P>
                        <E T="03">Saturated Fat.</E>
                         The final rule also streamlines and simplifies the criteria for saturated fat. Similar to the proposed limits for added sugars, the proposed limits for saturated fat for combination foods varied depending on the specific food groups that contributed to the FGEs (see 87 FR at 59192 to 59193). For combination foods, the proposed saturated fat limits ranged from ≤5% of the DV to ≤25% of the DV, depending on the food group components (id.). As with the other nutrient criteria, the different possibilities for saturated fat limits of combination foods were numerous and resulted in complicated calculations. Therefore, to simplify the requirements, the final rule sets a single saturated fat limit value for each combination food category (mixed products, main dish products, meal products) (see § 101.65(d)(3)(iii)-(v)). Similar to the limits for sodium and added sugars, the limits for saturated fat for combination foods increases incrementally across combination food categories. For mixed products, we are setting one limit for saturated fat of ≤10% of the DV per RACC or per 50 g for RACCs ≤50 g (see § 101.65(d)(3)(iii)). In determining the saturated fat limit for mixed products, we found that some considerations were different than those for added sugars and sodium. For example, there are already modifications to the saturated fat criteria to allow flexibility for inherent saturated fat for some food groups (
                        <E T="03">i.e.,</E>
                         where the fat composition is made up of predominantly unsaturated fat). In addition, there are options to use other types of fat, specifically unsaturated fats, to replace saturated fat in foods (
                        <E T="03">e.g.,</E>
                         using vegetable oils higher in unsaturated fat instead of palm oil or butter). Therefore, unlike for added sugars and sodium, we did not make additional adjustments for mixed products above the highest saturated fat limit for individual foods and the rule sets the limit for saturated fat at ≤10% of the DV per RACC or per 50 g for RACCs ≤50 g (see § 101.65(d)(3)(iii)). As described for determination of the added sugars and sodium limits, the nutrient limits across combination foods should appropriately reflect the increasing sizes and number of food group components in each food category. Thus, for main dish products which consist of two full FGEs, we are setting the saturated fat limit at ≤15% of the DV per labeled serving (see § 101.65(d)(3)(iv)). For meal products, we are setting the limit at ≤20% of the DV per labeled serving (see § 101.65(d)(3)(v)). As with the other criteria, the saturated fat limits increase across the food categories. The limits range from ≤5% DV for some individual foods to ≤20% DV for meal products. The saturated fat limits for the original “healthy” definition aligned with the “low saturated fat” nutrient content claim. Depending on the weight of the main dish or meal product, the saturated fat limits in the final rule are the same or higher than the original limits. Increasing the saturated fat limits, compared to the original definition, results in different nutrient-dense foods being able to contribute towards FGEs for combination foods. For example, certain nutrient-dense foods that contain higher amounts of saturated fat, such as low-fat dairy or eggs, are recommended by the Dietary Guidelines as core elements of healthy dietary patterns. Combination foods that have these nutrient-dense foods as contributors to the FGE requirements are useful in building healthy dietary patterns and the saturated fat limits reflect this. The streamlined and simplified criteria for combination foods are provided in the table below.
                    </P>
                    <GPH SPAN="3" DEEP="138">
                        <GID>ER27DE24.007</GID>
                    </GPH>
                    <PRTPAGE P="106127"/>
                    <P>(Comment 107) One comment claims that FDA provided very few examples of food products that would or would not meet the “healthy” criteria. The comment asserts that the lack of examples makes it difficult to evaluate the proposed definition, especially for combination foods. The comment mentions it is difficult to determine if a combination product on the market meets the minimum FGE requirements without access to the product's recipe. The comment urges FDA to conduct testing of the proposed definition with a variety of combination products to gain a better understanding of what products would or would not qualify, provide additional examples to the public, and determine what modifications to the proposed criteria are needed.</P>
                    <P>
                        (Response 107) The NTL calculations for combination foods are based on the FGE and NTL criteria for various individual foods and the level of nutrients present in a particular food is readily available from the Nutrition Facts label. We used our marketplace review to compare products available in the current marketplace against the limits for saturated fat, sodium, and added sugars for combination foods. For example, we reviewed the increases to the proposed added sugars limits for mixed products, main dishes, and meals, and the increase to the proposed sodium limit for mixed products that are discussed in Response 106. Our marketplace review indicates that these increased limits provide more flexibility for nutrient-dense combination foods to be able to meet the NTL requirements, for example, certain bagged salads with dressing, plant-based patties, frozen grain and vegetable bowls, and frozen meals with sauces and seasonings, depending on their formulations (Ref. 2). Whether a particular combination food product will qualify for the “healthy” claim depends on the ingredients and recipe for the particular product (
                        <E T="03">e.g.,</E>
                         for determining which category a product would fall under—an individual food, mixed product, main dish, or meal—and therefore which nutrient to limit and FGE requirements apply); thus, it is difficult for FDA to provide extensive examples of combination food products that would qualify. However, manufacturers, who have access to all information necessary to determine a products eligibility, will be able to determine if their own foods, formulations, and recipes meet the requirements of the “healthy” definition to label their foods appropriately.
                    </P>
                    <P>
                        (Comment 108) One comment disagrees with FDA's proposal to count multiple equivalents of beans, peas, and lentils as either a protein food or a vegetable for combination foods, but not both, unless multiple types of food (
                        <E T="03">e.g.,</E>
                         both split peas and black beans) are present.
                    </P>
                    <P>The comment asserts that an FGE in excess of one does not lose nutritional value simply because only one member of the subgroup is present. The comment says such a restriction may lead to decreased product innovation on the part of manufacturers, who may choose to avoid using any volumes of such foods in excess of one equivalent if such volumes do not provide a potential labeling advantage via the “healthy” claim.</P>
                    <P>(Response 108) Under FDA's proposed framework, if a combination food has more than one type of food from the beans, peas, and lentils subgroup, in amounts such that each food meets the food group requirements individually, the amount of one food from the beans, peas, and lentils subgroup could meet the vegetable group requirement while another food from the same subgroup could be used to meet the protein food requirement. If, however, the food product consists of only one type of food from the beans, peas, and lentils subgroup, the one type could not count toward both the vegetable and protein food group requirements in the same combination food. (See 87 FR 59168 at 59191).</P>
                    <P>
                        Although we proposed that beans, peas, and lentils may individually count as either a vegetable or a protein food in a combination food for purposes of FGE criteria, this requirement does not prevent combinations of bean, peas, and lentils from qualifying for the claim. There are many scenarios where these combinations can meet the “healthy” requirements. For example, a food that has beans and peas (or any combination of beans, peas, and lentils) could qualify as mixed products or main dishes depending on the amount of FGEs contained. A mixed product food would need the amount of beans and peas to total one full FGE (
                        <E T="03">e.g.,</E>
                          
                        <FR>1/2</FR>
                         FGE beans plus 
                        <FR>1/2</FR>
                         FGE peas). A main dish food would need the amount of beans and peas to total two full FGEs (
                        <E T="03">e.g.,</E>
                         1 FGE beans plus 1 FGE peas). Foods that are solely a mixture of these protein foods without other ingredients would also be able to qualify for the claim under the single-ingredient exemption. For example, a dry mix of black beans and peas could qualify under the single-ingredient exemption because both dry black beans and dry peas are single-ingredient protein foods. Similarly, mixtures of solely one of the subgroup foods could fall under the single-ingredient exemption, such as a mixture of a dry black beans and dry red beans, which are both in the beans subgroup and single-ingredient protein foods. Foods that have just a single type of subgroup foods, such as only black beans, in excess of one FGE, could also qualify for the claim. The food could be considered as an individual food, a black bean food, and could fall under the requirements for individual protein foods. Having a food group ingredient in excess of the FGE does not automatically place the food into a combination food category. The criteria for “healthy,” including the single-ingredient-exemption, provides many different opportunities for beans, peas, and lentils, both in combination with each other or individually, to qualify for the claim.
                    </P>
                    <HD SOURCE="HD3">2. Mixed Product (§ 101.65 (d)(3)(iii))</HD>
                    <P>
                        (Comment 109) One comment requests additional clarification regarding the criteria for mixed products. The comment questions whether products that contain sufficient amounts from two different protein food subgroups, for example, a product that contains 
                        <FR>1/2</FR>
                         FGE of both seafood and nuts, would be eligible to bear the “healthy” claim.
                    </P>
                    <P>
                        (Response 109) Consideration under the criteria for combination foods, including mixed products, requires that the food contain components of more than one food group, such as protein foods and whole grains (see § 101.65(d)(3)(iv)-(vi)). Foods that contain multiple food components from the same food group, such as a food containing a mixture of fruit or a food that contains seafood and nuts, could qualify for the claim, but would be considered individual foods, rather than combination foods. As discussed in a previous response, the components of a mixed product can occur in varying proportions provided that the total FGE effectively is still one FGE and the FGE amount from each food group is not less than 
                        <FR>1/4</FR>
                         FGE.
                    </P>
                    <P>
                        (Comment 110) One comment expresses concern that blended 100% juice products would be unfairly penalized under the proposed rule. The comment notes that, to qualify under the proposed rule, a 100% juice would either need to have 
                        <FR>1/2</FR>
                         cup fruit and 
                        <FR>1/2</FR>
                         cup vegetables, or 
                        <FR>1/4</FR>
                         cup fruit and 
                        <FR>1/4</FR>
                         cup vegetables. The comment notes that, under this proposed framework, a blended 100% juice product with 
                        <FR>1/3</FR>
                         cup fruit and 
                        <FR>1/6</FR>
                         cup vegetables would have 
                        <FR>1/2</FR>
                         cup total fruit and vegetables but would not have 
                        <FR>1/4</FR>
                         cup each of fruit and vegetables and would thus be ineligible to bear the “healthy” claim. The comment asserts that 100% blended 
                        <PRTPAGE P="106128"/>
                        juices should qualify as “healthy” if they contain at least 
                        <FR>1/2</FR>
                         c-eq of 100% juice, regardless of the proportion of fruit juice and vegetable juice. The comment also notes that, in a combination food containing fruit equivalents and protein equivalents, it will be challenging to meet the combination food requirements for FGEs. The comment provides that generally, 100% juice blends with protein contain protein isolates rather than whole protein sources. The comment urges FDA to allow combination foods to contain one FGE rather than both or allow protein isolates to be included in the protein subgroup.
                    </P>
                    <P>
                        (Response 110) As proposed, blends of juices containing both fruit juices and vegetable juices that did not contain at least 
                        <FR>1/2</FR>
                         FGE of each would not have been able to qualify for the “healthy” claim. However, as discussed in Response 9, the final rule expands the proposed exemption for raw, whole fruits and vegetables to individual foods or mixed products that are comprised of one or more nutrient-dense foods encouraged by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         (with no other added ingredients except for water). Therefore, a juice that is a blend of 100% fruit juice (a single-ingredient fruit product) and 100% vegetable juice (a single-ingredient vegetable product) now qualifies for the “healthy” claim without needing to meet the FGE criteria or NTL criteria (see § 101.65(d)(3)(i)). In addition, as described in Response 106, the rule provides additional flexibility for mixed products by allowing varying proportions of the qualifying food groups provided that the total FGE is still one FGE and the FGE amounts from each of the qualifying food groups is not less than 
                        <FR>1/4</FR>
                         FGE (
                        <E T="03">i.e.,</E>
                         minimum of 
                        <FR>1/8</FR>
                         c-eq each of fruit or vegetable) (see § 101.65(d)(3)(iii)). Therefore, a blended 100% juice product with 
                        <FR>1/3</FR>
                         cup-eq fruit and 
                        <FR>1/6</FR>
                         cup-eq vegetables (that meets the NTL criteria) would now qualify for the “healthy” claim.
                    </P>
                    <P>Likewise, a juice blend of 100% juice and a single-ingredient food from other food groups, such as a single-ingredient protein food, would also be included in the exemption for single-ingredient foods and mixtures of single-ingredient foods. The juice blend could not have any other ingredients except water to qualify for the exemption. If other ingredients were included in the product, then the product would need to meet all requirements for a standard mixed product, specifically the FGE requirements and the NTL criteria. As discussed in the earlier section on protein foods, however, ingredients such as soy protein concentrates and soy protein isolates would not count toward meeting protein FGEs and would also not be considered a single-ingredient protein food (see Response 36). Therefore, a juice blend with 100% juice and soy protein isolates would not be eligible for the single-ingredient exemption for “healthy” but could still qualify for use of the claim as an individual food if the applicable criteria were met.</P>
                    <HD SOURCE="HD3">3. Main Dish (§ 101.65 (d)(3)(iv))</HD>
                    <P>(Comment 111) One comment asserts that the proposed FGE requirements are misaligned with the regulatory definitions for main dishes and meals and are not consistent with the Dietary Guidelines. The comment provides that main dishes are defined, in part, as two 40 g food portions from at least two food groups and meals are defined, in part, as three 40 g food portions from at least 2 food groups. The comment notes that a meal, pursuant to FDA's regulatory definition of “meal,” could be comprised of 80 g of vegetables and 40 g of protein and, even though nutrient-dense, would not qualify for the healthy claim as proposed because it is not comprised of 3 full FGEs from three different food groups. The comment asserts that FDA should allow for the calculation of composite FGEs that take into account meaningful contributions to multiple food groups.</P>
                    <P>(Response 111) For the purposes of making a nutrient content claim, a main dish product contains not less than two 40 g portions of foods from at least two food groups and a meal product contains not less than three 40 g portions of foods from two or more food groups (§ 101.13(l)-(m)). The final rule requires that a main dish product contain a total of two FGEs from two food groups and meal products contain a total of three FGEs from three food groups (see § 101.65(d)(3)(iv)). The requirements for the “healthy” claim do not conflict with the definitions of main dish and meal products in § 101.13, they are more limited, consistent with the purpose of the claim. While not all main dish and meal products will meet the criteria for the “healthy” claim, those that contain the required minimum FGE amounts and qualify for use of the claim will be products which are particularly useful in meeting the recommended food group amounts and, therefore, in building a healthy dietary pattern. See Response 105 and § 101.65(d)(3)(iv) and (v) for the additional flexibility we are providing in the proportions of individual FGEs required for main dishes and meal products.</P>
                    <P>(Comment 112) A comment asks that FDA establish saturated fat limits based on food categories that reflect the serving size of the food, rather than being dependent upon which food groups are present in the product. The comment notes that, for plant-based products, the proposed saturated fat levels would disqualify soy-based products, such as plant-based burgers, due to the levels established for saturated fat. The comment asserts that higher limits for saturated fat are warranted to account for their role on the plate.</P>
                    <P>
                        (Response 112) The final rule streamlines the criteria for saturated fat in combination foods, so that the limits are not dependent upon which food groups are present in the product. Whereas under the proposed rule, the saturated fat limits varied depending on the food group components, the final rule modifies the saturated fat limits for combination foods to a consistent amount, regardless of the food groups or subgroups contained in the mixed product, main dish, or meal (see § 101.65(d)(3)(iv)-(vi)). Additionally, the saturated fat inherent in soybeans does not contribute to the saturated fat limit (see § 101.65(d)(3)(ii)). These changes provide more flexibility (
                        <E T="03">e.g.,</E>
                         higher saturated fat limits), compared to the proposed rule, for soy-based products such as plant-based patties. (See Response 59.)
                    </P>
                    <HD SOURCE="HD3">4. Meal Product (§ 101.65 (d)(3)(v))</HD>
                    <P>(Comment 113) One comment opposes the proposed increase in the sodium limit for meal products. The comment notes that, under current FDA regulations, a meal product or main dish making a “healthy” claim must contain no more than 26% of the DV for sodium per labeled serving, but, under the proposed criteria, a meal product would be allowed to contain 30% of the DV for sodium per labeled serving. The comment asserts that FDA should not increase the limit for sodium, as meals lower in sodium are healthier for consumers and more consistent with FDA's 2016 draft long-term Voluntary Sodium Reduction Goals.</P>
                    <P>
                        (Response 113) One of the objectives for updating the “healthy” definition is to ensure that the foods that are able to bear the “healthy” claim are those that are recommended by dietary guidance, such as the Dietary Guidelines, as being particularly useful in building healthy dietary patterns. Therefore, individual foods such as grains, dairy, and vegetables that meet the individual sodium limit of ≤10% of the DV per RACC are able to qualify for the claim. It follows that combinations of those 
                        <PRTPAGE P="106129"/>
                        individual foods that qualify for the claim should be able to be eligible to bear the “healthy” claim as well. Setting the sodium limits at ≤20% DV and ≤30% DV per labeled serving, respectively, allows two full FGEs of individual foods that qualify for “healthy” to be combined into one “healthy” main dish product and three full FGEs of individual foods that qualify for “healthy” to be combined into one “healthy” meal product. Setting the limits at lower amounts would prevent some products that are combinations of “healthy” individual foods from using the “healthy” claim, thus preventing consumers from identifying combination foods that are consistent with the recommendations in the Dietary Guidelines and healthy eating patterns. The limits we are setting for sodium for the “healthy” claim, however, are upper limits, and combination foods are not required to contain sodium at that amount. The sodium limits for main dish products and meal products in the rule are ≤20% and ≤30% of the DV per labeled serving, respectively (§ 101.65(d)(3)(iv) and (v)).
                    </P>
                    <P>(Comment 114) A number of comments request that meal replacement shakes be allowed a higher added sugar limit. One comment notes that meal replacement products are intended to replace one or more conventional meals per day for weight management. The comment recommends that the rule contain a higher limit for added sugars of up to 30% DV in meal replacement products. The comment asserts that the change would increase palatability and could reduce the overall daily sugar intake for consumers compared to the current average.</P>
                    <P>(Response 114) Meal replacement products typically fall under the RACC categories for dairy, specifically the sub-category for shakes and shake substitutes, and would need to meet the criteria for those types of individual food products in order to bear the “healthy” claim. Depending on the ingredients, these shakes could also be mixed products if there were FGE contributions from different food groups and the FGE amounts met the mixed product requirements. In this case, the mixed product would have higher added sugars limits (≤10% of the DV) than would individual dairy foods (≤5% of the DV). For foods that serve as a full meal, the criteria for the meal product category could apply. The criteria for meal products are higher than those for individual foods and mixed products due to their role in the daily diet as the entirety of a meal. For example, meal products have an added sugar limit of 20% of the DV. If a shake product is consistent with an entire meal, the shake could fall under the meal product category and be subject to the higher threshold for added sugars and the other NTL provided that the products also met the size and food group requirements for meal products. We also note that this a voluntary claim and meal replacement products are not limited in how much added sugar they can contain based on this rule.</P>
                    <HD SOURCE="HD2">F. Beverages</HD>
                    <P>
                        (Comment 115) Many comments support FDA's proposal to allow plain water and plain, carbonated water without any flavoring or additional ingredients to automatically qualify as “healthy.” Comments highlight that the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommends water as a primary beverage to be consumed as part of a healthy dietary pattern and explain that FDA's proposal reinforces Federal guidance that water is an overall healthy choice to maintain hydration and reduce consumption of sugar-sweetened beverages. Other comments note the proposal's consistency with recommendations in a 2021 Federally commissioned report that the National Clinical Care Commission submitted to Congress on “Leveraging Federal Programs to Prevent and Control Diabetes and Its Complications” that encourages the consumption of water, including in place of sugar-sweetened beverages. Some comments also state that labeling bottled water as “healthy” would generally remind consumers of the benefits of drinking plain water from any source.
                    </P>
                    <P>One comment opposes including calorie-free carbonated beverages like carbonated water in the definition asserting that carbon dioxide induces a hunger stimulating hormone that can lead to increased food consumption and faster weight gain in rats. Another comment states that, while sparkling and still water fall into the definition of “healthy,” labeling bottled water “healthy” is unnecessary, and FDA should focus on foods that are processed or have additives instead. Some comments discourage use of the “healthy” claim on bottled water, raising concerns it could be perceived as claiming bottled water is healthier than tap water or potentially take emphasis away from ensuring access to safe tap water. The comments voice concerns about promoting bottled water due to negative climate and environmental impacts resulting from plastic use and bottled water production and distribution.</P>
                    <P>
                        (Response 115) We agree that plain water and plain carbonated water should automatically qualify to bear the “healthy” claim. Water automatically qualifying for the “healthy” claim is appropriate as water is necessary for proper functioning of the human body and helps consumers choose beverages that fit in a healthy dietary pattern within calorie needs. Current nutrition science and Federal dietary guidance, as reflected in the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         recommend limiting consumption of foods higher in added sugars, which provide excess calories to the diet without contributing significant amounts of essential nutrients and identify water and sparkling water as beverages that are part of a healthy dietary pattern. Bottled plain water and plain carbonated water provide calorie-free alternatives to sugar-sweetened beverages in the marketplace, and bottled water bearing the “healthy” claim can help consumers identify beverages with no added sugars and calories.
                    </P>
                    <P>
                        As discussed in section V.D.2. (“Saturated Fat”), when developing regulations for nutrition-related claims and nutrition labeling, we review and consider many sources of scientific evidence, many sources of information, and dietary recommendations that may be relevant (
                        <E T="03">e.g.,</E>
                         conclusions of other expert or international bodies). Findings or research that represent consensus of experts in the field or an entire body of scientific literature are generally more informative than individual studies. We are updating the definition for the claim to help consumers maintain healthy dietary practices consistent with the current nutrition science and Federal dietary guidance, as reflected in the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommend calorie-free beverages, such as carbonated or sparkling water, to help people adopt healthy dietary patterns. We disagree that calorie-free carbonated water should not qualify to bear the “healthy” claim due to the reported effects of carbon dioxide from a single study in rats. We view the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         and its many sources of underlying scientific evidence as being more informative than a single study in rats for establishing criteria to bear the “healthy” claim. The comments discouraging use of the “healthy” claim on bottled water due to concerns about the possible perception of bottled water as healthier than tap water or potential to take emphasis away from ensuring access to safe tap water did not provide evidence to support their assertions and do not 
                        <PRTPAGE P="106130"/>
                        change our view. Comments regarding the environmental impacts of bottled water are outside the scope of this rulemaking.
                    </P>
                    <P>
                        (Comment 116) Many comments recommend including unsweetened coffee (including whole, ground, and roasted coffee beans) and unsweetened tea (derived from the 
                        <E T="03">Camellia sinensis</E>
                         plant) as beverages that automatically qualify to bear the “healthy” claim. The comments assert that, consistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         these products play a role in providing consumers with hydration but will not contribute to calories or added sugars intake. The comments assert there is strong and consistent research on the health benefits and antioxidant content of coffee and tea and also note the products include other compounds that the comments characterize as potentially beneficial, such as caffeine. The comments cite the 2015 DGAC scientific report's conclusion that drinking coffee is associated with a reduced risk of cardiovascular disease, diabetes, multiple cancers, and all-cause mortality. The comments mentioning tea refer to evidence for tea, derived from 
                        <E T="03">Camellia sinensis,</E>
                         supporting a beneficial effect of flavonoids, specifically flavan-3-ol on cardiometabolic outcomes. Some comments distinguish “herbal tea,” also referred to as “herbal infusions” or “tisanes” from tea, derived from the 
                        <E T="03">Camellia sinensis</E>
                         plant. Comments describe “herbal teas” and “herbal infusions,” hereafter referred to as herbal infusions, as a diverse category of beverages with about 400 different parts of plants from 300 different plants. The comments note that herbal infusions could be from a single plant species (
                        <E T="03">e.g.,</E>
                         camomile or peppermint) or a mixture of different plants that could include tea (
                        <E T="03">Camellia sinensis).</E>
                         These comments support allowing unsweetened herbal infusions (flavored or unflavored, caffeinated or decaffeinated) to be eligible for the “healthy” claim, stating that this would incentivize companies to offer additional products without added calories or added sugars that can contribute to a balanced diet. Some comments note that coffee or tea without added ingredients may contain intrinsic calories depending on the nature of the coffee bean or tea leaf and the brewing process, but request that FDA include such products regardless of intrinsic calorie content.
                    </P>
                    <P>
                        (Response 116) We agree that including unsweetened coffee and tea, in addition to plain and carbonated water, as beverages that automatically qualify to bear the “healthy” claim align with beverage choices recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         According to the Dietary Guidelines, beverages that are calorie-free, such as water, coffee, or tea without added sugar or cream, should be the primary beverages consumed. We view evidence submitted by comments on health outcomes of coffee and tea to further support the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         beverage recommendations. Allowing coffee and tea to automatically qualify for “healthy” could expand consumer choice of beverages that help maintain a healthy dietary pattern within calorie limits.
                    </P>
                    <P>
                        We agree that tea is derived from the plant 
                        <E T="03">Camellia sinensis.</E>
                         For example, we previously recognized that green tea is made from 
                        <E T="03">Camellia sinensis</E>
                         in our response to a qualified health claim petition regarding the relationship between green tea and certain cancers (Ref. 43). The comments state that herbal infusions are derived from an unspecified and broad range of plants and plant parts and also include mixtures. It is currently unclear how this vast category of beverages from single and combinations of unnamed plants and plant parts could help consumers maintain healthy dietary practices. At this time, we do not have sufficient information to determine whether herbal infusions should automatically qualify for the “healthy” claim. We therefore extend automatic qualification for the “healthy” claim to tea—derived from 
                        <E T="03">Camellia sinensis</E>
                        —and not to herbal infusions.
                    </P>
                    <P>
                        While the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommends coffee and tea, it also highlights some concerns about consuming caffeinated beverages (Ref. 1). Caffeine is a stimulant that can occur naturally in foods such as tea and coffee or that can be added to beverages. According to the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         many people consume caffeine during pregnancy or lactation. Caffeine passes to the infant in small amounts through breast milk, but usually has no adverse impacts when the mother consumes low to moderate amounts (about 300 milligrams or less per day, which is about 2 to 3 cups of coffee) (Ref. 1). Those who could be or are pregnant should consult their healthcare providers for advice concerning caffeine consumption. For healthy adults, FDA has cited 400 mg/day of caffeine as an amount not generally associated with dangerous, negative effects. However, due to general concerns about adults consuming over 400 mg/day and concerns about potential negative health effects of caffeine for those who may be pregnant or lactating, we are not permitting any beverages, including coffee and tea, with added caffeine as an ingredient to automatically qualify to bear the “healthy” claim. We view overconsumption of foods labeled as “healthy” as an important topic. We intend to educate consumers to help understand how to use the “healthy” claim to help build healthy dietary patterns and the importance of choosing a variety of nutrient-dense foods and beverages across all food groups, in recommended amounts, while staying within calorie limits, to build a healthy dietary pattern consistent with the Dietary Guidelines.
                    </P>
                    <P>
                        We decline to allow coffee or tea without added ingredients that contain 5 or more intrinsic calories to automatically qualify for the “healthy” claim, as it would be inconsistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommendations for calorie-free beverages and our existing definition of the nutrient content claim “calorie free.” Our regulations at 21 CFR 101.60(b), state that the terms, “calorie free,” “free of calories,” “no calories,” “zero calories,” “without calories,” “trivial source of calories,” “negligible source of calories,” or “dietarily insignificant source of calories” may be used on the label or in the labeling of foods, provided that the food contains less than 5 calories per RACC and per labeled serving. Thus, given that the recommendation in the Dietary Guidelines that is the basis for our inclusion of coffee and tea is limited to “calorie free” beverages and given our regulatory definition of the nutrient content claim “calorie free,” only those coffees and teas that contain less than 5 calories per RACC and per labeled serving may automatically bear the “healthy” claim.
                    </P>
                    <P>
                        (Comment 117) Many comments support expanding the automatic qualification to bear the “healthy” claim beyond plain water and plain carbonated water to other beverages such as carbonated or noncarbonated waters, coffee, and tea that contain certain added ingredients such as flavors, non-nutritive sweeteners, vitamins, minerals, and electrolytes. The comments posit that these additional beverages should be treated the same as plain water and plain carbonated water because Federal dietary recommendations encourage consumption of these beverages, in part, because they contain no added sugars. The comments assert there is no distinction for excluding waters with added flavors or non-nutritive sweeteners that are added for taste, which do not contribute calories or sugar, but make drinking water easier 
                        <PRTPAGE P="106131"/>
                        and more enjoyable. The comments assert that, by recognizing flavored carbonated or noncarbonated waters (including those with non-nutritive sweeteners) as “healthy,” FDA would be aligning its healthy definition with those beverages that are recommended choices under the Dietary Guidelines.
                    </P>
                    <P>One comment notes the potential for confusion if a healthy claim were included on plain and plain carbonated water but not on other calorie-free beverages. The comment provides that, to avoid consumer confusion, FDA might consider either not permitting water or any calorie-free beverages to carry a “healthy” claim as they do not provide nutrients or a food group, or permit all calorie-free beverages, including coffee, tea, flavored waters, and diet sodas, to carry a “healthy” claim.</P>
                    <P>Another comment argues that flavor extracts are exempt from nutrition labeling and this exemption supports the use of flavors in the definition of “healthy” as it shows that we view the significant function is for flavoring and is not nutritional. The comment suggests that recognizing calorie-free flavored water as “healthy” would allow companies to offer a variety of beverages with consumer appeal. The comments support extending the automatic qualification to these other non-caloric beverages asserting it would help people reduce calorie and sugar intake, is essential to combatting obesity in the United States, would foster hydration, and, in some cases, enhance nutrient intake, while allowing for flexibility and the ability for consumers to customize their beverage choices to align with a healthy dietary pattern.</P>
                    <P>Some comments assert that the addition of “lawful food ingredients,” such as flavors, carbonation, vitamins, minerals, and electrolytes to water for taste should not disqualify beverages from qualifying as “healthy” if they do not add significantly to their caloric or sugar content. The comments note that these added minerals or electrolytes include potassium, calcium, magnesium, and others, and are present at low levels—typically no more than 0.5% of the formulation—so their addition does not meaningfully affect the composition of the product, other than to slightly affect the taste of the water, and it does not affect the calorie or sugar content.</P>
                    <P>Some comments request that FDA allow beverages containing at least 10% of the DV of calcium, potassium, dietary fiber, Vitamin D, or iron to qualify as “healthy.” Another comment states that FDA should include high-fiber beverages without excessive amounts of harmful nutrients in the definition of “healthy,” suggesting that such beverages could be useful in helping Americans meet their recommended fiber intake.</P>
                    <P>
                        One comment asserts the Dietary Guidelines does not recognize fortified bottled waters or beverages such as coffee or tea or beverages sweetened with non-nutritive sweeteners as key components of a healthful dietary pattern. The comment asserts that such products may be formulated in a manner that enables other types of nutrition-related claims (
                        <E T="03">e.g.,</E>
                         zero calories, sugar-free) but should not be eligible for the “healthy” claim based on the rationale developed by FDA to link the use of this claim more closely to the recommendations in the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         Another comment supports such beverages being able to bear other types of nutrition-related claims but not the “healthy” claim. The comments assert that other calorie-free beverages like soft drinks with artificial sweeteners should not qualify for a “healthy” claim because they do not contribute to nutritional needs.
                    </P>
                    <P>
                        (Response 117) We agree with the comments that support expansion of the automatic qualification to bear the “healthy” claim to non-caloric beverages, such as carbonated or noncarbonated waters, coffee, and tea, containing non-caloric ingredients such as flavors, no- or low-calorie sweeteners, vitamins, and minerals. We consider vitamins and minerals to include electrolytes or essential minerals such as sodium, calcium, and potassium that play a role in many body functions. As discussed in section V.D.4 (“Added Sugars”), we consider no- or low-calorie sweeteners to include the terms artificial sweeteners, high-intensity sweeteners, non-nutritive sweeteners, and non-calorie or non-caloric sweeteners. We view the inclusion of certain calorie-free ingredients such as flavors, no- or low-calorie sweeteners, vitamins, and minerals in waters, coffee, and tea that bear the “healthy” claim to be consistent with current nutrition science, Federal dietary guidance, and our food additive regulations. Allowing certain calorie-free ingredients such as flavors, no- or low-calorie sweeteners, vitamins, and minerals in beverages that may bear the “healthy” claim can help consumers identify foods that help them to maintain healthy dietary practices by providing consumers variety in their beverage choices to align with a healthy dietary pattern. We decline to amend the rule to permit diet soft drinks or sodas to automatically qualify for the “healthy” claim. The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         recommends non-caloric beverages such as water, coffee, and tea, but does not include diet soft drinks or sodas. The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         explains that both the calories and nutrients that non-caloric beverages provide are important considerations. According to the Dietary Guidelines, beverages that are calorie-free, such as water, coffee, or tea without added sugar or cream, or that contribute beneficial nutrients, such as fat-free and low-fat milk and 100% juice, should be the primary beverages consumed. Diet soft drinks or sodas do not contribute beneficial nutrients and, as mentioned, are not included in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         as recommended calorie-free beverage options.
                    </P>
                    <P>We decline to modify the criteria to bear the “healthy” claim to contain a certain amount of the DV for specific vitamins and minerals and fiber. In section V.C (“Food Group Equivalents”) and section V.D (“Nutrients to Limit”), we discuss our basis for updating the “healthy” claim to be a food group-based approach in addition to NTL criteria.</P>
                    <P>
                        (Comment 118) Some comments express concerns about water containing non-caloric flavors and ingredients and state that if such beverages are allowed, FDA should set standards for the types of beverages that should qualify (
                        <E T="03">e.g.,</E>
                         how much flavoring or sweetener would be allowed, which types of non-nutritive or high-intensity sweeteners would be allowed).
                    </P>
                    <P>
                        Some comments oppose the inclusion of beverages containing low- or no-calorie sweeteners, citing research and global public health guidance warning against their use. Additionally, some comments state that safety data is lacking in children and recommend that children under 5 years old avoid low- or no-calorie sweeteners. One comment cites a state's prohibition on use of low- and no-calorie sweeteners for products served to children and recommends the exclusion of waters containing low- or no-calorie sweeteners because there is no way to distinguish between child and adult consumption in a retail setting. Some comments attribute possible adverse health impacts such as cravings for sweet or high-calorie foods and overconsumption of sweeteners such as aspartame to consumption of low- or no-calorie sweeteners. The comments express concern about the lack of evidence on the long-term impacts of low- or no-calorie sweeteners and cite that further research is needed to determine the observed associations between its consumption and risk for outcomes such as obesity, type 2 
                        <PRTPAGE P="106132"/>
                        diabetes, cardiovascular diseases, mortality, and unfavorable impacts on birthweight and adiposity in offspring. Other comments oppose allowing the “healthy” claim on calorie-free beverages such as soft drinks with artificial sweeteners asserting the proposed rule did not discuss the topic of high intensity sweeteners and quote the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         when stating “questions remain about their effectiveness as a long-term weight management strategy.”
                    </P>
                    <P>(Response 118) We discuss issues of safety and health impacts of consuming low- or no-calorie sweeteners in children and adults in section V.D.4 (“Added sugars”).</P>
                    <P>
                        (Comment 119) Another comment asserts that juice beverages (
                        <E T="03">i.e.,</E>
                         those containing less than 100% juice) can help contribute to a healthy dietary pattern by providing beneficial nutrients and requests we develop a more expansive “healthy” beverage category. The comment recommends we permit juice beverages to bear the “healthy” claim if they meet the following criteria: (1) contain no added sugar; (2) meet the proposed NTL criteria, and (3) contain either a full FGE (including products that contain half 100% juice and half water with 
                        <FR>1/2</FR>
                         cup of 100% juice or one full FGE of fruit) or 10% of the DV per RACC of certain nutrients (such as vitamin C, calcium, iron, potassium, vitamin D, etc.). The comment also recommends requiring juice beverages must meet the fortification policy to bear a “healthy” claim, so foods for which fortification is discouraged could not qualify.
                    </P>
                    <P>
                        (Response 119) We agree that there are beverages other than water or 100% juice that can contribute to healthy dietary patterns. Although we decline to adopt the specific criteria recommended by the comment, in principle, we agree that 100% juices with only the addition of water and no added sugars can be part of a healthy dietary pattern. Water automatically qualifies for the “healthy” claim, and 100% juices with only the addition of water (
                        <E T="03">e.g.,</E>
                         100% juices that have been diluted with water such that they are 50% juice and 50% water) automatically qualify under the single-ingredient exemption (see Response 9). We discuss in section V.C (“Food Group Equivalents”) that we are no longer requiring that foods bearing the “healthy” claim provide certain levels of NTE because there has been a shift in nutrition science toward overall healthy eating patterns and away from focusing on the amounts of individual nutrients consumed that led to the corresponding shift in the definition of the “healthy” claim. Including requirements for minimum amounts of foods from the recommended food groups better reflects the overall nutrient content of foods and how nutrients in the food groups and subgroups may work together as part of a healthy dietary pattern. Similarly, with this focus on food groups, the fortification policy is no longer relevant to the “healthy” claim and we decline to incorporate it into this rule (see Response 100).
                    </P>
                    <P>(Comment 120) As bottled water will qualify to bear the “healthy” claim, some comments request that FDA exempt bottled water from requiring nutrition labeling if a nutrient content claim such as “healthy” is used. The comments argue that most bottled water is exempt from nutrition labeling under § 101.9(j)(4) because it contains insignificant amounts of the mandatory nutrients. However, this exemption is contingent upon the product not bearing any nutrient content claims on its label or in labeling. The comments state that a bottled water product that bears the term “healthy,” even if otherwise exempt from nutrition labeling, would then be required to bear nutrition labeling despite the fact that the nutrition information would only convey “zero” of the mandatory nutrients. The comments request that FDA provide enforcement discretion from nutrition labeling when a bottled water product that otherwise is exempt from nutrition labeling under § 101.9(j)(4) bears a “healthy” claim in cases where they do not contain calories or other significant levels of nutrients.</P>
                    <P>(Response 120) We recognize that bottled water as well as certain coffee and tea products bearing the nutrient content claim “healthy” would no longer qualify for the exemption from nutrition labeling requirements at § 101.9(j)(4). Although we asked for comment in the proposed rule about the eligibility of calorie-free beverages, coffee, and tea to bear the “healthy” claim, we did not ask for comments specifically about the continued applicability of the exemption from nutrition labeling provisions under § 101.9(j)(4) and the proposed “healthy” claim. Until such time as we have had the opportunity to address this directly in a future rulemaking, we intend to consider the exercise of our enforcement discretion with respect to mandatory nutrition labeling on waters, coffee, and tea containing less than 5 calories per RACC that bear the “healthy” claim on their labels or labeling.</P>
                    <HD SOURCE="HD2">G. The Term “Healthy” and Related Terms or Derivatives of “Healthy”</HD>
                    <P>
                        (Comment 121) Many comments support finalizing use of the term “healthy” or related terms as an implied nutrient content claim and strongly oppose expanding the list of related terms. The comments ask that the final rule reaffirm that the definition of “healthy” applies only to those terms currently defined as derivatives for a “healthy” nutrient content claim, 
                        <E T="03">i.e.,</E>
                         “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness,” and only in those circumstances where the requisite “nutritional context” (
                        <E T="03">i.e.,</E>
                         an explicit or implicit characterization of the level of a nutrient) is present on the label. The comments request that, if additional synonyms are included, FDA identify the reliable consumer perception evidence upon which it relied sufficient to establish that a term is viewed as synonymous with “healthy” to restrict the use of additional terms, adding that without such consumer research and an opportunity for public notice and comment, FDA lacks authority to regulate the use of other terms under the implied nutrient content claim for “healthy.”
                    </P>
                    <P>Some comments request that FDA reconsider permitting any derivatives of “healthy” and argue that claim should be limited only to the term “healthy” to further standardize the claim and ensure consumer understanding. Some comments recommend removing the terms “healthier” and “healthiest,” suggesting these terms are hierarchical and comparative and thus not aligned with the original intent of demonstrating the “healthful” properties of a certain food. The comments assert that the terms “healthier” and “healthiest” could cause confusion for consumers, leading them to believe that products bearing such terms may meet a higher nutritional threshold when this is not the case. One comment recommends we emphasize the healthiness of single-ingredient products by establishing a further designation, such as “healthiest” that is exclusively reserved for whole, single-ingredient nuts, nut butters, whole grains, beans, legumes, seeds, fruits, and vegetables.</P>
                    <P>
                        Some comments urge FDA to include a complete list of related or derivative terms in the codified language and clearly state that other potentially synonymous terms not otherwise codified will not be considered implied “healthy” claims such that they can be used without meeting the criteria laid out in § 101.65(d). The comments assert that, although the proposed rule provides examples of related terms for “healthy,” the list of examples appears to be without limitation and arguably 
                        <PRTPAGE P="106133"/>
                        could include other terms (
                        <E T="03">e.g.,</E>
                         “wholesome,” “nutrient-dense,” or “nutritious”), causing confusion for both manufacturers and consumers absent a complete list.
                    </P>
                    <P>One comment states that if FDA also regulates terms that are synonymous with healthy, restaurants will be constrained in their communications to consumers, which will lead to less education and access to nutritionally beneficial foods and beverages by inadvertently limiting a restaurants ability to communicate to customers through menus, menu boards, and other channels.</P>
                    <P>(Response 121) As discussed in the 1994 final rule to establish the “healthy” nutrient content claim (59 FR 24232 at 24235), we determined that the regulatory definition of “healthy” should apply to the use of any of its derivatives in a nutritional context. Derivatives of “healthy” have the same general meaning and connotation as this term and, thus, when used in food labeling, may be construed by consumers to imply that the products on which they appear will be helpful in maintaining healthy dietary practices. After nearly 30 years of experience with the “healthy” nutrient content claim, we still conclude that it is appropriate to require that any of the derivatives of “healthy,” when used in a nutritional context in food labeling, must be in accordance with the definition of “healthy” in § 101.65(d). Accordingly, the final rule, at § 101.65(d)(3), provides that the term “healthy” or derivative terms “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness” can be used as an implied nutrient content claim on the label or in labeling of a food that is useful in creating a diet that is consistent with dietary recommendations if the food meets the criteria to bear the claim. We are amending § 101.65(d)(3) to clarify that the derivatives of “healthy” are “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness.” We agree with the comments requesting that we codify the complete list of derivatives for “healthy” to make clear that other terms not otherwise codified will not be considered derivatives of the “healthy” implied nutrient content claim under § 101.65(d).</P>
                    <P>With regard to the comments concerning potential consumer confusion over use of the terms “healthier” and “healthiest,” which suggest these terms are hierarchical and comparative and thus not aligned with the original intent of demonstrating the “healthful” properties of a certain food, the comments did not provide any data or other information to support such concerns, and we are therefore unpersuaded to change our position. Moreover, after nearly 30 years of experience with the “healthy” nutrient content claim, we have not been made aware of any consumer confusion resulting from any use of these derivative terms. As discussed, since the 1994 final rule, we have determined that it is appropriate to apply § 101.65(d) to the use of the derivatives of “healthy” in a nutritional context.</P>
                    <P>The comments regarding communications with consumers in restaurants are outside the scope of this rulemaking.</P>
                    <P>(Comment 122) Some comments argue that FDA should regulate additional terms as “healthy” claims, suggesting that there are several terms other than “healthy” and its derivatives that consumers may interpret as indicating that the levels of nutrients in a food are such that the food may help maintain healthy dietary practices. The comments assert that all words that characterize a food's general healthfulness, for example, “nutritious,” “nourishing,” “wholesome,” “nutritive,” and “good for you,” should be held to the uniform criteria as that of the final “healthy” definition. The comments express concern that such terms could otherwise be unduly confusing to consumers if not held to the same standards in the final rule. The comments assert that the most obvious of these terms is “nutritious” and its derivatives, such as “nutrition,” “nutritional,” “nutritiously,” and “nutritionally” and additional terms include “nutrient-dense,” “good for you,” “nourishing” and “wholesome.” The comments further assert that consumers likely perceive these claims as synonymous with “healthy” and the claims should be regulated as implied “healthy” claims and request that FDA expressly add “nutritious,” “nourishing,” “wholesome,” and their derivatives, and any other equivalent terms, to the final rule as examples of terms that are synonymous with “healthy.” The comments claim that these kinds of terms are relatively pervasive in marketing and advertising messages for food products and extending eligibility criteria for “healthy” to apply to these phrases may help prevent replacement of “healthy” on food labels with similar terms that are not regulated. The comments claim such additional regulation is necessary given the public skepticism of the government's regulation of food labels and mistrust of some food label claims. The comments assert that this, in turn, may help prevent consumer confusion and strengthen the consistency and utility of these terms in differentiating foods that are most useful in promoting achievement of recommended dietary patterns and urge FDA to conduct research to help it determine whether to recognize these terms as synonymous with “healthy” or to establish separate definitions for their use.</P>
                    <P>Other comments specifically oppose incorporating additional terms, such as wholesome, nutritious, or other similar terms, as synonyms for healthy, claiming consumers view those terms differently and that FDA has not provided any information or consumer research to establish that these terms should be viewed as synonyms for healthy. The comments assert that defining “healthy” is complex enough without expanding the reach of the rule to include other terms that might have competing or misaligned meanings.</P>
                    <P>(Response 122) As discussed in the 1994 final rule (59 FR 24232 at 24235), while we recognize that terms such as “nutritious,” “wholesome,” and “good for you” can be implied nutrient content claims when they appear in a nutritional context on a label or in labeling, we do not believe that they are necessarily synonymous with “healthy.” We do not have sufficient information to determine whether definitions for the terms mentioned in these comments are needed, and what those definitions should be. The comments did not provide sufficient information on which to develop definitions or to establish these terms as synonyms for the term “healthy.” Thus, we are not extending the definition of “healthy” to these terms. However, we note that when these terms appear on labels or labeling, they may be subject to regulation under the general misbranding provision of section 403(a) of the FD&amp;C Act.</P>
                    <HD SOURCE="HD2">H. Nutritional Context</HD>
                    <P>(Comment 123) Some comments support our proposal to broaden our interpretation of when a “healthy” claim constitutes a nutrient content claim. Other comments express concern that evaluating the use of “healthy” only in a nutritional context could be exploited by companies who would use the word in other contexts to mislead consumers. The comments state that if the word “healthy” is in the brand name or on the front of a food package, the product should meet the healthy definition and that anything different is deceptive.</P>
                    <P>
                        (Response 123) In the proposed rule (87 FR 59168 at 59181 through 59183), 
                        <PRTPAGE P="106134"/>
                        we discuss, among other things, that “healthy” is a broad term that can have connotations beyond the nutritional properties of a food. We proposed to define “healthy” as a nutrient content claim only when it is used in a nutritional context; in other words, the proposed criteria would only apply when “healthy” is used on a label or in labeling, and other information, such as other claims, images, or vignettes, about the nutrition content of the food is also present somewhere on the labeling. If the term “healthy” is used in a nutritional context on a label or in labeling, it is an implied nutrient content claim which highlights that a food, because of its nutrient content, is particularly useful in constructing a diet that is consistent with current dietary recommendations. Therefore, such use of the term “healthy” would be subject to the updated “healthy” criteria set forth in this rule.
                    </P>
                    <P>With regard to comments that suggest we regulate all uses of the term “healthy” as an implied nutrient content claim, we decline to do so. The preamble to the 1994 rule explains the reasons for which FDA determined that the term “healthy” should not be regulated as an implied nutrient content claim when not used in a nutritional context. Since that time, FDA has not received information on which to conclude that consumers would not be able to understand when “healthy” is used in a context in which it is not an implied nutrient content claim. Consequently, we have no reason to believe that consumers would infer that the term “healthy,” when used outside of a nutritional context, would signal that the food has a nutrient profile that would be helpful to consumers in structuring a diet that conforms to current dietary guidelines. Rather, such inferences are likely to be drawn only if the term “healthy” is accompanied by additional language or graphic material or is otherwise presented in a context that explicitly or implicitly suggests that the food has a particular nutrient profile (see 59 FR 24232 at 24234 to 24235). Accordingly, this regulation covers labeling claims that are implied nutrient content claims because they suggest that a food may help consumers maintain healthy dietary practices because of its nutrient content. However, we note that, even outside of the nutritional context, FDA has the authority to ensure that “healthy” is not used in a misleading manner under section 403(a)(1) of the FD&amp;C Act.</P>
                    <P>
                        (Comment 124) Some comments recommend that “healthy” (and related terms) be considered an implied nutrient content claim even when used as part of a health claim (
                        <E T="03">e.g.,</E>
                         “heart healthy”) or structure-function claim (
                        <E T="03">e.g.,</E>
                         “brain health”). The comments assert that any use of the term “healthy” on food labeling should be considered an implied nutrient content claim if the product's labeling also includes voluntary information about the nutrition content of the food (
                        <E T="03">e.g.,</E>
                         if another nutrient content claim appears on the package or product website) because the average consumer will not understand that the term “healthy” is regulated differently when used as part of a health claim, structure/function claim, or implied nutrient content claim. To address the potential for consumer confusion, some comments assert that all products using the term “healthy” as part of a labeling claim in any context should be held to the same nutrient criteria.
                    </P>
                    <P>In contrast, other comments state that the requirements of the rule should not apply to other labeling claims, such as structure/function claims, health claims, or other nutrient content claims that use the term “healthy” and FDA should explicitly state this in the rule. The comments note that, for example, structure/function claims often reference specific nutrients, however, use of the term “healthy” in such claims does not characterize the level of nutrient in the food; rather, it generally describes the role of the nutrient on the structure or function of the body. Some comments recommend FDA clarify it does not view compliance with “healthy” as a prerequisite for making other nutrient content claims, health claims, or structure/function claims that are subject to different nutritional requirements and regulations, or else it could negatively impact use of other labeling claims and lead to consumer confusion.</P>
                    <P>
                        (Response 124) Section III.A (“Background”) provides a brief overview of different types of claims and statements commonly made on food labels or in food labeling. While we generally agree with comments stating that not all claims that use the term “healthy” should be subject to requirements of this rule, we note that use of the term “healthy” in a claim or statement on a food label or labeling may place the term into a nutritional context, and therefore, would make “healthy” an implied nutrient content claim. We further note that, while different nutrition labeling claims have different purposes and criteria for their use, a term or statement may be considered to be more than one type of claim (
                        <E T="03">e.g.,</E>
                         a structure/function claim and a nutrient content claim), depending on the context of the use of the term or statement in light of the label and labeling as a whole. Additionally, other types of claims may be implied or explicit information about the nutrient content of the food, and therefore could be accompanying material that could put the use of “healthy” into a nutritional context. As stated in multiple parts of this rule, and consistent with FDA's approach to labeling regulation in other contexts, FDA considers whether a food product bears a claim, such as the “healthy” claim, on a case-by-case basis by looking at the claim in the context of the label and labeling as a whole.
                    </P>
                    <P>(Comment 125) One comment requests that the updated definition of “healthy” expressly exclude trademarks that are registered on the Principal Register of the U.S. Patent and Trademark Office (USPTO) that include the word “healthy” and that FDA confirm that such registered trademarks do not misbrand a food product. The comment notes that the intent of the rule is to define “healthy” as a nutrient content claim only when it is used in a nutritional context and asserts that use of “healthy” in a trademark registered on the USPTO's Principal Register is used outside of a nutritional context because it is intended to signify that the product came from a specific source and not to describe the product's nutrient levels.</P>
                    <P>The comment also states that FDA lacks statutory authority to restrict labeling references to trademarks registered on the Principal Register that include the word “healthy,” and that the term “healthy” when used in registered trademarks is not false or misleading labeling under sections 201(n) and 403(a) of the FD&amp;C Act because it does not misrepresent the characteristics or content of the food product itself, and its predominant meaning is a source identifier. Further, the comment argues that the update to the claim would represent a regulatory taking of the intellectual property of firms that have been using “healthy” in their product brand name.</P>
                    <P>
                        (Response 125) We intend to examine whether the use of the term “healthy” on labels and labeling could be considered an implied nutrient content claim if any other information on the label or labeling, such as other claims, images, or vignettes, puts the term into a nutritional context. We disagree that a brand name using the term “healthy” is primarily a source identifier. As we stated in the 1994 rule establishing the “healthy” claim, nutritional context is established “when the term appears in a brand name that by virtue of its use implies that the product is useful in 
                        <PRTPAGE P="106135"/>
                        achieving dietary recommendations” (59 FR 24232 at 24235). As we have also stated in response to similar comments since 1993, registering a trademark with the USPTO does not automatically place the use of “healthy” outside of a nutritional context. (See 58 FR 2372 at 2375, specifically stating “One comment stated that the proposed definition for general nutrition claims could have an impact on many proprietary trademarks or slogans . . . FDA disagrees that terms such as those cited in the comments should be excluded from regulation under section 403(r) of the act. The agency believes that these terms can be implied nutrient content claims when they appear in a nutritional context on a label or in labeling.”)
                    </P>
                    <P>As stated in other parts of this rule, we will consider the context of the use of the term by looking at the label and labeling as a whole. This approach is consistent with how FDA considers product or brand names on food labels or labeling in other contexts to determine whether a food product bears a claim.</P>
                    <P>
                        We also disagree that the rule would constitute a taking. The Fifth Amendment to the U.S. Constitution prohibits the government from taking private property for public use without just compensation. The Supreme Court has held that the government effects a “per se” taking when it physically appropriates property, which is the “clearest sort of taking.” 
                        <E T="03">Cedar Point Nursery</E>
                         v. 
                        <E T="03">Hassid,</E>
                         141 S. Ct. 2063, 2071 (2021). It is not clear that trademarks constitute “private property” within the meaning of the Fifth Amendment's Takings Clause. 
                        <E T="03">See, e.g., Clemente Props., Inc.</E>
                         v. 
                        <E T="03">Urrutia,</E>
                         693 F. Supp. 3d 215, 247 (D.P.R. 2023) (“A question raised by the motions before the Court is whether a trademark is the type of private property protected by the Takings Clause. The question is debatable and far from settled.”). Even assuming trademarks do constitute private property under the Takings Clause, a regulatory taking occurs where regulations that “restrict an owner's ability to use his own property” go “too far.” 
                        <E T="03">Cedar Point Nursery</E>
                         at 2071-72. In such cases, a taking may be found based “on a complex of factors, including: (1) the economic impact of the regulation on the claimant; (2) the extent to which the regulation has interfered with distinct investment-backed expectations; and (3) the character of the governmental action.” 
                        <E T="03">Murr</E>
                         v. 
                        <E T="03">Wisconsin,</E>
                         582 U.S. 383, 393 (2017) (cleaned up) (referred to as the “Penn Central factors” after 
                        <E T="03">Penn Central Transp. Co.</E>
                         v. 
                        <E T="03">New York City,</E>
                         438 U.S. 104, 124 (1978)). The force of any one of these three Penn Central factors may be “so overwhelming . . . that it disposes of the taking question.” 
                        <E T="03">Ruckelshaus</E>
                         v. 
                        <E T="03">Monsanto Co.,</E>
                         467 U.S. 986, 1005 (1984).
                    </P>
                    <P>
                        Regarding the character of the governmental action, it has long been established that the government may regulate products in the interests of public health and safety and such regulation “cannot, in any just sense, be deemed a taking.” 
                        <E T="03">Mugler</E>
                         v. 
                        <E T="03">Kansas,</E>
                         123 U.S. 623, 668 (1887). The takings doctrine is based on the concept that, when the government seizes property for the public benefit, such as land for a road or a dam, the public should compensate the owner. But that is a different scenario from where the government limits the use of property to protect public health and safety. 
                        <E T="03">See id.</E>
                         at 669. As the Supreme Court has elaborated, “[l]ong ago it was recognized that all property in this country is held under the implied obligation that the owner's use of it shall not be injurious to the community, and the Takings Clause did not transform that principle to one that requires compensation whenever the State asserts its power to enforce it.” 
                        <E T="03">Keystone Bituminous Coal Ass'n</E>
                         v. 
                        <E T="03">DeBenedictis,</E>
                         480 U.S. 470, 491-92 (1987) (cleaned up). As a result, restrictions on “uses of personal property” that are “directed at the protection of public health and safety” are “the type of regulation in which the private interest has traditionally been most confined and governments are given the greatest leeway to act without the need to compensate those affected by their actions.” 
                        <E T="03">Rose Acre Farms, Inc.</E>
                         v. 
                        <E T="03">United States,</E>
                         559 F.3d 1260, 1281 (Fed. Cir. 2009). As we have stated throughout this rule, here the updated definition of “healthy” directly advances our substantial government interests in providing information to consumers to indicate that the nutrient content of a food may help them maintain healthy dietary practices to promote public health, preventing misleading labeling, and reducing consumer confusion potentially caused by the use of inconsistent definitions for nutrient content claims. Updating the “healthy” definition to ensure that it is aligned with current nutrition science and Federal dietary guidance promotes public health by providing consumers with information about foods that, because of their nutrient content, are particularly useful in constructing a diet that is consistent with current dietary recommendations. Because the term “healthy” can lead consumers to believe a food will help them maintain healthy dietary practices when that term is used as an implied claim in a trademarked brand name, the same public health purposes are at issue.
                    </P>
                    <P>
                        The other Penn Central factors also weigh in favor of finding no taking here. With regard to economic impact, the comment asserts that the value of the property of food manufacturers with brand names that contain the term “healthy” will be diminished because some of their products bearing the name may no longer qualify for the “healthy” claim. However, many changes in government laws, regulations, and policies have economic consequences, and the Supreme Court has long recognized that “[g]overnment hardly could go on if to some extent values incident to property could not be diminished without paying for every such change in the general law.” 
                        <E T="03">Pennsylvania Coal Co.</E>
                         v. 
                        <E T="03">Mahon,</E>
                         260 U.S. 393, 413 (1922). The Supreme Court has explained that “mere diminution in the value of property, however serious, is insufficient to demonstrate a taking.” 
                        <E T="03">Concrete Pipe &amp; Prods.</E>
                         v. 
                        <E T="03">Constr. Laborers Pension Trust,</E>
                         508 U.S. 602, 645 (1993). Similarly, a “loss of profit” does not establish a taking. 
                        <E T="03">74 Pinehurst LLC</E>
                         v. 
                        <E T="03">New York,</E>
                         59 F.4th 557, 566 (2d Cir. 2023). And courts have rejected regulatory takings claims even where the government's actions “impose considerable costs on private actors in the regulated industry.” 
                        <E T="03">Mobile Relay Assocs.</E>
                         v. 
                        <E T="03">FCC,</E>
                         457 F.3d 1, 12 (D.C. Cir. 2006). Instead, in evaluating the economic impact of a regulation, courts have explained that the “touchstone” is “proportionality”: “the size of a liability only weighs in favor of finding a taking insofar as it is out of proportion to the legitimate obligations society may impose on individual entities.” 
                        <E T="03">B&amp;G Constr. Co.</E>
                         v. 
                        <E T="03">Dir., OWCP,</E>
                         662 F.3d 233, 260 (3d Cir. 2011) (cleaned up). Here, especially given the revisions from the proposed rule, we anticipate that some products that include “healthy” in their brand name would continue to qualify for the claim, and some others could qualify with appropriate modifications. While there may be changes to which products can qualify under the updated definition, it is unlikely that any trademarked brand name would be destroyed or even substantially restricted. These changes would, at most, constitute diminution in the value of property—and the comment does not provide evidence regarding how large any diminution in the value of the property would be. The comment further acknowledges that FDA could make changes to the nutrient and food group levels that were specified in the 
                        <PRTPAGE P="106136"/>
                        proposed rule that would result in more products that currently bear a brand name containing the term “healthy” continuing to qualify to bear the claim. As noted elsewhere in this final rule, FDA made multiple changes that increased flexibility from the proposed to the final rule, including increasing the added sugar limits for mixed dishes, main dishes, and meal products and providing for aggregation of food group equivalents.
                    </P>
                    <P>
                        With respect to the last Penn Central factor, a “reasonable investment-backed expectation must be more than a unilateral expectation or an abstract need.” 
                        <E T="03">Ruckelshaus,</E>
                         467 U.S. at 1005 (cleaned up). Courts have held that those who do business in highly regulated fields are on notice that changes are possible. 
                        <E T="03">Connolly</E>
                         v. 
                        <E T="03">Pension Ben. Guar. Corp.,</E>
                         475 U.S. 211, 226-27 (1986) (“Those who do business in the regulated field cannot object if the legislative scheme is buttressed by subsequent amendments to achieve the legislative end”) (cleaned up). As described at the beginning of this comment response, food manufacturers have been on notice since 1994 that their brand names, if making an implied claim, would need to comply with the “healthy” claim definition. As the claim definition is based on nutrition science, it is reasonable to expect that the definition would be updated over time to match updates in nutrition science and that the scope of products that would be able to bear the claim may shift to some extent.
                    </P>
                    <P>
                        (Comment 126) Many comments oppose our proposal to broaden the interpretation of nutritional context, arguing that what they perceived to be an overly broad interpretation of nutritional context could cause confusion and limit consumer access to relevant information when choosing a variety of foods within an overall healthy eating pattern. The comments assert that FDA acknowledged in the 1994 rule that the various uses of the term “healthy” demonstrate the need for us to take a flexible case-by-case approach in deciding whether a claim that uses the term “healthy” is an implied health claim or nutrient content claim, and we determined there was insufficient evidence to conclude consumers would not be able to discern the context in which the “healthy” claim appears on the label or labeling of a product. The comments state they believe this continues to be the case today and that more work and data (
                        <E T="03">e.g.,</E>
                         consumer studies) would be needed by FDA to justify an expanded definition of nutritional context.
                    </P>
                    <P>
                        The comments support what they state is FDA's longstanding position that “healthy” claims are only implied nutrient content claims when made “in connection with an explicit or implicit claim or statement about a nutrient (such as `healthy, contains 3 grams of fat')” and assert that this original standard provides clear parameters for determining whether a “healthy” claim is an implied nutrient content claim, 
                        <E T="03">i.e.,</E>
                         by requiring a direct nexus between the “healthy” claim and the nutrient statement. The comments argue that this original standard also aligns with FDA's statutory authority under the FD&amp;C Act, which authorizes FDA to establish nutrient content claim requirements only for claims that characterize the level of any nutrient which is of the type required by the FD&amp;C Act to be in the label or labeling of the food (section 403(r) of the FD&amp;C Act (21 U.S.C. 343(r)). The comments assert that industry has relied upon this standard for more than two decades and has developed product portfolios based on these established principles and disagree with FDA's proposal to alter this standard, arguing that the proposed changes to the interpretation of nutritional context would divert from FDA's current standards and would treat a broader class of “healthy” claims as implied nutrient content claims. The comments raise concerns about whether a brand name on the front of a label that uses the term “healthy” and a separate, back-of-pack claim that a product “provides essential vitamins and minerals” would be treated as an implied nutrient content claim by FDA. Some comments argue that only manufacturers who use the term “healthy” when describing the product's nutritional value should be required to comply and that manufacturers who simply use “healthy” as a term in the product's name-brand, slogan and/or logo/mascot, and who are not describing the nutritional content should be allowed to use the term without complying with this rule. The comments argue that the proposed interpretation of nutritional context would not only exceed FDA's statutory authority, but also would fail to advance FDA's policy aim, 
                        <E T="03">i.e.,</E>
                         to ensure that consumers have access to truthful and non-misleading information to inform healthy dietary choices.
                    </P>
                    <P>(Response 126) The minor revisions we are making to § 101.65(d)(1) defining implied nutrient content claims are consistent with FDA's longstanding approach to consider whether a food product bears a claim, such as the “healthy” claim, on a case-by-case basis by looking at the claim in the context of the labels and labeling as a whole. The revisions merely clarify that information on the label or labeling that puts “healthy” into a nutritional context need not be immediately adjacent to the implied nutrient content claim. Under the rule, we intend to continue using a flexible, case-by-case approach in evaluating and considering labeling claims, by placing the use of the term “healthy” into the context of the overall label or labeling.</P>
                    <P>Such revisions are also consistent with FDA's statutory authority under the FD&amp;C Act. As explained in section IV. (“Legal Authority”), section 403(r) of the FD&amp;C Act specifies that claims made in the label or labeling of the food that expressly or by implication characterize the level of any nutrient which is the type required by section 403(q)(1) or (q)(2) of the FD&amp;C Act to be in the label or labeling of the food are permitted only if they are made in accordance with FDA's authorizing regulations. As early as the 1994 rule, FDA determined that, when used in a nutritional context, the term “healthy” is making an implied claim that the levels of the nutrients in the food are such that the food would be useful in achieving a total diet that conforms to current dietary recommendations (59 FR 24232 at 24234). Consequently, it is squarely within FDA's authority to define implied nutrient content claims, such as “healthy,” by regulation, to clarify when a claim implies that a food, because of its nutrient content, may help consumers maintain healthy dietary practices. We therefore disagree with the comments that imply that the revisions to § 101.65(d)(1), which state that “healthy” is a nutrient content claim where it is used to characterize the food itself and “where there is also implied or explicit information about the nutrient content of the food,” are no longer aligned with FDA's statutory authority under the FD&amp;C Act.</P>
                    <P>
                        Furthermore, as explained in the proposed rule, the minor revisions made to § 101.65(d)(1) bring that provision in line with the updated criteria for the “healthy” claim. The updated criteria incorporate food group requirements in addition to individual NTL criteria. Therefore, § 101.65(d)(1) no longer requires that the accompanying material be a “claim or statement about a nutrient,” but instead requires that it be “information about the nutrient content of the food.” This change recognizes that material that states or implies that the nutrient content of the food would be useful to consumers in structuring a diet that is supported by current dietary 
                        <PRTPAGE P="106137"/>
                        recommendations is not limited to statements about the presence/level of one specific nutrient and reflects that the updated “healthy” criteria, along with current nutrition science and Federal dietary guidance, emphasize food groups and the overall nutrient content of the food, rather than one individual nutrient in isolation.
                    </P>
                    <P>Additionally, we disagree with comments stating that FDA should not consider use of the term “healthy” in a slogan, product name, logo, or mascot a nutrient content claim because it is not describing nutritional content. As stated above, under the rule, we intend to continue applying a flexible, case-by-case approach that considers the overall content of the food label and labeling when determining if a product label uses the “healthy” claim in a nutritional context. Contrary to what this comment asserts, this approach furthers FDA's goals to help ensure that consumers receive information that may help them maintain healthy dietary practices to promote public health, prevent misleading labeling, and reduce potential confusion caused by the use of inconsistent definitions for nutrient content claims. We address additional comments about the statutory authority to expand the nutritional context and about whether the requirements of the final rule directly advance FDA's asserted interests in section V.K (“Legal Comments”).</P>
                    <P>
                        (Comment 127) Many comments request that FDA reconsider its position that the inclusion of voluntary front-of-pack nutrition icons such as Facts Up Front, MyPlate, or other symbols on the label, that do not reference nutrients, would be considered “nutritional context” that would render the term “healthy” on the label being subject to the “healthy” nutrient content claim definition. The comments disagree that these labeling elements create a nutritional context. The comments assert that the Facts Up Front program represents the standardized and factual display of nutrient information about a food and does not create any sort of nutritional or health halo for the product and that other claims, such as those about whole grain or fruit content, do not characterize the nutrient content. The comments note that FDA referenced a MyPlate logo as creating nutritional context for a “healthy” nutrient content claim; however, the comments argue that there are a variety of MyPlate symbols, including icons providing an overview of food group contributions on a plate (
                        <E T="03">i.e.,</E>
                         half fruit and vegetables) but also other icons that can be used to signal the food groups present (fruits, vegetables, grains, dairy, protein, oils), or foods to limit, and even physical activity. The comments suggest that, provided they are used with appropriate context and not in a misleading manner, these icons do not create the nutritional context for “healthy” to be viewed as an implied nutrient content claim. The comments state that FDA has cited no consumer research or evidence to suggest that consumers view this type of information as creating a nutritional context.
                    </P>
                    <P>Some comments state that FDA should acknowledge that mandatory label elements, such as a statement of identity, or corporate, company, or subsidiary name in a distribution statement, or the Nutrition Facts label does not provide the requisite nutritional context for a “healthy” nutrient content claim, provided that the mandatory label elements appear on the label in a way consistent with FDA's labeling requirements. According to the comments, a company name, which is often a mandatory label component, should be able to appear anywhere on pack, including the front panel, without being viewed as nutritional context for an implied “healthy” nutrient content claim. The comments argue that corporate and company names are not easily changed, and in most cases, represent a large portfolio of products. As such, the comments request FDA to include a provision in the final regulation that expressly exempts corporate and/or company names from triggering the criteria for a “healthy” implied nutrient content claim provided that the corporate or company name is not otherwise false and misleading in the context of the entire label.</P>
                    <P>(Response 127) With regard to the use of MyPlate and other related graphic icons, we discussed in the proposed rule (87 FR 59168 at 59182) that there may be instances where the use of a graphic on the label of a food bearing “healthy” would place the term in a nutritional context; for example, if the label on a can of beans labeled “healthy” also used the MyPlate symbol (which graphically puts the food groups together in the context of an overall dietary pattern, as a translation of the Dietary Guidelines) or other voluntary front of pack labeling (such as the Facts Up Front labeling program) to imply that the product meets nutritional needs. We reiterate that FDA considers food labels and labeling as a whole and will consider the context of statements made in labels and labeling to determine whether a product bears a “healthy” implied nutrient content claim. For certain graphics mentioned by the comment, such as an “activity” button icon referring to physical activity, such an icon likely would not provide the requisite nutritional context to establish a “healthy” claim; however, many of the MyPlate graphic representations are voluntary information about the food groups present in a food and thus would provide the requisite nutritional context to establish an implied nutrient content claim. While we are not aware of specific studies regarding consumer understanding of whether these specific icons create nutritional context, such findings are not necessary to this particular determination, as the information contained in the graphic images of food groups or a plate with multiple food groups is consistent with our stated parameters for limiting our consideration of the term “healthy” as an implied nutrient content claim to instances in which it is used in a nutritional context. However, we agree that mandatory label elements, such as the statement of identity, corporate name of the manufacturer, or the Nutrition Facts label, do not place the use of the term “healthy” elsewhere on the product into a nutritional context.</P>
                    <P>(Comment 128) Some comments argue that it is inadequate to only consider nutrition criteria when labeling foods “healthy,” stating that FDA should fully “repeal” the ability for companies to use the word “healthy” until FDA reviews and requires further criteria for when foods can be labeled “healthy.” The comments suggest, at a minimum, that we consider the safety of food additives when determining whether a food is “healthy” by including requirements that such foods do not contain food additives that have been associated with health risks. Some comments discuss FDA's “Closer to Zero” plan for reducing dietary exposure of babies and young children to toxic elements and express concern about juice products being eligible for the “healthy” claim using only “nutrition-based criteria, without accounting for the levels of toxic elements where an FDA action level applies to them.” Similarly, other comments, noting that “healthy” will act as a nutrient content claim only when used in a nutritional context, recommend the inclusion of an accompanying statement such as “based on nutritional content only” to avoid consumer misconception.</P>
                    <P>
                        (Response 128) This final rule defines “healthy” as a nutrient content claim only when it is used in a nutritional context. As explained in the preamble to the proposed rule, since 1994, we have recognized that labeling that describes a food product as “healthy” in a nutritional context is making an implicit claim of the level of nutrients in the 
                        <PRTPAGE P="106138"/>
                        product. The presence or absence of ingredients other than nutrients in a food product, as described in the comments (
                        <E T="03">e.g.,</E>
                         toxic elements and non-nutrient food additives), is outside of the scope of the “healthy” nutrient content claim. However, as the comments note, our “Closer to Zero” plan describes the activities we are currently undertaking for reducing dietary exposure of babies and young children to contaminants from food (Ref. 35).
                    </P>
                    <P>As stated above, we have no reason to believe that consumers would infer that the term, “healthy,” when used outside of a nutritional context, would signal that the food has a nutrient profile that would be helpful to consumers in achieving a diet that is consistent with current dietary recommendations, and such inferences are only likely to be drawn if the term “healthy” is accompanied by additional material or is otherwise presented in a context that explicitly or implicitly suggests that the food has a particular nutrient profile. For this reason, it is not necessary to require an accompanying statement to the “healthy” nutrient content claim, such as “based on nutritional content only.”</P>
                    <HD SOURCE="HD2">I. Records Requirements</HD>
                    <P>(Comment 129) Many comments agree with our proposed requirement that food manufacturers of products (other than raw, whole fruits, raw whole vegetables, water, and individual foods where the standard information required on the food label provides sufficient information to verify that the food meets the FGE requirements) that bear the “healthy” claim make and keep written records to verify that the food meets the FGE requirements where the FGE contained in the product is not apparent from the label of the food. These comments express support for the flexibility we proposed for manufacturers to demonstrate compliance using records they believe best meet the requirements rather than being required to produce any specific form or documents. The comments note that such an approach is similar to FDA's recordkeeping system for nutrition labeling of added sugars and other nutrients for which no analytical test methods exist. The comments agree that updating the definition of “healthy” and requiring each manufacturer to make and keep written records to verify the food meets the definition supports the overall goal of promoting a healthier food supply for all. However, some comments argue that FDA does not have legal authority to access proprietary information, such as complete product formulation, and state that FDA should clarify that records kept to verify the food group contributions are limited in nature and need only include the specific information regarding the food group contribution information, rather than the full recipes or formulations that are confidential and trade secret information.</P>
                    <P>(Response 129) We disagree with the assertion that FDA does not have legal authority to access proprietary information such as complete product formulation. As discussed in section IV. (“Legal Authority”), the authority granted FDA under sections 701(a), 403(r), 403(a)(1) and 201(n) of the FD&amp;C Act not only includes authority to establish records requirements, but also includes access to such records. Without access to such records, FDA would not know whether the food meets the requirements to bear the “healthy” claim consistent with section 403(r) of the FD&amp;C Act, and whether the use of the claim is truthful and not misleading under sections 403(a)(1) and 201(n) of the FD&amp;C Act. The introduction or delivery for introduction into interstate commerce of a misbranded food is a prohibited act under section 301(a) of the FD&amp;C Act (21 U.S.C. 331(a)). Thus, to determine whether a food that is voluntarily bearing a “healthy” nutrient content claim is misbranded and the manufacturer has committed a prohibited act, we must have access to the manufacturer's records that we are requiring to be kept under § 101.65(d)(4). Failure to make and keep records and provide the records to FDA, as described in § 101.65(d)(4), would result in the food bearing the “healthy” claim being misbranded under section 403(r) and 403(a)(1) of the FD&amp;C Act.</P>
                    <P>However, as discussed in the preamble to the proposed rule (87 FR 59168 at 59194), manufacturers will be responsible for the type of records they maintain and are not required to produce any specific form or document. We proposed that records be kept as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records in accordance with 21 CFR part 11 and the records must be accurate, indelible, and legible. The manufacturer is in the best position to know which records provide the documentation required to determine compliance. In the preamble to the proposed rule (87 FR 59168 at 59194), we note that compliance with the requirements for NTL will be verifiable for all food products using the Nutrition Facts label; that is, it will be apparent from the Nutrition Facts label whether a food meets the applicable criteria for saturated fat, sodium, and added sugars content, and thus no additional records are required. In addition, for some foods, we will be able to use the product label (including the Nutrition Facts label, the ingredient list, the statement of identity, and any other information) to verify compliance with the food group requirements. Other foods will not need to provide records to document compliance because the single ingredient exemption in the final rule expands the types of foods that can automatically qualify for the “healthy” claim without needing to meet criteria for FGEs and NTL (see Response 9). Records used to verify that a food meets the FGE requirements for “healthy” could include recipes or formulations, batch records providing data on the weight of certain ingredient contributions to the total batch, certificates of analysis from ingredient suppliers, or other appropriate verification documentation that provides the needed assurance that a food bearing the “healthy” claim complies with the FGE requirements.</P>
                    <P>
                        We expect that manufacturers choosing to use the “healthy” claim will have the type of records needed to verify that the food meets the requirements, given that they will have to analyze their product to determine whether it meets the requirement to bear the claim. The records requirement is intended to provide flexibility in what records the manufacturer makes available to FDA to verify the claim. The records provided to FDA during an inspection would only need to provide information on the FGEs because, as discussed above, the information on NTL will be available on the food package. Most importantly, other information about the food can be redacted to ensure confidentiality of a food product formulation as long as the information provided can adequately verify compliance with the requirements to bear the “healthy” claim. Furthermore, even if a manufacturer's records contained confidential commercial information or trade secret information or a manufacturer believes that certain information should be protected from public disclosure, there are safeguards to protect against public disclosure of that information and mechanisms that a manufacturer can use to assert that certain information should be protected from disclosure. We protect confidential information from disclosure, consistent with applicable statutes and regulations, including 5 U.S.C. 552(b)(4), 18 U.S.C. 
                        <PRTPAGE P="106139"/>
                        1905, and part 20 (21 CFR part 20). For example, our regulations pertaining to disclosure of public information, at part 20, include provisions that protect trade secrets and commercial or financial information which is privileged or confidential. If a manufacturer keeps proprietary recipe information in its records, it should mark the information as such before providing the records to FDA upon request.
                    </P>
                    <P>(Comment 130) Some comments request that we recognize that records may be stored centrally and need not be physically available at the manufacturing facility and that allowing for central storage of records would be consistent with the approach FDA has taken in numerous other situations, citing 21 CFR 117.315(c).</P>
                    <P>(Response 130) Records must be made available to us upon request, during an inspection, for official review and photocopying or other means of reproduction (§ 101.65(d)(4)). As discussed in the proposed rule (87 FR 59168 at 59196), the records would need to be reasonably accessible (access to records within 24 hours can be considered reasonable) to FDA during an inspection at each manufacturing facility (even if not stored onsite) to determine whether the food meets the requirements for bearing the “healthy” claim. Records that can be immediately retrieved from another location by electronic means are considered reasonably accessible.</P>
                    <P>(Comment 131) Some comments request clarification regarding which party is responsible for keeping records in a situation where a contract manufacturer produces a product on behalf of another party and maintains the product recipe as confidential and proprietary, suggesting that it should be sufficient if the manufacturer provides to the distributor/own-brand company a signed statement confirming that the product is eligible for the “healthy” definition.</P>
                    <P>(Response 131) Companies using the “healthy” claim on their products may maintain the required records however they choose, including whatever arrangements they have with manufacturing partners, provided they are aware that they are responsible for ensuring that the products they introduce into interstate commerce are not misbranded under the FD&amp;C Act. As discussed in the previous response, if FDA inspects a manufacturer or manufacturing facility, the relevant records to demonstrate that a food meets the requirements for bearing the “healthy” claim would need to be provided within a reasonable time, such as someone providing the records electronically to FDA, if appropriate. As described above, redacted records are also potentially appropriate to maintain, provided the redacted records are able to demonstrate that the food meets the requirements for bearing the “healthy” claim. A signed statement confirming that the product is eligible for the “healthy” claim would not be sufficient to provide to FDA during an inspection to demonstrate that a food product qualifies to bear the “healthy” claim.</P>
                    <P>In the preamble to the proposed rule (87 FR 59168 at 59195), we also discussed how manufacturers should be able to obtain the necessary information from ingredient suppliers to demonstrate that any foods they manufacture that bear the “healthy” claim meet the requirements for the claim.</P>
                    <P>(Comment 132) Some comments suggest that FDA provide further clarity around calculating values for the designated thresholds, stating in instances where the requirements cannot be verified with the label and manufacturers have to maintain information in records to determine whether the product meets the FGE requirements, food formulators/food companies need clarification regarding whether unrounded values would need to be at or above thresholds and to what decimal place. Some comments urge FDA to clarify that either unrounded or rounded nutrient values may be used to determine compliance, suggesting that this would be consistent with FDA's approach for other absolute nutrient content claims such as “fat free,” where FDA indicated that “because there is no nutritional difference between rounded and unrounded values of a nutrient in a food, [FDA] does not see a need to specify which value should be used in determining whether or not a food qualifies to make a nutrient content claim” (see 58 FR 44020 at 44024 (August 18, 1993).) The comments claim that the same standard should apply to the updated “healthy” nutrient content claim definition because “healthy” is an absolute claim, where either the rounded or unrounded value could be used to assess compliance.</P>
                    <P>(Response 132) We agree with the comments and our previously stated position that because there is no nutritional difference between rounded and unrounded values of a nutrient in a food, we do not see a need to specify which value should be used in determining whether a food qualifies to bear the “healthy” nutrient content claim. As the comments note, this is consistent with our position in the final rule “Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms; Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and Cholesterol Content of Foods; Food Standards: Requirements for Foods Named by Use of a Nutrient Content Claim and a Standardized Term; Technical Amendment” (58 FR 44020, August 18, 1993).</P>
                    <P>(Comment 133) The comments assert that the rule should be accompanied by mechanisms to ensure food manufacturers adequately keep records and catalog the nutritional components of their foods to abide by the updated “healthy” standards. Some comments argue that the proposed recordkeeping requirements to ensure manufacturers are following the regulations seem to leave enforcement and compliance in a state of ambiguity and call for increased transparency regarding enforcement of compliance from food manufacturers. Some comments claim that the proposed rule involves limited recordkeeping requirements that entails non-standardized forms of evidence showing that combination foods and grains labeled as “healthy” meet FDA standards but there is no explicit information on how often inspections take place or how these records are verified for accuracy. Similarly, some comments argue that there is also no indication of what consequences are for failing to be compliant, claiming that with evidence that manufacturers have intentionally misrepresented labels in the past, it is essential for this action to be transparent regarding enforcement and consequences for lack of compliance.</P>
                    <P>
                        (Response 133) As discussed in the proposed rule (87 FR 59168 at 59194), where the requirements cannot be verified using the label, the manufacturer will have or should have the information required to determine whether the product meets the criteria for bearing the “healthy” claim. The information contained in manufacturers' records must be accurate for ensuring that the nutrient content claim is used in accordance with § 101.65(d) and that the food labeling complies with section 403(r) of the FD&amp;C Act. We conclude that the records will provide FDA with the necessary means to determine compliance with the criteria for bearing the “healthy” nutrient content claim. We are requiring that records be made available to us for examination or copying during an inspection upon request; this is consistent with our other recordkeeping regulations (see, 
                        <E T="03">e.g.,</E>
                         21 CFR 111.605 and 111.610). The records would need to be reasonably accessible (access to records within 24 hours can be considered reasonable) to FDA during an inspection at each 
                        <PRTPAGE P="106140"/>
                        manufacturing facility (even if not stored onsite) to determine whether the food meets the requirements for bearing the “healthy” claim. Records that can be immediately retrieved from another location by electronic means are considered reasonably accessible. We note that having a false declaration on the label is a violation of section 403(a)(1) of the FD&amp;C Act. In addition, providing false information in records to FDA may also be a potential criminal violation under 18 U.S.C. 1001. Under 18 U.S.C. 1001, whoever, in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States, knowingly and willfully: (1) Falsifies, conceals, or covers up by any trick, scheme, or device a material fact; (2) makes any materially false, fictitious, or fraudulent statement or representation; or (3) makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry may be subject to a fine or imprisonment.
                    </P>
                    <HD SOURCE="HD2">J. Effective and Compliance Dates</HD>
                    <P>
                        (Comment 134) Many comments support the proposed compliance date that is 3 years after the effective date (
                        <E T="03">i.e.,</E>
                         60 days after the date the final rule publishes in the 
                        <E T="04">Federal Register</E>
                        ) stating that this would provide adequate time for compliance. Some comments recommend that FDA revise the effective date to make it the same as the date the final rule is published in the 
                        <E T="04">Federal Register</E>
                         rather than 60 days after to allow manufacturers already in compliance with the rule to voluntarily label their products “healthy” as soon as possible. Similarly, some comments suggest that FDA provide enforcement discretion for products that elect to use the “healthy” term in compliance with the new definition prior to the compliance date. Some comments request an effective date that is the same at the compliance date (
                        <E T="03">i.e.,</E>
                         3 years after issuance of the final rule), stating that this is allowed under FDA's administrative regulations, which require that the effective date be at least 30 days after publication of the final rule, but do not restrict longer effective dates. Some comments urge FDA to confirm that “healthy” may be used during the compliance period consistent with the original regulation and that providing an effective date that is the same as the compliance date would reinforce that the original “healthy” definition may appropriately be used in the period after the final rule is issued and before the compliance date.
                    </P>
                    <P>
                        Some comments request that FDA recognize the compliance date as applying to the date a product is manufactured and labeled rather than the date it is introduced into interstate commerce, arguing that this is less confusing for distribution systems and easier to implement. The comments state that this would be consistent with how FDA has approached other labeling changes (
                        <E T="03">i.e.,</E>
                         considering the compliance date to apply to the date a food was labeled).
                    </P>
                    <P>
                        (Response 134) The comments suggest there may be some confusion with regard to the meaning of the effective date. The effective date is the date on which the Office of the Federal Register amends the 
                        <E T="03">Code of Federal Regulations</E>
                         in § 101.65(d) to reflect the new requirements for the “healthy” implied nutrient content claim as promulgated by this final rule. The effective date for this final rule is 60 days after the date of the final rule's publication in the 
                        <E T="04">Federal Register</E>
                        . The compliance date—meaning the date on which we would begin enforcing the rule—is 3 years after the effective date. As explained in the proposed rule, a compliance date that is 3 years after the effective date is intended to provide industry time to revise labeling to come into compliance with the new labeling requirements while balancing the need for consumers to have the information in a timely manner. However, although companies are not required to be in compliance with the new requirements for the “healthy” implied nutrient content claim until the date that is 3 years after the effective date, a company is free to choose to relabel in accordance with the new requirements sooner, as discussed further in section V.K (“Legal Comments”).
                    </P>
                    <P>
                        With regard to the comments requesting that we recognize the compliance date as applying to the date a product is labeled rather than the date it is introduced into interstate commerce, we agree. Compliance with the updated definition of “healthy” in § 101.65(d) will be assessed for products that are labeled (
                        <E T="03">i.e.,</E>
                         when the label is placed on the product) with the “healthy” implied nutrient content claim on or after the compliance date (3 years after the effective date). We will not begin to enforce the updated final rule requirements before the compliance date. We evaluate the date the food product was labeled for purposes of determining whether the product must meet the updated requirements.
                    </P>
                    <P>Further, as discussed in response to comment 161 below, manufacturers would not be required to comply with requirements of the final rule until the compliance date. Thus, once any new requirements for the definition of the nutrient content claim “healthy” are in effect, manufacturers could either comply with the new requirements or continue to use the original definition of “healthy” until the compliance date.</P>
                    <P>(Comment 135) One comment asserts that the compliance date would be difficult to meet due to the workload and costs associated with the rule. One comment argues that the time period before the rule takes effect should allow food manufacturers time to update their packaging and change their recipes to comply with the “healthy” definition to avoid damage to their brand. One comment suggests that FDA set a compliance date for small businesses that is 2 years after the proposed compliance date and use that period to educate small businesses on the rule and associated compliance issues, arguing that small businesses are at a disadvantage compared to large companies. One comment asserts the rule would benefit large consumer packaged goods companies that have the financial means to accommodate relabeling their products, thus placing small businesses at a competitive disadvantage because the rule would have disproportionate impacts on small businesses, and requests accommodations for small businesses relating to compliance and the provision of education resources.</P>
                    <P>
                        (Response 135) FDA has gone through an extensive and transparent rulemaking process to update the definition of the “healthy” claim and has established a generous compliance period for manufacturers to come into compliance. Although one comment did suggest an additional 2 years (or a total of 5 years) is needed, we do not have information that would enable us to determine whether all or merely some small businesses need additional time to comply with the rule, nor do we have information that would enable us to determine how much, if any, additional time is needed for small businesses generally. If we were to extend the compliance date for all small businesses to 5 years, consumer confusion could result because different versions of the “healthy” claim would exist in the market for a longer period of time. The differences could frustrate, rather than enhance, the consumer's ability to maintain healthy dietary practices and potentially undermine public confidence in use of the claim. We also note that businesses may choose to include a “healthy” claim on food product labeling that meets the criteria in this rule, but are not required to do so, and that our estimates indicate that only a small number of products will need to relabel or reformulate their 
                        <PRTPAGE P="106141"/>
                        products to comply with the new definition (see Ref. 39).
                    </P>
                    <HD SOURCE="HD2">K. Legal Comments</HD>
                    <HD SOURCE="HD3">1. Statutory Authority</HD>
                    <P>(Comment 136) One comment agrees that FDA has the authority to make changes to the “healthy” definition according to the most recent science. While some comments acknowledge that the FD&amp;C Act “allows FDA to define terms that expressly or implicitly characterize the nutrient content of a food,” where the nutrients are those required to be labeled within the Nutrition Facts label, other comments argue that the statute does not give FDA authority to require foods bearing nutrient content claims to have a minimum amount of food group equivalents. Another comment asserts that FDA knew or agreed it did not have authority to include food groups in this context because we have not done so in the past. Another comment states that FDA's food group criteria are “nutrient-agnostic” and therefore outside of the scope of section 403(r) of the FD&amp;C Act.</P>
                    <P>(Response 136) We disagree with the comments that included an overly narrow reading of section 403(r)(1)(A) of the FD&amp;C Act. As discussed above, the statutory language describes nutrient content claims as claims in the label or labeling of a food that “expressly or by implication” “characterize[ ] the level of any nutrient which is of the type required . . . to be in the label or labeling of the food.” (section 403(r)(1)(A) of the FD&amp;C Act). FDA regulations define “implied nutrient content claims,” in part, as claims that “suggest[ ] that [a] food, because of its nutrient content, may be useful in maintaining healthy dietary practices,” (§ 101.13(b)(2)(ii)). As we stated in the 1993 final rule establishing this claim, “a claim that a food, because of its nutrient content, may be useful in maintaining healthy dietary practices is clearly a claim that characterizes the level of nutrient in that food. The claim is essentially saying that the level of nutrients in the food is such that the food will contribute to good health” (58 FR 2302 at 2375, January 6, 1993). Therefore, the “healthy” claim by implication characterizes the level of nutrients in a food, and as such, the claim must be made in accordance with FDA regulations under section 403(r) of the FD&amp;C Act.</P>
                    <P>
                        Although the comments advocate for a narrow interpretation of the statute, the Supreme Court has embraced broad constructions of the FD&amp;C Act based on the Court's understanding of its text, congressional intent, and remedial purpose. See, 
                        <E T="03">e.g., United States</E>
                         v. 
                        <E T="03">Bacto-Unidisk,</E>
                         394 U.S. 784, 798 (1969) (“Congress fully intended that the [FD&amp;C] Act's coverage be as broad as its literal language indicates.”); 
                        <E T="03">United States</E>
                         v. 
                        <E T="03">Dotterweich,</E>
                         320 U.S. 277, 280 (1943) (“The purposes of [the FD&amp;C Act] thus touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words.”). Moreover, Congress may “expressly delegate to an agency the authority to give meaning to a particular statutory term” and to “prescribe rules to `fill up the details' of a statutory scheme.” 
                        <E T="03">Loper Bright Enters.</E>
                         v. 
                        <E T="03">Raimondo,</E>
                         144 S. Ct. 2244, 2263 (2024) (cleaned up). The best reading of the NLEA is that Congress “delegate[d] discretionary authority” to FDA. 
                        <E T="03">Id.</E>
                         Relevant provisions appear throughout section 403(r) and specifically in section 403(r)(2)(A)(i) of the FD&amp;C Act, which requires nutrient content claims to “use[ ] terms which are defined in regulations of the Secretary.” Therefore, the best reading of sections 403(r)(1)(A) and 403(r)(2)(A)(i) of the FD&amp;C Act is that they delegate discretionary authority to FDA to decide, as appropriately informed by its technical expertise and within the limits of its statutory authority, how particular claims may characterize the level of any nutrient in a food.
                    </P>
                    <P>The food group equivalent criteria included in the updated definition of “healthy” help ensure that foods bearing the “healthy” claim have a nutrient profile that may help consumers maintain healthy dietary practices, in line with the definition and purpose of this implied nutrient content claim. Each food group that is part of the food group equivalent requirements represents the inclusion of multiple important nutrients. The use of food groups better accounts for how all these nutrients contribute to, and may work synergistically to create, a healthy dietary pattern and improve health outcomes, consistent with current nutrition science. By requiring products to contain a certain amount of a food group, the rule will help ensure foods bearing the “healthy” claim contain a variety of important beneficial nutrients and, therefore, that their labeling provides non-misleading information that assists people who wish to choose foods that will meet recommended nutrient intakes and maintain healthy dietary patterns.</P>
                    <P>Accordingly, consistent with Congress's objectives to provide appropriate nutritional information to consumers, the statutory phrase “characterize[ ] the level of any nutrient which is of the type required . . . to be in the label or labeling of the food” is best understood in light of current science to encompass both limits on certain individual nutrients and food group criteria that more broadly incorporate a variety of nutrients from nutrient-dense foods. The updated “healthy” claim implicitly characterizes the level of a number of nutrients that are of the type required to be declared on the Nutrition Facts label. As we explained in the proposed rule and elsewhere in this final rule, the updated definition of this implied claim, consistent with current dietary guidelines, includes food groups that represent a number of different nutrients and the claim is thus characterizing the overall nutrient content of the food, rather than focusing on one individual nutrient in isolation, for example, as with an express nutrient content claim.</P>
                    <P>
                        Thus, we also disagree that our previous definition of, or examples regarding, the “healthy” claim indicate that FDA did not believe it had the authority to go beyond individual nutrients in the context of the implied “healthy” claim to focus on food groups in addition to specific nutrient levels. The changes made by this rulemaking are due to evolving science, not a change in FDA's understanding of its legal authority. For years, FDA has defined “healthy” in the context of the overall characteristics of foods as they contribute to building a healthy dietary pattern and the definition has used a number of nutrient levels. In the 1994 definition of the claim, levels for nine different individual nutrients were discussed: fat, saturated fat, cholesterol, vitamin A, vitamin C, calcium, iron, protein, and fiber (previously § 101.65(d)(2)(i)). As discussed elsewhere in this document, in recent years the Dietary Guidelines have shifted from focusing on such individual nutrients to recommending healthy dietary patterns and the consumption of food groups in certain quantities to achieve adequate nutrient intake, based on the understanding that each food group contributes an array of important nutrients to the diet (Ref. 1). Thus, the way various nutrients are counted for the definition of the “healthy” claim has been updated to account for that evolution in nutrition science. The reference in the statute to 
                        <PRTPAGE P="106142"/>
                        “characteriz[ing] the level of any nutrient” and the reference in the regulation to “maintaining healthy dietary practices” incorporate a scientific component because both the characterization and the assessment of healthy dietary practices involve an evaluation of the impact of diet on health. And, as science has evolved over time, the understanding of an implied claim that a food contains levels of nutrients that aid in maintaining healthy dietary practices should also evolve. To ensure that such a claim is not misleading, avoids consumer confusion, and continues to assist people who wish to choose foods whose nutritional content contributes to good health, FDA has concluded that the definition of the claim should be updated to match the current scientific understanding of the underlying facts. Thus, it is appropriate and consistent with the statutory and regulatory framework, including Congress's express delegation of rulemaking authority to the Agency to define terms in nutrient content claims, for FDA to update definitions related to implied nutrient content claims based on current science, including the “healthy” claim, which FDA has long regulated as an implied nutrient content claim. To the extent that this rulemaking entails a change in the exercise of our statutory authority, it is justified by these advances in nutrition science that have led to broader recommendations, including in the Dietary Guidelines and as discussed in greater detail throughout this final rule and the proposed rule, to explicitly refer to food groups as a way to build a healthy dietary pattern (see 
                        <E T="03">Home Care Ass'n of Am.</E>
                         v. 
                        <E T="03">Weil,</E>
                         799 F.3d 1084 (D.C. Cir. 2015) (stating the Administrative Procedure Act (APA) imposes “no special burden when an Agency elects to change course” and the “reasoned explanation” under the APA for an alternative approach includes an Agency awareness of the change in position and good reasons for the change (citing 
                        <E T="03">FCC</E>
                         v. 
                        <E T="03">Fox Television Stations, Inc.,</E>
                         556 U.S. 502, 515 (2009)).
                    </P>
                    <P>(Comment 137) One comment argues that the use of the phrase “maintain healthy dietary practices” is outside of the FD&amp;C Act's nutrient content claim authority, as section 403(r) of the FD&amp;C Act only focuses on levels of specific nutrients in a food.</P>
                    <P>
                        (Response 137) This comment misunderstands the implied nutrient content claim scheme that has been in place since 1993 and the statutory basis for it. First, as we quoted above, the 1993 final rule stated that “a claim that a food, because of its nutrient content, may be useful in maintaining healthy dietary practices is clearly a claim that characterizes the level of nutrient in that food. The claim is essentially saying that the level of nutrients in the food is such that the food will contribute to good health” (58 FR 2302 at 2375). Therefore, the comment is incorrect in asserting that this standard is irrelevant for nutrient content claims, especially implied claims. Additionally, section 403(r) of the FD&amp;C Act itself uses the phrase “. . . will assist consumers in maintaining healthy dietary practices” to describe the basis for certain types of nutrient content claims (see, 
                        <E T="03">e.g.,</E>
                         section 403(r)(2)(A)(ii)(II) and (r)(2)(A)(iii)(I) of the FD&amp;C Act). Moreover, we have found that “Congress was clearly concerned with such claims. The October 24, 1990, proceedings in the Senate show that one purpose of the 1990 amendments was to regulate the use of nutrient content claims that appear on food labels and labeling to help consumers make appropriate dietary choices (136 Congressional Record S16610 (October 24, 1990))” (see 58 FR 2302 at 2375). Ensuring that the information presented to consumers on food labels can help consumers identify foods that will help them maintain a healthy diet has been a part of our authority under both sections 403(q) and 403(r) of the FD&amp;C Act since the passage of the 1990 NLEA Amendments.
                    </P>
                    <P>Further, the original definition of the “healthy” claim at § 101.65(d)(1)(i) has specifically included language about helping consumers maintain healthy dietary practices since it was finalized in 1994. This is not new language, but instead aligns with the statutory and regulatory framework that has been applied for almost 30 years since the inception of the claim.</P>
                    <P>(Comment 138) One comment argues that by broadening the basis on which the “healthy” claim can be put in a nutritional context and focusing on the overall characteristics of a food, rather than a tie to a specific level of an individual nutrient, FDA no longer has the statutory authority to regulate the “healthy” claim.</P>
                    <P>(Response 138) We disagree that the minor changes to the description of how FDA assesses, on a case-by-case basis, whether a claim “expressly or by implication” characterizes the level of any nutrient, places “healthy” outside the scope of a nutrient content claim as described in section 403(r) of the FD&amp;C Act. As discussed above in Response 136, under section 403(r) of the FD&amp;C Act, nutrient content claims include both express and implied claims that characterize the level of any nutrient which is of the type required to be in the label or labeling of a food. Additionally, claims that characterize the level of nutrients in the food include claims about the overall nutrition profile of the food. This is especially true for defined implied nutrient content claims like “healthy,” where, since the relevant regulations were issued, FDA's focus has been on foods that are useful in creating a diet consistent with dietary recommendations because of their nutrient content. Nothing in the FD&amp;C Act requires a reference to a specific level of one individual nutrient to impliedly characterize the level of any nutrient in the food as directed by section 403(r) of the FD&amp;C Act (see Response 136 for further discussion).</P>
                    <P>(Comment 139) One comment discusses our statutory authority in setting nutrient to limit thresholds, asserting that, in setting these thresholds, we must ground the types and levels of such nutrients on a “permitted” statutory basis, specifically referring to either section 403(r)(2)(A)(vi) or 403(r)(2)(B) of the FD&amp;C Act.</P>
                    <P>
                        (Response 139) This comment misstates the statutory authority for setting the nutrient to limit thresholds within the definition of the “healthy” claim. The statutory basis, as discussed in previous responses (
                        <E T="03">e.g.,</E>
                         Response 136), is section 403(r)(1)(A) of the FD&amp;C Act as well as section 403(r)(2)(A)(i) of the FD&amp;C Act. Section 403(r)(2) of the FD&amp;C Act sets out specific requirements for making defined claims and states that a claim, such as “healthy,” may be made only in accordance with FDA regulations defining the term. The limitations for added sugars, sodium, and saturated fat are part of the definition of the term “healthy.” In contrast, the limitations on nutrients described in section 403(r)(2)(A)(vi) and 403(r)(2)(B) of the FD&amp;C Act, referenced by the comment, refer to “another nutrient in the food” rather than the nutrients actually incorporated into the definition of the claim, and are not relevant here.
                    </P>
                    <P>
                        (Comment 140) Some comments say that we did not present support for the added sugars limits set forth in the proposed rule to demonstrate that added sugars amounts above those limits would reflect the amounts at which a “healthy” claim would become “misleading.” Furthermore, some comments suggest that we could only set limits for added sugars if there was a determination by the Secretary of HHS that these limits reflect the levels at which added sugars increase the risk of a disease or health-related condition 
                        <PRTPAGE P="106143"/>
                        that is diet related in the general population.
                    </P>
                    <P>(Response 140) We disagree that FDA must demonstrate that added sugar amounts above the limits set forth in the rule would reflect the amounts at which a “healthy” claim would become “misleading” or that a level of added sugars has a direct link to chronic disease under section 403(r) of the FD&amp;C Act. The primary purposes behind section 403(r) of the FD&amp;C Act and FDA's nutrient content claim regulations are to provide information to consumers that may help them maintain healthy dietary practices, to help prevent misleading labeling, and to reduce consumer confusion potentially caused by the use of inconsistent definitions for nutrient content claims. Preventing misleading labeling is only one of these purposes. The updated regulation for the “healthy” claim defines the claim with standardized criteria, such as the added sugars limit, for use on foods that useful in creating a diet that is consistent with dietary recommendations, to ensure that consumers are adequately informed and not misled. Furthermore, there is no requirement, under the statute or First Amendment jurisprudence, that limits FDA's authority over nutrient content claims to only regulating claims shown to be inherently or actually misleading. Nor is there any legal requirement that FDA determine that a nutrient increase the risk of a disease or health-related condition that is diet related in the general population in order to include limits for such nutrients as part of the regulatory definition for a nutrient content claim. While section 403(r)(2)(B) of the FD&amp;C Act does refer to a nutrient at a level that increases the risk of diet-related diseases or health-related conditions in the general population, this provision is in the context of a required disclosure statement regarding a nutrient that is not the subject of the nutrient content claim and is therefore not relevant to FDA's authority to set criteria as part of a nutrient content claim definition.</P>
                    <P>(Comment 141) Several comments argue that we have statutory direction to follow the Dietary Guidelines, with one comment citing 7 U.S.C. 5341(a)(1) FD&amp;C Act, and argue that FDA is not authorized to implement rules that deviate from the Dietary Guidelines' recommendations, including in setting the added sugars and sodium limits.</P>
                    <P>
                        (Response 141) We disagree with the comments that FDA is deviating from the Dietary Guidelines in a way that is not permitted by statute. The provision cited by the comment, 7 U.S.C. 5341(a)(1) of the FD&amp;C Act, states that the Dietary Guidelines “shall be promoted by each Federal agency in carrying out any Federal food, nutrition, or health program.” The cited provision, 7 U.S.C. 5341(a)(1) of the FD&amp;C Act, does not elaborate on what it means for Agencies to successfully promote the Dietary Guidelines through their work and, further, there is nothing in 7 U.S.C. 5341(a)(1) of the FD&amp;C Act that states that an Agency may not make any independent scientific considerations in rulemaking. Because we relied on and incorporated the recommendations in the current edition of the Dietary Guidelines in developing the final rule, as a result, the “healthy” rule promotes the Dietary Guidelines. The entire focus of the healthy rule is identifying foods that can be the foundation of building a healthy dietary pattern as specified in the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                         For example, modifications to the NTL thresholds were made for foods that are identified as underconsumed and promoted by the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         such as nuts and seeds and seafood.
                    </P>
                    <P>
                        Beyond this one citation to a general provision about “promoting” the overall Dietary Guidelines, the comments that raise this issue do not point to any statutory requirement, such as in section 403(r) of the FD&amp;C Act, that FDA follow the Dietary Guidelines or statutory language that states that FDA is not authorized to deviate from any individual recommendation in the Dietary Guidelines. Overall, the changes made to update the “healthy” criteria are consistent with current nutrition science and Federal dietary guidance, including the Dietary Guidelines. We have made certain adjustments to the baseline criteria to provide additional flexibility, to reflect practical realities (
                        <E T="03">e.g.,</E>
                         marketplace conditions), consistent with the purpose of the “healthy” claim. Thus, there is no violation of any statutory directive regarding the Dietary Guidelines in the rule.
                    </P>
                    <P>(Comment 142) One comment questions whether added sugar is a “nutrient” as the basis for an argument that FDA may not have the authority to include added sugars levels as part of a nutrient content claim definition. While acknowledging that there is no regulatory definition of “nutrient,” the comment states that other nutrients used in section 403(r) of the FD&amp;C Act are “chemically and structurally distinct from each other and have different physiological effects on the body.”</P>
                    <P>(Response 142) We disagree that FDA does not have the authority to include added sugars levels as part of a nutrient content claim definition. First, section 403(r) of the FD&amp;C Act states that nutrient content claims “characterize” the level of any nutrient which is of the type required by paragraph (q)(1) or (q)(2) [of section 403 of the FD&amp;C Act] to be in the label or labeling of the food.” Added sugars, thus, are a nutrient as described in section 403(r) of the FD&amp;C Act because, pursuant to regulation, the amount of added sugars is required to be declared under section 403(q)(2)(A) of the FD&amp;C Act (see 81 FR 33742 at 33801 through 33803 adding added sugars to the list of required nutrients to be declared on the Nutrition Facts label under section 403(q)(2)(A) of the FD&amp;C Act). Therefore, limiting the amount of added sugars in a food is an appropriate criterion for a nutrient content claim under section 403(r) of the FD&amp;C Act.</P>
                    <P>Given the statutory language in section 403 of the FD&amp;C Act, whether other nutrients that are the subject of section 403(q) of the FD&amp;C Act are chemically and structurally distinct from each other and have different effects on the body is not relevant to the analysis of whether added sugars is a nutrient as described in section 403(r) of the FD&amp;C Act. Additionally, even if it were relevant, FDA does not agree that all the other nutrients are distinct in this way. For example, the listed section 403(q) of the FD&amp;C Act declarations include broad categories (like total carbohydrates and total fat) and subsets of those categories (like fiber and saturated fat), which are clearly not entirely distinct. Thus, this argument is not persuasive.</P>
                    <HD SOURCE="HD3">2. Administrative Procedure Act (APA)</HD>
                    <P>(Comment 143) One comment argues that it was arbitrary for FDA to incorporate FGEs into the definition of “healthy” because consumers will not be able to determine why the food qualifies for the claim or if the claim was made in error.</P>
                    <P>
                        (Response 143) The purpose of the “healthy” claim is to help manufacturers provide information to consumers so that they can easily and quickly identify foods that are particularly useful in helping them build a healthy diet. The comment does not provide any explanation of why consumers need to be able to determine the basis for qualification for the “healthy” claim at the point of decision-making about a food. The basis for the “healthy” criteria is explained in the rule, which will help consumers understand what foods qualify for the “healthy” claim and whether foods are labeled with the claim when they should not be. We also plan to conduct consumer education regarding the 
                        <PRTPAGE P="106144"/>
                        updated definition of the “healthy” claim to support consumers in their use of the claim to identify foods with which to build their healthy diets.
                    </P>
                    <P>
                        Although the rule will help consumers be better informed about which foods can help form the basis of a healthy diet, FDA recognizes that consumers may not have access to all documentation supporting the healthy claim for each individual product that they purchase. This is similar to many labeling requirements, and the fact consumers may lack some kinds of information does not mean that the rule is arbitrary or does not serve the goals of better informing consumers and preventing them from being misled (see 
                        <E T="03">Home Box Office, Inc.</E>
                         v. 
                        <E T="03">FCC,</E>
                         567 F.2d 9, 36 n. 58 (D.C. Cir. 1977), 
                        <E T="03">cert. denied,</E>
                         434 U.S. 829 (1977) (“In determining what points are significant, the `arbitrary and capricious' standard of review must be kept in mind . . . only comments which, if true, raise points relevant to the agency's decision and which, if adopted, would require a change in an agency's proposed rule or cast doubt on the reasonableness of a position taken by the agency.”)).
                    </P>
                    <P>(Comment 144) A comment suggests that FDA's rationale for allowing food groups to have different baseline nutrient thresholds is an “arbitrary inconsistency” that should be addressed by making the baseline thresholds the same for all food groups. Several comments argue that FDA setting different baseline threshold limits for different nutrients, “not having a consistent methodology” for calculating the thresholds and providing flexibility for some food categories and not others made FDA's approach to NTL arbitrary and capricious. One comment asserts that we have failed to satisfy the arbitrary and capricious standard that has been described in the case law.</P>
                    <P>Several comments argue specifically that the nutrient limits for whole grains are lower than and do not provide the same flexibility as the limits for certain meats, nuts, eggs, and seafood, resulting in an arbitrary difference without an adequate rationale. Another comment argues that allowing added sugars in dairy and whole grain products, but not in fruit and vegetable products, is an arbitrary difference.</P>
                    <P>
                        (Response 144) We note at the outset that arbitrary and capricious claims under the APA are reviewed under the APA's “narrow” and “deferential” arbitrary and capricious standard. 
                        <E T="03">Motor Vehicle Mfrs. Ass'n of U.S., Inc.</E>
                         v. 
                        <E T="03">State Farm Mut. Auto. Ins. Co.,</E>
                         463 U.S. 29, 43 (1983); 
                        <E T="03">FCC</E>
                         v. 
                        <E T="03">Prometheus Radio Project,</E>
                         141 S. Ct. 1150, 1158 (2021). The court “simply ensures that the agency has acted within a zone of reasonableness” and “has reasonably considered the relevant issues and reasonably explained the decision.” 
                        <E T="03">Prometheus Radio Project,</E>
                         141 S. Ct. at 1158. In addition, courts should “give[ ] a high level of deference to [FDA's] scientific judgments.” 
                        <E T="03">Pharm. Mfg. Rsch. Servs., Inc.</E>
                         v. 
                        <E T="03">FDA,</E>
                         957 F.3d 254, 262 (D.C. Cir. 2020). In this rulemaking, FDA has provided a thorough explanation of its scientific judgment on these issues (see sections V.C. (“Food Group Equivalents”) and V.D. (“Nutrients to Limit”)).
                    </P>
                    <P>We disagree with the characterization in the comments that we did not have a consistent methodology for establishing the nutrient to limit amounts in the rule. As described in section V.D (“Nutrients to Limit”), we started with a ≤5% DV limit for each nutrient to limit based on the amount that has historically been associated with the nutritional advice of what is considered to be “low” in any nutrient, as well as, in some cases, what would qualify the food for a “low” nutrient content claim, such as saturated fat. Some minor adjustments to the established baseline limits were made as necessary to help consumers maintain healthy dietary practices and for consistency with the Dietary Guidelines, such as increasing the saturated fat limit to ≤10% DV for fat-free and low-fat dairy so that those foods could qualify for “healthy” as they are recommended by the Dietary Guidelines (see section V.D.2 (“Saturated Fat”)). As explained further in section V.D.3 (“Sodium”), it was determined that a ≤5% DV limit would be too low for sodium given the functions of sodium in foods and current levels of sodium in the food supply, so an adjustment was made to have a baseline sodium limit of ≤10% DV. Accordingly, we have provided a reasoned scientific basis for each decision in the rulemaking and these adjustments were thoroughly reasoned and consistent with the statutory purpose.</P>
                    <P>Further, contrary to the comment's assertion, the difference between how meat, eggs, seafood, and nuts as compared to how whole grains were treated in the proposed rule was carefully explained, including based on consistency with the Dietary Guidelines (see sections V.D.2 (“Saturated Fat”) and V.D.4 (“Added Sugars”) for further discussion). The final rule provides additional flexibilities for other products after additional information was provided about adjustments that would help consumers maintain healthy dietary practices. Similarly, FDA has explained the reasons why some amounts of added sugars were able to be included in certain products and not others. We also note that some of the added sugars limits have been adjusted in the final rule, such as accommodating small amounts of added sugars in fruit and vegetable products, thus minimizing the difference noted by the comment. See section V.D.4. (“Added Sugars”).</P>
                    <P>(Comment 145) One comment asserts that the nutrient to limit thresholds are arbitrary because FDA did not demonstrate their connection to chronic disease risk or any other level at which a food becomes unhealthy. Another comment asserts that because the amount of added sugars is not directly related to chronic disease risk, there is no reason for the added sugars limit to be lower than that of sodium.</P>
                    <P>(Response 145) The comment's references to chronic disease risk or the level at which an individual food becomes “unhealthy” are misplaced. Determining a level at which individual foods become “unhealthy” would be inconsistent with current nutrition science and our numerous previous statements in a variety of contexts that all foods can be incorporated into a healthy dietary pattern. As discussed, this implied nutrient content claim describes a food that, because of its nutrient levels, will help consumers maintain healthy dietary practices. The NTL thresholds are used to identify foods that will be the foundation or building blocks of a healthy dietary pattern and are specifically not designed to be a level at which a particular food becomes “unhealthy.” See section III. (“Background”) for more on this issue. Determining a level at which foods become “unhealthy” would be inconsistent with current nutrition science and our numerous previous statements in a variety of contexts that all foods can be incorporated into a healthy dietary pattern. Claims like “healthy” help consumers identify which foods are the foundation of building a healthy dietary pattern.</P>
                    <P>
                        Similarly, impact on chronic disease risk is not the basis for the “healthy” claim. While maintaining healthy dietary practices will likely lead to reduced chronic disease risk in the case of diet-related diseases, the purpose of labeling, such as the “healthy” claim, is to provide information to help consumers choose foods that can help them build a healthy dietary pattern. This recognition does not make FDA's position arbitrary—far from it, FDA has made reasoned, rational choices for the limits for each nutrient included in the definition based on current nutrition science and Federal dietary guidance.
                        <PRTPAGE P="106145"/>
                    </P>
                    <P>We further note that the rationales for the added sugars and sodium limits are discussed at length in both the proposed rule (87 FR 59168 at sections VI.A.2.C. and VI.A.2.B) and elsewhere in this final rule (see sections V.D.4 (“Added Sugars”) and V.D.3 (“Sodium”)) and, as stated above, the definitions of nutrient content claims are not related to chronic disease risk, but to expressly or impliedly characterizing the levels of the nutrients in the food.</P>
                    <P>(Comment 146) One comment argues that the added sugars thresholds are arbitrary because we failed to articulate a consistent rationale for them. Another comment asserts that FDA lacked justification for its added sugars limit and therefore had not met the “reasoned basis” required by the APA.</P>
                    <P>(Response 146) We provided a reasoned scientific rationale for the added sugars limits in the proposed rule (87 FR 59168 at section VI.A.2.C) and in the final rule (see section V.D.4 (“Added Sugars”)). The proposed rule explained that while there is not a nutrient content claim for added sugars on which to begin to base our determination of the threshold levels for added sugars in the “healthy” claim, we were instead able to draw justification for the baseline level from consistency with how we were treating the other NTL like saturated fat.</P>
                    <P>The proposed rule explained that while there is not a nutrient content claim for added sugars on which to begin to base our determination of the threshold levels for added sugars in the “healthy” claim, we were instead able to draw justification for the baseline level from consistency with how we were treating the other NTL like saturated fat.</P>
                    <P>Once we had established an appropriate baseline limit, we went on to describe our reasoning each time a variation from the proposed baseline level of added sugars was determined to be appropriate based on market conditions, consumption patterns, or how added sugars are used in certain food groups. For example, while the baseline amount of added sugars to qualify for the “healthy” claim was proposed at 5% DV, we described in the proposed rule how added sugars usually are not present in vegetable, fruit, and protein products. We also stated our rationale for the variation in the section regarding fruit, that we did not want the addition of added sugars to such otherwise nutrient-dense food products (87 FR 59186).</P>
                    <P>We also note that, in response to comments, the final rule raises the added sugar limits for the vegetable, fruit, and protein food groups to accommodate small amounts of added sugars, which comments explained can be used to balance flavors when there is variation in natural sweetness of crops, or in sauces, seasonings and other recipe components. We also raised the added sugar limit for the whole grain food group based in part on comments that described the current market conditions such that a majority of recommended whole grain cereal products were unable to qualify to use the claim as proposed. Each of these adjustments were carefully considered and reasoned in crafting the final rule.</P>
                    <P>(Comment 147) One comment argues that a frozen vegetable product with a sauce and 300 mg of sodium being unable to qualify for the “healthy” claim because the amount of sodium is more than 230 mg is an arbitrary result when the foods (vegetables) are ones that consumers should be encouraged to select.</P>
                    <P>(Response 147) As stated previously, the goal of updating the criteria for a food being labeled with the “healthy” claim is to provide consumers with information to help them identify foods that are the foundation of a healthy eating pattern and the DGAs recommend nutrient-dense forms of foods to build a healthy dietary pattern. Although frozen vegetables can be nutrient-dense, including sodium in excess of the limits set in the rule makes a food one that may not be able to be used routinely in a foundational way. Labeling such a product as “healthy,” accordingly, would not serve the purposes of this rule—to help consumers have information to build healthy dietary patterns. This is particularly so when consumers have options for nutrient-dense forms of frozen vegetables that do not contain sodium in excess of the limits established for the “healthy” claim. Thus, that frozen vegetable products with sauces that exceed the sodium threshold do not qualify for the “healthy” claim is not arbitrary but is based on the scientific evaluation of how much sodium can be accommodated in a healthy dietary pattern and in the foundational foods that can be used to build such a diet. Additionally, as noted elsewhere in the rule, such products could be marketed with other claims describing their benefits that are not false or misleading.</P>
                    <P>(Comment 148) One comment asks FDA to market test the revised requirements to ensure they do not arbitrarily exclude nutrient-dense foods, such as small RACC foods, in violation of the APA. Another comment specifically argues that applying added sugars limits across a wide range of RACCs/serving sizes establishes arbitrary and overly restrictive requirements for foods with larger RACCs/serving sizes and would disqualify many nutrient-dense foods, including those that are encouraged by the Dietary Guidelines, from bearing the “healthy” claim.</P>
                    <P>(Response 148) Although we disagree with any assertion that the proposal was arbitrary in how the requirements were constructed, we have revised the final rule in light of a number of comments that raised concerns about the inability of foods with small RACC sizes to qualify for the claim under the proposed criteria because such foods would not have enough FGEs. In the final rule, we revised the requirements regarding the way small RACC foods can calculate FGEs, as discussed in Response 8, as well as expanding the exemption for raw fruits and vegetables to all single-ingredient foods, which will result in a number of small RACC foods qualifying without needing to address FGE requirements at all. These changes address the concern that this comment is expressing and result in more nutrient dense foods with small RACCs qualifying for the claim. We note that we also conducted a review of products currently available in the marketplace to help support our decisions to make changes to address issues such as this one raised in comments.</P>
                    <P>The application of the added sugar limits to foods with different serving sizes is also not arbitrary under the APA. Regardless of the size of the food product, it is the amount of added sugars being contributed to the diet that is the subject of the claim definition. Therefore, there is a reasoned basis for the added sugar limit, consistent with the stated purpose of the claim, to help consumers identify foods that are useful in creating a diet consistent with dietary recommendations. An added sugars limit for foods to qualify for the claim will help consumers stay under the recommended daily limit for this nutrient. Regardless of the size of the food product, it is the amount of added sugars being contributed to the diet that is the subject of the claim definition. Further, nutrient-dense foods, as described by the Dietary Guidelines, by definition have limited amounts of added sugars, so it is not likely that a nutrient-dense food that is recommended by the Dietary Guidelines would not be able to meet the NTL amounts specified in the final rule.</P>
                    <P>
                        (Comment 149) Several comments argue that the proposed rule deviates from the Dietary Guidelines and nutrition science without a “convincing” justification and that such 
                        <PRTPAGE P="106146"/>
                        a deviation violates the APA. One comment further asserts that there are “scant” explanations for the deviations from the Dietary Guidelines in the proposed rule. Another comment opines that the different levels of added sugars allowed in different food categories are arbitrary and deviate from the Dietary Guidelines.
                    </P>
                    <P>(Response 149) FDA disagrees that we did not provide justification or explanations for the requirements set forth in this rule that differ from the recommendations in the Dietary Guidelines. As a preliminary matter, and as discussed further in response 140, FDA is not required to precisely follow the Dietary Guidelines. Consistent with 7 U.S.C. 5341(a)(1) of the FD&amp;C Act, the definition of “healthy” established in this rule “promote[s]” the Dietary Guidelines. But it is true that, as explained elsewhere in this rule, in certain instances FDA determined that a deviation for the recommendations in the Dietary Guidelines was warranted to serve the purposes of this rule.</P>
                    <P>
                        FDA provided a reasoned justification for each of the criteria for bearing the claim “healthy” that differ from the recommendations in the Dietary Guidelines. The APA only requires that Agencies provide “a rational connection between the facts found and the choice made.” (
                        <E T="03">Motor Vehicles Mfrs. Ass'n of the United States Inc.</E>
                         v. 
                        <E T="03">State Farm Mut. Auto. Ins. Co.,</E>
                         463 U.S. 29, 43 (1983)). While current nutrition science and the Dietary Guidelines have provided the foundation for the revisions to the definition of “healthy,” FDA determined that certain deviations from the Dietary Guidelines were appropriate based on various considerations, such as consumer consumption patterns, our marketplace review of nutrient-dense foods encouraged by the Dietary Guidelines, or consistent evidence of beneficial health effects (
                        <E T="03">i.e.,</E>
                         that underlie qualified health claims or health claims) (see, 
                        <E T="03">e.g.,</E>
                         sections V.C. (“Food Group Equivalents”) and V.D.2 (“Saturated Fat”)). For each such deviation, FDA provided a justification. For example, as discussed in Response 32, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         discussed alternatives to dairy and, at the time the Dietary Guidelines was published, the only beverage that it identified as having a nutritional profile similar to cow's milk was soy-based, so the Dietary Guidelines specifically recommended the example of soy-based dairy alternative beverage products. In this rule, we include other plant-based beverages that have a similar nutrition profile to cow's milk in the beverage alternatives that can qualify for the “healthy” claim in the dairy category. While the Dietary Guidelines did not specifically recommend these other products, we found no reason to exclude these other beverages when they have the same nutrient profile as cow's milk, as the focus here is on the nutrient levels present, and they can serve as useful choices to maintain healthy dietary practices consistent with the purpose of the claim.
                    </P>
                    <P>
                        (Comment 150) One comment argues that FDA has not provided an adequate basis for its proposal to depart from the NTE approach that has been in place for decades, by basing this decision on reducing indiscriminate fortification. Another comment asserts that eliminating the NTE criteria was arbitrary, that there were internal inconsistencies in the limits FDA set for the NTL, and that FDA failed to justify those limits and the FGE requirements for combination products, citing 
                        <E T="03">Dist. Hosp. Partners, L.P.</E>
                         v. 
                        <E T="03">Burwell,</E>
                         786 F.3d 46, 59 (D.C. Cir. 2015) (agency action arbitrary and capricious if it is ” `internally inconsistent and inadequately explained' ”); 
                        <E T="03">Bus. Roundtable</E>
                         v. 
                        <E T="03">SEC,</E>
                         647 F.3d 1144, 1153 (D.C. Cir. 2011) (vacating rule that was “internally inconsistent and therefore arbitrary”).
                    </P>
                    <P>(Response 150) We disagree that we did not provide an adequate basis for eliminating the NTE as part of the definition of the “healthy” claim. The comment asserts incorrectly that FDA based this decision solely on reducing indiscriminate fortification. FDA recognizes that it is aware of and discussed the concern with indiscriminate fortification, but the comment ignores the explanation provided above and in the proposed rule regarding the reasons for changing the definition of the “healthy” claim—namely the shift in nutrition science toward overall eating patterns and away from focusing on the amounts of individual nutrients consumed. That definitional changed involved, in part, replacing specific NTE with FGEs, as already addressed in section V.C (“Food Group Equivalents”).</P>
                    <P>
                        The comment does not specify how it believes the levels for the NTL are internally inconsistent, but in both the proposed rule and here in the final rule, FDA has provided lengthy discussion and justification for the qualifying levels set for the NTL for all types of products. Specifically for combination products, FDA has laid out the basis for how each limit was determined and how foods can satisfy the criteria if those foods can serve as a mixed product, main dish, or meal product. For example, after detailing how the sodium limit for individual foods was set at 10% DV and how that baseline level is consistent with sodium reduction efforts and the current status of the food supply, the proposed rule explained each time there was a variation from the baseline level for a particular food group or subgroup why the value was adjusted from the baseline (
                        <E T="03">e.g.,</E>
                         5% instead of 10% DV for salad dressings and oil-based spreads because of their small RACC size). Then, for combination products, the proposed rule further explained how the NTL levels for each of the food groups in the product would be averaged together for mixed products and added together for main dishes and meal products. This consistent approach was taken for each of the NTL in the proposed rule. In this final rule, FDA streamlined and further standardized these requirements so that manufacturers do not need to consider as many different nutrient levels when looking to calculate whether they meet the NTL criteria for their products. This change was made in response to a number of comments that requested more simplicity (see section V.E (“Combination Foods”)). The final rule is internally consistent and has a reasoned basis for each of the values.
                    </P>
                    <P>Additionally, the citations to the two cases regarding internal inconsistency are misplaced for the reasons provided above. Every decision about the nutrient limits and FGEs was consistently made to further the goal of helping consumers identify foods that are particularly useful in building a healthy dietary pattern consistent with current dietary recommendations. In certain cases, different levels for different nutrients or different food groups were determined to best further this goal because of factors like current market conditions and consumer consumption patterns. This difference in nutrient levels does not make the rule or its justifications internally inconsistent, but rather makes them narrowly tailored to achieving the rule's goals.</P>
                    <P>(Comment 151) Several comments assert that the APA prohibits FDA from implementing the proposed rule because of its overly narrow definition of the word “healthy” and arbitrarily restrictive labeling standards.</P>
                    <P>
                        (Response 151) The comments do not explain the basis for the assertion that the “narrowness” and “restrictiveness” of the definition of the claim “healthy” is arbitrary or capricious under the APA. Elsewhere in the rule, for example, in Response 143, we have explained why the definition is not arbitrary or capricious under the APA. As we have stated previously, the “healthy” claim is voluntary and has 
                        <PRTPAGE P="106147"/>
                        been defined by regulation since 1994 for use when it suggests that the food is useful in creating a diet consistent with dietary recommendations. It is not arbitrary to restrict the use of this claim to foods that meet nutritional parameters consistent with current dietary recommendations in nutrition science and Federal dietary guidance and it is not overly narrow to tailor the definition to ensure that the claim only appears on the labels of foods that will help consumers achieve these dietary recommendations, given the current food marketplace and consumption patterns.
                    </P>
                    <P>(Comment 152) One comment argues that it is illogical that an ingredient could be used in an authorized health claim but at the same time disqualify a food from bearing the “healthy” claim.</P>
                    <P>(Response 152) Health claims provide information about a specific food substance and a specific disease, while the “healthy” nutrient content claim provides information to help consumers identify foods that are foundational to establishing and maintaining healthy dietary practices consistent with current nutrition guidance. These are different purposes and there may be times where a health claim discusses a specific benefit, such as reducing dental caries, but the food may not meet the broader criteria for the “healthy” claim due to nutrient levels that are not consistent with the purpose of the “healthy” claim.</P>
                    <HD SOURCE="HD3">3. First Amendment</HD>
                    <P>(Comment 153) Some comments say that the use of the “healthy” claim on products that do not meet the updated regulatory criteria to bear the claim are truthful, non-misleading commercial speech that is protected by the First Amendment. One comment asserts that FDA cannot narrowly define a term and then conclude that any other use of that term is misleading. Another comment says that the use of the “healthy” claim on non-compliant products cannot be false or misleading because a large number of products that would be excluded from the proposed definition of “healthy” are products that are currently promoted by the Dietary Guidelines. Other comments say that FDA has not provided evidence that using the “healthy” claim for foods that comply with the original regulations is false or misleading.</P>
                    <P>(Response 153) We disagree with these comments to the extent that they suggest that updating the definition of “healthy” will restrict truthful and non-misleading speech. The intention behind the statutory and regulatory requirements for nutrient content claims on food labels or labeling, including any “healthy” claims, is to help ensure that consumers are adequately informed and not misled by such claims so that they can identify foods that may help them maintain healthy dietary practices. It is appropriate and consistent with the statutory and regulatory framework for FDA to update the definition of “healthy” based on current science to help ensure that the claim remains truthful and non-misleading. As we have explained since 1994, the use of “healthy” constitutes an implied claim that a food, “based on [its] nutrient levels, [is] particularly useful in constructing a diet that conforms to current dietary guidelines” (see 59 FR 24232 at 24233). When dietary guidelines change, a formerly truthful and non-misleading “healthy” claim can become misleading if it no longer accords with those guidelines. Thus, contrary to the suggestions in the comments, updating the “healthy” definition in light of that current science is necessary to ensure that the use of the claim does not lead consumers astray. Indeed, Congress' purpose in enacting this legislation was to help ensure that consumers are not misled and that they can make informed nutritional choices without confusion caused by the use of claims with inconsistent meanings.</P>
                    <P>
                        Through the Nutrition Labeling and Education Act (NLEA) of 1990, Congress granted FDA the authority to regulate nutrient content claims because it recognized that consumers were being misled by the use of inconsistent and confusing terms on food labeling. See, 
                        <E T="03">e.g.,</E>
                         136 Cong. Rec. H5836, H5840 (July 30, 1990) (statement of Rep. Waxman) (“[Under the NLEA,] content claims would have to be consistent with terms defined by . . . the Food and Drug Administration. Today, companies use terms such as `low' and `light' differently and inconsistently. . . . The bill would correct this deceptive and misleading state of affairs by requiring that terms such as `light' have a single meaning.”) and id. at H5843 (statement of Rep. Madigan) (“Consumers today are confronted with a variety of labels that provide them with disjointed and confusing information. . . . In the past few years, important scientific evidence has been repeatedly reported that clearly links dietary habits to good health. For this reason, the need to provide consumers with better information about the foods they eat is important.”); see also 136 Cong. Rec. H12951, H12953-54 (October 26, 1990) (statement of Rep. Madigan) (“[T]he bill requires that content claims such as light, low, et cetera, would have to be consistent with terms defined by the FDA. This is to address the current problem of companies using these terms differently and inconsistently.”). As discussed at length in the preamble to the proposed rule and in section IV (“Legal Authority”), the NLEA created section 403(r) of the FD&amp;C Act, which provides specifications for a claim made in the label or labeling of the food which expressly or by implication characterizes the level of any nutrient which is the type required by section 403(q)(1) or (2) of the FD&amp;C Act to be in the label or labeling of the food. The statute permits the use of these label and labeling claims that expressly or by implication characterize the level of any nutrient in a food, but only if the claims are made in accordance with FDA's authorizing regulations (section 403(r)(1)(A) and (r)(2)(A) of the FD&amp;C Act). Such claims are referred to as “nutrient content claims” (87 FR 59168 at 59174). By taking this approach in the NLEA, Congress permitted only those nutrient content claims that FDA defines or approves. 58 FR 2302, 2392 (January 6, 1993); see also 136 Cong. Rec. S06607, S16608 (October 24, 1990) (statement of Sen. Metzenbaum) (“[FDA] is required to define in regulations the terms which may be used to characterize the level of a nutrient in food. In determining which terms to allow, the Secretary should consider the different ways such terms are used today. . . . By considering current uses and current consumer understanding, the Secretary can best decide how to define the term under this bill.”). To assist consumers in maintaining healthy dietary practices, and to ensure that claims in food labeling do not mislead them, Congress granted FDA broad authority to develop appropriate definitions for nutrient content claims. See id. at S16609 (statement of Sen. Metzenbaum).
                    </P>
                    <P>
                        Shortly after the NLEA was passed, in 1994, FDA issued an implementing regulation in which we defined “healthy” when the term is used as an implied nutrient content claim. We explained that we determined that, when used in a nutritional context, the term “healthy” is making an implied claim about the levels of the nutrients in the food; that is, that these levels are such that the food would be useful in maintaining healthy dietary practices and achieving a total diet that conforms to current dietary recommendations (56 FR 60421 at 60423). Therefore, since 1994, our regulations have included an established definition for the “healthy” nutrient content claim, which highlights that a food, because of its nutrient content, is particularly useful in 
                        <PRTPAGE P="106148"/>
                        constructing a diet that is consistent with to current dietary guidelines.
                    </P>
                    <P>
                        In line with its statutory authority, FDA has given the nutrient content claim “healthy” a definition with a “special and particular meaning” (
                        <E T="03">Am. Acad. of Pain Mgmt</E>
                         v. 
                        <E T="03">Joseph,</E>
                         353 F.3d 1099, 1108 (9th Cir. 2004)). As such, the use of the nutrient content claim “healthy” without meeting the established criteria is at least potentially misleading, because it may convey to consumers and the public that FDA's established definition for the term has been met, which it has not (see id.). As we have said previously, “because nutrition claims are of great importance to the public,” they have “a greater potential to be deceptive,” and they are “difficult for consumers to verify independently” (58 FR 2302 at 2394). FDA's efforts to establish and update the criteria for the “healthy” nutrient content claim are reflective of its statutory mandate to standardize nutrition and health-related terms on food labels or labeling, by regulation, for the benefit of consumers.
                    </P>
                    <P>
                        To the extent that these comments suggest that FDA did not provide evidence demonstrating the need to update the definition for the “healthy” nutrient content claim, we also disagree. FDA provided evidence throughout the proposed rule that the existing definition of “healthy” is outdated and in some ways inconsistent with current nutrition science and Federal dietary guidance (see, 
                        <E T="03">e.g.,</E>
                         87 FR 59168, 59172 at section IV.B., “Need to Update `Healthy' ”). The proposed rule provides, among other things, that the existing definition relies on nutrients that were of sufficient public health significance to warrant their inclusion on the nutrition label in 1994, when the final rule was published, and FDA has issued final rules updating the nutrition information on food labels in various ways since then to be consistent with nutrition science over time. It also discusses how the Dietary Guidelines have changed to focus on the importance of dietary patterns as a whole and replacement of less healthy food choices with nutrient-dense foods and provided examples of certain foods that are encouraged by the 
                        <E T="03">Dietary Guidelines</E>
                         that cannot bear the “healthy” claim under the existing definition (id.). The proposed rule explained that, in light of evolving nutrition science and Federal dietary guidance, changes to the criteria for the “healthy” claim are important to ensure that the claim is consistent with the longstanding purpose of this type of implied claim to indicate that the nutrient levels in a food may help consumers maintain healthy dietary practices (87 FR 59168 at 59172 through 59173). As explained throughout this section, such changes also advance FDA's goals of preventing misleading labeling and reducing consumer confusion potentially caused by the use of inconsistent definitions for nutrient content claims.
                    </P>
                    <P>
                        Moreover, we disagree that the use of the “healthy” claim on non-compliant products cannot be false or misleading because a large number of products that would be excluded from the proposed definition of “healthy” are products that are currently promoted as healthy by the 
                        <E T="03">Dietary Guidelines.</E>
                         Dietary recommendations can change and evolve over time as scientific evidence develops, and therefore, a food that was recommended to be consumed as the foundation of a healthy dietary pattern years ago could no longer be considered a foundational food. We explain throughout this rule that the updated “healthy” criteria are consistent with the Dietary Guidelines recommendations to consume nutrient-dense foods (
                        <E T="03">e.g.,</E>
                         containing little or no added sugars, saturated fat, and sodium) and we provide examples of specific foundational foods promoted by the Dietary Guidelines that would qualify to bear the “healthy” claim based on the updated criteria (
                        <E T="03">e.g.,</E>
                         certain varieties of fruits and vegetables, whole grains, fat-free and low-fat dairy, lean meat, eggs, beans, peas, lentils, nuts, seeds, water, etc.). However, where possible and consistent with current dietary recommendations, FDA has adjusted certain criteria to provide greater flexibility for foods to qualify to bear the “healthy” claim in this final rule. Our response to comments raising similar concerns can be found in Response 155.
                    </P>
                    <P>
                        (Comment 154) Several comments say that the proposed updated criteria for the “healthy” claim is a restriction on commercial speech and question whether it would satisfy the First Amendment test set forth in 
                        <E T="03">Central Hudson Gas &amp; Elec. Corp.</E>
                         v. 
                        <E T="03">Pub. Serv. Comm'n,</E>
                         447 U.S. 557, 563-66 (1980). One comment asserts that FDA does not have a substantial government interest as required by 
                        <E T="03">Central Hudson</E>
                         because government lacks “an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information,” citing 
                        <E T="03">Thompson</E>
                         v. 
                        <E T="03">W. States Med. Ctr.,</E>
                         535 U.S. 357, 374 (2002). Other comments argue that the proposed criteria for the “healthy” claim do not directly and materially advance FDA's substantial interest in reducing chronic disease. Some of these comments cite the proposed rule to support this assertion because its quantifiable benefits calculation estimated that “a small number (0 to 0.4% of people that try to follow current dietary guidelines) of . . . consumers would use the `healthy' implied nutrient content claim to make meaningful, long-lasting food purchasing decisions” (87 FR 59168 at 59168, 59195).
                    </P>
                    <P>
                        (Response 154) As a preliminary matter, as discussed in Response 153, the intention behind the statutory and regulatory requirements for nutrient content claims on food labels or labeling, including any “healthy” claims, is to help ensure that consumers are adequately informed and not misled by such claims so that they can identify foods that may help them maintain healthy dietary practices. The use of the “healthy” claim on products that do not meet the updated criteria for “healthy” may be misleading for several reasons, including that such use may imply that the definition and regulatory requirements have been met when they have not. The use of “healthy” on food labels or labeling could be shown to be misleading for a myriad of other reasons based on the particular product and circumstances. Because, under the threshold step of the 
                        <E T="03">Central Hudson</E>
                         framework, the government can restrict speech that is false or inherently or actually misleading, at least some “healthy” claims would not be entitled to First Amendment protection because they are false or misleading.
                    </P>
                    <P>
                        However, on a facial challenge, it may not be possible to categorically determine whether the universe of hypothetical claims is false or misleading. Under the 
                        <E T="03">Central Hudson</E>
                         framework, if commercial speech is truthful and is not inherently or actually misleading, the government must establish that the regulation directly advances a substantial government interest, and the regulation is no more extensive than necessary to serve that interest (
                        <E T="03">Central Hudson,</E>
                         447 U.S. at 563-66). That means that government regulation of speech that is 
                        <E T="03">potentially misleading</E>
                         is subject to review under these remaining 
                        <E T="03">Central Hudson</E>
                         steps. See, 
                        <E T="03">e.g., Pearson</E>
                         v. 
                        <E T="03">Shalala,</E>
                         164 F.3d 650, 655 (D.C. Cir. 1999); 
                        <E T="03">Public Citizen, Inc.</E>
                         v. 
                        <E T="03">La. Atty. Disciplinary Bd.,</E>
                         632 F.3d 212, 218 (5th Cir. 2011). Under the 
                        <E T="03">Central Hudson</E>
                         framework, “there is no question” that the government's interest “in ensuring the accuracy of commercial information in the marketplace is substantial,” 
                        <E T="03">Edenfield</E>
                         v. 
                        <E T="03">Fane,</E>
                         507 U.S. 761, 769 (1993), including “undoubtedly” the “[p]rotection of health and prevention of consumer fraud.” 
                        <E T="03">Bellion Spirits, LLC</E>
                         v. 
                        <E T="03">
                            United 
                            <PRTPAGE P="106149"/>
                            States,
                        </E>
                         393 F. Supp. 3d 5, 24 (D.D.C. 2019), 
                        <E T="03">aff'd,</E>
                         7 F.4th 1201 (D.C. Cir. 2021).
                    </P>
                    <P>
                        Here, the substantial government interest is in providing information to consumers to indicate that the nutrient content of a food may help them maintain healthy dietary practices to promote public health, preventing misleading labeling, and reducing consumer confusion potentially caused by the use of inconsistent definitions for nutrient content claims. Courts have long recognized that the government has a significant interest in promoting or protecting public health by regulating the information in food labeling. See, 
                        <E T="03">e.g., Rubin</E>
                         v. 
                        <E T="03">Coors Brewing Co.,</E>
                         514 U.S. 476, 485 (1995); 
                        <E T="03">see also Am. Meat Inst.</E>
                         v. 
                        <E T="03">U.S. Dep't Agric.,</E>
                         760 F.3d 18 (D.C. Cir. 2014) (en banc) (finding individual health concerns related to food products to be one of several substantial government interests underlying USDA labeling disclosures); 
                        <E T="03">N.Y. State Rest. Ass'n</E>
                         v. 
                        <E T="03">N.Y. City Bd. of Health,</E>
                         556 F.3d 114, 134 (2d Cir. 2009) (recognizing “informed consumer decision-making so as to reduce obesity and the diseases associated with it” through posting of calorie content information on menus as a substantial government interest); 
                        <E T="03">Bellion Spirits, LLC</E>
                         v. 
                        <E T="03">United States,</E>
                         393 F. Supp. 3d at 25 (stating that the Alcohol and Tobacco Tax and Trade Bureau preventing a company from labeling and advertising its alcohol product to promote its biological benefits is directly connected to the substantial government interests of promoting health and preventing potential consumer deception). Moreover, we disagree that the Court's rationale in 
                        <E T="03">Western States</E>
                         is applicable to this rulemaking. In that case, the Court explained that, in general, the government should not restrict product advertising for the sole purpose of preventing members of the public from making bad decisions based on the advertising information. However, as described above, the interests here do not involve preventing members of the public from making bad decisions. To the contrary, the updated requirements to use the “healthy” claim support consumer choice. The requirements advance government interests related to providing consumers with important product information at the point of sale so that they can identify foods that may help them maintain healthy dietary practices if they choose, and preventing misleading labeling and reducing consumer confusion potentially caused by the use of inconsistent definitions for nutrient content claims.
                    </P>
                    <P>
                        The updated definition directly advances our substantial government interests in providing information to consumers to indicate that the nutrient content of a food may help them maintain healthy dietary practices to promote public health, preventing misleading labeling, and reducing consumer confusion potentially caused by the use of inconsistent definitions for nutrient content claims. Updating the “healthy” definition to ensure that it is aligned with current nutrition science and Federal dietary guidance promotes public health by providing consumers with information about foods that, because of their nutrient content, are particularly useful in constructing a diet that is consistent with current dietary recommendations. Consumers may then use that information, at the point of decision-making, to identify foods that are foundational to a healthy diet. As explained in the preamble to the proposed rule, advancements in nutrition science have provided a greater understanding of, and focus on, the importance of healthy dietary patterns, and how dietary components may act synergistically to affect health. Other regulations, such as those updating the Nutrition Facts label and serving size information for packaged foods, have been updated to reflect new scientific information, including the 
                        <E T="03">Dietary Guidelines, 2015-2020,</E>
                         consensus reports, national survey intake data, and research regarding consumer use and understanding of the label. 87 FR 59172. Likewise, the updated criteria for the “healthy” claim, outlined in this rule, reflect the recommendations of the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         which have shifted to recommending healthy dietary patterns and the consumption of food groups in certain quantities to achieve adequate nutrient intake, based on the understanding that each food group contributes an array of important nutrients to the diet. Specifically, the updated “healthy” criteria include food group requirements instead of requirements for NTE (as in the original “healthy” definition) to reflect current nutrition science and Federal dietary guidance, including the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         which describes a healthy dietary pattern as consisting of “nutrient-dense forms of foods and beverages, across all food groups, in recommended amounts, and within calorie limits.” As stated previously, the food group approach better accounts for how nutrients contribute to, and may work synergistically to create, a healthy dietary pattern and improve health outcomes (see sections V.C. “Food Group Equivalents” and V.D.6 “Nutrients to Encourage” for further discussion about FGE requirements and NTE). Moreover, as explained further in other parts of this rule, the updated criteria also change the NTL requirements, for example, by incorporating limits on added sugars and removing limits on total fat and cholesterol. These changes reflect current nutrition science and the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         which now emphasize limiting added sugars intake and have moved away from recommending a specific intake for total fat. Rather, current dietary recommendations emphasize replacement of saturated fats in the diet with unsaturated fats, particularly polyunsaturated fats, and a dietary pattern that is low in saturated fat is typically low in dietary cholesterol (rendering a cholesterol limit unnecessary). (See section V.D.4 “Added Sugars” for further discussion of the added sugars limits and section V.D.5 “Nutrients Not Included” for further discussion of the elimination of total fat and dietary cholesterol limits in the updated “healthy” criteria).
                    </P>
                    <P>As demonstrated by these examples, and by others throughout the rule, this rule ensures that the criteria for “healthy” are harmonized with current regulations, nutrition science, and Federal dietary guidelines, and therefore that the “healthy” claim accurately indicates to consumers that a food, based on its nutrient levels, may help them maintain healthy dietary practices. Providing this information to consumers enables them to make more informed choices about the foods that can be the foundation of a healthy dietary pattern. It also comports with the legislative objectives of the NLEA to empower FDA to standardize nutrient content claims to ensure that they are accurate, not misleading, and can help consumers identify foods that can help them maintain healthy dietary practices.</P>
                    <P>
                        In addition, the updated definition prevents misleading labeling and reduces consumer confusion potentially caused by the use of inconsistent definitions for nutrient content claims by requiring that foods bearing the “healthy” claim meet standardized nutritional criteria that reflects current, up-to-date, nutrition science and dietary recommendations. As discussed in Response 153, the need for consistent labeling claims on foods to prevent the public from being misled was an explicit motivation of Congress when it passed the NLEA's nutrient content claim provisions. See, 
                        <E T="03">e.g.,</E>
                         136 Cong. Rec. H12954 (October 26, 1990) (statement of Rep. Moakley) (“The 
                        <PRTPAGE P="106150"/>
                        current format for nutrition labeling on foods is often inadequate for today's consumer needs. In many cases the information is confusing and, in some cases, very misleading. Terms such as lite, high fiber, and low cholesterol, which now have little or no guidelines, will be defined and their use restricted to the FDA definition. This bill will help curb misleading claims . . .”). As such, the updated definition directly advances the goals of preventing misleading labeling and reducing consumer confusion potentially caused by the use of inconsistent definitions for nutrient content claims by ensuring that the term, “healthy,” when used in a nutritional context, has a consistent meaning that is supported by current nutrition science and Federal dietary guidance. Moreover, an updated, consistent definition for “healthy” enables consumers to identify foods that, based on current nutrition science and Federal dietary guidance, are particularly useful in building a healthy eating pattern, and to make more informed food selections and comparisons.
                    </P>
                    <P>We further disagree that the updated criteria for the “healthy” claim do not directly advance FDA's asserted government interests due to the quantifiable benefits calculation included in the proposed rule. This calculation considers numerous factors to estimate all of the potential benefits of the rule, such as a reduction in all-cause morbidity and mortality stemming from consumers selecting and consuming more healthful foods. However, as explained throughout this rule, the longstanding purpose of FDA's definition of the “healthy” nutrient content claim is to provide information to consumers that indicates that the nutrient levels of a food may help consumers maintain healthy dietary practices. Achieving specific changes in rates of chronic disease are not the government interests we assert, and the law therefore does not require that such changes be demonstrated.</P>
                    <P>(Comment 155) One comment states that, while FDA does have a substantial interest in promoting public health through lawful restrictions on food labeling, the proposed added sugars and sodium limits for grain products would not directly advance that objective and would prohibit a broad range of nutrient-dense whole grain products from bearing “healthy,” which is in conflict with FDA's public health objectives and the Dietary Guidelines.</P>
                    <P>
                        (Response 155) We disagree that the added sugars and sodium limits, as applied to grain products, do not advance FDA's asserted interests, and that the sodium limit for grain products in this final rule would prohibit a broad range of nutrient-dense, whole grain products from bearing the “healthy” claim. The 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         emphasizes that there is little room in most dietary patterns for excess sodium and state that shifts to more nutrient-dense forms of grains will help consumers to build healthy dietary patterns. Whole grain products that meet the established criteria for sodium are particularly useful, because of their nutrient content (including sodium amounts), in helping consumers identify foods that are the foundation of a healthy dietary pattern. As explained in section V.D.3 (“Sodium”), the sodium limits for grain products are consistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         which recommends that consumers limit sodium in their diets as part of building healthy dietary patterns. Our marketplace review conducted in response to comments on this topic demonstrates that there are many whole grain products, including whole grain bread products (
                        <E T="03">i.e.,</E>
                         English muffin products and some whole grain tortillas) and cereals, that meet the ≤10% DV limit for sodium.
                    </P>
                    <P>
                        We note that after considering comments received, this final rule has increased the added sugars limit for whole grain products from ≤5% DV to ≤10% DV. FDA has determined that increasing the added sugars limit for whole grain products to ≤10% DV aligns with the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         by resulting in more whole grain cereal products, which can be important sources of nutrients based on their high likelihood of fortification, being able to qualify for the “healthy” claim. This increase is supported by our marketplace review that examined the added sugars content of whole grain products, including ready-to-eat cereals, hot cereals, and whole grain breads and crackers.
                    </P>
                    <P>
                        In alignment with the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         the framework of this rule emphasizes healthy dietary patterns and nutrient density by incorporating both FGE criteria and NTL criteria in the definition for the “healthy” claim. The FGE criteria combined with the added sugars and sodium limits ensure that grain products are nutrient-dense and contain levels of those nutrients that will help consumers identify foods that can be the foundation for a healthy dietary pattern, consistent with current nutrition science and Federal dietary guidance. Accordingly, such limits directly advance FDA's government interests in providing information to consumers that indicates that a food's nutrient content may help them maintain healthy dietary practices to promote public health, preventing misleading labeling, and reducing consumer confusion potentially caused by the use of inconsistent definitions for nutrient content claims.
                    </P>
                    <P>
                        (Comment 156) Several comments state that the updated criteria are unduly restrictive and are therefore unconstitutional under 
                        <E T="03">Central Hudson.</E>
                         Some comments say that FDA is required to demonstrate that the updated criteria are the least restrictive means to achieve our goals, which the comments assert it cannot do. Other comments state that the criteria are more extensive than necessary to serve FDA's substantial government interest and are thus constitutionally impermissible under 
                        <E T="03">Central Hudson.</E>
                         One comment argues that FDA failed to consider less restrictive alternatives for the updated criteria because FDA could run a public education campaign to discourage consumers from eating food with added sugars or encourage them to eat foods that contain large servings from multiple food groups, which would lead consumers to eat food that FDA prefers. Some comments assert that FDA could engage in its own affirmative speech by running advertisements or distributing literature promoting its own vision of what constitutes a healthy diet and that Supreme Court precedent requires FDA to consider whether it can achieve its goals through its own informational efforts.
                    </P>
                    <P>
                        (Response 156) We disagree that the rule is unduly restrictive. As an initial matter, more than one comment mischaracterizes the relevant inquiry under the 
                        <E T="03">Central Hudson</E>
                         standard, stating that the rule must be the least restrictive means to achieve the asserted government interest. The standard does not require the government to adopt the least restrictive means of advancing its goal (
                        <E T="03">Bd. of Trustees of the State Univ. of New York</E>
                         v. 
                        <E T="03">Fox,</E>
                         492 U.S. 469, 480 (1989)). Instead, the relevant inquiry is whether the fit between the government's ends and the means chosen to accomplish those ends “is not necessarily perfect, but reasonable” (Id.). Put another way, the question is not whether there is “no conceivable alternative” but instead whether the “regulation [does] not burden substantially more speech than is necessary to further the government's interests.” 
                        <E T="03">Fleminger, Inc.</E>
                         v. 
                        <E T="03">U.S. Dep't of Health &amp; Hum. Servs.,</E>
                         854 F. Supp. 2d 192, 196 (D. Conn. 2012), citing 
                        <E T="03">Clear Channel Outdoor, Inc.</E>
                         v. 
                        <E T="03">City of New York,</E>
                         594 F.3d 94, 104 (2d Cir. 2010); 
                        <E T="03">Bd. of Trustees,</E>
                         492 U.S. at 478.
                        <PRTPAGE P="106151"/>
                    </P>
                    <P>
                        FDA's approach to updating the definition for “healthy” is no more extensive than necessary to serve our interests in providing information to consumers to indicate that a food's nutrient content may help them maintain healthy dietary practices to promote public health, preventing misleading labeling, and reducing consumer confusion potentially caused by the use of inconsistent nutrient content claims. The “healthy” nutrient content claim is voluntary. As we have discussed previously, nutrient content claims are not prohibited, but are permitted by statute and regulation under a range of circumstances. See section 403(r) of the FD&amp;C Act and part 101, subpart D, “Specific Requirements for Nutrient Content Claims.” Nutrient content claim regulations prescribe that the information be presented in standardized form, using uniform terms defined by the Agency, so that consumers will not be misled (58 FR 2302 at 2394). Moreover, nutrient content claims are just one type of claim permitted on food labeling. As stated in multiple parts of this rule, there are many other avenues available for manufacturers to promote the benefits, including the nutrition- or health-related benefits, of their food products on their product labels or labeling. However, where the “healthy” claim is used in a nutritional context, and therefore suggests that a food, because of its nutrient content, may help consumers maintain healthy dietary practices, FDA's approach ensures that the foods meeting the criteria to bear the claim are those that can be consumed to help consumers in achieving a total diet that conforms to current dietary recommendations. This approach is a “reasonable fit” between FDA's ends and the means chosen to accomplish those ends (
                        <E T="03">Fox,</E>
                         492 U.S. at 480).
                    </P>
                    <P>
                        We carefully considered the requirements of the updated criteria to ensure they align with current nutrition science and Federal dietary guidance, including the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         while providing flexibility where possible, based on relevant information such as current market conditions, consumer consumption patterns, consistent evidence of beneficial health effects, and our marketplace review. In certain instances, the rule sets forth exceptions from the updated criteria for certain foods that can contribute to a healthy dietary pattern without meeting the baseline FGE or NTL requirements. For example, after considering comments related to foods with small RACCs and their inability to meet FGE requirements, FDA determined that it is appropriate to apply the “healthy” criteria to individual foods with a RACC less than 50 g or less than 3 Tbsp on a per 50 g basis instead of a per RACC basis. This adjustment for small RACC foods is reflective of current nutrition science and Federal dietary guidance because there are many foods recognized by the Dietary Guidelines that are foundational to a healthy dietary pattern but that have RACCs that are smaller than the required FGE. As another example, the rule excludes the inherent saturated fat content in seafood and nuts, seeds, and soybeans, from the saturated fat limit because they have a fatty acid profile that is predominantly unsaturated fats, and scientific evidence demonstrates that there is a beneficial relationship between fatty acids contained in these foods and reduced risk of heart disease.
                    </P>
                    <P>
                        Moreover, FDA carefully tailored the final rule by making adjustments across FGE and NTL criteria and food categories. Compared to the proposed rule, the final rule establishes more generous limits for FGEs for dairy products and for added sugars limits in a variety of food categories, such as grains, fruits and vegetables, protein foods, and mixed products and main dishes. Where no adjustments have been made, we determined, based on a number of factors, including practical considerations (
                        <E T="03">e.g.,</E>
                         current market conditions and the feasibility of food products in certain categories meeting the criteria, ability of consumers to choose from multiple options in such categories), that the foods that are eligible to bear the claim are those that are particularly useful in helping consumers to achieve a diet that conforms to current dietary recommendations.
                    </P>
                    <P>We disagree with the comments that suggest that informational efforts, such as a consumer education and outreach campaign, would be a sufficiently effective alternative to advancing the government interests. FDA recognizes the utility of consumer education and outreach campaigns and plans to educate consumers on the use of and updated definition for the “healthy” claim (see section V.L.4 “Comments Regarding Consumer Education” for further discussion of consumer education about the updated “healthy” definition). However, we disagree that a consumer education campaign of the type suggested by the comment would be an appropriate alternative to the rule.</P>
                    <P>
                        Even if a consumer education campaign, or other informational efforts led by FDA, including advertising and other literature, were appropriately designed to inform consumers about foods that are foundational to a healthy eating pattern, these efforts alone are not a practical or legitimate alternative to updating the criteria for the “healthy” claim. However helpful such efforts may be in providing general information to consumers about building a healthy eating pattern, they are no substitute for the updated “healthy” requirements, which, consistent with Congressional intent, ensure that the “healthy” claim on a specific food product serves as a quick signal to consumers, at the point of decision-making, that the food is particularly useful in achieving a diet that is consistent with current dietary recommendations. This situation is thus very far from that considered in 
                        <E T="03">Nat'l Inst. of Family &amp; Life Advocates</E>
                         v. 
                        <E T="03">Becerra (NIFLA),</E>
                         where the Court found it crucial that California was seeking to compel private clinics to provide notice that “in no way relate[d] to the services th[e] licensed clinics provide” but, instead, “require[d] these clinics to disclose information about 
                        <E T="03">state</E>
                        -sponsored services.” 585 U.S. 755, 769 (2018). The Court's conclusion that a State-sponsored public information campaign is appropriate and effective to inform the public about a State-sponsored service is unremarkable. In the context of a communication about a specific food product's nutritional content, however, informational efforts may not reach the same audience in the same timeframe as a “healthy” claim that is compliant with the updated criteria, and the generalized content of the informational campaign efforts would not be directly targeted to communication about a specific product. Here, in contrast to the situation in 
                        <E T="03">NIFLA,</E>
                         we are regulating claims a private party makes about the very product it is selling.
                    </P>
                    <P>
                        Furthermore, these comments' suggestions would produce the result of FDA failing to update the original “healthy” definition, established in 1994, which is outdated and, in some ways, inconsistent with current nutrition science and Federal dietary guidance, while conducting consumer education and outreach to inform consumers about foods that, based on their nutrient levels, are particularly useful in constructing a diet that conforms to 
                        <E T="03">current</E>
                         dietary recommendations. Educational and outreach efforts of this nature are not a viable regulatory alternative because they could contradict the use of the existing “healthy” claim due to such claim's reliance on nutrition science and Federal dietary guidance from 1994. Accordingly, these efforts, by themselves, cannot ensure that the use 
                        <PRTPAGE P="106152"/>
                        of the “healthy” claim on food packages is consistent with current nutrition science and Federal dietary guidance. Nor do they signal to the consumer, at the point of decision-making, that a specific food is particularly useful in helping them to build a diet that conforms to current dietary recommendations. As such, while we considered a variety of alternative approaches, we determined that they would be insufficiently effective in advancing FDA's interests in providing information to consumers to indicate that a food, because of its nutrient content, may help them maintain healthy dietary practices to promote public health, preventing misleading labeling, and reducing consumer confusion potentially caused by the use of inconsistent nutrient content claims.
                    </P>
                    <P>We note that FDA's nutrition labeling efforts, including this rule, are broadly intended to provide information to consumers about foods that can help them identify healthier choices and build a healthy eating pattern. Additionally, as explained further in section III. (“Background”), the rule does not represent an endorsement of certain foods by FDA and is not intended to discourage the consumption of certain foods as part of the total diet. To put it plainly, FDA does not have “preferences” about foods that consumers eat or do not eat, and therefore, any consumer education campaign pursued by FDA could not be designed to discourage or encourage consumption of foods consistent with such “preferences.”</P>
                    <P>(Comment 157) One comment asserts that the proposed definition of “healthy” would burden “far more speech than necessary” because it prevents “most objectively healthy foods,” including those promoted by the Dietary Guidelines, from bearing the “healthy” claim. Some comments argue that a large percentage of foods on the official recipe website of the Dietary Guidelines would be unable to bear the “healthy” claim. One comment further asserts that many nutrient-dense foods, including many whole grain breads, breakfast bars, yogurts, cereals, canned fruits, canned vegetables, and salad kits could not bear the claim, even though they are included in the current Dietary Guidelines.</P>
                    <P>
                        (Response 157) We disagree that the updated definition of “healthy” is more restrictive than necessary to serve our interests because it excludes “most objectively healthy foods,” including those promoted by the Dietary Guidelines or included in the recipes on the Dietary Guidelines website. As discussed at length in different parts of this rule, foods that are eligible to bear the “healthy” claim are those that are particularly useful in constructing a diet that conforms to current dietary recommendations. Foods that do not qualify for “healthy” are not necessarily “unhealthy” and may still be part of a healthy dietary pattern, and their nutritional attributes can be conveyed to consumers through other truthful and not misleading statements on the food label or in food labeling. Furthermore, many of the examples of foods included in the comment may qualify to bear the “healthy” claim under the finalized criteria, depending on their specific nutrient profiles. As discussed in section V.D.3 (“Sodium”), our marketplace review found that many canned vegetables, including low-sodium canned vegetables and some reduced-sodium canned vegetables, do not exceed the finalized ≤10% DV sodium limit. As discussed in the same section, many whole grain breads do not exceed the ≤10% DV sodium limit, and we have provided additional flexibility for whole grain products, including whole grain breads, by increasing the added sugars limit from ≤5% DV to ≤10% DV for the grains group. Salad kits, or bagged salads with dressing or toppings, discussed in section V.D.4 (“Added Sugars”) above, could be considered mixed products or main dishes, depending on their formulation, and the final rule increases the added sugars limits for mixed products, meals, and main dishes, to provide more flexibility for these types of nutrient-dense products while still aligning with current nutrition science and Federal dietary guidelines. Similarly, many of the recipes on the Dietary Guidelines' website are mixed products and main dishes rather than individual foods, and therefore, the foods in those recipes may be subject to the criteria for mixed products and main dishes, including the increased added sugars limits. We further note that, as explained in section V.D.6, while all of the MyPlate recipes contain nutrient-dense ingredients, some of the recipes are for foods, such as dessert foods, that are not the foundation of a healthy dietary pattern (
                        <E T="03">e.g.,</E>
                         recipes for apple crisps, chocolate squash cake, banana cupcakes, etc.). As such, not all foods for which recipes are included in the MyPlate website are particularly useful in achieving a healthy dietary pattern, and therefore, they may not qualify to bear the “healthy” claim.
                    </P>
                    <P>Additionally, as discussed in Response 155, the rule accounts for specific foods with a nutrient profile that may help consumers maintain healthy dietary practices but that may not meet certain generally applicable NTL or FGE requirements. If no exemption was established, we have determined that it is generally both practicable for foods to meet the updated criteria for the “healthy” claim and essential that they do so to ensure that the “healthy” claim provides a quick signal to consumers that foods bearing the claim are foundational to a healthy diet. As demonstrated by the examples above, FDA's approach to the updated criteria is narrowly tailored to serve our interests in providing information to consumers to indicate that a food's nutrient content may help them maintain healthy dietary practices to promote public health, preventing misleading labeling, and reducing consumer confusion potentially caused by the use of inconsistent nutrient content claims.</P>
                    <P>
                        (Comment 158) One comment states a belief that FDA is drawing the line in “the most restrictive way possible” and that the “healthy” criteria precludes foods from bearing “healthy” that align with the Dietary Guidelines. The comment suggests that FDA adopt its alternative approach to updating the “healthy” nutrient content claim, which includes a number of suggestions, such as maintaining NTE criteria as an alternative to FGE criteria (see Comment 3), incorporating a small RACC subcategory with modified criteria (see Comment 4), adopting a first ingredient approach (see Comment 7), aggregating food groups (Comment 101), and combining the individual and mixed food categories and increasing sodium, added sugars, and saturated fat limits in a stepwise manner based on RACC size (see Comment 65, Comments 70-72, Comment 102). Another comment says that the proposed limits for added sugars and sodium are “far more restrictive than necessary” because less restrictive limitations, such as the 20% DV limitations and alternative RACC Framework proposed by the comment, would allow FDA to better foster the consumption of whole grain products while controlling for added sugar and sodium consumption. The alternative RACC Framework would adopt higher nutrient limits for foods with RACCs above 30 g (
                        <E T="03">e.g.,</E>
                         a 20% DV limit for added sugars and sodium) and lower nutrient limits for foods with RACCs at or below 30 g (
                        <E T="03">e.g.,</E>
                         a 10% DV limit for added sugars and sodium).
                    </P>
                    <P>
                        (Response 158) We disagree that the updated “healthy” criteria have been developed in the “most restrictive way possible” and that they preclude foods from being labeled as “healthy” that align with the Dietary Guidelines. Foods 
                        <PRTPAGE P="106153"/>
                        that qualify to bear “healthy” based on the updated criteria are those foods that are particularly useful in helping consumers build a diet that conforms to current dietary recommendations. In other sections, we explain why we have or have not adopted the suggestions included in the commenter's proposed alternative approach to updating the “healthy” nutrient content claim (see Responses 7, 8, 11, 69, 74-76, 105, and 106). Responses 155 and 156 provide further explanation of why the updated “healthy” criteria is narrowly tailored to serve our substantial government interests and information to support that such criteria are consistent with current nutrition science and Federal dietary guidance, including the 
                        <E T="03">Dietary Guidelines, 2020-2025.</E>
                    </P>
                    <P>
                        In regard to the alternative RACC framework and higher nutrient limits for sodium and added sugars, as discussed in section V.D.3 (“Sodium”), we agree that there should be a stepwise approach across food categories (
                        <E T="03">i.e.,</E>
                         gradual increases in sodium or added sugars for individual foods with smaller RACCs, individual foods with larger RACCs, mixed products, main dishes, and meals), and we have modified the criteria by providing alternative criteria for foods with smaller RACCs. However, we disagree that a  ≤20% DV limit for sodium or added sugars for whole grain products is an appropriate less restrictive alternative to the finalized limits. As explained further above, a 20% DV for individual foods would be inconsistent with the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         because it could result in the use of the claim on foods that contain more than limited amounts of sodium or added sugars. According to our regulations, products that contain 20% DV of sodium per serving are high in sodium or added sugars (§ 101.54(b)), and therefore, a 20% DV limit for sodium or added sugars would run counter to the Dietary Guidelines recommendations for consumers to limit sodium and added sugars in their diets. However, as discussed in section V.D.4 (“Added Sugars”), we have increased the added sugars limit for whole grain products from ≤5% DV to ≤10% DV such that more nutrient-dense whole grain products, such as whole grain cereals, with limited amounts of added sugars to increase palatability, will qualify for the “healthy” claim.
                    </P>
                    <P>Accordingly, FDA has considered the suggestions included in the alternative approach, including a framework to adopt higher nutrient limits for foods with larger RACCs and lower nutrient limits for foods with smaller RACCs, and nutrient limits at 20% DV for sodium and added sugars for grain products, proposed by these comments, and either determined that the suggestions are appropriate to incorporate in the updated “healthy” criteria or that they would not be sufficiently effective in advancing FDA's stated interests in providing information to consumers to indicate that a food's nutrient content may help them maintain healthy dietary practices to promote public health, preventing misleading labeling, and reducing consumer confusion potentially caused by the use of inconsistent nutrient content claims.</P>
                    <P>(Comment 159) One comment states that the rule is not narrowly tailored to its objective because it would exclude many foods that are nutrient-dense from qualifying to bear the “healthy” claim due to small differences between the criteria and the foods' food group amounts, added sugars content, and sodium content. It also states that in many instances, the rule would exclude products that might have otherwise met the “healthy” criteria, but that due to an added component, such as a sauce, may exceed the proposed nutrient limits, even though the sauce is the component that is likely to encourage consumers to eat the food. Another comment asks FDA to consider whether the nutrient limits in the rule are no more extensive than needed, particularly where a healthy dietary pattern could accommodate more flexibility in added sugars, sodium, and food groups than proposed, and where the rule would exclude foods encouraged as healthful by dietary guidance.</P>
                    <P>
                        (Response 159) We carefully considered comments that suggest lower FGE requirements and higher nutrient limits as part of the “healthy” criteria, and in some cases, have adopted more generous FGE requirements and nutrient limits where this will result in more nutrient-dense foods recommended by the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         being able to qualify for the “healthy” claim. In particular, to address concerns about the potential inability for nutrient-dense foods with limited amounts of added sugars to qualify for “healthy,” we increased the added sugars limit for individual fruits, vegetables, and protein foods, as well as mixed products, meals, and main dishes, to accommodate the purpose of added sugars in the formulation of these products, including texture, flavor standardization, and use of seasonings, sauces, and other ingredients in the formulation of recipes, while still aligning with current nutrition science and Federal dietary guidance. See section V.D.4 (“Added Sugars”) for further discussion of the added sugars limits for fruits, vegetables, and protein foods.
                    </P>
                    <P>
                        Additional flexibility has been incorporated into other FGE requirements and nutrient limits, where aligned with the Dietary Guidelines recommendations and feasible and practical as demonstrated by our marketplace review. For example, we are finalizing a lower FGE requirement for dairy products at 
                        <FR>2/3</FR>
                         c-eq per RACC, as opposed to the proposed 
                        <FR>3/4</FR>
                         c-eq per RACC. We are increasing the added sugars limit for whole grain products from ≤5% DV to ≤10% DV and are excluding the inherent saturated fat in seafood and nuts, seeds, and soybeans from the saturated fat limits. We are further providing for automatic qualification, regardless of FGE or NTL criteria, for the following single-ingredient, nutrient-dense foods, with no other added ingredients except for water: vegetables, fruits, whole grains, fat-free and low-fat dairy, lean game meat, seafood, eggs, beans, peas, lentils, nuts, and seeds, and for waters (carbonated or noncarbonated), coffee, and tea containing certain non-caloric ingredients such as flavors, low- or no-calorie sweeteners, vitamins, and minerals that contain less than 5 calories per RACC and per labeled serving. Consequently, the adjustments and exceptions from the FGE and NTL requirements are intended to strike a balance between alignment with the Dietary Guidelines recommendations to consume nutrient-dense foods with little or no added sugars, sodium, or saturated fat, and providing for practical flexibility for consumers and industry.
                    </P>
                    <P>We reiterate that all foods can be part of a healthy dietary pattern, but foods that qualify for the “healthy” claim are those foods that, based on current nutrition science and Federal dietary guidance, are particularly useful in constructing a diet that conforms to current dietary recommendations. Foods that do not qualify for the “healthy” claim are not necessarily unhealthy and may have beneficial nutritional attributes that can be promoted through other truthful and not misleading statements on the food label or in food labeling.</P>
                    <P>
                        (Comment 160) Some comments assert that FDA failed to consider less restrictive alternatives for the added sugars requirements. One comment states that disclosure of the amount of added sugars in a food is already required on the Nutrition Facts label and FDA cannot explain why consumer cannot make decisions based on this data. The comment suggests that FDA could require foods with added sugars and bearing the “healthy” claim to 
                        <PRTPAGE P="106154"/>
                        include the added sugars in larger type or in a separate box. Other comments suggest that FDA could require foods containing certain amounts of added sugars and bearing the “healthy” claim to bear an additional disclosure contextualizing the use of the word “healthy,” such as “see nutrition information for added sugars content.”
                    </P>
                    <P>
                        (Response 160) We disagree that the added sugars declaration on the Nutrition Facts label or an alternative disclosure regarding added sugar content in addition to the “healthy” claim is a reasonable alternative to the added sugar limits in the definition of the “healthy” claim. First, the added sugars declaration and the “healthy” nutrient content claim convey distinct information on food labels and labeling. The added sugars declaration discloses the amount of added sugars in a food, while the “healthy” claim, when voluntarily used in a nutritional context, makes an implicit claim that the levels of nutrients in a food are such that the food is particularly useful in constructing a diet that conforms to current dietary recommendations. As explained in the proposed rule, current nutrition science, as reflected in the 
                        <E T="03">Dietary Guidelines, 2020-2025,</E>
                         recommends limiting consumption of foods higher in added sugars, which provide excess calories to the diet without contributing significant amounts of essential nutrients. The original “healthy” criteria do not include limits for added sugars, which makes the criteria inconsistent with current nutrition science and Federal dietary guidance (87 FR 59168 at 59173). The updated “healthy” definition is intended to better represent the overall nutrient profile of foods and to identify foods that are nutrient dense—described in the 
                        <E T="03">Dietary Guidelines for Americans, 2020-2025,</E>
                         in part, as having little or no added sugars—and can be the foundation of a healthy dietary pattern. Therefore, updating the “healthy” criteria without imposing the added sugars limit, as suggested by these comments, would result in foods with added sugars over the recommended levels qualifying to bear the “healthy” claim, which could thus provide inaccurate or misleading information to consumers about whether the food contains nutrient levels that may help them maintain healthy dietary practices. Such an approach would not be sufficiently effective in advancing FDA's asserted government interests.
                    </P>
                    <P>Second, requiring an additional disclosure of added sugar content on the label of products bearing the “healthy” claim or a statement to “see nutrition information for added sugars content” would be problematic under the same reasoning. Although such disclosures may provide or highlight information about a food's added sugars content, foods with excess added sugars could still qualify to bear the “healthy” claim, and therefore, the claim would not help consumers identify foods that, based on their nutrient levels, are particularly useful in constructing a diet that conforms to current nutrition science and Federal dietary guidance. This result would undermine the purpose of the “healthy” claim.</P>
                    <P>
                        Moreover, even if a product bearing a “healthy” claim included an additional disclosure or disclaimer to “contextualize the use of the word, `healthy,'” as suggested by the comment, or to explain that a food product bearing the “healthy” claim includes added sugars above the levels recommended by current nutrition science and Federal dietary guidance, such a statement would be contradictory to the “healthy” claim. Adding a disclaimer that does not serve to help consumer understanding, but merely contradicts the claim, is not a viable regulatory alternative. See, 
                        <E T="03">e.g., Resort Car Rental System, Inc.</E>
                         v. 
                        <E T="03">FTC,</E>
                         518 F.2d 962, 964 (9th Cir. 1975) (per curiam) (upholding FTC order to excise “Dollar a Day” trade name as deceptive because “by its nature [it] has a decisive connotation for which any qualifying language would result in contradiction in terms.”), 
                        <E T="03">cert denied,</E>
                         423 U.S. 827 (1975); 
                        <E T="03">Continental Wax Corp.</E>
                         v. 
                        <E T="03">FTC,</E>
                         330 F.2d 475, 480 (2d Cir. 1964) (same); 
                        <E T="03">Pasadena Research Labs</E>
                         v. 
                        <E T="03">United States,</E>
                         169 F.2d 375 (9th Cir. 1948) (discussing “self-contradictory labels”). In the FDA context, courts have repeatedly found such disclaimers ineffective see, 
                        <E T="03">e.g., United States</E>
                         v. 
                        <E T="03">Millpax, Inc.,</E>
                         313 F.2d 152, 154 &amp; n.1 (7th Cir. 1963) (disclaimer stating that “no claim is made that the product cures anything, either by the writer or the manufacturer” was ineffective where testimonials in a magazine article promoted the product as a cancer cure); 
                        <E T="03">United States</E>
                         v. 
                        <E T="03">Kasz Enters., Inc.,</E>
                         855 F. Supp. 534, 543 (D.R.I. 1994) (“The intent and effect of the FDCA in protecting consumers from . . . claims that have not been supported by competent scientific proof cannot be circumvented by linguistic game-playing.”), 
                        <E T="03">judgment amended on other grounds,</E>
                         862 F. Supp. 717 (1994). Here, because an added sugars-related disclaimer would be similarly ineffective, FDA reasonably chose to incorporate an added sugars limit into the updated criteria for the “healthy” claim.
                    </P>
                    <HD SOURCE="HD3">4. Other Legal Issues</HD>
                    <P>(Comment 161) One comment suggests that FDA ensure that express preemption protection apply during the “transition period” between the publication of the final rule and the compliance date for the rule to prevent an influx of State lawsuits alleging that a failure to comply immediately with the new Federal requirements (before the Federal compliance date of such requirements) is actionable under State law. The comment noted that implied preemption was found by many courts during the designated Federal regulatory compliance period for other rules and specifically requested that FDA confirm that: (1) State law claims are preempted if they arise from labeling (on products manufactured, sold or distributed during the transition period) that complies with either the current version or the new version of the rule; and (2) failure to comply with the new rule is not a basis for determining that a product is not eligible for a “healthy” implied nutrient content claim until the final rule's compliance date. Other comments request that, should FDA give companies the choice of whether to comply with either the current version of the rule or the new version of the rule during the period between the publication of the final rule and the compliance date, FDA confirm that both versions of the rule would establish preemptive Federal “requirements” for the “healthy” nutrient content claim within the meaning of section 343-1 of the FD&amp;C Act—such that section 343-1(a) of the FD&amp;C Act expressly preempts State law requirements that differ from either version of the rule.</P>
                    <P>(Response 161) As discussed in Section V.J (“Effective and Compliance Dates”), manufacturers would not be required to comply with requirements of the final rule until the compliance date. Thus, once any new requirements for the definition of the nutrient content claim “healthy” are in effect, manufacturers could either comply with the new requirements or continue to use the original definition of “healthy” until the compliance date.</P>
                    <P>
                        The express preemption provision in section 403A (21 U.S.C. 343-1) of the FD&amp;C Act preempts State and local requirements specifically regarding food labeling claims. In FDA's view, the rule's compliance period does not create any exemption from the normal operation of preemption under section 403A of the FD&amp;C Act or other applicable preemption principles. To the extent the theories raised in State 
                        <PRTPAGE P="106155"/>
                        lawsuits regarding a failure to comply immediately with the new Federal requirements for the “healthy” claim depend on the contours of FD&amp;C Act requirements, FDA does not intend to enforce against products that are in compliance with the original definition of “healthy” before the compliance date. We also highlight that section 745(a) of the Consolidated Appropriations Act, 2024 (Pub. L. 118-42), signed into law on March 9, 2024, states that manufacturers may continue to comply with requirements of the original definition of “healthy” until the compliance date of this final rule. Section 745(b) of the Consolidated Appropriations Act, 2024 states that any food manufactured and labeled as “healthy” before the compliance date of this final rule shall not be subject to state requirements for bearing the claim that are not identical to either: (1) FDA's original requirements in effect as of the date FDA published this final rule; or (2) FDA's updated “healthy” requirements if State-law requirements go into effect before the compliance date of this final rule.
                    </P>
                    <P>(Comment 162) One comment asserts that the rule would result in a significant number of labeling and product formulation changes and that it would take longer to comply than the compliance period allows. The comment suggests that, instead of finalizing the rule, FDA should “try out the new requirements on a small scale” such as with only one food group initially, which would take “into account the principles of avoidance of unnecessary barriers to trade and harmonization in the Agreement on Technical Barriers to Trade.” Another comment raises the issue of U.S. products sold in other countries and suggests that companies, consumers, and investors are helped by alignment and transparency regarding the criteria and thresholds for front-of-pack labels and claims on food products.</P>
                    <P>(Response 162) FDA has gone through an extensive and transparent rulemaking process to update the definition of the “healthy” claim and has established a 3-year compliance period. The comment failed to assert why additional time was needed beyond the 3 years provided in the proposed compliance date and made general, vague assertions about the difficulty of complying with the new definition. We address similar comments in section V.J (“Effective and Compliance Dates”). We do not agree that dividing the rule and only promulgating the new definition for one food group will serve the purpose of the definition of the claim and the comment did not provide any information about which food group it was proposing to begin the gradual change with, thus we have no basis on which to make such a decision to change the rule in this way. Further, we do not see how any unnecessary barriers to trade have been created with the updated rule, as the rule applies equally to foods manufactured in all parts of the world and sold in the United States and all food manufacturers have been provided 3 years to make any adjustments to their products. This is a voluntary claim, not a mandatory claim that would apply to all products. We note that our estimates (Ref. 39) indicate that only a small number of products will need to be relabeled or reformulated to comply with the new definition. Also, for products manufactured in the United States but sold abroad, we agree that alignment on labeling issues is helpful to the extent possible, but different countries have different legal structures and authorities under which to promulgate their labeling regulations, and that is no different for the area of claims than it is for any of our other labeling efforts. Whether there is a need for transparency regarding thresholds for various NTL as part of the healthy claim criteria is discussed in section V.K.2 (“Administrative Procedure Act”).</P>
                    <HD SOURCE="HD2">L. Miscellaneous Comments</HD>
                    <HD SOURCE="HD3">1. Comments Regarding Infants and Children Under 2 Years of Age</HD>
                    <P>
                        (Comment 163) Comments supporting our proposal state that it would not be appropriate to allow the “healthy” claim on products intended for infants and children under 2 years of age because they have very specific nutritional needs in this life stage. Some comments express concern that the “healthy” claim could be used to market products not recommended by nutrition experts for this age group (
                        <E T="03">e.g.,</E>
                         “toddler milks” that often contain added sugars). Another requests we limit use of the claim on products marketed to children in an age range that includes 2 years, such as 12-36 months.
                    </P>
                    <P>
                        Other comments disagree with our proposal to exclude use of the claim on products intended for infants and children younger than 2 years of age. Some comments suggest we use recommendations in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         or data from the Feeding Infants and Toddler Study to develop specific requirements or a framework for the use of the claim on foods intended for infants and children under the age of two. This could include modifying the “healthy criteria” to reflect the amount of food and number of eating occasions in this age group, adjusting FGEs to account for the dietary patterns of children 1 to 2 and 2 to 3 years of age, and considering other age-appropriate nutritional considerations. Without doing so, a comment asserts that products intended for 2 to 3 year olds, such as pureed fruit and vegetable pouches, cannot meet the definition and other products recommended by the Dietary Guidelines, such as iron and zinc fortified infant cereal products, cannot bear the claim. The comment asserts that this could confuse parents if other fruit and vegetable products, such as canned or frozen varieties that may include added salt and sugar, are labeled “healthy” while baby food versions are not simply because they are marketed for infants. Additionally, some comments raise concern about unintended consequences given infants and children under two eat many of the same foods as older children and adults. For example, only skim milk bearing the “healthy” label when very young children require whole, full-fat milk for development or 100% fruit juice being labeled “healthy,” when it is not recommended for consumption in children under the age of 2. A comment also recommends that any “healthy” symbol clearly indicates age ranges.
                    </P>
                    <P>
                        (Response 163) Infants and children under the age of 2 years have specific nutrient needs, consume small amounts more frequently than do older children and adults, and the types and amounts of foods that they can consume change rapidly, particularly in the first year of life. Proper nutrition is critically important for growth and brain development in this age group. As discussed in the proposed rule (87 FR 59168 at 59181), we relied primarily on the science articulated in the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         in developing the specific criteria on which to base the definition of the “healthy” claim. Historically, the Dietary Guidelines have been directed to adults and children 2 years of age and older. However, the 
                        <E T="03">Dietary Guidelines, 2020-2025</E>
                         highlights the importance of encouraging healthy dietary patterns at every life stage and includes new recommendations for healthy dietary patterns for infants and children younger than 2 years of age in this lifespan approach. The Dietary Guidelines, 
                        <E T="03">2020-2025</E>
                         also notes that this is a key time for establishing healthy dietary patterns that may influence the trajectory of eating behaviors and health throughout the course of life (Ref. 1).
                    </P>
                    <P>
                        Infants and children younger than 2 years of age have specific nutritional 
                        <PRTPAGE P="106156"/>
                        needs that apply to their particular life stages and their dietary recommendations are different from the recommendations for other age groups. In our last update to the Nutrition Facts label (81 FR 33742), we established DVs specifically for infants 7 through 12 months and children 1 through 3 years of age. The science underlying the recommended intake levels of individual nutrients demonstrates the specific nutritional needs of infants and children in this life stage. Evaluating the specific nutritional needs of this population can help us in determining whether it is appropriate to extend use of the claim “healthy” to foods directed at infants and children younger than 2 years of age in the future. While the comments provided helpful data and information for consideration, at this time, given our limited resources and considering the importance of ensuring that any labeling provided for this vulnerable age group is sound, we are not extending use of the “healthy” claim to foods marketed for consumption by infants and children younger than 2 years of age. We need additional time to consider current nutrition recommendations for children under 2 years of age as well as unique considerations for products intended for this age group as they relate to the “healthy” claim.
                    </P>
                    <P>With respect to the comments expressing concerns that parents may unknowingly feed a product with a “healthy” claim to an infant or child under the age of two where the product is not recommended for that age group, the “healthy” claim is but one piece of information on the label that can be used by consumers to identify foods that contribute to a healthy dietary pattern. It does not take the place of advice from a pediatrician, or other healthcare provider, nor should it signal that the product should be consumed by all individuals, regardless of their unique health considerations.</P>
                    <P>As for the comments that express concern that products intended for children 2 through 3 years of age would not be eligible to bear the claim because the RACCs for those foods are smaller than the proposed FGEs, as discussed in Response 9, individual foods and mixed products comprised of one or more foods encouraged by the Dietary Guidelines with no added ingredients, except for water, automatically qualify to bear the claim. Therefore, products intended for children 2 to 3 years of age, such as fruit and vegetable puree pouches, with no other ingredients added other than water, would be eligible to bear the claim.</P>
                    <HD SOURCE="HD3">2. Comments Regarding Coordination With Other Nutrition Initiatives</HD>
                    <P>(Comment 164) Some comments recommend that the “healthy” definition and healthy symbol align and work together and that FDA share consumer research data they have collected so that companies can make the best use of the “healthy” claim and symbol. The comments encourage FDA to complete research and consumer testing on “healthy” symbols and state that the release of this final rule should include the symbol. Some comments request clarity regarding the regulatory relationship between the “healthy” definition and the development of front-of-package (FOP) labeling and request that research related to this endeavor be shared.</P>
                    <P>(Response 164) The healthy symbol is intended to represent the nutrient content claim “healthy.” While these initiatives related to “healthy” are related, they are on separate tracks, and therefore, we disagree the “healthy” claim final rule should include the symbol. FDA is continuing research into and consideration of the “healthy” symbol, and this work should not hold up the implementation of the “healthy” final rule and its associated benefits given that the current definition is not consistent with current nutrition science and Federal dietary guidelines.</P>
                    <P>
                        FDA's work on front-of-package (FOP) nutrition labeling is a separate initiative and is intended to complement the Nutrition Facts label that is required on food packages by displaying simplified, at-a-glance nutrition information that gives consumers additional context to help them quickly and easily make more informed food selections. We have announced our intent to publish a proposed rule on this topic. Additional information about our FOP research may be found on FDA's website (
                        <E T="03">https://www.fda.gov/food/food-labeling-nutrition/front-package-nutrition-labeling</E>
                        ) and will be shared as part of that rulemaking.
                    </P>
                    <HD SOURCE="HD3">3. Comments Regarding Coordination With USDA</HD>
                    <P>
                        (Comment 165) The comments express concerns that given that meat and poultry were not included as protein foods under FDA's proposed “healthy” definition, and FSIS has not yet proposed a similar definition that looks at food groups such as meat and poultry, it is unclear how to assess FSIS-regulated products under FDA's proposed framework. The comments state that this makes it challenging for companies to assess the impact of the proposed rule across their entire product portfolios, particularly where the term “healthy” is used in a brand name across a portfolio, and to provide comments on how this framework would impact all foods. The comments explain that there is considerable uncertainty as to whether FSIS will update its “healthy” rule, whether there will be a significant delay in any such update, and whether FSIS will take a similar approach to that of FDA, for example, because FDA has not addressed meat and poultry products, it is not clear if a chicken noodle soup that contains 
                        <FR>1/2</FR>
                         FGE protein (
                        <E T="03">i.e.,</E>
                         chicken) and 
                        <FR>1/2</FR>
                         FGE vegetables (
                        <E T="03">i.e.,</E>
                         the food group requirements for a mixed product), and otherwise satisfies the NTL criteria, would qualify for the claim. The comments assert that this example underscores that close coordination between the Agencies responsible for the regulation of food labeling in the United States is needed for cohesive and consistent implementation of the rule and request that, before finalizing the rule, FDA seek input from FSIS on when FSIS plans to update its “healthy” definition and what approach will be used, to ensure that the approach specifically would work equally for FDA-regulated and FSIS-regulated products.
                    </P>
                    <P>One comment encourages FDA to engage with FSIS to ensure that the FDA healthy criteria can be voluntarily applied to products under FSIS's authority if a food company wants to use the claim. The comments also ask FDA to encourage USDA to provide enforcement discretion for products that would qualify for the FDA's updated definition to bear a “healthy” claim, assuming that meat or poultry would be considered part of the protein foods group, as is the case under the Dietary Guidelines. One comment notes the ambiguity in determination/calculation of FGE of certain dairy foods such as yogurt and suggests that to remediate this problem, FDA should maintain and publish a compendium or database for manufacturers to use in calculating the amount of FGEs delivered by each food. The comment suggests this should be done in coordination with USDA—who maintains such information for the purpose of dietary monitoring programs via the FPED. One comment asserts that the changes in the rule would likely lead to change to the USDA meal patterns in the National School Lunch and School Breakfast Programs and stated that transition time for implementation to address such changes would be helpful.</P>
                    <P>
                        (Response 165) FDA consulted with USDA and other Federal Agencies to ensure we appropriately considered the 
                        <PRTPAGE P="106157"/>
                        policies established by those Agencies when updating the “healthy” nutrient content claim. While we have different regulatory frameworks and authorities, FDA and USDA routinely collaborate on issues, including those related to food labeling and the healthy claim.
                    </P>
                    <HD SOURCE="HD3">4. Comments Regarding Consumer Education</HD>
                    <P>
                        (Comment 166) Some comments recommend, given that “healthy” is a voluntary nutrient content claim, that the use of the claim be accompanied by efforts that help consumers make informed food choices. The comments recommend that the “healthy” rule provide additional opportunities for meaningful nutrition education and improved consumer understanding of healthy dietary patterns, asserting that as proposed, the rule does not afford consumers any additional context on how the “healthfulness” of a food is determined. One comment says FDA should allow for or require additional labeling to facilitate consumer education on the meaning of “healthy” when it is used as a nutrient content claim and state one such example could be the labeling scheme identified by USDA MyPlate, which requires the additional quantitative declaration of the amount of FGEs afforded by a food for consumer education (
                        <E T="03">e.g.,</E>
                         “this product provides 
                        <FR>3/4</FR>
                         cup dairy equivalent. According to the DGA, 3 cup equivalents are recommended per day”) in order to use the MyPlate logo on foods. The comments claim that a greater public understanding of the criteria on which a “healthy” food is determined would further contribute to a reduction in chronic disease and support health equity, more specifically, consumers would have a basis for structuring all decisions in the context of their daily food group requirements. Some comments recommend that culturally appropriate resources on the food labeling update be disseminated to Native Americans, Alaskan Natives, and Native Hawaiian communities upon issuing the rule.
                    </P>
                    <P>(Response 166) We agree that consumer education about nutrition and healthy dietary practices would likely benefit a number of consumers in the United States and that consumer education will be an important tool for implementing the updated “healthy” claim and for maximizing the effectiveness of the “healthy” claim to help consumers identify foods that can be the foundation for a healthy dietary pattern. We are committed to helping increase understanding and use of the updated “healthy” claim to improve healthy dietary patterns through consumer education, in collaboration with key Federal partners, as well as with industry partners. Broadly, aspects of those education and outreach activities may include how the presence of the claim is important to consider when constructing a healthy dietary pattern making clear that foods labeled as “healthy” are foundational foods in a healthy dietary pattern and that the claim does not imply that all other foods are considered unhealthy and the importance of choosing a variety of nutrient-dense foods and beverages across all food groups, in recommended amounts, while staying within calorie limits, to build a healthy dietary pattern consistent with the Dietary Guidelines.</P>
                    <HD SOURCE="HD2">VI. Economic Analysis of Impacts</HD>
                    <HD SOURCE="HD3">A. Introduction</HD>
                    <P>We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, Executive Order 14094, the Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801, Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).</P>
                    <P>Executive Orders 12866, 13563, and 14094 direct us to assess all benefits, costs, and transfers of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Rules are “significant” under Executive Order 12866, section 3(f)(1) (as amended by Executive Order 14094) if they “have an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of the Office of Information and Regulatory Affairs (OIRA) for changes in gross domestic product); or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities.” OIRA has determined that this final rule is a significant regulatory action under Executive Order 12866, section 3(f)(1).</P>
                    <P>Because this rule is likely to result in an annual effect on the economy of $100 million or more or meets other criteria specified in the Congressional Review Act/Small Business Regulatory Enforcement Fairness Act, OIRA has determined that this rule falls within the scope of 5 U.S.C. 804(2).</P>
                    <P>The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because we estimate that the economic impact of this final rule will not exceed 3 percent of annual revenue, we certify that this rule will not have a significant economic impact on a substantial number of small entities.</P>
                    <P>The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes estimates of anticipated impacts, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $183 million, using the most current (2023) Implicit Price Deflator for the Gross Domestic Product. This final rule will result in an expenditure in any year that meets or exceeds this amount.</P>
                    <HD SOURCE="HD2">B. Overview of Benefits, Costs, and Transfers</HD>
                    <P>
                        Some consumers use nutrient content claims such as “healthy” to inform their food purchases. Based on a 2019 meta-analysis on the effects of food labeling, we estimate that a small number of these consumers (0 to 0.4% of people that try to follow current dietary guidelines) would use the “healthy” implied nutrient content claim to make meaningful, long-lasting food purchasing decisions (Ref. 45). If the foods bearing the “healthy” claim more closely align with Federal dietary guidance, the claim can help consumers who are selecting those products in choosing a more healthful diet, which may result in lower chronic, diet-related diseases, including cardiovascular disease and type 2 diabetes. Quantifiable benefits of the final rule are the estimated reduction over time in all-cause mortality stemming from consumers selecting and consuming more healthful foods. This is calculated through the negative association between a Healthy Eating Index score and all-cause mortality. The estimated benefits account for expected uncertainty and variability in consumer use of the “healthy” nutrient content claim and its long-term health impact. Discounted at 3 percent over 20 years, the mean present value of benefits accrued to consumers using the “healthy” nutrient content claim is $686 million, with a lower bound estimate of $21 million and an upper bound estimate of $1.9 billion. Discounted at 7 percent over 20 years, the mean present value of benefits of the final rule is $438 million, with a lower bound estimate of 
                        <PRTPAGE P="106158"/>
                        $14 million and an upper bound estimate of $1.2 billion.
                    </P>
                    <P>Quantified costs to manufacturers associated with updating the “healthy” claim are labeling, reformulating, and recordkeeping. Overall, about 27,000 UPCs, or 10 percent of total UPCs, qualify for the original “healthy” implied nutrient content claim but only 5 percent (12,500 UPCs) choose to label. The use of the “healthy” nutrient content claim is voluntary, but if the final rule results in some products needing to remove the claim to avoid being misbranded, manufacturers would incur costs due to the rule. Manufacturers with food products currently using the “healthy” claim would need to confirm whether the products meet the proposed criteria and decide whether a label change is needed.</P>
                    <P>Manufacturers with products that currently do not meet the “healthy” criteria but do meet the final rule's criteria have the option of labeling these products. In some cases, manufacturers may choose to reformulate a product so that it meets the final rule's criteria. Some recordkeeping is required for certain products using the “healthy” claim and the required food components equivalents are likely to increase time spent on recordkeeping. It is possible that manufacturers of products that include the term “healthy” within the brand name may choose to rebrand products instead of reformulating. We lack the data to quantify this effect but discuss it qualitatively. The estimated costs account for expected uncertainty and variability in industry use of the “healthy” nutrient content claim and industry response to the final rule, including potential reformulation. Discounted at 3 percent over 20 years, the mean present value of costs accrued to manufacturers using the “healthy” nutrient content claim, assuming the current 5 percent adoption rate, is $403 million, with a lower bound of $188 million and an upper bound of $737 million. Discounted at 7 percent over 20 years, the mean present value of costs of the proposed rule is $346 million, with a lower bound of $161 million and an upper bound of $633 million.</P>
                    <GPH SPAN="3" DEEP="476">
                        <PRTPAGE P="106159"/>
                        <GID>ER27DE24.008</GID>
                    </GPH>
                    <P>
                        We have developed an Economic Analysis of Impacts that assesses the impacts of the final rule. The full analysis of economic impacts is available in the docket for this final rule (Ref. 39) and at 
                        <E T="03">https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.</E>
                    </P>
                    <HD SOURCE="HD1">VII. Analysis of Environmental Impact</HD>
                    <P>We have determined under 21 CFR 25.30(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.</P>
                    <HD SOURCE="HD1">VIII. Paperwork Reduction Act of 1995</HD>
                    <P>The final rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The title, description, and respondent description of the information collection provisions are shown in the following paragraphs with an estimate of the annual recordkeeping and third-party disclosure burdens. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.</P>
                    <P>
                        <E T="03">Title:</E>
                         Food Labeling Regulations, OMB Control Number 0910-0381—Revision.
                    </P>
                    <P>
                        <E T="03">Description of Respondents:</E>
                         The respondents to this information collection are manufacturers of food products using the “healthy” implied nutrient content claim marketed in the United States. Respondents are from the private sector (for-profit businesses).
                    </P>
                    <P>
                        <E T="03">Description:</E>
                         The final rule amends § 101.65(d) to require manufacturers using the “healthy” implied nutrient content claim on their products to make and keep written records to verify that the products comply with this requirement. Examples of these records include analyses of databases, recipes, formulations, information from recipes 
                        <PRTPAGE P="106160"/>
                        or formulations, or batch records. Manufacturers must provide these records upon request from FDA during an inspection for official review and photocopying or other means of reproduction.
                    </P>
                    <P>The final rule also requires some manufacturers to relabel products to comply with the criteria for the “healthy” implied nutrient content claim. A product that does not meet the criteria will need to remove the claim from its label, and a product that becomes eligible will be permitted to use the claim on its label.</P>
                    <P>We estimate the recordkeeping burden of this collection of information as follows:</P>
                    <GPH SPAN="3" DEEP="80">
                        <GID>ER27DE24.009</GID>
                    </GPH>
                    <P>The final rule requires that each manufacturer of a food that bears the implied nutrient content claim “healthy” must create and maintain written records to verify that the food meets the FGE requirements when it is not apparent from the label of the food. Examples of records include analyses of databases, recipes, formulations, information from recipes or formulations, or batch records. However, the product label (including the Nutrition Facts label, the ingredient list, the statement of identity, and any other information) may be used to verify compliance with the food group requirements for certain foods. For example, it would be apparent from the ingredient list of an oil product whether the product contains 100% oil. Similarly, it would likely be ascertainable from the ingredient list of a frozen spinach product that contains only spinach and salt whether the product contains enough spinach (vegetables) to bear the “healthy” claim. Thus, this recordkeeping estimate does not include food groups where the equivalent requirements are apparent from the label of the food. These estimates are based on the analysis in Table 12 of the Final Regulatory Impact Analysis (FRIA) (Ref. 39). Table 12 of the FRIA estimates that 5,702 products will need recordkeeping, which equals about 1,900 products annually over a 3-year period (5,702 ÷ 3). We estimate that each year approximately 1,900 manufacturers will each create and maintain 1 written record for a total of 1,900 records. We estimate that each record will require 15 to 30 minutes of recordkeeping for an annual recordkeeping burden of 950 hours (1,900 records × 0.5 hour).</P>
                    <GPH SPAN="3" DEEP="95">
                        <GID>ER27DE24.010</GID>
                    </GPH>
                    <P>We assume there are two categories of UPCs that could require re-labeling. First, if a UPC currently labeled “healthy” does not meet the required criteria, the manufacturer could choose to remove the “healthy” claim or reformulate. In either case, the label would need to change, either to remove the “healthy” claim or to change the NFL after reformulation. Given the current UPCs labeled “healthy” that do not meet the required criteria, we estimate the number of UPCs that would remove the “healthy” claim or reformulate. Second, if a UPC not labeled “healthy” now meets the required criteria, the manufacturer could choose to add the “healthy” claim. Table 8 of the FRIA estimates the need for 21,328 total label changes, which would be about 7,109 label changes annually over a 3-year period. Because this claim is voluntary, we do not know how many establishments will make labeling changes. For the purpose of this analysis, we assume that the number of respondents is the same as the number of disclosures. Each disclosure will take an estimated 1 hour to complete for an annual third-party disclosure burden of 7,109 hours.</P>
                    <P>The information collection provisions in this final rule have been submitted to OMB for review as required by section 3507(d) of the Paperwork Reduction Act of 1995.</P>
                    <P>
                        Before the effective date of this final rule, FDA will publish a notice in the 
                        <E T="04">Federal Register</E>
                         announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
                    </P>
                    <HD SOURCE="HD1">IX. Federalism</HD>
                    <P>We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires Agencies to “construe . . . a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.”</P>
                    <P>
                        Section 403A of the FD&amp;C Act (21 U.S.C. 343-1) is an express preemption provision. Section 403A(a) of the FD&amp;C Act provides, with minor exceptions, 
                        <PRTPAGE P="106161"/>
                        that no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce with respect to any requirement for nutrition labeling of food that is not identical to requirements established under section 403(r) of the FD&amp;C Act.
                    </P>
                    <P>The express preemption provision of section 403A(a) of the FD&amp;C Act does not preempt any State or local requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food (section 6(c)(2) of the Nutrition Labeling and Education Act of 1990, Public Law 101-535 (1990)); however, it is possible that such a requirement could be preempted on another basis, such as under principles of implied preemption. This final rule creates requirements that fall within the scope of section 403A(a) of the FD&amp;C Act.</P>
                    <HD SOURCE="HD1">X. Consultation and Coordination With Indian Tribal Governments</HD>
                    <P>We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive Order and, consequently, a tribal summary impact statement is not required.</P>
                    <HD SOURCE="HD1">XI. References</HD>
                    <P>
                        The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see 
                        <E T="02">ADDRESSES</E>
                        ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at 
                        <E T="03">https://www.regulations.gov.</E>
                         References without asterisks are not on public display at 
                        <E T="03">https://www.regulations.gov</E>
                         because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. Although FDA verified the website addresses in this document, please note that websites are subject to change over time.
                    </P>
                    <EXTRACT>
                        <P>
                            *1. USDA and HHS. Dietary Guidelines for Americans, 2020-2025. 9th Edition. December 2020. Retrieved from: 
                            <E T="03">https://www.DietaryGuidelines.gov.</E>
                        </P>
                        <P>*2. FDA. Human Foods Program. WenYen Juan, Ph.D., Nutritionist, Nutrition Assessment and Evaluation Branch, Division of Nutrition Labeling, Science and Claims, Office of Nutrition and Food Labeling. Memorandum to Administrative Record: “Description of the Process To Review and Determine Which Foods in the Current Marketplace Meet the Updated Definition of Healthy.” December 2024.</P>
                        <P>
                            *3. USDA, Agricultural Research Service, Food Surveys Research Group. Food Patterns Equivalents Database: Methodology and User Guide. Retrieved from: 
                            <E T="03">http://www.ars.usda.gov/nea/bhnrc/fsrg.</E>
                        </P>
                        <P>
                            *4. USDA and HHS. 2015-2020 Dietary Guidelines for Americans. 8th Edition. December 2015. Retrieved from: 
                            <E T="03">https://www.DietaryGuidelines.gov.</E>
                        </P>
                        <P>
                            *5. FDA. “Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements: Draft Guidance for Industry.” February 2023. Retrieved from: 
                            <E T="03">https://www.fda.gov/media/165420/download?attachment.</E>
                        </P>
                        <P>
                            6. White House National Strategy on Hunger, Nutrition, and Health. Retrieved from: 
                            <E T="03">https://www.whitehouse.gov/wp-content/uploads/2022/09/White-House-National-Strategy-on-Hunger-Nutrition-and-Health-FINAL.pdf.</E>
                        </P>
                        <P>
                            *7. USDA: Agricultural Research Service: FoodData Central. Retrieved from: 
                            <E T="03">https://fdc.nal.usda.gov/index.html.</E>
                        </P>
                        <P>
                            *8. Dietary Guidelines Advisory Committee. 2020. Scientific Report of the 2020 Dietary Guidelines Advisory Committee: Advisory Report to the Secretary of Agriculture and the Secretary of Health and Human Services. USDA, Agricultural Research Service, Washington, DC. Retrieved from: 
                            <E T="03">https://www.dietaryguidelines.gov/2020-advisory-committee-report.</E>
                        </P>
                        <P>9. IOM of the National Academies. “Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 8: Dietary Fats: Total Fat and Fatty Acids”: Washington, DC: National Academies Press; 2002.</P>
                        <P>
                            *10. National Academies of Sciences, Engineering, and Medicine 2017. “Guiding Principles for Developing Dietary Reference Intakes Based on Chronic Disease.” Washington, DC: The National Academies Press. Retrieved from: 
                            <E T="03">https://doi.org/10.17226/24828.</E>
                        </P>
                        <P>
                            *11. National Academies of Sciences, Engineering, and Medicine 2019. “Dietary Reference Intakes for Sodium and Potassium.” Washington, DC: The National Academies Press. Retrieved from: 
                            <E T="03">https://nap.nationalacademies.org/catalog/25353/dietary-reference-intakes-for-sodium-and-potassium.</E>
                        </P>
                        <P>
                            *12. FDA. “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods: Guidance for Industry.” October 2021. Retrieved from: 
                            <E T="03">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-voluntary-sodium-reduction-goals.</E>
                        </P>
                        <P>
                            *13. FDA. “Health Claim Notification for the Substitution of Saturated Fat in the Diet with Unsaturated Fatty Acids and Reduced Risk of Heart Disease.” 2007. Retrieved from: 
                            <E T="03">https://www.fda.gov/food/food-labeling-nutrition/health-claim-notification-substitution-saturated-fat-diet-unsaturated-fatty-acids-and-reduced-risk.</E>
                        </P>
                        <P>
                            *14. FDA. “The Use of an Alternate Name for Potassium Chloride in Food Labeling: Guidance for Industry.” December 2020. Retrieved from: 
                            <E T="03">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-use-alternate-name-potassium-chloride-food-labeling.</E>
                        </P>
                        <P>
                            *15. FDA. “Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods: Proposed Rule.” April 10, 2023. 88 FR 21148. Retrieved from: 
                            <E T="03">https://www.federalregister.gov/documents/2023/04/10/2023-06456/use-of-salt-substitutes-to-reduce-the-sodium-content-in-standardized-foods.</E>
                        </P>
                        <P>
                            16. Murphy M.M., C.G. Scrafford, L.M. Barraj, et al., “Potassium Chloride-Based Replacers: Modeling Effects on Sodium and Potassium Intakes of the U.S. Population with Cross-Sectional Data From NHANES 2015-2016 and 2009-2010,” 
                            <E T="03">American Journal of Clinical Nutrition,</E>
                             2021;114(1):220-30. doi: 10.1093/ajcn/nqab020.
                        </P>
                        <P>17. Antman E.M., L.J. Appel, D. Balentine, et al., Stakeholder Discussion To Reduce Population-Wide Sodium Intake and Decrease Sodium in the Food Supply: A Conference Report From The American Heart Association Sodium Conference 2013 Planning Group. Circulation. 2014 June 24;129(25):e660-79. doi:10.1161/CIR.0000000000000051.</P>
                        <P>
                            *18. FDA. “Use of the Term “Healthy” in the Labeling of Human Food Products: Guidance for Industry.” September 2016. Retrieved from: 
                            <E T="03">https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM521692.pdf.</E>
                        </P>
                        <P>
                            *19. USDA and HHS. “Scientific Report of the 2015 Dietary Guidelines Advisory Committee,” Advisory Report to the Secretary of Health and Human Services and the Secretary of Agriculture. Washington, DC, 2015. Retrieved from: 
                            <E T="03">http://health.gov/dietaryguidelines/2015-scientific-report/PDFs/Scientific-Report-of-the-2015-Dietary-Guidelines-Advisory-Committee.pdf.</E>
                        </P>
                        <P>
                            *20. USDA and HHS. “Dietary Guidelines for Americans,” Home and Gardening Bulletin No. 232, 1st Ed. Washington DC: U.S. Government Printing Office, 1980. Retrieved from: 
                            <E T="03">https://www.DietaryGuidelines.gov.</E>
                        </P>
                        <P>
                            *21. USDA and HHS. “Dietary Guidelines for Americans,” Home and Gardening Bulletin No. 232, 2nd Ed. Washington DC: U.S. Government Printing Office, 1985. Retrieved from: 
                            <E T="03">https://www.DietaryGuidelines.gov.</E>
                        </P>
                        <P>
                            *22. USDA and HHS. “Nutrition and Your Health, Dietary Guidelines for Americans,” Home and Gardening Bulletin No. 232, 3rd Ed. Washington DC: U.S. Government Printing Office, 1990. Retrieved from: 
                            <E T="03">https://www.DietaryGuidelines.gov.</E>
                        </P>
                        <P>
                            *23. USDA and HHS. “Nutrition and Your Health, Dietary Guidelines for Americans,” 
                            <PRTPAGE P="106162"/>
                            Home and Gardening Bulletin No. 232, 4th Ed. Washington DC: U.S. Government Printing Office, 1995. Retrieved from: 
                            <E T="03">https://www.DietaryGuidelines.gov.</E>
                        </P>
                        <P>
                            *24. USDA and HHS. “Nutrition and Your Health, Dietary Guidelines for Americans,” Home and Gardening Bulletin No., 232, 5th Ed. Washington DC: U.S. Government Printing Office, 2000. Retrieved from: 
                            <E T="03">https://www.DietaryGuidelines.gov.</E>
                        </P>
                        <P>
                            *25. USDA and HHS. “Nutrition and Your Health, Dietary Guidelines for Americans,” Home and Gardening Bulletin No. 232, 6th ed. Washington DC: U.S. Government Printing Office, 2005. Retrieved from: 
                            <E T="03">https://www.DietaryGuidelines.gov.</E>
                        </P>
                        <P>
                            *26. USDA and HHS. “Dietary Guidelines for Americans, 2010,” 7th Ed. Washington DC: U.S. Government Printing Office, 2010. Retrieved from: 
                            <E T="03">https://www.DietaryGuidelines.gov.</E>
                        </P>
                        <P>
                            *27. USDA. MyPlate Kitchen website. Retrieved from: 
                            <E T="03">https://www.myplate.gov/myplate-kitchen.</E>
                        </P>
                        <P>
                            *28. USDA. Food and Nutrition Service. Thrifty Food Plan, 2021. Retrieved from: 
                            <E T="03">https://www.fns.usda.gov/cnpp/usda-food-plans.</E>
                        </P>
                        <P>
                            29. Cifelli, C.J., S. Agarwal, and V.L. Fulgoni III. “Association of Yogurt Consumption with Nutrient Intakes, Nutrient Adequacy, and Diet Quality in American Children and Adults.” 
                            <E T="03">Nutrients 2020,</E>
                             12, 3435.
                        </P>
                        <P>
                            *30. FDA. “Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals: Guidance for Industry.” Retrieved from: 
                            <E T="03">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-nutrition-and-supplement-facts-labels-questions-and-answers-related-compliance.</E>
                        </P>
                        <P>
                            31. Baker-Smith C et al. (2019). “The Use of Nonnutritive Sweeteners in Children.” 
                            <E T="03">Pediatrics,</E>
                             144(5), 1-18.
                        </P>
                        <P>
                            32. Johnson R.K., A.H. Lichtenstein, C.A.M. Anderson, J.A. Carson, et al.; American Heart Association Nutrition Committee of the Council on Lifestyle and Cardiometabolic Health; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Quality of Care and Outcomes Research; and Stroke Council. “Low-Calorie Sweetened Beverages and Cardiometabolic Health: A Science Advisory From the American Heart Association.” 
                            <E T="03">Circulation.</E>
                             2018 August 28;138(9):e126-e140. doi: 10.1161/CIR.0000000000000569. PMID: 30354445.
                        </P>
                        <P>
                            *33. FDA: FDA Evaluated Substances: Aspartame and Other Sweeteners in Food. Retrieved from: 
                            <E T="03">https://www.fda.gov/food/food-additives-petitions/aspartame-and-other-sweeteners-food.</E>
                        </P>
                        <P>
                            *34. WHO, Nutrition and Food Safety. April 12, 2022. “Health Effects of the Use of Non-Sugar Sweeteners: A Systematic Review and Meta-Analysis.” Retrieved from: 
                            <E T="03">https://www.who.int/publications/i/item/9789240046429.</E>
                        </P>
                        <P>
                            *35. FDA. “Closer to Zero: Reducing Childhood Exposure to Contaminants From Food.” Retrieved from: 
                            <E T="03">https://www.fda.gov/food/environmental-contaminants-food/closer-zero-reducing-childhood-exposure-contaminants-foods.</E>
                        </P>
                        <P>
                            *36. USDA, Agricultural Research Service, Food Surveys Research Group. “Continuing Survey of Food Intakes by Individuals 1989-91 and Diet and Health Knowledge Survey 1989-91.” Retrieved from: 
                            <E T="03">https://www.ars.usda.gov/northeast-area/beltsville-md-bhnrc/beltsville-human-nutrition-research-center/food-surveys-research-group/docs/csfii-1989-1991-and-dhks-1989-1991/.</E>
                        </P>
                        <P>
                            *37. Centers for Disease Control and Prevention. National Center for Health Statistics. “National Health and Nutrition Examination Survey.” 2015-2016. Retrieved from: 
                            <E T="03">https://wwwn.cdc.gov/nchs/nhanes/continuousnhanes/default.aspx?BeginYear=2015.</E>
                        </P>
                        <P>
                            *38. Centers for Disease Control and Prevention. National Center for Health Statistics. “National Health and Nutrition Examination Survey.” 2017-2020. Retrieved from: 
                            <E T="03">https://wwwn.cdc.gov/nchs/nhanes/continuousnhanes/default.aspx?Cycle=2017-2020.</E>
                        </P>
                        <P>
                            *39. FDA. Final Regulatory Impact Analysis. Retrieved from: 
                            <E T="03">https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria.</E>
                        </P>
                        <P>
                            *40. USDA School Nutrition and Meal Cost Study. Retrieved from: 
                            <E T="03">https://www.fns.usda.gov/school-nutrition-and-meal-cost-study.</E>
                        </P>
                        <P>
                            *41. WHO Draft Guideline: Use of Non-Sugar Sweeteners. Retrieved from: 
                            <E T="03">https://extranet.who.int/dataformv3/upload/surveys/155928/files/NSS%20guideline_DRAFT_PC%20July%202022.pdf.</E>
                        </P>
                        <P>
                            *42. WHO Guideline: Use of Non-Sugar Sweeteners. Geneva: World Health Organization, 2023. Retrieved from: 
                            <E T="03">https://iris.who.int/bitstream/handle/10665/367660/9789240073616-eng.pdf?sequence=1.</E>
                        </P>
                        <P>
                            *43. FDA. “Letter Responding to Health Claim Petition dated January 27, 2004: Green Tea and Reduced Risk of Cancer Health Claim (Docket number FDA-2004-Q-0427). Retrieved from: 
                            <E T="03">https://Labeling &amp; Nutrition &gt; Letter Responding to Health Claim Petition</E>
                             dated January 27, 2004: Green Tea and Reduced Risk of Cancer Health Claim (Docket number FDA-2004-Q-0427) (
                            <E T="03">archive-it.org</E>
                            ).
                        </P>
                        <P>
                            44. Reedy, J., S.M. Krebs-Smith, P.E. Miller, et al., “Higher Diet Quality Is Associated with Decreased Risk of All-Cause, Cardiovascular Disease, and Cancer Mortality Among Older Adults.” 
                            <E T="03">The Journal of Nutrition,</E>
                             144(6):881-889, 2014.
                        </P>
                        <P>
                            45. Shangguan, S., A. Afshin, M. Shulkin, et al., “A Meta-Analysis of Food Labeling Effects on Consumer Diet Behaviors and Industry Practices.” 
                            <E T="03">American Journal of Preventive Medicine,</E>
                             56(2):300-314, 2019.
                        </P>
                        <P>
                            46. CDC. Food Service Guidelines Toolkit. Retrieved from: 
                            <E T="03">https://www.cdc.gov/food-service-guidelines-toolkit/php/strategize-act/cultural-food-preferences.html.</E>
                        </P>
                        <P>
                            47. FDA. “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2): Draft Guidance for Industry.” August 2024. Retrieved from: 
                            <E T="03">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-voluntary-sodium-reduction-goals-edition-2.</E>
                        </P>
                    </EXTRACT>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects in 21 CFR Part 101</HD>
                        <P>Food labeling, Nutrition, Reporting and record keeping requirements.</P>
                    </LSTSUB>
                    <P>Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 101 is amended as follows:</P>
                    <PART>
                        <HD SOURCE="HED">PART 101—FOOD LABELING</HD>
                    </PART>
                    <REGTEXT TITLE="21" PART="101">
                        <AMDPAR>1. The authority citation for part 101 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority: </HD>
                            <P> 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271.</P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="21" PART="101">
                        <AMDPAR>2. In § 101.13, revise paragraph (b)(2)(ii) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 101.13</SECTNO>
                            <SUBJECT>Nutrient content claims—general principles.</SUBJECT>
                            <STARS/>
                            <P>(b) * * *</P>
                            <P>(2) * * *</P>
                            <P>
                                (ii) Suggests that a food, because of its nutrient content, may be useful in maintaining healthy dietary practices, where there is also implied or explicit information about the nutrition content of the food (
                                <E T="03">e.g.,</E>
                                 “healthy”).
                            </P>
                            <STARS/>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="21" PART="101">
                        <AMDPAR>3. In § 101.65, revise paragraphs (a)(2) and (d) to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 101.65</SECTNO>
                            <SUBJECT>Implied nutrient content claims and related label statements.</SUBJECT>
                            <P>(a) * * *</P>
                            <P>(2) The claim is made in accordance with the general requirements for nutrient content claims in § 101.13, with the exception of § 101.13(h) when the nutrient content claim is made in accordance with paragraph (d) of this section; and</P>
                            <STARS/>
                            <P>
                                (d) 
                                <E T="03">General nutritional claims.</E>
                                 (1) This paragraph covers labeling claims that are implied nutrient content claims because they suggest that a food may help consumers maintain healthy dietary practices due to its nutrient content, where there is also implied or explicit information about the nutrition content of the food.
                            </P>
                            <P>
                                (2) For purposes of this section, a “food group equivalent” identifies qualifying amounts of foods from each food group based on nutritional content. A food group equivalent is equal to the following:
                                <PRTPAGE P="106163"/>
                            </P>
                            <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s75,r100,r100">
                                <TTITLE>
                                    Table 1 to Paragraph 
                                    <E T="01">(d)(2)</E>
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">Food group</CHED>
                                    <CHED H="1">Food group equivalent</CHED>
                                    <CHED H="1">Examples</CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">(i) Vegetable</ENT>
                                    <ENT>1/2 cup equivalent vegetable</ENT>
                                    <ENT>1/2 cup cooked green beans; 1 cup raw spinach</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">(ii) Fruit</ENT>
                                    <ENT>1/2 cup equivalent fruit</ENT>
                                    <ENT>
                                        1/2 cup strawberries; 
                                        <FR>1/2</FR>
                                         cup 100% orange juice; 
                                        <FR>1/4</FR>
                                         cup raisins
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">(iii) Grains</ENT>
                                    <ENT>3/4 oz equivalent whole grain</ENT>
                                    <ENT>
                                        1 slice of bread; 
                                        <FR>1/2</FR>
                                         cup cooked brown rice
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">(iv) Dairy</ENT>
                                    <ENT>2/3 cup equivalent dairy</ENT>
                                    <ENT>2/3 cup fat free milk; 1 oz nonfat cheese</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">(v) Protein foods</ENT>
                                    <ENT>
                                        1 
                                        <FR>1/2</FR>
                                         oz equivalent game meat
                                    </ENT>
                                    <ENT>
                                        1 
                                        <FR>1/2</FR>
                                         oz venison
                                    </ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>1 oz equivalent seafood</ENT>
                                    <ENT>1 oz tuna</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>1 oz equivalent egg</ENT>
                                    <ENT>1 large egg</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>1 oz equivalent beans, peas, or lentils</ENT>
                                    <ENT>1/4 cup black beans</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>1 oz equivalent nuts, seeds, or soy products</ENT>
                                    <ENT>1/2 oz walnuts</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>(3) You may use the term “healthy” or derivative terms “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness” as an implied nutrient content claim on the label or in labeling of a food that is useful in creating a diet that is consistent with dietary recommendations if the food meets the criteria of one or more of the following paragraphs (d)(3)(i) through (vi) of this section as follows:</P>
                            <P>(i) An individual food or mixed product that is comprised of one or more of the following foods that are the foundation of a healthy dietary pattern, with no other added ingredients except for water:</P>
                            <P>(A) Vegetable;</P>
                            <P>(B) Fruit;</P>
                            <P>(C) Whole grains;</P>
                            <P>(D) Fat-free or low-fat dairy;</P>
                            <P>(E) Lean meat, seafood, eggs, beans, peas, lentils, nuts, or seeds.</P>
                            <P>(ii) Individual foods.</P>
                            <P>(A) An individual food that has a reference amount customarily consumed (RACC) greater than 50 g or greater than 3 tablespoons and meets the conditions per RACC in table 2 of this section; or</P>
                            <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,r50,r50,r50,r50,r50">
                                <TTITLE>
                                    Table 2 to Paragraph 
                                    <E T="01">(d)(3)(ii)(A)</E>
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">If the food is . . .</CHED>
                                    <CHED H="2">Main category</CHED>
                                    <CHED H="2">
                                        Sub-category
                                        <LI>(if applicable)</LI>
                                    </CHED>
                                    <CHED H="1">It must contain at least . . .</CHED>
                                    <CHED H="1">The added sugars content must be no greater than . . .</CHED>
                                    <CHED H="1">The sodium content must be no greater than . . .</CHED>
                                    <CHED H="1">The saturated fat content must be no greater than . . .</CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">
                                        (
                                        <E T="03">1</E>
                                        ) A vegetable product 
                                    </ENT>
                                    <ENT> </ENT>
                                    <ENT>1/2 cup equivalent vegetable</ENT>
                                    <ENT>2% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>5% DV.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">
                                        (
                                        <E T="03">2</E>
                                        ) A fruit product
                                    </ENT>
                                    <ENT> </ENT>
                                    <ENT>1/2 cup equivalent fruit</ENT>
                                    <ENT>2% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>5% DV.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">
                                        (
                                        <E T="03">3</E>
                                        ) A grain product
                                    </ENT>
                                    <ENT> </ENT>
                                    <ENT>3/4 oz equivalent whole grain</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>5% DV.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">
                                        (
                                        <E T="03">4</E>
                                        ) A dairy product
                                    </ENT>
                                    <ENT> </ENT>
                                    <ENT>2/3 cup equivalent dairy</ENT>
                                    <ENT>5% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>10% DV.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">
                                        (
                                        <E T="03">5</E>
                                        ) Protein Foods
                                    </ENT>
                                    <ENT>
                                        <E T="03">(i)</E>
                                         Game meats
                                    </ENT>
                                    <ENT>
                                        1 
                                        <FR>1/2</FR>
                                         oz equivalent
                                    </ENT>
                                    <ENT>2% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>10% DV.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>
                                        <E T="03">(ii)</E>
                                         Seafood
                                    </ENT>
                                    <ENT>1 oz equivalent</ENT>
                                    <ENT>2% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>5% DV, excluding saturated fat inherent in seafood.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>
                                        <E T="03">(iii)</E>
                                         Egg
                                    </ENT>
                                    <ENT>1 oz equivalent</ENT>
                                    <ENT>2% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>10% DV.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>
                                        <E T="03">(iv)</E>
                                         Beans, peas, and lentils
                                    </ENT>
                                    <ENT>1 oz equivalent</ENT>
                                    <ENT>2% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>5% DV.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>
                                        <E T="03">(v)</E>
                                         Nuts, seeds, and soy products
                                    </ENT>
                                    <ENT>1 oz equivalent</ENT>
                                    <ENT>2% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>5% DV, excluding saturated fat inherent in nuts, seeds, and soybeans.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">
                                        (
                                        <E T="03">6</E>
                                        ) Oils
                                    </ENT>
                                    <ENT>
                                        <E T="03">(i)</E>
                                         100% Oil
                                    </ENT>
                                    <ENT> </ENT>
                                    <ENT>0% DV</ENT>
                                    <ENT>0% DV</ENT>
                                    <ENT>20% of total fat.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>
                                        <E T="03">(ii)</E>
                                         Oil-based spreads whose fats come solely from oil
                                    </ENT>
                                    <ENT> </ENT>
                                    <ENT>0% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>20% of total fat.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>
                                        <E T="03">(iii)</E>
                                         Oil-based dressing containing at least 30% oil and oils meet the requirements in paragraph (d)(3)(ii)(A) or (B)(6)(
                                        <E T="03">i)</E>
                                         of this section
                                    </ENT>
                                    <ENT> </ENT>
                                    <ENT>2% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>20% of total fat.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>
                                (B) An individual food that has a RACC of 50 g or less or 3 tablespoons or less and meets the conditions per 50 g of food in table 3 of this section:
                                <PRTPAGE P="106164"/>
                            </P>
                            <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,r50,r50,r50,r50,r50">
                                <TTITLE>
                                    Table 3 to Paragraph 
                                    <E T="01">(d)(3)(ii)(B)</E>
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">If the food is . . . </CHED>
                                    <CHED H="2">Main category</CHED>
                                    <CHED H="2">
                                        Sub-category
                                        <LI>(if applicable)</LI>
                                    </CHED>
                                    <CHED H="1">It must contain at least . . .</CHED>
                                    <CHED H="1">The added sugars content must be no greater than . . .</CHED>
                                    <CHED H="1">The sodium content must be no greater than . . .</CHED>
                                    <CHED H="1">The saturated fat content must be no greater than . . .</CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">
                                        (
                                        <E T="03">1</E>
                                        ) A vegetable product
                                    </ENT>
                                    <ENT> </ENT>
                                    <ENT>1/2 cup equivalent vegetable</ENT>
                                    <ENT>2% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>5% DV.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">
                                        (
                                        <E T="03">2</E>
                                        ) A fruit product
                                    </ENT>
                                    <ENT> </ENT>
                                    <ENT>1/2 cup equivalent fruit</ENT>
                                    <ENT>2% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>5% DV.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">
                                        (
                                        <E T="03">3</E>
                                        ) A grain product
                                    </ENT>
                                    <ENT> </ENT>
                                    <ENT>3/4 oz equivalent whole grain</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>5% DV.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">
                                        (
                                        <E T="03">4</E>
                                        ) A dairy product
                                    </ENT>
                                    <ENT> </ENT>
                                    <ENT>2/3 cup equivalent dairy</ENT>
                                    <ENT>5% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>10% DV.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">
                                        (
                                        <E T="03">5</E>
                                        ) Protein Foods
                                    </ENT>
                                    <ENT>
                                        <E T="03">(i)</E>
                                         Game meats
                                    </ENT>
                                    <ENT>
                                        1 
                                        <FR>1/2</FR>
                                         oz equivalent
                                    </ENT>
                                    <ENT>2% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>10% DV.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>
                                        <E T="03">(ii)</E>
                                         Seafood
                                    </ENT>
                                    <ENT>1 oz equivalent</ENT>
                                    <ENT>2% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>5% DV, excluding saturated fat inherent in seafood.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>
                                        <E T="03">(iii)</E>
                                         Egg
                                    </ENT>
                                    <ENT>1 oz equivalent</ENT>
                                    <ENT>2% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>10% DV.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>
                                        <E T="03">(iv)</E>
                                         Beans, peas, and lentils
                                    </ENT>
                                    <ENT>1 oz equivalent</ENT>
                                    <ENT>2% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>5% DV.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>
                                        <E T="03">(v)</E>
                                         Nuts, seeds, and soy products
                                    </ENT>
                                    <ENT>1 oz equivalent</ENT>
                                    <ENT>2% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>5% DV, excluding saturated fat inherent in nuts, seeds, and soybeans.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="01">
                                        (
                                        <E T="03">6</E>
                                        ) Oils
                                    </ENT>
                                    <ENT>
                                        <E T="03">(i)</E>
                                         100% Oil
                                    </ENT>
                                    <ENT> </ENT>
                                    <ENT>0% DV</ENT>
                                    <ENT>0% DV</ENT>
                                    <ENT>20% of total fat.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>
                                        <E T="03">(ii)</E>
                                         Oil-based spreads whose fats come solely from oil
                                    </ENT>
                                    <ENT> </ENT>
                                    <ENT>0% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>20% of total fat.</ENT>
                                </ROW>
                                <ROW>
                                    <ENT I="22"> </ENT>
                                    <ENT>
                                        <E T="03">(iii)</E>
                                         Oil-based dressing containing at least 30% oil and oils meet the requirements in paragraph (d)(3)(ii)(A) or (B)(6)(
                                        <E T="03">i)</E>
                                         of this section
                                    </ENT>
                                    <ENT> </ENT>
                                    <ENT>2% DV</ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>20% of total fat.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>(iii) A mixed product that meets the following conditions per RACC:</P>
                            <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s75,r30,r30,r60">
                                <TTITLE>
                                    Table 4 to Paragraphs 
                                    <E T="01">(d)(3)(iii)</E>
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">If the mixed product contains at least . . .</CHED>
                                    <CHED H="1">
                                        The added sugars content must be
                                        <LI>no greater than . . .</LI>
                                    </CHED>
                                    <CHED H="1">
                                        The sodium content
                                        <LI>must be no</LI>
                                        <LI>greater than . . .</LI>
                                    </CHED>
                                    <CHED H="1">
                                        Excluding saturated fat inherent in
                                        <LI>seafood, nuts, seeds, and soybeans</LI>
                                        <LI>in soy products (if applicable),</LI>
                                        <LI>the saturated fat content must be</LI>
                                        <LI>no greater than . . .</LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">
                                        One total food group equivalent with no less than 
                                        <FR>1/4</FR>
                                         food group equivalent from at least two food groups, as specified in paragraph (d)(2) of this section
                                    </ENT>
                                    <ENT>10% DV</ENT>
                                    <ENT>15% DV</ENT>
                                    <ENT>10% DV.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>(iv) A main dish product as defined in § 101.13(m) that meets the following conditions per labeled serving:</P>
                            <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s75,r30,r30,r60">
                                <TTITLE>
                                    Table 5 to Paragraph 
                                    <E T="01">(d)(3)(iv)</E>
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">If the main dish product contains at least . . .</CHED>
                                    <CHED H="1">The added sugars content must be no greater than . . .</CHED>
                                    <CHED H="1">
                                        The sodium content
                                        <LI>must be no</LI>
                                        <LI>greater than . . .</LI>
                                    </CHED>
                                    <CHED H="1">
                                        Excluding the saturated fat inherent in
                                        <LI>seafood, nuts, seeds, and soybeans</LI>
                                        <LI>in soy products (if applicable),</LI>
                                        <LI>the saturated fat content must be</LI>
                                        <LI>no greater than . . .</LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">
                                        Two total food group equivalents with no less than 
                                        <FR>1/2</FR>
                                         food group equivalent from at least two food groups, as specified in paragraph (d)(2) of this section
                                    </ENT>
                                    <ENT>15% DV</ENT>
                                    <ENT>20% DV</ENT>
                                    <ENT>15% DV.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <PRTPAGE P="106165"/>
                            <P>(v) A meal product as defined in § 101.13(l) that meets the following conditions per labeled serving:</P>
                            <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s75,r30,r30,r60">
                                <TTITLE>
                                    Table 6 to Paragraph 
                                    <E T="01">(d)(3)(v)</E>
                                </TTITLE>
                                <BOXHD>
                                    <CHED H="1">If the meal product contains at least . . .</CHED>
                                    <CHED H="1">
                                        The added sugars content must be no
                                        <LI>greater than . . .</LI>
                                    </CHED>
                                    <CHED H="1">
                                        The sodium content
                                        <LI>must be no</LI>
                                        <LI>greater than . . .</LI>
                                    </CHED>
                                    <CHED H="1">
                                        Excluding the saturated fat inherent in
                                        <LI>seafood, nuts, seeds, and soybeans</LI>
                                        <LI>in soy products (if applicable),</LI>
                                        <LI>the saturated fat content must be</LI>
                                        <LI>no greater than . . .</LI>
                                    </CHED>
                                </BOXHD>
                                <ROW>
                                    <ENT I="01">
                                        Three total food group equivalents with no less than 
                                        <FR>1/2</FR>
                                         food group equivalent from at least three food groups, as specified in paragraph (d)(2) of this section
                                    </ENT>
                                    <ENT>20% DV</ENT>
                                    <ENT>30% DV</ENT>
                                    <ENT>20% DV.</ENT>
                                </ROW>
                            </GPOTABLE>
                            <P>(vi) All water, tea, and coffee with less than 5 calories per RACC and per labeled serving.</P>
                            <P>
                                (4) Each manufacturer of a food (other than foods where the standard information required on the food label, such as the list of ingredients, provides sufficient information to verify that the food meets the food group equivalent requirements to bear the claim, and foods described in paragraphs (d)(3)(i) and (vi) of this section) that bears the implied nutrient content claim “healthy” must make and keep written records (
                                <E T="03">e.g.,</E>
                                 analyses of databases, recipes, formulations, information from recipes or formulations, or batch records) to verify that the food meets the food group equivalent requirements of paragraph (d)(2) of this section. These records must be kept for a period of at least 2 years after introduction or delivery for introduction of the food into interstate commerce. Such records must be provided to FDA upon request, during an inspection, for official review and photocopying or other means of reproduction. Records may be kept either as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records that must be kept in accordance with part 11 of this chapter. These records must be accurate, indelible, and legible.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <SIG>
                        <DATED>Dated: December 12, 2024.</DATED>
                        <NAME>Robert M. Califf,</NAME>
                        <TITLE>Commissioner of Food and Drugs.</TITLE>
                    </SIG>
                </SUPLINF>
                <FRDOC>[FR Doc. 2024-29957 Filed 12-19-24; 11:15 am]</FRDOC>
                <BILCOD>BILLING CODE 4164-01-P</BILCOD>
            </RULE>
        </RULES>
    </NEWPART>
    <VOL>89</VOL>
    <NO>248</NO>
    <DATE>Friday, December 27, 2024</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="106167"/>
            <PARTNO>Part VI</PARTNO>
            <AGENCY TYPE="P"> Securities and Exchange Commission</AGENCY>
            <CFR>17 Part 232, 239, 249, et al.</CFR>
            <TITLE>EDGAR Filer Access and Account Management; Final Rule</TITLE>
        </PTITLE>
        <RULES>
            <RULE>
                <PREAMB>
                    <PRTPAGE P="106168"/>
                    <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                    <CFR>17 CFR Parts 232, 239, 249, 269, and 274</CFR>
                    <DEPDOC>[Release Nos. 33-11313; 34-101209; 39-2557; IC-35343; File No. S7-15-23]</DEPDOC>
                    <RIN>RIN 3235-AM58</RIN>
                    <SUBJECT>EDGAR Filer Access and Account Management</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Securities and Exchange Commission.</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Final rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>The Securities and Exchange Commission (“Commission”) is adopting rule and form amendments concerning access to and management of accounts on the Commission's Electronic Data Gathering, Analysis, and Retrieval system (“EDGAR”) that are related to certain technical changes to EDGAR (collectively referred to as “EDGAR Next”). EDGAR Next will improve the security of EDGAR, enhance filers' ability to manage their EDGAR accounts, and modernize connections to EDGAR. The amendments require electronic filers (“filers”) to authorize and maintain designated individuals as account administrators and to take certain actions, through their account administrators, to manage their accounts on EDGAR. Further, pursuant to these amendments, filers may only authorize individuals as account administrators or in the other roles described herein if those individuals first obtain individual account credentials in the manner specified in the EDGAR Filer Manual. As part of the EDGAR Next changes, optional Application Programming Interfaces (“APIs”) will be offered to filers for machine-to-machine communication with EDGAR. Moreover, we are amending Volume I of the EDGAR Filer Manual to accord with these changes. Filers will have 12 months from the issuance of this release to transition to EDGAR Next.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P/>
                        <P>
                            <E T="03">Effective date:</E>
                             The effective date for this rule is March 24, 2025. The incorporation by reference of certain material listed in this rule is approved by the Director of the Federal Register as of March 24, 2025.
                        </P>
                        <P>
                            <E T="03">Compliance date:</E>
                             The compliance date for amended Form ID is March 24, 2025. The compliance date for all other rule and form amendments (other than the EDGAR Filer Manual changes) is September 15, 2025. See 
                            <E T="02">SUPPLEMENTARY INFORMATION</E>
                             for more information on compliance and the EDGAR Filer Manual changes.
                        </P>
                    </EFFDATE>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>Rosemary Filou, Deputy Director and Chief Counsel; Daniel K. Chang, Senior Special Counsel; E. Laurita Finch, Senior Special Counsel; Jane Patterson, Senior Special Counsel; Margaret Marrero, Senior Counsel; Lidian Pereira, Senior Special Counsel; EDGAR Business Office at 202-551-3900, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549.</P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <P>The Commission is adopting amendments to 17 CFR 232.10 (“Rule 10”) and 17 CFR 232.11 (“Rule 11”) under 17 CFR part 232 (“Regulation S-T”); and amendments to Form ID (referenced in 17 CFR 239.63, 249.446, 269.7, and 274.402). The Commission is also adopting an updated Filer Manual, Volume I: “EDGAR Filing,” Version 42 (issued September 27, 2024) and amendments to 17 CFR 232.301 (“Rule 301”). The updated Filer Manual is incorporated by reference into the Code of Federal Regulations.</P>
                    <HD SOURCE="HD1">Table of Contents</HD>
                    <EXTRACT>
                        <FP SOURCE="FP-2">I. Introduction</FP>
                        <FP SOURCE="FP-2">II. Discussion</FP>
                        <FP SOURCE="FP1-2">A. Individual Account Credentials</FP>
                        <FP SOURCE="FP1-2">B. Individual Roles: Account Administrator, User, Technical Administrator</FP>
                        <FP SOURCE="FP1-2">1. Account Administrators</FP>
                        <FP SOURCE="FP1-2">2. Users</FP>
                        <FP SOURCE="FP1-2">3. Technical Administrators</FP>
                        <FP SOURCE="FP1-2">C. Delegated Entities</FP>
                        <FP SOURCE="FP1-2">1. Delegating Authority To File</FP>
                        <FP SOURCE="FP1-2">2. Separation of Authority of Filer and Delegated Entity</FP>
                        <FP SOURCE="FP1-2">3. Delegated Entities</FP>
                        <FP SOURCE="FP1-2">4. Delegated Users</FP>
                        <FP SOURCE="FP1-2">5. User Group Functionality at Delegated Entities</FP>
                        <FP SOURCE="FP1-2">6. Technical Administrators at Delegated Entities</FP>
                        <FP SOURCE="FP1-2">D. Hours of Operation of the Dashboard</FP>
                        <FP SOURCE="FP1-2">E. Optional Application Programming Interfaces</FP>
                        <FP SOURCE="FP1-2">1. APIs That Commission Staff Will Provide</FP>
                        <FP SOURCE="FP1-2">2. API Tokens</FP>
                        <FP SOURCE="FP1-2">F. Final Amendments to Rules and Forms</FP>
                        <FP SOURCE="FP1-2">1. Rule 10 of Regulation S-T</FP>
                        <FP SOURCE="FP1-2">2. Rule 11 of Regulation S-T</FP>
                        <FP SOURCE="FP1-2">3. Form ID</FP>
                        <FP SOURCE="FP1-2">G. EDGAR Filer Manual Changes</FP>
                        <FP SOURCE="FP1-2">H. Transition Process</FP>
                        <FP SOURCE="FP1-2">1. Enrollment Process</FP>
                        <FP SOURCE="FP1-2">2. Compliance</FP>
                        <FP SOURCE="FP-2">III. Other Matters</FP>
                        <FP SOURCE="FP-2">IV. Economic Analysis</FP>
                        <FP SOURCE="FP1-2">A. Baseline</FP>
                        <FP SOURCE="FP1-2">B. Consideration of Benefits and Costs as Well as the Effects on Efficiency, Competition, and Capital Formation</FP>
                        <FP SOURCE="FP1-2">1. Benefits</FP>
                        <FP SOURCE="FP1-2">2. Costs</FP>
                        <FP SOURCE="FP1-2">3. Effects on Efficiency, Competition, and Capital Formation</FP>
                        <FP SOURCE="FP1-2">C. Reasonable Alternatives</FP>
                        <FP SOURCE="FP1-2">1. Add and Allow Bulk Confirmation for Related CIKs</FP>
                        <FP SOURCE="FP1-2">2. Extend the ABSCOMP Process to Affiliated Entities</FP>
                        <FP SOURCE="FP1-2">3. Retire the CCC for Filing Submissions</FP>
                        <FP SOURCE="FP1-2">4. Requirements for Individual and Small Filers</FP>
                        <FP SOURCE="FP1-2">5. Implementing Performance-Based Standards</FP>
                        <FP SOURCE="FP-2">V. Paperwork Reduction Act</FP>
                        <FP SOURCE="FP1-2">A. Summary of Comment Letters on PRA Estimates</FP>
                        <FP SOURCE="FP1-2">B. Form ID</FP>
                        <FP SOURCE="FP1-2">C. The Dashboard</FP>
                        <FP SOURCE="FP-2">VI. Final Regulatory Flexibility Analysis</FP>
                        <FP SOURCE="FP1-2">A. Need for and Objectives of the Rule and Form Amendments</FP>
                        <FP SOURCE="FP1-2">B. Significant Issues Raised by Public Comments</FP>
                        <FP SOURCE="FP1-2">C. Small Entities Subject to the Rule and Form Amendments</FP>
                        <FP SOURCE="FP1-2">D. Projected Reporting, Recordkeeping, and Other Compliance Requirements</FP>
                        <FP SOURCE="FP1-2">E. Agency Action to Minimize Effects on Small Entities</FP>
                        <FP SOURCE="FP-2">Statutory Authority</FP>
                        <FP SOURCE="FP-2">Appendix A—Form ID</FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">I. Introduction</HD>
                    <P>
                        The Commission is seeking to enhance the security of EDGAR, improve the ability of filers 
                        <SU>1</SU>
                        <FTREF/>
                         to securely manage and maintain access to their EDGAR accounts, facilitate the responsible management of filer credentials, and simplify procedures for accessing EDGAR.
                        <SU>2</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             For purposes of this release, we use the term “filer” to mean “electronic filer,” as defined in Rule 11 of Regulation S-T: “A person or an entity that submits filings electronically pursuant to Rules 100 or 101 of Regulation S-T.”
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             For a discussion of the current EDGAR access and account management processes, please refer to 
                            <E T="03">EDGAR Filer Access and Account Management,</E>
                             Release No. 33-11232 (September 13, 2023) [88 FR 65524 (September 22, 2023)] (“Proposing Release”).
                        </P>
                    </FTNT>
                    <P>
                        In furtherance of these goals, on September 30, 2021, the Commission issued a Request for Comment on Potential Technical Changes to EDGAR Filer Access and Filer Account Management Processes (“2021 Request for Comment”).
                        <SU>3</SU>
                        <FTREF/>
                         The Commission received comments in response to the 2021 Request for Comment,
                        <SU>4</SU>
                        <FTREF/>
                         and Commission staff subsequently engaged in a dialogue with commenters and other interested parties,
                        <SU>5</SU>
                        <FTREF/>
                         considered feedback from these parties, and gathered additional information about filers' interactions with EDGAR. Staff discussed a variety of topics with commenters including the addition of optional APIs for submission and for verifying certain information on 
                        <PRTPAGE P="106169"/>
                        EDGAR; filers' annual confirmation of the accuracy of their account information; whether accession numbers should be traceable to the individuals making the submissions; bulk submissions and user group functionality; delegation of authority to file; a potential transition process to implement the contemplated changes; and other technical matters.
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             For a discussion of the 2021 Request for Comment, please refer to the Proposing Release.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             Comment letters related to the 2021 Request for Comment are available at 
                            <E T="03">https://www.sec.gov/comments/s7-12-21/s71221.htm.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             Memoranda describing these meetings with SEC officials are available at 
                            <E T="03">https://www.sec.gov/comments/s7-15-23/s71523.htm.</E>
                        </P>
                    </FTNT>
                    <P>After consideration of the information provided by commenters in response to the 2021 Request for Comment, the Commission issued a Proposing Release on September 13, 2023, that included proposed amendments to Rule 10 of Regulation S-T concerning filer access and account management and related matters; Form ID, the application for EDGAR access; and Rule 11 of Regulation S-T, containing the definitions of terms in Regulation S-T. The Commission proposed changes to Rule 10 and Form ID to require each EDGAR filer to authorize and maintain individual account administrators to manage the filer's EDGAR account on a dashboard on EDGAR and to authorize account administrators and other individuals only if those individuals obtained individual account credentials. The Commission further proposed that each filer, through its account administrators, be required to confirm annually that the filer authorized all individuals and delegated entities reflected on the dashboard to act on its behalf, and that all information about the filer on the dashboard was accurate. The Commission also proposed requirements to maintain accurate and current information on EDGAR concerning the filer's account and securely maintain information relevant to the ability to access the filer's EDGAR account. In addition to the proposed rule and form amendments, the Commission described in the Proposing Release the possible addition of optional APIs to allow machine-to-machine submissions on and retrieval of certain information from EDGAR and indicated that, to connect to the optional APIs, filers, through their account administrators, would be required to authorize at least two technical administrators and present certain security tokens to EDGAR as specified in the EDGAR Filer Manual.</P>
                    <P>
                        The Commission considered comment letters received in response to the Proposing Release that included both comments on the proposed rule and form changes as well as technical feedback on functionality discussed in the Proposing Release.
                        <SU>6</SU>
                        <FTREF/>
                         We considered both the comments on the rule and form amendments as well as feedback on EDGAR Next technical functionality and discuss both aspects together in this release. While we discuss aspects of EDGAR Next technical functionality in this release together with the final rule and form amendments, we anticipate that this technical functionality will evolve over time in response to, for example, changes in filer needs, security requirements, and technological developments, among other circumstances. As is the case today and has been historically, updates to the EDGAR system typically will be communicated through the EDGAR Filer Management website and reflected in amendments to the EDGAR Filer Manual from time to time.
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             The public comments we received are available at 
                            <E T="03">https://www.sec.gov/comments/s7-15-23/s71523.htm.</E>
                             A few commenters asserted that the comment period was not sufficient and asked the Commission to extend it. 
                            <E T="03">See</E>
                             Comment Letter of XBRL US (October 27, 2023) and Toppan Merrill Comment Letter (November 20, 2023) (“Toppan Merrill Comment Letter”). The comment period for the Proposing Release was open for 60 days, and we do not believe an extension of the comment period is necessary. Moreover, we have considered all comment letters received, including those submitted after the comment period closed.
                        </P>
                    </FTNT>
                    <P>The Commission is adopting the proposed amendments to Rules 10 and 11 of Regulation S-T and Form ID substantially as proposed. We believe that the rule and form amendments adopted in this release and the related technical changes further the goals of enhancing the security of EDGAR access and improving EDGAR account management and are responsive to the comments received in response to the Proposing Release and the 2021 Request for Comment.</P>
                    <P>
                        The obligations for filers are generally being codified in Rule 10 of Regulation S-T, new paragraph (d).
                        <SU>7</SU>
                        <FTREF/>
                         Under paragraph (d)(1) of Rule 10 as adopted, only those individuals who obtain individual account credentials 
                        <SU>8</SU>
                        <FTREF/>
                         can be authorized to act on the filer's behalf on the dashboard on EDGAR.
                        <SU>9</SU>
                        <FTREF/>
                         Paragraph (d)(2) of Rule 10 as adopted requires each filer to authorize and maintain individuals as its account administrators 
                        <SU>10</SU>
                        <FTREF/>
                         to manage the filer's EDGAR account on the filer's behalf, in accord with the EDGAR account access and account management requirements set forth in this release and in the EDGAR Filer Manual as it is being amended. Pursuant to the amendments to Form ID and the EDGAR Filer Manual, the filer can authorize someone who is not an employee of the filer or its affiliates to be the filer's account administrator if an authorized individual for the filer 
                        <SU>11</SU>
                        <FTREF/>
                         provides a relevant notarized power of attorney.
                        <SU>12</SU>
                        <FTREF/>
                         Paragraph (d)(3) of Rule 10 as adopted requires any filer that decides to connect to an optional API 
                        <SU>13</SU>
                        <FTREF/>
                         to authorize, through its account administrators, at least two technical administrators 
                        <SU>14</SU>
                        <FTREF/>
                         to manage the API unless the filer arranges to use the filer API tokens and API connections of its 
                        <PRTPAGE P="106170"/>
                        delegated entities.
                        <SU>15</SU>
                        <FTREF/>
                         Further, the EDGAR Filer Manual is being amended to require that filers present certain security tokens to connect to the APIs. As adopted, paragraph (d)(4) of Rule 10 will require each filer, through its authorized account administrators, to confirm annually that all account administrators, users,
                        <SU>16</SU>
                        <FTREF/>
                         delegated entities,
                        <SU>17</SU>
                        <FTREF/>
                         and technical administrators reflected on the dashboard for the filer's EDGAR account are authorized by the filer and that all information regarding the filer on the dashboard is accurate. Paragraph (d)(5) of Rule 10 as adopted will require each filer, through its authorized account administrators, to maintain accurate and current information about the filer on EDGAR, and paragraph (d)(6) of Rule 10 as adopted will require each filer, through its authorized account administrators, to securely maintain information relevant to the ability to access the filer's EDGAR account.
                    </P>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             In addition to the changes discussed below, Rule 10 is being amended to implement certain clarifying and conforming changes. 
                            <E T="03">See</E>
                             section II.F.1.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             We are amending Rule 11 of Regulation S-T to define “individual account credentials” as credentials issued to individuals for purposes of EDGAR access, as specified in the EDGAR Filer Manual. See the discussion of amendments to Rule 11 in section II.F.2. The EDGAR Filer Manual is being amended to specify that individual account credentials must be obtained through Login.gov, a sign-in service of the U.S. Government that employs multifactor authentication.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             We are amending Rule 11 of Regulation S-T to define the “dashboard” as an interactive function on EDGAR where electronic filers manage their EDGAR accounts and individuals that electronic filers authorize may take relevant actions for electronic filers' accounts. See the discussion of amendments to Rule 11 in section II.F.2. In connection with this rulemaking, the dashboard will be integrated into the EDGAR Filer Management website, 
                            <E T="03">https://www.filermanagement.edgarfiling.sec.gov.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             We are amending Rule 11 of Regulation S-T to define an “account administrator” as an individual that an electronic filer authorizes to manage the electronic filer's EDGAR account on EDGAR, and to make filings on EDGAR on the electronic filer's behalf. See the discussion of amendments to Rule 11 in section II.F.2. Applicants (individuals and companies) for EDGAR access must authorize account administrators on Form ID. 
                            <E T="03">See</E>
                             amended Form ID.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             We are amending Rule 11 of Regulation S-T to define “authorized individual.” This definition mirrors the definition of “authorized individual” in the EDGAR Filer Manual, Volume I. See the discussion of amendments to Rule 11 in section II.F.2 and EDGAR Filer Manual, Volume I.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             For example, if a filer wishes to authorize an individual employed by its filing agent to act as the filer's account administrator, the filer must upload with the Form ID a power of attorney signed by an authorized individual of the filer, with that signature notarized, authorizing the employee of the filing agent to be the filer's account administrator. 
                            <E T="03">See</E>
                             amended Form ID, Part 3. The EDGAR Filer Manual, Volume I sets forth the requirements for notarization of the signature of an authorized individual. Among other things, pursuant to Volume I of the EDGAR Filer Manual, notarization may be obtained through a remote online notary recognized by the law of any State or territory in the U.S. or the District of Columbia.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             We are amending Rule 11 of Regulation S-T to define an “Application Programming Interface” or “API” as a software interface that allows computers or applications to communicate with each other. See the discussion of amendments to Rule 11 in section II.F.2.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             We are amending Rule 11 of Regulation S-T to define a “technical administrator” as an individual that the filer authorizes on the dashboard to manage the technical aspects of the filer's use of EDGAR APIs on its behalf. See the discussion of amendments to Rule 11 in section II.F.2. Technical administrators need not be software developers or technical experts to carry out the requirements to manage the filer's use of APIs and filer API tokens, as discussed more fully below.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             
                            <E T="03">See</E>
                             paragraph (d)(3) of Rule 10 as adopted addressing the technical administrator requirements and the provision therein allowing filers to use their delegated entities' API connections and filer API tokens so long as those delegated entities comply with the requirement to maintain two technical administrators.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             We are amending Rule 11 of Regulation S-T to define a “user” as an individual that the filer authorizes on the dashboard to make submissions on EDGAR on the filer's behalf. See the discussion of amendments to Rule 11 in section II.F.2.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             We are amending Rule 11 of Regulation S-T to define a “delegated entity” as an electronic filer that another electronic filer authorizes, on the dashboard, to file on EDGAR on its behalf. See the discussion of amendments to Rule 11 in section II.F.2.
                        </P>
                    </FTNT>
                    <P>
                        We are amending Form ID to implement the changes to Rule 10, including but not limited to the requirement to provide information about the applicant's account administrators, to make the form more user friendly,
                        <SU>18</SU>
                        <FTREF/>
                         and to improve the utility of the form for Commission staff.
                        <SU>19</SU>
                        <FTREF/>
                         Moreover, we are amending Rule 11 of Regulation S-T to define new terms related to the rule and form amendments.
                        <SU>20</SU>
                        <FTREF/>
                         We are further amending the EDGAR Filer Manual to accord with the EDGAR Next changes.
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             As an example of the changes being made to make the form more user friendly, additional instruction will be added to guide applicants through completion and submission of the form, and the user interface will be improved.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             As an example of the changes being made to improve the utility of the form for Commission staff, a checkbox will be added to each address field for identification of non-U.S. locations, which will improve data analytics.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             Please refer to amended Rule 11 of Regulation S-T, set forth in this release, for definitions of the terms used in the release. The amendments to Rule 11 also update or delete reference to outdated terminology and clarify the definition of the EDGAR Filer Manual.
                        </P>
                    </FTNT>
                    <P>
                        The EDGAR Next transition process will begin with the issuance of this adopting release. For the initial six months, from September 30, 2024 to March 21, 2025, filers may prepare for the changes by testing in and modifying their internal software systems to accord with an EDGAR Next Adopting Beta environment reflecting the adopted rule and form amendments and related technical changes, including but not limited to testing the optional APIs that will be provided, as well as gathering information necessary to enroll on EDGAR. On Monday, March 24, 2025, a new EDGAR Filer Management website that includes the dashboard will go live, and related changes in the EDGAR Filer Manual, Volume I will be effective. At that time, compliance with amended Form ID will be required, all applicants for EDGAR access must apply on amended Form ID through the dashboard, and the prior version of the form will be ineffective. If Commission staff grant the amended Form ID application, the filer will be in compliance with the EDGAR Next changes, and thus will not be required to subsequently enroll on the dashboard. In addition, beginning Monday, March 24, 2025, existing filers may begin to enroll on the dashboard, and once enrolled may connect to the optional APIs while still being able to use the legacy filing process. Compliance with the remaining EDGAR Next changes will be required on Monday, September 15, 2025, when all EDGAR websites will require, among other things, 
                        <E T="03">Login.gov</E>
                         individual account credentials and dashboard authorization to make submissions on EDGAR. Filers who have not enrolled by September 15, 2025 will not be able to make submissions or take other actions in EDGAR other than enroll. Enrollment will be permitted for an additional three months, until December 19, 2025.
                        <SU>21</SU>
                        <FTREF/>
                         On December 22, 2025, filers who have not enrolled in EDGAR Next or been granted access through amended Form ID will be required to submit the amended Form ID through the dashboard to apply for access to their existing EDGAR accounts. Section II.H below provides additional information regarding the transition to EDGAR Next.
                    </P>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             In total, the enrollment period will extend nine months, from March 24, 2025 to December 19, 2025. If filers enroll on the dashboard during this period, they will not be required to apply for access on amended Form ID. Please see section II.H for additional information about enrollment.
                        </P>
                    </FTNT>
                    <P>
                        Additional details regarding EDGAR Next technical changes, including dashboard functionality and APIs, as well as the transition process are available on the EDGAR Next page on 
                        <E T="03">SEC.gov.</E>
                        <SU>22</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             
                            <E T="03">See</E>
                             EDGAR Next-Improving Filer Access and Account Management, U.S. Securities and Exchange Commission, available at 
                            <E T="03">https://www.sec.gov/edgar/filer-information/edgar-next.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">II. Discussion</HD>
                    <P>
                        We are adopting, substantially as proposed, amendments to Rule 10 of Regulation S-T concerning EDGAR filer access and account management and related matters; Form ID, the application for EDGAR access; and Rule 11 of Regulation S-T, containing the definitions of terms in Regulation S-T. We are further amending the EDGAR Filer Manual in accord with the rule and form amendments.
                        <SU>23</SU>
                        <FTREF/>
                         These amendments will, among other things, benefit filers by improving the security of their EDGAR accounts and making it easier for filers to manage and maintain access to their EDGAR accounts.
                    </P>
                    <FTNT>
                        <P>
                            <SU>23</SU>
                             A blackline of the changes to Volume I of the EDGAR Filer Manual is available at 
                            <E T="03">www.sec.gov/rules-regulations.</E>
                        </P>
                    </FTNT>
                    <P>
                        The amendments to Rule 10 and Form ID set forth requirements for each EDGAR filer to authorize and maintain individual account administrators to manage the filer's EDGAR account on a dashboard on EDGAR and to authorize to act on the filer's behalf only those individuals who obtain individual account credentials. The EDGAR Filer Manual is being amended to specify 
                        <E T="03">Login.gov</E>
                         as the individual account credential provider. Each filer, through its account administrators, will be required to confirm annually that all account administrators, users, technical administrators, and delegated entities reflected on the filer's dashboard are authorized by the filer to act on its behalf and that all information regarding the filer on the dashboard is accurate; maintain accurate and current information on EDGAR concerning the filer's account; and securely maintain information relevant to the ability to access the filer's EDGAR account.
                    </P>
                    <P>
                        In addition to the rule and form amendments, this release describes the EDGAR Next functionality that will be offered to filers, including but not limited to optional APIs that will improve the efficiency and accuracy of filers' interactions with EDGAR by providing a machine-to-machine method of making submissions, retrieving information, and performing account management tasks. EDGAR will make available 15 optional APIs in total, which include the three APIs discussed in the Proposing Release and 12 additional APIs, many of which were requested by commenters. Among other things, these APIs will replicate much of 
                        <PRTPAGE P="106171"/>
                        the dashboard account management functionality, allowing filers to manage their EDGAR accounts with minimal manual interaction with EDGAR.
                    </P>
                    <P>If a filer chooses to connect to the optional APIs, the filer, through its account administrators, must authorize at least two technical administrators, pursuant to paragraph (d)(3) of Rule 10, unless the filer arranges to use the filer API tokens and API connections of its delegated entity (and the delegated entity complies with the requirement to maintain at least two technical administrators), as requested by commenters. Filers choosing to connect to the optional APIs must also present specified security tokens of limited duration in the form of filer API tokens and user API tokens, as set forth in the EDGAR Filer Manual as amended. These token requirements are intended to provide security for API connections. Filers using their delegated entities' API connections must use their delegated entities' filer API tokens, and individuals at those filers must present a user API token to interact with the APIs to allow identification of the individual taking action on EDGAR if those APIs require presentation of a user API token.</P>
                    <P>Filers that do not connect to the optional EDGAR APIs will not need to comply with these API-related requirements and may continue to make web-based submissions on EDGAR.</P>
                    <HD SOURCE="HD2">A. Individual Account Credentials</HD>
                    <P>Paragraph (d)(1) of Rule 10 as proposed and adopted will require that a filer only authorize an individual to perform functions on the dashboard on the filer's behalf if that individual possesses individual account credentials, obtained in the manner specified in the EDGAR Filer Manual. In addition to what was noted in the Proposing Release, however, and in response to commenter concerns, the EDGAR Filer Manual is being amended to clarify that individual account credentials may not be shared with other individuals as the credentials are intended to identify the individual who takes action on EDGAR.</P>
                    <P>
                        As contemplated in the Proposing Release, we are amending the EDGAR Filer Manual to specify that individual account credentials must be obtained through 
                        <E T="03">Login.gov,</E>
                         a secure sign-in service of the U.S. General Services Administration.
                        <SU>24</SU>
                        <FTREF/>
                          
                        <E T="03">Login.gov</E>
                         is used by participating Federal agencies, as well as State, local, and territorial governments to provide a secure login process and to allow members of the public to use a single account that is protected by encryption, multifactor authentication, and additional safeguards.
                        <SU>25</SU>
                        <FTREF/>
                         To obtain individual account credentials for EDGAR, an individual must respond to prompts on the 
                        <E T="03">Login.gov</E>
                         website to provide an email address, create a password, and select a multifactor authentication option.
                        <SU>26</SU>
                        <FTREF/>
                         The EDGAR Filer Manual will specify that the email address provided to 
                        <E T="03">Login.gov</E>
                         must match the email address the individual has provided or intends to provide to EDGAR (during enrollment, on amended Form ID, or to the relevant account administrator).
                        <SU>27</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             
                            <E T="03">https://www.login.gov/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             
                            <E T="03">See Login.gov,</E>
                             “About us,” at 
                            <E T="03">https://www.login.gov/about-us/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             As of the date of this release, 
                            <E T="03">Login.gov</E>
                             multifactor authentication options include: (1) a security key; (2) Federal government employee or military PIV or CAC cards; (3) authentication application; (4) biometric (face or fingerprint) verification; (5) text message/SMS or telephone call; and (6) backup codes. With respect to option (3), current 
                            <E T="03">Login.gov</E>
                             authentication applications include: Android and iOS options (Google Authenticator, Authy, LastPass, 1Password), Windows and Mac apps (1Password and OTP Manager), and Chrome extensions (Authenticator). 
                            <E T="03">See generally</E>
                              
                            <E T="03">Login.gov,</E>
                             Authentication Options at 
                            <E T="03">https://www.login.gov/help/get-started/authentication-options/. See also generally Login.gov,</E>
                             “Privacy and security: Our security practices,” at 
                            <E T="03">https://login.gov/policy/our-security-practices/</E>
                             for information on 
                            <E T="03">Login.gov</E>
                            's security practices.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             If an individual changes the email address that she uses in connection with EDGAR (for example, because of a change of domain name), the individual should first change her email address on the dashboard and then change it on 
                            <E T="03">Login.gov.</E>
                             This will prevent interruptions in access to EDGAR. If an individual permanently loses access to her email before taking the steps above, the individual should create another account on 
                            <E T="03">Login.gov</E>
                             with a new email address, and the filer's account administrator should add her to the filer's account on the dashboard using the new email address.
                        </P>
                    </FTNT>
                    <P>
                        In accord with amended paragraph (d) of Rule 10 and the EDGAR Filer Manual, and as proposed, all account administrators, users, and technical administrators must enter their individual account credentials and complete multifactor authentication to log into EDGAR. After entering the email address and the password created on 
                        <E T="03">Login.gov,</E>
                         the individual will be prompted to complete the multifactor authentication option the individual selected when obtaining individual account credentials at 
                        <E T="03">Login.gov.</E>
                        <SU>28</SU>
                        <FTREF/>
                         Thus, through 
                        <E T="03">Login.gov,</E>
                         multifactor authentication for individual accounts will be required to access EDGAR.
                    </P>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             If the individual loses or forgets her 
                            <E T="03">Login.gov</E>
                             password, the individual can reset the password through 
                            <E T="03">Login.gov,</E>
                             simplifying and automating the process of password retrieval.
                        </P>
                    </FTNT>
                    <P>
                        The use of multifactor authentication aligns with modern security practices, such as those set forth in Executive Order No. 14028, issued May 12, 2021, directing Federal agencies to modernize and implement stronger cybersecurity standards (“executive order”),
                        <SU>29</SU>
                        <FTREF/>
                         including but not limited to the deployment of multifactor authentication as a foundational security tool at Federal agencies. As stated in the executive order, the use of multifactor authentication enhances system security. It further follows digital identity guidelines for Federal agencies issued by the National Institute of Standards and Technology (“NIST”).
                        <SU>30</SU>
                        <FTREF/>
                         Multifactor authentication is a widely accepted security tool that will improve the security of access to EDGAR by adding a layer of validation each time an individual signs into EDGAR.
                    </P>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             
                            <E T="03">See</E>
                             Exec. Order No. 14028 (2021), 60 FR 26633, 26636 (May 17, 2021).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>30</SU>
                             
                            <E T="03">See</E>
                             Digital Identity Guidelines: Authentication and Lifecycle Management, National Institute of Standards and Technology, NIST SP 800-63, 
                            <E T="03">available at https://csrc.nist.gov/pubs/sp/800/63/b/upd2/final,</E>
                             at section 4 of NIST SP 800-63B (“Any PII or other personal information—whether self-asserted or validated—requires multi-factor authentication.”).
                        </P>
                    </FTNT>
                    <P>In sum, EDGAR Next will enhance the security of filers' accounts by requiring anyone seeking to make a submission on EDGAR on behalf of a filer to sign in with individual account credentials, complete multifactor authentication, be authorized by the filer or the filer's account administrator and enter the filer's EDGAR account/central index key number (“CIK”) and central index key confirmation code (“CCC”).</P>
                    <P>
                        Commenters generally agreed that requiring individual account credentials for EDGAR access would improve EDGAR security, provide individual accountability and, by implementing multifactor authentication, align EDGAR with current best practices.
                        <SU>31</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Comment Letter of Cory (September 19, 2023) (“Cory I Comment Letter”) (“[This is] essential to verify the identity and legitimacy of those managing financial data, mitigating the risk of unauthorized access and fraud”); Comment Letter of XBRL US (November 21, 2023) (“XBRL II Comment Letter”) (“Multi-factor authentication is a step forward in increasing EDGAR security and has become a standard for most companies.”); Comment Letter of Block Transfer (November 21, 2023) (“Block Transfer Comment Letter”) (“We agree with the [Commission's] position that individual accountability through people-based, not organization-wide, accounts will lead to greater accountability, transparency, and efficiency in the market”).
                        </P>
                    </FTNT>
                    <P>
                        Several commenters expressed concerns that the introduction of individual account credentials could be disruptive or unduly burdensome for individuals with reporting obligations pursuant to section 16 of the Securities Exchange Act of 1934 (“Exchange Act”).
                        <SU>32</SU>
                        <FTREF/>
                         For the reasons discussed 
                        <PRTPAGE P="106172"/>
                        below, we do not think that the issues raised by these commenters will be disruptive or unduly burdensome for section 16 filers. One commenter asserted that many individuals use 
                        <E T="03">Login.gov</E>
                         for personal matters and suggested that these individuals may not wish to use their existing 
                        <E T="03">Login.gov</E>
                         accounts for EDGAR matters.
                        <SU>33</SU>
                        <FTREF/>
                         The EDGAR Filer Manual as amended will require individuals to present an email address that matches the email address the individual will use in connection with EDGAR 
                        <SU>34</SU>
                        <FTREF/>
                         to obtain 
                        <E T="03">Login.gov</E>
                         individual account credentials for EDGAR.
                        <SU>35</SU>
                        <FTREF/>
                         The email address will become the individual's username for 
                        <E T="03">Login.gov</E>
                         individual account credentials and will be used for identification and notification purposes on EDGAR. Therefore, if an individual currently has a 
                        <E T="03">Login.gov</E>
                         account created with her personal email address and does not intend to use that email address in connection with EDGAR matters, or is otherwise concerned that her personal email address may become visible on the EDGAR Filer Management dashboard, she should create new 
                        <E T="03">Login.gov</E>
                         individual account credentials with the email address she wishes to use in connection with EDGAR.
                        <SU>36</SU>
                        <FTREF/>
                         This email address could be the one provided to the individual by her employer or that the individual uses for business purposes. Individuals can continue to use their 
                        <E T="03">Login.gov</E>
                         personal email address and password for personal matters. They will separately use the 
                        <E T="03">Login.gov</E>
                         individual account credentials they created for use on EDGAR to log into EDGAR.
                    </P>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Comment Letter of Society for Corporate Governance (August 30, 2024) (“SCG Comment Letter”) (“[I]t appears that some 
                            <PRTPAGE/>
                            companies have assumed their third-party filing agents would handle this major EDGAR overhaul without significant disruption or additional work by in-house personnel. However, the comment letters by filing agents and other vendors suggest otherwise.”); XBRL II Comment Letter (“[W]e do not believe the rule proposal adequately addresses the needs of Section 16 filers and single individual filers [who] will perform their own code management.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             
                            <E T="03">See</E>
                             SCG Comment Letter (“[T]here was also concern with respect to the fact that 
                            <E T="03">Login.gov</E>
                             is used, in many instances, for individuals' 
                            <E T="03">personal</E>
                             matters (
                            <E T="03">e.g.,</E>
                             Social Security). Using a single account for both personal and public filings is likely to lead to confusion and hesitation on the part of the Section 16 filers. Such individuals may not wish to comingle their personal matters with their public filing obligations.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>34</SU>
                             Individuals will provide their email addresses on Form ID, during enrollment, and to account administrators to identify themselves. The dashboard will display individuals' email addresses for identification and individuals will receive email notifications from EDGAR at their email addresses. Therefore, individuals should present to 
                            <E T="03">Login.gov</E>
                             the email address that they intend to provide to EDGAR, that will identify them to others on EDGAR, and that they will use to receive communications from EDGAR.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>35</SU>
                             
                            <E T="03">See</E>
                             amended EDGAR Filer Manual, Volume I, at section 3(a).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             By contrast, if individuals currently have 
                            <E T="03">Login.gov</E>
                             accounts used in connection with EDGAR, they may choose to rely upon those existing 
                            <E T="03">Login.gov</E>
                             individual account credentials.
                        </P>
                    </FTNT>
                    <P>
                        Several commenters further suggested that it would be a burden on section 16 filers to apply for EDGAR access and to enroll in EDGAR Next themselves and requested that EDGAR permit a corporate secretary or legal personnel of a registrant to obtain EDGAR access for an individual section 16 filer pursuant to a power of attorney.
                        <SU>37</SU>
                        <FTREF/>
                         In response to these comments, we clarify that EDGAR will permit this. Individuals with individual or single-member company filer EDGAR accounts may avoid obtaining 
                        <E T="03">Login.gov</E>
                         individual account credentials for EDGAR if they authorize an individual at their filing agent or other third party to enroll them in EDGAR Next and during enrollment authorize one or more individuals at these entities to act as their account administrators.
                        <SU>38</SU>
                        <FTREF/>
                         For enrollment, presentation of a power of attorney for the person performing enrollment or being authorized as an account administrator will not be necessary, although we urge all filers to carefully coordinate regarding the person they will authorize to enroll them. For enrollment, the codes required to be entered will act as validation of the filer's intent.
                        <SU>39</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>37</SU>
                             
                            <E T="03">See, e.g.,</E>
                             SCG Comment Letter (“We believe that the corporate secretary or legal personnel of the registrant—with a Power of Attorney (POA)—should be able to complete the process for obtaining EDGAR access codes or passphrases without further involvement from an individual Section 16 filer.”); XBRL II Comment Letter (“[W]e do not believe the rule proposal adequately addresses the needs of Section 16 filers and single individual filers will perform their own code management.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>38</SU>
                             Only one individual (the individual need not be an account administrator so long as the filer authorizes the individual to enroll) would enroll the filer, providing information about authorized account administrators during enrollment. After enrollment, the account administrators would manage the filer's account on the dashboard, adding account administrators, users and technical administrators, if connecting to APIs, and delegating authority to file, if relevant.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>39</SU>
                             
                            <E T="03">See infra</E>
                             text accompanying and following note 208 (the filer's CIK, CCC, and EDGAR passphrase must be provided to validate the enrollment request as legitimate).
                        </P>
                    </FTNT>
                    <P>
                        Separately, individual or single-member company filers who apply for access on amended Form ID may authorize one or two individuals at their filing agents or relevant companies as their account administrators on Form ID; however, for Form ID, individual or single-member company applicants must also provide signed, notarized powers of attorney to those persons to be uploaded to EDGAR together with the completed Form ID. Thereafter, the filer's authorized account administrators would obtain individual account credentials from 
                        <E T="03">Login.gov</E>
                         and manage the filer's account on the dashboard. In summary, the individual or single-member company filer would not need to obtain 
                        <E T="03">Login.gov</E>
                         individual account credentials in these circumstances.
                    </P>
                    <P>
                        The commenter also expressed concerns regarding how section 16 filers and others would navigate the multifactor authentication process when making filings.
                        <SU>40</SU>
                        <FTREF/>
                         As an initial matter, we do not believe that it will be difficult for section 16 filers and other individuals to navigate the 
                        <E T="03">Login.gov</E>
                         multifactor authentication process as it is substantially the same as the process used by numerous financial and other websites for verification. It is therefore likely that section 16 filers and other individuals have experience in performing multifactor authentication. Alternatively, as discussed above, section 16 filers and other individual filers may provide notarized powers of attorney to authorize account administrators to manage filers' accounts and make submissions on filers' behalf, eliminating the need for section 16 filers and other individual filers to obtain individual account credentials or perform multifactor authentication themselves.
                        <SU>41</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>40</SU>
                             
                            <E T="03">See</E>
                             SCG Comment Letter (“[Our members] expressed concerns about how registrants, Section 16 insiders, and their filing agents would navigate the new MFA process when making filings.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>41</SU>
                             
                            <E T="03">See</E>
                             sections II.B.1 and II.B.2.
                        </P>
                    </FTNT>
                    <P>
                        The commenter further raised issues surrounding the security of 
                        <E T="03">Login.gov.</E>
                        <SU>42</SU>
                        <FTREF/>
                         The matters raised by the commenter pertain to 
                        <E T="03">Login.gov</E>
                        's provision of identity assurance level 2 (“IAL2”) services,
                        <SU>43</SU>
                        <FTREF/>
                         which generally require gathering certain sensitive personally identifiable information such as copies of drivers' licenses, passports, or similar documents. EDGAR's agreement with 
                        <E T="03">Login.gov,</E>
                         however, is to provide identity assurance level 1 (“IAL1”) services, which do not require presentation of such sensitive personally identifiable information. To obtain individual account credentials from 
                        <E T="03">Login.gov</E>
                         for EDGAR, the 
                        <PRTPAGE P="106173"/>
                        individual need only provide her email address, create a password, and select a multifactor authentication method. The security of 
                        <E T="03">Login.gov</E>
                        's provision of IAL1 services has not been called into question, and as noted above, numerous Federal and State agencies successfully use 
                        <E T="03">Login.gov</E>
                         on an ongoing basis.
                    </P>
                    <FTNT>
                        <P>
                            <SU>42</SU>
                             
                            <E T="03">See</E>
                             SCG Comment Letter (“Given that the security of 
                            <E T="03">Login.gov</E>
                             has been questioned by Congress and the Internal Revenue Service has expressed reservations about using the platform, the Commission should not mandate 
                            <E T="03">Login.gov</E>
                             as the sole platform that registrants and their Section 16 filers may use for multi-factor authentication.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>43</SU>
                             
                            <E T="03">See</E>
                             “GSA Misled Customers on 
                            <E T="03">Login.gov</E>
                            's Compliance with Digital Identity Standards,” Press Release, Office of the Inspector General, U.S. General Services Administration, available at 
                            <E T="03">https://www.gsaig.gov/content/gsa-misled-customers-logingovs-compliance-digital-identity-standards</E>
                             (“GSA knowingly billed IAL2 customer agencies over $10 million for services, including alleged IAL2 services that did not meet IAL2 standards.”)
                        </P>
                    </FTNT>
                    <P>
                        Other commenters suggested that EDGAR provide filers with the option to continue to use a password and CCC instead of 
                        <E T="03">Login.gov</E>
                         during a transition period to EDGAR Next.
                        <SU>44</SU>
                        <FTREF/>
                         In response to these comments, we clarify that from March 24, 2025 to September 12, 2025, EDGAR will continue to allow submissions to be made when the password and CCC are presented. One commenter asked that the Commission allow section 16 filers to continue to log into EDGAR under the existing process for six months after enrollment ends.
                        <SU>45</SU>
                        <FTREF/>
                         We are offering the legacy filing process for six months from March 24, 2025 through September 12, 2025, during which time filers may also enroll. In addition, we are allowing filers to continue to enroll on the dashboard for an additional three months after the compliance date.
                        <SU>46</SU>
                        <FTREF/>
                         The 12 months that precede compliance, consisting of six months to prepare for the changes and six months to enroll while legacy filing processes continue, plus an additional three months after compliance to enroll, effectively operate as a phased-in implementation of the new requirements, and permits filers multiple means of accessing EDGAR, while they coordinate with their filing agents and other relevant parties regarding how they will manage their accounts, and ensures timely compliance.
                        <SU>47</SU>
                        <FTREF/>
                         We considered comments regarding offering the legacy filing process beyond the transition period, but we determined that doing so would increase the risk of EDGAR security issues arising by delaying the implementation of, among other things, multifactor authentication and individual account credentials.
                        <SU>48</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>44</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Comment Letter of Donnelley Financial Solutions (May 8, 2024) (“DFIN II Comment Letter”) (“[W]e encourage the Commission to consider supporting the current authentication method for an overlapping period of time as an alternative during the EDGAR Next roll out. This will help with the transition and minimize market disruption.”); SCG Comment Letter (“We agree with DFIN's suggestion that registrants and their Section 16 filers should be allowed to use current authentication methods during the transition to EDGAR Next to minimize disruptions or filing delays.”)
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>45</SU>
                             
                            <E T="03">See</E>
                             SCG Comment Letter (“We also ask that the Commission consider allowing all Section 16 filers to continue to use the existing EDGAR system for an 
                            <E T="03">additional six months</E>
                             after the enrollment period ends, so they do not miss any deadlines while the enroll in EDGAR Next.”) (emphasis in original).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>46</SU>
                             Further, the commenter appeared to base the comment in part upon the assumption that there would be a one-month preparation period prior to enrollment in EDGAR Next. Instead, the Commission is offering filers a six-month preparation period which we believe will allay the commenter's expressed concerns.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>47</SU>
                             
                            <E T="03">See</E>
                             SCG Comment Letter (“[t]he Commission has prudently provided phased-in implementation for other rules, such as for XBRL tagging and the Form 8-K cybersecurity incident disclosure rules, and we believe that a phased-in approach makes sense given the hundreds of corporate directors who may have to obtain 
                            <E T="03">Login.gov</E>
                             accounts and then enroll through the EDGAR Next dashboard.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>48</SU>
                             In addition, it is not technically feasible for EDGAR to extend legacy filing processes for one subset of filers.
                        </P>
                    </FTNT>
                    <P>
                        Several commenters suggested that filers should have the option to use alternatives to 
                        <E T="03">Login.gov</E>
                         as technology evolves.
                        <SU>49</SU>
                        <FTREF/>
                         Another commenter requested alternatives to 
                        <E T="03">Login.gov</E>
                         in the event the service is unavailable but did not suggest what alternatives were appropriate.
                        <SU>50</SU>
                        <FTREF/>
                         Another commenter approved of the choice of 
                        <E T="03">Login.gov.</E>
                        <SU>51</SU>
                        <FTREF/>
                          
                        <E T="03">Login.gov</E>
                         is a secure Federal sign-in service that aligns with the modern security practices set forth in the executive order and follows the digital identity guidelines for Federal agencies issued by NIST, as indicated above. Using a single secure sign-in service strengthens the ability of Commission staff to monitor, identify, and address login issues related to EDGAR. It also increases efficiency in terms of EDGAR and filer programming, maintenance and customer support and ensures that individuals attempting to access EDGAR are able to achieve similar experiences in the login process. Moreover, we are not aware of any recurrent 
                        <E T="03">Login.gov</E>
                         outage issues that necessitate implementing additional Federally accepted tools. If in the future it is possible to meet the Commission's goals of individual traceability and multifactor authentication with improved alternative technology, that technology will be considered as appropriate. EDGAR will be able to substitute or add other methods of obtaining individual account credentials and completing multifactor authentication if it is beneficial to do so. If the Commission determines to change or add methods of authentication to EDGAR, we would inform filers in advance and specify the changes in the EDGAR Filer Manual.
                    </P>
                    <FTNT>
                        <P>
                            <SU>49</SU>
                             
                            <E T="03">See</E>
                             DFIN II Comment Letter (“We continue to believe that Edgar filers should have the optionality to use alternatives to 
                            <E T="03">Login.Gov</E>
                             as technology offerings evolve.”); Comment Letter of the Investment Company Institute (September 11, 2024) (“ICI Comment Letter”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>50</SU>
                             
                            <E T="03">See</E>
                             SCG Comment Letter (“There will be busy filing periods, such as 40 days after the end of a fiscal quarter when larger companies make their periodic filings, where it would be helpful to have alternative platforms for authentication in case 
                            <E T="03">Login.gov</E>
                             is not available.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>51</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“
                            <E T="03">Login.gov</E>
                             is a good choice for EDGAR access since it was created and is maintained by the federal government. It is already utilized by other government agencies and some public users.”).
                        </P>
                    </FTNT>
                    <P>
                        Some commenters raised concerns that requiring individual account credentials for EDGAR access could be burdensome and confusing in specific situations, such as where individuals sit on multiple boards of different issuers, or an individual retires or is terminated.
                        <SU>52</SU>
                        <FTREF/>
                         The use of individual account credentials and multifactor authentication is a widely used account management process. While we acknowledge that requiring individual account credentials imposes some additional burden in that it interposes a new step in the EDGAR access process, we do not believe that requiring individual account credentials will be unduly burdensome or confusing because the use of individual user permissions is a standard practice in software applications and computer systems. Moreover, certain examples cited by commenters appear to stem from some confusion regarding dashboard authorization as it pertains to individual account credentials.
                    </P>
                    <FTNT>
                        <P>
                            <SU>52</SU>
                             
                            <E T="03">See, e.g.,</E>
                             XBRL II Comment Letter (discussing situations involving individual filers who sit on multiple boards of different issuers); Comment Letter of Workiva (November 20, 2023) (“Workiva Comment Letter”) (noting that individual account credentials must be managed at an individual level, which could cause problems for filers if individuals retire or are terminated).
                        </P>
                    </FTNT>
                    <P>
                        Several commenters raised concerns about specific scenarios involving individual account credentials, such as when an individual the filer has authorized to act on her behalf retires or is terminated,
                        <SU>53</SU>
                        <FTREF/>
                         or when an individual sits on multiple boards.
                        <SU>54</SU>
                        <FTREF/>
                         In the first scenario, an account administrator would be able to remove the authorization of an individual on the dashboard, at which point the individual could no longer use her individual account credentials to access the filer's account. In the second scenario, an individual who sits on multiple boards would be able to make submissions on any of her EDGAR accounts in several different ways. First, the individual need not obtain 
                        <E T="03">Login.gov</E>
                         individual account credentials or interact with the dashboard at all if she authorized one or more individuals employed at her filing agents or other relevant companies as her account administrators (up to a total of 20) with notarized powers of attorney, as discussed above. Second, she could log 
                        <PRTPAGE P="106174"/>
                        into the dashboard and delegate to her filing agents and other relevant companies the authority to make submissions on her behalf. Third, the individual could log into the dashboard and authorize account administrators or users of her choice to make submissions on her behalf. Fourth, she could be her own account administrator or user and log into the dashboard with her individual account credentials and make submissions. We further note that for enrollment, she can authorize individuals as her account administrators without presenting a notarized power of attorney, although we advise section 16 and other filers to carefully plan whom they authorize to enroll them in EDGAR Next. Once a filer has authorized account administrators, the account administrators would make submissions on the filer's behalf and otherwise manage the account and perform annual confirmation. Given these various options and solutions, we do not believe that the final amendments' requirements are onerous.
                    </P>
                    <FTNT>
                        <P>
                            <SU>53</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>54</SU>
                             
                            <E T="03">See</E>
                             XBRL II Comment Letter.
                        </P>
                    </FTNT>
                    <P>
                        Commenters also asserted that individual account credentials would not guarantee EDGAR security, since for example individuals could intentionally share their individual account credentials with unauthorized persons or EDGAR could be otherwise compromised.
                        <SU>55</SU>
                        <FTREF/>
                         We acknowledge that requiring individual credentials will not entirely remove threats to EDGAR security, but mandating such credentials will improve the overall security of the EDGAR system. For example, even if the individual account credentials were shared, Commission staff and filers would know whose credentials were shared. Moreover, the use of individual account credentials that employ multifactor authentication complies with current best practices for information security at U.S. Federal agencies, such as those described in the executive order and the NIST digital identity guidelines.
                    </P>
                    <FTNT>
                        <P>
                            <SU>55</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Workiva Comment Letter (stating that delegated entities may try to share individual account credentials for a single individual among various employees at the delegated entity); XBRL II Comment Letter (noting that multifactor authentication would protect the Filer Management dashboard but would not stop malicious entities who somehow obtained the filer's filer API token and user API token from using those tokens).
                        </P>
                    </FTNT>
                    <P>
                        Individual account credentials will enhance the ability of filers to securely maintain access to their EDGAR accounts. Filers currently share access codes among multiple individuals, making it difficult to track with whom the codes are shared or to trace a filing to a specific individual. The use of individual account credentials should enable Commission staff and those with filing obligations to determine more easily the individuals making specific filings on EDGAR, because the person-specific nature of the credentials coupled with the individual's multifactor authentication will identify individuals associated with EDGAR actions—unlike access codes, which are tied to a particular EDGAR account rather than to an individual.
                        <SU>56</SU>
                        <FTREF/>
                         Linking individuals to the filings they make will be particularly useful for Commission staff and filers when problematic filings are made on EDGAR and will enhance the security and integrity of the system. Thus, for example, without individual account credentials, if an EDGAR filing is submitted that appears on its face to be materially misleading, Commission staff and the filer may confer about the contents of the filing, but it may be difficult for them to ascertain who submitted it given that the filer may have widely shared its access codes.
                    </P>
                    <FTNT>
                        <P>
                            <SU>56</SU>
                             
                            <E T="03">See</E>
                             amended EDGAR Filer Manual, Volume I, at section 3(a).
                        </P>
                    </FTNT>
                    <P>
                        To address the concern that security may be compromised by individuals intentionally sharing their individual account credentials with unauthorized persons,
                        <SU>57</SU>
                        <FTREF/>
                         we are amending the EDGAR Filer Manual to clarify that individual account credentials may not be shared with other individuals. The Commission intends that individual account credentials identify the individual who takes action on EDGAR and sharing of credentials defeats that goal. In addition, the sharing of individual account credentials among multiple individuals undermines the purpose of multifactor authentication, which is intended to be specific to a known individual.
                    </P>
                    <FTNT>
                        <P>
                            <SU>57</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Workiva Comment Letter (stating that delegated entities may try to share individual account credentials for a single individual among various employees at the delegated entity).
                        </P>
                    </FTNT>
                    <P>
                        Use of individual account credentials also will provide additional assurance that only individuals who have been properly authorized by the filer can take actions on the filer's behalf on EDGAR. Currently, filers' interactions with EDGAR require the use of several codes. Because individual account credentials will be used to authenticate individuals accessing EDGAR pursuant to Rule 10 as amended, the EDGAR password, password modification authorization code (“PMAC”), and passphrase will not be needed to make submissions after the compliance date, as discussed in section II.H.
                        <SU>58</SU>
                        <FTREF/>
                         The historic use of several codes with differing functions is not in accord with current industry best practices. The use of individual account credentials aligns more closely with modern access processes, including multifactor authentication, as set forth in the executive order and the NIST guidelines discussed above.
                    </P>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             Filers enrolling during the three-month period after the compliance date will be required to present the CIK, CCC, and passphrase to complete enrollment.
                        </P>
                    </FTNT>
                    <P>The CCC will continue to function as the code required for filing, but those seeking to make submissions will also need to sign in with individual account credentials, complete multifactor authentication, and be authorized by the filer or an account administrator for the filer. Because of these additional safeguards, the filer's CCC will be displayed on the dashboard for account administrators and users.</P>
                    <P>
                        One commenter suggested eliminating the CCC as unnecessary given the requirement to authorize individuals through the dashboard.
                        <SU>59</SU>
                        <FTREF/>
                         In addition to dashboard authorization, EDGAR will continue to require the CCC to provide additional security, for example, to complement API tokens, as well as to avoid the need to make additional infrastructure and form changes to EDGAR at this time. To maintain the CCC in a secure environment and remove the need for a filer to email or circulate the CCC, the CCC will appear on the dashboard of individuals authorized to make submissions for the filer.
                        <SU>60</SU>
                        <FTREF/>
                         The CCC may be eliminated in the future if feasible from a technical and security standpoint.
                    </P>
                    <FTNT>
                        <P>
                            <SU>59</SU>
                             
                            <E T="03">See</E>
                             Comment Letter of the Securities Industry and Financial Markets Association (“SIFMA Comment Letter”) (“[I]t would seem that by granting authority to the agent through EDGAR Next, there would not be a need for the CCC.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>60</SU>
                             Specifically, this will include the filer's account administrators, users, delegated administrators, and delegated users.
                        </P>
                    </FTNT>
                    <P>
                        One commenter indicated that certain 
                        <E T="03">Login.gov</E>
                         multifactor authentication methods are restricted in certain countries.
                        <SU>61</SU>
                        <FTREF/>
                         While we understand that not all the methods for multifactor authentication on 
                        <E T="03">Login.gov</E>
                         may be available to those in certain countries, we note that 
                        <E T="03">Login.gov</E>
                         offers individuals several different authentication methods, including a security key, certain Federal Government employee or military cards, authentication applications, biometric (face or fingerprint) verification, text message/SMS or telephone call, and backup codes. Further, there are several authentication applications accepted by 
                        <PRTPAGE P="106175"/>
                        <E T="03">Login.gov.</E>
                        <SU>62</SU>
                        <FTREF/>
                         Individuals need only choose one method available to them. Therefore, we expect that filers in such countries will be able to choose an alternative method on 
                        <E T="03">Login.gov</E>
                         to satisfy the multifactor authentication requirement.
                    </P>
                    <FTNT>
                        <P>
                            <SU>61</SU>
                             
                            <E T="03">See</E>
                             SCG Comment Letter (“In addition, some features of 
                            <E T="03">Login.gov</E>
                             (
                            <E T="03">e.g.,</E>
                             text or voice MFA options) are restricted in certain countries, which could impose an added burden on filers based outside the United States.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>62</SU>
                             Current 
                            <E T="03">Login.gov</E>
                             authentication applications include Android and iOS options (Google Authenticator, Authy, LastPass, 1Password), Windows and Mac apps (1Password and OTP Manager), and Chrome extensions (Authenticator). 
                            <E T="03">See generally</E>
                              
                            <E T="03">Login.gov,</E>
                             Authentication Options at 
                            <E T="03">https://www.login.gov/help/get-started/authentication-options/.</E>
                        </P>
                    </FTNT>
                    <P>
                        Another commenter asserted that in lieu of individual account credentials and multifactor authentication, as contemplated in the Proposing Release, 
                        <E T="03">Login.gov</E>
                         should allow EDGAR authentication via EDGAR Next API keys.
                        <SU>63</SU>
                        <FTREF/>
                         API keys alone, however, do not provide the security assurances of multifactor authentication.
                    </P>
                    <FTNT>
                        <P>
                            <SU>63</SU>
                             
                            <E T="03">See</E>
                             Block Transfer Comment Letter (“[W]e respectfully submit to the Commission that 
                            <E T="03">Login.gov</E>
                             might present material benefits to issuers if it replaced the proposed security interface using EDGAR Next API keys.”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. Individual Roles: Account Administrator, User, Technical Administrator</HD>
                    <P>
                        Paragraph (d)(2) of Rule 10 as proposed and adopted requires each filer to authorize and maintain at least two individuals with individual account credentials as account administrators to manage the filer's EDGAR account and to make submissions on EDGAR on behalf of the filer, unless the filer is an individual or single-member company,
                        <SU>64</SU>
                        <FTREF/>
                         in which case the filer will be required to authorize and maintain at least one individual with individual account credentials as an account administrator.
                        <SU>65</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>64</SU>
                             As defined in amended Rule 11 and amended Form ID, a “single-member company” will be a company that has a single individual who acts as the sole equity holder, director, and officer (or, in the case of an entity without directors and officers, holds position(s) performing similar activities as a director and officer).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>65</SU>
                             Minor revisions to paragraph (d)(2) as proposed were made to the paragraph as adopted to clarify that each individual or single-member company electronic filer must authorize and maintain at least one individual as an account administrator to manage its EDGAR account.
                        </P>
                    </FTNT>
                    <P>
                        Account administrators, acting on behalf of the filer, may authorize and de-authorize individuals with individual account credentials as users, additional account administrators, or technical administrators for the filer, as needed, using the dashboard (or the optional APIs that will enable filers to access much of the dashboard's functionality via machine-to-machine connections).
                        <SU>66</SU>
                        <FTREF/>
                         This process is illustrated in diagram 1 below.
                    </P>
                    <FTNT>
                        <P>
                            <SU>66</SU>
                             See the EDGAR Next page on 
                            <E T="03">SEC.gov</E>
                             for guidance regarding actions on the dashboard.
                        </P>
                    </FTNT>
                    <GPH SPAN="3" DEEP="211">
                        <GID>ER27DE24.011</GID>
                    </GPH>
                    <P>An individual could be authorized to perform more than one role for a filer. For example, one individual could be both an account administrator and a technical administrator, or one individual could be both a technical administrator and a user. An account administrator could not be a user, however, because account administrators can perform all the functions of a user themselves, including making submissions on EDGAR. Analogous roles will exist at delegated entities. The key functions that could be performed by each role are illustrated in diagram 2 below.</P>
                    <GPH SPAN="3" DEEP="300">
                        <PRTPAGE P="106176"/>
                        <GID>ER27DE24.012</GID>
                    </GPH>
                    <HD SOURCE="HD3">1. Account Administrators</HD>
                    <P>
                        Paragraphs (d)(4), (5), and (6) of Rule 10 as proposed and adopted require that the filer, through its account administrators, maintain accurate and current information on EDGAR concerning the filer's account and confirm such information annually, and securely maintain information relevant to the ability to access the filer's EDGAR account, including but not limited to access through optional APIs. Commenters broadly supported the implementation of account administrators to manage filers' accounts,
                        <SU>67</SU>
                        <FTREF/>
                         although commenters raised concerns about specific issues as discussed below.
                    </P>
                    <FTNT>
                        <P>
                            <SU>67</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Cory I Comment Letter (“One of the cornerstones of EDGAR Next is the requirement for filers to designate account administrators. . . . In an era of machine-driven manipulation, this human oversight is crucial for detecting and preventing illicit activities.”); Toppan Merrill Comment Letter (“Yes, a required account Administrator [sic] role is necessary for every filer (every CIK). Ideally two Administrators [sic] should be required.”).
                        </P>
                    </FTNT>
                    <P>Under EDGAR Next, each filer will be responsible, through its account administrators, for the security of the filer's EDGAR account and the accuracy of the filer's information on EDGAR. Account administrators will manage the filer's account on the dashboard or through optional APIs replicating most dashboard functionality in machine-to-machine connections. The filer will be required, through its account administrators, to perform annual confirmation on the dashboard. Account administrators will also be able to use the dashboard or optional APIs to add and remove users, account administrators and technical administrators (including removing themselves as an account administrator); create and edit groups of users; delegate filing authority to other EDGAR accounts and remove delegation; generate a new CCC; and receive notifications regarding significant events affecting the account (notifications will also be emailed to the account administrator's email address provided to EDGAR). Further, account administrators will be able to make submissions on behalf of the filer on EDGAR, which will allow filers to manage their accounts and make submissions through a limited number of individuals, if they choose. Each account administrator will be co-equal, possessing the same authority and responsibility to manage the filer's EDGAR account. All actions required to be performed by account administrators can be performed by any of them individually and will not require joint action.</P>
                    <P>
                        In addition, account administrators will serve as the points of contact for questions from Commission staff regarding the filer's account.
                        <SU>68</SU>
                        <FTREF/>
                         One commenter suggested that existing filers with a single EDGAR point of contact for information, inquiries, and access codes (“EDGAR POC”) typically rely upon legal staff, whereas under EDGAR Next those filers may choose to authorize, for example, services staff as account administrators.
                        <SU>69</SU>
                        <FTREF/>
                         The commenter stated that the EDGAR POC for existing filers should be automatically enrolled as a “super administrator” for the filer and notified regarding significant events affecting the account.
                        <SU>70</SU>
                        <FTREF/>
                         Because filers may wish to designate a single account administrator as a primary EDGAR POC, EDGAR will offer an option to allow account administrators to designate one account administrator as the filer's EDGAR POC. EDGAR will by default designate the first account administrator listed on Form ID or an existing filer's enrollment as the filer's EDGAR POC. The filer, through its account administrator, may 
                        <PRTPAGE P="106177"/>
                        change its EDGAR POC thereafter on the dashboard. Commission staff may contact the filer's other account administrators if, for example, the EDGAR POC cannot be reached or is nonresponsive. The EDGAR POC will not be a “super administrator,” as suggested by the commenter, however, and each account administrator will have co-equal authority to take action on EDGAR as well as to receive notices of actions on the filer's account. Other than acting as a central point of contact, the EDGAR POC will not differ in any other respect from other account administrators.
                    </P>
                    <FTNT>
                        <P>
                            <SU>68</SU>
                             Technical administrators will serve as the Commission staff's points of contact regarding the filer's use of the APIs. 
                            <E T="03">See infra</E>
                             section II.B.3.a.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>69</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“The current POC is likely a different type of staff, such as legal staff, from the administrators who are likely to be reporting or services staff.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>70</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“We further suggest automatically enrolling the current POC as super administrator. The super administrator should be contacted before any severe action on the EDGAR account is taken, such as account deactivation.”).
                        </P>
                    </FTNT>
                    <P>
                        Several commenters stated that the dashboard should provide a mechanism for authorized users or other interested parties to easily identify and contact the filer's account administrators.
                        <SU>71</SU>
                        <FTREF/>
                         The dashboard will be enhanced to provide this functionality. In this regard, account administrators will also serve as points of contact for technical administrators, users and delegated entities.
                    </P>
                    <FTNT>
                        <P>
                            <SU>71</SU>
                             
                            <E T="03">See, e.g.,</E>
                             XBRL II Comment Letter (“There should be a mechanism in the filing management dashboard where the company (
                            <E T="03">e.g.</E>
                             technical admin) can identify and contact their administrators . . .”); Workiva Comment Letter (“[A] a user may not necessarily know who the administrators are to contact. We suggest adding a “Contact Administrator” function in the EDGAR Dashboard to facilitate.”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">a. Filer Authorization of Account Administrators</HD>
                    <P>
                        As proposed and adopted, applicants for EDGAR access will designate on amended Form ID the individuals that the filer authorizes as account administrators.
                        <SU>72</SU>
                        <FTREF/>
                         Pursuant to paragraph (d)(1) of Rule 10 as proposed and adopted, the filer can only authorize individuals as account administrators if those individuals obtain individual account credentials in the manner specified in the EDGAR Filer Manual. We are adopting the amendments to Form ID largely as proposed, as discussed in section II.F.3. In response to commenter concerns, however, it will not be necessary for Form ID to be completed or submitted by one of the applicant's prospective account administrators, as contemplated in the Proposing Release. This change will allow a filer to choose who will complete and submit Form ID so long as the filer complies with the continued requirement that the form be signed by the filer's authorized individual, as that term is defined in Rule 11 of Regulation S-T and Volume I of the EDGAR Filer Manual, and that the signature is notarized. Additionally, given commenter concerns that asset-backed securities (“ABS”) issuing entities that make “Request Asset-Backed Securities (ABS) Issuing Entities Creation” submissions (“ABSCOMP” submissions”) should have their account information automatically copied to any serial companies, EDGAR will allow for new serial companies requested to be created via the ABSCOMP process to automatically inherit all dashboard information associated with the ABS issuing entity that made the ABSCOMP submission.
                    </P>
                    <FTNT>
                        <P>
                            <SU>72</SU>
                             A separate process of enrollment will be employed to transition existing filers, as discussed in section II.H.
                        </P>
                    </FTNT>
                    <P>
                        Consistent with current requirements, an applicant must complete Form ID and electronically submit it, and also upload a copy of the completed Form ID signed by an authorized individual of the applicant with the signature notarized. As a departure from what we contemplated in the Proposing Release, it will not be necessary for Form ID to be completed or submitted by one of the applicant's prospective account administrators. Some commenters were concerned that requiring an account administrator to complete and submit Form ID would be burdensome and unnecessarily restrictive.
                        <SU>73</SU>
                        <FTREF/>
                         We understand that providing flexibility in terms of who completes and submits Form ID will facilitate the application process.
                    </P>
                    <FTNT>
                        <P>
                            <SU>73</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Comment Letter of Donnelley Financial Services (November 21, 2023) (“DFIN Comment Letter”) (“[In addition to account administrators,] any “User” should also be allowed to submit a Form ID. The account administrator(s) might be busy, unavailable, or decide it's a menial task.”); Workiva Comment Letter (“[I]t is not necessary to require an account administrator to submit the Form ID. A user should also be able to submit the Form ID. The Form ID is already required to be signed and notarized by authorized personnel. . . . A user is adequate for submission.”).
                        </P>
                    </FTNT>
                    <P>
                        As contemplated in the proposal, entity applicants will be able to authorize as account administrators either (i) individuals employed at the filer or an affiliate of the filer or (ii) any other individual provided the filer submits a notarized power of attorney authorizing that individual to be its account administrator.
                        <SU>74</SU>
                        <FTREF/>
                         Individual applicants will be able to authorize as account administrators either (i) themselves or (ii) any other individual provided the filer submits a notarized power of attorney authorizing that individual as account administrator. Commenters provided mixed feedback on this issue, with one supporting the notarization requirement as contemplated in the proposal; another advancing that the requirement should not apply to employees of affiliates; and another expressing concern that the notarization requirement as a whole would be unduly burdensome.
                        <SU>75</SU>
                        <FTREF/>
                         Although we acknowledge the added time and effort required to obtain a notarized power of attorney, the process is relatively straightforward, analogous to the current process of notarization of the authorized individual signature on Form ID, and not unduly time consuming. Moreover, the process will provide greater assurance that a filer indeed intends to authorize an individual not employed at the filer or an affiliate of the filer to manage the filer's EDGAR account. We therefore are implementing the notarized power of attorney requirements as proposed, and the amended Form ID and EDGAR Filer Manual will reflect those requirements.
                    </P>
                    <FTNT>
                        <P>
                            <SU>74</SU>
                             The amended EDGAR Filer Manual specifies that an “authorized individual” must sign a power of attorney on behalf of the filer in this context. 
                            <E T="03">See</E>
                             amended EDGAR Filer Manual, Volume I, at section 3.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>75</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Toppan Merrill Comment Letter (“We support the proposal to have the initial account administrator require a notarized power of attorney, if applicable.”); DFIN Comment Letter (“[I]f the account administrator is an employee of the filer's affiliate, they should not be required to be authenticated via a notarized power of attorney.”); Workiva Comment Letter (“We believe that a notarized power of attorney should not be required to add an employee of another entity as an administrator. This could significantly increase the burden for the individual reporting owners. . . .”).
                        </P>
                    </FTNT>
                    <P>
                        A commenter questioned why the requirement to present a notarized power of attorney to authorize an employee of an entity other than the filer as account administrator on Form ID is needed when authorization of additional account administrators through the dashboard does not require notarization.
                        <SU>76</SU>
                        <FTREF/>
                         The requirement to present a notarized power of attorney to authorize individuals who are not employed at the applicant or an affiliate as account administrators on Form ID provides Commission staff—who review each Form ID to determine whether access should be granted—a means of confirming that these individuals are indeed authorized on behalf of the applicant. The requirement lessens the risk that unauthorized persons will attempt to establish or access an account by submitting a false or misleading Form ID. We did not include a notarization requirement for account administrators added through the dashboard, because once Commission staff grant access to EDGAR, filers are responsible, through their account administrators, for the security of the 
                        <PRTPAGE P="106178"/>
                        filer's EDGAR account and the accuracy of the filer's information on EDGAR. Filers can take the additional steps they determine are necessary to comply with the Rule 10 and EDGAR Filer Manual requirements to secure their accounts.
                    </P>
                    <FTNT>
                        <P>
                            <SU>76</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“In addition, since the power of attorney is only needed initially, and once an administrator is added to the EDGAR Dashboard additional administrators can be added without a new power of attorney; it seems inconsistent and somewhat arbitrary that there is a higher threshold for the first one.”).
                        </P>
                    </FTNT>
                    <P>
                        We also received several comments regarding the authorization of account administrators in situations unique to specific types of filers. One commenter recommended that account administrators associated with ABS issuing entities that make ABSCOMP submissions should automatically be copied to any serial companies created as a result of that submission, and another commenter suggested that all account information associated with the ABS issuing entity should be automatically copied over to the newly created serial companies.
                        <SU>77</SU>
                        <FTREF/>
                         Up to 100 serial companies can be created via a single ABSCOMP submission, and we recognize that it would be time consuming to require identical addresses, account administrators, and other information to be manually inputted for each serial company. Consequently, the ABSCOMP process will be available in the dashboard, and new serial companies requested to be created via that process will automatically inherit all dashboard information (
                        <E T="03">e.g.,</E>
                         contact information, account administrators, users, technical administrators, and delegations) associated with the ABS issuing entity that made the ABSCOMP submission. Changes to the inherited information could be made after creation of the new serial companies. For example, individuals could be added or removed on the dashboard by the serial company's account administrators, while filer information such as name, address, and State of incorporation could be updated via Company Update submissions (“COUPDATs”), consistent with current practice.
                    </P>
                    <FTNT>
                        <P>
                            <SU>77</SU>
                             
                            <E T="03">See</E>
                             DFIN Comment Letter (“[T]he Account Administrator and information from the ABS Issuer's Account Administrator should be copied to the new serial account, after which, any changes can be made.”); Cadwalader, Wickersham &amp; Taft LLP Comment Letter (November 21, 2023) (“Cadwalader Comment Letter”) (“For [commercial mortgage-backed securities] issuers, allowing automatic inheritance by the individual serial trusts of all information from the depositor would be the most efficient approach.”).
                        </P>
                    </FTNT>
                    <P>
                        Another commenter indicated that making the ABSCOMP process available in the dashboard would be sufficient for ABS entities to manage the creation of new EDGAR accounts and suggested that similar functionality should be provided for other issuers that have a structure with multiple related parties, such as co-registrants and beneficial ownership reporting filers, to allow them to more easily manage EDGAR accounts.
                        <SU>78</SU>
                        <FTREF/>
                         We have determined not to extend the above-described ABSCOMP process to include other entities such as investment companies and co-registrants, because ABSCOMP is unique in allowing rapid creation of multiple serial companies via a single transaction, predicated in part upon the serial companies all being largely identical (
                        <E T="03">e.g.,</E>
                         contact information, account administrators, etc.). In contrast, although beneficial ownership reporting filers and co-registrants may be related parties, each of these filers typically possesses separate filer-specific information such as name, address, and contact information. Furthermore, these filers could have separate reporting obligations (for example, beneficial ownership reporting filers in the context of different issuers, and co-registrants in the context of different securities offerings). Thus, in the EDGAR Next framework, each of these filers presumably would want to authorize her own account administrators, and it would be inappropriate to automatically assign all such filers the same account administrators. In addition, the optional APIs being added to EDGAR Next should serve to mitigate any additional burdens for these filers by allowing the filers to rapidly add account administrators and make other changes as necessary, as discussed further in section II.E below.
                    </P>
                    <FTNT>
                        <P>
                            <SU>78</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“The proposed functionality for an ABS account administrator to access the dashboard for serial companies could be utilized for other issuers who have a related structure with multiple entities . . . [i]ncluding . . . corporate issuers with co-registrants [and] beneficial ownership reporting filers (
                            <E T="03">e.g.,</E>
                             144, SC 13D, SC 13G, and section 16 filers), and ABS issuers . . . . If the existing option to create a serial company by the `ABSCOMP' process is available in EDGAR Next functionality that will be sufficient for ABS entities to manage creating new CIKs.”).
                        </P>
                    </FTNT>
                    <P>The Proposing Release also requested comment on whether elimination of the ability of ABS issuers to create new ABS serial companies “on the fly” when filing a 424H submission would cause any problems, given that the EDGAR Next framework would continue to allow ABS issuers to request creation of serial companies via ABSCOMP submissions. We received no comments on this issue. EDGAR data indicates that ABS issuers have not used the “on the fly” process for several years, and accordingly EDGAR will be updated to remove the ability of ABS issuers to create new serial companies “on the fly.”</P>
                    <HD SOURCE="HD3">b. Number of Account Administrators</HD>
                    <P>As contemplated in the proposal, paragraph (d)(2) of Rule 10 as adopted requires filers who are individuals or single-member companies to authorize and maintain at least one account administrator; all other filers will be required to authorize and maintain at least two account administrators. The maximum number of account administrators on the dashboard is 20. Although individuals and single-member companies are only required to authorize and maintain at least one account administrator, we encourage them to authorize additional account administrators in the event the sole account administrator becomes unavailable to manage the account.</P>
                    <P>
                        Commenters generally supported the proposed requirement to maintain a minimum of two account administrators,
                        <SU>79</SU>
                        <FTREF/>
                         although various commenters recommended technical changes or additional clarification. One commenter sought clarification regarding whether, for single-member companies and individuals, the required account administrator must be the single member or individual herself.
                        <SU>80</SU>
                        <FTREF/>
                         Paragraph (d)(2) of Rule 10 does not require this. Filers will have the flexibility to authorize individuals at their filing agents or other third parties as account administrators, so long as they provide notarized powers of attorney authorizing those individuals. Another commenter requested that an additional warning be provided when the “single-member company” selection is made to alert the filer that she would be unable to manage her EDGAR account if the single account administrator is not available.
                        <SU>81</SU>
                        <FTREF/>
                         A warning notice will be added to the online version of Form ID as requested if the “single-member company” selection is made. Separately, although single-member companies will only be required to have a single account administrator, we encourage filers to authorize additional account administrators on the dashboard as 
                        <PRTPAGE P="106179"/>
                        necessary (up to a maximum of 20) to ensure that an account administrator is always available to take necessary actions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>79</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Toppan Merrill Comment Letter (“Yes, we believe requiring two account administrators is appropriate.”); Workiva Comment Letter (“We believe at least two account administrators for filing entities (other than single-member companies) is appropriate.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>80</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“For individuals and single-member companies, please clarify if the one minimum administrator must be the individual himself or herself.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>81</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“We suggest that additional warnings are provided when the `single-member companies' selection is made. The warning should alert that access to the filer management website will be lost if the single administrator is no longer available, which may lead to loss of ability to file on EDGAR”).
                        </P>
                    </FTNT>
                    <P>Requiring most filers to authorize at least two account administrators will increase the ability of filers to manage their EDGAR accounts without interruption. Thus, if an account administrator unexpectedly resigns or otherwise ceases to be available to manage the filer's account, the remaining account administrators will continue to manage the account and will be able to authorize additional account administrators. If the account administrator who seeks to resign is one of the required two account administrators for an entity filer, then that account administrator could not be removed from the filer's EDGAR account unless the filer first added another account administrator through the dashboard to meet the required minimum of two account administrators. For example, if there are two account administrators for the account and one unexpectedly becomes unavailable, the remaining account administrator could add another account administrator to the account and then remove the unavailable individual. For individual and single-member company filers, at least one account administrator will always be required because those filers typically consist of only one individual. A dashboard limit of 20 account administrators should be sufficient to allow for management of large accounts, while avoiding the confusion that a larger number of account administrators might cause.</P>
                    <P>
                        We encourage filers to authorize more than the minimum number of account administrators, if possible, because if all account administrators for a filer cease to be available to manage the filer's account, the filer will be required to submit a new Form ID to authorize new account administrators.
                        <SU>82</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>82</SU>
                             In this case, the filer would select the option on Form ID indicating that it had lost electronic access to its existing CIK account. This option also encompasses other scenarios, such as when a filer loses access due to failure to satisfy required annual confirmation requirements. 
                            <E T="03">See infra</E>
                             note 90.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">c. Account Administrator Authorization and Removal of Users, Technical Administrators, and Other Account Administrators</HD>
                    <P>An account administrator will be able to add or remove an individual as a user, account administrator, or technical administrator for an EDGAR account through the dashboard, as discussed in the Proposing Release. An account administrator will “add” the individual on the dashboard and EDGAR will send an invitation to the individual by email and through the dashboard (if the individual has a role for any filer on EDGAR) indicating that the account administrator for the filer sought to add her to the filer's account in a particular role or roles. The individual must accept the invitation, either through the email or on the dashboard, to accept the new role(s) and become authorized in those role(s) for the filer. The same process of invitation both through email and the dashboard applies to all invitations, and the individual receiving the invitation may accept via the email or the dashboard invitation.</P>
                    <P>
                        Commenters expressed general support for notifying filers when an account administrator removes or adds another account administrator.
                        <SU>83</SU>
                        <FTREF/>
                         Some commenters, however, expressed the view that while filer notification would be appropriate, filer consent is not necessary and should not be required.
                        <SU>84</SU>
                        <FTREF/>
                         In response to this point, EDGAR will be enhanced to provide notifications to all relevant account administrators through the dashboard and by email when individuals are added or removed from an account, or the roles for those individuals are changed. The discussion of this matter in the Proposing Release did not indicate that filers would need to consent to these changes, and EDGAR will not require such consent for the changes to be effective. These notifications will allow account administrators to monitor relevant activity while minimizing the delay that might result from approval of each individual action.
                    </P>
                    <FTNT>
                        <P>
                            <SU>83</SU>
                             
                            <E T="03">See, e.g.,</E>
                             XBRL II Comment Letter (“As well as requiring a minimum of two administrators . . . we do think notification is appropriate. Alerting other administrators when an administrator is added or leaves will improve the ability for the network to react to administrator changes.”); DFIN Comment letter (“We also think that a filer should be notified when additional account administrators are added or removed.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>84</SU>
                             
                            <E T="03">See</E>
                             XBRL II Comment Letter (“Addition without consent should be allowed, to manage emergencies that may arise. . . We understand that there is still a potential risk with rogue actors at firms, but firms are managing the risk of rogue actor employees today and should be left to manage that problem in regard to EDGAR Next.”); Workiva Comment Letter (“We believe the filer's consent is not necessary as long as the filer has an administrator that will be notified and can take additional action if needed.”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">d. Annual Confirmation</HD>
                    <P>Paragraph (d)(4) of Rule 10 as proposed and adopted requires each filer to perform an annual confirmation on EDGAR that all the filer's users, account administrators, technical administrators, and delegated entities are authorized by the filer to act on its behalf, and that all information related to the filer reflected on the filer's dashboard is accurate. Account administrators will act for the filer to carry out this function. Annual confirmation will assist the filer in tracking those authorized to file on EDGAR and will provide an opportunity for account administrators to confirm the accuracy of those individuals and delegated entities associated with the filer and to remove those no longer authorized. In a change from what was contemplated in the Proposing Release, in response to commenter concerns, we are extending the grace period before account deactivation for filers that fail to timely perform annual confirmation from two weeks (as discussed in the Proposing Release) to three months following the annual confirmation deadline. During the three-month grace period, filers will be able to continue to make submissions and take actions on EDGAR as usual, while account administrators will receive notices reminding them to complete annual confirmation by the end of the grace period, as discussed in more detail below.</P>
                    <P>To provide flexibility to filers, EDGAR will allow account administrators to select one of four quarterly dates as the filer's ongoing confirmation deadline: March 31, June 30, September 30, and December 31 (or the next business day if the date falls upon a weekend or holiday when EDGAR is not operating). An account administrator need not wait until the deadline to confirm. An account administrator may choose to perform confirmation at an earlier date within the quarter when confirmation is due. Further, an account administrator will be able to perform confirmation on any date in a quarter earlier than the quarter of the current deadline, thereby changing the quarter when confirmation is due going forward. Confirmation in an earlier quarter will result in a confirmation deadline one year after the end of the quarter in which the early confirmation occurred. For example, if a December 31 confirmation deadline were selected by the account administrator for the initial annual confirmation, but the account administrator submitted the confirmation for the following year in August, the filer's annual confirmation deadline for the next year would be September 30 (or the next business day, if the date fell upon a weekend or holiday when EDGAR was not operating).</P>
                    <P>
                        Commenters generally expressed support for account administrator performance of annual confirmation as contemplated in the Proposing 
                        <PRTPAGE P="106180"/>
                        Release.
                        <SU>85</SU>
                        <FTREF/>
                         One commenter asserted that annual confirmations would be overly burdensome, while two other commenters recommended that confirmations be performed more frequently than annually, such as quarterly or every six months.
                        <SU>86</SU>
                        <FTREF/>
                         We believe that annual confirmation strikes the appropriate balance of periodically ensuring the accuracy of filers' information in EDGAR, without unduly burdening filers and account administrators. To facilitate the confirmation process and remind account administrators about confirmation deadlines, as discussed in the Proposing Release, EDGAR will provide periodic notices to account administrators both by email and on the dashboard regarding each upcoming confirmation deadline, a notice of completion of confirmation, and numerous notices of failure to timely confirm prior to deactivation of the account. Specifically, prior to the confirmation deadline, EDGAR will send notices six weeks, three weeks and each of the five business days leading up to the confirmation deadline.If filers fail to perform annual confirmation on or before the confirmation deadline, EDGAR will send reminders to all account administrators for the filer each business day after the confirmation deadline until expiration of the three-month grace period. EDGAR will also offer an optional API to allow filers to programmatically check filing credentials and upcoming confirmation deadlines.
                    </P>
                    <FTNT>
                        <P>
                            <SU>85</SU>
                             
                            <E T="03">See, e.g.,</E>
                             DFIN Comment Letter (“The proposed annual confirmation requirement is sufficient”); Cadwalader Comment Letter (for annual confirmation for serial trusts, “We believe that such an approach is both appropriate and efficient.”); Toppan Merrill Comment Letter (asserting that the annual confirmation requirement would create additional burden for filers but expressing agreement with the requirement as proposed.).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>86</SU>
                             
                            <E T="03">Compare</E>
                             Block Transfer Comment Letter (“. . . the benefits of the security measure proposed . . . would outweigh the significant burden it would impose on filers' internal controls.”) 
                            <E T="03">with</E>
                             Comment Letter of Uchi (September 13, 2023) (requesting a “3 or 6 month renewal check for the company to ensure all administrative accounts assigned to the company are still valid as employees incase [sic] of termination while maintaining administrative access to said company filing permissions.”); Comment Letter of Alexander (September 15, 2023) (same).
                        </P>
                    </FTNT>
                    <P>
                        Several commenters suggested that the Commission allow bulk annual confirmations to be performed for related EDGAR accounts, such as accounts that share the same administrators, users, delegations, and corporate and contact information.
                        <SU>87</SU>
                        <FTREF/>
                         As discussed above, related EDGAR accounts (such as co-registrant) may often have different dashboard information, which suggests that bulk confirmation is not appropriate given the need to separately review and confirm the accuracy of dashboard information for each filer.
                        <SU>88</SU>
                        <FTREF/>
                         We are further concerned that account administrators might inadvertently perform a bulk confirmation of hundreds of filers without carefully reviewing each filer's information. To ensure the accuracy of the filer's information on EDGAR, a filer must, through its account administrator, carefully inspect the information on the filer's dashboard. As a result, bulk confirmation will not be permitted. Filers may achieve efficiencies in the confirmation process by leveraging optional APIs that will allow them to rapidly add and remove individuals, change authorized roles, and perform delegations to ensure the accuracy of information on the dashboard prior to performing confirmation. For example, in preparation for confirmation, a filer could view all individuals authorized to act on behalf of the filer through an API being made available for that purpose. If updates to the roles or authorization of individuals were needed, the filer could add and remove individuals and change individuals' roles through APIs being made available for those purposes.
                    </P>
                    <FTNT>
                        <P>
                            <SU>87</SU>
                             
                            <E T="03">See</E>
                             Cadwalader Comment Letter (“On an operational level, we do not expect individual serial trusts to have account administrators, technical administrators, users or delegated entities that are not also performing the same functions for the depositor, although the depositor may have certain additional account administrators, technical administrators, users or delegated entities who are not assigned to all of the related serial trusts. Therefore, depositor-level confirmation of its authorized parties would also encompass all individuals assigned roles with respect to each individual serial trust.”); Toppan Merrill Comment Letter (responding to a request for comment regarding whether bulk confirmations should be permitted by stating “Yes, affiliated filers with the same administrators, users, delegations, and corporate and contact information should be allowed similar functionality[.]”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>88</SU>
                             
                            <E T="03">See supra</E>
                             text following note 52.
                        </P>
                    </FTNT>
                    <P>
                        As noted above, the Proposing Release contemplated a two-week grace period for filers that failed to perform annual confirmation. Some commenters stated that the annual confirmation requirement would impose a significant additional burden on filers and recommended that filers should initially be suspended before they are deactivated, while others requested an extension of the grace period before deactivating the filer's access.
                        <SU>89</SU>
                        <FTREF/>
                         After considering these comments, we will expand from two weeks to three months the grace period following a missed confirmation deadline, during which the filer will be able to continue to make submissions and take actions on the filer's account as usual and the filer's account administrators will receive a final series of notices reminding them to complete annual confirmation. If no account administrator performs the annual confirmation by the end of the three-month grace period, EDGAR will deactivate the filer's access and the filer will be required to submit a new Form ID application to request access to file on its account.
                        <SU>90</SU>
                        <FTREF/>
                         If Commission staff grant the Form ID, the filer will continue to have the same account number/CIK previously assigned and its filing history will be maintained. The filer's account administrators listed on Form ID, however, will need to invite through the dashboard, as if to a new account, additional account administrators, and any technical administrators and users, and delegate authority to file, if relevant. Although the need to reapply for access and in particular the need to invite account administrators, users, and technical administrators anew will impose an additional burden on filers, failure to perform an annual confirmation, particularly after receipt of multiple notices, could signal that the filer is no longer managing or controlling the account. Removing individuals from the filer's account upon deactivation safeguards information regarding individuals whose information is listed on the filer's dashboard. For example, if someone other than the original filer's account administrators submitted a Form ID application for access to the account, and the original account administrators did not respond to Commission staff inquiries regarding the Form ID, the process outlined above will prevent the new account holder from accessing the names, addresses, and contact information of the individuals formerly associated with the account. Collectively, this framework will provide filers that inadvertently 
                        <PRTPAGE P="106181"/>
                        miss their annual confirmation deadlines an additional three months within which to perform their confirmation, during which time they will receive multiple notices, while maintaining good account hygiene by inactivating defunct accounts and safeguarding information regarding individuals listed in the dashboard of defunct filers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>89</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Workiva Comment Letter (“We strongly recommend temporary suspension over account deactivation. . . . Failure to confirm annually may signal a problem occurred in the notification process rather than the filer being no longer in control of the account. . . . Deactivation should only occur after six months of suspension.”); XBRL II Comment Letter (“The annual confirmation requirement will create a significant additional burden for filers that use a filing agent's SEC credentials, in particular for those filers who make sporadic submissions such as Section 16 filers. . . . We encourage the Commission to consider imposing a temporary 2-week suspension if the confirmation requirement is not met before deactivating a nd removing information from an existing account.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>90</SU>
                             In this case, the filer would select the option on Form ID indicating that it had lost electronic access to its existing CIK account. This option would also encompass other scenarios, such as when all the filer's account administrators cease to be available to manage the filer's account. 
                            <E T="03">See supra</E>
                             note 82.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">e. User Groups</HD>
                    <P>Largely as contemplated in the Proposing Release, the dashboard will provide functionality to allow an account administrator to group subsets of the filer's users into user groups. The user group function will assist delegated entities to authorize certain of their users to make submissions on behalf of specific filers, as explained below. By employing user groups, the delegated administrator can add or remove the ability to make submissions for a certain filer to all users in the group at once and can give specific groups of users the ability to make submissions for certain filers, leading to efficiencies of time in managing users.</P>
                    <P>
                        One commenter stated that EDGAR should allow multiple users to be added to a user group simultaneously to ensure that user groups can be built quickly and efficiently.
                        <SU>91</SU>
                        <FTREF/>
                         As requested by the commenter, the dashboard will be updated to permit filers to add multiple users to a user group simultaneously. In addition, optional APIs will be provided so that filers can view individuals in any role for a CIK, add individuals, remove individuals, and change roles for individuals; collectively, this should facilitate the ability of filers to manage user groups.
                    </P>
                    <FTNT>
                        <P>
                            <SU>91</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“The system should allow for multiple users to be uploaded at the same time. This will ensure that users groups can be built quickly and efficiently.”)
                        </P>
                    </FTNT>
                    <P>
                        One commenter stated that user group functionality would be improved by allowing wildcard searches to include first and last names.
                        <SU>92</SU>
                        <FTREF/>
                         Accordingly, the dashboard will be enhanced to enable first and last name wildcard searches of individuals.
                    </P>
                    <FTNT>
                        <P>
                            <SU>92</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“User group functionality would be improved by allowing for wildcard searches to include first and last names. Currently, the search disregards any name after the space between the first and last name.”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Users</HD>
                    <P>
                        Largely as contemplated in the Proposing Release, account administrators will be able to authorize individuals with individual account credentials as users to make submissions on EDGAR on behalf of the filer.
                        <SU>93</SU>
                        <FTREF/>
                         Account administrators and Commission staff will be able to determine which users made which submissions; however, this information will not be made public on EDGAR. The dashboard will allow users to generate, view, and copy user API tokens, if using optional APIs that require presentation of a user API token; view relevant notifications (which will also be provided to users by email); and view basic information about the filer's account, including the filer's name, CIK, CCC, corporate and contact information, as well as contact information for account administrators. Users will not, however, be able to add or remove individuals from the dashboard other than themselves. Users also will not be able to generate a new CCC. Separately, users will be able to make COUPDAT submissions to update filer information such as name, address, and State of incorporation, as filers currently do.
                    </P>
                    <FTNT>
                        <P>
                            <SU>93</SU>
                             Commenters were generally supportive of the user role. See comments by Toppan Merrill, DFIN, SIFMA, and XBRL II.
                        </P>
                    </FTNT>
                    <P>
                        As part of the login and authentication process for the EDGAR filing websites, a user will be able to select the EDGAR account number (CIK) of the entity for which submissions are being made (“login CIK”). That CIK will be reflected in the first part of the unique identifier associated with each submission (the “accession number”).
                        <SU>94</SU>
                        <FTREF/>
                         Users will be able to change their login CIK at any time to any other account for which they are authorized.
                    </P>
                    <FTNT>
                        <P>
                            <SU>94</SU>
                             An accession number is a unique identifier assigned automatically to EDGAR submissions for tracking and reference purposes. The first 10 digits are intended to represent the CIK of the entity making the submission, which may be an entity with reporting obligations or a third party (such as a filing agent).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">a. Becoming Authorized as a User</HD>
                    <P>An account administrator can “add” an individual through a dashboard function that will generate an invitation to the individual to be a user for the filer's account. Prospective users will receive email invitations from EDGAR and, if the prospective user has a role for any EDGAR account, a notification of the invitation will appear on the prospective user's dashboard. The individual must accept the invitation, through either the email or dashboard invitation, to become a user. As noted, the same process of invitation and acceptance both through email and the dashboard applies to all invitations.</P>
                    <P>
                        One commenter suggested the addition of functionality to allow filers to directly authorize their financial advisers (
                        <E T="03">i.e.,</E>
                         registered representatives of broker-dealers) to act as users.
                        <SU>95</SU>
                        <FTREF/>
                         Although there are additional requirements related to the authorization of third parties as account administrators on Form ID, those requirements will not apply to users.
                        <SU>96</SU>
                        <FTREF/>
                         Account administrators will be able to authorize any individual with Login.gov credentials as a user, therefore, for example, account administrators will be able to authorize financial advisers as users to make submissions on the filer's behalf.
                    </P>
                    <FTNT>
                        <P>
                            <SU>95</SU>
                             
                            <E T="03">See</E>
                             SIFMA Comment Letter (“We recommend that the SEC provide functionality that would allow retail clients to directly authorize their financial advisers (
                            <E T="03">i.e.,</E>
                             registered representatives of the broker-dealer) to act as a `user' for the sole purpose of filing the Form 144s.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>96</SU>
                             
                            <E T="03">See supra</E>
                             note 75 and accompanying and following text (discussing notarization requirements for individuals who are not employed at the filer or an affiliate of the filer).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">b. Number of Users</HD>
                    <P>There will be no minimum number of users because account administrators will be able to make submissions on behalf of the filer. We are setting the maximum number of users per filer on the dashboard at 500, as proposed.</P>
                    <P>
                        The Proposing Release discussed a maximum of 500 users per filer, based in part on feedback received from commenters on the 2021 Request for Comment. One commenter that responded to the 2021 Request for Comment conducted a filer survey that indicated that 4% of the filers it surveyed would be interested in authorizing 20 or more users, up to a maximum of 150 users per filer.
                        <SU>97</SU>
                        <FTREF/>
                         In response to the 500-user limit contemplated in the Proposing Release, one commenter agreed that a limit of 500 users would be sufficient.
                        <SU>98</SU>
                        <FTREF/>
                         In contrast, one commenter suggested that the limit should be increased but did not provide a specific number, while another suggested that the limit should be tripled to 1500 users per filer on the grounds that doing so would “accommodate larger entities.” 
                        <SU>99</SU>
                        <FTREF/>
                         We believe that a maximum of 500 users per filer on the dashboard should be sufficient to accommodate sophisticated filers making a large number of varied 
                        <PRTPAGE P="106182"/>
                        filings.
                        <SU>100</SU>
                        <FTREF/>
                         Five hundred users is more than three times the high-end number cited in the commenter survey conducted in connection with the 2021 Request for Comment, and was deemed to be sufficient by an industry membership organization.
                        <SU>101</SU>
                        <FTREF/>
                         Moreover, filers will be able to more efficiently and rapidly make submissions through optional APIs, mitigating the need to have more than 500 users per filer.
                        <SU>102</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>97</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (November 30, 2021) (“Based on the survey we conducted, about 1% of respondents indicated their plan to set up as high as 10-30 account administrators, while 4% indicated 20-150 users.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>98</SU>
                             
                            <E T="03">See</E>
                             XBRL II Comment Letter (“We believe that the limit of 500 authorized users per filer is sufficient.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>99</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“Additionally, EDGAR Next should allow an organization to add more than 500 authorized users, as needed.”); DFIN Comment Letter (“To accommodate larger entities, we suggest an increase to the authorized user limit from 500 to 1,500.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>100</SU>
                             In the future, if it seems that there is a need for additional users to be added, the limit on the number of users may be reevaluated.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>101</SU>
                             
                            <E T="03">See supra</E>
                             notes 97-98.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>102</SU>
                             
                            <E T="03">See generally</E>
                             section II.E.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Technical Administrators</HD>
                    <P>Paragraph (d)(3) of Rule 10 as adopted and largely as proposed requires filers that opt to connect to the EDGAR APIs to authorize, through their account administrators, at least two technical administrators to manage the technical aspects of a filer's connection to the APIs, unless the filer arranges to use its delegated entity's API connections and the delegated entity is in compliance with the requirement to authorize at least two technical administrators. We anticipate that the role of technical administrator could be filled by someone with a primarily administrative background because the requirements of the role are to generate and provide filer API tokens and to manage the filer's connections to APIs. We are not requiring that the technical administrator role be filled by software developers or other technically expert staff; rather, the technical administrator should have a basic understanding of API processes and be available to communicate with Commission staff and the filer's developers or other technical experts expeditiously, in addition to generating and managing the filer API tokens.</P>
                    <P>
                        Commenters generally indicated support for adding a technical administrator role as beneficial to help manage a filer's connection to APIs.
                        <SU>103</SU>
                        <FTREF/>
                         One commenter suggested that it saw “material problems” with the role of technical administrator but did not enumerate what those problems were.
                        <SU>104</SU>
                        <FTREF/>
                         The commenter suggested Congressional consideration regarding creation of a “unified, government-wide platform that ensures robust authentication and streamlined management of API interaction for various Federal services, including EDGAR.” 
                        <SU>105</SU>
                        <FTREF/>
                         We note that such an undertaking is outside the scope of this rulemaking.
                    </P>
                    <FTNT>
                        <P>
                            <SU>103</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“[We] believe a technical administrator role is beneficial to help manage a filer's use of APIs.”); Workiva Comment Letter (“[W]e agree with the option to have a technical administrator role for those who wish to utilize IT support to manage API tokens . . . . .”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>104</SU>
                             
                            <E T="03">See</E>
                             Block Transfer Comment Letter (“We respectfully submit . . . an innovative approach . . . because(i) the role of technical administrator has material problems and (ii) other Federal agencies require machine-to-machine data submission from the private sector, most generally from financial services firms.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>105</SU>
                             
                            <E T="03">See</E>
                             Block Transfer Comment Letter (“We respectfully submit . . . an innovative approach . . . [that] envisages a unified, government-wide platform that ensures robust authentication and streamlined management of API interactions for various Federal services, including EDGAR. . . . For these reasons and more, we respectfully submit . . . that a brief Congressional consideration is in order to ponder the creation of a report as to the strengths and weaknesses a unified Login.gov machine-to-machine authentication system may bestow upon on our cybersecurity interests both domestically and abroad. . . .”).
                        </P>
                    </FTNT>
                    <P>
                        We are adopting paragraph (d)(3) of Rule 10 with a modification to permit a filer to use the API connections and filer API tokens of its delegated entity (as long as that delegated entity is in compliance with the requirement to authorize at least two technical administrators); and a filer that does so will not be required to authorize at least two technical administrators and generate a filer API token itself.
                        <SU>106</SU>
                        <FTREF/>
                         The relevant individual at the filer interacting with the API, however, must present a valid user API token to the API if the relevant API requires presentation of a user API token, to allow identification of the individual taking action on EDGAR. To accommodate this change and to better reflect the technical connection of filers to the optional APIs, paragraph (d)(3) of Rule 10 will refer to filers that “connect to” APIs rather than filers that “use” APIs. This option is being offered for filers who would like their account administrators and users to be able to interact with the APIs directly, but who do not wish to undertake the expense to connect to the APIs and authorize technical administrators.
                        <SU>107</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>106</SU>
                             
                            <E T="03">See generally</E>
                             section II.C.6.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>107</SU>
                             As set forth in paragraph (d)(3) of Rule 10, filers who do not want their account administrators or users to generate user API tokens could alternatively allow their delegated entities to make submissions on their behalf through APIs, and individuals at the delegated entities would present their own user API tokens to make submissions.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">a. Authority of Technical Administrators</HD>
                    <P>A technical administrator will issue and deactivate filer API tokens required to connect to the optional APIs. Technical administrators will also serve as points of contact for questions from Commission staff regarding the filer's connections to the APIs and will receive relevant notifications on the dashboard and by email, such as reminders regarding upcoming expiration dates for filer API tokens.</P>
                    <P>
                        Two commenters suggested that the technical administrator and account administrator roles could be filled by the same person.
                        <SU>108</SU>
                        <FTREF/>
                         As discussed in the Proposing Release, a filer will have the option of designating the same individual to serve as both its technical administrator and account administrator, but the filer may also choose to authorize different individuals to serve in these roles provided those individuals possess individual account credentials obtained in the manner specified in the EDGAR Filer Manual.
                    </P>
                    <FTNT>
                        <P>
                            <SU>108</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“[W]e believe that the administrator and the technical administrator can be the same person and would likely be most of the time.”); XBRL II Comment Letter (“We do not understand the difference between a technical administrator and an account administrator. The addition of a technical administrator role may further complicate the process. It could be useful if this role were optional and could be combined into the account administrator if the company chose to, for example if the account administrator could generate the filer token.”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">b. Becoming a Technical Administrator</HD>
                    <P>To authorize an individual as a technical administrator, an account administrator will add the individual in that role on the dashboard, triggering an invitation to the individual. The prospective technical administrator will receive the invitation by email, and, if the individual already has a role for any EDGAR account, on the dashboard. The prospective technical administrator must accept either the dashboard or the email invitation to become authorized as a technical administrator.</P>
                    <HD SOURCE="HD3">c. Number of Technical Administrators</HD>
                    <P>Paragraph (d)(3) of Rule 10 as proposed and adopted will require filers that choose to connect to an API to authorize, through its account administrators, at least two technical administrators. In a change to what was proposed, however, paragraph (d)(3) of Rule 10 will not impose a requirement to authorize at least two technical administrators if the filer arranges to use its delegated entity's API connections and filer API tokens and the delegated entity is in compliance with the requirement to authorize at least two technical administrators. Further, while the Proposing Release indicated that filers would be able to authorize a maximum of 10 technical administrators, in response to requests from commenters, the maximum number of technical administrators will be increased to 20.</P>
                    <P>
                        One commenter generally supported the designation of at least two technical 
                        <PRTPAGE P="106183"/>
                        administrators for filers connecting to APIs.
                        <SU>109</SU>
                        <FTREF/>
                         Two commenters generally supported the minimum of two technical administrators for companies, but asserted that only one technical administrator should be required for individuals and single-member companies, in order to parallel the minimum number of account administrators needed for those entities.
                        <SU>110</SU>
                        <FTREF/>
                         One commenter stated that “requiring two technical admins presents many material legal, efficiency and operational risks,” but did not specify the anticipated risks or how many technical administrators would be sufficient to address those anticipated risks.
                        <SU>111</SU>
                        <FTREF/>
                         We believe that requiring a minimum of two technical administrators for filers that choose to connect to optional APIs will increase the likelihood that Commission staff can contact one of the filer's technical administrators and reduce the chance of disruption of API connections. We believe that larger filers and filing agents using APIs should have sufficient staff to authorize two technical administrators. In addition, if individuals and single-member companies choose to connect to APIs, we anticipate that they will either employ filing agents, use their delegated entities' API connections, or otherwise have available staff to comply with the paragraph (d)(3) requirement of Rule 10 to authorize at least two technical administrators.
                    </P>
                    <FTNT>
                        <P>
                            <SU>109</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“[A] minimum of two technical administrators should be required to manage a filer's APIs. . . .”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>110</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“[I]ndividuals or single-member firms should have the option to handle everything directly without involving an additional party. The requirement of at least two technical administrators would impose the need to involve a second person purely for the purpose of using software to file.”); DFIN Comment Letter (“We think the technical administrator minimum requirements should parallel the account administrator minimum requirements.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>111</SU>
                             
                            <E T="03">See</E>
                             Block Transfer Comment Letter.
                        </P>
                    </FTNT>
                    <P>
                        As noted, as a departure from what was contemplated in the Proposing Release, a filer may use its delegated entity's filer API tokens and API connections if the delegated entity is in compliance with the paragraph (d)(3) requirement of Rule 10 to authorize two technical administrators. The filer must delegate authority to file through the dashboard and coordinate with the relevant delegated entity to use the delegated entity's API connections and filer API tokens, and the individual at the filer making the submission must present her own user API token to the API, if the relevant API requires presentation of a user API token. This change will obviate the need for filers to create their own API connections and authorize their own technical administrators should they want their account administrators and users to make submissions and interact with EDGAR through the optional APIs, and further responds to suggestions raised by a commenter.
                        <SU>112</SU>
                        <FTREF/>
                         These filers may leverage the API connections and filer API tokens of filers' delegated entities, and the individual at the filer need only supply her user API token to the API, if the relevant API requires presentation of a user API token.
                        <SU>113</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>112</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“One solution would be to allow the registrant's authorized user to use their token with the delegated filing software's filer token.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>113</SU>
                             Alternatively, if filers wish to make submissions through APIs but do not wish their staff to be required to generate user API tokens, filers could arrange for their delegated entities to make submissions through APIs on their behalf. In this case, delegated entities would create the API connections, maintain at least two technical administrators, and generate filer API tokens, and the relevant delegated administrators and delegated users for these filers (at the delegated entities) would present their own user API tokens, if the APIs require presentation of a user API token. Of course, filers who wish to make submissions through APIs may also determine to create their own API connections to EDGAR, authorize at least two technical administrators, present their own filer API tokens, and have their account administrators and users generate and present their user API tokens, if the APIs require presentation of a user API token.
                        </P>
                    </FTNT>
                    <P>Because paragraph (d)(3) of Rule 10 as amended will require a filer to authorize, through its account administrators, at least two technical administrators to connect to the optional APIs, the dashboard will not allow a technical administrator to be removed from a filer's account when only two technical administrators are authorized on the account. An account administrator will first need to add another technical administrator on the dashboard.</P>
                    <P>
                        In a change from the contemplated maximum of 10 technical administrators per filer, there will be a maximum of 20 technical administrators per filer. Several commenters suggested that this limit be increased to parallel the limit for the maximum number of account administrators.
                        <SU>114</SU>
                        <FTREF/>
                         Having the same maximum limit for account administrators and technical administrators will facilitate the ability of filers to authorize the same individuals in those roles.
                    </P>
                    <FTNT>
                        <P>
                            <SU>114</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“A minimum of two technical administrators should be required to manage a filer's APIs, as proposed. We would prefer that the maximum number of technical administrators match the number of account administrators (20). This ensures that larger entities will not encounter any limitations.”); Workiva Comment Letter (“[T]he technical administrator and administrators can often be the same person. Thus, we believe the limits for administrators and technical administrators can be the same.”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">C. Delegated Entities</HD>
                    <P>
                        Largely as contemplated in the Proposing Release, a filer will be able to delegate authority to file on its behalf to any other EDGAR account, such as a filing agent, which will become a delegated entity for the filer. As discussed above, the CCC will appear on the dashboard of individuals authorized to make submissions for the filer, including delegated administrators and delegated users.
                        <SU>115</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>115</SU>
                             
                            <E T="03">See supra</E>
                             note 60.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. Delegating Authority To File</HD>
                    <P>
                        A filer's account administrator may delegate authority to file to another EDGAR account through a function on the dashboard, as discussed in the Proposing Release.
                        <SU>116</SU>
                        <FTREF/>
                         After the account administrator selects the EDGAR account to which the filer seeks to delegate authority to file, EDGAR will send both email and dashboard invitations to the account administrators for that account. One account administrator for the prospective delegated entity must accept either the email or the dashboard invitation for the delegation to become effective. If the filer's account administrators wish to terminate the delegation, they can do so on the dashboard. Removal of delegation will not require acceptance by the delegated entity. An account administrator will be able to delegate authority to file to an unlimited number of EDGAR accounts, allowing filers to delegate to multiple filing agents, for example, should they so choose. Similarly, an EDGAR account can accept an unlimited number of delegations from filers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>116</SU>
                             An optional delegation API will be offered in addition to the delegation capabilities of the dashboard.
                        </P>
                    </FTNT>
                    <P>In response to commenter suggestions, the dashboard will be enhanced to: (1) provide bulk delegation functionality to allow filers to delegate to multiple EDGAR accounts more easily; (2) enable prospective delegated entities to send delegation requests to filers; and (3) allow EDGAR accounts to automatically accept delegations and become delegated entities if they choose.</P>
                    <P>
                        Commenters generally supported the ability to delegate,
                        <SU>117</SU>
                        <FTREF/>
                         although various commenters raised concerns about certain situations or recommended 
                        <PRTPAGE P="106184"/>
                        certain changes as discussed further herein. Multiple commenters requested that bulk delegation be permitted, so that filers could delegate to multiple EDGAR accounts simultaneously via a single invitation.
                        <SU>118</SU>
                        <FTREF/>
                         After considering these comments, bulk delegation functionality will be added to the dashboard to allow filers to delegate to multiple EDGAR accounts more easily. For recordkeeping and administrative purposes, delegated administrators will receive separate invitations for each delegation, but they will be able to accept multiple invitations in bulk, which should address commenters' concerns about minimizing burdens on delegated administrators who receive bulk delegations.
                    </P>
                    <FTNT>
                        <P>
                            <SU>117</SU>
                             
                            <E T="03">See, e.g.,</E>
                             DFIN Comment Letter (“Filers should be able to delegate to anyone they want to file on their behalf.”); Toppan Merrill Comment Letter (“We agree that an account administrator should be able to delegate filing authority to any EDGAR filer.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>118</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Comment Letter of Wanda Welch (November 13, 2023) (“Welch Comment Letter”) (“We would like the ability to delegate to more than one CIK at a time and receipt of one email invite.”); XBRL II Comment Letter (“[We] recommend that a bulk delegation function be made available to assist filers that have multiple CIKs, and that this capability be allowed using a single invitation request (rather than multiple invitations for multiple CIKs.”); DFIN Comment Letter (“We think that a bulk delegation function would be beneficial for filers that have multiple CIKs. Also, the bulk delegation should produce one invitation request. The recipient would then only need to accept one invitation as opposed to several invitations.”); ICI Comment Letter (“There should be consideration for bulk delegation for a group of CIKs.”).
                        </P>
                    </FTNT>
                    <P>
                        Multiple commenters also asked that prospective delegated entities be able to request delegation.
                        <SU>119</SU>
                        <FTREF/>
                         This process would enable filing agents, for example, to assist their client filers in delegating to the correct EDGAR accounts. In response to these comments, the dashboard will be enhanced to enable prospective delegated entities to send delegation requests to filers. The delegation requests will prompt filers' account administrators to send delegation invitations to the delegated entities, and filers' account administrators can determine whether they wish to send such delegation invitations. If the filers' account administrators send the delegation invitations, the delegated entities' account administrators must accept the invitations for the delegation to be effective.
                    </P>
                    <FTNT>
                        <P>
                            <SU>119</SU>
                             
                            <E T="03">See, e.g.,</E>
                             SIFMA Comment Letter (“We recommend that the system permit filing agents . . . to affirmatively request delegated authority (on an individual or bulk basis) from a given filer or filers.”); Workiva Comment Letter (“[We] recommend adding the capability for an entity to request delegation.”); XBRL II Comment Letter (“Vendors should be able to proactively request delegation from the registrant and receive confirmation [of delegation] on the site.”).
                        </P>
                    </FTNT>
                    <P>
                        Separately, several commenters requested that prospective delegated entities be able to automatically accept delegation invitations to lessen the burden on delegated entities' account administrators to manually accept each invitation.
                        <SU>120</SU>
                        <FTREF/>
                         The dashboard will be enhanced accordingly to allow prospective delegated entities to opt to automatically accept delegation invitations.
                    </P>
                    <FTNT>
                        <P>
                            <SU>120</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“[We] also suggest adding an option to allow filing agent-type CIKs to auto-accept delegations.”); XBRL II Comment Letter (asserting that filing agents/vendors should be able to request delegation, which could “be automatically approved by the registrant.”).
                        </P>
                    </FTNT>
                    <P>
                        One commenter was critical of the proposal's delegation of authority capabilities, warning that broad permissions granted to delegated entities to make submissions for the filer represent a significant risk regarding the accuracy and authenticity of filings.
                        <SU>121</SU>
                        <FTREF/>
                         We do not believe a delegated entity with permissions to make submissions for the filer will pose a significant risk because such risk is mitigated through the authorization requirements and verification. For example, delegated entities must be authorized and confirmed by a filer's account administrator on the dashboard, ensuring that only authorized and trusted entities are able to make submissions for the filer. Additionally, a delegated entity must have an EDGAR account and will be subject to the same requirements applicable to all filers. For the delegation to become effective, an account administrator of the delegated entity must accept the invitation, which means the account administrator at the delegated entity must first log into EDGAR using her individual account credentials and perform multifactor authentication.
                    </P>
                    <FTNT>
                        <P>
                            <SU>121</SU>
                             
                            <E T="03">See</E>
                             Block Transfer Comment Letter (“There is real risk that delegates, armed with expansive filing capabilities, might submit false or misleading information, either inadvertently or maliciously.”).
                        </P>
                    </FTNT>
                    <P>
                        Commenters also raised concerns regarding burdens potentially associated with delegating authority to make submissions to co-registrants and asked for clarity regarding how such delegations would work.
                        <SU>122</SU>
                        <FTREF/>
                         Commenters further urged the Commission not to require that co-registrants be added to an EDGAR account as a user, account administrator, delegated user, or delegated administrator to make submissions, so long as the individual making the submission had the correct role-based permissions for the primary registrant and had provided the correct CCCs for the co-registrants, as currently required.
                        <SU>123</SU>
                        <FTREF/>
                         We acknowledge that requiring separate dashboard permissions for each co-registrant to make submissions could potentially be confusing. We also recognize concerns that commenters separately raised about the need for additional optional APIs, including APIs to verify filing credentials, view filer account information, and replicate dashboard functionality that would assist filers if co-registrants were required to have dashboard permissions to make submissions.
                        <SU>124</SU>
                        <FTREF/>
                         EDGAR will not require role-based permissions for co-registrants at this time, and the addition of co-registrants to a filing will continue to be performed the same way it is currently performed (
                        <E T="03">i.e.,</E>
                         simply by listing the CIK and CCC of each co-registrant).
                    </P>
                    <FTNT>
                        <P>
                            <SU>122</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Welch Comment Letter (“Does the Subject Company and the Co-registrants need to be delegated? ”); DFIN Comment Letter (“[F]ilers would face difficulties in delegating co-registrants. Especially when it relates to merger acquisitions that may include hundreds of co-registrants.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>123</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Workiva Comment Letter (“Only the primary registrant's set of valid credentials should be required to file for all co-registrants, and delegation or a function to designate as `co-registrant' is not necessary. Adding designation requirements significantly increases the risk for the overall filing submission.”); XBRL II Comment Letter (“We encourage the Commission to continue the existing beta implementation [for co-registrants], which only forces the Filer and User Token requirements for the primary registrant, into the final rule/implementation phase.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>124</SU>
                             
                            <E T="03">See infra</E>
                             section II.E.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Separation of Authority of Filer and Delegated Entity</HD>
                    <P>
                        A filer's account administrator will not be able to access its delegated entity's dashboard or account or add or remove delegated users at the delegated entity, as discussed in the proposal. While delegated administrators and delegated users will be able to make EDGAR submissions and access the “Retrieve/Edit Data” section of the EDGAR Filing website on the filer's behalf,
                        <SU>125</SU>
                        <FTREF/>
                         delegated administrators and delegated users similarly will not be able to access the filer's dashboard 
                        <SU>126</SU>
                        <FTREF/>
                         or 
                        <PRTPAGE P="106185"/>
                        take dashboard actions on behalf of the filer.
                    </P>
                    <FTNT>
                        <P>
                            <SU>125</SU>
                             The “Retrieve/Edit Data” section of the EDGAR Filing website currently allows filers to perform certain administrative actions. Among other things, filers may view/edit their account information (such as the filer's name, contact information, and corporate information like State of incorporation and fiscal year-end), view the filer's current account balances and request the return of unused funds, and change the filer's password or CCC. As part of the transition to EDGAR Next, some of this functionality will be shifted to the dashboard, such as the filer's EDGAR POC. 
                            <E T="03">See infra</E>
                             note [125] and accompanying text.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>126</SU>
                             As discussed further below in section II.C, the dashboard will generally be used to manage a filer's EDGAR account, including management of individuals authorized to act as account administrators, users, and technical administrators; management of entities authorized to act as delegated entities; and management of filer and user API tokens. Delegated entities will not need to access the filer's dashboard in order to make filings on the filer's behalf, since filings will be made directly on the EDGAR filing websites or through the optional APIs, as opposed to through the filer's dashboard.
                        </P>
                    </FTNT>
                    <P>
                        Separately, as one commenter requested, the dashboard will be modified to allow delegated administrators and delegated users to make both COUPDAT and series and class update (“SCUPDAT”) submissions. The Proposing Release contemplated that delegated administrators and delegated users would be able to submit SCUPDAT submissions on the filer's behalf to update series and class information (such as a new share class) but would not be able to make COUPDAT submissions to update the filer's company information (such as a new business address). One commenter asserted that delegated administrators and delegated users should be able to submit both COUPDATs and SCUPDATs on behalf of the filer.
                        <SU>127</SU>
                        <FTREF/>
                         Because allowing delegated administrators and delegated users to make both COUPDAT and SCUPDAT submissions provides consistency and reduces burdens associated with these updates, to the extent that such updates could then be delegated by the filer, this capability will be implemented in EDGAR. The filer's account administrators would receive notice of COUPDAT and SCUPDAT submissions on the dashboard and could take appropriate action should any unauthorized activity occur.
                    </P>
                    <FTNT>
                        <P>
                            <SU>127</SU>
                             
                            <E T="03">See</E>
                             DFIN Comment Letter (“Delegated administrators and delegated users should have the ability to submit COUPDAT (company update submissions) and SCUPDAT (series &amp; class updates).”).
                        </P>
                    </FTNT>
                    <P>
                        Delegated entities will not be able to further delegate authority to file to other entities on behalf of filers that delegate authority to them.
                        <SU>128</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>128</SU>
                             For example, Filer A could delegate authority to file on its behalf to Filer B. Separately, Filer B could delegate authority to file on its behalf to Filer C. In this scenario, however, Filer B could not delegate to Filer C the authority to file on behalf of Filer A, and Filer C could not file on behalf of Filer A.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Delegated Entities</HD>
                    <P>
                        Because a delegated entity must have an EDGAR account, it must comply with the same requirements applicable to all filers. A delegated entity will therefore maintain its own EDGAR account with its own account administrators, users, and technical administrators. A delegated entity can be any EDGAR account, including but not limited to filing agents,
                        <SU>129</SU>
                        <FTREF/>
                         issuers making submissions on behalf of individuals filing pursuant to section 16 of the Exchange Act,a nd parent companies of large groups of related filers. On the dashboard, a delegated entity will be able to receive delegated authority to file for an unlimited number of filers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>129</SU>
                             We are adopting amendments to Rule 11 of Regulation S-T to define a “filing agent” as any person or entity engaged in the business of making submissions on EDGAR on behalf of filers. This definition includes law firms, financial services companies, broker dealers when making submissions on behalf of individuals filing pursuant to section 16 of the Exchange Act, and other entities engaged in the business of submitting EDGAR filings on behalf of their clients. See the discussion of amendments to Rule 11 in section II.F.2.
                        </P>
                    </FTNT>
                    <P>
                        Several commenters provided comments on delegation specifically related to individuals with filing obligations pursuant to section 16 of the Exchange Act. Commenters indicated that the delegation framework contemplated by the Proposing Release would help section 16 filers comply with their filing obligations.
                        <SU>130</SU>
                        <FTREF/>
                         Individuals with section 16 filing obligations will be able to delegate authority to make submissions to filing agents or any other representative with an EDGAR account on the dashboard. This process will allow those individuals to obtain assistance with their filings, while permitting each filing to be associated with a specific individual at the delegated entity. One commenter asserted that section 16 filers would face compliance burdens, however, that would not be adequately addressed by the proposal.
                        <SU>131</SU>
                        <FTREF/>
                         The commenter stated that section 16 filers can sit on the boards of multiple companies and concluded that section 16 filers need an easier method to delegate permissions. As discussed above and as separately requested by commenters, the dashboard will include bulk delegation functionality, which should assist filers with multiple filing agents or other representatives with EDGAR accounts, including section 16 filers delegating authority to make submissions to related issuers.
                        <SU>132</SU>
                        <FTREF/>
                         The staff will provide detailed information about bulk delegation and other account management topics to section 16 filers to prevent confusion. Moreover, section 16 filers may choose to execute notarized powers of attorney to authorize relevant individuals at their filing agents, related issuers, or other representative entities as account administrators, thereby avoiding the need to obtain individual account credentials, log into the dashboard, make filings or delegate authority on the dashboard.
                    </P>
                    <FTNT>
                        <P>
                            <SU>130</SU>
                             
                            <E T="03">See</E>
                             XBRL II Comment Letter (“Yes, the ability to delegate authority would help infrequent filers such as Section 16 filers.”); Workiva Comment Letter (responding to the Commission's request for comment regarding section 16 filers by stating: “We believe the proposed framework is adequate to support filing responsibilities.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>131</SU>
                             
                            <E T="03">See</E>
                             XBRL II Comment Letter (“[W]e do not believe the rule proposal adequately addresses the needs of Section 16 filers and single individual filers [who] will perform their own code management. For these filers, the rule does not specifically address how they can manage this. Many sit on boards of multiple companies, some as many as 20, and will need to set up or designate each individual as an account administrator. The Commission needs to address how there can be an easier method to delegate permission for someone to file on their behalf.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>132</SU>
                             
                            <E T="03">See supra</E>
                             note 107 and accompanying and following text; 
                            <E T="03">see also</E>
                             Toppan Merrill Comment Letter (“Allow bulk delegation for a group of CIKs. This would be useful for an Administrator of an Issuer and all of their Section 16 filer CIKs to delegate to Filing Agents as well as affiliated CIKs.”).
                        </P>
                    </FTNT>
                    <P>If a filer authorizes a delegated entity to file on its behalf, one of the delegated entity's account administrators must accept either the dashboard or the email invitation for the delegation to be effective; further, upon acceptance, all the delegated entity's account administrators will automatically become delegated administrators for the filer. All delegated administrators for the filer will have co-equal authority with regard to that filer. If the delegated entity adds or removes one of the account administrators for its own EDGAR account, then that individual will also be added or removed as a delegated administrator for the filer. These relationships are illustrated in diagram 3 below.</P>
                    <GPH SPAN="3" DEEP="199">
                        <PRTPAGE P="106186"/>
                        <GID>ER27DE24.013</GID>
                    </GPH>
                    <HD SOURCE="HD3">4. Delegated Users</HD>
                    <P>As described in the Proposing Release, if a delegated entity accepts a delegation from a filer, the delegated administrators can authorize specific users at the delegated entity to become delegated users with respect to that filer. As discussed below, delegated administrators will be able to authorize delegated users in accordance with the process outlined in the Proposing Release. In addition to what was discussed in the Proposing Release and taking account of a commenter's suggestion, the dashboard will be updated to generally enable bulk actions in various contexts, including delegation.</P>
                    <P>
                        Delegated users will not count as part of the 500-user limit on the dashboard for the delegating filer. If delegated administrators want all their users to become delegated users with respect to a filer, a delegated administrator can check a box on the dashboard to automatically authorize all users at the delegated entity as delegated users for the filer. Alternately, delegated administrators will be able to authorize a subset of the delegated entity's users as delegated users; authorize all of the delegated entity's users as delegated users for the filer; or not authorize any delegated users (because the delegated administrators will be able to file on behalf of the filer).
                        <SU>133</SU>
                        <FTREF/>
                         After the delegated user accepts the initial invitation from the delegated administrator, the user will receive notifications regarding further changes to its role (including changes to filers for which it will be a delegated user, and changes to the user groups it will be affiliated with), but the user will not need to accept those notifications or take any further action for the changes to be effective.
                    </P>
                    <FTNT>
                        <P>
                            <SU>133</SU>
                             For this reason, delegated administrators could not be authorized as delegated users regarding the delegating filer, because doing so would be redundant.
                        </P>
                    </FTNT>
                    <P>
                        One commenter stated that delegated administrators should be able to remove a delegated user from all delegations via a single bulk action without having to manually edit each delegation.
                        <SU>134</SU>
                        <FTREF/>
                         The commenter further asserted that delegated users should be able to remove themselves from all delegations without editing each delegation.
                        <SU>135</SU>
                        <FTREF/>
                         In these circumstances, we believe that it is more likely that a delegated administrator would remove a delegated user, or the delegated user would remove herself, as a user for the delegated filer, and thus the dashboard will not specifically provide these requested features. The dashboard will be enhanced, however, to generally enable bulk actions in various contexts, including with respect to delegation.
                        <SU>136</SU>
                        <FTREF/>
                         In addition, optional APIs will be offered to allow filers to add and remove individuals' authorizations rapidly and easily. These accommodations should largely address commenters' concerns; in addition, further technical enhancements to the dashboard will continue to be considered.
                    </P>
                    <FTNT>
                        <P>
                            <SU>134</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“[D]elegated admins should be able to remove a delegated user from all delegations without having to edit each delegation one by one as the person may need to remain on the Dashboard for a role other than the delegated role.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>135</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“[D]elegated users should have the ability to remove themselves from all delegations without editing one by one.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>136</SU>
                             
                            <E T="03">See</E>
                             text following note 118 (discussing the dashboard's bulk delegation functionality).
                        </P>
                    </FTNT>
                    <P>Delegated users will be able to submit filings on behalf of the filer on the EDGAR filing websites or through the optional submission API, as discussed below.</P>
                    <HD SOURCE="HD3">5. User Group Functionality at Delegated Entities</HD>
                    <P>Delegated entities, through their delegated administrators, will be able to employ user groups to assign certain users to different filers for which they possess delegated authority to file, as described in the Proposing Release. An example is provided in diagram 4 below.</P>
                    <GPH SPAN="3" DEEP="199">
                        <PRTPAGE P="106187"/>
                        <GID>ER27DE24.014</GID>
                    </GPH>
                    <P>• In diagram 4, the account administrators for Filer A and Filer B delegated to Filer C. As a result, Filer C's account administrators became delegated administrators for Filers A and B. In this example, Filer C might be a filing agent to which Filer A or Filer B gave authority to make filings on its behalf, and Filer A and Filer B might be public companies or investment companies.</P>
                    <P>• A delegated administrator at Filer C created User Group 1 containing Filer C's Users 1, 2, and 3. The delegated administrator assigned authority to file for Filer A to User Group 1. Users 1, 2, and 3 are thus delegated users for Filer A because they are members of User Group 1. If additional users from Filer C were added to User Group 1, those additional users would also become delegated users for Filer A.</P>
                    <P>• The delegated administrator at Filer C also created User Group 2 containing Filer C's User 3. The delegated administrator assigned authority to file for Filer B to User Group 2. User 3 is a delegated user for Filer B.</P>
                    <P>• By employing the user group function, the delegated administrator at Filer C restricted delegated filing permissions for Filer A to Filer C Users 1, 2, and 3 only (via User Group 1) and delegated filing permissions for Filer B to Filer C User 3 only (via User Group 2). Filer C User 4 has not been authorized as a delegated user for any filers.</P>
                    <P>• In diagram 4, each user group has only been assigned authority to file for a single filer, but user groups could be assigned authority to file for multiple filers.</P>
                    <P>Delegated administrators will also be able to authorize a default user group of individuals who will be automatically assigned as delegated users for all future delegations. The ability to have a default user group will provide an efficient way for delegated administrators to authorize groups of their users as delegated users for any filer.</P>
                    <P>Users will receive notifications when added to or removed from a user group, and when the user group to which they belonged becomes authorized to make submissions for a filer, or when that authorization is removed. As noted, users will not need to accept or otherwise take any action on these notifications.</P>
                    <P>
                        As discussed above, in response to comments received, the dashboard will be enhanced to allow wildcard searches including first and last names, which should make it easier for filers to construct user groups and to generally manage individuals on the dashboard.
                        <SU>137</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>137</SU>
                             
                            <E T="03">See supra</E>
                             note 92 and accompanying and following text.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">6. Technical Administrators at Delegated Entities</HD>
                    <P>If the delegated entity chooses to connect to APIs, the delegated entity will be required to authorize its own technical administrators, as discussed in the Proposing Release, and required by paragraph (d)(3) of Rule 10 as adopted. The delegated entity's technical administrators will be responsible for managing the API connections and the filer API tokens for the delegated entity. The delegated entity may make submissions for any filers that delegate authority to it using the delegated entity's API connections and filer API tokens, and the individual at the delegated entity making submissions for the filer would present his user API token generated on the dashboard, if the relevant API requires presentation of a user API token.</P>
                    <P>In addition, as discussed above, in a change from what was contemplated in the Proposing Release, paragraph (d)(3) of Rule 10 as adopted now specifies that a filer may use its delegated entity's API connections and filer API tokens so long as the delegated entity complies with the requirement to maintain at least two technical administrators. The delegated entity's technical administrators may share the delegated entity's filer API tokens with its filers, as discussed further below. The delegated entity's technical administrators will not need to generate different filer API tokens for different delegating filers that use the delegated entity's API connections. The individual at the filer using the delegated entity's API connections and filer API tokens must present her own user API token to the APIs, if the particular APIs require presentation of a user API token.</P>
                    <HD SOURCE="HD2">D. Hours of Operation of the Dashboard</HD>
                    <P>As contemplated in the Proposing Release, the dashboard will be available during EDGAR operating hours, 6 a.m. to 10 p.m. Eastern Time each day except Saturdays, Sundays, and Federal holidays. Optional APIs that provide much of the same functionality as the dashboard will also be available during those hours because the APIs rely on dashboard availability.</P>
                    <P>
                        Several commenters requested increased dashboard operating hours, including requests that the dashboard be available during weekends and/or 24 hours a day.
                        <SU>138</SU>
                        <FTREF/>
                         While we acknowledge 
                        <PRTPAGE P="106188"/>
                        commenters' concerns, the dashboard will be available during current EDGAR operating hours, the time period during which EDGAR filings can be submitted,
                        <SU>139</SU>
                        <FTREF/>
                         which is 16 hours per business day. We believe this availability should generally be sufficient for filers' needs, as it has been for EDGAR filing availability to date. Further, optional APIs providing much of the functionality on the dashboard will allow filers to rapidly make submissions and otherwise transmit and receive information from EDGAR, significantly increasing filers' efficiency during EDGAR operating hours. In addition, filers that build internal systems to connect to the optional APIs could potentially include features such as scheduling filings for submission, as filers currently do, reducing the need for the dashboard to be offered 24 hours a day or during weekends and holidays.
                    </P>
                    <FTNT>
                        <P>
                            <SU>138</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Toppan Merrill Comment Letter (“It would be beneficial to allow the dashboard to be open 24 hours a day, Monday through Friday.”); Block Transfer Comment Letter (“We respectfully 
                            <PRTPAGE/>
                            believe the Commission should not limit EDGAR Next operations to the DC workweek. . . . [W]e believe a 24/7 EDGAR would revolutionize international capital markets by providing a standard for all issuers.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>139</SU>
                             Regulation S-T provides that filings “may be submitted to the Commission each day, except Saturdays, Sundays, and Federal holidays, from 6 a.m. to 10 p.m., Eastern Standard Time or Eastern Daylight Saving Time, whichever is currently in effect.” 17 CFR 232.12(c).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">E. Optional Application Programming Interfaces</HD>
                    <P>
                        Commenters broadly supported the addition of optional APIs to EDGAR, including those listed in the Proposing Release.
                        <SU>140</SU>
                        <FTREF/>
                         EDGAR will therefore offer the optional APIs detailed below to provide filers with secure, efficient and automated methods of interacting with EDGAR. These optional APIs will be available to enrolled filers upon the effective date of the rule and form changes on March 24, 2025. The optional APIs include those discussed in the Proposing Release—a submission API to allow filers to make both live and test submissions on EDGAR (“submission API”); a submission status API to allow filers to check the status of an EDGAR submission (“submission status API”); and an operational status API to allow filers to check EDGAR operational status (“EDGAR operational status API”)—as well as 12 additional optional APIs requested by commenters, detailed below.
                    </P>
                    <FTNT>
                        <P>
                            <SU>140</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Comment Letter of Andrew Danneffel (November 20, 2023) (“Danneffel II Comment Letter”) (“The introduction of APIs to interact with EDGAR is very much welcome.”); Toppan Merrill Comment Letter (“The proposed APIs accomplish the objectives of secure, efficient, and automated machine-to-machine communication.”); Comment Letter of Chris V. (Nov 21, 2023) (“Chris V. Comment Letter”) (“For this proposal, I believe specifically the API access outlined in Rule 10(d)(3) is the most crucial item which should be added to the regulations.”).
                        </P>
                    </FTNT>
                    <P>
                        Commenters recommended that optional APIs mirroring the functionality in the dashboard be added to those discussed in the Proposing Release to reduce the burden associated with manual dashboard tasks.
                        <SU>141</SU>
                        <FTREF/>
                         We will offer the majority of APIs that commenters requested, which should largely address commenters' concerns regarding account administrators' manual management of numerous individuals and accounts on the dashboard, as well as commenters' request for enhanced EDGAR automation. For example, APIs will assist individuals who are account administrators for multiple EDGAR accounts, such as investment company fund families or asset-backed securities issuers with potentially hundreds of affiliated EDGAR accounts.
                        <SU>142</SU>
                        <FTREF/>
                         We previously indicated that more APIs would be added if feasible, and the additional APIs requested by commenters will be made available to enrolled filers when the EDGAR Filer Management dashboard goes live on March 24, 2025. In addition, filers whose application on amended Form ID is granted on or after March 24, 2025, will be able to connect to the optional APIs. Collectively, the optional APIs will provide in machine-to-machine connections the majority of functions on the dashboard for those filers that choose to manage their EDGAR accounts in a more automated manner.
                        <SU>143</SU>
                        <FTREF/>
                         Additional APIs may be made available in the future as feasible. Connection to APIs is optional.
                    </P>
                    <FTNT>
                        <P>
                            <SU>141</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Workiva Comment Letter (“All functionality provided by the EDGAR Dashboard should be available via APIs. . . . The administration burden and ongoing maintenance costs [of manually using the dashboard] will be significant and could ultimately impact the cost burden on the filers”); XBRL II Comment Letter (“A complete set of Filer Management APIs must be made available for effective management by filing agents and other entities that support large numbers of registrants. . . . This scale is not manageable using the Filer Management dashboard and would result in an overwhelming amount of email and incur a significant support burden and associated costs.”); Chris V. Comment Letter (“My suggestion for improving the proposal is to provide the API on a wider scale.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>142</SU>
                             
                            <E T="03">See, e.g.,</E>
                             ICI Comment Letter (“EDGAR Next should provide a mechanism to provide for filers who have a multi-filer structure, such as Funds.”); Toppan Merrill Comment Letter (“EDGAR Next should provide a mechanism to affiliate and manage filers who have a multi-filer structure.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>143</SU>
                             The APIs will be available concurrently with EDGAR Filer Management dashboard availability—during EDGAR business hours, from 6 a.m. to 10 p.m. Eastern Time, each day except Saturdays, Sundays, and Federal holidays. 
                            <E T="03">See</E>
                             section II.D.
                        </P>
                    </FTNT>
                    <P>
                        If filers choose to connect to APIs, filers must comply with the requirement of paragraph (d)(3) of Rule 10, as adopted, to authorize, through their account administrators, at least two technical administrators, unless the filer uses the filer API tokens and API connections of its delegated entity (so long as that entity is in compliance with the requirement to maintain at least two technical administrators pursuant to paragraph (d)(3) of Rule 10), as discussed further herein. Additionally, filers that choose to connect to the APIs must comply with the requirements of the EDGAR Filer Manual as amended to present filer API tokens and user API tokens to EDGAR generated on the dashboard on a periodic basis, unless filers use the filer API tokens and API connections of their delegated entity (and the individual at the filer presents her user API token, if required by that API). Filers, including delegated entities, that maintain at least two technical administrators and connect to APIs must present a filer API token and the individual at the filer must present a user API token to the APIs (if the relevant API requires a user API token). If a filer chooses to use the filer API token and API connections of its delegated entity, that filer's individual account administrator or user must still present to the API a user API token the individual generates on the dashboard (if the relevant API requires a user API token).
                        <SU>144</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>144</SU>
                             This requirement is included in the EDGAR Filer Manual, as amended. 
                            <E T="03">See</E>
                             amended EDGAR Filer Manual, Volume I. We note that specific required inputs vary by API. For example, the EDGAR operational status API will not require user API tokens, as discussed further below.
                        </P>
                    </FTNT>
                    <P>The API tokens represent a security requirement that eliminates the need for manually entering individual account credentials and performing multifactor authentication each time a submission is made. Instead, multifactor authentication and individual identification occurs when the technical administrator logs into the dashboard to generate the filer API token annually and when the relevant account administrator or user logs into the dashboard to generate a user API token every 30 days, in accord with the time durations of the tokens specified in the EDGAR Filer Manual as amended.</P>
                    <P>
                        Filers who choose to connect to optional APIs will need to create certain software to make technical connections to the APIs, as they would any other API. Commission staff are providing filers with open-source code for a sample filing application that will facilitate filers' connections to the three APIs noted in the Proposing Release in the EDGAR API Development Toolkit (“API Toolkit”), available on 
                        <E T="03">SEC.gov.</E>
                         The sample filing application will 
                        <PRTPAGE P="106189"/>
                        provide technical details and a working code base that could be either copied into existing filing applications or used as a base for developing a new filing application.
                        <SU>145</SU>
                        <FTREF/>
                         Commission staff are also offering filers a list of technical standards for the APIs, the expected inputs and outputs, and information regarding whether only a filer API token or both filer and user API tokens are required for particular APIs in the Overview of EDGAR Application Programming Interfaces (“Overview of EDGAR APIs”), available on 
                        <E T="03">SEC.gov.</E>
                         We anticipate that the API Toolkit and the Overview of EDGAR APIs will save filers time and effort in connecting to the optional APIs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>145</SU>
                             The sample filing application code is a starting point for smaller filers that may not already have a filing application and want to enter the API space. This sample code can serve as a troubleshooting guide/reference material for all developers because it uses specific technologies (
                            <E T="03">e.g.,</E>
                             PostgreSQL, NodeJS, Angular) that are well documented, standard, and can be understood by a mid-level programmer.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. APIs That Commission Staff Will Provide</HD>
                    <HD SOURCE="HD3">a. Submission API</HD>
                    <P>
                        Consistent with the discussion in the Proposing Release, the submission API will give filers the option to submit test and live filer-constructed EDGAR submissions.
                        <SU>146</SU>
                        <FTREF/>
                         This API should allow filers to rapidly and efficiently submit large numbers of filings in an automated manner, instead of requiring them to manually log into EDGAR to make filings one at a time.
                        <SU>147</SU>
                        <FTREF/>
                         Successful connection to the submission API will transmit a filer-constructed submission to EDGAR, at which point the submission will be subject to routine EDGAR validation checks and processing.
                    </P>
                    <FTNT>
                        <P>
                            <SU>146</SU>
                             Currently, EDGAR accepts approximately 525 submission types, of which approximately 500 (95%) permit filer construction.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>147</SU>
                             Filers who do not wish to use the API to make filer-constructed submissions, and filers making other types of submissions, could continue to file through the web-based EDGAR filing websites. Whether submissions were made through the API or the EDGAR filing websites, filers will specify the CIK for which they are making submissions. That CIK number will be reflected in the accession number associated with those submissions. Filers could change the login CIK reflected in the accession number at any time to any other CIK for which the filer is authorized to file on EDGAR. For example, a filing agent could choose to submit filings for a client filer using its own login CIK, or by using its client filer's login CIK.
                        </P>
                    </FTNT>
                    <P>
                        One commenter suggested the introduction of submission endpoints specific to major forms offered to filers.
                        <SU>148</SU>
                        <FTREF/>
                         The commenter asserted this could be used to control filing permissions for specific forms so that, for example, a filer could delegate permissions for only certain specific form types. Although some filers may wish to engage in limited delegations of authority, there is no current plan to introduce that level of granularity to EDGAR. Under EDGAR Next, a filer's account administrators will receive a notification when the delegated entity makes a submission for the filer, and if that submission is made without the filer's authorization, the filer's account administrators will be able to remove the delegated entity's authority to make submissions on the filer's behalf and take other corrective actions. Moreover, providing form-specific filing permissions could be logistically difficult to administer as EDGAR currently accepts 525 submission types.
                    </P>
                    <FTNT>
                        <P>
                            <SU>148</SU>
                             
                            <E T="03">See</E>
                             Block Transfer Comment Letter (“We respectfully present to the Commission that there should be submission endpoints specific to major forms offered to filers. Specific routes for each filing enable the Commission to check for route-specific endpoint authorization. That way, an issuer that authorizes another filer to submit automated insider transaction reports does not have to worry about the agent submitting a Form 10-K.”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">b. Submission Status API</HD>
                    <P>
                        As discussed in the Proposing Release, a submission status API will allow filers to leverage their filing application to simultaneously check the status of multiple submissions in a batch process, instead of manually logging into EDGAR and individually checking the status of each submission. The submission status API will indicate whether each submission has been submitted and accepted, but not yet publicly disseminated; 
                        <SU>149</SU>
                        <FTREF/>
                         submitted and accepted, and publicly disseminated; or submitted and suspended.
                    </P>
                    <FTNT>
                        <P>
                            <SU>149</SU>
                             Generally, filings are first accepted and then subsequently disseminated. Certain filings, however, remain nonpublic and are never disseminated. Therefore, those filings never progress from accepted to disseminated status.
                        </P>
                    </FTNT>
                    <P>
                        One commenter requested that the submission status API be modified to provide additional information so that filers could more fully understand the exact status of their EDGAR submissions.
                        <SU>150</SU>
                        <FTREF/>
                         As requested by the commenter, the submission status API will be enhanced to provide all information currently contained in EDGAR submission notifications.
                    </P>
                    <FTNT>
                        <P>
                            <SU>150</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“Missing information includes, but is not limited to, warning/error labels (as shown on 
                            <E T="03">https://www.sec.gov/edgar/messages</E>
                            ), the number of documents processed, the received and filing dates, series/class information, Section 16 reporting owner/issuer details, Subject Company, file number(s), and Item Submission accession number and type information for combined filings. The current Submission Notification HTML document contains this information and the API should be modified to include this document . . . .”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">c. EDGAR Operational Status API</HD>
                    <P>
                        As discussed in the Proposing Release, an EDGAR operational status API will allow filers to leverage their filing application to check the operational status of EDGAR at any given time. The EDGAR operational status API will indicate whether EDGAR is fully operational, unavailable (after business hours), or not fully operational in whatever regard at that point in time (for example, if EDGAR is not disseminating to 
                        <E T="03">SEC.gov</E>
                        ). We did not receive any comments specifically regarding the EDGAR operational status API.
                    </P>
                    <P>In addition to the APIs discussed in the Proposing Release, the following APIs will be offered in response to commenter requests, as described below.</P>
                    <HD SOURCE="HD3">d. Filing Credentials Verification API</HD>
                    <P>
                        Several commenters requested the addition of an API to allow filers to confirm the validity of all credentials involved in an API-based filing.
                        <SU>151</SU>
                        <FTREF/>
                         One commenter asserted that this API would be used thousands of times per day and would help detect authorization errors prior to submission, which would in turn reduce the amount of invalid filing submissions and reduce the load on both filing software and EDGAR systems.
                        <SU>152</SU>
                        <FTREF/>
                         A “filing credentials verification API” will be added, as requested by commenters, which should assist filers in verifying the status of their credentials, allowing them to accurately schedule and submit filings. The API will indicate if the provided credentials have filing permissions with regarding the provided CIK, and if so, will also provide the upcoming account confirmation deadline and the expiration dates of the provided API tokens.
                    </P>
                    <FTNT>
                        <P>
                            <SU>151</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Workiva Comment Letter (“We suggest adding an API which would return specific, comprehensive information about the status of all credentials involved in an API-based filing.”); Danneffel II Comment Letter (“I'd like to suggest an additional API be added that tests the validity of a user/filer token combination . . . ., The proposed API would check:—If the user token is valid (exists and is not expired)—If the filer token is valid (exists and is not expired)—If the user token is authorized to file using the filer token . . . .”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>152</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“This new API would be accessed prior to every filing submission, so it could be expected to be called thousands of times per day—although detecting authorization errors prior to submitting a filing would reduce the amount of invalid filing submissions and would reduce the load on both filing software and EDGAR systems.”).
                        </P>
                    </FTNT>
                    <PRTPAGE P="106190"/>
                    <HD SOURCE="HD3">e. APIs To View Individuals, Add Individuals, Remove Individuals, and Change Roles</HD>
                    <P>
                        Several commenters requested the addition of optional APIs to replicate dashboard functionality to allow filing agents and other entities that support large numbers of registrants to more easily manage filer accounts.
                        <SU>153</SU>
                        <FTREF/>
                         Separate optional APIs will be provided so that filers may view individuals authorized for a CIK, add individuals, remove individuals, and change roles for individuals.
                        <SU>154</SU>
                        <FTREF/>
                         Collectively, these APIs should enable filing agents and other entities that support large numbers of filers to rapidly and efficiently manage individual authorizations and roles for those filers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>153</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“All functionality provided by the EDGAR Dashboard should be available via APIs. While the Dashboard may be sufficient for individual registrants, it will be unworkable for many filing agents.”); XBRL II Comment Letter (“A complete set of Filer Management APIs must be made available for effective management by filing agents and other entities that support large numbers of registrants. . . . This scale is not manageable using the Filer Management dashboard and would result in an overwhelming amount of email and incur a significant support burden and associated cost.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>154</SU>
                             In addition, APIs will be provided related to delegation and CCCs.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">f. APIs To Send Delegation Invitations, Request Delegation Invitations, and View Delegations</HD>
                    <P>
                        As discussed above, commenters requested the addition of optional APIs to replicate dashboard functionality to allow filing agents and other entities that support large numbers of registrants to more easily manage filer accounts.
                        <SU>155</SU>
                        <FTREF/>
                         Separate optional APIs will be provided to allow filers to send delegation invitations to prospective delegated entities, request delegation invitations from prospective delegating filers, and view delegations currently in place (including both delegations received from filers and also delegations provided to delegated entities). Collectively, these optional APIs should enable filing agents and other entities that support large numbers of filers to manage delegations rapidly and efficiently for those filers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>155</SU>
                             
                            <E T="03">See supra</E>
                             note 141153.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">g. APIs To View Filer Account Information, Generate CCC, and Create Custom CCC</HD>
                    <P>
                        Several commenters requested the addition of an optional API to make available on a machine-to-machine basis the same functionality that is currently provided within the “Retrieve/Edit Data” section of the EDGAR Filing website.
                        <SU>156</SU>
                        <FTREF/>
                         That functionality includes, but is not limited to, the ability to view/edit filer account information such as the filer's name, contact information, and corporate information like State of incorporation and fiscal year-end, view the filer's current account balances and request the return of unused funds, and change the filer's password or CCC. As part of the transition to EDGAR Next, some of this functionality will be shifted to the dashboard, such as the filer's EDGAR POC. In addition, the fee-related aspects of this functionality raise unique technical challenges that make providing APIs for those functions more difficult due to the current systems and processes surrounding payment and fee information.
                        <SU>157</SU>
                        <FTREF/>
                         For those reasons, separate APIs will not be added at this time for each of the functions currently provided in the “Retrieve/Edit Data” section of the EDGAR Filing website.
                    </P>
                    <FTNT>
                        <P>
                            <SU>156</SU>
                             
                            <E T="03">See</E>
                             XBRL II Comment Letter (“All functionality provided under the Retrieve/edit data section of the EDGAR site should have an equivalent API implementation. . . .”); Toppan Merrill Comment Letter (“Ideally, all functionality that is currently available within the `Retrieve/Edit' data under a CIK within EDGAR will be available through an API in EDGAR Next.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>157</SU>
                             Filing fee information will remain in the “Retrieve/Edit Data” section of the EDGAR Filing website; it will not be accessible on the dashboard.
                        </P>
                    </FTNT>
                    <P>To address commenter concerns, however, a “view filer account information API,” as well as a “generate CCC API” and a “create custom CCC API,” will be added. The optional view filer account information API will allow filers to view the filer's name, contact information, CCC, CIK type (company, single-member company, or individual), and next confirmation date. The optional generate CCC and create custom CCC APIs will allow filers to generate a new CCC at any time to enhance filer security without causing filing delays.</P>
                    <HD SOURCE="HD3">h. Enrollment API</HD>
                    <P>
                        To facilitate the requirement that existing filers enroll in EDGAR Next, an optional API designed to automate the enrollment process will be added. As stated in the Proposing Release, filers may enroll in EDGAR Next either through, (a) manual enrollment of single accounts on an account-by-account basis or (b) enrollment of multiple accounts simultaneously, by completing and uploading a spreadsheet of up to 100 filers (100 rows) per bulk enrollment. Several commenters expressed concerns regarding the volume and complexity of enrollment and requested that some form of automation or increased flexibility be provided regarding the enrollment process.
                        <SU>158</SU>
                        <FTREF/>
                         The “enrollment API” should help address these concerns by streamlining the enrollment process.
                    </P>
                    <FTNT>
                        <P>
                            <SU>158</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Workiva Comment Letter (“[W]e suggest automatically enrolling the current POC as a super administrator by default. . . . We highly recommend that the initial transition should include preloaded delegations based on filing history, with the option of automatic acceptance by filing agents. . . .”); XBRL II Comment Letter (“We recommend that the CSV limit be increased to 500, from the proposed limit of 100.”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. API Tokens</HD>
                    <P>For filers that opt to connect to APIs, filer API tokens and user API tokens if the relevant API requires presentation of a user API token, will be required by the EDGAR Filer Manual as amended, as discussed in the Proposing Release. The use of tokens to connect to optional APIs is a security requirement designed to minimize the potential for unauthorized access to filers' accounts on EDGAR.</P>
                    <P>As discussed in the Proposing Release, the EDGAR Filer Manual will be amended to require that filers that connect to the optional APIs have a technical administrator generate a filer API token on the dashboard to authenticate the filer. The filer API token will remain valid for up to one year. In a change to what was discussed in the proposal, a filer will be allowed to use its delegated entities' filer API tokens and API connections (and rely upon its delegated entities' technical administrators), so long as the filer's delegated entity has authorized at least two technical administrators pursuant to paragraph (d)(3) of Rule 10 and the individual at the filer using its delegated entity's filer API tokens and API connections provides a valid user API token if the relevant API requires presentation of a user API token, as set forth below. Further, as discussed in the Proposing Release, the EDGAR Filer Manual will be amended to require that an individual user or account administrator generate a user API token on the dashboard to authenticate herself. In a change to the discussion in the Proposing Release indicating that the EDGAR Filer Manual would require that the user API token would remain valid for up to one year so long as the user logged into EDGAR at least every 30 days, the EDGAR Filer Manual will specify that the user API token will remain valid for 30 days from the time the token is generated.</P>
                    <P>
                        One commenter recommended that a filer be able to use the filer API token generated by the filer's delegated entity.
                        <SU>159</SU>
                        <FTREF/>
                         This suggestion will be 
                        <PRTPAGE P="106191"/>
                        implemented to make the optional APIs more accessible for smaller filers. As discussed above, filers may use their delegated entity's API connections and filer API tokens so long as the delegated entity has authorized at least two technical administrators pursuant to paragraph (d)(3) of Rule 10. Filers that do so will not need to authorize their own technical administrators or obtain and maintain their own filer API tokens. Individuals at these filers must, however, supply their own user API tokens, if the relevant API requires presentation of a user API token. As a result, smaller filers that may not have the resources to develop API connections or employ their own technical administrators, but who nevertheless would like their personnel to interact with EDGAR through APIs, may use the APIs that their delegated entity develops and maintains.
                    </P>
                    <FTNT>
                        <P>
                            <SU>159</SU>
                             Workiva Comment Letter (“[T]he proposed delegation scenario is not well suited for automated filing solutions, since while the filing software can 
                            <PRTPAGE/>
                            use its filer token, an employee of the filing software provider would not typically be involved to provide their user token. One solution would be to allow the registrant's authorized user to use their user token with the delegated filing software's filer token.”).
                        </P>
                    </FTNT>
                    <P>
                        Another commenter expressed concern that expiring API tokens could frustrate the ability of filers to plan ahead to make filings and suggested that the Commission provide an API to allow filers to programmatically check expiration dates for relevant filer API tokens and user API tokens.
                        <SU>160</SU>
                        <FTREF/>
                         As discussed further above, an optional filing credentials API will be offered so that filers can check filing credentials, including information regarding API token expiration dates and account confirmation deadlines.
                    </P>
                    <FTNT>
                        <P>
                            <SU>160</SU>
                             
                            <E T="03">See</E>
                             XBRL II Comment Letter (“We also suggest that the Commission give users the ability to see information about the token, for example what is the upcoming expiration date. This could be executed through an API that provides visibility into whether the token should work, and if it is not functional, an explanation as to why it is not working.”).
                        </P>
                    </FTNT>
                    <P>
                        Many commenters objected to the 30-day login requirement for the user API token discussed in the proposal and stated that it would be especially burdensome for infrequent filers.
                        <SU>161</SU>
                        <FTREF/>
                         One commenter also expressed concerns about the complexity and multiple layers of requirements contemplated for user API tokens, citing the one-year validity period and 30-day login requirements.
                        <SU>162</SU>
                        <FTREF/>
                         Another commenter supported the 30-day login requirement as being justified in terms of providing additional security.
                        <SU>163</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>161</SU>
                             
                            <E T="03">See, e.g.,</E>
                             XBRL II Comment Letter (“[T]he requirement to log into an EDGAR website, interactively, every 30 days means that many Section 16 reporting owners will be continuously inactivated.”); SIFMA Comment Letter (“[W]e recommend that EDGAR Next access credentials not be removed for mere inactivity, which the Commission indicates would happen with API tokens that are not used during a 30 day period.”); Workiva Comment Letter (“According to our customer survey, about 72% of the respondents indicated that [the 30-day login requirement for user API tokens] poses a significant burden or risk to their filing teams. We strongly recommend that the Commission eliminate this requirement.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>162</SU>
                             
                            <E T="03">See</E>
                             XBRL II Comment Letter (“[W]e are concerned about the multiple layers of requirements for the token API, for example, the expiration and 30-day login requirements, which will be challenging, particularly for sporadic filers.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>163</SU>
                             
                            <E T="03">See</E>
                             Chris V. Comment Letter (“In the vein of additional security, the proposal as written also currently suggests requiring monthly logins to maintain access to an API access code which is open for one year. I feel this could be considered heavyhanded in comparison to the fairly lax standards which exist today, but I do think it's worth the additional security and expectation from those submitting data.”).
                        </P>
                    </FTNT>
                    <P>
                        We considered these comments as well as the need to enhance system security. As a result, in a change to what was discussed in the Proposing Release, the EDGAR Filer Manual as amended will specify that the user API token will expire 30 days after the individual generates the token. The Proposing Release by contrast contemplated that the user API token would remain valid for one year so long as the user logged into the dashboard every 30 days. Thus, rather than logging in every 30 days to keep the user API token active, as discussed in the Proposing Release, the individual is required to log in every 30 days to generate a new user API token. The shorter duration of the user API token will enhance the security of APIs, especially in light of the annual duration of the filer API token. Shorter validity periods and more frequent expiration dates limit the risk exposure of a token being lost or stolen during the validity period, and thus more frequent expiration dates are generally preferable from a security perspective. Separately, the 30-day duration of the user API token avoids the potential confusion posed by a token that persists for one year only if the user logs into EDGAR every 30 days, a concern expressed by one commenter noted above.
                        <SU>164</SU>
                        <FTREF/>
                         We note that an optional API will be offered, as requested by commenters and discussed above, to allow filers easily to retrieve the expiration dates of the filer API token and user API token.
                    </P>
                    <FTNT>
                        <P>
                            <SU>164</SU>
                             
                            <E T="03">See</E>
                             XBRL II Comment Letter (“[W]e are concerned about the multiple layers of requirements for the token API, for example, the expiration and 30-day login requirements, which will be challenging, particularly for sporadic filers.”).
                        </P>
                    </FTNT>
                    <P>While we understand the concerns raised by commenters, we do not think it is unduly burdensome for section 16 and other periodic filers who choose to make submissions through APIs to log into the dashboard and generate a new user API token once per month or otherwise prior to making an infrequent filing. Further, as is the case currently, the individual making the submission need not be the filer itself. Section 16 and other periodic filers could authorize through powers of attorney relevant individuals at their filing agents or other representatives as account administrators, eliminating the need for the section 16 or other periodic filer to obtain individual account credentials or otherwise interact with the dashboard. Alternatively, section 16 and other periodic filers could delegate authority to file to one of these entities (so long as that entity has an EDGAR account), thereby eliminating the need for the section 16 filer herself to log into the dashboard to generate user API tokens. In addition, as noted elsewhere in this release, generating a user API token is a straightforward process accomplished on the dashboard, and we estimate that a user API token could be generated within approximately one minute of logging into the dashboard. Moreover, the ability of a filer to authorize multiple account administrators and users, each with a user API token expiring at a different time, lessens concerns about the need to generate a new user API token for a particular user when a filing deadline is approaching.</P>
                    <P>
                        A commenter suggested that the SEC allow the use of “organizational user tokens” that would represent the filer as a whole, as opposed to identifying a specific individual.
                        <SU>165</SU>
                        <FTREF/>
                         Similarly, another commenter suggested that filers using third-party filing software should be able to submit filings by presenting a user API token belonging to an individual at the third-party filing software company, so that the individual who was making the filing would not need to obtain a user API token to identify herself.
                        <SU>166</SU>
                        <FTREF/>
                         We decline to implement these suggestions because they would frustrate the Commission's objective of identifying the individual making the filings and taking actions on EDGAR through APIs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>165</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (indicating that the SEC should allow an organizational user token that represents the organization as a whole and that could be managed the same way as an individual user API token).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>166</SU>
                             
                            <E T="03">See</E>
                             Comment Letter of Martin Francisco (November 21, 2023) (“Would it be deemed permissible to use a single user token belonging to the administrator of a third-party filing solution to submit filings created by independent users of that third-party filing solution? Such a deployment would make it easier for users of that third-party solution (no individual token management needed).”).
                        </P>
                    </FTNT>
                    <P>
                        Other commenters suggested that API tokens should have no expiration dates or alternately should be automatically 
                        <PRTPAGE P="106192"/>
                        renewed upon expiration.
                        <SU>167</SU>
                        <FTREF/>
                         Although we acknowledge commenters' concerns that limiting the duration of API tokens could be inconvenient, we balance those concerns against our goals of maintaining EDGAR security by requiring authenticating credentials to be updated periodically via multifactor authentication, and by requiring new tokens periodically to avoid unauthorized use of a persistent token. A one-year validity period for filer API tokens is consistent with current EDGAR security requirements, which require passwords to be changed once per year before they expire. In addition, a 30-day validity period for user API tokens will reduce the risk that a long-persistent token will be compromised.
                    </P>
                    <FTNT>
                        <P>
                            <SU>167</SU>
                             
                            <E T="03">See</E>
                             XBRL II Comment Letter (“We recommend never letting the token expire, or at a minimum setting a longer time for the token expiration period.”); Comment Letter of Jacob Halstead (January 17, 2024) (suggesting the SEC should “allow applications to . . . renew the token without user interaction.”).
                        </P>
                    </FTNT>
                    <P>
                        One commenter suggested that filers and filing agents may in practice share filer API tokens and user API tokens across multiple organizations with the result that submissions will not be as secure as anticipated and not necessarily be associated with the individual who generated the user API token.
                        <SU>168</SU>
                        <FTREF/>
                         To be clear, Rule 10 as amended requires that individuals access EDGAR by logging in with their own 
                        <E T="03">Login.gov</E>
                         individual account credentials and employ multifactor authentication. The EDGAR Filer Manual as amended will further require that user API tokens be associated with the individual logging into EDGAR. As discussed in this release, the Commission seeks to trace submissions to the individual who logs into EDGAR with individual account credentials and completes multifactor authentication. For APIs, presentation of the individual's user API token allows the Commission to identify who makes each submission or takes action on EDGAR, a primary goal of this rulemaking. We agree that the potential scenario described by the commenter compromises EDGAR security, and we reiterate that we expect filers to comply with the requirements of Rule 10 and the EDGAR Filer Manual as amended.
                    </P>
                    <FTNT>
                        <P>
                            <SU>168</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“We feel that the proposed filer and user tokens system may be less secure in practice than anticipated. Since many registrant and reporting owner filings are handled by multiple filing agents and due to additional administration and management requirements in the EDGAR Next proposal, these long-lived tokens will likely be shared amongst multiple organizations and may provide no actual assurance that a filing is being submitted by the user associated with the token.”).
                        </P>
                    </FTNT>
                    <P>EDGAR Next provides filers flexibility to manage the security tokens required for connection to optional APIs. Filers may generate an unlimited number of filer API tokens on the dashboard. Filers may use the filer API tokens and API connections of their delegated entities. With respect to user API tokens, filers have several options to authorize up to 500 individuals to make submissions. Filers may authorize up to 20 account administrators in total (including individuals not employed at the filer or its affiliates through notarized powers of attorney), and those account administrators may authorize up to 500 users, all of whom would be authorized to make submissions on behalf of the filer and would be able to generate user API tokens. Filers may delegate authority to filing agents or any other EDGAR account to file on their behalf, and those entities may each have up to 20 account administrators and 500 users. Any of these individuals would be able to generate a user API token and make submissions on behalf of the filer in compliance with EDGAR Next.</P>
                    <HD SOURCE="HD2">F. Final Amendments to Rules and Forms</HD>
                    <HD SOURCE="HD3">1. Rule 10 of Regulation S-T</HD>
                    <P>
                        The Commission proposed to amend Rule 10 of Regulation S-T to add new paragraph (d) and to make certain clarifying and conforming changes in paragraph (b) and in the note to Rule 10. We did not receive any comments concerning the proposed amendments to Rule 10. We received one comment peripheral to paragraph (b)(2) of Rule 10 requesting that the technical process of uploading PDFs to EDGAR be improved. As discussed in more detail below, that improvement to EDGAR will be made.
                        <SU>169</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>169</SU>
                             EDGAR will be enhanced to ensure that when a Form ID PDF is created from the dashboard, that PDF will not contain hyperlinks that may interfere with the upload of the document to EDGAR. To be clear, this technical change is unrelated to the amendments to Rule 10.
                        </P>
                    </FTNT>
                    <P>We are adopting, largely as proposed, amendments to Rule 10 of Regulation S-T to add paragraph (d). New paragraphs (d)(1) through (4) are discussed in full above. As discussed above, we are adopting paragraph (d)(3) of Rule 10 with a few slight modifications from the proposal: paragraph (d)(3) of Rule 10 will refer to filers that “connect to” APIs rather than filers that “use” APIs, and will not apply to a filer that has delegated authority to file on the dashboard to a delegated entity that is in compliance with the rule's requirements. In addition, as noted above, minor revisions to paragraph (d)(2) as proposed were made to the paragraph as adopted to clarify that each individual or single-member company electronic filer must authorize and maintain at least one individual as an account administrator to manage its EDGAR account.</P>
                    <P>
                        We are adopting amendments, as proposed, to add new paragraph (d)(5) of Rule 10 to require that the filer, through its authorized account administrators, maintain accurate and current information on EDGAR concerning the filer's account, including but not limited to accurate corporate information and contact information, such as mailing and business addresses, email addresses, and telephone numbers. This constitutes an ongoing obligation for the filer to update its information on EDGAR as necessary. New paragraph (d)(5) is analogous to the existing requirements set forth in the EDGAR Filer Manual, Volume I to maintain accurate company information on EDGAR, which we are amending accordingly to reference new paragraph (d)(5).
                        <SU>170</SU>
                        <FTREF/>
                         The requirement in paragraph (d)(5) of Rule 10 will provide greater assurance to Commission staff and the public about the accuracy of the filer's information contained in EDGAR.
                    </P>
                    <FTNT>
                        <P>
                            <SU>170</SU>
                             
                            <E T="03">Compare</E>
                             current EDGAR Filer Manual, Volume I, at section 5 (“Filers must maintain accurate company information on EDGAR, including but not limited to a filer's current name, business mailing address, and business email address.”) 
                            <E T="03">with</E>
                             amended EDGAR Filer Manual, Volume I, at section 4 (“As required by Rule 10(d)(5) of Regulation S-T, 17 CFR 232.10(d)(5), filers must maintain accurate and current company information on EDGAR concerning the filer's account, including but not limited to accurate contact information and corporate information, if relevant.”).
                        </P>
                    </FTNT>
                    <P>
                        We are also adopting amendments, as proposed, to add paragraph (d)(6) of Rule 10, which requires the filer, through its authorized account administrators, to securely maintain information relevant to the ability to access the filer's EDGAR account, including access through any EDGAR API. This requirement is designed to ensure that information relevant to the ability to access the filer's account, such as individual account credentials and API tokens, is securely maintained and not publicly exposed or otherwise compromised. New paragraph (d)(6) of Rule 10 is analogous to requirements set forth in the EDGAR Filer Manual, Volume I to securely maintain EDGAR access and to maintain accurate company information on EDGAR.
                        <SU>171</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>171</SU>
                             
                            <E T="03">Compare</E>
                             current EDGAR Filer Manual, Volume I, at section 4 (“Filers must securely maintain all EDGAR access codes and limit the number of persons who possess the codes. EDGAR access codes include the password, passphrase, CCC, and password modification authorization code 
                            <PRTPAGE/>
                            (PMAC).”) 
                            <E T="03">with</E>
                             amended EDGAR Filer Manual, Volume I, at section 3 (“Each applicant or filer may only authorize to act on its behalf on EDGAR those individuals who have obtained individual account credentials through 
                            <E T="03">Login.gov</E>
                            . . . . Individual account credentials are intended for the use of the individual who obtained them to allow identification of the individual taking action on EDGAR. Individual account credentials must not be shared with other individuals.”).
                        </P>
                    </FTNT>
                    <PRTPAGE P="106193"/>
                    <P>
                        The Commission is also adopting, substantially as proposed, amendments to Rule 10 to make certain clarifying and conforming changes. Paragraph (b) of Rule 10 is being revised to refer to “each electronic filer” required to submit Form ID before filing on EDGAR, instead of “each registrant, third party filer, or filing agent.” 
                        <SU>172</SU>
                        <FTREF/>
                         This change is not intended to alter the scope of who is subject to paragraph (b) of Rule 10, but instead clarifies that all new electronic filers are required to submit Form ID for review and approval by Commission staff before they may file on EDGAR.
                    </P>
                    <FTNT>
                        <P>
                            <SU>172</SU>
                             
                            <E T="03">Compare</E>
                             current paragraph (b) of Rule 10 of Regulation S-T (“Each registrant, third party filer, or filing agent must, before filing on EDGAR . . .” 
                            <E T="03">with</E>
                             amended paragraph (b) of Rule 10 of Regulation S-T (“Each electronic filer must, before filing on EDGAR . . .”).
                        </P>
                    </FTNT>
                    <P>
                        In addition, we are adopting as proposed an amendment to paragraph (b)(2) of Rule 10, which currently states that an authenticating document for Form ID must be signed by the applicant, to also state that the authenticating document may be signed by an authorized individual of the applicant.
                        <SU>173</SU>
                        <FTREF/>
                         This final amendment is intended to conform the language in paragraph (b)(2) of Rule 10 with the text of the EDGAR Filer Manual, which provides that the authenticating document shall be signed by an authorized individual, including a person with a relevant power of attorney.
                        <SU>174</SU>
                        <FTREF/>
                         We proposed to separately amend paragraph (b) of Rule 10 of Regulation S-T to require Form ID to be completed by an individual authorized by the electronic filer as its account administrator. In a modification from the proposal, however, as discussed in section II.B.1.a, it will not be necessary for Form ID to be completed or submitted by one of the applicant's prospective account administrators. Thus, that proposed amendment to paragraph (b) of Rule 10 is not being adopted.
                    </P>
                    <FTNT>
                        <P>
                            <SU>173</SU>
                             
                            <E T="03">Compare</E>
                             current paragraph (b)(2) of Rule 10 of Regulation S-T (“File . . . a notarized document, signed by the applicant . . .” 
                            <E T="03">with</E>
                             amended paragraph (b)(2) of Rule 10 of Regulation S-T (“File . . . a notarized document, signed by the electronic filer or its authorized individual . . .”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>174</SU>
                             
                            <E T="03">See</E>
                             EDGAR Filer Manual, Volume I, at section 3(b).
                        </P>
                    </FTNT>
                    <P>
                        As noted above, we received one comment requesting additional details concerning the PDF requirements for Form ID authenticating documents required to be uploaded to EDGAR pursuant to proposed paragraph (b)(2) of Rule 10.
                        <SU>175</SU>
                        <FTREF/>
                         The commenter stated that Form ID authenticating documents could not be successfully uploaded to EDGAR because those PDFs contained hyperlinks which prevented the documents from being accepted by EDGAR. PDF documents required to be uploaded pursuant to paragraph (b)(2) of Rule 10 are subject to the same EDGAR validation requirements that apply to all PDF documents uploaded to EDGAR, including prohibitions on active content (
                        <E T="03">e.g.,</E>
                         embedded JavaScript) and external references (hyperlinks, etc.).
                        <SU>176</SU>
                        <FTREF/>
                         Any URLs contained in PDFs must be in plain text. To facilitate the process of uploading PDFs to EDGAR pursuant to paragraph (b)(2) of Rule 10, EDGAR will be enhanced to ensure that when a Form ID authenticating document PDF is created from the dashboard, that PDF will not contain hyperlinks.
                    </P>
                    <FTNT>
                        <P>
                            <SU>175</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“Additional detail around the requirements for PDF documents under 232.10(b)(2) would be helpful (
                            <E T="03">e.g.,</E>
                             what PDF formats acceptable [sic], is the PDF required to be searchable, are hyperlinks allowed, etc.) Currently, the Form ID application contains many URLs, which when printed to PDF, electronically signed and uploaded do not pass validation. It would be helpful to hide these URLs from the printed version of the Form ID authentication document.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>176</SU>
                             
                            <E T="03">See</E>
                             EDGAR Filer Manual, Volume II, at section 5.2.3.2 (discussing EDGAR validation requirements for PDFs).
                        </P>
                    </FTNT>
                    <P>
                        Finally, we are adopting revisions to the note to Rule 10 largely as proposed to state that the Commission staff carefully review each Form ID application and that filers should expect that the Commission staff will require sufficient time to approve and review the Form ID. For clarity, the final amendments express this as an affirmative statement (“filers should expect that the Commission staff will require sufficient time to review the Form ID”) as opposed to how this concept was proposed (“filers should not assume that the Commission staff will automatically approve the Form ID”). Therefore, the final amendments provide that filers should submit Form ID “well in advance” of their first required filing.
                        <SU>177</SU>
                        <FTREF/>
                         We believe this revised language makes clear that Commission staff need an appropriate amount of time to review the Form ID. Due to the frequently high volume of Form ID applications submitted for Commission staff review, potential applicants should allow sufficient time for the review process to be conducted in the event that staff is concurrently reviewing a high volume of applications.
                    </P>
                    <FTNT>
                        <P>
                            <SU>177</SU>
                             As adopted, the note to Rule 10 states: “The Commission staff carefully review each Form ID application, and electronic filers should expect that the Commission staff will require sufficient time to review the Form ID upon its submission. Therefore, any applicant seeking EDGAR access is encouraged to submit the Form ID for review well in advance of the first required filing to allow sufficient time for staff to review the application.” Current staff guidelines regarding the minimum time needed for Commission staff to review Form ID can be found in the “Prepare and Submit my Form ID Application” section of the “EDGAR — How Do I” FAQs, at 
                            <E T="03">https://www.sec.gov/submit-filings/filer-support-resources/how-do-i-guides/prepare-submit-my-form-id-application.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Rule 11 of Regulation S-T</HD>
                    <P>As proposed, we are adopting amendments to Rule 11 of Regulation S-T, “Definitions of terms used in this part,” to add and define new terms and update the definitions of certain existing terms. The amendments include terms and definitions specific to the rule and form amendments that delineate how individuals and entities access, file on, and manage EDGAR accounts.</P>
                    <P>Under the final amendments, certain terms define the new roles for individuals under EDGAR Next. Those roles are as follows:</P>
                    <P>“Account administrator” means the individual that the filer authorizes to manage its EDGAR account and to make filings on EDGAR on the filer's behalf. The designation of an account administrator helps to ensure that only authorized persons are able to file and take other actions on behalf of the filer.</P>
                    <P>“Authorized individual” means an individual with the authority to legally bind an entity or individual for purposes of Form ID, or an individual with a power of attorney from an individual with the authority to legally bind an entity or individual for purposes of Form ID. The adopted definition specifies that the power of attorney document must clearly state that the individual receiving the power of attorney has general legal authority to bind the entity or individual or specific legal authority to bind the entity or individual for purposes of Form ID.</P>
                    <P>“Delegated entity” means a filer that another filer authorizes on the dashboard to file on its behalf. As itself a filer, a delegated entity is subject to all applicable rules for filing on EDGAR. Delegated entities are not permitted to further delegate authority to file for the delegating filer, nor are they permitted to take action on the delegating filer's dashboard.</P>
                    <P>
                        “Filing agent” means any person or entity engaged in the business of making submissions on EDGAR on behalf of filers. As discussed above in section II.C., to act as a delegated entity for a 
                        <PRTPAGE P="106194"/>
                        filer, a filing agent must be a filer with an EDGAR account.
                    </P>
                    <P>“Single-member company” describes a company that only has a single individual who acts as the sole equity holder, director, and officer (or, in the case of an entity without directors and officers, holds position(s) performing similar activities as a director and officer).</P>
                    <P>“Technical administrator” means an individual that the filer authorizes on the dashboard to manage the technical aspects of the filer's connection to EDGAR APIs on the filer's behalf.</P>
                    <P>“User” means an individual that the filer authorizes on the dashboard to make submissions on EDGAR on the filer's behalf.</P>
                    <P>Other terms identify new applications and upgrades to access and maintain filers' accounts on EDGAR, including the following:</P>
                    <P>“Application Programming Interface” (API) means a software interface that allows computers or applications to communicate with each other.</P>
                    <P>“Dashboard” means an interactive function on EDGAR where filers manage their EDGAR accounts and where individuals that filers authorize may take relevant actions for filers' accounts.</P>
                    <P>
                        “Individual account credentials” means credentials issued to individuals for purposes of EDGAR access, as specified in the EDGAR Filer Manual, and used by those individuals to access EDGAR. The EDGAR Filer Manual as amended specifies that individual account credentials must be obtained through 
                        <E T="03">Login.gov,</E>
                         a sign-in service of the United States Government that employs multifactor authentication.
                    </P>
                    <P>The final amendments also update or delete outdated terminology from certain definitions in Rule 11, such as references to “telephone sessions” in the definition of “direct transmission.” Although some filers may still use dial-up internet to access EDGAR, we expect that nearly all filers currently rely on broadband, cable, or other internet technologies.</P>
                    <P>Finally, we are adopting amendments to update the definition of “EDGAR Filer Manual” to more clearly describe its contents. Rule 11 currently describes the “EDGAR Filer Manual” as “. . . setting out the technical format requirements for an electronic submission.” The EDGAR Filer Manual has been updated over time, however, to include additional requirements for filers, including those pertaining to EDGAR access, maintaining EDGAR company information, and submitting online filings. Accordingly, we are updating the EDGAR Filer Manual definition to indicate the inclusion of these procedural requirements. We believe that the final amendments to the definition will better inform filers of the scope of the EDGAR Filer Manual requirements.</P>
                    <P>
                        We received three comments on the proposed definitions in the Proposing Release. Two commenters agreed that the proposed amendments to the definitions in Rule 11 were appropriate.
                        <SU>178</SU>
                        <FTREF/>
                         One of the commenters also requested that the terms “Filer API Token” and “User API Token” be defined.
                        <SU>179</SU>
                        <FTREF/>
                         We do not think it is necessary to amend Regulation S-T to provide definitions of “Filer API Token” and “User API Token” because those terms are not referenced in Regulation S-T. Further, we are making one change to the definition of Technical Administrator to accord with the change from the word “use” in proposed paragraph (d)(3) of Rule 10 to the word “connect” in adopted paragraph (d)(3) of Rule 10. The word “connect” will similarly be substituted for the word “use” in the definition of technical administrator for the reasons given above.
                    </P>
                    <FTNT>
                        <P>
                            <SU>178</SU>
                             
                            <E T="03">See</E>
                             DFIN Comment Letter; Toppan Merrill Comment Letter.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>179</SU>
                             
                            <E T="03">See</E>
                             DFIN Comment Letter (“ `Filer API Token' and `User API Token' should be defined.”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Form ID</HD>
                    <P>
                        Form ID is an online fillable form that must be completed and submitted to the Commission by individuals, companies, and other organizations that seek access to file electronically on EDGAR.
                        <SU>180</SU>
                        <FTREF/>
                         Among other things, Form ID seeks information about the identity and contact information of the applicant. The applicant is required to print 
                        <SU>181</SU>
                        <FTREF/>
                         the completed online Form ID application, obtain the notarized signature of the applicant's authorized individual 
                        <SU>182</SU>
                        <FTREF/>
                         on the printed document, and upload the signed notarized document (the Form ID authentication document) to EDGAR to confirm the authenticity of the application. In certain cases, applicants may also be required to upload additional documentation to assist Commission staff in determining the nature and legitimacy of the application.
                        <SU>183</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>180</SU>
                             
                            <E T="03">Compare</E>
                             current Rule 10(b) (providing that each registrant, third party filer, or agent seeking EDGAR access must submit Form ID) 
                            <E T="03">with</E>
                             Rule 10(b) as adopted (providing that each electronic filer seeking EDGAR access must submit Form ID).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>181</SU>
                             The applicant may print the form to PDF and need not print a physical hard copy of the form.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>182</SU>
                             The term “authorized individual” is defined in the EDGAR Filer Manual, Volume I as well as Rule 11, as amended.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>183</SU>
                             For example, if an applicant represents that it has acquired or otherwise assumed control of the filer listed on the existing EDGAR account, then the applicant must also supply documents to Commission staff to establish the legal transition from the filer on record in EDGAR to the applicant claiming authority to file on the existing EDGAR account.
                        </P>
                    </FTNT>
                    <P>We are adopting amendments to Form ID largely as proposed to include changes to information required to be reported on the form as well as technical changes. As a departure from what we contemplated in the Proposing Release, however, and as discussed above, it will not be necessary for Form ID to be completed or submitted by one of the applicant's prospective account administrators.</P>
                    <P>As outlined above, the final amendments to Form ID will require an applicant for EDGAR access to provide certain additional information, including:</P>
                    <P>
                        (1) Designating on Form ID specific individuals the applicant authorizes to act as its account administrators to manage its EDGAR account on a dedicated dashboard on EDGAR. Applicants will generally be required to authorize at least two account administrators, although individuals and single-member companies will only be required to authorize at least one account administrator. If a prospective account administrator is not (1) the applicant (in the case of an individual applicant) or (2) an employee of the applicant or its affiliate (in the case of a company applicant), the applicant will also be required to disclose the prospective account administrator's employer and CIK, if any, and provide a notarized power of attorney to authorize the individual to manage the applicant's EDGAR account as an account administrator. As discussed above, as a departure from the proposal, amended Form ID will also include information to alert applicants that EDGAR will by default designate the first account administrator listed on Form ID as the filer's EDGAR POC.
                        <SU>184</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>184</SU>
                             
                            <E T="03">See supra</E>
                             text accompanying and following note 70.
                        </P>
                    </FTNT>
                    <P>
                        (2) The applicant's Legal Entity Identifier 
                        <SU>185</SU>
                        <FTREF/>
                         (“LEI”) number, if any. 
                        <PRTPAGE P="106195"/>
                        Applicants that have not yet obtained an LEI will not be required to do so to submit Form ID. For those applicants that have obtained an LEI, inclusion of this information will facilitate the ability of Commission staff to link the identity of the applicant with information reported on other filings or sources that are currently or will be reported elsewhere in the future, if LEIs become more widely used by regulators and the financial industry.
                    </P>
                    <FTNT>
                        <P>
                            <SU>185</SU>
                             The LEI is a global, 20-character, alphanumeric, identifier standard that uniquely and unambiguously identifies a legal entity. Initially developed by the International Organization for Standardization as ISO 17442, the LEI is nonproprietary and the LEI data is made publicly available under an open license. The LEI is used worldwide in the private and public sectors and, in certain jurisdictions, including the United States, is used for regulatory reporting. In some cases, the LEI can be used to identify the filer of a particular report, as well as entities related to the filer, such as its subsidiaries or parents. The Commission and eight other Federal agencies recently proposed establishing joint data standards, which would include LEI, under the Financial Data Transparency Act of 2022. 
                            <E T="03">See Financial Data Transparency Act Joint Data Standards,</E>
                             Release No. 33-11295 (August 2, 2024) [89 FR 67890 (August 22, 2024)].
                        </P>
                    </FTNT>
                    <P>(3) Providing more specific contact information about the filer, and the filer's account administrator(s), authorized individual (the individual authorized to sign Form ID on the filer's behalf, as defined in the EDGAR Filer Manual), and billing contact (including mailing, business, and billing information, as applicable). More specific contact information will allow Commission staff to reach account administrators, the authorized individual, and billing contacts associated with the filer when necessary.</P>
                    <P>To streamline the form, some of the specific contact information that was proposed to be collected on Form ID will not be included. For example, Form ID will not require secondary phone numbers or email addresses in addition to the filer's mailing and business addresses. We believe that the additional contact information we will collect on amended Form ID will be sufficient to meet Commission staff's needs. Similarly, although we proposed amendments to the filer's mailing address that would allow filers to input “care of” information so that a company applicant could list a filing agent, for example, we are not amending Form ID to implement that change. We believe that including a separate address line for “care of” information could encourage applicants to list the names of specific individuals who might not want to be publicly listed in EDGAR as part of the filer's mailing address. The Form ID fields related to the filer's mailing address will continue to have multiple street address lines, as proposed, which we believe will provide sufficient opportunity for applicants that wish to include such information to do so.</P>
                    <P>(4) Specifying whether the applicant, its authorized individual, person signing a power of attorney (if applicable), account administrator, or billing contact has been criminally convicted as a result of a Federal or State securities law violation, or civilly or administratively enjoined, barred, suspended, or banned in any capacity, as a result of a Federal or State securities law violation. Information about whether the applicant or certain individuals named on Form ID may be subject to relevant bars and prohibitions (including but not limited to officer and director bars, prohibitions from associating with brokers, dealers, investment advisers, and/or other securities entities, and bars from participation in certain industries) will allow Commission staff to determine whether such bars or prohibitions are relevant to the application for EDGAR access. Individuals disclosing the existence of a criminal conviction, or civil or administrative injunction, bar, suspension, or ban may be contacted by Commission staff to determine the applicant's eligibility for EDGAR access.</P>
                    <P>(5) Indicating whether the applicant, if a company, is in good standing with its State or country of incorporation. Good standing is a term widely used by State divisions of corporations and/or secretaries of State to refer generally to whether a company is legally authorized to do business in the relevant State (or country).</P>
                    <P>
                        One commenter inquired what action the SEC will take if the Form ID applicant indicates that it is not in good standing with its State or country of incorporation.
                        <SU>186</SU>
                        <FTREF/>
                         Although the lack of good standing will not prevent a company from obtaining EDGAR access, this information could be relevant in determining whether it may be appropriate for the staff to review additional documentation as part of its assessment of the application.
                    </P>
                    <FTNT>
                        <P>
                            <SU>186</SU>
                             
                            <E T="03">See</E>
                             DFIN Comment Letter (“The `Violations of federal or state securities laws' section in the proposal has a Yes or No question. When yes is selected a message [says] `If you indicate `Yes', the SEC staff may contact you to determine your eligibility for EDGAR access.' However, the `Is the company in good standing in its state or country of incorporation?' section does not provide any additional information when `No' is selected. If `No' is selected what actions are taken by the SEC?”)
                        </P>
                    </FTNT>
                    <P>(6) Requiring submission of a new Form ID for an existing filer that indicates that it has: (i) lost electronic access to its existing CIK account or (ii) is the legal successor of the filer named on the existing CIK account but did not receive access from that filer. As a technical change from the proposal, amended Form ID will refer to applicants that are “the legal successor of the filer named on the existing CIK account but did not receive access from that filer” as opposed to applicants that “assumed legal control of the filer listed on the existing CIK account but did not receive EDGAR access,” as proposed.</P>
                    <P>
                        Currently, applicants seeking to obtain control of an existing EDGAR account are required to submit certain summary information but are not required to submit a full application on Form ID. To assist Commission staff in determining whether applicants seeking to obtain control of existing EDGAR accounts are legitimate, we will require such applicants to submit a new Form ID. To facilitate the application process, certain publicly available corporate and contact information (such as the filer's name, “doing business as” name, foreign name, mailing and business addresses, State/country of incorporation, and fiscal year end) will be automatically prepopulated from EDGAR so that applicants will not need to resubmit that information, although applicants could update that information on Form ID as necessary.
                        <SU>187</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>187</SU>
                             The filer will nevertheless need to submit a COUPDAT to update its existing corporate and contact information on EDGAR (other than the filer's account administrator information) if the Form ID is granted. As they presently do, broker-dealers will submit a Form BD amendment to FINRA to update their corporate and contact information.
                        </P>
                    </FTNT>
                    <P>
                        (7) Requiring those seeking access to an existing EDGAR account to upload to EDGAR the documents that establish the applicant's authority over the company or individual listed in EDGAR on the existing account.
                        <SU>188</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>188</SU>
                             The EDGAR Filer Manual currently provides guidance regarding what documents are sufficient to establish the applicant's authority. 
                            <E T="03">See</E>
                             EDGAR Filer Manual, Volume I.
                        </P>
                    </FTNT>
                    <P>
                        In addition, we will make certain conforming, formatting, and ancillary changes to modernize Form ID without significantly altering the information required to be reported on the form. For example, a checkbox will be added to each address field for identification of non-U.S. locations, which will improve data analytics. As another example, company applicants will be required to provide their primary website address, if any, to provide staff additional contact and other information regarding the filer. Further, certain warnings that are currently listed in the EDGAR Filer Manual and the landing page of the EDGAR Filing website will be incorporated into Form ID to more clearly provide notice of those matters to filers.
                        <SU>189</SU>
                        <FTREF/>
                         Additionally, as a technical change to what was proposed, language in amended Form ID and the amended Instructions to Form ID that advises 
                        <PRTPAGE P="106196"/>
                        applicants not to provide unsolicited personally identifiable information will be updated to refer to attachments as well, and to provide examples including birth certificates, driver's licenses, and passports. Similarly, as a technical change from the proposal, amended Form ID and the amended Instructions to Form ID will remind applicants not to name specific individuals or include personally identifiable information in the filer's mailing address or contact information unless the applicant would like that information to become publicly available. In addition, as a technical change from the proposal, the amended Instructions to Form ID will be revised to avoid implying that companies must become incorporated to apply for EDGAR access (since, for example, EDGAR filers could include unincorporated trusts).
                        <SU>190</SU>
                        <FTREF/>
                         Further, as a technical change from the proposal, instructions for existing applicants that are broker-dealers or “paper filers” seeking to electronically file on EDGAR will be clarified to indicate that this option is intended to capture applicants that are seeking electronic access for the first time. In addition, as a technical change from the proposal, certain language in Form ID that provided examples related to authorized individuals and individuals with individual account credentials will be revised to more generally express those concepts.
                        <SU>191</SU>
                        <FTREF/>
                         Finally, as a technical change from the proposal, language in Form ID that instructs filers to upload a Form ID authenticating document along with their Form ID submission will be revised to clarify that the upload should be in PDF format.
                    </P>
                    <FTNT>
                        <P>
                            <SU>189</SU>
                             Amended Form ID will include a section titled “Important information” that will include the following warning: “Misstatements or omissions of fact in connection with an application for EDGAR access and/or in a submission on EDGAR may constitute a criminal violation under 18 U.S.C. 1001 and 1030 and/or a violation of other criminal and civil laws. If the SEC has reason to believe that an application for EDGAR access and/or a submission on EDGAR is misleading, manipulative, and/or unauthorized, the SEC may prevent acceptance or dissemination of the application/submission and/or prevent future submissions or otherwise remove a filer's access to EDGAR pursuant to Rule 15 of Regulation S-T, 17 CFR 232.15.”
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>190</SU>
                             The proposed Instructions to Form ID stated that filers should select “none” for State of incorporation and “N/A” for fiscal year end if they had “not yet incorporated.” In contrast, the amended Instructions to Form ID provide that filers should select “none” for State of incorporation and “N/A” for fiscal year end if they had “not incorporated.”
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>191</SU>
                             For example, language in Part 6 of the Instructions will be revised to replace “Authorized Person” with “Authorized Individual,” and to conform with the usage of the term “authorized individual” elsewhere in the form.
                        </P>
                    </FTNT>
                    <P>
                        Two commenters suggested that we amend Form ID to permit applicants to indicate that they have an urgent upcoming filing deadline. One specifically requested that a checkbox be included in Form ID to indicate a rush service, and that we provide guidance for which filing scenarios could prompt a rush process.
                        <SU>192</SU>
                        <FTREF/>
                         The other recommended that filers be able to input the date they anticipate needing EDGAR codes in order to submit a filing, thereby allowing the SEC to prioritize applications more effectively.
                        <SU>193</SU>
                        <FTREF/>
                         While we acknowledge the commenters' requests, we believe that allowing filers with pending filing deadlines to “skip the queue” for Form ID processing would encourage filers to delay preparing for their filing and increase Form ID processing times for other filers that timely submit their EDGAR access applications. As noted above, we are revising the note to Rule 10 to clarify that the Commission staff carefully review each Form ID application and that filers should expect that the Commission staff will require sufficient time to review the Form ID upon its submission. Therefore, filers should submit EDGAR access applications on Form ID “well in advance” of their first required filing.
                    </P>
                    <FTNT>
                        <P>
                            <SU>192</SU>
                             
                            <E T="03">See</E>
                             DFIN Comment Letter (“A checkbox included in the Form ID to indicate a rush service and provide guidance for what filing scenarios could prompt a rush process may be beneficial.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>193</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“It may be helpful for filers who have an urgent need to complete a filing to input the date they anticipate needing EDGAR codes to file. This may allow the SEC to prioritize the applications more effectively.”).
                        </P>
                    </FTNT>
                    <P>
                        Another commenter suggested there should be a mechanism for an individual to modify her email information without imposing the undue burden of submitting a new Form ID.
                        <SU>194</SU>
                        <FTREF/>
                         Filers will be able to continue to update their EDGAR POC information, including email address on file, as they currently do, by submitting a COUPDAT, until the compliance date or the filer enrolls in EDGAR Next, whichever comes first. Beginning March 24, 2025, filers that enroll must make all updates to their EDGAR POC on the dashboard by updating the EDGAR POC account administrator information or changing the account administrator designated as the EDGAR POC. Filers that have not enrolled will be able to submit a COUPDAT to update EDGAR POC information until September 12, 2025. Beginning September 15, 2025, all filers must make updates to their EDGAR POC information on the dashboard.
                    </P>
                    <FTNT>
                        <P>
                            <SU>194</SU>
                             
                            <E T="03">See</E>
                             Block Transfer Comment Letter (“There ought to exist more reasonable documentation as to how an individual without access to EDGAR Next or their old EDGAR Next dashboard email might modify their email without imposing the undue burden of submitting a new Form ID (for example, because of a change of domain name).”).
                        </P>
                    </FTNT>
                    <P>
                        A commenter asked that the Form ID application process be streamlined, asserting that the process of printing and uploading documents was not intuitive, based on its experience in the beta environment that was provided during the comment period to allow commenters to test the EDGAR Next functionality discussed in the Proposing Release (“Proposing Beta”).
                        <SU>195</SU>
                        <FTREF/>
                         The Proposing Beta required applicants to complete Form ID online, including attaching any additional documentation required by Part 5 of proposed Form ID, inputting their name and title in the signature page in Part 6 of proposed Form ID, and then returning to Part 5 of proposed Form ID to print the completed electronic form (or save it as a PDF). The printed form (or PDF) would then be manually (or electronically) signed by the applicant and notarized to serve as the proposed Form ID authenticating document. This authenticating document would then be uploaded and submitted in Part 5 of proposed Form ID. We will continue to require the Form ID authenticating document, which we believe is a helpful means to verify the identity of the applicant. However, to address the commenter's concern, we will change the order of Parts 5 and 6 in Form ID, so that applicants will be able to complete Parts 1-5 of the form and then will only need to attach, print (or save as a PDF), and upload documents in Part 6 (as opposed to going back and forth between Parts 5 and 6 as in the Proposing Beta).
                    </P>
                    <FTNT>
                        <P>
                            <SU>195</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“The Form ID process should be streamlined, technically. Currently the EDGAR Next Beta system requires the user to upload power of attorney documents and then print the application. After which, users must exit the application before uploading the signed authentication document. We recommend streamlining the process so that all the steps are intuitive and built into the process.”).
                        </P>
                    </FTNT>
                    <P>
                        The commenter also asked that hyperlinks included in Form ID be suppressed when the Form ID authenticating document is created, on the grounds that those hyperlinks cause Form ID authenticating documents that were saved as PDFs to fail EDGAR validation when those PDFs are uploaded to EDGAR.
                        <SU>196</SU>
                        <FTREF/>
                         As discussed above, we will implement this suggestion.
                    </P>
                    <FTNT>
                        <P>
                            <SU>196</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“Remove hyperlinks when creating the PDF. When the PDF is printed and electronically signed, the hyperlinks cause the filing to fail validation upload.”).
                        </P>
                    </FTNT>
                    <P>
                        Collectively, the final amendments to Form ID will enhance the security of EDGAR by allowing Commission staff to obtain more information about the applicant and its contacts. This, in turn, will help staff to confirm the identity of the applicant and the individuals associated with the applicant, assess whether the application is properly authorized, and determine whether there are any other issues relevant to the application for EDGAR access for staff's consideration.
                        <PRTPAGE P="106197"/>
                    </P>
                    <HD SOURCE="HD2">G. EDGAR Filer Manual Changes</HD>
                    <P>
                        As discussed throughout this release, the Commission is amending Volume I of the EDGAR Filer Manual in accord with the rule and form amendments. The Filer Manual contains information needed for filers to make submissions on EDGAR. Filers must comply with the applicable provisions of the Filer Manual in order to assure the timely acceptance and processing of filings made in electronic format.
                        <SU>197</SU>
                        <FTREF/>
                         Filers must consult the Filer Manual in conjunction with our rules governing mandated electronic filings when preparing documents for electronic submission.
                    </P>
                    <FTNT>
                        <P>
                            <SU>197</SU>
                             
                            <E T="03">See</E>
                             Rule 301 of Regulation S-T.
                        </P>
                    </FTNT>
                    <P>Amendments to Volume I of the EDGAR Filer Manual are being made to reflect the EDGAR Next changes, including the following in particular:</P>
                    <P>
                        (1) The requirement that each applicant or filer may only authorize to act on its behalf on EDGAR those individuals who have obtained individual account credentials, and instructions regarding how those individuals must obtain those individual account credentials through 
                        <E T="03">Login.gov;</E>
                         
                        <SU>198</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>198</SU>
                             
                            <E T="03">See generally</E>
                             section II.A.
                        </P>
                    </FTNT>
                    <P>
                        (2) The requirement to submit a new Form ID for an existing filer seeking EDGAR access if the filer indicates it has: (i) lost electronic access to its existing CIK account because, for example, the filer failed timely to perform annual confirmation or (ii) is the legal successor of the filer named on the existing CIK account but did not receive access from that filer; 
                        <SU>199</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>199</SU>
                             
                            <E T="03">Id.</E>
                            187.
                        </P>
                    </FTNT>
                    <P>
                        (3) The requirement for applicants seeking access to an existing EDGAR account to upload to EDGAR the documents that establish the applicant's authority over the company or individual listed in EDGAR on the existing account; 
                        <SU>200</SU>
                        <FTREF/>
                         and
                    </P>
                    <FTNT>
                        <P>
                            <SU>200</SU>
                             
                            <E T="03">Id.</E>
                            188.
                        </P>
                    </FTNT>
                    <P>
                        (4) Instructions regarding filer API tokens and user API tokens, including information on when these tokens will be required and how they will be used.
                        <SU>201</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>201</SU>
                             
                            <E T="03">See generally</E>
                             section II.E.2.
                        </P>
                    </FTNT>
                    <P>
                        Along with the adoption of the amendments to Volume I of the Filer Manual, we are amending Rule 301 of Regulation S-T to provide for the incorporation by reference into the Code of Federal Regulations of the current revisions. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The updated EDGAR Filer Manual, issued September 27, 2024, is available at 
                        <E T="03">https://www.sec.gov/edgar/filerinformation/current-edgar-filer-manual.</E>
                    </P>
                    <P>In addition, prior to the compliance date for all other rule and form amendments on September 15, 2025, the Commission expects to adopt additional changes to Volume II of the EDGAR Filer Manual in accord with the rule and form amendments. These changes will be addressed in a separate release.</P>
                    <HD SOURCE="HD2">H. Transition Process</HD>
                    <P>Compliance with EDGAR Next will be required 12 months from the issuance of this release. An initial six-month preparation period for the EDGAR Next changes will begin September 30, 2024 and extend until March 21, 2025, as requested by several commenters. On March 24, 2025, the EDGAR Filer Management dashboard will go live and compliance with the amended Form ID, which must be submitted through the dashboard, will be required. In addition, beginning March 24, 2025, filers may begin to enroll on the dashboard and connect to optional EDGAR APIs if they wish to do so, while still being able to file pursuant to the legacy filing process. Legacy filing on the EDGAR filing websites will continue until September 12, 2025. Compliance with all rule and form changes is required on September 15, 2025. Filers may continue to enroll after the compliance period for another three months, until December 19, 2025. Beginning December 22, 2025, filers that have not enrolled in EDGAR Next or received access through submission of amended Form ID will be required to submit amended Form ID to request access to their existing accounts.</P>
                    <P>The transition period is consistent with certain commenters' recommendations, which suggested that filers would need preparation time of approximately six months and enrollment time of approximately six months, as detailed in further detail below. We are offering preparation time of six months, enrollment prior to compliance of six months, and enrollment after compliance of three months. We address commenters' feedback on the transition period in the compliance section below.</P>
                    <P>
                        An Adopting Beta will be available shortly after the issuance of this release and will remain open throughout the transition period until at least December 19, 2025. We believe this Adopting Beta will help filers to test the EDGAR Next functionality and will also bring awareness to the public regarding the forthcoming changes. Commenters were broadly in favor of additional beta testing and for additional public outreach regarding the EDGAR Next changes, as discussed below.
                        <SU>202</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>202</SU>
                             
                            <E T="03">See, e.g.,</E>
                             SCG Comment Letter (urging the Commission to consider a third round of beta testing for the EDGAR Next platform, and to conduct additional outreach during the enrollment period to educate market participants). 
                            <E T="03">Cf.</E>
                             DFIN II Comment Letter (supporting a third beta testing session before the Commission finalizes the rulemaking so that testing allows for end-to-end processing through filing.); ICI Comment Letter (same).
                        </P>
                    </FTNT>
                    <P>The following graphic illustrates the transition period to EDGAR Next:</P>
                    <GPH SPAN="3" DEEP="481">
                        <PRTPAGE P="106198"/>
                        <GID>ER27DE24.015</GID>
                    </GPH>
                    <P>
                        From Monday, September 30, 2024 to Friday, March 21, 2025, filers will be afforded a preparation period of approximately six months during which they may test in the Adopting Beta and conduct related development, including but not limited to connection to beta versions of all APIs to be offered as part of EDGAR Next. In addition, individuals that filers intend to authorize to act on their behalf may obtain 
                        <E T="03">Login.gov</E>
                         individual account credentials. Further, filers may assemble information they will need to enroll in EDGAR Next, including but not limited to ensuring that they possess their current passphrase and determining whom they will authorize as account administrators.
                    </P>
                    <P>On Monday, March 24, 2025, the new EDGAR Filer Management website including the dashboard will go live, enrollment of existing filers will commence, and applicants for EDGAR access will be required to comply with the amended Form ID. Existing filers will enroll on the dashboard. Prospective new filers and other filers that are unable to enroll must complete and submit amended Form ID on the dashboard. Individuals will need Login.gov individual account credentials to log into the dashboard.</P>
                    <P>
                        A person authorized by the filer will log into the dashboard to enroll the filer. On the dashboard, the person authorized by the filer will enter the filer's CIK, CCC, and passphrase, as well as the names of and relevant information about the individuals the filer is authorizing as its account administrators. If the information is accurate, enrollment could be effective the same day submitted. Enrolled filers will be able to make submissions through the optional APIs if they otherwise satisfy the requirements to connect to the APIs, while still being able to file pursuant to the legacy filing process. Submissions on the legacy EDGAR filing websites (EDGAR Online Forms and EDGAR Filing) will continue to be made using the legacy EDGAR 
                        <PRTPAGE P="106199"/>
                        access codes until September 12, 2025, according to the same process currently in place. The period during which the legacy filing process is available after enrollment begins is being set at six months to minimize the period during which confusion may arise due to simultaneous EDGAR operations in both the EDGAR Next and the legacy EDGAR frameworks.
                    </P>
                    <P>
                        In addition, on March 24, 2025, compliance will be required with amended Form ID. On that date, prospective new filers and existing EDGAR filers that are unable to enroll must apply for EDGAR access on the amended Form ID. They will do so by logging into the dashboard on the new EDGAR Filer Management website with 
                        <E T="03">Login.gov</E>
                         individual account credentials, navigating to Apply for Access, and completing the requirements of the form. Those required to apply for EDGAR access on amended Form ID include both prospective filers seeking access to EDGAR for the first time and existing filers that must apply for access to EDGAR because they: (i) lost electronic access to their existing EDGAR account; (ii) are a legal successor of the filer named on the existing EDGAR account but did not receive access from that filer; or (iii) are a broker-dealer or “paper filer” seeking electronic access for the first time in order to file electronically on an existing EDGAR account in their name. If Commission staff grant the amended Form ID application, the filer will be in compliance with the EDGAR Next changes, and thus will not be required to subsequently enroll on the dashboard.
                    </P>
                    <P>
                        The EDGAR filing websites will continue to employ the current submission process for all filers until Friday, September 12, 2025. On Monday, September 15, 2025, the compliance date, all EDGAR websites will require filers' compliance with the EDGAR Next rule and form changes in order to make submissions, including but not limited to 
                        <E T="03">Login.gov</E>
                         individual account credentials and authorization through the dashboard.
                    </P>
                    <P>
                        On September 15, 2025, the compliance date, EDGAR will require individual account credentials on the EDGAR filing websites (as well as the EDGAR Filer Management website). At that time, individuals who seek to make submissions and take other actions for filers on EDGAR will be required to enter 
                        <E T="03">Login.gov</E>
                         individual account credentials and be authorized to access EDGAR through enrollment, on amended Form ID, or on the dashboard.
                    </P>
                    <P>
                        After the compliance date, until December 19, 2025, filers who have not yet enrolled will not be able to make submissions or take other actions in EDGAR other than enroll on the EDGAR Filer Management dashboard. The enrollment process will remain the same as prior to the compliance date—requiring the filer to provide their CIK, CCC, passphrase, and names and information about authorized account administrators. If filers do not possess their CCC or passphrase, methods will be available for them to reset those codes in order to enroll.
                        <SU>203</SU>
                        <FTREF/>
                         After December 19, 2025, filers who have not enrolled in EDGAR Next will be required to submit the amended Form ID on the dashboard to apply for access to their existing EDGAR accounts.
                    </P>
                    <FTNT>
                        <P>
                            <SU>203</SU>
                             
                            <E T="03">See supra</E>
                             note 208.
                        </P>
                    </FTNT>
                    <P>The detailed transition timeline is as follows:</P>
                    <FP>September 30, 2024—Prepare for EDGAR Next changes</FP>
                    <P>○ Adopting Beta will open.</P>
                    <P>○ Adopting Beta will reflect the new EDGAR Filer Management website and the dashboard including all dashboard functionality discussed in this release. Testers can submit a “test” amended Form ID to establish fictional testing accounts.</P>
                    <P>○ Adopting Beta will contain beta versions of all optional APIs that will be available in March 2025: Submission, submission status, EDGAR operational status, filing credentials verification, view individuals, add individuals, remove individuals, change role, send delegation invitations, request delegation invitations, view delegations, view filer account information, create custom CCC, generate CCC, and EDGAR Next enrollment.</P>
                    <P>○ The Overview of EDGAR APIs and API Toolkit will be available to filers.</P>
                    <P>○ Adopting Beta will reflect the current versions of the two legacy EDGAR filing websites with the current submission process, because filers making submissions on the two legacy EDGAR filing websites (EDGAR Online Forms and EDGAR Filing) between March 24, 2025 and September 12, 2025, will do so according to current EDGAR processes.</P>
                    <FP>
                        <E T="03">March 24, 2025—Enrollment of existing filers begins; application for access on amended Form ID required for prospective new filers and filers unable to enroll</E>
                    </FP>
                    <P>
                        ○ New EDGAR Filer Management website including the dashboard will go live and will require 
                        <E T="03">Login.gov</E>
                         individual account credentials for login.
                    </P>
                    <P>○ Amended Form ID will be required.</P>
                    <P> New applicants seeking access to EDGAR must submit the amended Form ID through the dashboard on the new EDGAR Filer Management website.</P>
                    <P>
                         Existing filers required to submit Form ID must submit the amended Form ID through the dashboard on the new EDGAR Filer Management website.
                        <SU>204</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>204</SU>
                             Existing filers may need to submit a new Form ID in the following situations: (i) the filer is a broker-dealer or “paper filer” seeking electronic access for the first time in order to file electronically on EDGAR; (ii) the filer lost electronic access to its existing CIK account; or (iii) the applicant is a legal successor of the filer named on the existing CIK account but did not receive access from that filer.
                        </P>
                    </FTNT>
                    <P> If Commission staff grant the amended Form ID application, the filer will be in compliance with the EDGAR Next changes, and thus will not be required to subsequently enroll on the dashboard.</P>
                    <P>○ Enrollment for EDGAR Next will begin.</P>
                    <P>○ All APIs provided in the Adopting Beta will go live and be available to filers enrolled in EDGAR Next and filers whose amended Form ID applications have been granted by Commission staff.</P>
                    <P>○ Filers will make submissions on the legacy EDGAR filing websites using the current EDGAR process until September 12, 2025.</P>
                    <P>
                        ○ ABSCOMP submissions will be made through the dashboard, as opposed to through the “Retrieve/Edit Data” section of the EDGAR Filing website as is currently the case. Because new serial companies requested to be created via the ABSCOMP process will automatically inherit all dashboard information (
                        <E T="03">e.g.,</E>
                         contact information, account administrators, users, technical administrators, and delegations) associated with the ABS issuing entity that made the ABSCOMP submission, an ABS issuing entity will need to enroll in EDGAR Next to populate its information in the dashboard before making an ABSCOMP submission. Existing serial companies can be enrolled in EDGAR Next at any time up until the compliance date just as any other filer, since their enrollment will not affect the ability of the ABS issuing entity to make an ABSCOMP submission.
                    </P>
                    <P>○ The Adopting Beta will continue to be available and will be updated to reflect new versions of the EDGAR filing websites to enable filers to prepare for compliance with EDGAR Next on September 15, 2025, as discussed further below.</P>
                    <FP>
                        <E T="03">September 15, 2025—Compliance with all EDGAR Next rule and form amendments required; enrollment continues</E>
                    </FP>
                    <PRTPAGE P="106200"/>
                    <P>
                        ○ Access to all EDGAR websites—EDGAR Online Forms, EDGAR Filing, and EDGAR Filer Management—will require 
                        <E T="03">Login.gov</E>
                         individual account credentials.
                    </P>
                    <P>○ Filers must comply with all requirements of Rule 10 and the EDGAR Filer Manual to make submissions on EDGAR.</P>
                    <P>○ The Adopting Beta will continue to be available until at least December 19, 2025.</P>
                    <P>○ Because individual account credentials will be required to access all EDGAR websites, legacy EDGAR access codes (password, passphrase, and PMAC) will no longer be used to access EDGAR. (Filers who seek to enroll between September 15, 2025 and December 19, 2025, however, must enter a CCC and a passphrase to do so, therefore, the ability to reset the CCC and the passphrase will remain available.).</P>
                    <P>○ Filers may continue to enroll after the compliance date, until December 19, 2025.</P>
                    <FP>
                        <E T="03">December 19, 2025—Enrollment ends</E>
                    </FP>
                    <P>○ Enrollment ends on December 19, 2025.</P>
                    <FP>
                        <E T="03">December 22, 2025—Application on amended Form ID required for all existing and prospective filers seeking access to EDGAR</E>
                    </FP>
                    <P>○ Existing filers that have not enrolled or otherwise no longer have access and all prospective filers must apply for access to EDGAR on amended Form ID on the dashboard beginning December 22, 2025.</P>
                    <HD SOURCE="HD3">1. Enrollment Process</HD>
                    <P>Existing filers will enroll in EDGAR Next through the dashboard on the new EDGAR Filer Management website and will not be required to submit a Form ID. The enrollment section of the dashboard will provide two options: (i) manual enrollment of single EDGAR accounts on an account-by-account basis; and (ii) enrollment of multiple accounts simultaneously. In addition, as discussed in section II.E.1.b.v, an enrollment API will be provided to help streamline the enrollment process. Although the enrollment API will be available to all filers, we expect it will generally be used by filing agents, service providers, or corporate affiliates that will manually enroll themselves earlier in the transition period and then connect to the enrollment API to enroll their clients and affiliated entities.</P>
                    <P>
                        Two commenters appeared to suggest that enrollment should occur automatically without filer involvement, so that filing agents would be automatically authorized as account administrators and delegated entities for any CIK for which the filing agent had previously made a submission.
                        <SU>205</SU>
                        <FTREF/>
                         We decline to adopt the commenters' suggestion. To enroll, an individual authorized by the filer to perform enrollment on its behalf must enter the file's CIK, CCC and passphrase, as well as information about the individuals being authorized as account administrators.
                        <SU>206</SU>
                        <FTREF/>
                         The entry of account administrator information during enrollment represents the filer's affirmative authorization of account administrators, who play a key role in the EDGAR Next framework as the individuals who manage the filer's account. Further, if the filer determined to authorize individuals employed at the filer or at a different filing agent as its account administrators due to business needs, personal preference, or whatever other reason, a process of affirmative enrollment ensures that the filer indeed intends to authorize those individuals to manage its account.
                    </P>
                    <FTNT>
                        <P>
                            <SU>205</SU>
                             
                            <E T="03">See</E>
                             DFIN II Comment Letter (“We believe that, in connection with the final rule, the SEC should create a new role, `Trusted Filer'. . . . By grandfathering in existing Filing Agents and their filing activity, this would establish a baseline of existing EDGAR filers.”); ICI Comment Letter (“Grandfathering existing filing agents and their filing activity would establish a baseline of existing EDGAR filers.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>206</SU>
                             Individual and single-member company filers do not need to themselves enroll in EDGAR Next, although they may do so if they choose. As with other filers, individual or single-member company filers may authorize a representative to enroll them, so long as they provide that representative with the necessary codes and account administrator information. The representative authorized to enroll the filer need not be an “authorized individual” as that term is defined in amended Rule 11 and Volume I of the EDGAR Filer Manual.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">a. Preparing for Enrollment—Individual Account Credentials</HD>
                    <P>
                        Individuals may obtain individual account credentials from 
                        <E T="03">Login.gov</E>
                         in advance of enrollment. Individuals with existing 
                        <E T="03">Login.gov</E>
                         credentials based upon a personal email address may create separate 
                        <E T="03">Login.gov</E>
                         credentials for EDGAR based upon a different email address that they will use in connection with EDGAR.
                        <SU>207</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>207</SU>
                             
                            <E T="03">See supra</E>
                             text accompanying note 36.
                        </P>
                    </FTNT>
                    <P>As a result, when enrollment begins, filers will be able to immediately enroll any individuals who have obtained individual account credentials.</P>
                    <HD SOURCE="HD3">b. Manual Enrollment for a Single EDGAR Account</HD>
                    <P>
                        As a preliminary matter, each filer will be required to authorize at least two individuals to manage the filer's EDGAR account as account administrators, with the exception of individuals and single-member companies, which will be required to authorize at least one account administrator. On behalf of each filer, an individual authorized to enroll the filer will enter her individual account credentials to log into the dashboard to enroll. That individual will manually enter the filer's CIK, CCC, and EDGAR passphrase,
                        <SU>208</SU>
                        <FTREF/>
                         to confirm to EDGAR that the individual is authorized by the filer. If EDGAR authenticates that data, the individual authorized to enroll the filer will proceed to enter account administrator names, contact information, and the email addresses each individual used to obtain 
                        <E T="03">Login.gov</E>
                         individual account credentials. By entering that information, the filer will indicate its authorization of the listed individuals as the filer's account administrators, as well as the accuracy of the information provided.
                    </P>
                    <FTNT>
                        <P>
                            <SU>208</SU>
                             Filers that have lost or forgotten their CCC will be able to reset it by providing their CIK and passphrase and using the “Generate New EDGAR Access Codes” option in the Filer Management website until March 21, 2025. Similarly, filers that have lost or forgotten their passphrase will be able to reset it by selecting the “Update Passphrase” option on the EDGAR Filer Management website to send a security token to the email associated with the account until March 21, 2025, and, until that date, if the POC email address is not current, filers can first submit a COUPDAT to update the email address associated with the account. Filers that have lost or forgotten their passphrase, no longer have access to the email associated with the account, and cannot submit a COUPDAT through the “Retrieve/Edit Data” section of the EDGAR Filing website to update the email associated with the account, must reapply for EDGAR access on Form ID. We encourage filers that have lost or forgotten their access codes to reset their credentials on or before March 21, 2025, to avoid delay in enrollment. The current “Generate New EDGAR Access Codes” and “Update Passphrase” options will no longer be available on the EDGAR Filer Management website after that website is updated on March 24, 2025. From March 24, 2025 through December 19, 2025, filers will be able to update their passphrase on the dashboard by selecting “Enroll in EDGAR Next,” following the prompts to request a passphrase reset token and resetting the passphrase. The email address associated with the account must be current to use the dashboard passphrase reset process, and filers would similarly need to update the email address in EDGAR before using this process should the email address on file be inaccessible. The ability to reset the CCC will also be provided to filers during this time.
                        </P>
                    </FTNT>
                    <P>
                        Commenters generally agreed that CIK, CCC, and EDGAR passphrase would be sufficient to authenticate filers for transition purposes, but noted that filing agents typically do not retain filers' passphrases and expressed concerns regarding burdens associated with obtaining filers' passphrases.
                        <FTREF/>
                        <SU>209</SU>
                          
                        <PRTPAGE P="106201"/>
                        While we acknowledge that many filing agents do not know the passphrases of their filers and some filers have forgotten and may need to reset their passphrases, we believe that provision of the filer's passphrase is critical to authenticating a filer and confirming the filer's intent to enroll. Filers that have lost or forgotten their passphrase may automatically reset their passphrase by requesting a security token be sent to their POC email address on record in EDGAR, consistent with current practice. Filers that have lost or forgotten their passphrase and that no longer have access to the POC email associated with the account should update their POC email address on record by making a COUPDAT submission via the “Retrieve/Edit Data” section of the EDGAR Filing website. The staff will provide filers step-by-step instructions on the EDGAR Next page on 
                        <E T="03">SEC.gov</E>
                         when the Adopting Beta opens regarding how to automatically reset their passphrase, as well as how to update their POC email address on record. We anticipate that filers following these instructions should be able to reset their passphrase relatively quickly.
                        <SU>210</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>209</SU>
                             
                            <E T="03">See, e.g.,</E>
                             DFIN Comment Letter (“We think those credentials are sufficient. However, Filing Agents do not typically ask for or retain the passphrases. Unless the EDGAR contact in the company information is able to use the security token process to obtain a new passphrase, the manual process of obtaining a new passphrase is time consuming.”); Workiva Comment Letter (“Passphrases are used to reset accounts, and they are likely infrequently used. Many administrators 
                            <PRTPAGE/>
                            and individual reporting owners may not know the passphrase or how to obtain it . . . If the passphrase must be required, the Commission may want to consider a process for inactive entities to refresh their passphrase.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>210</SU>
                             If a filer cannot reset its passphrase by following this guidance, it may submit a manual passphrase update request. To do so, an authorized individual of the filer must submit a signed and notarized document to Commission staff that includes an explanation of why the request is being made, the CIK of the EDGAR account to which access is sought, the filer name on the account, and the contact information of the requesting entity purporting to have current control over the filer associated with the account. Commission staff may request the applicant to submit additional documents for staff review. Filers submitting manual passphrase update requests should expect that Commission staff may need a substantial amount of time to review their requests, especially if a large volume of requests is received. As discussed above, the manual passphrase update option available via “Update Passphrase” will no longer be available on the EDGAR Filer Management website after that website is updated on March 24, 2025. Instead, from March 24, 2025 through December 19, 2025, filers will be able to update their passphrase on the dashboard. 
                            <E T="03">See supra</E>
                             note 208.
                        </P>
                    </FTNT>
                    <P>
                        We requested comment on whether a filer's CCC should be automatically reset as a security measure following enrollment. Commenters generally opposed this measure on the grounds that it would impose burdens on filers to communicate the updated CCC to those that should have access and could impose burdens and risks to the filing process.
                        <SU>211</SU>
                        <FTREF/>
                         Separately, one commenter stated that if the Commission decides to change a filer's CCC after enrollment then similar precautions should also be taken regarding the passphrase.
                        <SU>212</SU>
                        <FTREF/>
                         Although we are sensitive to the concerns raised by commenters that resetting the filer's CCC after enrollment could be burdensome, we balance those concerns with our efforts to protect the security of EDGAR. Just as with someone's personal password, security is improved by frequently changing access codes. Changing the CCC is particularly important in the context of enrollment because the code could be shared insecurely when preparing to enroll. Further, for filers that have not reset their CCC for some period of time, changing the CCC upon enrollment represents a clean start, and assures that someone who possesses the legacy CCC but is not authorized by the filer at or after enrollment could not continue to make submissions for the filer from March 24, 2025 to September 12, 2025, when legacy filing codes will continue to be used to make web-based submissions. Moreover, the presence of the CCC on the dashboard after it is reset will ensure that it is available for all individuals that the filer is currently authorizing to take action on its account. Accordingly, following a filer's enrollment in EDGAR Next, the filer's CCC will be automatically reset. To minimize burdens associated with communicating the new CCC to relevant individuals, however, the new CCC will appear on the dashboard for all individuals with the ability to make submissions on the filer's behalf (
                        <E T="03">i.e.,</E>
                         account administrators, users, delegated administrators, and delegated users). In addition, APIs will be offered to view filer account information, including CCC, and verify filing credentials, including CCC. Collectively, these APIs should minimize burdens associated with notifying relevant individuals regarding changes to a filer's CCC, both in the enrollment context and as a general matter.
                        <SU>213</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>211</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Workiva Comment Letter (“A sweeping change of CCCs should especially be avoided as it could pose a significant burden and risks to the filing process. Filers concerned about the CCC could choose to change it themselves. A filer led approach puts the security responsibility and control in the filer's hand to ensure the CCC update happens at a time that does not put their immediate filings at risk.”); Toppan Merrill Comment Letter (“It would be unnecessary to reset the CCC upon enrollment. If bulk enrollment is utilized it would most likely be completed by an entity [. . .] that already has access to the filer's CCC. It would be burdensome for the filer if the CCC is automatically changed as they would need to communicate the updated CCC to those that should have access.”); ICI Comment Letter (“Bulk enrollment should be permitted without reset CCCs upon re-enrollment.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>212</SU>
                             
                            <E T="03">See</E>
                             DFIN Comment Letter (“We agree that notification of a completed enrollment should be provided to all account administrators.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>213</SU>
                             
                            <E T="03">See supra</E>
                             section II.E.1.b.i (discussing the filing credentials verification API) and section II.E.1.b.iv (discussing the view filer account information API).
                        </P>
                    </FTNT>
                    <P>Separately, on the compliance date of September 15, 2025, legacy EDGAR access codes will be deactivated, including the passphrase, password and PMAC, because the filer will no longer have any need for these codes. For example, the passphrase is used to authenticate the generation of access codes such as CCC and password, but after enrollment, use of the passphrase and password will be discontinued, and filers will generate the CCC on the dashboard. The EDGAR Next framework of individual account credentials, account administrator dashboard invitation, and CCC will supplant these codes.</P>
                    <P>
                        Successful enrollment will result in notifications being provided to all newly authorized account administrators, as recommended by a commenter.
                        <SU>214</SU>
                        <FTREF/>
                         These notifications will be sent both by email and through the dashboard, consistent with all other notifications to individuals who are authorized on the dashboard. One commenter suggested that the existing EDGAR POC should also be notified in the event of a successful enrollment.
                        <SU>215</SU>
                        <FTREF/>
                         Another commenter noted that currently no notification is provided to the previous EDGAR POC when the contact email address is updated, and asserted that such a notification would be redundant to the extent it would be going to the same person who enrolled the filer and who listed herself as the filer's account administrator.
                        <SU>216</SU>
                        <FTREF/>
                         After considering these comments, EDGAR will be enhanced to notify the existing EDGAR POC in the event of a successful enrollment. Although in some cases this will result in redundant notifications (if the existing EDGAR POC is one of the new account administrators being authorized during enrollment), sending uniform notifications to all existing 
                        <PRTPAGE P="106202"/>
                        EDGAR POCs will provide clarity to filers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>214</SU>
                             
                            <E T="03">See</E>
                             DFIN Comment Letter (“We agree that notification of a completed enrollment should be provided to all account administrators.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>215</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“We support auto-notification to the POC about the enrollment if the POC is not also enrolled as an administrator . . .”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>216</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“Currently, there is no alert to the previous/existing EDGAR Contact when the EDGAR Contact email address is updated. We do not believe it is necessary to alert the current EDGAR POC during the transition to EDGAR Next. It is possible that many of the EDGAR POCs will have been recently updated to reset the passphrase as part of the EDGAR Next transition. Therefore, this alert would go to the person who completed the EDGAR Next transition and may be redundant.”).
                        </P>
                    </FTNT>
                    <P>
                        We will not require the existing EDGAR POC to consent to the filer's enrollment. As mentioned by one commenter, the filer's EDGAR POC on record may not be current, and missing or outdated EDGAR POCs could cause confusion and delays in the enrollment process.
                        <SU>217</SU>
                        <FTREF/>
                         Separately, we believe that requiring CIK, CCC, and passphrase will be sufficient to authenticate filers for transition purposes, as discussed above and as supported by commenters.
                        <SU>218</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>217</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“We believe that confirmation from the current POC should not be required. When a POC was set up a long time ago, there may have been turnover, and the contact information may not be up to date even with an email on file. The administrators also may not know who their POCs are. POC confirmation should not be required because this is a mandatory transition and missing or outdated POC could be a prohibiting factor and a serious risk of chaos for the enrollment process.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>218</SU>
                             
                            <E T="03">See supra</E>
                             note 209 and accompanying text.
                        </P>
                    </FTNT>
                    <P>
                        Each EDGAR account will enroll once. If there is an attempt to enroll an EDGAR account that is already enrolled, the subsequent attempted enrollment will be denied. An individual filer who makes submissions related to multiple companies (
                        <E T="03">e.g.,</E>
                         the CEO of one company who is also on the board of directors of other companies) may have more than one filing agent and/or representative at such companies who have access to her CIK, CCC, and EDGAR passphrase. Accordingly, an individual filer should authorize one representative to enroll her EDGAR account and determine whom she will authorize as her initial account administrator(s) during enrollment. After enrollment, the authorized account administrator(s) would communicate with the filer's other filing agents and/or company representatives and add such other filing agents and/or company representatives to the filer's account as account administrators, users, or delegated entities through the dashboard. Any individuals to be authorized on the filer's account will be required to possess individual account credentials.
                    </P>
                    <HD SOURCE="HD3">c. Bulk Enrollment of Multiple EDGAR Accounts</HD>
                    <P>Simultaneous bulk enrollment of multiple EDGAR accounts, together with those filers' account administrators, will be available. This process should prove efficient and time saving for filing agents, as well as individuals and entities that control multiple EDGAR accounts, such as serial companies created by ABS issuing entities or investment companies under the control of a single investment adviser.</P>
                    <P>
                        To begin bulk enrollment, an individual authorized to enroll the relevant filer accounts will log in to an enrollment page on EDGAR with his individual account credentials. The individual will complete and upload a spreadsheet accommodating multiple rows of data, with each row pertaining to a single filer. The individual will enter data for each filer on each row, including CIK, CCC, and EDGAR passphrase to ensure that enrollment is being performed by a properly authenticated individual. In addition, the individual will enter on each row information regarding the filer's prospective account administrators, including names, contact information, and the email addresses associated with the individual account credentials of the account administrators, to indicate that the filer authorizes those account administrators to manage its EDGAR account. The bulk enrollment process will allow a filer to list two account administrators. Although all filers are encouraged to list two account administrators for bulk enrollment purposes, single-member companies and individuals who self-identify as such will be permitted to list only one account administrator. There will be a limit of 100 filers (100 rows) per bulk enrollment. Commenters generally supported the bulk enrollment option as contemplated in the Proposing Release, including the limitation of 100 filers per spreadsheet, although one commenter suggested that the limit per spreadsheet be increased to 500 filers.
                        <SU>219</SU>
                        <FTREF/>
                         There will be a limit of 100 rows per spreadsheet as it appears that number is sufficient for most filers. Filers that wish to submit bulk enrollment requests on behalf of more than 100 CIKs may engage in multiple, separate bulk enrollments.
                    </P>
                    <FTNT>
                        <P>
                            <SU>219</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“Yes, bulk enrollment should be permitted as planned.”); DFIN Comment Letter (“We agree that the limitation of 100 is acceptable for bulk enrollment.”); ICI Comment Letter (“Bulk enrollment should be permitted. . ..”); XBRL II Comment Letter (“We agree with the proposed approach to allow bulk enrollment of multiple EDGAR accounts. We recommend that the CSV limit be increased to 500, from the proposed limit of 100.”).
                        </P>
                    </FTNT>
                    <P>
                        As discussed above, each successful enrollment will result in notifications to all newly authorized account administrators, as recommended by a commenter.
                        <SU>220</SU>
                        <FTREF/>
                         In addition, EDGAR will be enhanced to notify the existing EDGAR POC in the event of a successful notification.
                        <SU>221</SU>
                        <FTREF/>
                         Following a filer's enrollment in EDGAR Next, EDGAR will automatically reset the filer's CCC and deactivate the filer's passphrase for security reasons.
                        <SU>222</SU>
                        <FTREF/>
                         Also as discussed above, enrollment will only occur once per EDGAR account, and each filer should carefully coordinate with its staff and other representatives to determine the person to be authorized to enroll the filer and the persons to be authorized as account administrators during the enrollment. Authorized account administrators may thereafter manage the account (
                        <E T="03">e.g.,</E>
                         adding additional account administrators, users and technical administrators) on the dashboard.
                    </P>
                    <FTNT>
                        <P>
                            <SU>220</SU>
                             
                            <E T="03">See supra</E>
                             note 214 and accompanying and following text.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>221</SU>
                             
                            <E T="03">See supra</E>
                             note 215 and accompanying and following text.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>222</SU>
                             
                            <E T="03">See supra</E>
                             note 211 and accompanying and following text.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Compliance</HD>
                    <P>Compliance with the final amendments and transition to EDGAR Next will be required on September 15, 2025, 12 months after the issuance of this adopting release. Filers may begin to enroll on March 24, 2025, six months prior to the compliance date. Filers will be able to enroll until December 19, 2025, three months after the compliance date.</P>
                    <P>
                        Commenters requested varied periods of time to prepare, enroll and transition to EDGAR Next. One commenter recommended a transition period of 12 months.
                        <SU>223</SU>
                        <FTREF/>
                         The commenter requested three months prior to the enrollment period within which to prepare for enrollment, noting that filers need to do more than enrolling to complete transition, including but not limited to creating and modifying software and processes, studying the rule, and providing information and instructions to filers.
                        <SU>224</SU>
                        <FTREF/>
                         The commenter further stated that according to its customer survey a majority of respondents indicated that six months would be an 
                        <PRTPAGE P="106203"/>
                        adequate amount of time to enroll provided that it occurred after annual filing season.
                        <SU>225</SU>
                        <FTREF/>
                         A second commenter requested a minimum of nine months to transition to EDGAR Next, and indicated that filers would need six months to enroll if they were afforded six months after adoption to prepare for enrollment.
                        <SU>226</SU>
                        <FTREF/>
                         A third commenter recommended a 12-month transition period for filers to enroll. 
                        <SU>227</SU>
                        <FTREF/>
                         A fourth commenter agreed with a 12-month transition period for filers to enroll, but requested an additional six months for section 16 filers to enroll.
                        <SU>228</SU>
                        <FTREF/>
                         A fifth commenter recommended a minimum of nine months for implementation, and suggested that it would require adequate time in advance of enrollment to establish processes and procedures for EDGAR Next.
                        <SU>229</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>223</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“Moreover, we recommend extending the transition period to twelve months to allow time for process and system changes.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>224</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“With the above considerations, we suggest three months from final rule adoption to start enrollment instead of one month.”) (“However, we strongly believe that six months is not adequate for the full transition. Filers need to do more than enrolling to completely transition. They have to modify their processes based on the new EDGAR Next requirements and the filing software that they use. Likewise, filing agents and software providers do not only have to enroll their own users and ensure all delegations are properly set up (which again could be in the tens of thousands), they also need to learn about the final rule, provide information and instructions to their filers, do software development, roll out changes to their filers, potentially with a beta process of their own.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>225</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“Based on the enrollment activities described in the proposed rule, we believe that six months is adequate to enroll. According to our customer survey, over 53% of respondents indicated that six months work fine, provided that it is after the annual filing season.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>226</SU>
                             
                            <E T="03">See</E>
                             DFIN II Comment Letter (“DFIN is reinforcing our responses to Question 59 [of DFIN I Comment Letter], a nine-month enrollment period, as numerous registrants are not participating in the Beta.”) and DFIN I Comment Letter (“If filers are allowed six months after the proposed rule goes final and before enrollment, we agree that the compliance timeline is sufficient. If the six-month period before enrollment is not met, we suggest a nine-month enrollment period.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>227</SU>
                             XBRL II Comment Letter (“We recommend a 12-month transition period for filers to enroll their EDGAR accounts into EDGAR Next.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>228</SU>
                             
                            <E T="03">See</E>
                             SCG Comment Letter (requesting a 12-month enrollment period, with an additional six months for section 16 filers to transition).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>229</SU>
                             
                            <E T="03">See</E>
                             ICI Comment Letter (“ICI recommends a minimum of nine months for implementation given the complexity and number of Fund filings. The outreach and coordination necessary for Funds to appropriately delegate filing authority to their filing agents makes an extended transition period for bulk EDGAR filers vital. The proposed transition period would give these bulk filers only one month to establish processes and procedures for using EDGAR Next.”).
                        </P>
                    </FTNT>
                    <P>
                        We have considered these comments and noted that several commenters expressed a need for adequate time after adoption to prepare for enrollment.
                        <SU>230</SU>
                        <FTREF/>
                         As a result, we determined to significantly extend the time for filers to prepare for enrollment from one month as proposed to six months as adopted, which aligns with the recommendation of those commenters.
                        <SU>231</SU>
                        <FTREF/>
                         During this time, the beta environment will be available to filers to test the EDGAR Next changes, prepare their systems and develop any necessary software. In addition, filers will be able to ensure they have all the information needed to enroll, such as their CIK, CCC, and passphrase (and will have time to reset their passphrase if necessary). Filers will have time to determine whom they will authorize as account administrators and make arrangements with potential delegated entities and individuals, as well as to execute relevant notarized powers of attorney if needed. Filing agents will have an opportunity to communicate with their current client filers about enrollment. Section 16 filers may determine how they wish to authorize management of their EDGAR account. Filers may further test the enrollment process in the beta environment and be fully prepared to enroll at the end of the six-month preparation period.
                    </P>
                    <FTNT>
                        <P>
                            <SU>230</SU>
                             
                            <E T="03">See</E>
                             DFIN II Comment Letter; Workiva Comment Letter; ICI Comment Letter.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>231</SU>
                             
                            <E T="03">See</E>
                             DFIN II Comment Letter; Workiva Comment Letter; ICI Comment Letter.
                        </P>
                    </FTNT>
                    <P>
                        We believe that the 12-month transition process, including a six-month preparation period and a six-month enrollment period, that we are providing is consistent with commenters' recommendations. As noted above, filers will have six months to conduct preparations and testing prior to the beginning of enrollment. When enrollment commences, individuals whom filers have authorized to perform enrollment should be prepared to log into the new dashboard with individual account credentials they have obtained from 
                        <E T="03">Login.gov</E>
                         and to enter filers' CIK, CCC, and passphrase, as well as information to authorize account administrators to enroll on the dashboard. Filers will have six months within which to enroll prior to the compliance date. Once enrolled, account administrators can delegate authority to file and otherwise set up filers' accounts on the dashboard. Once authorized by account administrators, technical administrators can generate filer API tokens for filers connecting to APIs, and filers can begin to connect to those APIs to make submissions and otherwise communicate with EDGAR.
                    </P>
                    <P>
                        One commenter requested an additional six months for section 16 filers to transition to EDGAR Next.
                        <SU>232</SU>
                        <FTREF/>
                         We believe that the additional three months after the compliance date for enrollment that we are offering should assist periodic filers, such as section 16 filers, to enroll in EDGAR Next and meet their filing obligations if they do not enroll prior to the compliance date. Further, we believe that the transition period affords sufficient time for section 16 and other filers to prepare for EDGAR Next and enroll prior to the compliance date. The staff plans to provide information to section 16 filers through the EDGAR Next page on 
                        <E T="03">SEC.gov</E>
                         and other communications.
                    </P>
                    <FTNT>
                        <P>
                            <SU>232</SU>
                             
                            <E T="03">See</E>
                             SCG Comment Letter (requesting an additional six months for section 16 filers to transition).
                        </P>
                    </FTNT>
                    <P>
                        A bulk enrollment option will allow enrollment of multiple filers simultaneously. In addition, as discussed above, an enrollment API will be available to streamline enrollment. As soon as filers enroll in EDGAR Next, they will be able to connect to all available APIs. We believe that filers will be incentivized to enroll by the availability of APIs upon enrollment, and they will have had time to develop connections and test those APIs. The Adopting Beta will be available throughout the transition period until at least December 19, 2025. We believe the transition period will provide sufficient time for filers to prepare and enroll in EDGAR Next, while maintaining security and efficiency for filers and EDGAR operation.
                        <SU>233</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>233</SU>
                             Of 208,000 active EDGAR accounts (those in which a filing has been made in the past two years), approximately 140,000 represent entity filers and approximately 68,000 represent individual filers. In total, regardless of account activity, there are approximately 1,000,000 filer accounts in EDGAR, however, we believe that most of the approximately 800,000 inactive EDGAR filer accounts are defunct and therefore would not transition to EDGAR Next.
                        </P>
                    </FTNT>
                    <P>
                        To assist filers in their transition to EDGAR Next, Commission staff will begin public outreach immediately after the issuance of this release. Staff will publicize the transition to EDGAR Next and link to additional information in announcements and email distributions, SEC social media, and the homepage of 
                        <E T="03">SEC.gov</E>
                        . Commission staff also will provide multiple resources on a dedicated EDGAR Next web page to assist with the transition, including but not limited to, written step-by-step guidance for testing a range of functionality in the Adopting Beta environment and information about staff webinars and API technical help sessions for the public. On the SEC YouTube channel, staff will post videos to walk filers through various aspects of the EDGAR Next changes. To assist filers with any issues that may arise, Commission staff will provide dedicated telephone support and an email help desk—
                        <E T="03">EDGARNextBeta@sec.gov</E>
                        —as well as an online form (available in the Adopting Beta) to report technical bugs.
                    </P>
                    <HD SOURCE="HD1">III. Other Matters</HD>
                    <P>
                        If any of the provisions of these rules, or the application thereof to any person or circumstance, is held to be invalid, such invalidity shall not affect other provisions or application of such provisions to other persons or circumstances that can be given effect without the invalid provision or application.
                        <PRTPAGE P="106204"/>
                    </P>
                    <P>Pursuant to the Congressional Review Act, the Office of Information and Regulatory Affairs has designated these rules as a “major rule,” as defined by 5 U.S.C. 804(2).</P>
                    <HD SOURCE="HD1">IV. Economic Analysis</HD>
                    <P>
                        Individuals and entities submit filings electronically with the Commission through EDGAR in order to comply with various provisions of the Federal securities laws. While EDGAR has provided an effective means for individuals and entities to satisfy their electronic filing obligations, there are limitations to the current system. EDGAR does not currently track a filing to the specific individual who made it. EDGAR access is currently governed by a complex combination of several codes with differing functions.
                        <SU>234</SU>
                        <FTREF/>
                         In addition, the Commission is aware that some filers may have failed to maintain secure access to their EDGAR accounts.
                        <SU>235</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>234</SU>
                             
                            <E T="03">See</E>
                             EDGAR Filer Manual, Volume I, at section 4. For a discussion of the functions of these access codes, please see the “Understand and utilize EDGAR CIKs, passphrases, and access codes” section of the “EDGAR—How Do I” FAQs, at 
                            <E T="03">https://www.sec.gov/edgar/filer-information/how-do-i</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>235</SU>
                             
                            <E T="03">See</E>
                             EDGAR Filer Management, 
                            <E T="03">available at https://www.filermanagement.edgarfiling.sec.gov</E>
                            ; EDGAR Filing, 
                            <E T="03">available at https://www.edgarfiling.sec.gov/Welcome/EDGARLogin.htm</E>
                            ; and EDGAR Online Forms, 
                            <E T="03">available at https://www.edgarfiling.sec.gov/Welcome/EDGAROnlineFormsLogin.htm</E>
                            .
                        </P>
                    </FTNT>
                    <P>EDGAR Next will improve the ability of filers to securely manage and maintain access to their EDGAR accounts and simplify procedures for accessing EDGAR by modernizing the mechanism by which filers and individuals they authorize act on filers' behalf on EDGAR and streamlining the management of filers' accounts in EDGAR. Various technical features and optional APIs will also be integrated into EDGAR to facilitate communication with EDGAR, thus enhancing filing efficiency and providing automation for filers that wish to connect to the optional APIs. EDGAR Next will benefit both filers and the Commission by simplifying procedures for accessing EDGAR and identifying the specific individuals submitting filings, thereby facilitating the responsible management of filer credentials and enhancing the security of EDGAR. Enhancing the security of EDGAR will better protect against unauthorized access to the system, thereby decreasing the likelihood of unauthorized filings that might result in economic costs for the public, filers, and the Commission.</P>
                    <P>
                        The discussion below addresses the potential benefits and costs that may result from the final rule and form amendments the Commission is adopting in this release, and certain related technical changes, as well as the likely effects of EDGAR Next on efficiency, competition, and capital formation.
                        <SU>236</SU>
                        <FTREF/>
                         We also discuss the potential economic effects of certain alternatives to the approaches taken in this release. Where possible, we have attempted to quantify the benefits, costs, and effects on efficiency, competition, and capital formation expected to result from the final amendments. In many cases, however, the Commission is unable to quantify certain economic effects because it lacks the information necessary to provide estimates or ranges. In those circumstances where we do not have the requisite data to assess the quantitative impact of the EDGAR Next changes, we have analyzed their economic impact qualitatively.
                    </P>
                    <FTNT>
                        <P>
                            <SU>236</SU>
                             Section 2(b) of the Securities Act (15 U.S.C. 77b(b)), section 3(f) of the Exchange Act (17 U.S.C. 78c(f)) and section 2(c) of the Investment Company Act (15 U.S.C. 80a-2(c)) require the Commission, when engaging in rulemaking where it is required to consider or determine whether an action is necessary or appropriate in (or, with respect to the Investment Company Act, consistent with) the public interest, to consider, in addition to the protection of investors, whether the action will promote efficiency, competition, and capital formation. Further, section 23(a)(2) of the Exchange Act (17 U.S.C. 78w(a)(2)) requires the Commission, when making rules under the Exchange Act, to consider the impact that the rules will have on competition, and prohibits the Commission from adopting any rule that would impose a burden on competition not necessary or appropriate in furtherance of the purposes of the Exchange Act. The technological changes contemplated by EDGAR Next will work together with the final rule and form amendments to enhance EDGAR access requirements. Because it is difficult to isolate the economic effects associated with the technological changes from those attributable solely to the final rule and form amendments, for purposes of this economic analysis, we have considered these effects collectively.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">A. Baseline</HD>
                    <P>
                        Our baseline includes the current requirements to obtain access to and file on the Commission's EDGAR system, as well as the account management practices as they exist today. The main parties directly affected by EDGAR Next are current and prospective filers as well as relevant individuals or entities acting on the filers' behalf. Filers are individuals or entities (
                        <E T="03">e.g.,</E>
                         public operating companies, investment companies, broker-dealers, transfer agents, and other institutions that have filing obligations with the Commission) that make a submission electronically through EDGAR. For example, beneficial ownership reporting filers (such as individual filers who are officers and/or directors with reporting obligations under section 16 of the Exchange Act) routinely rely upon the companies for which they serve to make filings on their behalf on EDGAR.
                        <SU>237</SU>
                        <FTREF/>
                         Other filers may make filings on behalf of affiliated or related entities, such as investment companies on behalf of other companies in their fund family or asset-backed securities issuers on behalf of the serial companies they create. In 2023, the Commission received approximately 73,600 Form ID submissions.
                        <SU>238</SU>
                        <FTREF/>
                         From 2018 to 2023, an average of approximately 63,984 Form IDs were submitted per year to the Commission.
                        <SU>239</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>237</SU>
                             
                            <E T="03">See</E>
                             15 U.S.C. 78p.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>238</SU>
                             This number includes 63,676 applications from prospective filers without CIKs, 9,602 applications from filers that had lost EDGAR access and were seeking to regain access to EDGAR (currently submitted as passphrase updates, but pursuant to EDGAR Next will be submitted on Form ID), and 322 applications from filers with CIKs who had not yet filed electronically on EDGAR.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>239</SU>
                             Similarly, this number includes applications from prospective filers without CIKs, applications from filers that had lost EDGAR access and were seeking to regain access to EDGAR (currently submitted as passphrase updates, but pursuant to EDGAR Next will be submitted on Form ID), and applications from filers with CIKs who had not yet filed electronically on EDGAR.
                        </P>
                    </FTNT>
                    <P>
                        Individuals and entities that seek to file on EDGAR must apply for access in accordance with Rule 10 of Regulation S-T by completing the Form ID application online. Applicants must then print a copy of the completed form. An authorized individual, as defined in the EDGAR Filer Manual, Volume I, must sign the completed form, and this signature must be notarized, pursuant to the EDGAR Filer Manual, Volume I. Filers have the flexibility to obtain notarization of the authorized individual's signature on Form ID through manual, electronic, or remote online notarization in accord with Volume I of the EDGAR Filer Manual and Rule 10 of Regulation S-T.
                        <SU>240</SU>
                        <FTREF/>
                         The signed, notarized copy of the completed Form ID is the Form ID authenticating document, and the applicant must upload that document for Commission staff review.
                        <SU>241</SU>
                        <FTREF/>
                         Form ID currently collects information including but not limited to the applicant's contact information and EDGAR POC. If the application is granted by Commission staff, the filer receives a unique CIK, and the EDGAR POC generates access codes, including but not limited to a password and a CCC, by using its CIK and passphrase. These codes allow the filer to make submissions on its EDGAR account. The current co-registrant filing process does not require the 
                        <PRTPAGE P="106205"/>
                        presentation of a password for all entities.
                    </P>
                    <FTNT>
                        <P>
                            <SU>240</SU>
                             
                            <E T="03">See supra</E>
                             note 12.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>241</SU>
                             
                            <E T="03">See</E>
                             Regulation S-T, Rule 10; EDGAR Filer Manual, Volume I.
                        </P>
                    </FTNT>
                    <P>
                        If a filer loses or must update its passphrase, it can request that a security token be sent to the POC email address on record with EDGAR. If necessary, the filer can first update the POC email address to ensure it receives the security token. If, for some reason, a filer is unable to update its passphrase via a security token, a manual passphrase update request must be submitted.
                        <SU>242</SU>
                        <FTREF/>
                         In conjunction with a manual passphrase update request, the authorized individual must submit a signed and notarized document to Commission staff that includes an explanation of why the request is being made, the CIK of the EDGAR account to which access is sought, the filer name on the account, and the contact information of the requesting entity purporting to have current control over the filer associated with the account. Depending upon the circumstances of the access request, additional documents may need to be submitted to Commission staff for review. For example, additional documents would need to be provided when the applicant indicates it has assumed control of the entity on the EDGAR account so that Commission staff can establish whether a legal transition from the filer on the account to the applicant occurred.
                    </P>
                    <FTNT>
                        <P>
                            <SU>242</SU>
                             
                            <E T="03">See</E>
                             EDGAR Filer Manual, Volume I, at section 4(b).
                        </P>
                    </FTNT>
                    <P>
                        EDGAR filers are subject to certain requirements set forth in the EDGAR Filer Manual, according to which they must: (1) renew their EDGAR password annually; (2) maintain accurate company information on EDGAR; and (3) securely maintain EDGAR access codes.
                        <SU>243</SU>
                        <FTREF/>
                         Filers can update their POC information, including email address on file, by submitting a COUPDAT via the Retrieve/Edit Company Submission Data tab on the EDGAR filing website. Filers can similarly submit a SCUPDAT or ABSCOMP using the Retrieve/Edit Company Submission Data tab. Filers can submit up to 100 ABS issuing entities in a single submission.
                        <SU>244</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>243</SU>
                             
                            <E T="03">See</E>
                             EDGAR Filer Manual, Volume I, at section 5 (“Filers must maintain accurate company information on EDGAR, including but not limited to a filer's current name, business mailing address, and business email address.”); 
                            <E T="03">see also</E>
                             EDGAR Filer Manual, Volume I, at section 4 (“Filers must securely maintain all EDGAR access codes and limit the number of persons who possess the codes. EDGAR access codes include the password, passphrase, CCC, and password modification authorization code (PMAC).”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>244</SU>
                             
                            <E T="03">See</E>
                             Staff Guidance for EDGAR Filing for Asset-Backed Securities Issuers, available at 
                            <E T="03">https://www.sec.gov/divisions/corpfin/abs092418.pdf</E>
                            . This guidance represents the views of Commission staff. It is not a rule, regulation, or statement of the Commission. The Commission has neither approved nor disapproved its content. Staff statements have no legal force or effect: they do not alter or amend applicable law, and they create no new or additional obligations for any person.
                        </P>
                    </FTNT>
                    <P>
                        Currently, access to EDGAR does not incorporate individual account credentials or multifactor authentication. Commission staff have no systematic way to determine with whom the filer has shared EDGAR access codes, or when the filer has revoked an individual's authorization to file. Filers are responsible for safeguarding their access codes and limiting the number of individuals who receive the codes.
                        <SU>245</SU>
                        <FTREF/>
                         Certain filers and filing agents currently devise their own internal systems to track who possesses their EDGAR access codes. Because the Commission does not collect the personal information of the specific individual who makes the submission, nor does the Commission issue identifying credentials to individuals acting on behalf of filers, it is currently difficult for Commission staff to match filings to specific individuals who made the filings.
                    </P>
                    <FTNT>
                        <P>
                            <SU>245</SU>
                             
                            <E T="03">See</E>
                             EDGAR Filer Manual, Volume I, at section 4 (“Filers must securely maintain all EDGAR access codes and limit the number of persons who possess the codes.”).
                        </P>
                    </FTNT>
                    <P>
                        EDGAR receives a large volume of filings, typically more than 500,000 per calendar year, and has approximately 208,000 active filers, of which approximately 140,000 represent entities and approximately 68,000 represent individuals.
                        <SU>246</SU>
                        <FTREF/>
                         Filers make submissions on EDGAR through one of three web-based user interfaces, depending on the type of submission made.
                        <SU>247</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>246</SU>
                             
                            <E T="03">See supra</E>
                             note 233.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>247</SU>
                             
                            <E T="03">See</E>
                             EDGAR Filer Management website available at 
                            <E T="03">https://www.filermanagement.edgarfiling.sec.gov</E>
                            ; EDGAR Filing website available at 
                            <E T="03">https://www.edgarfiling.sec.gov/Welcome/EDGARLogin.htm</E>
                            ; and EDGAR Online Forms website available at 
                            <E T="03">https://www.edgarfiling.sec.gov/Welcome/EDGAROnlineFormsLogin.htm</E>
                            .
                        </P>
                    </FTNT>
                    <P>
                        The majority of EDGAR filings are made by filing agents on behalf of their client filers.
                        <SU>248</SU>
                        <FTREF/>
                         Certain filing agents and filers use proprietary custom software to interface with EDGAR to eliminate the need for human web-based interaction with the EDGAR filing websites. To create this custom software, these filing agents and filers extract data from the EDGAR filing websites and then configure their custom software to mimic a web-based interaction. This mode of interaction with EDGAR requires frequent maintenance of the custom software; however, since whenever EDGAR filing websites change their content or structure, those changes impact the custom software. Although Commission staff do not provide technical or other support for custom software interaction with EDGAR, staff seeks to minimize filing disruptions and strives to provide notice to filers prior to making website changes. As a result, technical changes to the EDGAR system (
                        <E T="03">e.g.,</E>
                         maintenance, updates, etc.) may be slowed by the fact that staff is mindful of the downstream effect of such technical changes on the custom software used by filing agents and filers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>248</SU>
                             
                            <E T="03">See</E>
                             CompSci Resources Comment Letter (November 19, 2021); Workiva Comment Letter (November 30, 2021).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. Consideration of Benefits and Costs as Well as the Effects on Efficiency, Competition, and Capital Formation</HD>
                    <HD SOURCE="HD3">1. Benefits</HD>
                    <P>EDGAR Next is designed to: provide a more secure framework for filers to manage and maintain access to their EDGAR accounts; facilitate the responsible management of filer credentials; and simplify procedures for accessing EDGAR. We anticipate the main economic benefits of the final amendments will be to enhance the security of EDGAR by reducing the risks of unauthorized access to filers' accounts and unauthorized filings. Reducing these risks will in turn mitigate the adverse economic consequences, such as financial harms, to filers and market participants that could result from unauthorized access and filings. EDGAR Next will also streamline the management of filer credentials and accounts, simplify procedures to access EDGAR, and allow for a more automated filing process and preparation. This may result in cost savings for some filers and delegated filers and help enhance the Commission's regulatory oversight through greater prevention and timely detection of unauthorized access and filings. We discuss below the benefits of specific provisions of EDGAR Next.</P>
                    <HD SOURCE="HD3">a. Form ID</HD>
                    <P>
                        As discussed in section II.F.3, Form ID as adopted, will include changes to information required to be reported on the form as well as technical changes. Individuals, companies, and other organizations that seek access to file electronically on EDGAR, or to establish or re-establish their electronic access to an existing account, will be required to submit Form ID as amended.
                        <SU>249</SU>
                        <FTREF/>
                         The 
                        <PRTPAGE P="106206"/>
                        final amendments to Form ID will enhance the security of EDGAR and benefit EDGAR users by providing additional identity assurances that individuals taking actions on EDGAR on behalf of the filer are authorized to do so, thus minimizing the risk of unauthorized access to filers' EDGAR accounts. For instance, if the applicant authorizes a prospective account administrator who is not employed by the applicant or its affiliate, amended Form ID requires a notarized power of attorney from the applicant to authorize the designated individual to be its account administrator. In the case of certain applicants who seek to re-establish access to an existing account, the amended Form ID requires an applicant to upload to EDGAR the documents establishing the applicant's authority over the account, consistent with current requirements.
                        <SU>250</SU>
                        <FTREF/>
                         The provision of more specific contact information about the filer, the filer's account administrator(s), authorized individual, and billing contact will allow Commission staff to reach the filer's account administrators, authorized individual, and billing contacts when necessary, which will benefit the filer and the Commission by facilitating a swift resolution to potential issues that may affect their accounts.
                    </P>
                    <FTNT>
                        <P>
                            <SU>249</SU>
                             Applicants will, among other things: (1) designate on Form ID specific individuals that the filer authorizes to take action on its behalf as account administrator(s); (2) provide the applicant's 
                            <PRTPAGE/>
                            LEI, if any; (3) provide more specific contact information about the filer and the filer's account administrator(s), authorized individual, and billing contact; (4) specify whether the applicant, its authorized individual, person signing a power of attorney, account administrator, or billing contact has been criminally convicted or civilly or administratively enjoined barred, suspended, or banned in any capacity as a result of a Federal or State securities law violation; (5) indicate whether the company seeking access is in good standing with its State or country of incorporation; and (6) require those seeking access to an existing EDGAR account to upload documents establishing their authority over the account.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>250</SU>
                             The EDGAR Filer Manual will provide guidance regarding what documents are sufficient to establish the applicant's authority. 
                            <E T="03">See</E>
                             amended EDGAR Filer Manual, Volume I, at section 3.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">b. Individual Account Credentials</HD>
                    <P>
                        As discussed in section II.B.1, paragraph (d)(1) of Rule 10 as adopted, will require that all existing and prospective filers authorize individuals on the dashboard to act on their behalf only if those individuals have obtained individual account credentials. The EDGAR Filer Manual, Volume I is being amended to specify that individual account credentials be obtained through 
                        <E T="03">Login.gov,</E>
                         a U.S. agency site that employs multifactor authentication. Paragraph (d)(1) of Rule 10 as proposed and adopted will generally improve the security of the EDGAR system by: eliminating the use of multiple EDGAR access codes and the sharing of them with others in an unsecure manner outside of the EDGAR system; associating a filing with the relevant individual who submitted the filing (due to the person-specific nature of individual account credentials); and providing an additional layer of validation with multifactor authentication. Improving the security of EDGAR will generally minimize the risk of unauthorized access to filers' accounts as well as unauthorized filings, thereby also minimizing any resulting adverse economic consequences, such as market manipulation or financial harm to a company or its investors. For instance, unauthorized filings can lead to the release of false information about a public company, which could negatively impact its investors, investors' trust in the company, and the company's access to capital markets.
                    </P>
                    <P>
                        Some commenters agreed that the individual account credential requirements will improve security, promote individual accountability, and adhere to current best practices.
                        <SU>251</SU>
                        <FTREF/>
                         Other commenters questioned the benefit of paragraph (d)(1) of Rule 10, asserting that individual account credentials could intentionally be shared with unauthorized persons.
                        <SU>252</SU>
                        <FTREF/>
                         The EDGAR Filer Manual is being amended to clarify that individual account credentials may not be shared with other individuals as individual account credentials are intended to identify the individual taking action on EDGAR.
                        <SU>253</SU>
                        <FTREF/>
                         To the extent that authorized persons nonetheless inadvertently share their individual account credentials, this could limit the benefits described above. Because we anticipate that such instances will be rare, we believe that requiring individual account credentials will meaningfully enhance the overall security of the EDGAR system.
                    </P>
                    <FTNT>
                        <P>
                            <SU>251</SU>
                             
                            <E T="03">See supra</E>
                             note 31.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>252</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Workiva Comment Letter (stating that individuals may share their individual account credentials among various employees at the delegated entity); XBRL II Comment Letter (noting that multifactor authentication is “only required to administer the Filer Management dashboard and obtain [] filer and user tokens which could leave the system vulnerable to a malicious entity” that somehow obtained the filer's filer API token and user API token from using those tokens for 30 days).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>253</SU>
                             
                            <E T="03">See</E>
                             amended EDGAR Filer Manual, Volume I, at section 3(a).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">c. Account Administrators</HD>
                    <P>As discussed in section II.B.1, amended paragraph (d)(2) of Rule 10 will require filers to authorize account administrators to act on the filers' behalf to manage their accounts on the dashboard. The addition of account administrators will help ensure that filers' accounts are secure by preventing unauthorized access, thereby reducing the risk of security incidents and the resulting financial harms. Account administrators will be able to authorize, view, and de-authorize the individuals and delegated entities on the dashboard as warranted. Requiring filers to authorize account administrators will enhance security and improve filer compliance with EDGAR Next requirements by facilitating the prevention and timely detection of potential economic harms resulting from unauthorized access. For example, account administrators will oversee the filer's EDGAR account and can promptly revoke access for users who are no longer authorized by the filer. Moreover, by granting account administrators direct authority to oversee the filer's account, account administrators can promptly address user access problems and correct errors in a timely manner, ensuring faster resolution of issues that may affect filers' accounts.</P>
                    <HD SOURCE="HD3">d. Final Amendments to Paragraphs (d)(4), (d)(5), and (d)(6) of Rule 10 and Rule 11</HD>
                    <P>
                        As discussed in section II, the final amendments to paragraphs (d)(4), (d)(5), and (d)(6) of Rule 10 require the filer, through its authorized account administrators: to annually confirm that all individuals reflected on the dashboard for the filer's EDGAR account are authorized by the filer and that all information regarding the filer on the dashboard is accurate; to maintain accurate and current information about the filer on EDGAR; and to securely maintain information relevant to the ability to access the filer's EDGAR account. The final amendments will assist the filer in tracking and confirming those individuals and delegated entities authorized to act on behalf of the filer and to remove those no longer authorized. Confirming the accuracy of information about individuals authorized to act on behalf of filers while safeguarding access to account-related information will reduce the risk of unauthorized access to filers' accounts and the potential for unauthorized filings, thereby enhancing the security of EDGAR. Taking measures that help prevent unauthorized access is inherently more efficient than remediating the consequences of such events after they have occurred, which may include damage to public confidence in the filings provided, with corresponding adverse effects for markets.
                        <PRTPAGE P="106207"/>
                    </P>
                    <P>The final amendments to Rule 11 of Regulation S-T will define new terms related to EDGAR Next, update the definitions of certain existing terms, and delete outdated terminology from certain definitions in Rule 11. Rule 11 also defines “dashboard” as an interactive function on EDGAR where filers manage their EDGAR accounts and where individuals that filers authorize may take relevant actions for filers' accounts. These amendments should help facilitate compliance by filers and filing agents with the EDGAR Next filing requirements.</P>
                    <P>The dedicated EDGAR dashboard will offer a range of benefits to filers related to their obligations under paragraphs (d)(4), (d)(5) and (d)(6) of Rule 10 in the form of: (1) simplified management of EDGAR accounts because account administrators can manage the filer's account through a number of functions on the dashboard; (2) streamlined compliance because account administrators can utilize efficient account management functions, including editing filer information and performing the required annual confirmation on the dashboard; (3) enhanced security by allowing account administrators to remove individuals and entities no longer authorized to act on behalf of the filer, and requiring individual account credentials and multifactor authentication to access the dashboard; and (4) increased efficiency by providing a secure and centralized way to manage the filer's EDGAR account, reducing the risk of human error in managing account information or compromised access codes.</P>
                    <P>Commission staff are aware that certain filers and filing agents currently have internal systems that track which individuals possess their EDGAR access codes. While the cost to these filers of transitioning to the dashboard is expected to be the same as that for filers that do not have internal systems, filers with internal systems will benefit on an ongoing basis if they use the dashboard instead of their current system due to the elimination of ongoing maintenance costs for their internal tracking system. Moreover, the dashboard will offer the advantage of being a uniform system for all filers that additionally allows Commission staff visibility into which individuals are authorized to act for the filer, thereby enhancing regulatory oversight and subsequently the reliability of the information made available through EDGAR. Furthermore, filers without a system for tracking individuals in possession of EDGAR codes will be afforded a tool to do so through EDGAR, thereby facilitating compliance with existing EDGAR Filer Manual requirements and amended EDGAR Next obligations in Rule 10 and the EDGAR Filer Manual to securely maintain access to their accounts.</P>
                    <P>As proposed and adopted, paragraph (d)(6) of Rule 10 is analogous to requirements set forth in the EDGAR Filer Manual requiring a filer to securely maintain its EDGAR access codes. As adopted, filers, through their account administrators, will be required to securely maintain information relevant to their ability to access their EDGAR accounts. Because an existing analogous obligation is currently set forth in the EDGAR Filer Manual, the benefits of final paragraph (d)(6) of Rule 10 are expected to be marginal. However, in the context of the adopted amendments, paragraph (d)(6) of Rule 10 makes clear that this obligation persists under EDGAR Next and that filers are responsible for meeting the obligation through their account administrators.</P>
                    <HD SOURCE="HD3">e. Optional APIs and Technical Administrators</HD>
                    <P>
                        As discussed in section II.E, EDGAR Next will introduce optional APIs.
                        <SU>254</SU>
                        <FTREF/>
                         Filers may choose to connect to these APIs in order to facilitate the transmission of information to, and retrieval of information from, EDGAR. The optional APIs will particularly benefit larger filers with numerous users and CIKs by increasing filing efficiency and timeliness, thereby potentially reducing costs associated with making filings. In addition, the optional APIs aim to automate most of the functions of the dashboard, thereby increasing the efficiency of accurately managing EDGAR accounts for filers that use the optional APIs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>254</SU>
                             
                            <E T="03">See supra</E>
                             section II.E.1 for a description of the APIs.
                        </P>
                    </FTNT>
                    <P>
                        The APIs will streamline the submission and retrieval process by allowing automated server-to-server interaction. As discussed above, many filing agents employ a web scraping process to retrieve information from EDGAR and create custom software that allows filing agents to make submissions on and retrieve information from EDGAR in an automated manner. Filing agents' custom software depends on the underlying content and structure of the EDGAR web pages being scraped. Thus, filing agents continually incur costs to adjust their custom software, and could experience system downtime, because minor changes to EDGAR content and structure are frequently made, as with any major system. The optional APIs will provide a more reliable automated way for filers to interact with EDGAR because filers will not be dependent upon web scraping and impacted by EDGAR content and web page changes. This should further reduce the ongoing maintenance and personnel costs associated with custom software. Also, the optional APIs will reduce the likelihood of errors and inconsistencies in several ways. For example, the submission API will streamline the filing process by enabling filers to submit large volumes of filings rapidly and efficiently in an automated manner. This will eliminate the need to manually log into EDGAR and submit filings one by one, reducing the reliance on manual processes, which are more prone to human error.
                        <SU>255</SU>
                        <FTREF/>
                         The submission status API also will allow filers to check the status of multiple submissions in a batch process. In addition, the submission status API will provide all information currently contained in EDGAR submission notifications, enabling the filer to engage in prompt identification and correction of any inconsistencies.
                        <SU>256</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>255</SU>
                             
                            <E T="03">See supra</E>
                             note 147.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>256</SU>
                             
                            <E T="03">See supra</E>
                             section II.E.1 for a description of the APIs. In the event that a filer connects to the submission status API, they will continue to receive EDGAR submission notifications.
                        </P>
                    </FTNT>
                    <P>As described in sections II.E.1.a.ii and iii, filers and filing agents, as well as those using third-party custom applications, continuously interact with the EDGAR system to inquire as to the status of submissions or the operating status of EDGAR. These frequent inquiries may generate significant network traffic to and from EDGAR. Instead of manually logging into EDGAR and individually checking the status of each submission, the submission status and operational status APIs will benefit filers by allowing them to simultaneously check the status of multiple submissions in a machine-to-machine batch process, thereby reducing network traffic for filers.</P>
                    <P>
                        Paragraph (d)(3) of Rule 10 as adopted requires any filer that decides to connect to an optional API to authorize, through its account administrator(s), at least two technical administrators to manage the API, unless the filer arranges to use its delegated entity's filer API tokens and API connections so long as the delegated entity has authorized at least two technical administrators pursuant to paragraph (d)(3) of Rule 10. Filers will be allowed a maximum of 20 technical administrators to facilitate communication with Commission staff on API-related technical issues. This requirement will benefit filers because it will reduce the chance that filers' API access would be interrupted for any 
                        <PRTPAGE P="106208"/>
                        unforeseen technical issues. This requirement will also benefit both filers and the Commission by providing Commission staff with multiple points of contact in case of technical issues and increases the likelihood that an individual familiar with APIs and related technical issues is available to address any difficulties that may arise.
                    </P>
                    <HD SOURCE="HD3">f. Adopting Beta and Transition Period</HD>
                    <P>
                        The Commission will provide an Adopting Beta environment shortly after issuance of this release, which will be available to filers throughout the transition period until at least December 19, 2025. The Adopting Beta will benefit filers by providing them with time and resources to prepare for the EDGAR Next changes. Filers will be able to test in the Adopting Beta and conduct related development, including but not limited to creation of connections to the optional APIs, should they choose to do so. Testing, identification, and resolution of issues in the deployment of a new system will benefit filers by reducing the risk of errors and minimizing disruptions to filers' EDGAR operations during the transition. During the 12-month transition period, individuals that filers intend to authorize to act on their behalf may obtain 
                        <E T="03">Login.gov</E>
                         individual account credentials and filers may assemble information that they will need to enroll in EDGAR Next, such as their current CIK, CCC and passphrase, and information about the individuals that they will authorize as account administrators. The transition period will enable filers to transition to EDGAR Next in a planned and flexible manner, allowing filers to coordinate their own specifics onboarding needs and processes over the 12-month period. This degree of flexibility afforded to filers in timing their transition activities will facilitate compliance to EDGAR Next and reduce the risk of non-compliance. This is especially advantageous to small filers with fewer resources that may need more time to adapt to the new requirements.
                    </P>
                    <HD SOURCE="HD3">2. Costs</HD>
                    <P>
                        The costs associated with EDGAR Next include one-time costs for filers (including filing agents) to setup their EDGAR dashboard, create connecting API internal filing applications and adjust any other relevant internal software if they opt to connect to the APIs.
                        <SU>257</SU>
                        <FTREF/>
                         The costs associated with EDGAR Next also include ongoing costs for filers (including filing agents) to comply with new Rule 10 requirements related to access and management of EDGAR accounts. The compliance costs associated with EDGAR Next will vary depending on the size of the filer, the number of individuals acting on behalf of the filer, the filer's existing software, and the complexity of a filer's EDGAR application. EDGAR Next, however, may not increase filers' overall net compliance costs since modernizing the EDGAR access and account management processes will likely reduce ongoing compliance costs for some activities and for some reporting entities, such as filing agents and larger filers, due to streamlined management of filer credentials and accounts, simplified procedures to access EDGAR, and a more automated process for filing on EDGAR and retrieval of account information.
                    </P>
                    <FTNT>
                        <P>
                            <SU>257</SU>
                             
                            <E T="03">See infra</E>
                             section V.
                        </P>
                    </FTNT>
                    <P>Filers that opt to interact with the APIs will need to create internal applications to connect to APIs and discontinue or modify their current usage of any custom software, but the one-time cost of doing these tasks will be mitigated by the elimination of these filers' current ongoing maintenance costs associated with scraping EDGAR and adjusting custom software each time EDGAR undergoes changes. To facilitate filers' use of the optional APIs and help mitigate the associated costs, Commission staff have developed technical resources to assist filers in creating software to connect to APIs. Filers will be offered a list of technical standards for the APIs, the expected inputs and outputs, and additional API token information. Commission staff will also offer an open-source code for a sample filing application to facilitate connection to the initial three APIs in the API Toolkit and serve as a model for connection to the other APIs being offered.</P>
                    <HD SOURCE="HD3">a. Form ID</HD>
                    <P>
                        The Commission is adopting amendments to Form ID requiring all filers seeking electronic access to EDGAR to submit certain additional information for review and approval by Commission staff before such access may be granted.
                        <SU>258</SU>
                        <FTREF/>
                         As filers are already subject to the requirements of Form ID, the additional requirements for Form ID will entail certain incremental compliance costs.
                        <SU>259</SU>
                        <FTREF/>
                         The Commission estimates that compliance costs associated with the new Form ID will increase by approximatively $100 per filer for each Form ID submission.
                        <SU>260</SU>
                        <FTREF/>
                         For applicants seeking access to an existing EDGAR account, this cost may be mitigated by the fact that certain fields of the form will be prepopulated with certain publicly available information of the filer, which may reduce the cost associated with completing the amended form.
                        <SU>261</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>258</SU>
                             
                            <E T="03">See supra</E>
                             section II.F.3.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>259</SU>
                             
                            <E T="03">See infra</E>
                             section V.B.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>260</SU>
                             The $100 estimate is based on the following calculations: $101 (hourly rate for an operations specialist at $168 for 0.6 hours) ≉ $100. Salaries for estimates are derived from SIFMA's Management &amp; Professional Earnings in the Securities Industry 2013, modified to account for an 1,800-hour work-year and inflation, and multiplied by 5.35 to account for bonuses, firm size, employee benefits and overhead. 
                            <E T="03">See infra</E>
                             section V.B.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>261</SU>
                             
                            <E T="03">See supra</E>
                             note 187.
                        </P>
                    </FTNT>
                    <P>
                        One commenter argued that requiring a notarized power of attorney to add an employee of another entity as an account administrator could significantly increase the burden for individual reporting owners and render the option of using an outside account administrator practically not viable.
                        <SU>262</SU>
                        <FTREF/>
                         We disagree that requiring a notarized power of attorney in this instance creates an additional cost because, as stated in the baseline, the EDGAR Filer Manual currently requires filers to provide a notarized power of attorney. Therefore, given that the power of attorney requirement is consistent with an existing requirement, we do not expect a material difference in cost compared to the baseline.
                    </P>
                    <FTNT>
                        <P>
                            <SU>262</SU>
                             Workiva Comment Letter (“We believe that a notarized power of attorney should not be required to add an employee of another entity as an administrator. This could significantly increase the burden for the individual reporting owners, especially considering staffing changes at the affiliated entities. The burden could render the option of using an outside administrator practically not viable.”).
                        </P>
                    </FTNT>
                    <P>
                        One commenter opposed the notarization requirement for non-employee account administrators authorized on Form ID, stating that the notarization may not be readily accessible for everyone, which might result in unaccounted for burdens such as travel time and notarization costs.
                        <SU>263</SU>
                        <FTREF/>
                         Though we acknowledge the commenter's concern, we do not believe these additional costs are likely to be significant because the notarization process is relatively straightforward and analogous to the current requirement for all filers to obtain the notarized signature of the authorized individual on Form ID contained in the EDGAR Filer Manual. Furthermore, for filers that may not have access to physical notaries, online remote notarization is 
                        <PRTPAGE P="106209"/>
                        already permitted and will continue to be permitted by the Commission.
                        <SU>264</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>263</SU>
                             Block Transfer Comment Letter (“Notaries can pose challenges for an ever-increasing population with less and less access to physical bank branches and a distinct lack of other no-cost notarization providers.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>264</SU>
                             
                            <E T="03">See</E>
                             EDGAR Filer Manual, Volume I, at section 3. The EDGAR Filer Manual specifies the instructions filers must follow when making electronic filings on EDGAR and is incorporated by reference in the Code of Federal Regulations by 17 CFR 232.301 (Regulation S-T, Rule 301). Rule 10 of Regulation S-T and the EDGAR Filer Manual permit manual, electronic, and remote online notarizations, authorized by the law of any State or territory of the U.S. or DC 
                            <E T="03">See</E>
                             17 CFR 232.10 and EDGAR Filer Manual, Volume I, at section 3. An “authorized individual” for purposes of the Form ID notarization process is an individual with the authority to legally bind an entity or individual, or an individual with a power of attorney from an individual with the authority to legally bind an entity or individual, as defined in Volume I of the EDGAR Filer Manual and Rule 11 of Regulation S-T.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">b. Individual Account Credentials, Account Administrators</HD>
                    <P>
                        Final paragraph (d)(1) of Rule 10 will require that all existing and prospective filers only authorize an individual to perform functions on the dashboard on their behalf if that individual possesses individual account credentials obtained through 
                        <E T="03">Login.gov</E>
                        . Requiring individual account credentials will impose the minimal step of obtaining individual account credentials from 
                        <E T="03">Login.gov</E>
                         in the EDGAR access process resulting in some additional time burden for individuals who will have an EDGAR role for filers. Because the use of individual user permissions is a standard practice in software applications and computer systems, and 
                        <E T="03">Login.gov</E>
                         is free to use, we do not believe that requiring individual account credentials will be unduly burdensome or confusing.
                    </P>
                    <P>
                        One commenter stated that the introduction of individual account credentials could be disruptive and unduly burdensome for section 16 filers.
                        <SU>265</SU>
                        <FTREF/>
                         The commenter argued that section 16 filers will face additional burdens when applying for EDGAR access and enrolling in EDGAR Next themselves and requested that EDGAR permit a corporate secretary or legal personnel of a registrant to obtain EDGAR access for an individual section 16 filer pursuant to a power of attorney.
                        <SU>266</SU>
                        <FTREF/>
                         We acknowledge the commenter's concern; however, we do not believe that section 16 filers will face additional costs beyond the costs that other filers incur, given the various compliance options available to them. For example, as discussed above in section II.B, section 16 filers with existing accounts may avoid obtaining 
                        <E T="03">Login.gov</E>
                         individual account credentials for EDGAR if they authorize an individual at their filing agent or other third party to enroll them in EDGAR Next and during enrollment authorize one or more individuals at these entities to act as their account administrators. Likewise, section 16 filers who are applying for access on amended Form ID may use a notarized power of attorney to delegate to another person the process of obtaining individual account credentials and making filings on their behalf. The commenter also stated that some features of 
                        <E T="03">Login.gov</E>
                         (
                        <E T="03">e.g.,</E>
                         text or voice MFA options) are restricted in certain countries, which could impose an added burden on filers based outside the United States.
                        <SU>267</SU>
                        <FTREF/>
                         As discussed in section II.A, 
                        <E T="03">Login.gov</E>
                         offers individuals several different authentication methods and individuals need only choose one method available to them. Therefore, we do not anticipate any additional costs for filers based outside of the United States.
                    </P>
                    <FTNT>
                        <P>
                            <SU>265</SU>
                             
                            <E T="03">See</E>
                             SCG Comment Letter.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>266</SU>
                             
                            <E T="03">See</E>
                             SCG Comment Letter.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>267</SU>
                             
                            <E T="03">See</E>
                             SCG Comment Letter.
                        </P>
                    </FTNT>
                    <P>
                        Final paragraph (d)(2) of Rule 10 will require filers to authorize at least two account administrators to act on the filers' behalf to manage their accounts. Filers that are individuals or single-member companies will be required to authorize and maintain at least one account administrator. Prospective EDGAR filers will designate on amended Form ID the individuals that the filer authorizes as account administrators. As such, the compliance costs associated with the new Form ID 
                        <SU>268</SU>
                        <FTREF/>
                         reflects the burden associated with the enrollment of account administrators. Existing filers will authorize their account administrators through a function on the dashboard, which is encompassed in the one-time cost that filers will incur to set up their accounts on the EDGAR Next dashboard.
                        <SU>269</SU>
                        <FTREF/>
                         Additionally, other costs associated with account administrators are encompassed by the costs associated with ongoing maintenance of the dashboard.
                        <SU>270</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>268</SU>
                             
                            <E T="03">See supra</E>
                             note 260.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>269</SU>
                             
                            <E T="03">See infra</E>
                             note 274.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>270</SU>
                             
                            <E T="03">See infra</E>
                             note 275.
                        </P>
                    </FTNT>
                    <P>We do not expect individual or single-member filers to hire additional personnel in order to comply with final paragraph (d)(2) of Rule 10 because individual or single-member filers may act as their own account administrators or authorize an individual at their filing agent or other representative entity as an account administrator. Existing filers also may authorize an individual at their filing agent or other third party to enroll them in EDGAR Next and during enrollment authorize one or more individuals at these entities to act as their account administrators. Similarly, filers who apply for access on amended Form ID may authorize one or two individuals at their filing agents or relevant companies as their account administrators, so long as they execute a relevant notarized power of attorney. Nevertheless, this requirement will result in the opportunity cost of personnel being less available to attend to other matters while performing their account administrator duties.</P>
                    <P>
                        Two commenters asserted that the Proposing Release's economic analysis did not sufficiently account for additional non-developmental support costs imposed on filing agents and law firms that may need to hire additional personnel to manage the administrative aspects of the dashboard, which likely will be passed on to registrants.
                        <SU>271</SU>
                        <FTREF/>
                         One commenter acknowledged that the additional support and management burden for filing agents is difficult to quantify, which makes it hard for the Commission to evaluate.
                        <SU>272</SU>
                        <FTREF/>
                         As stated in the Proposing Release, filers with a large number of users would spend a greater amount of time managing their dashboard accounts.
                        <SU>273</SU>
                        <FTREF/>
                         We anticipate that most large filers and filing agents will authorize their own employees or affiliates in order to comply with final paragraph (d)(2) of Rule 10 and will not need to hire additional personnel. However, we acknowledge that a large filer or filing agent will face additional costs if it needs to hire additional personnel to comply, and we recognize that, although only two account administrators are required, a filer or filing agent may hire as many as 20 account administrators. To the extent additional personnel need to be hired, there will be costs associated with the hiring process.
                    </P>
                    <FTNT>
                        <P>
                            <SU>271</SU>
                             XBRL Comment Letter (“[t]he economic [analysis] described in the proposed rule does not include the additional non-developmental support costs. Filing agents and law firms are estimated to be responsible for over 90% of EDGAR filings. Additional support costs are likely to be passed on to registrants.”); Workiva Comment Letter (“[t]he economic [ ] analysis also does not include the additional non-developmental support costs imposed on filing agents and law firms, estimated to be responsible for over 90% of EDGAR filings, which would presumably be passed on to their customers/registrants. The additional support and management burden for filing agents will be substantial but hard to quantify at this point.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>272</SU>
                             Workiva Comment Letter.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>273</SU>
                             Proposing Release at 65549 (“[w]e recognize that due to these factors, the burden incurred would vary across filers. Filers with a large number of users and significant turnover would likely spend a greater amount of time managing their dashboard accounts.”); 
                            <E T="03">see also infra</E>
                             note 277.
                        </P>
                    </FTNT>
                    <PRTPAGE P="106210"/>
                    <HD SOURCE="HD3">c. Final Amendments to Paragraphs (d)(4), (d)(5), and (d)(6) of Rule 10, and Rule 11</HD>
                    <P>
                        As adopted, paragraph (d)(4) of Rule 10 will require each filer through its account administrators to perform an annual confirmation on EDGAR that all account administrators, users, technical administrators, and delegated entities reflected on its dashboard are authorized by the filer to act on its behalf and that all information about the filer on the dashboard is accurate. The annual confirmation requirement will impose additional compliance costs on filers to review the accuracy of their EDGAR account information on the dashboard. We estimate that, in the first year, there will be a one-time cost of approximatively $200 per filer, on average, to set-up the filer's account on the EDGAR Next dashboard.
                        <SU>274</SU>
                        <FTREF/>
                         We also estimate that, there will be a recurring cost, including in the first year, of approximatively $200 per filer, on average, to manage the filer's dashboard.
                        <SU>275</SU>
                        <FTREF/>
                         These costs will likely vary with the number of users that the filer authorizes and the amount of turnover of relevant personnel.
                        <SU>276</SU>
                        <FTREF/>
                         For example, a filer with a large number of users that experiences high turnover in users could have to spend more time managing its dashboard, in which instance it will incur additional costs to do so.
                        <SU>277</SU>
                        <FTREF/>
                         Filing agents are also likely to face higher dashboard management costs if they authorize a large number of individuals and have multiple accepted delegations and user groups for which delegated users will need to be maintained.
                        <SU>278</SU>
                        <FTREF/>
                         Such costs will likely be mitigated by active notifications and other efficiencies provided by the dashboard, and the optional APIs as an account management tool.
                    </P>
                    <FTNT>
                        <P>
                            <SU>274</SU>
                             The $200 estimate is based on the following calculations: $168 (hourly rate for an operations specialist at $168 for 1 hour) ≉ $200. Salaries for estimates are derived from SIFMA's Management &amp; Professional Earnings in the Securities Industry 2013, modified to account for an 1,800-hour work-year and inflation, and multiplied by 5.35 to account for bonuses, firm size, employee benefits and overhead. 
                            <E T="03">See infra</E>
                             section V.C.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>275</SU>
                             The $200 estimate is based on the following calculations: $168 (hourly rate for an operations specialist at $168 for 1 hour) ≉ $200. Salaries for estimates are derived from SIFMA's Management &amp; Professional Earnings in the Securities Industry 2013, modified to account for an 1,800-hour work-year and inflation, and multiplied by 5.35 to account for bonuses, firm size, employee benefits and overhead. 
                            <E T="03">See infra</E>
                             section V.C.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>276</SU>
                             
                            <E T="03">See infra</E>
                             section V.C.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>277</SU>
                             If a filer fails to perform a timely annual confirmation, after a three-month grace period, it must complete and submit a Form ID to apply for access to file on EDGAR. If Commission staff grant the Form ID, a filer will need to re-invite any users, technical administrators, and additional account administrators to its account, and reissue delegation invitations, if relevant. Re-issuing invitations will take longer for larger filers and filing agents with many users acting on behalf of the filer.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>278</SU>
                             
                            <E T="03">See infra</E>
                             section V.C.
                        </P>
                    </FTNT>
                    <P>We have sought to ease the transition to EDGAR Next for filers by allowing enrollment of multiple accounts simultaneously on the dashboard, via bulk enrollment of up to 100 filers and their account administrators. The bulk enrollment feature will particularly benefit large filing agents enrolling multiple accounts by saving time and labor costs, which will help mitigate against any higher compliance costs these entities would otherwise incur. We are also offering an optional API to facilitate the enrollment process and lower costs.</P>
                    <P>
                        As adopted, paragraphs (d)(5) and (d)(6) of Rule 10 are analogous to existing requirements set forth in the EDGAR Filer Manual, and filers are not expected to incur significant incremental costs of compliance given they should already be complying with these requirements when using the EDGAR system.
                        <SU>279</SU>
                        <FTREF/>
                         We also do not expect filers to incur compliance costs related to the new terms defined in amended Rule 11.
                    </P>
                    <FTNT>
                        <P>
                            <SU>279</SU>
                             
                            <E T="03">See supra</E>
                             notes 170 and 171.
                        </P>
                    </FTNT>
                    <P>
                        One commenter said that proposed paragraph (d)(4) of Rule 10 contributes to an overall higher complexity for filing agents with a large number of accounts and associated individuals due to the sheer amount of information required to review.
                        <SU>280</SU>
                        <FTREF/>
                         The provision of multiple notices of the impending confirmation deadline to account administrators via email and dashboard notifications,
                        <SU>281</SU>
                        <FTREF/>
                         as well as the three-month grace period provided after the confirmation deadline has passed before deactivation occurs,
                        <SU>282</SU>
                        <FTREF/>
                         will help ensure that the filer's account administrators receive adequate notice and opportunity to timely perform confirmation without negatively affecting their submission preparation lead time. This will help minimize the administrative burden and ongoing maintenance costs related to the requirement to perform annual confirmation on the dashboard. In addition, delegated entities such as filing agents will be able to use the “view filer account information API” to programmatically check impending confirmation deadlines for filers that have delegated filing authority to them.
                        <SU>283</SU>
                        <FTREF/>
                         This will allow filing agents to remind their client filer's account administrators to perform annual confirmation in a timely manner.
                        <SU>284</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>280</SU>
                             Workiva Comment Letter (“The annual confirmation requirement would increase the burden on all filers due to the amount of user content to review, and it contributes to the overall higher complexity for filers to manage in order to file.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>281</SU>
                             
                            <E T="03">See supra</E>
                             section II.B.1.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>282</SU>
                             These notices will be provided in the dashboard and also be sent via email to all account administrators' email addresses (
                            <E T="03">e.g.,</E>
                             the confirmation deadline notices will be periodically provided in both email and via the dashboard multiple times leading up to the deadline to ensure that the account administrators are fully aware of the pending deadlines). 
                            <E T="03">See supra</E>
                             section II.1 (discussing account administrators).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>283</SU>
                             
                            <E T="03">See supra</E>
                             section II.E.2.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>284</SU>
                             Delegated account administrators cannot perform annual confirmation for the filer.
                        </P>
                    </FTNT>
                    <P>
                        Filers will have the flexibility to perform annual confirmation on any date prior to the confirmation deadline, thus allowing filers to comply with the requirement at a time that is best suited for them and thereby lessening this compliance cost. Filers are required to authorize at least two account administrators to act on the filers' behalf to manage their accounts and they may authorize up to 20 account administrators on the dashboard.
                        <SU>285</SU>
                        <FTREF/>
                         Having multiple account administrators facilitates the management of large accounts since each account administrator will possess the same authority to manage the filer's EDGAR account and perform the confirmation. This will reduce the burden on any one account administrator by making the confirmation more manageable and reducing the likelihood of a single account administrator failure. Furthermore, the dashboard is structured to facilitate the annual confirmation review by allowing account administrators to manage the filer's account on the dashboard and through optional APIs. The optional APIs will enable cost efficiencies in the review process by allowing filers to rapidly add and remove individuals, change roles, and perform delegations to ensure the accuracy of information on the dashboard in advance of confirmation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>285</SU>
                             Single member companies and individuals are only required to authorize and maintain at least one account administrator.
                        </P>
                    </FTNT>
                    <P>
                        Two commenters argued that the annual confirmation requirement would impose a significant burden on those who file infrequently, such as section 16 filers.
                        <SU>286</SU>
                        <FTREF/>
                         We do not believe that the annual confirmation requirement would impose a significant burden on infrequent filers, such as section 16 filers. While section 16 filers who wish to act as their own account 
                        <PRTPAGE P="106211"/>
                        administrators may log into the dashboard, review the information there, and proceed through a short confirmation process once per year, they may instead rely upon other individual(s) they authorize as account administrators to perform the annual confirmation requirement on their behalf. Additionally, as stated above, account administrators will receive multiple notices of the impending confirmation deadline via email and dashboard notifications,
                        <SU>287</SU>
                        <FTREF/>
                         as well as the three-month grace period provided after the confirmation deadline has passed before deactivation occurs.
                        <SU>288</SU>
                        <FTREF/>
                         These features will provide ample reminders to filers, including infrequent filers, of the annual confirmation requirement process.
                    </P>
                    <FTNT>
                        <P>
                            <SU>286</SU>
                             XBRL Comment Letter (“The annual confirmation requirement will create a significant additional burden for filers that use a filing agent's SEC credentials, in particular for those filers who make sporadic submissions such as Section 16 filers.”). 
                            <E T="03">See also</E>
                             Toppan Merrill Comment Letter (“This update particularly impacts Section 16 filers who do not frequently file or rely on the Issuer to submit their filings.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>287</SU>
                             
                            <E T="03">See supra</E>
                             note 281.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>288</SU>
                             
                            <E T="03">See supra</E>
                             note 282.
                        </P>
                    </FTNT>
                    <P>
                        One commenter further stated that the current annual password renewal requirement does not represent a similar burden to the annual confirmation requirement since filers can retain their EDGAR access by using a filing agent's CIK and password.
                        <SU>289</SU>
                        <FTREF/>
                         As discussed above, all filers will receive, both via email and through the dashboard, notices of an impending confirmation deadline, and daily notices of failure to timely confirm over a three-month period prior to deactivation of the account. Further, an optional filing credentials API will be provided to allow filers that opt to connect to APIs to programmatically check upcoming confirmation deadlines.
                    </P>
                    <FTNT>
                        <P>
                            <SU>289</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“This is not currently a burden with the EDGAR annual password expiration. Filers can continue to access EDGAR, as well as submit filings on EDGAR, using a filing agent's valid CIK and Password”).
                        </P>
                    </FTNT>
                    <P>
                        One commenter asserted that suspension of the filer's account due to failure to complete the annual confirmation requirement by the end of the two-week grace period as proposed would pose undue burden on American small businesses and hinder small business' access to capital.
                        <SU>290</SU>
                        <FTREF/>
                         Another commenter expressed concerns about deactivation risk and recommended a temporary suspension over account deactivation since failure to confirm may result from other circumstances rather than account abandonment.
                        <SU>291</SU>
                        <FTREF/>
                         We acknowledge these concerns and have extended the grace period following a missed confirmation deadline from two weeks to three months, which should help reduce the burdens associated with unanticipated account deactivation. Filers will maintain their EDGAR access through the three-month grace period and will receive daily notifications reminding them to satisfy their annual confirmation requirement. Further, following account deactivation, EDGAR will preserve the filer's filing history. While filers with deactivated accounts will incur the cost of having to reapply for access and re-invite all individuals previously authorized, such burden may be alleviated for filers that use the APIs offered by EDGAR. The APIs will allow filers to: change individuals' roles; send delegation invitations; request delegations; add individuals to CIKs in various roles; and remove individuals from CIKs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>290</SU>
                             
                            <E T="03">See</E>
                             Block Transfer Comment Letter (“[W]e respectfully believe that automatically closing accounts without annual verifications as proposed on page 88 would hinder SBAC [Small Business Access to Capital] and pose an undue burden on American small businesses.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>291</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“We strongly recommend temporary suspension over account deactivation with removal of all user and delegation information. Failure to confirm annually may signal a problem occurred in the notification process rather than the filer being no longer in control of the account. For example, email blocking or email going to the spam folder could lead to the filer not receiving the annual confirmation reminders. It is also possible that the administrator(s) may be on leave or out of office. Based on our customer survey, about 23% of the respondents indicated the annual confirmation requirement is a low burden, while over 33% indicated that the annual confirmation requirement is a high burden and they are “concerned” to “highly concerned” about the potential account deactivation risk.”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">d. Optional APIs and Technical Administrators</HD>
                    <P>
                        Filers or filing agents that choose to connect to the available APIs will incur a one-time cost to adjust their internal software systems to the optional APIs. We have estimated the direct costs to filers or filing agents that wish to connect to the optional APIs, including time and personnel costs to build a filing application integrated with all functions to successfully connect to the EDGAR APIs. These expenses are likely to vary across filers depending on their existing software and the complexity of their application and individual business models, among other factors. Based on the experience of Commission staff in developing the sample filing application to connect to certain EDGAR APIs being offered to filers, the total estimated cost per filer for filing applications to connect to an EDGAR API by an external programmer analyst 
                        <SU>292</SU>
                        <FTREF/>
                         should be approximatively $33,000 
                        <SU>293</SU>
                        <FTREF/>
                         for filers with a preexisting filing application and approximatively $41,000 for filers that do not have a preexisting filing application.
                        <SU>294</SU>
                        <FTREF/>
                         Given that the APIs are optional, filers may choose to incur this cost to the extent that they expect the benefit of using the APIs to exceed the cost of doing so.
                    </P>
                    <FTNT>
                        <P>
                            <SU>292</SU>
                             We do not expect this programming work to be performed by technical administrators. As indicated below, we expect technical administrators will be operations specialists, 
                            <E T="03">see infra</E>
                             note 307.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>293</SU>
                             The $33,000 estimate is based on the following calculations: $32,544 (hourly rate for a senior programmer analyst at $339 for 96 hours) ≉ $33,000. Salaries for estimates are derived from Payscale, 
                            <E T="03">available at www.payscale.com.</E>
                             Using data from the 75th percentile in February 2023, adjusting for an 1,800 hour work year and inflation, and multiplying by the 5.35 factor which normally is used to include benefits but here is used as an approximation to offset the fact that New York salaries are typically higher than the rest of the country, the result is $324 per hour.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>294</SU>
                             The $41,000 estimate is based on the following calculations: $40,680 (hourly rate for a senior programmer analyst at $339 for 120 hours) ≉ $41,000. Salaries for estimates are derived from Payscale, 
                            <E T="03">available at www.payscale.com.</E>
                             Using data from the 75th percentile in February 2023, adjusting for an 1,800 hour work year and inflation, and multiplying by the 5.35 factor which normally is used to include benefits but here is used as an approximation to offset the fact that New York salaries are typically higher than the rest of the country, the result is $324 per hour.
                        </P>
                    </FTNT>
                    <P>Filers will need to create connections to the optional APIs and may modify other existing internal software systems to comport with connections to APIs. For filers that have been scraping EDGAR web pages and creating custom software, the one-time cost of setting up API connections and adjusting internal software systems will be mitigated by the elimination of these filers' current ongoing maintenance costs associated with scraping EDGAR web pages and adjusting custom software each time EDGAR undergoes changes. Not all filers currently use custom software to interface with EDGAR, however, and some filers instead submit their filings directly through the EDGAR filing website. We have observed, for instance, that small filers typically do not use custom filing software and are unlikely to choose to connect to the optional APIs, therefore we do not expect they will incur this cost. Small filers that do not currently use custom software or lack the resources to develop their own API connections or employ their own technical administrators may use the APIs that their delegated entity develops and maintains as set forth in paragraph (d)(3) of Rule 10.</P>
                    <P>
                        One commenter recommended revising the APIs to accept path parameters rather than raw XML and to consider this revision in the economic analysis.
                        <SU>295</SU>
                        <FTREF/>
                         The commenter asserted 
                        <PRTPAGE P="106212"/>
                        that modern APIs use path parameters and implementing path parameters in the APIs would simplify machine-to-machine information retrieval as opposed to raw XML, which the commenter stated is not friendly to developers.
                        <SU>296</SU>
                        <FTREF/>
                         This comment does not accurately reflect the nature of the APIs that are being provided by Commission staff. The APIs, as designed, will take advantage of path parameters, which should largely address the commenter's concerns. Path parameters are intended to be used to identify specific resources or data points, such as a filer's CIK, and they are not suitable for providing complex nested data, such as the information that would be required to be included in an EDGAR submission. In those cases, XML is better suited for providing structured data in a format that can be easily interpreted and accepted by the APIs. Commission staff have developed the APIs accordingly.
                    </P>
                    <FTNT>
                        <P>
                            <SU>295</SU>
                             Block Transfer Comment Letter (“[T]here should be certain simplified endpoints which accept path parameters rather than raw XML. This would simplify the machine-to-machine reporting of important market information for all issuers. It would also drastically streamline the technical inclusion of route-specific authorizations).
                        </P>
                        <P>
                            Despite the vast efficiencies that the detail-oriented XML framework brought to the industry 
                            <PRTPAGE/>
                            over the past 27 years through standardized reporting, we respectfully submit to the Commission that the markup language is not friendly to developers, international locale standards, or efficient machine-to-machine code. Modern APIs use path parameters, eliminating the need to compile variables into a file before submission.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>296</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        A commenter stated that the economic analysis in the Proposing Release failed to account for the costs of filing agents likely needing to update or develop an application to manage delegation.
                        <SU>297</SU>
                        <FTREF/>
                         We disagree with the commenter that this is a significant cost that should have been accounted for in the Proposing Release. Because EDGAR Next already offers multiple ways to manage delegations, we do not believe that filers and filing agents will need to update or develop an application for this purpose. As stated in the Proposing Release and herein, the filer's account administrator may delegate authority to file to another EDGAR account through a function on the dashboard where they can also terminate delegation.
                        <SU>298</SU>
                        <FTREF/>
                         The dashboard will be enhanced to: (1) provide bulk delegation functionality to allow filers to delegate to multiple CIKs more easily; (2) enable prospective delegated entities to send delegation requests to filers; and (3) allow filers to automatically accept delegations and become delegated entities if they choose. These three enhancements are available on the dashboard, and do not require creation or updating of an application. Moreover, for filers that opt to use the available APIs, an optional delegation API will also be offered replicating most dashboard functionality in machine-to-machine connections. Although filers who wish to use the delegation API will need to create connections to the API to do so, this is no different from how filers will connect to the other APIs and we do not expect any unique costs will apply in this context. Account administrators will be able to delegate authority to file to an unlimited number of EDGAR accounts, allowing filers to delegate to multiple filing agents, for example.
                    </P>
                    <FTNT>
                        <P>
                            <SU>297</SU>
                             
                            <E T="03">See</E>
                             DFIN Comment Letter (“Estimated cost should include the likelihood that filing agents would need to update or create an application to manage delegations.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>298</SU>
                             
                            <E T="03">See</E>
                             Proposing Release, section III.C.1; 
                            <E T="03">see also supra</E>
                             section II.C.1.
                        </P>
                    </FTNT>
                    <P>
                        Another commenter stated that the proposed API connective software development time was overly optimistic, and that the proposal's costs estimates failed to account for many important items, such as API integration time, the software changes for token management and filing preparation, customer discovery and beta testing.
                        <SU>299</SU>
                        <FTREF/>
                         We agree with the commenter that API connective software development time should encompass API integration time, the software changes for token management and filing preparation, customer discovery and beta testing. Our cost estimate in the proposal and herein captures these items. First, our cost estimate assumes that the sample application will be built from scratch with no documentation or open-source code base. Second, our estimate includes building a basic application with limited user interface functions that submits LIVE and TEST filings and requests system status and submission status from the EDGAR API, which are essential for beta testing and filing preparation. To further facilitate API integration time and mitigate some of the aforementioned development costs, Commission staff will offer filers technical resources, such as an API Development Toolkit and a sample filing application, to assist filers in developing their own connective filing software. The sample filing application will provide technical details and a working code base that could be either copied into existing filing applications or used as a base for developing a new filing application. The sample filing application code is a starting point for smaller filers that may not already have a filing application and want to enter the API space. This sample code can serve as a troubleshooting guide/reference material for all developers because it uses specific technologies (
                        <E T="03">e.g.,</E>
                         PostgreSQL, NodeJS, Angular) that are well-documented, commonly used, and can be understood by a mid-level programmer.
                    </P>
                    <FTNT>
                        <P>
                            <SU>299</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“If an actual user must be associated with the process due to the need to present a user token, this could potentially impose additional services . . .”); (“In our opinion, the development time estimate of 96-120 hours is a very low estimate. Considering the API integration time, the software changes for token management and filing preparation, customer discovery and beta testing time, the estimate could be an order of magnitude higher. In addition, monitoring and adapting to changes in the EDGAR Next beta environment will incur ongoing costs through March 2024. The economic [ ] analysis also does not include the additional non-developmental support costs imposed on filing agents and law firms . . .”).
                        </P>
                    </FTNT>
                    <P>
                        One commenter questioned the implementation of filer and user tokens within the delegation framework and asserted that the EDGAR Next framework could lead to longer filing preparation time and hinder the efficiency of an automated filing process.
                        <SU>300</SU>
                        <FTREF/>
                         To address the commenter's concern, and in a change from the proposal, filers that utilize a delegated entity also have, under the final amendments, the option of using a delegated entity's filer API token and API connections to make submissions on behalf of the filer, so long as the delegated entity has authorized at least two technical administrators in accordance with paragraph (d)(3) of Rule 10. This change may further serve to mitigate concerns about development costs. As a result, APIs may be more accessible for smaller filers that may not have the resources to develop API connections or employ their own technical administrators, as they may instead delegate to a larger filer or filing agent that can develop API connections and obtain and maintain filer API tokens and two technical administrators.
                    </P>
                    <FTNT>
                        <P>
                            <SU>300</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“[c]hange of provider could require longer lead time due to the delegation set up and acceptance process, as well as making the tokens available in the filing systems. This could put pressure on the filers when they need to respond to unforeseen situations.”).
                        </P>
                    </FTNT>
                    <P>
                        Two commenters were critical of the proposal's use of filer and user tokens.
                        <SU>301</SU>
                        <FTREF/>
                         One commenter claimed the use of specific user tokens would subject filing agents to a higher cost of service and longer filing preparation lead time.
                        <SU>302</SU>
                        <FTREF/>
                         We do not think the use of specific user tokens is unduly burdensome for filers that choose to make submissions through APIs. Generating a filer API token or a user API token is a straightforward process accomplished on the dashboard within approximately one minute of logging in. Furthermore, the use of tokens to 
                        <PRTPAGE P="106213"/>
                        connect to APIs is a security requirement designed to minimize the potential for unauthorized intrusions to EDGAR. In addition, presentation of the individual's user API token allows the Commission to identify who makes each submission on EDGAR, a primary goal of this rulemaking. Removing the user API token requirement would frustrate the Commission's objective of enhancing the security of EDGAR and tracing filings to the individuals who make them.
                    </P>
                    <FTNT>
                        <P>
                            <SU>301</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter and XBRL Comment Letter.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>302</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“the potential impact on increased manual intervention resulting in higher services costs, which are hard to accurately estimate at this point although we expect it to be far reaching due to the percentage of public registrants potentially impacted by this.”).
                        </P>
                    </FTNT>
                    <P>
                        Two commenters argued that the monthly user multifactor authentication login requirement would create a significant burden for their filing teams and their section 16 filers.
                        <SU>303</SU>
                        <FTREF/>
                         In a change to the proposing release, rather than the user API token remaining valid for up to one year so long as the user logged into EDGAR at least every 30 days, the individual will need to log in to generate a new user API token every 30 days or otherwise prior to making an infrequent filing. While we acknowledge that the requirement that a person log in to generate a new user API token every 30 days (if necessary to make a filing) may inconvenience some filers, the cost of this burden will not be significant because generating a user API token is a straightforward process accomplished on the dashboard. We estimate that a user API token could be generated within approximately one minute of logging into the dashboard. Section 16 filers may either authorize an individual at their filing agent or other third party to enroll them in EDGAR Next and during enrollment authorize one or more individuals at these entities to act as their account administrators or, when applying for access on amended Form ID, authorize individuals at their filing agents or other representative entity as their account administrators using a notarized power of attorney, each of whom may file on their behalf. Also, any incremental burdens imposed by the monthly user multifactor authentication login requirement must be considered in light of the potential benefits it will provide. User API tokens will enhance authentication, provide traceability for filings, and improve EDGAR security.
                    </P>
                    <FTNT>
                        <P>
                            <SU>303</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter (“We believe a user role that has only the authority to file and manage its credentials and membership is appropriate. However, one proposed requirement for users is to log into one of the three EDGAR sites at least once every 30 days in order to keep the user token active. According to our customer survey, about 72% of the respondents indicated that this requirement poses a significant burden or risk to their filing teams.”); Block Transfer Comment Letter (“We respectfully submit to the Commission that development based access keys should not be subject to monthly user MFA checks. We believe that imposing such checks on these keys may introduce unnecessary complexities and hinder the efficiency of development teams working on various projects.”).
                        </P>
                    </FTNT>
                    <P>
                        Another commenter estimated a total of 240 developer hours towards securely storing and managing the filer and user API tokens.
                        <SU>304</SU>
                        <FTREF/>
                         We believe, however, that the commenter's estimate of 240 additional developer hours due to the API token requirements is likely overstated. As discussed above, we estimate that it will take between 96 and 120 hours to configure the filer's filing application correctly to be able to interact with the API.
                        <SU>305</SU>
                        <FTREF/>
                         This estimate includes the time that filers will spend to implement a method to store the tokens in a database and to use the tokens within filers' applications to connect to the EDGAR APIs. Thus, we believe that the API application development cost estimate provided above already adequately incorporate the above steps of integrating and managing the API tokens.
                    </P>
                    <FTNT>
                        <P>
                            <SU>304</SU>
                             
                            <E T="03">See</E>
                             XBRL Comment Letter (“Furthermore, the changes to securely store and manage Filer and User Tokens could easily add 240 developer hours.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>305</SU>
                             
                            <E T="03">See supra</E>
                             notes 293 and 294, estimating 96 hours for filers with an existing filing application and 120 hours for filers that do not have a preexisting filing application.
                        </P>
                    </FTNT>
                    <P>
                        Filers that choose to connect to the APIs will also incur the additional cost of authorizing, through their account administrator(s), at least two technical administrators to manage the technical aspects of the APIs.
                        <SU>306</SU>
                        <FTREF/>
                         The Commission estimates that annually, on average, each filer that chooses to connect to the APIs will incur approximately $170 in compliance costs per CIK with respect to the technical administrators' responsibilities.
                        <SU>307</SU>
                        <FTREF/>
                         These costs may vary depending on the size of the filer, the number of filer API tokens the filer employs at any given time, and the business needs of the filer with regards to the usage and management of APIs (including but not limited to the security standards imposed by the filer). We do not expect that filers will need to hire new employees to fill the technical administrator role since the primary responsibilities for the technical administrator are to generate the filer API token on an annual basis and securely store it within a filer's application and to be available in the event that a technical issue arises with APIs. We believe that larger filers and filing agents using APIs will have sufficient staff to authorize at least two technical administrators. Smaller filers who choose to connect to APIs will likely employ a delegated entity to avoid the burden of obtaining and maintaining their own filer API tokens, engineering their own API connections, and designating two technical administrators. Final paragraph (d)(3) of Rule 10's requirement that a filer authorize, through its account administrator(s), at least two technical administrators will not apply to a filer that uses the filer API token and API connections of its delegated entity, so long as the delegated entity has authorized its own technical administrators in accordance with paragraph (d)(3) of Rule 10. Filers that rely upon their delegated entity's filer API token and API connections will not need to obtain and maintain their own filer API tokens or engineer their own API connections, although their account administrators and users will need to supply their own user API tokens to the APIs, if those APIs require presentation of a user API token.
                    </P>
                    <FTNT>
                        <P>
                            <SU>306</SU>
                             
                            <E T="03">See</E>
                             paragraph (d)(3) of Rule 10 as adopted.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>307</SU>
                             The $170 estimate is based on the following calculations: $168 (hourly rate for an operations specialist at $168 for 1 hour) ≉ $170. Salaries for estimates are derived from SIFMA's Management &amp; Professional Earnings in the Securities Industry 2013, modified to account for an 1,800-hour work-year and inflation, and multiplied by 5.35 to account for bonuses, firm size, employee benefits and overhead. These represent costs beyond the quantified costs for technical administrators that are associated with dashboard management. 
                            <E T="03">See supra</E>
                             note 275 for an estimate of the annual cost of dashboard management. Based on Commission staff experience and knowledge regarding the filing agent industry, we estimate there will be 208 filers that will be required to satisfy the technical administrator requirements.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">e. Adopting Beta and Transition Period</HD>
                    <P>
                        During the transition process to EDGAR Next, filers will incur certain ancillary costs related to testing and quality assurance. These costs may also include documentation and technical support cost for personnel managing the transition at the filer. For example, one commenter estimated 8 hours per week to track changes in the Proposing Beta through March 2024.
                        <SU>308</SU>
                        <FTREF/>
                         We expect that there will be a similar cost to track changes in the Adopting Beta. However, to help mitigate some of these costs, Commission staff will provide dedicated telephone support and an email help desk—
                        <E T="03">EDGARNextBeta@sec.gov</E>
                        —as well as an online form (available in the Adopting Beta) to report technical bugs. A more improved user experience will ultimately reduce the possibility of errors and disruption for filers, thus minimizing the cost burden associated with transitioning to the new filing regime. The Adopting Beta will help 
                        <PRTPAGE P="106214"/>
                        minimize disruptions to the filing processes for all filers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>308</SU>
                             XBRL Comment Letter (“There is also an estimated 8 hours per week to track changes in the beta through March 2024.”).
                        </P>
                    </FTNT>
                    <P>
                        Filers will have six months prior to the compliance date and three months after the compliance date within which to enroll through a function on the dashboard. Once a filer enrolls in EDGAR Next, the filer's CCC will be automatically reset. One commenter stated that requiring the CCC to be reset after a filer enrolls will negatively impact filing preparation lead time as individuals must first log in to view any CCC changes before submission.
                        <SU>309</SU>
                        <FTREF/>
                         We disagree with the commenter's characterization of the additional cost associated with viewing any CCC changes. To protect the security of the filer's EDGAR account, EDGAR will automatically reset the filer's CCC following the filer's enrollment in EDGAR Next. To leave the CCC unchanged after enrollment would frustrate the Commission's effort to enhance the security of EDGAR. We do not expect a one-time reset of the filer's CCC to cause any major disruptions because filers should be aware that the CCC will change and that they can manage it themselves on the dashboard after enrollment. To reduce the cost associated with resetting the CCC, the new CCC will be visible on the dashboard to all individuals with the ability to make submissions on the filer's behalf. Further, EDGAR will offer APIs to view filer account information and verify filing credentials, including the filer's CCC. We therefore do not believe that resetting the CCC upon enrollment will negatively impact filing preparation lead time.
                    </P>
                    <FTNT>
                        <P>
                            <SU>309</SU>
                             Workiva Comment Letter (“As discussed in the response to question 35, sweeping changes to CCC is a big disruption and risk factor to the filing chain. Coordination issues could be easily resolvable on a small scale, but at this large scale even for filing agents that have been delegated to or added as account administrators, the time requirement to log in and view CCC changes could significantly impact filing lead time given the volume and the concentration of these issues.”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Effects on Efficiency, Competition, and Capital Formation</HD>
                    <P>The final amendments will enhance the security of EDGAR by improving the security of submissions, the individual traceability of filings, and regulatory oversight into filings. The amendments will also streamline the filing process, including filing preparations, and enhance the efficiency of the Commission's review and processing of EDGAR submissions. The amendments therefore will better protect against unauthorized access to filers' accounts and unauthorized filings on the EDGAR system. This will reduce the risk that unauthorized access and filings disrupt market efficiency and affect capital formation by affected filers. The amendments will also enhance investor confidence in, and therefore use of, the financial information available through EDGAR filings, thereby helping investors make more informed investment decisions.</P>
                    <P>We do not expect the EDGAR Next changes to impact competition because the final rules and amendments are designed to impose modest compliance costs, which are largely one-time in nature and not expected to significantly affect small filers. As discussed in sections IV.B.2.d and IV.B.2.c, the Commission is making certain technical resources available to all filers in connection with the final amendments, such as optional APIs and open-source software to connect to certain APIs, which should mitigate compliance costs, including for small filers. Larger filers and filing agents could experience ongoing compliance cost savings under EDGAR Next due to the streamlined management of filer credentials and accounts, simplified access procedures, and greater automation of the filing process and preparation. This need not disproportionately disadvantage smaller filers, however, as smaller filers will have the option to rely on delegated entities to supply API connections and filer API tokens. To the extent that, as discussed above, delegated entities experience ongoing compliance cost savings under EDGAR Next, then competition among delegated entities may lead them to pass on some of these cost savings to their clients in the form of lower fees, including to smaller filers.</P>
                    <HD SOURCE="HD2">C. Reasonable Alternatives</HD>
                    <HD SOURCE="HD3">1. Add and Allow Bulk Confirmation for Related CIKs</HD>
                    <P>
                        As adopted, paragraph (d)(4) of Rule 10 will require each filer to perform an annual confirmation on EDGAR of all of the filer's users, account administrators, technical administrators, and delegated entities, as well as any other information related to the filer appearing on the dashboard. Several technical features will be introduced to facilitate compliance with the rule and form requirements. For example, bulk enrollment will permit filers and filing agents to simultaneously enroll up to 100 filers, along with their authorized account administrators, in a single batch. Several commenters suggested that the Commission should also allow bulk confirmations to be performed for related CIKs, such as CIKs that share the same administrators, users, delegations, and corporate and contact information.
                        <SU>310</SU>
                        <FTREF/>
                         This alternative might facilitate the confirmation of multiple filers simultaneously, but the annual confirmation for related CIKs does not lend itself to bulk processing. While some related CIKs may share the same administrators, users, delegations, and corporate and contact information, not all of them do. Related CIKs (such as CIKs for co-registrants or filers with beneficial ownership obligations) will often have different information that is to be provided on the dashboard; for example, co-registrants may have different individuals authorized to act on their behalf.
                        <SU>311</SU>
                        <FTREF/>
                         Thus, adding a bulk confirmation feature for related CIKs could lead to the inadvertent confirmation of dashboard information without proper review and verification for accuracy, thus undermining the intended benefits of the annual confirmation requirement. For this reason, we are not implementing this alternative. Filers may already achieve under EDGAR Next efficiencies in the confirmation process by leveraging the newly added APIs that will allow them to reduce confirmation preparation lead time by rapidly adding and removing individuals, changing roles, and performing delegations in advance of confirmation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>310</SU>
                             Cadwalader Comment Letter (“On an operational level, we do not expect individual serial trusts to have account administrators, technical administrators, users or delegated entities that are not also performing the same functions for the depositor, although the depositor may have certain additional account administrators, technical administrators, users or delegated entities who are not assigned to all of the related serial trusts. Therefore, depositor-level confirmation of its authorized parties would also encompass all individuals assigned roles with respect to each individual serial trust.”); Toppan Merrill Comment Letter (responding to a question regarding whether bulk confirmations should be permitted by stating “[y]es, affiliated filers with the same administrators, users, delegations, and corporate and contact information should be allowed similar functionality . . .”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>311</SU>
                             
                            <E T="03">See supra</E>
                             section II.B.1.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Extend the ABSCOMP Process to Affiliated Entities</HD>
                    <P>
                        EDGAR permits certain filings to be submitted on behalf of multiple filers, that are treated as co‐registrants for purposes of the filing. Examples of several types of issuers that manage and file with related entities include investment companies filing on behalf of other affiliated investment companies, corporate issuers with co‐registrants, beneficial ownership reporting filers (
                        <E T="03">e.g.,</E>
                         Form 144, Schedule 13D, Schedule 13G, and section 16 filers), and ABS issuers. While these registrants have a separate CIK for each filer, they are managed by one entity. In particular, ABS issuers, 
                        <PRTPAGE P="106215"/>
                        usually the depositor in an ABS transaction, may create multiple serial companies each year, each of which represents a distinct legal entity with its own CIK, even though each generally has the same contact information as the ABS issuer. The ABSCOMP process streamlines the ABS issuer's submission process, by allowing for rapid creation of multiple serial companies and by automatically copying all account information associated with the ABS issuing entity to any created serial companies.
                    </P>
                    <P>
                        One commenter recommended expanding the ABSCOMP process to other issuers that have a related structure with multiple related parties.
                        <SU>312</SU>
                        <FTREF/>
                         This alternative, however, would not provide the same benefits to filers with related party structure as it does for ABS issuers because the same dashboard information would be disseminated to all related entities involved in the ABSCOMP process. While ABS issuers and their serial companies share the same underlying dashboard information, other related party entities, such as investment companies and co-registrants, do not share this characteristic, as each of these filers typically possesses separate filer-specific information such as name, address, and contact information, as well as separate reporting obligations. Thus, expanding the ABSCOMP process to other related party filers could increase the risk of filing errors and inconsistencies, resulting in additional administrative burden and delays in the submission process for the related party filers in scope. For this reason, we are not implementing this alternative. The added APIs under EDGAR Next should already substantially address the commenter's concerns by allowing filers to rapidly add account administrators and make other changes as necessary, as discussed further in section II.E above.
                    </P>
                    <FTNT>
                        <P>
                            <SU>312</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (“The proposed functionality for an ABS account administrator to access the dashboard for serial companies could be utilized for other issuers who have a related structure with multiple entities . . . including corporate issuers with co-registrants [and] beneficial ownership reporting filers. . . . If the existing option to create a serial company by the `ABSCOMP' process is available in EDGAR Next functionality that will be sufficient for ABS entities to manage creating new CIKs.”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Retire the CCC for Filing Submissions</HD>
                    <P>The final amendments will maintain the CCC as the code required for filing. The CCC code will be displayed on the dashboard. Alternatively, one commenter suggested eliminating the use of a filer's CCC to submit a filing. The commenter stated that the CCC requirement will be redundant as individuals accessing the CCC through the dashboard will also need to sign in with their respective individual account credentials, complete multifactor authentication, and be authorized by the filer.</P>
                    <P>
                        Retiring the CCC could result in a modest efficiency gain for filers by eliminating the additional step of presenting the CCC as a requirement for submission authorization resulting in a moderate reduction in submission preparation time. The CCC could be eliminated in the future if feasible from a technical and security standpoint.
                        <SU>313</SU>
                        <FTREF/>
                         At this time, however, we continue to believe that the required use of the CCC enhances submission security. Moreover, some commenters 
                        <SU>314</SU>
                        <FTREF/>
                         expressed their preferences for maintaining the current co-registrant filings process unchanged, and this process requires both the CCC and CIK for submission success. Also, EDGAR Next will introduce a view account information API that will allow filers and filing agents to view the filer's CCC via an API (so long as the user API token belongs to an individual who has permissions to view the CCC and use the filer API token). Facilitating access to the CCC via the dashboard and the APIs should ease the burden of submitting the CCC for each filing.
                    </P>
                    <FTNT>
                        <P>
                            <SU>313</SU>
                             
                            <E T="03">See supra</E>
                             section II.A.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>314</SU>
                             
                            <E T="03">See supra</E>
                             note 123.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">4. Requirements for Individual and Small Filers</HD>
                    <P>EDGAR Next will apply to all prospective and existing filers regardless of size. Alternatively, the Commission could implement scaled requirements for small entities and individual filers. For example, the Commission could consider exempting section 16 filers from amended paragraph (d)(4) of Rule 10(d)(4), which will require filers, through their authorized account administrators, to confirm annually that all account administrators, users, and delegated entities, and technical administrators reflected on the dashboard for the filer's EDGAR account are authorized by the filer and that all information regarding the filer on the dashboard is accurate. Further, the Commission could exempt small filers from amended paragraph (d)(1) of Rule 10(d)(1), and instead allow small filers to independently develop practices and recordkeeping to track individuals acting on their behalf and safeguard their account access codes. Such scaled requirements would lower the compliance costs for small entities and individual filers.</P>
                    <P>
                        Exempting any subgroup of filers from paragraph (d)(1) or (d)(4) of Rule 10(d)(1) or Rule 10(d)(4), or the other EDGAR Next changes, would lessen the security benefits of EDGAR Next with regard to these filers. The EDGAR Next changes are designed to enhance the security of EDGAR filings, including by, among other things, strengthening the security of access to filers' EDGAR accounts by establishing a uniform method for authorizing, identifying, and tracking all individuals authorized to act on each filer's behalf. Exempting small filers from obtaining individual account credentials would increase the risks that small entities and individual filers are subject to unauthorized access to their EDGAR accounts and unauthorized filings, thereby undermining the benefits of EDGAR Next. Also, as discussed in sections IV.B.2.d and IV.B.2.c, (the Commission is making certain technical resources available to filers in connection with the final amendments, such as optional APIs,
                        <SU>315</SU>
                        <FTREF/>
                         the Adopting Beta, and a transition period, all of which should help mitigate compliance costs for smaller entities and individual filers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>315</SU>
                             As discussed above in section IV.B.2.d, while we do not expect smaller entities to develop their own software, they may be able to use the optional APIs of a delegated entity pursuant to adopted paragraph (d)(3) of Rule 10.
                        </P>
                    </FTNT>
                    <P>
                        As another alternative, the Commission could allow smaller filers additional time to come into compliance. One commenter suggested that Section 16 filers be granted an additional six months after the enrollment period ends so that they do not miss any deadlines while they enroll in EDGAR Next.
                        <SU>316</SU>
                        <FTREF/>
                         A longer enrollment period would lower the compliance cost for small filers by enabling a transition to EDGAR Next at a pace that suits their needs, allowing these filers with fewer resources more time to adapt to the new requirements. EDGAR Next will allow filers an additional three months after compliance within which to enroll, although the legacy filing regime will not be extended beyond the compliance date. Extending the legacy filing regime would lessen the security benefits of EDGAR Next by delaying the implementation of the multifactor authentication and individual account credential requirements.
                        <SU>317</SU>
                        <FTREF/>
                          
                        <PRTPAGE P="106216"/>
                        Nevertheless, filers who must make a required filing within three months after the compliance date, and who have not yet enrolled, will be able to quickly enroll and access their EDGAR accounts in order to make timely submissions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>316</SU>
                             SCG Comment Letter (“We also ask that the Commission consider allowing all Section 16 filers to continue to use the existing EDGAR system for an 
                            <E T="03">additional six months</E>
                             after the enrollment period ends, so they do not miss any deadlines while they enroll in EDGAR Next.”) (emphasis in original).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>317</SU>
                             
                            <E T="03">See supra</E>
                             note 48.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">5. Implementing Performance-Based Standards</HD>
                    <P>EDGAR Next mandates certain prescribed requirements to enhance the security of EDGAR's filing regime. We could consider an alternative with a more performance-based approach that would not spell out the precise actions filers need to take in order to improve the security of EDGAR. For instance, we could simply state that filers should have practices and recordkeeping that allow the Commission to more easily identify anyone who takes action on EDGAR on the filer's behalf and also ensure that only individuals authorized by the filer are privy to the filer's access codes. This could, for instance, lead beneficial ownership reporting filers to opt to forgo authorizing account administrators to manage their EDGAR account, or other filers could determine that they do not need multifactor authentication for designated individuals authorized to act on their behalf on the dashboard.</P>
                    <P>
                        The benefits of a more performance-based approach would be that filers would have more flexibility in what their practices and recordkeeping cover. For instance, they could tailor their EDGAR access compliance requirements to their specific circumstances and have greater discretion in how they manage their EDGAR accounts and safeguard their account access codes. While this approach would provide more flexibility for filers, we are not implementing this alternative as allowing individual filers to decide which security measures to implement would undermine our objective of enhancing the existing security requirements for the EDGAR system. In particular, individual account credential requirements, including multifactor authentication, are a key security enhancement that allows us to modernize and implement stronger cybersecurity standards, consistent with current best practices, as described in Executive Order No. 14028 and the NIST guidelines.
                        <SU>318</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>318</SU>
                             
                            <E T="03">See supra</E>
                             notes 29 and 30 and accompanying text.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">V. Paperwork Reduction Act</HD>
                    <P>
                        Certain provisions of our rules and forms that will be affected by the final amendments contain “collection of information” requirements within the meaning of the Paperwork Reduction Act of 1995 (“PRA”).
                        <SU>319</SU>
                        <FTREF/>
                         The Commission published a notice requesting comment on changes to these collection of information requirements in the Proposing Release and submitted these requirements to the Office of Management and Budget (“OMB”) for review in accordance with the PRA.
                        <SU>320</SU>
                        <FTREF/>
                         An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Compliance with the information collection is mandatory. Responses to the information collection are not kept confidential, and there is no mandatory retention period for the information disclosed. The title for the existing collection of information that we are amending is “Form ID—EDGAR Password” (OMB Control No. 3235-0328). We also are adding a new collection of information titled “the dashboard.” The final amendments to Form ID and the implementation of the dashboard are designed to harness the benefits of improved technology and to modernize the EDGAR access and account management functions. A detailed description of the final amendments, including the amendments to Form ID and the implementation of the dashboard, including the need for the information and its intended use, as well as a description of the likely respondents, can be found in section II above, and a discussion of the expected economic impact of the amendments can be found in section IV above.
                    </P>
                    <FTNT>
                        <P>
                            <SU>319</SU>
                             44 U.S.C. 3501 
                            <E T="03">et seq.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>320</SU>
                             44 U.S.C. 3507(d); 5 CFR 1320.11.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">A. Summary of Comment Letters on PRA Estimates</HD>
                    <P>
                        In the Proposing Release, the Commission requested comment on the PRA burden hour and cost estimates and the analysis used to derive the estimates. We received two comment letters addressing the PRA estimates. One letter inquired whether notarization had been accounted for in our burden estimates.
                        <SU>321</SU>
                        <FTREF/>
                         We affirm that the PRA estimates, both previously approved by OMB and the estimates contained in these final amendments, reflect the overall burden of compliance with Form ID, including the notarization requirements.
                        <SU>322</SU>
                        <FTREF/>
                         The second letter recommended that the amendments lead to an update to the “Paperwork Reduction Act” as it will require more filings by companies through EDGAR.
                        <SU>323</SU>
                        <FTREF/>
                         To the extent that the filer was referring to the PRA burden estimates associated with EDGAR Next, as discussed below, we are revising those estimates to reflect the EDGAR Next changes, although we do not expect the EDGAR Next changes to cause a significant increase in the number of filings on EDGAR.
                    </P>
                    <FTNT>
                        <P>
                            <SU>321</SU>
                             
                            <E T="03">See</E>
                             Block Transfer Comment Letter.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>322</SU>
                             The burden represents an estimate of the average compliance burden. Consequently, the burden could be lower for some filers (such as those that do not need to add notarizations for account administrators), and higher for other filers (such as those that do need to include notarizations for account administrators).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>323</SU>
                             
                            <E T="03">See</E>
                             comment Letter of Akash Chand (September 13, 2023).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. Form ID </HD>
                    <P>Form ID must be completed online and submitted to the Commission by individuals, companies, and other organizations that seek access to file electronically on EDGAR.</P>
                    <P>
                        As outlined above, the final amendments to Form ID will require an applicant for EDGAR access to undertake certain additional obligations, including most significantly: (1) designating on Form ID specific individuals the applicant authorizes as its account administrator(s) to manage its EDGAR account on a dedicated dashboard on EDGAR; (2) indicating the applicant's LEI, if any; (3) providing more specific contact information about the filer, its account administrator(s), its authorized individual (the individual authorized to sign Form ID on the filer's behalf as defined in the EDGAR Filer Manual), and its billing contact (including mailing, business, and billing information, as applicable); (4) specifying whether the applicant, its authorized individual, person signing a power of attorney (if applicable), account administrator, or billing contact has been criminally convicted as a result of a Federal or State securities law violation, or civilly or administratively enjoined, barred, suspended, or banned in any capacity, as a result of a Federal or State securities law violation; (5) indicating whether the applicant, if a company, is in good standing with its State or country of incorporation; (6) requiring submission of a new Form ID for both prospective filers seeking access to EDGAR for the first time and existing filers that must apply for access to EDGAR because they: (i) are the legal successor of the filer named on the existing CIK account but did not receive access from that filer, (ii) lost electronic access to their existing CIK account, or (iii) are broker-dealers or “paper filers” seeking electronic access for the first time in order to file electronically on EDGAR; and (7) requiring those seeking access to an existing EDGAR account to 
                        <PRTPAGE P="106217"/>
                        upload to EDGAR the documents that establish the applicant's authority over the company or individual listed in EDGAR on the existing account. The final amendments will also simplify filer account management by eliminating the EDGAR password, PMAC, and passphrase.
                    </P>
                    <P>
                        For purposes of the Paperwork Reduction Act, the currently approved collection of information includes an estimate of 57,329 Form ID filings annually and further estimates approximately 0.30 hours per response to prepare and file Form ID, for a total of 17,199 annual burden hours. Those estimates include the number of Form ID filings for filers without CIKs (48,089 filings), filers with CIKs that are seeking to regain access to EDGAR (8,836 filings), and filers with CIKs that have not filed electronically on EDGAR (404 filings).
                        <SU>324</SU>
                        <FTREF/>
                         These estimates assume that filers are responsible for 100% of the total burden hours.
                    </P>
                    <FTNT>
                        <P>
                            <SU>324</SU>
                             48,089 filings for users without CIKs + 8,836 filings for filers who are seeking to regain access to EDGAR + 404 filings for filers with CIKs who have not yet filed electronically on EDGAR = 57,329 filings.
                        </P>
                    </FTNT>
                    <P>
                        There were 73,600 Form ID filings in calendar year 2023. The estimate includes the number of filers without CIKs, filers with CIKs that have not filed electronically on EDGAR, and filers with CIKs that are seeking to regain access EDGAR.
                        <SU>325</SU>
                        <FTREF/>
                         For purposes of the Paperwork Reduction Act, we estimate that the number of Form ID filings under the final amendments will remain the same and that the number of hours to prepare Form ID will increase by 0.30 hours as a result of the adoption of the access changes and Form ID amendments.
                        <SU>326</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>325</SU>
                             63,676 filings for users without CIKs + 9,602 filings for filers who are seeking to regain access to EDGAR + 322 filings for filers with CIKs who have not yet filed electronically on EDGAR = 73,600 filings.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>326</SU>
                             The increase in burden will vary by applicant depending on whether certain of their responses required additional information (
                            <E T="03">e.g.,</E>
                             explaining the circumstances surrounding any specified individuals who are currently subject to Federal or State securities law investigations, proceedings, convictions, suspensions, or bars, and for applicants seeking access to an existing CIK account, providing the documents that establish the applicant's authority over the company or individual currently listed in EDGAR as corresponding to the existing CIK account).
                        </P>
                    </FTNT>
                    <P>
                        Thus, for purposes of the Paperwork Reduction Act, the estimated total number of annual Form ID filings will increase from 57,329 filings to 73,600 filings. The estimate of 0.30 hours per response will increase to 0.60 hours per response. The estimated total annual burden will increase from 17,199 hours to 44,160 hours.
                        <SU>327</SU>
                        <FTREF/>
                         The estimate that the filers are responsible for 100% of the total burden hours will remain the same.
                    </P>
                    <FTNT>
                        <P>
                            <SU>327</SU>
                             73,600 filings × 0.60 hours/filing = 44,160 hours.
                        </P>
                    </FTNT>
                    <GPH SPAN="3" DEEP="73">
                        <GID>ER27DE24.016</GID>
                    </GPH>
                    <HD SOURCE="HD2">C. The Dashboard</HD>
                    <P>As outlined above, pursuant to paragraph (d) of Rule 10 as adopted each filer will be required to authorize individuals to act on its behalf on the dashboard, and those individuals must have obtained individual account credentials for EDGAR in the manner specified in the EDGAR Filer Manual. Moreover, pursuant to paragraph (d) of Rule 10 as adopted, each filer, through its account administrators, will be required to: (i) authorize and maintain at least two individuals as authorized account administrators to act on the filer's behalf to manage the filer's EDGAR account, except a filer who is an individual or single-member company must authorize and maintain at least one individual as an account administrator; (ii) confirm annually on EDGAR that all users, account administrators, technical administrators, and/or delegated entities reflected on the dashboard for the filer's EDGAR account are authorized by the filer, and that the filer's information on the dashboard is accurate; (iii) maintain accurate and current information on EDGAR concerning the filer's account, including but not limited to accurate corporate information and contact information (such as mailing and business addresses, email addresses, and telephone numbers); (iv) securely maintain information relevant to the ability to access the filer's EDGAR account, including but not limited to access through any EDGAR API; and (v) if the filer chooses to connect to an EDGAR API, authorize, through its account administrator(s) at least two technical administrators to manage technical matters related to the filer's connection to the API, or the filer may use the API connections and filer API tokens of its delegated entity so long as the delegated entity is in compliance with the technical administrator and other API requirements.</P>
                    <P>EDGAR will facilitate account administrators' management of filers' accounts by allowing them to: (i) add and remove users, account administrators, and technical administrators (including removing themselves as an account administrator); (ii) create and edit groups of users; (iii) delegate filing authority to other EDGAR accounts and remove such delegations; (iv) generate a new CCC; and (v) receive notifications regarding significant events affecting the account (which will also be provided via email to the account administrators' email addresses).</P>
                    <P>
                        For purposes of the PRA, we estimate that each filer will spend approximately one hour in the first year setting up the dashboard, and additionally, on average, approximately one hour per annum managing the filer's account on the dashboard. This burden will vary across filers depending on the size of the filer, the number of users, account administrators, technical administrators, and delegated entities authorized by the filer, as well as the amount of annual staff turnover for those individuals and entities, among other factors. For a small number of filers, the annual burden may significantly exceed our estimate (
                        <E T="03">e.g.,</E>
                         filing agents that may authorize a large number of individuals and that have multiple accepted delegations and user groups for which delegated users will need to be maintained). On the other hand, for the vast majority of filers, the annual burden will presumably be less than our estimate because we expect most filers will authorize a small number of individuals and will experience little or no annual turnover 
                        <PRTPAGE P="106218"/>
                        with regard to those individuals.
                        <SU>328</SU>
                        <FTREF/>
                         Consequently, the anticipated aggregate average annual burden attributed to the dashboard for all filers will be approximately 270,400 burden hours, based on a three-year average burden of 1.3 hours per filer.
                        <SU>329</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>328</SU>
                             A filer survey conducted by a filing agent found that at least 64% of its respondents planned to have three or fewer account administrators, and 96% of its respondents planned to have fewer than 20 users. 
                            <E T="03">See</E>
                             Workiva Comment Letter (November 30, 2021). Moreover, since filers are not required to authorize users, technical administrators, or delegations, filers who did not choose to authorize such individuals or third parties would not have any associated burdens.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>329</SU>
                             The estimate of 1.3 hours per filer is based on the following calculations: For dashboard set up, 1 hour in the first year ÷ 3 years = 0.3 hours on average; for dashboard management, 1 hour per year ÷ 3 years = 1 hour on average; 0.3 hours for dashboard set up + 1 hour for dashboard management = 1.3 hours on average for all dashboard responsibilities. The estimate of 270,400 hours is based on the following calculations: 0.3 hours for dashboard set up × 208,000 filers = 62,400 hours; 1 hour for dashboard management × 208,000 filers = 208,000 hours; 62,400 hours + 208,000 hours = 270,400 hours.
                        </P>
                    </FTNT>
                    <GPH SPAN="3" DEEP="142">
                        <GID>ER27DE24.017</GID>
                    </GPH>
                    <HD SOURCE="HD1">VI. Final Regulatory Flexibility Analysis</HD>
                    <P>
                        The Regulatory Flexibility Act (“RFA”) 
                        <SU>330</SU>
                        <FTREF/>
                         requires an agency, when issuing a rulemaking adoption, to prepare and make available a Final Regulatory Flexibility Analysis (“FRFA”) that describes the impact of the final rule on small entities.
                        <SU>331</SU>
                        <FTREF/>
                         This FRFA has been prepared in accordance with the RFA and relates to the amendments to Rules 10 and 11 of Regulation S-T and Form ID described in section II.F above.
                    </P>
                    <FTNT>
                        <P>
                            <SU>330</SU>
                             5 U.S.C. 601 
                            <E T="03">et seq.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>331</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">A. Need for and Objectives of the Rule and Form Amendments</HD>
                    <P>The purpose of the final amendments is to enhance the security of EDGAR accounts, improve the ability of filers to securely maintain access to their EDGAR accounts, facilitate the responsible management of EDGAR filer credentials, and simplify procedures for accessing EDGAR. Among other things, the final amendments will require each filer to:</P>
                    <P> Authorize individuals to act on its behalf on the dashboard only if those individuals have obtained individual account credentials in the manner specified in the EDGAR Filer Manual;</P>
                    <P> Authorize and maintain individuals as account administrators to manage their EDGAR accounts on the dashboard;</P>
                    <P> Confirm annually on EDGAR, through their account administrators, that all account administrators, users, technical administrators and delegated entities reflected on the dashboard for the filer's EDGAR account are authorized by the filer to act on its behalf, and that all information about the filer on the dashboard is accurate;</P>
                    <P> Maintain accurate and current information on EDGAR concerning the filer's account; and</P>
                    <P> Securely maintain information relevant to the ability to access the filer's EDGAR account.</P>
                    <P>Filers that choose to connect to the optional EDGAR APIs to make submissions on EDGAR and take other actions, will, among other things, generally be required through their account administrators to authorize at least two technical administrators to manage tokens and other technical aspects of the EDGAR APIs unless they use the API connections and filer API tokens of their delegated entities that have authorized at least two technical administrators, in which case an individual at the relevant filer need only supply a user API token, if the relevant API requires presentation of a user API token.</P>
                    <HD SOURCE="HD2">B. Significant Issues Raised by Public Comments</HD>
                    <P>
                        We received no comments on the Initial Regulatory Flexibility Analysis contained in the Proposing Release. Commenters did state, however, that several aspects of the rulemaking would have both financial and workload impacts on their business and services offered, including: the requirement to obtain individual account credentials resulting in “additional costs and confusion for individuals and small entity filers,” 
                        <SU>332</SU>
                        <FTREF/>
                         dashboard requirements resulting in “administrative burden and ongoing maintenance costs,” 
                        <SU>333</SU>
                        <FTREF/>
                         and requirements for API tokens resulting in “higher service costs.” 
                        <SU>334</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>332</SU>
                             
                            <E T="03">See</E>
                             Toppan Merrill Comment Letter (regarding the individual account credential requirement: “Yes, there will be additional costs and confusion for individuals and entity filers. It will be beneficial for the SEC to provide a well-publicized education and an information campaign to help prepare filers for the EDGAR Next mandate. We commend the SEC for providing the EDGAR Next Beta testing environment and hosting introductory webinars. To encourage more registrant participation, it would be beneficial for the SEC to post step-by-step videos on its YouTube channel of each essential part of the EDGAR Next process.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>333</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter, discussed 
                            <E T="03">supra</E>
                             note 141 (“All functionality provided by the EDGAR Dashboard should be available via APIs . . . . The administration burden and ongoing maintenance costs [of manually using the dashboard] will be significant and could ultimately impact the cost burden on the filers”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>334</SU>
                             
                            <E T="03">See</E>
                             Workiva Comment Letter, discussed 
                            <E T="03">supra</E>
                             note 302 (asserting regarding the requirement that API tokens be manually obtained pursuant to multifactor authentication, that “manual intervention result[s] in higher services costs, which are hard to accurately estimate at this point although we expect it to be far reaching due to the percentage of public registrants potentially impacted by this.”).
                        </P>
                    </FTNT>
                    <P>
                        As noted above, to further facilitate individuals' and small entity filers' experience with the EDGAR Next transition, Commission staff will begin public outreach immediately after the 
                        <PRTPAGE P="106219"/>
                        issuance of this release.
                        <SU>335</SU>
                        <FTREF/>
                         Staff will publicize the transition to EDGAR Next and link to additional information in announcements and email distributions, SEC social media, and the homepage of 
                        <E T="03">SEC.gov.</E>
                         Commission staff also will provide multiple resources on a dedicated EDGAR Next web page to assist with the transition, including but not limited to, written step-by-step guidance for testing a range of functionality in the Adopting Beta environment and information about staff webinars and API technical help sessions for the public. On the SEC YouTube channel, staff will post videos to walk filers through various aspects of the EDGAR Next changes. To assist filers with any issues that may arise, Commission staff will provide dedicated telephone support and an email help desk—
                        <E T="03">EDGARNextBeta@sec.gov</E>
                        —as well as an online form (available in the Adopting Beta) to report technical bugs. To facilitate the transition to EDGAR Next and mitigate the associated costs of obtaining individual account credentials and setting up and managing the dashboard, and obtaining API tokens, we are extending the transition period for compliance with the final amendments from seven months (as proposed) to 12 months (as adopted).
                        <SU>336</SU>
                        <FTREF/>
                         This transition period will provide filers six months to prepare during which the Adopting Beta will be available, followed by six months to enroll in EDGAR Next prior to the compliance date, followed by an additional three months after the compliance date during which any remaining filers can enroll. The additional three months to enroll in EDGAR Next after the compliance date should help ease burdens on small entities that may need more time to transition to EDGAR Next.
                    </P>
                    <FTNT>
                        <P>
                            <SU>335</SU>
                             
                            <E T="03">See</E>
                             section II.H.2.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>336</SU>
                             
                            <E T="03">See generally</E>
                             section II.H.
                        </P>
                    </FTNT>
                    <P>
                        In addition, to minimize administrative burden and ongoing maintenance costs related to the dashboard, we are extending the grace period for filers to timely perform annual confirmations from two weeks to three months.
                        <SU>337</SU>
                        <FTREF/>
                         Commission staff will also offer 12 optional APIs beyond what was contemplated in the proposal, as well as an API Development Toolkit and a sample filing application to assist filers in developing their own filing software to connect to the APIs.
                        <SU>338</SU>
                        <FTREF/>
                         As discussed above, these new optional APIs will replicate much of the account management functionality provided on the dashboard, which should allow filers to reduce burdens and manage their EDGAR accounts in a more automated manner.
                        <SU>339</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>337</SU>
                             
                            <E T="03">See supra</E>
                             text accompanying and following note 89.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>338</SU>
                             
                            <E T="03">See generally</E>
                             section II.E.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>339</SU>
                             
                            <E T="03">See supra</E>
                             text accompanying note 141.
                        </P>
                    </FTNT>
                    <P>
                        Furthermore, in a change from the proposal, filers with delegated entities will be able to use the API connections and filer API tokens of their delegated entities 
                        <SU>340</SU>
                        <FTREF/>
                         and will not need to authorize technical administrators, so long as the delegated entity maintains at least two technical administrators. This will alleviate the need for filers with delegated entities to authorize at least two technical administrators, create API connections and maintain their own filer API tokens in order for their users to interact with EDGAR through APIs, although individuals at these filers will need to generate and present user API tokens to interact with the APIs, if those APIs require presentation of a user API. While filers could rely completely on their delegated entities to interact with EDGAR on their behalf, certain filers may wish to retain the ability to have their users interact with EDGAR through APIs. This change allows them to do so in a cost-effective fashion and, as a result, may make APIs more accessible for smaller filers that may not have the resources to connect to the APIs or employ their own technical administrators. Individuals at filers using their delegated entities' filer API tokens and API connections must nevertheless supply their own user API tokens to interact with the EDGAR APIs, if those APIs require presentation of a user API token.
                    </P>
                    <FTNT>
                        <P>
                            <SU>340</SU>
                             See 
                            <E T="03">supra</E>
                             text accompanying note 112.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">C. Small Entities Subject to the Rule and Form Amendments</HD>
                    <P>
                        The final amendments will affect individuals and entities that have EDGAR accounts or that seek to open EDGAR accounts. The RFA defines “small entity” to mean “small business,” “small organization,” or “small governmental jurisdiction.” 
                        <SU>341</SU>
                        <FTREF/>
                         For purposes of the RFA, under our rules, an issuer, other than an investment company, is a small entity if it had total assets of $5 million or less on the last day of its most recent fiscal year.
                        <SU>342</SU>
                        <FTREF/>
                         We estimate there are 800 issuers that file with the Commission—other than investment companies—that will be considered small entities for purposes of this analysis.
                        <SU>343</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>341</SU>
                             5 U.S.C. 601(6).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>342</SU>
                             
                            <E T="03">See</E>
                             17 CFR 240.0-10(a)).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>343</SU>
                             This estimate is based on staff analysis of issuers potentially subject to the final amendments, excluding co-registrants, with EDGAR filings on Form 10-K, or amendments thereto, filed during the calendar year of January 1, 2023 to December 31, 2023. This analysis is based on data from XBRL filings, Compustat, Ives Group Audit Analytics, and manual review of filings submitted to the Commission.
                        </P>
                    </FTNT>
                    <P>
                        With respect to investment companies and investment advisers, an investment company, including a business development company, is considered to be a small entity if it, together with other investment companies in the same group of related investment companies, has net assets of $50 million or less as of the end of its most recent fiscal year.
                        <SU>344</SU>
                        <FTREF/>
                         We estimate that there are 87 registered investment companies (including business development companies and unit-investment trusts) that will be considered small entities.
                        <SU>345</SU>
                        <FTREF/>
                         An investment adviser is generally considered a small entity if it: (1) has assets under management having a total value of less than $25 million; (2) did not have total assets of $5 million or more on the last day of the most recent fiscal year; and (3) does not control, is not controlled by, and is not under common control with another investment adviser that has assets under management of $25 million or more, or any person (other than a natural person) that had total assets of $5 million or more on the last day of its most recent fiscal year.
                        <SU>346</SU>
                        <FTREF/>
                         We estimate that there are 471 investment advisers that will be considered small entities.
                        <SU>347</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>344</SU>
                             
                            <E T="03">See</E>
                             17 CFR 270.0-10.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>345</SU>
                             This estimate is derived from an analysis of data obtained from Morningstar Direct as well as data filed with the Commission (on Forms N-CSR, NPORT-P, 10-Q, and 10-K) for the last quarter of 2023.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>346</SU>
                             17 CFR 275.0-7.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>347</SU>
                             We based this estimate on registered investment adviser responses to Item 12 of Form ADV.
                        </P>
                    </FTNT>
                    <P>
                        A transfer agent is considered to be a small entity if it: (1) received less than 500 items for transfer and less than 500 items for processing during the preceding six months (or in the time that it has been in business, if shorter); (2) transferred items only of issuers that would be deemed “small businesses” or “small organizations” as defined in 17 CFR 240.0-10; (3) maintained master shareholder files that in the aggregate contained less than 1,000 shareholder accounts or was the named transfer agent for less than 1,000 shareholder accounts at all times during the preceding fiscal year (or in the time that it has been in business, if shorter); and (4) is not affiliated with any person (other than a natural person) that is not a small business or small organization under 17 CFR 240.0-10.
                        <SU>348</SU>
                        <FTREF/>
                         We estimate 
                        <PRTPAGE P="106220"/>
                        that there are 131 transfer agents that will be considered small entities.
                        <SU>349</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>348</SU>
                             17 CFR 240.0-10(h).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>349</SU>
                             We based this estimate on transfer agent responses to questions 4(a) and 5(a) on their latest filing on Form TA-2.
                        </P>
                    </FTNT>
                    <P>
                        With respect to municipal securities dealers and broker-dealers, a municipal securities dealer that is a bank (including any separately identifiable department or division of a bank) is a small entity if it: (1) had, or is a department of a bank that had, total assets of less than $10 million at all times during the preceding fiscal year (or in the time that it has been in business, if shorter); (2) had an average monthly volume of municipal securities transactions in the preceding fiscal year (or in the time it has been registered, if shorter) of less than $100,000; and (3) is not affiliated with any person (other than a natural person) that is not a small business or small organization as defined in 17 CFR 240.0-10.
                        <SU>350</SU>
                        <FTREF/>
                         We estimate there are 185 municipal securities dealers that will be considered small entities.
                        <SU>351</SU>
                        <FTREF/>
                         A broker-dealer is a small entity if it: (1) had total capital (net worth plus subordinated liabilities) of less than $500,000 on the date in the prior fiscal year as of which its audited financial statements were prepared pursuant to § 240.17a-5(d) or, if not required to file such statements, a broker or dealer that had total capital (net worth plus subordinated liabilities) of less than $500,000 on the last business day of the preceding fiscal year (or in the time that it has been in business, if shorter); and (2) is not affiliated with any person (other than a natural person) that is not a small business or small organization as defined in 17 CFR 240.0-10.
                        <SU>352</SU>
                        <FTREF/>
                         We estimate that there are 737 broker-dealers that will be considered small entities.
                        <SU>353</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>350</SU>
                             17 CFR 240.0-10(f).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>351</SU>
                             This estimate is based on MSRB data filed during the calendar year of January 1, 2023 to December 31, 2023.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>352</SU>
                             17 CFR 240.0-10(c).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>353</SU>
                             This estimate is based on FOCUS Report data filed during the calendar year of January 1, 2023 to December 31, 2023.
                        </P>
                    </FTNT>
                    <P>
                        A clearing agency is a small entity if it: (1) compared, cleared and settled less than $500 million in securities transactions during the preceding fiscal year (or in the time that it has been in business, if shorter); (2) had less than $200 million of funds and securities in its custody or control at all times during the preceding fiscal year (or in the time that it has been in business, if shorter); and (3) is not affiliated with any person (other than a natural person) that is not a small business or small organization as defined in 17 CFR 240.0-10.
                        <SU>354</SU>
                        <FTREF/>
                         We estimate there are zero clearing agencies that are small entities, as of December 31, 2023.
                    </P>
                    <FTNT>
                        <P>
                            <SU>354</SU>
                             17 CFR 240.0-10(d).
                        </P>
                    </FTNT>
                    <P>
                        An exchange is a small entity if it: (1) has been exempted from the reporting requirements of § 242.601 of this chapter; and (2) is not affiliated with any person (other than a natural person) that is not a small business or small organization as defined in 17 CFR 240.0-10.
                        <SU>355</SU>
                        <FTREF/>
                         We estimate there are zero exchanges that are small entities, as of December 31, 2023. A securities information processor is a small entity if it: (1) had gross revenues of less than $10 million during the preceding fiscal year (or in the time it has been in business, if shorter); (2) provided service to fewer than 100 interrogation devices or moving tickers at all times during the preceding fiscal year (or in the time that it has been in business, if shorter); and (3) is not affiliated with any person (other than a natural person) that is not a small business or small organization under 17 CFR 240.0-10.
                        <SU>356</SU>
                        <FTREF/>
                         We estimate there are zero securities information processors that are small entities, as of December 31, 2023.
                    </P>
                    <FTNT>
                        <P>
                            <SU>355</SU>
                             17 CFR 240.0-10(e).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>356</SU>
                             17 CFR 240.0-10(g).
                        </P>
                    </FTNT>
                    <P>Collectively, we estimate that there are 2,411 small entities that will be potentially subject to the amendments, based on our review of data reported as of December 31, 2023.</P>
                    <HD SOURCE="HD2">D. Projected Reporting, Recordkeeping, and Other Compliance Requirements</HD>
                    <P>
                        As noted above, the purpose of the amendments will be to update access and provide secure management of individual and entity filers' EDGAR accounts. The amendments will apply to all applicants and current EDGAR accounts and will apply to small entities to the same extent as other entities, irrespective of size. Therefore, we generally expect the nature of any benefits and cost associated with the amendments to be similar for large and small entities. As discussed above,
                        <SU>357</SU>
                        <FTREF/>
                         all existing and new EDGAR filers will be subject to certain fixed costs to update and maintain an EDGAR account under the amendments, which may result in a proportionally larger burden on small filers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>357</SU>
                             
                            <E T="03">See</E>
                             section III.C.2.
                        </P>
                    </FTNT>
                    <P>We expect that the amendments to the rules and form to update requirements regarding access and management of EDGAR accounts will have a small incremental effect on existing reporting, recordkeeping and other compliance burdens for all existing and new EDGAR filers, including small entities. At the same time, the EDGAR Next changes will simplify account management by providing an interactive dashboard on EDGAR, populated with EDGAR account information, as the central platform for account administrators and other delegated individuals to manage access to the account, update account information and send communications and notifications. Some of the amendments, including requirements for all filers to confirm the accuracy of their account information, including authorizations for all account administrators, users, technical administrators, and/or delegated entities, will require the use of administrative and technical skills, and increase compliance costs for registrants, although, as discussed in further detail in section IV, we do not expect these additional costs will be significant.</P>
                    <HD SOURCE="HD2">E. Agency Action To Minimize Effects on Small Entities</HD>
                    <P>The RFA directs us to consider alternatives that will accomplish our stated objectives, while minimizing any significant adverse impact on small entities. In connection with the amendments, we considered the following alternatives:</P>
                    <P>i. Establishing different compliance requirements for individual and entity EDGAR account managers that take into account the resources available to small entities;</P>
                    <P>ii. Clarifying, consolidating, or simplifying compliance and reporting requirements under the rules for small entities;</P>
                    <P>
                        iii. Using performance rather than design standards; 
                        <SU>358</SU>
                        <FTREF/>
                         and
                    </P>
                    <FTNT>
                        <P>
                            <SU>358</SU>
                             See the discussion of performance-based standards in section IV.D.3.
                        </P>
                    </FTNT>
                    <P>iv. Exempting small entities from all or part of the requirements.</P>
                    <P>
                        Regarding the first, third, and fourth alternatives,
                        <SU>359</SU>
                        <FTREF/>
                         we do not believe that establishing different compliance requirements, using performance rather than design standards, or exempting small entities from the requirements will permit us to obtain our desired objectives. We are concerned that each of these alternatives would undermine our efforts to enhance the security of EDGAR, improve the ability of filers to securely manage and maintain access to their EDGAR accounts, facilitate the responsible management of EDGAR filer credentials, and simplify procedures for accessing EDGAR. The amendments set forth uniform requirements for each filer 
                        <PRTPAGE P="106221"/>
                        to formally authorize individuals to act on the filer's behalf in EDGAR as account administrators, users, and technical administrators, which will allow EDGAR to determine whether individuals authorized by the filer were accessing and taking actions regarding the filer's EDGAR account. In connection with the EDGAR Next changes, all individuals accessing EDGAR will be required to sign in with individual account credentials and multifactor authentication, which will allow EDGAR to identify the individuals accessing EDGAR. As discussed above, we believe that by imposing these requirements on all existing and prospective EDGAR filers, the EDGAR Next rulemaking will generally improve the security of the EDGAR system by establishing a uniform method for authorizing, identifying, and tracking all individuals authorized to act on each filer's behalf. We anticipate that establishing different compliance requirements, using performance rather than design standards, or exempting small entities would result in a patchwork compliance regime that would frustrate the ability of filing agents and other service providers to efficiently manage filer credentials and manage and maintain access to filers' EDGAR accounts, and would likewise frustrate our efforts to simplify procedures for accessing EDGAR.
                        <SU>360</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>359</SU>
                             See the discussion of compliance requirements in section IV.D.2.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>360</SU>
                             
                            <E T="03">See</E>
                             Proposing Release, at notes 28-29 (indicating that 60 to 90% of EDGAR filings may be submitted by filing agents).
                        </P>
                    </FTNT>
                    <P>
                        As noted above,
                        <SU>361</SU>
                        <FTREF/>
                         the Commission considered using a performance-based approach rather than the design standards used in the EDGAR Next changes and the amended rules and forms. A more performance-based approach would reduce the regulatory burden for certain filers by permitting them to tailor their EDGAR access compliance requirements to fit their own particular circumstances. For example, small filers could determine that they do not need the additional security provided by multifactor authentication for designated individuals to be authorized to act on their behalf on the dashboard. Furthermore, larger filers might opt to authorize and maintain only one account administrator rather than authorize and maintain two such individuals. However, after consideration, we believe that permitting filers to tailor their EDGAR access compliance requirements to fit their own particular circumstances would diminish the intended benefits of the EDGAR Next changes. As discussed earlier,
                        <SU>362</SU>
                        <FTREF/>
                         bypassing the individual account credential requirements would make it difficult for the Commission to match specific filings to the relevant individual who made the submissions. Likewise, generally allowing filers to have only one account administrator would increase the likelihood that Commission staff could not reach an account administrator when it had time-sensitive questions about access to or activity on the account. Overall, a performance-based approach would create inconsistencies in improving the overall security of EDGAR, facilitating the responsible management of EDGAR filer credentials, and simplifying procedures for accessing EDGAR. In addition, any cost savings associated with a performance-based approach would likely be minimal because filers would still incur costs to adjust to new EDGAR access requirements. Further, this alternative would limit the magnitude of the benefits for filers that would result from the contemplated EDGAR Next changes.
                    </P>
                    <FTNT>
                        <P>
                            <SU>361</SU>
                             
                            <E T="03">See</E>
                             section III.D.3.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>362</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>In addition, establishing different compliance requirements, using performance rather than design standards, or exempting small entities could permit individuals to access EDGAR accounts for small filers without being authorized on the dashboard, without multifactor authentication, and without their EDGAR permissions being individually verified by EDGAR. Furthermore, if these exemptions or alternatives for small entities were implemented so that individuals acting on behalf of small entities were not required to obtain individual account credentials, the Commission would not be able to associate individuals with the specific filings they submitted on behalf of small entities. Collectively, this would reduce the security of EDGAR accounts for small entities, hinder the ability of the Commission and filers to prevent and resolve problematic and unauthorized filings, and frustrate our efforts to require all entities to responsibly manage EDGAR filer credentials.</P>
                    <P>
                        Regarding the second alternative, we believe the rulemaking is clear, and that clarifying, consolidating, or simplifying compliance requirements for EDGAR filers, including small entities, is not necessary. All EDGAR users currently follow the same process and rules to access and maintain their EDGAR accounts. The changes to EDGAR account management will in many ways simplify procedures for accessing EDGAR and EDGAR account management. Among other things, the changes will eliminate the need for individuals to track and share EDGAR passwords, PMACs, and passphrase codes for each CIK. Instead, each individual will only be responsible for tracking a single set of individual account credentials, which will be issued by 
                        <E T="03">Login.gov</E>
                        . Once the individual logs into EDGAR using those credentials, the dashboard will automatically authenticate the individual and provide her with the appropriate access to each CIK for which she had been authorized to take action. The dashboard will also display any relevant individual codes or tokens (such as user API tokens or CCCs), instead of requiring the individual to personally track or record those codes or tokens. This should result in more streamlined, modern access processes that will benefit all filers, including individuals and small entities.
                    </P>
                    <HD SOURCE="HD1">Statutory Authority</HD>
                    <P>
                        We are amending Rules 10 and 11 of Regulation S-T and Form ID under the authority in sections 6, 7, 8, 10, and 19(a) of the Securities Act,
                        <SU>363</SU>
                        <FTREF/>
                         sections 3, 4A, 4B, 12, 13, 14, 15, 15B, 23, and 35A of the Exchange Act,
                        <SU>364</SU>
                        <FTREF/>
                         section 319 of the Trust Indenture Act of 1939,
                        <SU>365</SU>
                        <FTREF/>
                         and sections 8, 30, 31, and 38 of the Investment Company Act.
                        <SU>366</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>363</SU>
                             15 U.S.C. 77f, 77g, 77h, 77j, and 77s (a).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>364</SU>
                             15 U.S.C. 78c, 78
                            <E T="03">l,</E>
                             78m, 78n, 78
                            <E T="03">o,</E>
                             78
                            <E T="03">o</E>
                            -4, 78w, and 78
                            <E T="03">ll.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>365</SU>
                             15 U.S.C. 77sss.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>366</SU>
                             15 U.S.C. 80a-8, 80a-29, 80a-30, and 80a-37.
                        </P>
                    </FTNT>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects</HD>
                        <CFR>17 CFR Part 232</CFR>
                        <P>Administrative practice and procedure, Confidential business information, Electronic filing, Incorporation by reference, Reporting and recordkeeping requirements, Securities.</P>
                        <CFR>17 CFR Part 239</CFR>
                        <P>Administrative practice and procedure, Confidential business information, Reporting and recordkeeping requirements, Securities.</P>
                        <CFR>17 CFR Part 249</CFR>
                        <P>Administrative practice and procedure, Brokers, Fraud, Reporting and recordkeeping requirements, Securities. </P>
                        <CFR>17 CFR Part 269</CFR>
                        <P>Reporting and recordkeeping requirements, Securities, Trusts and trustees.</P>
                        <CFR>17 CFR Part 274</CFR>
                        <P>
                            Administrative practice and procedure, Electronic funds transfers, 
                            <PRTPAGE P="106222"/>
                            Investment companies, Reporting and recordkeeping requirements, Securities.
                        </P>
                    </LSTSUB>
                    <P>For the reasons discussed above, we are amending title 17, chapter II of the Coe of Federal Regulations as follows:</P>
                    <PART>
                        <HD SOURCE="HED">PART 232—REGULATION S-T—GENERAL RULES AND REGULATIONS FOR ELECTRONIC FILINGS</HD>
                    </PART>
                    <REGTEXT TITLE="17" PART="232">
                        <AMDPAR>1. The general authority citation for part 232 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>
                                 15 U.S.C. 77c, 77f, 77g, 77h, 77j, 77s(a), 77z-3, 77sss(a), 78c(b), 78
                                <E T="03">l,</E>
                                 78m, 78n, 78n-1, 78o(d), 78w(a), 78
                                <E T="03">ll,</E>
                                 80a-6(c), 80a-8, 80a-29, 80a-30, 80a-37, 7201 
                                <E T="03">et seq.;</E>
                                 and 18 U.S.C. 1350, unless otherwise noted.
                            </P>
                        </AUTH>
                        <STARS/>
                    </REGTEXT>
                    <REGTEXT TITLE="17" PART="232">
                        <AMDPAR>2. Amend § 232.10 by revising paragraph (b), adding paragraph (d), and revising the note to § 232.10 to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 232.10</SECTNO>
                            <SUBJECT> Application of part 232.</SUBJECT>
                            <STARS/>
                            <P>(b) Each electronic filer must, before filing on EDGAR:</P>
                            <P>(1) File electronically the information required by Form ID (§§ 239.63, 249.446, 269.7, and 274.402 of this chapter), the application for EDGAR access and</P>
                            <P>(2) File, by uploading as a Portable Document Format (PDF) attachment to the Form ID filing, a notarized document, signed by the electronic filer or its authorized individual, that includes the information required to be included in the Form ID filing and confirms the authenticity of the Form ID filing.</P>
                            <STARS/>
                            <P>(d) To file on EDGAR, each electronic filer must comply with the EDGAR account access and account management requirements set forth in this section and in the EDGAR Filer Manual.</P>
                            <P>(1) The electronic filer may only authorize individuals to act on its behalf on the dashboard if those individuals have obtained individual account credentials for EDGAR in the manner specified in the EDGAR Filer Manual;</P>
                            <P>(2) Each electronic filer must authorize and maintain at least two individuals as account administrators to act on the electronic filer's behalf to manage its EDGAR account, except each individual or single-member company electronic filer must authorize and maintain at least one individual as an account administrator to manage its EDGAR account;</P>
                            <P>(3) If the electronic filer chooses to connect to an EDGAR Application Programming Interface, the electronic filer, through its authorized account administrator(s), must authorize at least two technical administrators to manage technical matters related to the electronic filer's connection to any EDGAR Application Programming Interface, unless the electronic filer delegates to a delegated entity that is in compliance with the technical administrator requirements of this paragraph and connects to the EDGAR Application Programming Interface using its delegated entity's filer API tokens and API connections;</P>
                            <P>(4) The electronic filer, through its authorized account administrator(s), must confirm annually on EDGAR that all account administrators, users, technical administrators, and/or delegated entities reflected on the dashboard for its EDGAR account are authorized by the electronic filer to act on its behalf, and that all information about the filer on the dashboard is accurate;</P>
                            <P>(5) The electronic filer, through its authorized account administrator(s), must maintain accurate and current information on EDGAR concerning the electronic filer's account, including but not limited to accurate corporate information and contact information; and</P>
                            <P>(6) The electronic filer, through its authorized account administrator(s), must securely maintain information relevant to the ability to access the electronic filer's EDGAR account, including but not limited to access through any EDGAR Application Programming Interfaces.</P>
                            <NOTE>
                                <HD SOURCE="HED">Note 1 to § 232.10:</HD>
                                <P>The Commission staff carefully review each Form ID, and electronic filers should expect that the Commission staff will require sufficient time to review the Form ID upon its submission. Therefore, any applicant seeking EDGAR access is encouraged to submit the Form ID for review well in advance of the first required filing to allow sufficient time for staff to review the application.</P>
                            </NOTE>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="17" PART="232">
                        <AMDPAR>3. Amend § 232.11 by:</AMDPAR>
                        <AMDPAR>a. Adding definitions for “Account administrator”, “Application Programming Interface”, “Authorized individual”, “Dashboard”, and “Delegated entity” in alphabetical order;</AMDPAR>
                        <AMDPAR>b. Revising the definitions of “Direct transmission” and “EDGAR Filer Manual”;</AMDPAR>
                        <AMDPAR>c. Removing the note following the definition of “EDGAR Filer Manual”; and</AMDPAR>
                        <AMDPAR>d. Adding definitions for “Filing agent”, “Individual account credentials”, Single-member company”, “Technical administrator”, and “User” in alphabetical order.</AMDPAR>
                        <P>The additions and revisions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 232.11</SECTNO>
                            <SUBJECT> Definitions of terms used in this part.</SUBJECT>
                            <STARS/>
                            <P>
                                <E T="03">Account administrator.</E>
                                 The term 
                                <E T="03">account administrator</E>
                                 means an individual that the electronic filer authorizes to manage its EDGAR account and to make filings on EDGAR on the electronic filer's behalf.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Application Programming Interface.</E>
                                 The term 
                                <E T="03">Application Programming Interface,</E>
                                 or 
                                <E T="03">API,</E>
                                 means a software interface that allows computers or applications to communicate with each other.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Authorized individual.</E>
                                 The term 
                                <E T="03">authorized individual</E>
                                 means an individual with the authority to legally bind an entity or individual for purposes of Form ID, or an individual with a power of attorney from an individual with the authority to legally bind an entity or individual for purposes of Form ID. The power of attorney document must clearly state that the individual receiving the power of attorney has either general legal authority to bind the entity or individual or specific legal authority to bind the entity or individual for purposes of Form ID.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Dashboard.</E>
                                 The term 
                                <E T="03">dashboard</E>
                                 means an interactive function on EDGAR where electronic filers manage their EDGAR accounts and individuals that electronic filers authorize may take relevant actions for electronic filers' accounts.
                            </P>
                            <P>
                                <E T="03">Delegated entity.</E>
                                 The term 
                                <E T="03">delegated entity</E>
                                 means an electronic filer that another electronic filer authorizes, on the dashboard, to file on EDGAR on its behalf. Delegated entities must themselves be electronic filers and must follow all rules applicable to electronic filers. Delegated entities are not permitted to further delegate authority to file for a delegating electronic filer, nor are they permitted to take action on the delegating electronic filer's dashboard.
                            </P>
                            <P>
                                <E T="03">Direct transmission.</E>
                                 The term 
                                <E T="03">direct transmission</E>
                                 means the transmission to EDGAR of one or more electronic submissions.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">EDGAR Filer Manual.</E>
                                 The term 
                                <E T="03">EDGAR Filer Manual</E>
                                 means the manual that sets forth the requirements for access to EDGAR and the procedural requirements to make electronic submissions on EDGAR. 
                                <E T="03">See</E>
                                 Rule 301 of Regulation S-T (§ 232.301).
                            </P>
                            <STARS/>
                            <PRTPAGE P="106223"/>
                            <P>
                                <E T="03">Filing agent.</E>
                                 The term 
                                <E T="03">filing agent</E>
                                 means any person or entity engaged in the business of making submissions on EDGAR on behalf of electronic filers. To act as a delegated entity for an electronic filer, a filing agent must be an electronic filer with an EDGAR account.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Individual account credentials.</E>
                                 The term 
                                <E T="03">individual account credentials</E>
                                 means credentials issued to individuals for purposes of EDGAR access, as specified in the EDGAR Filer Manual, and used by those individuals to access EDGAR.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Single-member company.</E>
                                 The term 
                                <E T="03">single-member company</E>
                                 means a company that has a single individual who acts as the sole equity holder, director, and officer (or, in the case of an entity without directors and officers, holds position(s) performing similar activities as a director and officer).
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">Technical administrator.</E>
                                 The term 
                                <E T="03">technical administrator</E>
                                 means an individual that the electronic filer authorizes on the dashboard to manage the technical aspects of the electronic filer's connection to EDGAR Application Programming Interfaces on the electronic filer's behalf.
                            </P>
                            <STARS/>
                            <P>
                                <E T="03">User.</E>
                                 The term 
                                <E T="03">user</E>
                                 means an individual that the electronic filer authorizes on the dashboard to make submissions on EDGAR on the electronic filer's behalf.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="17" PART="232">
                        <AMDPAR>4. Section 232.301 is revised to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 232.301</SECTNO>
                            <SUBJECT> EDGAR Filer Manual.</SUBJECT>
                            <P>
                                Filers must prepare electronic filings in the manner prescribed by the EDGAR Filer Manual, promulgated by the Commission, which sets forth the technical formatting requirements for electronic submissions. The requirements for becoming an EDGAR Filer and updating company data are set forth in the EDGAR Filer Manual, Volume I: “General Information,” Version 42 (issued September 27, 2024). The requirements for filing on EDGAR are set forth in the updated EDGAR Filer Manual, Volume II: “EDGAR Filing,” Version 71 (September 2024). All of these provisions have been incorporated by reference into the Code of Federal Regulations, which action was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You must comply with these requirements in order for documents to be timely received and accepted. The EDGAR Filer Manual is available for inspection at the Commission and at the National Archives and Records Administration (NARA). The EDGAR Filer Manual is available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. Operating conditions may limit access to the Commission's Public Reference Room. For information on the availability of the EDGAR Filer Manual at NARA, visit 
                                <E T="03">www.archives.gov/federal-register/cfr/ibr-locations.html</E>
                                 or email 
                                <E T="03">fr.inspection@nara.gov.</E>
                                 The EDGAR Filer Manual may also be obtained from 
                                <E T="03">https://www.sec.gov/edgar/filerinformation/current-edgar-filer-manual.</E>
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <PART>
                        <HD SOURCE="HED">PART 239—FORMS PRESCRIBED UNDER THE SECURITIES ACT OF 1933</HD>
                    </PART>
                    <REGTEXT TITLE="17" PART="239">
                        <AMDPAR>4. The authority citation for part 239 continues to read, in part, as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>
                                 15 U.S.C. 77c, 77f, 77g, 77h, 77j, 77s, 77z-2, 77z-3, 77sss, 78c, 78
                                <E T="03">l,</E>
                                 78m, 78n, 78
                                <E T="03">o</E>
                                (d), 78
                                <E T="03">o</E>
                                -7 note, 78u-5, 78w(a), 78
                                <E T="03">ll,</E>
                                 78mm, 80a-2(a), 80a-3, 80a-8, 80a-9, 80a-10, 80a-13, 80a-24, 80a-26, 80a-29, 80a-30, 80a-37, and sec. 71003 and sec. 84001, Pub. L. 114-94, 129 Stat. 1321, unless otherwise noted.
                            </P>
                        </AUTH>
                        <EXTRACT>
                            <STARS/>
                            <P>
                                Sections 239.63 and 239.64 are also issued under 15 U.S.C. 77f, 77g, 77h, 77j, 77s(a), 77sss(a), 78c(b), 78
                                <E T="03">l,</E>
                                 78m, 78n, 78
                                <E T="03">o</E>
                                (d), 78w(a), 80a-8, 80a-24, 80a-29, and 80a-37.
                            </P>
                        </EXTRACT>
                    </REGTEXT>
                    <REGTEXT TITLE="17" PART="239">
                        <AMDPAR>5. Section 239.63 is revised to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 239.63</SECTNO>
                            <SUBJECT> Form ID, application for EDGAR access.</SUBJECT>
                            <P>Form ID must be filed by electronic filers, or by their account administrators, to request EDGAR access and to authorize account administrators to manage the electronic filer's EDGAR account. </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="17" PART="239">
                        <AMDPAR>6. Form ID (referenced in §§ 239.63, 249.446, 269.7, and 274.402) is revised to read as follows:</AMDPAR>
                        <NOTE>
                            <HD SOURCE="HED">Note:</HD>
                            <P> Form ID is attached as Appendix A at the end of this document. Form ID will not appear in the Code of Federal Regulations.</P>
                        </NOTE>
                    </REGTEXT>
                    <PART>
                        <HD SOURCE="HED">PART 249—FORMS, SECURITIES EXCHANGE ACT OF 1934</HD>
                    </PART>
                    <REGTEXT TITLE="17" PART="249">
                        <AMDPAR>7. The general authority citation for part 249 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority: </HD>
                            <P>
                                15 U.S.C. 78a 
                                <E T="03">et seq.</E>
                                 and 7201 
                                <E T="03">et seq.;</E>
                                 12 U.S.C. 5461 
                                <E T="03">et seq.;</E>
                                 18 U.S.C. 1350; Sec. 953(b) Pub. L. 111-203, 124 Stat. 1904; Sec. 102(a)(3) Pub. L. 112-106, 126 Stat. 309 (2012), Sec. 107 Pub. L. 112-106, 126 Stat. 313 (2012), Sec. 72001 Pub. L. 114-94, 129 Stat. 1312 (2015), and secs. 2 and 3 Pub. L. 116-222, 134 Stat. 1063 (2020), unless otherwise noted.
                            </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="17" PART="249">
                        <AMDPAR>8. Section 249.446 is revised to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 249.446 </SECTNO>
                            <SUBJECT>Form ID, application for EDGAR access.</SUBJECT>
                            <P>Form ID must be filed by electronic filers, or by their account administrators, to request EDGAR access and to authorize account administrators to manage the electronic filer's EDGAR account. </P>
                        </SECTION>
                    </REGTEXT>
                    <PART>
                        <HD SOURCE="HED">PART 269—FORMS PRESCRIBED UNDER THE TRUST INDENTURE ACT OF 1939</HD>
                    </PART>
                    <REGTEXT TITLE="17" PART="269">
                        <AMDPAR>9. The authority citation for part 269 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority: </HD>
                            <P>15 U.S.C. 77ddd(c), 77eee, 77ggg, 77hhh, 77iii, 77jjj, 77sss, and 78ll(d), unless otherwise noted.</P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="17" PART="269">
                        <AMDPAR>10. Section 269.7 is revised to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 269.7</SECTNO>
                            <SUBJECT> Form ID, application for EDGAR access.</SUBJECT>
                            <P>Form ID must be filed by electronic filers, or by their account administrators, to request EDGAR access and to authorize account administrators to manage the electronic filer's EDGAR account. </P>
                        </SECTION>
                    </REGTEXT>
                    <PART>
                        <HD SOURCE="HED">PART 274—FORMS PRESCRIBED UNDER THE INVESTMENT COMPANY ACT OF 1940</HD>
                    </PART>
                    <REGTEXT TITLE="17" PART="270">
                        <AMDPAR>11. The authority citation for part 274 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P> 15 U.S.C. 77f, 77g, 77h, 77j, 77s, 78c(b), 78l, 78m, 78n, 78n-1, 78o(d), 80a-8, 80a-24, 80a-26, 80a-29, and sec. 939A, Pub. L. 111-203, 124 Stat. 1376, unless otherwise noted.</P>
                        </AUTH>
                        <STARS/>
                    </REGTEXT>
                    <REGTEXT TITLE="17" PART="270">
                        <AMDPAR>12. Section 274.402 is revised to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 274.402</SECTNO>
                            <SUBJECT> Form ID, application for EDGAR access.</SUBJECT>
                            <P>Form ID must be filed by electronic filers, or by their account administrators, to request EDGAR access and to authorize account administrators to manage the electronic filer's EDGAR account.</P>
                        </SECTION>
                    </REGTEXT>
                    <SIG>
                        <P>By the Commission.</P>
                        <DATED>Dated: September 27, 2024</DATED>
                        <NAME>J. Matthew DeLesDernier,</NAME>
                        <TITLE>Deputy Secretary.</TITLE>
                    </SIG>
                    <NOTE>
                        <HD SOURCE="HED">Note: </HD>
                        <P>The following appendix will not appear in the Code of Federal Regulations.</P>
                    </NOTE>
                    <APPENDIX>
                        <PRTPAGE P="106224"/>
                        <HD SOURCE="HED">APPENDIX A—FORM ID</HD>
                        <HD SOURCE="HD1">FORM ID</HD>
                        <HD SOURCE="HD1">APPLICATION FOR EDGAR ACCESS</HD>
                        <P>Persons who respond to the collection of information contained in this form are not required to respond unless the form displays a current valid OMB control number.</P>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">IMPORTANT INFORMATION</HD>
                        <P>Complete Form ID by reference to:</P>
                        <P>• Rules 10 and 11 of Regulation S-T, 17 CFR 232.10 and 232.11;</P>
                        <P>• The requirements set forth in of Volume I of the EDGAR Filer Manual; and</P>
                        <P>• The Form ID General Instructions on this interface.</P>
                        <P>On Form ID, the applicant must authorize two (2) individuals as account administrators; except an applicant that is an individual or single-member company must authorize one (1) individual as account administrator.</P>
                        <P>• The first account administrator listed on Form ID will be considered the applicant's EDGAR point of contact (“EDGAR POC”) should the Form ID application be granted.</P>
                        <P>• SEC staff will attempt to contact the EDGAR POC first but may contact other account administrators if the EDGAR POC is not available.</P>
                        <P>Information submitted on Form ID may become public.</P>
                        <P>• Do not enter personal contact information on Form ID that you do not wish to become public.</P>
                        <P>• Your Form ID application may be rejected if you submit unsolicited sensitive personally identifiable information on the form or in any attachments.</P>
                        <FP SOURCE="FP-DASH"/>
                        <P>Misstatements or omissions of fact in connection with an application for EDGAR access and/or in a submission on EDGAR may constitute a criminal violation under 18 U.S.C. 1001 and 1030 and/or a violation of other criminal and civil laws. If the SEC has reason to believe that an application for EDGAR access and/or a submission on EDGAR is misleading, manipulative, and/or unauthorized, the SEC may prevent acceptance or dissemination of the application/submission and/or prevent future submissions or otherwise remove a filer's access to EDGAR pursuant to Rule 15 of Regulation S-T, 17 CFR 232.15.</P>
                        <FP SOURCE="FP-DASH"/>
                        <P>If your Form ID application is granted, be aware that EDGAR filers must comply with the rules and regulations governing access to the EDGAR system set forth in Regulation S-T and the EDGAR Filer Manual, including but not limited to the following:</P>
                        <P>• Filers must only provide access to EDGAR to persons or entities authorized by the filer to take action on behalf of the filer.</P>
                        <P>• Immediately upon determining that a person or entity is no longer authorized to take action on the filer's behalf, filers must remove the EDGAR access of that person or entity.</P>
                        <P>• Filers must inform the SEC immediately upon receiving information of any unauthorized activity in the filer's EDGAR account. Filers should contact EDGAR Filer Support at (202) 551-8900.</P>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD3">Privacy Act Statement</HD>
                        <P>
                            AUTHORITIES: The information is sought pursuant to 15 U.S.C. 77a 
                            <E T="03">et seq.,</E>
                             15 U.S.C. 77aaa 
                            <E T="03">et seq.,</E>
                             78a 
                            <E T="03">et seq.,</E>
                             80a-1 
                            <E T="03">et seq.,</E>
                             and 17 CFR 232.10.
                        </P>
                        <P>PURPOSE: The information solicited on this form will be used to determine whether to allow applicants to make filings on EDGAR, and, where access is granted, to establish and maintain the filer's EDGAR account</P>
                        <P>
                            ROUTINE USES: Uses for the information collected can be found in the System of Records Notice SEC-33: General Information Technology Records. See 
                            <E T="03">https://www.sec.gov/about/privacy/sorn/sec-33_sec_general_information_technology_records.pdf.</E>
                        </P>
                        <P>DISCLOSURE: Providing this information is voluntary. Failure to provide the information requested on this form, however, may affect the determination whether to allow applicants to make filings on EDGAR.</P>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">PART 1—APPLICATION FOR EDGAR ACCESS</HD>
                        <FP>
                            (To be completed by 
                            <E T="03">all applicants</E>
                            )
                        </FP>
                        <P>
                            <E T="03">Is this application for a new EDGAR account or for access to an existing EDGAR account?</E>
                        </P>
                        <P>
                            ☐ 
                            <E T="03">New</E>
                             EDGAR account (new EDGAR account number, known as a Central Index Key (CIK), will be issued)
                        </P>
                        <P>
                            ☐ 
                            <E T="03">Existing</E>
                             EDGAR account (applicant currently has an EDGAR account and Central Index Key (CIK))
                        </P>
                        <P>
                            <E T="03">Enter existing CIK account number</E>
                        </P>
                        <FP SOURCE="FP-DASH"/>
                        <P>
                            <E T="03">Indicate the reason the applicant is seeking access to an existing EDGAR account.</E>
                        </P>
                        <P>
                            ☐ Broker-dealer or “paper filer” seeks electronic access for the first time in order to 
                            <E T="03">file electronically</E>
                             on EDGAR
                        </P>
                        <P>
                            ☐ Filer 
                            <E T="03">lost electronic access</E>
                             to its existing CIK account
                        </P>
                        <P>
                            ☐ Applicant is the 
                            <E T="03">legal successor</E>
                             of the filer named on the existing CIK account but did not receive access from that filer
                        </P>
                        <HD SOURCE="HD1">Applicant Information</HD>
                        <P>
                            <E T="03">Is the applicant a company or an individual?</E>
                        </P>
                        <P>Only apply as an individual if you seek an EDGAR account for yourself as a natural person. All others should apply as a company.</P>
                        <FP SOURCE="FP-1">
                            ☐ 
                            <E T="03">Applicant is a company</E>
                        </FP>
                        <FP SOURCE="FP-1">
                            <E T="03">Enter company's full legal name:</E>
                        </FP>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-1">Conformed name ________ (the name that will appear on public EDGAR)</FP>
                        <FP SOURCE="FP-1">
                            ☐ 
                            <E T="03">Applicant is an individual</E>
                        </FP>
                        <FP SOURCE="FP-1">
                            <E T="03">Enter individual's full legal name, including middle name:</E>
                        </FP>
                        <FP SOURCE="FP-DASH">First name</FP>
                        <FP SOURCE="FP-DASH">Middle name </FP>
                        <FP SOURCE="FP-1">☐ No middle name</FP>
                        <FP SOURCE="FP-DASH">Last name </FP>
                        <FP SOURCE="FP-DASH">Suffix </FP>
                        <FP SOURCE="FP-DASH">Conformed name</FP>
                        <HD SOURCE="HD1">Applicant Type</HD>
                        <FP SOURCE="FP-1">
                            <E T="03">Select one (1) most relevant applicant type.</E>
                        </FP>
                        <FP SOURCE="FP1-2">
                            <E T="03">Select “Filer” if none of the other applicant types listed below apply.</E>
                        </FP>
                        <FP SOURCE="FP-2">☐ Filer</FP>
                        <FP SOURCE="FP-2">☐ Filing Agent</FP>
                        <FP SOURCE="FP1-2">The “filing agent” applicant type should be selected ONLY if the applicant is engaged in the business of making submissions to EDGAR on behalf of filers and does not intend to make live filings on its own behalf on EDGAR. A filing agent that wishes to make live filings on its own behalf should select the “filer” applicant type.</FP>
                        <FP SOURCE="FP-2">☐ Funding Portal</FP>
                        <FP SOURCE="FP-2">☐ Institutional Investment Manager (Form 13F Filer)</FP>
                        <FP SOURCE="FP-2">☐ Investment Company, Business Development Company or Insurance Company Separate Account</FP>
                        <FP SOURCE="FP-2">☐ Large Trader</FP>
                        <FP SOURCE="FP-2">☐ Municipal Advisor</FP>
                        <FP SOURCE="FP-2">☐ Nationally Recognized Statistical Rating Organization</FP>
                        <FP SOURCE="FP-2">☐ Non-Investment Company Applicant under the Investment Company Act of 1940</FP>
                        <FP SOURCE="FP-2">☐ Security-Based Swap Data Repository</FP>
                        <FP SOURCE="FP-2">☐ Security-Based Swap Dealer and Major Security-Based Swap Participant</FP>
                        <FP SOURCE="FP-2">☐ Security-Based Swap Execution Facility</FP>
                        <FP SOURCE="FP-2">☐ Transfer Agent</FP>
                        <FP SOURCE="FP1-2">A “transfer agent” CIK may only be used for submitting transfer agent filings on EDGAR.</FP>
                        <FP SOURCE="FP-2">☐ Training Agent</FP>
                        <FP SOURCE="FP1-2">A “training agent” CIK may only be used for submitting test filings on EDGAR. This applicant type is typically selected by a filing agent or third-party EDGAR software provider that needs a dedicated EDGAR CIK for testing their script or software configuration interface with EDGAR.</FP>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">ONLY FOR NON-PUBLIC DRAFT REGISTRATION/OFFERING STATEMENTS (DRS/DOS)</HD>
                        <P>If a company is applying for EDGAR access to submit non-public draft registration/offering statements on submission types DRS or DOS, select Yes.</P>
                        <FP>☐ Yes</FP>
                        <P>
                            <E T="03">Selecting “Yes” will prevent the new CIK number and EDGAR account information from being made publicly available on SEC.gov until a public filing is made.</E>
                        </P>
                        <P>
                            <E T="03">This option is only available for companies who plan to submit submission types DRS or DOS.</E>
                        </P>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">Applicant's Mailing Address and Preferred Contact Information</HD>
                        <P>The applicant may list its own information, or information for its registered agent, law firm, or filing agent (collectively, “third-party service provider”) in this section.</P>
                        <FP SOURCE="FP-1">☐ Address is for a non-U.S. location (do not select if address is for U.S. territory)</FP>
                        <FP SOURCE="FP-DASH">Street address (line 1) </FP>
                        <FP SOURCE="FP-DASH">Street address (line 2) (optional) </FP>
                        <FP SOURCE="FP-DASH">City</FP>
                        <FP SOURCE="FP-DASH">State/U.S. Territory </FP>
                        <FP SOURCE="FP-DASH">
                            Zip/Postal code (optional for non-U.S. locations)
                            <PRTPAGE P="106225"/>
                        </FP>
                        <FP SOURCE="FP-DASH">Province/Country </FP>
                        <FP SOURCE="FP-DASH">Telephone number (optional)</FP>
                        <HD SOURCE="HD1">Violations of Federal or State Securities Laws</HD>
                        <P>
                            Has the applicant (company or individual) been criminally convicted as a result of a Federal or state securities law violation, or civilly or administratively enjoined, barred, suspended, or banned in any capacity (
                            <E T="03">e.g.,</E>
                             officer or director bar, prohibition from associating with brokers, dealers, investment advisers, and/or other securities entities, or bar from participation in certain industries), as a result of a Federal or state securities law violation?
                        </P>
                        <FP>☐ Yes </FP>
                        <FP>☐ No</FP>
                        <P>If you indicate “Yes,” the SEC staff may contact you to determine your eligibility for EDGAR access.</P>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">PART 2—COMPANY APPLICANT INFORMATION</HD>
                        <FP SOURCE="FP-1">(To be completed only by applicants who are not natural persons)</FP>
                        <HD SOURCE="HD1">Company Business Information</HD>
                        <FP SOURCE="FP-DASH">
                            Company's Tax or Federal Identification Number (
                            <E T="03">do not enter Social Security Number</E>
                            ) 
                        </FP>
                        <FP SOURCE="FP-DASH"/>
                        <FP SOURCE="FP-DASH">Legal Entity Identifier (LEI), if any </FP>
                        <FP SOURCE="FP-DASH">Legal name </FP>
                        <FP SOURCE="FP-DASH">Doing business as name, if different from legal name </FP>
                        <FP SOURCE="FP-DASH">U.S. state of incorporation </FP>
                        <FP SOURCE="FP-DASH">If foreign issuer, country of incorporation </FP>
                        <FP>Foreign issuer name, if different than English name used in U.S. ____(enter only English characters)</FP>
                        <FP SOURCE="FP-DASH">Fiscal year end (mm/dd) </FP>
                        <FP SOURCE="FP-DASH">Company's primary website, if any </FP>
                        <P>Is the company in good standing in its state or country of incorporation? Generally, this means a company is legally authorized to do business in that state or country and has filed all required reports and paid all related fees to the relevant jurisdiction.</P>
                        <FP>☐ Yes</FP>
                        <FP>☐ No</FP>
                        <HD SOURCE="HD1">Company's Primary Business Information</HD>
                        <P>This must be the applicant company's primary business information, or that of the company's registered agent. Do not enter the address of the company's law firm or filing agent.</P>
                        <P>You must enter the actual physical address; P.O. boxes are not acceptable.</P>
                        <P>☐ Primary business information is the same as the mailing address and preferred contact information in Part 1. If this box is selected, the relevant information will be added below.</P>
                        <P>☐ Address is for a non-U.S. location (do not select if address is for U.S. territory)</P>
                        <FP SOURCE="FP-DASH">Street address (line 1) </FP>
                        <FP SOURCE="FP-DASH">Street address (line 2) (optional) </FP>
                        <FP SOURCE="FP-DASH">City </FP>
                        <FP SOURCE="FP-DASH">State/U.S. Territory </FP>
                        <FP SOURCE="FP-DASH">Zip/Postal code (optional for non-U.S. locations) </FP>
                        <FP SOURCE="FP-DASH">Province/Country </FP>
                        <FP SOURCE="FP-DASH">Telephone number </FP>
                        <P>Single-Member Company? You should select “Yes” if the company only has a single individual who acts as the sole equity holder, director, and officer (or, in the case of an entity without directors and officers, holds position(s) performing similar activities as a director and officer).</P>
                        <FP>☐ Yes</FP>
                        <FP>☐ No</FP>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">PART 3—PROSPECTIVE ACCOUNT ADMINISTRATOR INFORMATION</HD>
                        <FP>
                            (To be completed by 
                            <E T="03">all applicants</E>
                            )
                        </FP>
                        <P>
                            <E T="03">Account administrators are individuals authorized by the applicant to manage the applicant's EDGAR account on EDGAR should the Form ID application be granted.</E>
                        </P>
                        <HD SOURCE="HD1">Prospective Account Administrator 1</HD>
                        <P>The first account administrator listed on Form ID will be considered the applicant's EDGAR point of contact (“EDGAR POC”) if the Form ID application is granted.</P>
                        <P>SEC staff will attempt to contact the EDGAR POC first but may contact other account administrators if the EDGAR POC is not available.</P>
                        <FP SOURCE="FP-1">
                            <E T="03">Enter full legal name, including middle name</E>
                        </FP>
                        <FP SOURCE="FP-DASH">First name </FP>
                        <FP SOURCE="FP-DASH">Middle name </FP>
                        <FP SOURCE="FP-1">☐ No middle name</FP>
                        <FP SOURCE="FP-DASH">Last name </FP>
                        <FP SOURCE="FP-DASH">Suffix </FP>
                        <FP SOURCE="FP-DASH">Business title/position </FP>
                        <P>Is Prospective Account Administrator 1 the applicant (for an individual applicant), or an employee of the applicant or its affiliate (for a company applicant)?</P>
                        <FP>☐ Yes</FP>
                        <FP>☐ No</FP>
                        <P>Provide the full legal name of the prospective account administrator's employer and the employer's CIK, if any. In addition, you must attach to your submission a notarized power of attorney authorizing the individual as an account administrator to manage the applicant's EDGAR account, as set forth more fully in Part 6 of this form.</P>
                        <FP SOURCE="FP-DASH">Employer (full legal name) </FP>
                        <FP SOURCE="FP-DASH">CIK of employer (if any) </FP>
                        <HD SOURCE="HD1">Business Address and Contact Information</HD>
                        <FP SOURCE="FP-1">☐ Contact information is the same as the mailing address and preferred contact information in Part 1. If this option is selected, the relevant information will be added below.</FP>
                        <FP SOURCE="FP-1">☐ Contact information is the same as the primary business information in Part 2. If this option is selected, the relevant information will be added below.</FP>
                        <FP SOURCE="FP-1">☐ New information added below</FP>
                        <FP SOURCE="FP-1">☐ Address is for a non-U.S. location (do not select if address is for U.S. territory)</FP>
                        <FP SOURCE="FP-DASH">Street address (line 1) </FP>
                        <FP SOURCE="FP-DASH">Street address (line 2) (optional) </FP>
                        <FP SOURCE="FP-DASH">City </FP>
                        <FP SOURCE="FP-DASH">State/U.S. Territory </FP>
                        <FP SOURCE="FP-DASH">Zip/Postal code (optional for non-U.S. locations)</FP>
                        <FP SOURCE="FP-DASH">Province/Country </FP>
                        <FP SOURCE="FP-DASH">Email</FP>
                        <FP SOURCE="FP-DASH">Telephone number </FP>
                        <HD SOURCE="HD1">Violations of Federal or State Securities Laws</HD>
                        <P>
                            Has the individual being authorized as Prospective Account Administrator 1 been criminally convicted as a result of a Federal or state securities law violation, or civilly or administratively enjoined, barred, suspended, or banned in any capacity (
                            <E T="03">e.g.,</E>
                             officer or director bar, prohibition from associating with brokers, dealers, investment advisers, and/or other securities entities, or bar from participation in certain industries), as a result of a Federal or state securities law violation?
                        </P>
                        <FP>☐ Yes </FP>
                        <FP>☐ No</FP>
                        <P>If you indicate “Yes,” the SEC staff may contact you to determine your eligibility for EDGAR access.</P>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">Prospective Account Administrator 2</HD>
                        <FP SOURCE="FP-1">
                            <E T="03">Enter full legal name, including middle name</E>
                        </FP>
                        <FP SOURCE="FP-DASH">First name </FP>
                        <FP SOURCE="FP-DASH">Middle name </FP>
                        <FP SOURCE="FP-1">☐ No middle name</FP>
                        <FP SOURCE="FP-DASH">Last name </FP>
                        <FP SOURCE="FP-DASH">Suffix </FP>
                        <FP SOURCE="FP-DASH">Business title/position </FP>
                        <P>Is Prospective Account Administrator 2 the applicant (for an individual applicant), or an employee of the applicant or its affiliate (for a company applicant)?</P>
                        <FP>☐ Yes</FP>
                        <FP>☐ No</FP>
                        <P>Provide the full legal name of the prospective account administrator's employer and the employer's CIK, if any. In addition, you must attach to your submission a notarized power of attorney authorizing the individual as an account administrator to manage the applicant's EDGAR account, as set forth more fully in Part 6 of this form.</P>
                        <FP SOURCE="FP-DASH">Employer (full legal name) </FP>
                        <FP SOURCE="FP-DASH">CIK of employer (if any) </FP>
                        <HD SOURCE="HD1">Business Address and Contact Information</HD>
                        <FP SOURCE="FP-1">☐ Contact information is the same as the mailing address and preferred contact information in Part 1. If this option is selected, the relevant information will be added below.</FP>
                        <FP SOURCE="FP-1">☐ Contact information is the same as the primary business information in Part 2. If this option is selected, the relevant information will be added below.</FP>
                        <FP SOURCE="FP-1">☐ New information added below</FP>
                        <FP SOURCE="FP-1">☐ Address is for a non-U.S. location (do not select if address is for U.S. territory)</FP>
                        <FP SOURCE="FP-DASH">Street address (line 1) </FP>
                        <FP SOURCE="FP-DASH">Street address (line 2) (optional) </FP>
                        <FP SOURCE="FP-DASH">City </FP>
                        <FP SOURCE="FP-DASH">State/U.S. Territory </FP>
                        <FP SOURCE="FP-DASH">Zip/Postal code (optional for non-U.S. locations)</FP>
                        <FP SOURCE="FP-DASH">Province/Country </FP>
                        <FP SOURCE="FP-DASH">Email </FP>
                        <FP SOURCE="FP-DASH">Telephone number </FP>
                        <HD SOURCE="HD1">Violations of Federal or State Securities Laws</HD>
                        <P>
                            Has the individual being authorized as Prospective Account Administrator 2 been criminally convicted as a result of a Federal 
                            <PRTPAGE P="106226"/>
                            or state securities law violation, or civilly or administratively enjoined, barred, suspended, or banned in any capacity (
                            <E T="03">e.g.,</E>
                             officer or director bar, prohibition from associating with brokers, dealers, investment advisers, and/or other securities entities, or bar from participation in certain industries), as a result of a Federal or state securities law violation?
                        </P>
                        <FP>☐ Yes </FP>
                        <FP>☐ No</FP>
                        <P>If you indicate “Yes,” the SEC staff may contact you to determine your eligibility for EDGAR access.</P>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">PART 4—BILLING INFORMATION</HD>
                        <FP>(To be completed only by company applicants and filing agents)</FP>
                        <HD SOURCE="HD1">Billing Contact for SEC Fee Account and Billing</HD>
                        <FP SOURCE="FP-1">
                            <E T="03">Enter full legal name, including middle name</E>
                        </FP>
                        <FP SOURCE="FP-DASH">First name </FP>
                        <FP SOURCE="FP-DASH">Middle name </FP>
                        <FP SOURCE="FP-1">☐ No middle name</FP>
                        <FP SOURCE="FP-DASH">Last name </FP>
                        <FP SOURCE="FP-DASH">Suffix </FP>
                        <FP SOURCE="FP-DASH">Business title/position </FP>
                        <FP SOURCE="FP-DASH">Employer </FP>
                        <HD SOURCE="HD1">Billing Business Address and Contact Information</HD>
                        <FP SOURCE="FP-1">☐ Contact information is the same as the mailing address and preferred contact information in Part 1. If this option is selected, the relevant information will be added below.</FP>
                        <FP SOURCE="FP-1">☐ Contact information is the same as the primary business information in Part 2. If this option is selected, the relevant information will be added below.</FP>
                        <FP SOURCE="FP-1">☐ New information added below</FP>
                        <FP SOURCE="FP-1">☐ Address is for a non-U.S. location (do not select if address is for U.S. territory)</FP>
                        <FP SOURCE="FP-DASH">Street address (line 1) </FP>
                        <FP SOURCE="FP-DASH">Street address (line 2) (optional) </FP>
                        <FP SOURCE="FP-DASH">City </FP>
                        <FP SOURCE="FP-DASH">State/U.S. Territory</FP>
                        <FP SOURCE="FP-DASH">Zip/Postal code (optional for non-U.S. locations)</FP>
                        <FP SOURCE="FP-DASH">Province/Country </FP>
                        <FP SOURCE="FP-DASH">Email </FP>
                        <FP SOURCE="FP-DASH">Telephone number </FP>
                        <HD SOURCE="HD1">Violations of Federal or State Securities Laws</HD>
                        <P>
                            Has the billing contact been criminally convicted as a result of a Federal or state securities law violation, or civilly or administratively enjoined, barred, suspended, or banned in any capacity (
                            <E T="03">e.g.,</E>
                             officer or director bar, prohibition from associating with brokers, dealers, investment advisers, and/or other securities entities, or bar from participation in certain industries), as a result of a Federal or state securities law violation?
                        </P>
                        <FP>☐ Yes</FP>
                        <FP>☐ No</FP>
                        <P>If you indicate “Yes,” the SEC staff may contact you to determine your eligibility for EDGAR access.</P>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">PART 5—SIGNATURE</HD>
                        <FP SOURCE="FP-1">
                            (To be completed by 
                            <E T="03">all applicants</E>
                            )
                        </FP>
                        <P>
                            <E T="03">An authorized individual of the applicant must sign Form ID.</E>
                        </P>
                        <P>
                            <E T="03">Refer to the EDGAR Filer Manual, Volume I for the definition of authorized individual and additional relevant information.</E>
                        </P>
                        <P>
                            <E T="03">By signing Form ID, the authorized individual authorizes the prospective account administrator(s) listed on Form ID to manage the filer's EDGAR account on EDGAR on the filer's behalf.</E>
                        </P>
                        <FP SOURCE="FP-1">
                            <E T="03">Enter full legal name, including middle name</E>
                        </FP>
                        <FP SOURCE="FP-DASH">First name </FP>
                        <FP SOURCE="FP-DASH">Middle name </FP>
                        <FP SOURCE="FP-1">☐ No middle name</FP>
                        <FP SOURCE="FP-DASH">Last name </FP>
                        <FP SOURCE="FP-DASH">Suffix </FP>
                        <FP SOURCE="FP-DASH">Business title/position </FP>
                        <FP SOURCE="FP-DASH">Employer</FP>
                        <HD SOURCE="HD1">Business Address and Contact Information</HD>
                        <FP SOURCE="FP-1">☐ Contact information is the same as the mailing address and preferred contact information in Part 1. If this option is selected, the relevant information will be added below.</FP>
                        <FP SOURCE="FP-1">☐ Contact information is the same as the primary business information in Part 2. If this option is selected, the relevant information will be added below.</FP>
                        <FP SOURCE="FP-1">☐ New information added below</FP>
                        <FP SOURCE="FP-1">☐ Address is for a non-U.S. location (do not select if address is for U.S. territory)</FP>
                        <FP SOURCE="FP-DASH">Street address (line 1) </FP>
                        <FP SOURCE="FP-DASH">Street address (line 2) (optional) </FP>
                        <FP SOURCE="FP-DASH">City </FP>
                        <FP SOURCE="FP-DASH">State/U.S. Territory </FP>
                        <FP SOURCE="FP-DASH">Zip/Postal code (optional for non-U.S. locations)</FP>
                        <FP SOURCE="FP-DASH">Province/Country</FP>
                        <FP SOURCE="FP-DASH">Email</FP>
                        <FP SOURCE="FP-DASH">Telephone number </FP>
                        <HD SOURCE="HD1">Violations of Federal or State Securities Laws</HD>
                        <P>
                            Has the authorized individual signing this application been criminally convicted as a result of a Federal or state securities law violation, or civilly or administratively enjoined, barred, suspended, or banned in any capacity (
                            <E T="03">e.g.,</E>
                             officer or director bar, prohibition from associating with brokers, dealers, investment advisers, and/or other securities entities, or bar from participation in certain industries), as a result of a Federal or state securities law violation?
                        </P>
                        <FP>☐ Yes</FP>
                        <FP>☐ No</FP>
                        <P>If you indicate “Yes,” the SEC staff may contact you to determine your eligibility for EDGAR access.</P>
                        <FP SOURCE="FP-DASH">Authorized individual signature</FP>
                        <FP>[Notary seal]</FP>
                        <FP SOURCE="FP-DASH">Date</FP>
                        <P>Is Form ID being signed pursuant to a Power of Attorney?</P>
                        <FP>☐ Yes</FP>
                        <FP>☐ No</FP>
                        <P>
                            <E T="03">Person signing Power of Attorney, if application is made pursuant to a Power of Attorney. Refer to the EDGAR Filer Manual, Volume I for more information.</E>
                        </P>
                        <FP SOURCE="FP-1">
                            <E T="03">Enter full legal name, including middle name</E>
                        </FP>
                        <FP SOURCE="FP-DASH">First name </FP>
                        <FP SOURCE="FP-DASH">Middle name </FP>
                        <FP SOURCE="FP-1">☐ No middle name</FP>
                        <FP SOURCE="FP-DASH">Last name </FP>
                        <FP SOURCE="FP-DASH">Suffix </FP>
                        <FP SOURCE="FP-DASH">Business title/position </FP>
                        <FP SOURCE="FP-DASH">Employer</FP>
                        <P>
                            <E T="03">Person signing Power of Attorney business address and contact information.</E>
                        </P>
                        <FP SOURCE="FP-1">☐ Contact information is the same as the mailing address and preferred contact information in Part 1. If this option is selected, the relevant information will be added below.</FP>
                        <FP SOURCE="FP-1">☐ Contact information is the same as the primary business information in Part 2. If this option is selected, the relevant information will be added below.</FP>
                        <FP SOURCE="FP-1">☐ New information added below</FP>
                        <FP SOURCE="FP-1">☐ Address is for a non-U.S. location (do not select if address is for U.S. territory)</FP>
                        <FP SOURCE="FP-DASH">Street address (line 1) </FP>
                        <FP SOURCE="FP-DASH">Street address (line 2) (optional) </FP>
                        <FP SOURCE="FP-DASH">City </FP>
                        <FP SOURCE="FP-DASH">State/U.S. Territory </FP>
                        <FP SOURCE="FP-DASH">Zip/Postal code (optional for non-U.S. locations)</FP>
                        <FP SOURCE="FP-DASH">Province/Country</FP>
                        <FP SOURCE="FP-DASH">Email </FP>
                        <FP SOURCE="FP-DASH">Telephone number </FP>
                        <HD SOURCE="HD1">Violations of Federal or State Securities Laws</HD>
                        <P>
                            Has the person who signed the Power of Attorney been criminally convicted as a result of a Federal or state securities law violation, or civilly or administratively enjoined, barred, suspended, or banned in any capacity (
                            <E T="03">e.g.,</E>
                             officer or director bar, prohibition from associating with brokers, dealers, investment advisers, and/or other securities entities, or bar from participation in certain industries), as a result of a Federal or state securities law violation?
                        </P>
                        <FP>☐ Yes</FP>
                        <FP>☐ No</FP>
                        <P>If you indicate “Yes,” the SEC staff may contact you to determine your eligibility for EDGAR access.</P>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">PART 6—DOCUMENTS</HD>
                        <FP>
                            (To be completed by 
                            <E T="03">all applicants</E>
                            )
                        </FP>
                        <P>
                            <E T="03">All filers must upload a notarized Form ID authentication document to EDGAR as a PDF attachment submitted with your Form ID.</E>
                        </P>
                        <P>See the EDGAR Filer Manual, Volume I, for more information about the notarized authentication document.</P>
                        <P>
                            <E T="03">Other documents to be uploaded in certain circumstances:</E>
                        </P>
                        <P>
                            • 
                            <E T="03">Prospective account administrator(s) not employed by the applicant, including filing agents and other third parties acting on behalf of the applicant:</E>
                        </P>
                        <P>➢ Must upload to EDGAR a notarized Power of Attorney clearly indicating that an authorized individual of the applicant, as defined in the EDGAR Filer Manual, Volume I, gives the individual(s) named as a prospective account administrator(s) the authority to act as the applicant's account administrator(s) and manage the applicant's EDGAR account.</P>
                        <P>
                            • 
                            <E T="03">Applicants for access to an existing CIK account:</E>
                            <PRTPAGE P="106227"/>
                        </P>
                        <P>➢ Must upload to EDGAR documents that clearly establish the applicant's authority over the company or individual whose name currently is listed in EDGAR on the existing CIK account.</P>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">GENERAL INSTRUCTIONS</HD>
                        <FP SOURCE="FP-DASH"/>
                        <P>All companies and individuals seeking access to file on EDGAR must refer to Rules 10 and 11 of Regulation S-T, Volume I of the EDGAR Filer Manual, and these instructions.</P>
                        <P>All applicants must:</P>
                        <P>(1) Complete and submit Form ID in electronic format on the EDGAR Filer Management website; and</P>
                        <P>(2) Create a copy of the completed, electronically submitted Form ID; have an authorized individual of the filer sign it in the “Form ID: Notarized Authentication” part in the presence of an official notary public; and upload that authenticating document to the EDGAR Filer Management website.</P>
                        <P>
                            <E T="03">Before beginning:</E>
                             Form ID must be completed and submitted by an individual authorized by the applicant to do so.
                        </P>
                        <P>• An account administrator is a person authorized by the filer to manage the filer's EDGAR account on EDGAR on behalf of the filer.</P>
                        <P>• Each applicant must identify one or more prospective account administrator(s) that the applicant authorizes on Form ID. If the Form ID application is granted, the prospective account administrator(s) listed on Form ID will become the initial account administrators of the applicant.</P>
                        <P>• Account administrators must create individual account credentials in the manner specified in the EDGAR Filer Manual. When entering email addresses for individuals on Form ID, note that email addresses may be visible to other persons with access to the EDGAR Filer Management dashboard. Accordingly, individuals should enter email addresses that they intend to use for EDGAR and other business purposes, which may be different from the email address that they use for personal purposes. Email addresses that individuals provide to Login.gov for individual account credentials should match the email addresses they provide on Form ID.</P>
                        <P>The “EDGAR Filer Manual Volume I: General Information” contains additional requirements regarding how to file electronically, including how to obtain individual account credentials, authorize account administrators, and use the CIK and CCC.</P>
                        <P>
                            <E T="03">Note that information submitted on Form ID may become public. Do not include personally identifiable information, such as personal addresses and contact information that the applicant does not wish to become public.</E>
                        </P>
                        <P>
                            <E T="03">Misstatements or omissions of fact in connection with an application for EDGAR access and/or in a submission on EDGAR may constitute a criminal violation under 18 U.S.C. 1001 and 1030 and/or a violation of other criminal and civil laws. If the SEC has reason to believe that an application for EDGAR access and/or a submission on EDGAR is misleading, manipulative, and/or unauthorized, the SEC may prevent acceptance or dissemination of the application/submission and/or prevent future submissions or otherwise remove a filer's access to EDGAR pursuant to Rule 15 of Regulation S-T, 17 CFR 232.15.</E>
                        </P>
                        <P>
                            <E T="03">Complete all items that are relevant to the application. If an item does not apply to the application, leave that item blank.</E>
                        </P>
                        <P>For assistance with procedural and technical questions about electronic filing or substantive questions, see the “EDGAR Filer Manual Volume II: Section 2.3.4 (Getting Help with EDGAR).</P>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">PART 1—APPLICATION FOR EDGAR ACCESS</HD>
                        <FP SOURCE="FP-1">
                            (To be completed by 
                            <E T="03">all applicants</E>
                            )
                        </FP>
                        <P>Indicate whether EDGAR access is being requested for a new CIK account or an existing CIK account. If access is being requested for an existing CIK account, indicate the basis for the request—whether the applicant is a broker-dealer or “paper filer” who wants to start filing electronically on EDGAR, lost electronic access to their CIK account, or is the legal successor of the filer named on the existing CIK account but did not receive access from that filer. A filer that has lost electronic access because it failed to satisfy annual confirmation requirements or because its account administrators are no longer available should select the “lost electronic access” option.</P>
                        <P>If the applicant is applying for access to an existing CIK account, some of the filer's currently publicly available corporate and contact information will be prepopulated into Form ID. That information can be updated on Form ID, but doing so will not update the filer's information in EDGAR (other than the filer's account administrator information). Changes to the filer's corporate and contact information must be made in EDGAR after the applicant's Form ID application is granted. However, filers who are broker-dealers that obtained an EDGAR account by submitting a Form BD to FINRA would need to update their information with FINRA directly. Broker-dealers that have made a full withdrawal of their registration, by submitting a Form BDW that has been accepted, should apply for a new EDGAR account instead of applying for access to the existing EDGAR account associated with the withdrawn registration.</P>
                        <P>Applicants should identify themselves as individuals or companies.</P>
                        <P>Provide the applicant's full legal name in English. Note that the applicant's name will be automatically conformed following submission to meet EDGAR standards. Specifically:</P>
                        <P>1. Leading and trailing blank spaces will be removed. Any embedded sequences of two or more spaces will be replaced with a single space.</P>
                        <P>2. For companies, the following words will be removed if they are the first word of the name:</P>
                        <FP>A</FP>
                        <FP>An</FP>
                        <FP>The</FP>
                        <P>3. For companies, the following text substitutions will be applied to all words except the first:</P>
                        <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s50,xs60">
                            <TTITLE> </TTITLE>
                            <BOXHD>
                                <CHED H="1">Original text</CHED>
                                <CHED H="1">Conformed text</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">Company</ENT>
                                <ENT>Co.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Corporation</ENT>
                                <ENT>Corp.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Incorporated</ENT>
                                <ENT>Inc.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Incorporation</ENT>
                                <ENT>Inc.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">And</ENT>
                                <ENT>&amp;</ENT>
                            </ROW>
                        </GPOTABLE>
                        <P>4. For companies, the following substitution will be applied if the word is neither the first in the name, nor is immediately followed by the word “Partnership”:</P>
                        <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s50,xs60">
                            <TTITLE> </TTITLE>
                            <BOXHD>
                                <CHED H="1">Original text</CHED>
                                <CHED H="1">Conformed text</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">Limited</ENT>
                                <ENT>Ltd.</ENT>
                            </ROW>
                        </GPOTABLE>
                        <P>5. For individuals, the name components (“Last,” “First,” “Middle,” and “Suffix”) will be combined left-to-right (separated by spaces) into a single field and truncated at 150 characters.</P>
                        <P>6. For individuals with a suffix, the following text substitutions will be applied:</P>
                        <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s50,xs60">
                            <TTITLE> </TTITLE>
                            <BOXHD>
                                <CHED H="1">Original text</CHED>
                                <CHED H="1">Conformed text</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="01">Junior</ENT>
                                <ENT>JR.</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">Senior</ENT>
                                <ENT>SR.</ENT>
                            </ROW>
                        </GPOTABLE>
                        <P>Select one (1) applicant type to indicate whether the applicant will send electronic submissions as one of the listed filer types.</P>
                        <P>Indicate whether the filer is applying for EDGAR access to submit non-public draft registration or offering statements on submission type DRS or DOS. If so, the applicant's new CIK number and EDGAR contact information will not be listed on the public EDGAR company database until the applicant makes a public filing.</P>
                        <P>Provide the preferred mailing address and contact information for the applicant. A company applicant should provide information for the department, unit, or group most directly responsible for the filer's EDGAR submissions. This may be the applicant's registered agent, law firm, or filing agent. In that case, identify them in the mailing address and contact information, but do not include any specific individuals by name or any personally identifiable information that you do not want to make publicly available because the mailing address and contact information will generally be publicly available.</P>
                        <P>
                            Indicate whether the applicant has been criminally convicted as a result of a Federal or state securities law violation, or civilly or administratively enjoined, barred, suspended, or banned in any capacity (
                            <E T="03">e.g.,</E>
                             officer or director bar, prohibition from associating with brokers, dealers, investment advisers, and/or other securities entities, or bar from participation in certain industries), as a result of a Federal or state securities law violation.
                        </P>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">PART 2—COMPANY INFORMATION</HD>
                        <FP SOURCE="FP-1">
                            (To be completed only by 
                            <E T="03">applicants who are not natural persons</E>
                            )
                        </FP>
                        <P>
                            Provide the applicant's tax or Federal identification number, the number issued by the Internal Revenue Service. (This does 
                            <E T="03">not</E>
                              
                            <PRTPAGE P="106228"/>
                            apply to individuals. Accordingly, do 
                            <E T="03">not</E>
                             enter a Social Security number.) If an investment company applicant is organized as a series company, the investment company may use the tax or Federal identification number of any one of its constituent series. Applicants that have applied for but not yet received their tax or Federal identification number and foreign applicants that do not have a tax or Federal identification number must include all zeroes.
                        </P>
                        <P>Provide the applicant's legal entity identifier (LEI), if any.</P>
                        <P>Indicate whether applicant is in good standing in its state or country of incorporation. Generally, this means a company is legally authorized to do business in that state or country and has filed all required reports and paid all related fees to the relevant jurisdiction.</P>
                        <P>
                            Provide the filer's state of incorporation and fiscal year end. Select “none” for state of incorporation and “N/A” for fiscal year end if the filer has not incorporated. Foreign filers should also include their country of organization. If the filer's fiscal year does not end on the same date each year (
                            <E T="03">e.g.,</E>
                             falls on last Saturday in December), the filer must enter the date the current fiscal year will end.
                        </P>
                        <P>Provide the company's primary website, if any.</P>
                        <P>
                            Provide the applicant company's primary business information or that of the company's registered agent. Do 
                            <E T="03">not</E>
                             enter the address of the company's law firm or filing agent.
                        </P>
                        <P>Indicate whether the filer is a single-member company. This refers to a company that only has a single individual who acts as the sole equity holder, director, and officer (or, in the case of an entity without directors and officers, holds position(s) performing similar activities as a director and officer).</P>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">PART 3—PROSPECTIVE ACCOUNT ADMINISTRATOR INFORMATION</HD>
                        <FP SOURCE="FP-1">(To be completed by all applicants)</FP>
                        <P>Identify the individuals being authorized as prospective account administrator(s) who will manage the filer's EDGAR account on the filer's behalf, should the Form ID application be granted, including the account administrator(s) business title(s)/position(s), address(es), and contact information. Individual filers and single-member companies must authorize at least one prospective account administrator. All other filers must authorize two prospective account administrators on Form ID. Additional account administrators may be added through the Filer Management dashboard, should the Form ID application be granted.</P>
                        <P>
                            For each individual being authorized as a prospective account administrator, indicate whether the individual has been criminally convicted as a result of a Federal or state securities law violation, or civilly or administratively enjoined, barred, suspended, or banned in any capacity (
                            <E T="03">e.g.,</E>
                             officer or director bar, prohibition from associating with brokers, dealers, investment advisers, and/or other securities entities, or bar from participation in certain industries), as a result of a Federal or state securities law violation.
                        </P>
                        <P>If an individual being authorized as a prospective account administrator is not the applicant (in the case of an individual applicant), or an employee of the applicant or its affiliate (in the case of a company applicant), disclose that fact and provide the name and CIK (if any) of the prospective account administrator's employer. In addition, a notarized power of attorney authorizing the prospective account administrator must be attached in Part 6.</P>
                        <P>For more information on account administrators, see Rules 10 and 11 of Regulation S-T and Volume I of the EDGAR Filer Manual.</P>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">PART 4—BILLING INFORMATION</HD>
                        <FP SOURCE="FP-1">(To be completed only by company applicants and filing agents)</FP>
                        <P>Billing information is used if questions arise related to account and billing matters, such as:</P>
                        <FP SOURCE="FP-1">1. Accounts activity statements</FP>
                        <FP SOURCE="FP-1">2. Account receivable letters</FP>
                        <FP SOURCE="FP-1">3. Refund questions</FP>
                        <P>Identify the individual who should receive account information and/or billing invoices from the SEC and include their email address. Ensure the accuracy of the email address and maintain an accurate, active email address in the EDGAR Filing website. EDGAR will send communications to the email address if there are questions pertaining to the account and billing information, and failure to maintain an accurate, active email address could result in failure to receive EDGAR account statements.</P>
                        <P>
                            Indicate whether the billing contact has been criminally convicted as a result of a Federal or state securities law violation, or civilly or administratively enjoined, barred, suspended, or banned in any capacity (
                            <E T="03">e.g.,</E>
                             officer or director bar, prohibition from associating with brokers, dealers, investment advisers, and/or other securities entities, or bar from participation in certain industries), as a result of a Federal or state securities law violation.
                        </P>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">PART 5—SIGNATURE</HD>
                        <FP SOURCE="FP-1">(To be completed by all applicants)</FP>
                        <P>If the applicant is not a natural person, indicate the capacity in which the authorized individual signs the Form ID on behalf of the applicant (business title/position). The authorized individual must be an individual with the authority to legally bind the applicant, or an individual with a power of attorney from an individual with the authority to legally bind the applicant for purposes of Form ID.</P>
                        <P>If the applicant is an individual, the applicant must sign the Form ID and should list their business title/position as “applicant,” unless the applicant executes a notarized power of attorney authorizing a third-party individual to sign the Form ID on the applicant's behalf.</P>
                        <P>
                            Indicate whether the authorized individual signing the Form ID has been criminally convicted as a result of a Federal or state securities law violation, or civilly or administratively enjoined, barred, suspended, or banned in any capacity (
                            <E T="03">e.g.,</E>
                             officer or director bar, prohibition from associating with brokers, dealers, investment advisers, and/or other securities entities, or bar from participation in certain industries), as a result of a Federal or state securities law violation.
                        </P>
                        <P>Indicate whether Form ID is being signed pursuant to a power of attorney.</P>
                        <P>If another person signs on behalf of the applicant, confirm in writing the authority of that person to sign by attaching a notarized power of attorney to the Form ID. For more information on the documentation needed to confirm the authority of a person signing the Form ID on behalf of the applicant, see Volume I of the EDGAR Filer Manual.</P>
                        <P>
                            • If relevant, provide the name, address, and contact information for the person signing the power of attorney. Indicate whether the person signing the power of attorney has been criminally convicted as a result of a Federal or state securities law violation, or civilly or administratively enjoined, barred, suspended, or banned in any capacity (
                            <E T="03">e.g.,</E>
                             officer or director bar, prohibition from associating with brokers, dealers, investment advisers, and/or other securities entities, or bar from participation in certain industries), as a result of a Federal or state securities law violation.
                        </P>
                        <P>• For Form IDs signed in connection with a power of attorney document, the person signing the power of attorney should indicate in the business title/position field: “By POA from [(a) name of the authorized individual signing the power of attorney (if opening an account for a natural person); or (b) name and business title/position of the authorized individual signing the power of attorney (if opening an account for a company)].” For example, a filing agent signing Form ID pursuant to a power of attorney from Roger Smith, the Chief Executive Officer of the applicant, could provide in the business title/position field: “By POA from Roger Smith, CEO.”</P>
                        <P>The applicant must upload a notarized copy of Form ID and any other required attachments to the electronic Form ID filing. The Form ID authenticating document must be attached to the electronic Form ID filing in PDF format. PDF attachments cannot: (i) be blank; (ii) be image-only; or (iii) contain active contents (Actions, embedded JavaScript, etc.), external references (Destinations, Hyperlinks, etc.), passwords, or document security controls.</P>
                        <FP SOURCE="FP-DASH"/>
                        <HD SOURCE="HD1">PART 6—DOCUMENTS</HD>
                        <FP SOURCE="FP-1">(To be completed by all applicants)</FP>
                        <P>Attach the mandatory notarized authenticating document in PDF format (Form ID authenticating document). The mandatory Form ID authenticating document must include the following information:</P>
                        <FP SOURCE="FP-1">• Signature of Authorized Individual</FP>
                        <FP SOURCE="FP-1">• Printed Name of Signature</FP>
                        <FP SOURCE="FP-1">• Title of Person Signing</FP>
                        <FP SOURCE="FP-1">• Notary Signature and Seal</FP>
                        <P>
                            Other documents to be provided with the Form ID must be attached in this part as well, including power of attorney documents. If an account administrator is not an employee of 
                            <PRTPAGE P="106229"/>
                            the applicant or its affiliates, or if the individual signing Form ID is doing so pursuant to a power of attorney, a notarized power of attorney must be attached. Do not upload documents containing potentially sensitive personally identifiable information, such as birth certificates, driver's licenses, or passports. Applicants seeking access to an existing CIK must upload documents that clearly establish their authority over the company or individual whose name is currently listed in EDGAR on the existing CIK account. For more information on documents that may need to be submitted with the Form ID application, see Volume I, section 3, of the EDGAR Filer Manual.
                        </P>
                    </APPENDIX>
                </SUPLINF>
                <FRDOC>[FR Doc. 2024-30494 Filed 12-19-24; 4:15 pm]</FRDOC>
                <BILCOD>BILLING CODE 8011-01-P</BILCOD>
            </RULE>
        </RULES>
    </NEWPART>
</FEDREG>
